State of New Jersey
OFFICE OF ADMINISTRATIVE LAW
INITIAL DECISION
OAL DKT. NO. BDS 10905-99S
AGENCY DKT. NO. --
DAVID SAMSON, ATTORNEY GENERAL OF
NEW JERSEY,
Complainant,
v.
LANCE L. GOOBERMAN, M.D., AND
DAVID BRADWAY, M.D.,
Respondents.
____________________________________
Douglas J. Harper, Deputy Attorney General, for complainant (David Samson, Attorney
General of New Jersey, attorney)
John S. Sitzler, Esq., for respondent Lance L. Gooberman, M.D.
Michael E. Riley, Esq., and Irwin L. Lifrak, Esq., appeared for respondent David
Bradway, M.D., during the hearings (Riley & Lifrak, attorneys); David Bradway,
M.D., filed a pro se brief1
Record Closed: June 19, 2002
Decided: November 15, 2002
BEFORE JEFF S. MASIN, ACTING CHIEF ALJ:
On October 1, 1999, the Attorney General of New Jersey (hereinafter referred to as either
“Attorney General” or “complainant”) filed a complaint with the New Jersey State Board of
Medical Examiners (“Board”). The Complaint alleged that between 1995 and 1999 respondent
physicians Lance Gooberman, M.D., (“Gooberman”) and David Bradway, M.D., (“Bradway”)
engaged in acts of gross malpractice, repeated gross malpractice, professional negligence,
professional incompetence and professional misconduct, in violation of their professional
1
Dr. Bradway relieved his counsel following the conclusion of testimony on the last day of hearings. He filed a pro se brief and summation.
NEW JERSEY IS AN EQUAL OPPORTUNITY EMPLOYER
OAL DKT. NO. BDS 10905-99S
responsibilities and in derogation of N.J.S.A. 45:1-21 (b) (c) and (e). The respondents filed
answers to the initial complaint. Thereafter, an amended complaint was filed on June 22, 2000,
and a second amended complaint was filed on December 19, 2000.
A Third Amended
Complaint was filed on August 23, 2001. A Fourth Amended Complaint was filed on February
28, 2002.
The Board determined that the case constituted a contested case and transferred the initial
complaint to the Office of Administrative Law (“OAL”) on December 17, 1999, pursuant to
N.J.S.A. 52:14B-1 to –15 and N.J.S.A. 52:14F-1 to –13. Extensive discovery followed the
transmittal, motions were filed and rulings were made. Hearings were held on thirty-six dates
between January and August 2001. Following completion of the hearings, the parties filed
briefs, the last of which was received on June 19, 2002, on which date the record closed. Due to
the exceedingly complex nature of this case, the massive record and the substantial time
commitments of this judge to administrative responsibilities as Acting Director of the OAL, it
has been necessary to obtain several extensions of time for the filing of this initial decision.
Additionally, on October 9, 2002, counsel for Dr. Gooberman filed a motion to reopen the record
to allow the introduction of additional evidence regarding a recently released study of UROD.
2
The response to that motion was filed on October 25, 2002. On November 1, 2002, I notified
counsel by a letter Interlocutory Order that the motion was granted, but that the admission would
be limited to the document, without any additional testimony.
The Complaint
Ultra Rapid Opioid Detoxification
The central focus of this case is the method of treatment that the respondent doctors
employed between 1995 and 1999 for the detoxification of approximately 2,350 persons addicted
to opiates.3 4 Since at least 1995, Dr. Gooberman, later joined by Dr. Bradway, has employed a
procedure referred to as Ultra Rapid Opiate Detoxification, known as “UROD.” This procedure
involves the placement of a person addicted to either heroin (diacetyl morphine) or methadone
2
McGregor, Ali, et al., A comparison of antagonist-precipitated withdrawal under anesthesia to standard inpatient withdrawal as a precursor to
maintenance Naltrexone treatment in heroin users: outcomes at 6 and 12 months, Drug and Alcohol Dependence 68 5-14 (2002).
3
Opioids are a generic class of drugs; opiates all come directly from the poppy plant. All opiates are opioids.
4
The respondents and the Board have entered into a consent order, pursuant to which the respondents have ceased providing UROD in New
Jersey, pending the outcome of the present hearings.
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under general anesthesia, followed by the introduction into the patient of several drugs that are
antagonistic to opiates (hence termed “antagonists”), as well as the implantation under the
patients’ skin of a pellet containing the drug naltrexone, which is itself an opiate antagonist.
Between the two respondents, they have performed nearly 2,350 UROD procedures, reportedly
accounting for roughly a quarter of the reported UROD procedures performed throughout the
world as of 1999. In the UROD procedure, antagonist drugs are employed to block the opiates
from attaching onto, and thereby affecting, the mμ receptors located on cells in the locus
coeruleus region of the brain, so that opiates such as heroin cannot affect the patient. According
to the theory behind the treatment, the antagonists introduced during the procedure by
introgastric tube place the patient into immediate withdrawal, as the antagonists “knock off” any
heroin already affecting the receptors.
These antagonists are effective in the short term,
operating for a period of several hours.
Experience demonstrates that persons seeking to
withdraw from opiates often cannot carry through with an opiate withdrawal, at least in
substantial part due to its severe physical and concomitant psychological effects during the first
extreme portions of the withdrawal process. Therefore, the theory behind UROD is that the
initial use of antagonists administered while the patient is anesthetized will allow the addicted
patient to go through the early extreme portion of the withdrawal process in an accelerated
manner while under general anesthesia. This allows the patient to avoid a conscious experience
of the most difficult portion of an altogether unpleasant process, thus giving the patient a better
opportunity to carry on with the withdrawal and reach a stage where he or she is hopefully able
to continue to refrain from opioid use.5 The naltrexone pellet is implanted to provide a longerterm block, reportedly lasting up to sixty days.
UROD is a variation on a procedure known as Rapid Opiate Detoxification (“ROD”).
ROD has generally been performed in a hospital or other medical facility and has involved an
overnight stay. The “Ultra” aspect of the Gooberman procedure is that it is performed while the
patient is anesthetized. In Gooberman’s method, UROD is an outpatient procedure and the
patient is released to the care of a “caretaker” and is generally not retained overnight in any
treatment or monitoring facility, be it a hospital or outpatient care facility6.
The Charges
5
6
More will be said later as to the need for post-withdrawal follow up in order to continue an abuser’s path to continued abstinence.
Generally, the caretaker is a family member, significant other or friend, and on occasion, a person paid to serve in that capacity.
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The Complaint alleges that “UROD/ROD is neither a medically established nor
recognized” treatment for opiate addiction.
According to the Complaint, it is instead a
“relatively new, highly controversial procedure,” which has not attained approval or acceptance
from any governmental or professional body and is not recommended by such groups. The
Complaint quotes from a 1996 unofficial report of the National Institute on Drug Abuse
(“NIDA”), which contends that UROD “is currently without ethical, medical, scientific or
financial justification as a clinical detoxification treatment.” Further, if UROD is subsequently
proven safe and effective with rigorous scientific investigations, it might have limited use in the
treatment of “extremely high risk patients.”7 The Complaint acknowledges that UROD/ROD is
provided in the United Kingdom and in some other portions of the United States, but asserts that
where it is performed, the procedure involves the presence of an anesthesiologist and patient
retention overnight with the availability of appropriate critical care physicians. The Complaint
asserts that the methods utilized by Drs. Gooberman and Bradway deviated from these
characteristics and instead involved the discharge of patients who were seriously limited in their
ability to walk, talk, communicate, care for themselves, breath properly, etc., and who were
released to the care and supervision of untrained and unsupervised family or friends (the
“caretakers”) who took the patients to a hotel or a residence that same day. This procedure
reportedly placed these patients in a dangerous situation that has, in fact, either directly or
indirectly caused or contributed to the deaths of seven patients (hereinafter referred to as the
“mortalities”) within a period of between approximately six and one-half hours up to seventyone and a half hours following discharge, and the need for emergency hospital treatment for
“dozens” of patients, of whom the complaint specifies only two specific patients (the
“morbidities”).8 The Complaint claims that the mortality and morbidity experience demonstrates
that as employed by Gooberman and Bradway, the UROD procedure constitutes “a clear and
imminent danger to the public’s health, safety and welfare.” Further, it alleges that the doctors’
employment of UROD involves deviations from the accepted standards of medical care existing
7
This contention has been included in each of the several amended versions of the Complaint.
The parties agree that the mortality rate for the respondents’ UROD patients was .03%. This calculation only deals with the seven deaths that
the Attorney General charges resulted directly or indirectly from UROD; any deaths of their patients that may have occurred at any time for other
reasons are not included and are not relevant to this case. It should also be noted that Dr. Herbert Kleber testified that the annual death rate
among heroin addicts is between 2 and 4%. It also must be noted that, while the Complaint alleges that “dozens” of patients have required
emergency room treatment and/or hospitalization within 24 hours after receiving UROD, the Complaint only identifies two such “morbidity”
cases. While, as will be discussed, the reference to “dozens” of such patients going to emergency rooms was drawn from an answer given by Dr.
Gooberman at a Board hearing, in terms of any attempt to determine whether the doctors’ treatment of such individuals presents issues of
negligence, malpractice and incompetence, the generalized statement about “dozens” of morbidity cases is, by itself, entirely unenlightening. Dr.
Gooberman’s explanation for the quote, discussed in the body of this opinion, may or may not accurately reflect the actual patient experience.
However, except for the evidence presented as to Messrs. Perez and Hendrix, who are the two persons identified in the Complaint, and the
doctors’ testimony about patients who went to emergency rooms seeking removal of the opiate blocking naltrexone pellet, apparently because
they desired to use heroin, the Attorney General has not presented any evidence to support the fact or the implications of the charge that “dozens”
8
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in the medical practices of addiction treatment and anesthesiology, and the regular occurrence of
gross malpractice, negligence and professional misconduct. More specifically, the Complaint
lists twenty-one deviations from the accepted standards of these two professional disciplines.
The details of these allegations will be explored in the body of this opinion, but in order to allow
a better understanding of the detailed expert testimony offered by both parties, these alleged
deviations are set forth here as reported in the Complaint.
As to Addiction Medicine
a. The implantation of a Naltrexone pellet without knowing by
objective data the duration of action of the antagonist provided
under the circumstances and how much heroin or other opiates are
blocked on a daily basis.
b. The failure to affirmatively arrange for post-detoxification
counseling as an essential component of rehabilitation.
c. The failure to properly establish inclusion and exclusion criteria
for those patients undergoing the procedure.
d. The failure to distinguish between those patients for whom
alternative forms of detoxification would be appropriate.
e. The failure to clearly and appropriately identify death as a risk
factor in the informed consent form signed by patients.
f. The creation and implementation of a complete waiver of
patient confidentiality including, but not limited to, an
acknowledgement of the right in Dr. Gooberman to publicize
medical data and treatment provided to the patient within the
public media. Said waiver, when viewed in relation to Dr.
Gooberman’s media (billboard) advertising stating the procedure
offered is confidential, is both a deviation from accepted standards
and a deceptive and misleading practice.
g. The failure to adequately provide for patient aftercare with
appropriately trained health care personnel.
h. The establishment of an aftercare, post-discharge protocol which
contemplates non-physicians prescribing or dispensing multiple
medications in response to patient complaints without prior
consultation with a physician.
of serious “morbidity” cases existed. On several occasions during the hearing, this judge noted this deficiency in the proofs, but no others were
identified by name or by evidence.
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i. The use of fentanyl transdermal patches, which were not
established as either a necessary or appropriate drug within the
UROD/ROD procedure provided by respondents which
accordingly introduced an experimental risk into said procedure
without appropriate patient consultation and informed consent.
j. The failure to provide safe and effective procedures and
personnel to ensure safe and effective patient recovery and
continuation of appropriate addiction treatment.
k. The creation and implementation of what effectively was an
experimental procedure without adequate disclosure of the
experimental nature to patients and without obtaining their
informed consent.
As to Anesthesiology
a. The administration of ketamine, midazolam and propofol on a
manner in which doses were not related to the patient’s weight as
well as titrated to the patient’s response to the drug.
b. The administration of anesthetic agents so as to produce
unconsciousness during a highly stressful period without
appropriate knowledge of the effects of said drugs and their
interactions with other drugs administered.
c. The failure to adequately preoperatively assess patients’ cardiac,
respiratory, hepatic, and renal systems to determine their ability to
tolerate the exceptional stresses of the UROD/ROD procedure.
d. The administration of fentanyl in a fashion such that the
procedure was rendered investigational or experimental in nature
without appropriate patient disclosure and consent.
e. The simultaneous provision of a procedure which is the medical
equivalent of general anesthesia in an outpatient setting for as
many as six patients through CRNAs and critical care nurses
subject to overarching medical supervision by a non
anesthesiologist and without the presence of a critical care
physician.
f. The failure to provide adequately for the management of
possible anesthesia emergencies such as difficult airways.
g. The failure to provide safe and adequate care post discharge
through adequately trained health care professionals and
appropriate safeguards.
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h. The premature discharge of patients.
i.
The establishment of a protocol and practice which
contemplates non physicians, namely critical nurses, receiving
telephone calls from care givers and deciding whether additional,
or different, medications should be prescribed based on presented
symptomatology without prior physician consultation.
j. The failure to provide safe and adequate post discharge
procedures and personnel to ensure safe and effective patient
recovery from anesthesia and detoxification procedures.
EVIDENCE
The complainant presented testimony from a series of family, friends and domestic
partners of the seven patients who died within a short time of undergoing the UROD procedure,
as well as from family members of two patients who required hospitalization after undergoing
UROD and who survived.9 Each of these witnesses accompanied a particular patient to Dr.
Gooberman’s Merchantville facility and was with the patient in the hours after his or her
discharge. For the decedents listed below, information is provided regarding the date of their
UROD treatment, the time of discharge and date and time of death, cause(s) of death attributed
by the medical examiner/coroner and information included in the toxicological report rendered as
to each. In addition, as to each, some pertinent information presented in the testimony of the
particular loved one, friend, etc., and other witnesses, is included. Additional facets of these
persons’ testimony, touching on subjects such as informed consent and aftercare, will be
presented later in this opinion, as well as other pertinent material.
While these comments regarding each of the decedents touch on the caretaker and
decedents’ or other patients’ experiences with the respondents and with UROD, and while
additional specifics will be addressed during the course of this opinion, as a general matter, a
history of each person’s experience can be summed up thusly. The patient and those with whom
he or she traveled arrived at the Gooberman office in Merchantville, New Jersey at around 7:00
A.M. on the day of the appointment. After meeting with a representative of the office and also
with either Dr. Gooberman or Bradway, and signing a Consent to Treatment form usually
9
At the specific request of their caretakers, the Attorney General requested that the identities of two of the patients be protected. This request
was granted, without objection.
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witnessed by the accompanying caretaker, the patient went to an inside area for treatment. The
caretaker was given an approximate time to expect the patient to be recovering from the
anesthesia and was given a number of prescriptions for injectible medication and for pills
(prefilled sandostatin syringes, trazodone, clonidine and/or baclofen). These prescriptions were
in each case filled at the Towne Pharmacy down the street from the Gooberman office, each
filled during the time that the patient was undergoing the procedure. In each instance, the
caregiver and any other accompanying person(s) returned to the office in the early to midafternoon. They each observed the patient to be very weak, sleepy, unsteady and unable to walk
without support. In each case, after a period of time during which they waited for the patient to
be released to them, they left the facility, with a set of written instructions, to take the patient to
either a local hotel/motel or to a private residence, generally either the patient’s or the caretaker’s
or that of another relative. In each instance the description of the condition of the patient during
the car trip and then afterwards in the motel room or at the residence is largely similar. The
patient remained weak, had difficulty speaking, experienced difficulty breathing, was unable to
walk without significant support, had to be assisted to the bathroom, vomited quite often and
often suffered projectile vomiting and had substantial diarrhea. The general pattern of events
was such that the caregiver(s) were extremely concerned about the condition of the patient and at
some point called the doctors’ office for assistance. In some instances these calls produced visits
to the patient by someone from the doctors’ office, at other times assurances that the pattern of
difficulties observed by the caregiver was “normal” and that the patient would be all right.
Eventually, the patient either expired in the home or the motel room, or was removed to a
hospital where death occurred. In each instance, the caregivers testified that they never gave the
patient any illicit drugs after the procedure, never saw the patient take any illicit drug and did not
give or observe the patient to take any prescription medication not prescribed by the doctor or his
office. The caretakers each claimed that the patients were so weak and unable to function that
they could not have taken any illicit drug, even during the short, although in some cases longer
periods, when the caregiver did not have the patient in his or her sight.
1) G.W., 40 years old, was treated on September 29, 1995. Mr. W. left the Gooberman
facility at approximately 11:30 A.M. that day and died at 8:11 a.m. on October 2, 1995, some
sixty-eight hours and eleven minutes after discharge. According to the postmortem report
prepared by the Chester County, Pennsylvania Coroner, the cause of his death was “acute
necrotizing pneumonia.” The report lists “diagnoses” as acute necrotizing bacterial pneumonia,
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acute pulmonary edema and congestion, acute superficial gastric erosions, moderately
pronounced mucinous degeneration of the anterior mitral leaflet and a history of heroin abuse.
The toxicological report lists blood concentrations of Phenobarbital, diazepam and temazepam.
Jean B., who was the domestic partner of Mr. W., had lived with him for seven years as
of the time of his death. Beginning in 1991, he was affected with chronic continuous migraines
several times a week and could not obtain any medical relief from the severe pain. Ms. B.
reported that, as a result, “we turned to heroin” and W. became addicted to the drug. He used it
for about one and one-half years before he died. He also had used cocaine before 1993 on an
irregular basis, as well as marijuana, although she claimed that he had stopped these drugs before
he started to use heroin.
According to Ms. B., by 1995, Mr. W. was in “poor health.” After four and one-half
years of frequent migraines, he could not sleep or digest his food well, and seemed to be
degenerating. He had no physician care in 1995. He decided to go “cold turkey,” but his three
or four attempts failed. He felt that because of the incessant pain he had to have heroin in order
to function. She attempted to obtain methadone for him, but there was no clinic nearby. They
then saw Dr. Gooberman on television, talking about his detoxification procedure.
Ms. B. testified that after going with Mr. W. to the Gooberman clinic on September 29,
1995, she first was permitted to see Mr. W. at the clinic at about 11:00 a.m., after the UROD
procedure was completed. He was lying face up on the table. She assumed that he was
“sleeping off” the anesthesia. She spoke to Dr. Gooberman before W. was discharged. He
advised that the procedure was completed, but that W. was having some difficulty, was vomiting
and was not recovering as rapidly as usual from the anesthesia. His bed was needed for another
patient and he was moved down the hall to another bed. He was discharged to her care in midafternoon. She recalled that he was unable to stand, even if assisted and a staff member “half
carried him” into the visiting area. He was “very groggy,” not fully conscious. B. spoke to
Gooberman about what to do, as, in B.’s description, W. was not reviving properly. The doctor
offered to put them up in a motel overnight so that he could continue to treat W. By 5:00 p.m.
they were at the motel. His status had not changed noticeably. She “nearly had to drag him into
the room.” He was put in bed. Later that evening, Gooberman stopped by the room. She cannot
recall if he had given her any medications earlier that day. At the time of his first visit to the
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room that evening, Gooberman supplied her with suppositories and instructed her how to use
them. He also administered something, but as W. could not swallow, she cannot recall how he
did that. The doctor remained for about ten to fifteen minutes and, after waking W. to see how
he felt, Gooberman left, indicating that he would return in the morning. Gooberman came to the
room either that one time, or perhaps a second time, that evening.
When W. awoke the next morning his condition was nearly the same, although he was
“more awake” and for longer, but not considerable, periods. He was also in great pain. His
breathing was “convulsive,” and she heard “rasping in the lungs.” Most of the time he slept and
was unresponsive to her. She does not recall if he was nauseous and vomiting.
Gooberman came to the room again on September 30, this time accompanied by another
doctor, whom the parties stipulate was Colin Brewer, a practitioner of UROD from London,
England, who was visiting with Gooberman at that time. Gooberman may have given her
medications for W. at that visit, but she does not recall giving W. any medications. During the
course of that day, his condition “improved and deteriorated.” He was awake for longer periods,
but she heard what sounded like fluid in his chest. She spoke to Gooberman, as she was greatly
concerned that W. did not seem to be showing significant signs of improvement and he was in
pain during the few occasions when he was awake. According to the witness, Gooberman
expressed to her his unwillingness to continue to treat W. He “advised her that she had to take
responsibility for W.,” but “she did not know how.” She insisted that Gooberman continue to
treat. He agreed to pay for one more night in the motel, but advised that he would not be
returning to see W. He suggested that they return home and go either to a doctor or to a hospital.
Their home was two hours away. It is possible that Gooberman did return later that evening with
medications, but she is not certain about that.
W. remained in essentially the same condition the rest of the day.
She gave W.
Phenobarbital suppositories that night, medication that Gooberman had supplied. They departed
the motel at 11:00 a.m. on October 1. She “carried” W. out to the car. They returned home,
arriving at about 1:00 or 2:00 p.m. She put him on a sofa bed and stayed with him. He was able
to take some fluids, but was not able to walk. She does not recall if Gooberman called or if she
called him. W. stayed awake more often and for longer periods. She told W. that she was
concerned that he was having symptoms precursory to pneumonia. She wanted to take him to a
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hospital, but apparently because both of their families had “horrendous” experiences with
hospitals and “Western medicine” had failed him for four and one-half years in helping him with
his problems, he was “confident” that a hospital “would only make things worse.” He was
unable to get out of bed or to bring up phlegm. Most of the time, he was unresponsive.
On October 2, W. was still in bed, unable to sit and experiencing “jerky” breathing. He
was able to take some fluids, and still refused to go to a hospital. B. cannot recall if there was
any contact with the Gooberman office. Later in the day, W. was not “responsive most of the
time,” but at about 7:00 p.m. he was responsive and said that for the first time he felt like
himself. She thought that they could make it through on their own. She went into the kitchen
and about five minutes later found him completely still on the sofa bed. He was not breathing
and after several cycles of CPR, during which some dark fluid came out, she was convinced that
he was dead. An ambulance came, but the technicians were unable to revive him.
Ms. B. denied that she gave W. any drugs other than those prescribed by Gooberman
after W. was discharged. He could not get out of bed to secure any himself. There were none in
the living room. She was with him “nearly around the clock.”
2) Frank Stavola, 43 years old, underwent the procedure on December 23, 1996. He left
the facility at about 3:30 p.m. and died that same evening at 10:07 p.m. at his parents’ home.
The Monmouth County Chief Medical Examiner originally reported the “diagnosis” as cerebral
edema, pulmonary congestion and edema, status post treatment in a detoxification center
including sandostatin, trazodone and clonidine, obesity, hepatosplenomegaly and bilateral
hydroceles. He later changed the cause of death from “pulmonary and cerebral edema due to
pending further examination” to “pulmonary and cerebral edema due to drug use (morphine,
cocaine, fentanyl and nordiazepam).” Microscopic diagnoses were cerebral edema, pulmonary
congestion and edema with focal anthracosis, early cirrhosis with fatty change and chronic
persistent hepatitis, minimal focal myocardial fibrosis and tubular necrosis.
Mr. Thomas Raffield, who became a good friend of Mr. Stavola’s after they originally
met through a business relationship, learned of Stavola’s heroin addiction in the late 1980’s.
Stavola never spoke of cocaine. Several “cold turkey” detoxification attempts were made over a
period of about six years. Raffield had seen a documentary on UROD as practiced in England
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and later saw Gooberman’s billboard on McCarter Highway in Newark. He accompanied
Stavola and Stavola’s father to the Gooberman clinic.
When the men returned to the clinic at about 2:00-2:30 p.m., they first saw Frank in a
bed, in a fetal position. He appeared unconscious. They tried to talk to him, but he did not
respond. A “rattling” sound was heard, “like a lot of phlegm.” Told that he was doing “alright,”
and that the “process was ongoing,” the men returned to the waiting room. Another person in the
waiting room waiting for her boyfriend to finish his treatment saw people walking Frank around,
wearing a diaper. They then saw him several times, but he seemed unconscious. While there
was “no significant change,” he was nevertheless discharged at about 3:30 p.m. He was dressed
and wheeled to the car where he could not get in himself and had to be placed in. He could not
stand unassisted. His responses to them were grunts and groans. The rattling sound continued.
The three men drove to Frank’s parents’ home in Atlantic Highlands. His lungs sounded
as if he was gurgling, as if they were wet. Asked how he was feeling, he made virtually no
response. He did make a “smart remark” about some comment that someone in the car made
about signs on the road, and they were glad that he was coming around. Otherwise, he appeared
to be sleeping the whole time.
They arrived at the house at around 5:00 p.m.
He was
unresponsive and could not walk by himself. They took him upstairs and put him in bed. He did
not speak. He was sweating very heavily and his breathing was labored.
Mr. Raffield was present at the parents’ home for a part of the time that Stavola was there
following their return from the Gooberman clinic, and while there, he neither gave drugs to
Stavola or saw him take any.10 He has no way of knowing if Stavola took any drugs while he
was not in his presence. When he returned to the house later that evening, Frank’s mother said
that she did not think that Frank was doing very well. They called Gooberman’s office and
spoke to someone, telling that person that Frank was non-responsive. Told that a Christmas
party was going on, they cursed at the person on the phone and Gooberman got on the line
immediately. They told him about the rattling and sweating. He told them to get him into a
standing position and he would cough up the phlegm. He also told them to give him a shot.
When they got him up, he vomited. They told him to hang on and he would be okay, but when
they came back to him, he was not breathing and had no pulse. While they waited for the
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emergency services to arrive in response to a 911 call, Raffield, who had military training in first
aid, tried CPR for twenty minutes without success.
3) Mark Beigelman, 31 years old, was treated on March 12, 1997, released after 2:00
p.m. and died that same day at 11:40 p.m. Dante Ragasa, M.D., the medical examiner for the
Burlington County Medical Examiner’s Office, originally listed the cause of death as “visceral
congestion” and the “manner of death” as “pending studies.” He later amended the cause of
death to “multiple drug intake, post detoxification therapy.”
The amended diagnosis was
cardiomegaly (400 grams) with biventricular dilatation and focal fatty infiltration of
myocardium, no arteriosclerosis nor infarction, mild visceral congestion, status post
detoxification therapy, with toxicology findings of non-lethal levels of heroin, cocaine
metabolite, naloxone, naltrexone, fentanyl, methadone and ketamine.
Mr. Beigelman’s mother testified that sometime before March 1997 she learned that her
son, who lived with her, had an addiction to heroin. He admitted only this addiction, and
reported no addiction to any other drug. He went to a methadone clinic for a couple of months,
but told his parents that he wanted to stop using drugs altogether. He learned of Gooberman and
eventually went to him. After he was discharged, the family went to a motel in Mt. Laurel. He
was eventually transferred to a hospital where he expired.
Describing her observations when she first returned to the Gooberman clinic at about
3:00 p.m. following Mark’s UROD, Mrs. Beigelman recalled that Dr. Gooberman came out to
her and told her that Mark was “okay.” When she went inside to see him, he was asleep in bed,
with tubes attached. When she touched him, he was very cold. She returned to the waiting room
and later he was brought out. He looked “terrible,” sweaty and very shaky. He did not speak,
and his breathing was very hard. He sat in the waiting room and she tried to speak to him, asking
how he felt. He replied that he was very cold and had pain in his body, especially his legs. He
could not stand up by himself and instead he lay flat on the couch. He was supported under each
arm and they placed him in the car. She sat in the back with him and they went to a motel, which
the parties stipulated was located in Mt. Laurel. While at the motel, Beigelman felt very bad,
cold, sweaty and with continued pain in his leg. They were able to get him into a first floor room
and into bed. He had to be assisted to the bathroom.
10
Mr. Raffield had to leave the house for a while to go to his home in Cranford, as Stavola’s parents had asked that he spend the night at their
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In the motel, Mr. Beigelman experienced nausea and vomited something very dark. In
the very early evening, his mother called Gooberman’s office. At a point, she heard a gurgle and
told her husband that they had lost their son. The police were summoned. He was removed to a
hospital, where Gooberman came as well.
4) On April 16, 1998, M.J., 44 years old, underwent the UROD administered by Dr.
Bradway. He was released at about 2:30 p.m. and died at his parents’ home before 8:30 a.m. on
April 17, 1998. Manual A. Bergnes, M.D., pathologist located in Jeffersonville, Pennsylvania,
performed an autopsy. He did not list a cause of death in his report, pending the receipt of a
toxicology report. He did note an anatomical diagnosis of severe acute pulmonary edema, mild
myocardial hypertrophy with ventricular dilatation, recent implantation of subcutaneous
‘capsule’ in left lower abdominal quadrant, and vascular congestion of abdominal viscera. The
toxicology report listed findings of fentanyl, naltrexone, and β-Naltrexol in the blood.
Mr. J.’s mother testified that she had known of his addiction to heroin since 1978.
Besides heroin, Mrs. J. was aware that he had “tried” everything, possibly including Xanax. She
did not believe that he was addicted to cocaine. Several times he detoxified “cold turkey” at her
home. He would “succeed,” then attend NA meetings, but ultimately would relapse. In 1996, he
suffered a stroke. In 1997, he detoxed at an inpatient facility in California. His insurance paid
for nineteen of what were supposed to be twenty-eight days in-patient.
In 1998, Mr. J. saw a billboard advertising Dr. Gooberman’s services and arranged to
receive UROD. His mother, having unpacked his luggage at their home the night before the
procedure, denied that he used heroin that night, although she did not know if he used prior to
coming to her home that evening.
Describing what occurred when she and her husband returned to the clinic at 11:30 p.m.,
Mrs. J. noted that her son was not yet ready for release at that time. At about 12:30 p.m. he was
brought to the door of the waiting room, with one person supporting him under each arm. His
lips were very swollen. He mumbled rather than talked, saying that that he was “okay.” To his
mother he did appear to be “okay.” J. was walked around for a while and was periodically
home with Frank. The parents were also present at the house.
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brought out to his parents, each time supported. He never walked on his own. At times, he
appeared extremely tired. She could hear comments coming from the recovery area, such as,
“Come on M., get up.” At 2:30 p.m. he was presented to his parents in a wheelchair, supposedly
ready for discharge. A male attendant told her husband to bring the care around and the
attendant placed M. in the front seat. He seemed “alright,” and they went directly home. In the
car he slept on and off and said things such as, “Tell my brother R. never to do this.” R. did not
use drugs. M. drifted “in and out.”
The family arrived home at about 3:30 p.m. M.J. could not walk on his own and his
parents supported him and took him upstairs. He could not undress himself and was exhausted.
He was starting to communicate, but was very tired. He complained about a pain in his stomach
and began to vomit by 4:00 p.m. After he was given clonidine, he began to experience “huge,
projectile vomiting,” all over the bed, walls, and rugs. He did this three to four times. He
complained of stomach pains in between these sessions of vomiting. She gave him sandostatin
injections as per the instructions she had received at the clinic. He was twitching, was nervous
and very uncomfortable, with back pain as well. His lips were blue and he coughed and
experienced difficulty breathing.
At 10:15 p.m., Dr. Bradway called and Mrs. J. described exactly what had happened. He
told her that everything was under control. He told her to give him oral trazodone, but he
vomited it up immediately. She then went to bed, thinking he would be calm, but fifteen to
twenty minutes later he called out, “Mother, mother.” He was sitting up, his hands held out, red,
hot and enormously swollen. He had extreme difficulty breathing. She called Bradway, but did
not get him immediately. She perceived that this was a crisis and repeated her call to Bradway,
not knowing what to do. Bradway called at 11:20 p.m. She told him that M. was coughing
terribly, his lips were purple and he was having trouble breathing. Bradway told her that perhaps
he was hyperventilating and that she should get a bag and asked if they had an inhaler in the
house, but she could not find one. As her husband took the phone, she held M., who lapsed into
unconsciousness. She called 911. As she knew CPR, she started to try to resuscitate him. She
heard gurgling in his chest. He died in her arms. EMTs arrived at about 11:45 p.m.
5) Lester Kindig, 50 years old, was treated on July 2, 1998, released that afternoon at
4:00 p.m., and died on July 3, 1998, at 12:17 a.m. Dr. Robert Segal, the Chief Medical Examiner
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for Camden County who also served as an Assistant Medical Examiner for Burlington County
and was on duty at the time of Mr. Kindig’s death, listed the cause of death as “adverse reaction
to drugs and rapid opiate detoxification.” His pathologic diagnosis was “rapid detoxification of
methadone and heroin addiction using general anesthesia and multiple medications, acute opiate
intoxication with morphine, methadone and Fentanyl in the blood, bilateral pulmonary
congestion and edema, pleural adhesions . . . .” The toxicology report rendered by Chief
Toxicologist Reng-lang Lin, Ph.D., of the New Jersey State Toxicology Laboratory, lists ethanol,
nordiazepam, morphine (free), diazepam, methadone, fentanyl and lidocaine in the blood.
Jan Klein, Mr. Kindig’s fiancée, met him in 1978. At some point in time she became
suspicious that something was wrong and although he first denied that there was a problem, in
1994 he acknowledged that he was addicted to heroin. She observed him injecting heroin. In
fact, he had been a heroin addict in the early 1970’s and had quit. Although she was aware that
at times he took valium for blood pressure problems, she did not see him taking it when he was
using heroin and she claimed that she never learned that he was using any other illicit drugs.
However, on cross-examination she acknowledged that at one time earlier in their friendship she
was aware that he used cocaine, “recreationally.” He tried to quit heroin himself and went to
London to undergo the detoxification program offered by the Center for the Investigation and
Treatment of Addiction (“CITA”). After a period of rehabilitation, he relapsed in late 1997.
After she confronted him, he tried to quit “cold turkey” several times. He never was able to get
past the first two and one-half to three days.
Mr. Kindig was told about Gooberman by friends who had seen him on television and he
then saw the doctor on television as well. Kindig came to New Jersey with Klein and a friend of
his, Mr. G., who was also coming to be detoxed. On the morning of the UROD, Kindig injected
heroin in the hotel where they stayed. She did not know whether anyone at Gooberman’s office
had told Kindig to use the drug before the procedure. He flushed his remaining heroin down the
toilet in front of her before they departed for the office, saying, “it’s out of my life now.”
Ms. Klein returned to the clinic at about 2:10 p.m. Another patient’s wife told her that
they had Lester up walking about a half hour earlier. When she went back to see him he was
lying on a gurney in his clothes. She tried to talk to him but he was agitated and did not want to
talk to her. He was tired and sleepy and said that he was cold. She stayed with him until about 3
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p.m. when he was taken to the car. She did not see him walk at any time; he just lay on the
gurney.
When it was time to go to the car, they got Mr. Kindig into a wheelchair and tried to talk
to him periodically, but he did not want to be bothered. They managed to “scoot his butt’ into
the car and once Mr. G. was also down at the car, they returned to the hotel. During the trip,
Kindig was listless, “like a zombie.” He kept saying “too soon” and that it was not like the “first
procedure,” presumably a reference to the London experience. In response, Klein told him that
“they were the doctors” and “this is it.” G. was either half asleep or passed out. Neither man
could speak clearly. With the assistance of Mike Bortnicker (known as “Big Mike”), a former
dialysis technician, gym instructor and former addict who was an associate of Dr. Gooberman
and who sometimes served as a paid caretaker, she managed to get Kindig out of the car. Klein
and Bortnicker leaned Kindig against the wall and assisted him to the elevator and into the room
at about 4:00 p.m. G. was placed in the next room. Placed in the bed, Kindig simply wanted to
be left alone. Up to this time no medications were given. While in bed, Kindig called her
several times and complained that his hair and clothes smelled. He was wearing a diaper. After
she administered medication, Mr. Bortnicker told her not to run each time he called. When he
complained about being restless, Bortnicker said that she could give him two baclofen pills,
which she did. Kindig kept saying he had to spit. He seemed to settle down at around 9:00 p.m.
She did not go to sleep until later.
Nothing happened after she gave him the medications until she went to sleep on the
couch. She could observe that his stomach was rising and falling. She awoke at 8:57 a.m. She
discovered that Kindig had died.
Ms. Klein denied that, other than the prescribed drugs, any drugs or alcohol, were given
to Kindig after he was discharged.
6) Victor Melendez, 30 years old when treated on May 26, 1999, was released at 2:55
p.m. and died on May 29, 1999, at 2:25 a.m. The autopsy report was prepared by Dr. Yvonne I.
Milewski of the Office of the Chief Medical Examiner of the City of New York. She listed the
cause of death as persistent nausea, diarrhea and vomiting, with ulcerative esophagitis, gastric
ulceration, gastrointestinal hemorrhage, mediastinitis and dehydration; and new onset
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generalized seizures and hyperpyrexia complicating rapid opiate detoxification. An “additional
factor” listed was hypertensive heart disease. Dr. Milewski listed several final diagnoses. These
included: chronic intravenous drug abuse/opioid dependence, with a history of methadone use of
300 mg. daily for two years; post-abdominal wall implantation of naltrexone pellets; partial tear
(microscopic) of esophageal muscularis and extensive acute hemorrhage of paraesophageal and
mediastinal soft tissue consistent with esophageal tear and mediastinitis; marked dehydration
with pre-renal azotemia and cardiovascular instability characterized by persistent tachycardia,
hypertension, episodic bradycardia/electromechanical dissociation and ventricular dysrhythmias
and ulceration of the epiglottis. She also noted that Melendez had marked steatosis, focal
hepatocellular necrosis, inflammatory and portal changes consistent with alcoholic liver disease
and hypertensive heart disease with left ventricular hypertrophy (heart weight 450 grams) and
left ventricular interstitial and perivascular fibrosis, and was asthmatic. The toxicology report
lists methadone, diazepam, trazodone, and metabolites of methadone in the blood and
methadone, amphetamines and benzodiazepines in the urine.
Mr. Melendez’ brother Anthony, a certified physical trainer, testified that he was aware
of his brother’s addiction in the early 1980’s and that he had on several occasions gone to clinics,
hospitals and rehabilitation centers, as well as going “cold turkey.” Victor had a heavy addiction
to heroin and became addicted to methadone in May 1998, obtaining his methadone on the
streets.
Anthony and other family members and Victor’s girlfriend transported Victor to the
Gooberman clinic to undergo UROD. After Victor went in for the treatment, Mr. Melendez left
and returned to the clinic at approximately 2:30 p.m. While in the waiting room he observed a
man come out who was unbalanced and stumbling and needed assistance to walk down the hall.
This man was wearing a diaper. When he asked if he could see his brother he was told that
Victor was still in recovery. He asked again ten minutes later and asked if he was okay. He was
told that Victor was groggy and tired. Allowed in to see him, they found him in a wheel chair
with his back to Anthony. When Anthony circled the chair, he saw that his brother did not look
like himself. He appeared very exhausted, with his cheeks sunken in. He whispered, “Get me to
a bed.” An aide said loudly, “Victor, lets go, your brother is here, they want to go home.”
Victor’s head was shaking. The aide said, “they all come out like that.” Anthony replied, “he
doesn’t look right to me.” He was advised to take his brother to a hotel. He went to get the car
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and two men picked up Victor and placed him in the car. When Victor was told that he was
going to be taken to a motel, he said in a very low voice, “This ain’t right, take me to a hospital.”
The clinic aides told Anthony not to worry, “all was going to be all right. He’ll be fine.” In the
car he was weak and trembling and kept saying that “this is not right, take me to a hospital.”
When they arrived at the hotel, they asked for a wheelchair, placed him in it and took him to the
room. He looked at them with a grin on his face and gave a “thumbs up,” “No more drugs.”
Anthony was not present at the hotel for long, as he had to go home. He returned to the
hotel the next evening at about 11:00 p.m. on May 27. He found the room a mess, with vomit all
over the sheets and lamp and high up on the walls, almost to the ceiling. Victor had a blank
stare, but was happy to see Anthony. He told Anthony, “this ain’t right.” As he had to leave for
Puerto Rico the next morning, Anthony could not stay and they left shortly after.
They
transported Victor home to his mother’s home in the Bronx, and on the ride he kept vomiting and
saying, “It hurts, hurts, stomach hurts.” He urged that they take him to a hospital at least four
times during the ride. They arrived home at about 1:00-1:30 a.m. As Victor could not walk,
they assisted him step by step to the second floor and placed him in the bed.
Sharon Gonzalez, who was Victor’s girlfriend for four years and is a certified home
health aide, testified that she was at the motel with Victor after Anthony left. Victor vomited
continuously. A phone call was placed to the Gooberman office and the family members were
told that Victor was “okay.” He kept vomiting and complaining of back and stomach pain and
cramps. Another phone call was made to the office later in the evening and a receptionist
answered. Diapers were delivered to the motel. When Victor began to throw up blood, office
personnel assured that this was due to the tube that had been placed in his throat during the
procedure and that “everything would be fine.” However, he kept vomiting until the morning.
Mike Bortnicker came to the motel at about 10:00 a.m. and stayed for twenty minutes, but Victor
would not respond to him. They told Mike that they would need more medication as they were
preparing to take Victor home. Medicine was sent to the motel by the pharmacy. Bortnicker
told them that Victor would be all right. However, he stayed about the same throughout the day,
vomiting regularly. He wanted to go to a hospital; however, the family kept telling him that the
doctors had advised them that he would be all right. When they returned home, Victor urinated
blood and they called Gooberman’s office and were again assured that he would be okay. When
he experienced fast breathing that would not slow down and his pulse was “not normal,” an
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ambulance was called. At the hospital, Victor was given ten milligrams of methadone. No other
drugs were given to him other than those prescribed by Gooberman.
Michael Bortnicker recalled that he had gone to the motel to follow up on Melendez and
found that he was sick, vomiting a lot and retching. He asked Melendez if he was okay and
Victor shook his head, but would not speak. He characterized Melendez as a “tough guy,”
neither a whiner nor a complainer, and Bortnicker did not see anything wrong with the fact that
he did not speak, although in his experience it was unusual for a patient who was awake not to
talk. Bortnicker called over to the office and advised that Melendez was quite sick. However, he
was not concerned that his life was in danger, as quite a few of the patients he dealt with were
sick after the procedure.
Mr. Melendez was eventually transported to Montefiore Hospital, where he died. Ms.
Gonzalez denied that, other than those prescribed by the respondent, Victor was given or used
any drugs after discharge. The parties stipulated that Anthony did not supply any illicit drugs to
Victor subsequent to discharge.
7) Lisa Flowers was twenty years old when treated on June 26, 1999.
She was
discharged at 11:30 a.m. and died at 5:53 a.m. on June 27, 1999, in the hospital, where she had
been taken from a residence in Toms River. Ms. Flower’s autopsy was performed by Dr. Lyla E.
Perez for the Ocean County Medical Examiner’s Office. She determined that the cause of death
was an acute myocardial infarction following rapid detoxification. She found that the decedent’s
heart had myocardial fibers that showed contraction band necrosis and lysis. In the absence of
coronary disease and given the age of the decedent, Dr. Perez concluded that the acute changes
found in the myocardium were related to the rapid detoxification. Of the drugs used in the
UROD procedure, only propofol, also known as diprivan, appeared in the PDR as causative of
ischemia and myocardial infarction; however, the cause and effect relationship was “unknown.”
The toxicology report from the New Jersey State Toxicology Laboratory lists morphine (free)
and fentanyl as found in the blood, and fentanyl in the stomach.
Jessica Martirano was a friend of Ms. Flowers. Flowers was dating Jessica’s cousin and
had a child with him, but the child died. Martirano learned of Lisa’s addiction in 1998, about a
year after the child’s death. Jessica observed Lisa using heroin.
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On June 26, 1999, Ms. Martirano and a cousin accompanied Ms. Flowers to Dr.
Gooberman’s office from Toms River, New Jersey. Flowers sniffed a bag of heroin in the office
parking lot. Martirano testified that Flowers told her that a nurse or receptionist at the office had
instructed Lisa to “come comfortable.” Flowers took this statement to mean that she should use
her normal amount of heroin so as not to come to the procedure “sick.” Flowers was just getting
over pneumonia and was an asthmatic.
The witness and her cousin returned to the clinic at about noon at about which time she
first saw Lisa, who was being discharged. She was seated in a wheelchair, appeared to be
heavily medicated, and did not talk. She could not stand by herself. Her cousin and an orderly
placed her in the car. She “looked sick” and tired. In the car on the way to Toms River, she
flipped from side to side, said that she was hot and then cold and that she had to go to the
bathroom and had diarrhea. Although Jessica did not actually see this, she was aware that her
cousin gave Lisa a shot. Lisa said that the people at the clinic were “very bad people.” She was
alternately awake and asleep.
When they returned home they got her out of the car and up the stairs. She could not
walk by herself. Once she was upstairs and was placed in a bed, she complained of nausea. She
was constantly hot, then cold and thirsty. Later that evening she appeared convulsive and her
eyes started to roll and her skin took on a different color. She seemed to breath in, but not out.
Her face was blue and she could not breathe or talk. She either slept or kicked the blanket off.
Her mother dialed 911. As instructed on the telephone they tried to turn her on her side. Lisa
vomited perhaps a pint of a dark green substance. While they waited “a long time” for the
emergency personnel to arrive, her cousin’s sister attempted CPR. Lisa was taken to a hospital.
Martirano denied that Flowers either received or took any drugs other than those
prescribed by the doctor during the time following her discharge until she was transported to the
hospital. She did not see her cousin provide any drugs to Flowers either. She also denied that
her cousin ever told her that he had advised Gooberman’s office that Flowers had ingested
twelve bags of heroin after the procedure.
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In addition to these patients, who died within at most about seventy-two hours after
receiving UROD, evidence was also presented about two patients who did not expire, but
experienced significant medical problems within a short time of receiving UROD and had to be
hospitalized as a result. These “morbidity” patients were Christopher Hendrix and Samuel
Perez.
Mr. Hendrix received UROD from Dr. Bradway on July 13, 1999. According to his
father, Chris is now thirty-five years old and hospitalized in Atlanta.
In October 1998, his father was aware of his son’s addiction to methadone. Chris wanted
to get off the drug.
He had also used heroin and cocaine.
Learning of Gooberman’s
detoxification process through either an advertisement or the Internet, Chris and his father
arranged an appointment with the doctor for UROD and journeyed to Merchantville.
Following a preliminary conversation with Dr. Bradway, Mr. Hendrix left the clinic and
returned at about 2:30-2:45 p.m. Personnel walked his son down the hallway. He was “very
pale,” “very, very weak” and could barely walk. He had to be held while going to the car. They
drove to a motel, arriving at about 3 or 3:30 p.m. Chris was too weak to respond when his father
tried to talk to him. In the car he was groggy, sleeping and did not speak. Once in the motel, he
went to bed. At about 9:00 p.m. he started to vomit. His father remained in the room with him
the whole time. Chris also had diarrhea. His father injected him three times, in accordance with
the instructions he had received earlier. He tried to give his son pills, but Chris vomited them up.
A phone call was placed to the doctor, but no call was received in response. Continued vomiting
and diarrhea occurred. By 2:00 a.m., Chris had to be moved to a different bed as the first was
saturated. Chris was sweating severely, was not speaking and seemed to be almost unconscious.
In addition, his vomit seemed to be bloody, an appearance different from that which had been
observed as late as 11:00 p.m. At 2:00 a.m., his father called the answering service, which told
him to call the office at 7:00 a.m. Vomiting continued until that hour. At 7:00 a.m., the father
spoke to Dr. Bradway, who said that he would send a staff person over to the motel.
At 10:00 a.m., someone arrived and called Dr. Bradway. The father insisted that he
needed help with his son, and Chris said “now.” The father was told to bring Chris to the clinic.
He was still almost comatose. At the office, Hendrix told the doctor that he needed fluid.
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Bradway told the father that he was going to place his son in a hospital. An ambulance arrived
and removed him to West Jersey Hospital, where he remained for seven or eight days, first in a
regular room and later in critical care. Hendrix was placed on a respirator and was given
medication through a cut under the collarbone, as they could not place I.V. lines in his veins. His
father was told that his son had aspirated vomitus and had aspiration pneumonia.
Lissette Munoz is the brother of Samuel Perez. He told her that he was addicted to
heroin, was on methadone, was very sick and needed help. In June 1999, they sought out Dr.
Gooberman’s services. Mr. Perez in now in prison.
On June 16, 1999, the witness went with her brother and other close relatives to the
Gooberman clinic.
Dr. Bradway spoke with the family prior to and then performed the
procedure. They were told that he might experience diarrhea and coughing. She can recall no
reference being made there to the possibility that her brother might have to go to a hospital.
The procedure started at about 8:30 a.m. When the family returned at about 4:30 p.m.
and saw Samuel he was “out of it” and had to be awoken. He was not able to respond to her
husband when he tried to speak to him. He mumbled and appeared drowsy. She did not see him
walking around at the clinic. He was placed in a wheelchair, taken out to the car and they then
proceeded to her house, where they had to drag him out of the car. They arrived home at about
5:00 p.m. He was placed on a mattress on the floor, undressed. He remained on the floor for the
entire night, “out of it,” mumbling and saying that he felt like he had diarrhea. In accordance
with instructions, he was given a syringe and was helped to the bathroom by her husband.
By the morning, Mr. Perez was coughing. He was given sips of water, but no other
drugs. A call was placed to Dr. Gooberman’s office at 7:00 a.m., but no one answered. Samuel
was by then coughing, producing mucous and spitting out blood. As his condition worsened and
Gooberman did not call back, her parents decided to take their son to the hospital, where he
remained for two or three weeks.
In addition to these testimonies, the respondents presented the testimony of UROD
recipients who described their experience. Morris Mizrachi, who owns his own business and has
a wife and three children, underwent UROD performed by Dr. Gooberman in March 1997. He
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was a long-term heroin addict who, after relapsing following a clean period of twelve years,
attempted to detox on many other occasions, both through “cold turkey” and in hospital settings.
He described his history of unsuccessful attempts to stay off drugs, and the difficulties
encountered in detoxification. He was ultimately recommended to Dr. Gooberman by a physician
who told him that if he could not go through another clonidine detoxification or a methadone
program that he ought to see Gooberman. He described his going to see Dr. Gooberman as a
“last resort.”
Mr. Mizrachi described his UROD experience. He was not told to come to the office
“comfortable,” but he did use heroin about seven hours before and cocaine about three hours
before arriving. He discussed the procedure with Dr. Bradway, although ultimately Gooberman
actually did the procedure. He was told that UROD was not an all-encompassing treatment, but
only a start. He was not told that UROD was experimental, but was told that “thousands” of
URODs had been performed. He was told that others who had undergone UROD had died, but
does not believe that he was told that others who had not used illicit drugs after UROD had died.
He did sign a publicity waiver. He was told that when he awoke from the anesthesia, it would be
like the fourth day of a heroin detoxification. He was told about the pellet and given a choice
whether to have it implanted or not. He agreed to the procedure. He was told that despite the fact
that he would not get high, if he used heroin or cocaine after UROD, there was a good chance
that he would overdose. He signed a consent form. He believes that he was aware that the AMA
did not sanction UROD and that insurance would not pay for it, both facts that “scared” him. He
woke up from the anesthesia feeling worse than he ever had. He became violent, and he was told
that he punched people. He punched a hole in the bathroom wall. He could not stand or walk by
himself, was able to speak and was “somewhat drowsy.” He thinks that some measure was taken
of his physical abilities before he was discharged, but he does not recall walking the
circumference of the office. After about twenty minutes (as he recalled), he was taken by Mike
Bortnicker to a hotel. He felt horrible and had diarrhea, nausea, and uncontrolled vomiting. He
was very tired, confused and cold. However, he never thought that his life was in danger. He
was in the hotel for two days and was then driven home (his wife having agreed to take him in).
He was sick at home for a week or two. He realized he had to change his life. He took
naltrexone every day. He attended meetings every day. He described himself as physically and
emotionally sick for two months. He still attends meetings and has turned his life around 180
degrees from where it was.
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Jennifer Faulk, another former Gooberman patient, was a heroin addict since age 15.
Having attempted to detox and go through rehabilitation on several occasions, the then twentythree-year-old saw Gooberman’s billboard in Newark while she was going to buy drugs.
Gooberman performed her UROD. He explained the procedure to her on the telephone and in
person, telling her of the serious danger of death if she used cocaine after UROD and telling her
not to have the procedure if she was going to use cocaine afterwards. He also explained that,
while post-UROD heroin use would not be fatal, it was “dangerous.” A naltrexone pellet was
implanted and she has gone back for other inserts. He advised her that she had to get a sponsor
and “go to ninety meetings in ninety days.” He also gave her a book with “all the meetings and
nights.”
Ms. Faulk, whose sister also underwent UROD, is “doing great” and has been sober for
four years.
The Expert Witnesses
In addition to fact witnesses, both the Attorney General and the respondents presented a
number of expert witnesses. These witnesses addressed a variety of often highly technical
issues, including, among others, such central questions as whether UROD is a safe procedure;
whether it was and/or should now be considered “experimental” or whether it is now or was an
accepted detoxification procedure; whether any or all of the deaths of the seven patients or the
two morbidities were directly caused or contributed to by the UROD procedure and what
standards of care may be applicable to the doctors’ UROD practice. In regard to the question of
the relationship, if any, between the patients having undergone UROD and their subsequent
demise, the establishment of the cause of each patient’s death was explored, with considerable
divergence as to the conclusions to be drawn. In view of the undisputed fact that each of the
deceased died within seventy-two hours of having undergone a UROD procedure that was
performed by either Dr. Gooberman or Dr. Bradway, all agree that there is no question as to the
existence of a “temporal relationship” between the occurrence of the procedure and the deaths.
Whether that temporal relationship is the only relationship or, more ominously, there is also a
causal relationship, and whether there was any negligence on the part of either or both
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respondents is a major area of contention between the several experts and the respondents
themselves.
It is also important to note that, while the most dramatic and arguably most
important concern in regard to the Gooberman/Bradway practice of UROD is whether the
procedure as practiced by them caused or contributed to deaths and/or morbidities, this case also
deals to a large degree with the question of whether particular aspects of the doctors’ practice
violated the applicable standards of care. This question exists separate and apart from the
possibility that death(s) resulted from their activities.
As the many expert witnesses addressed themselves to a wide variety of issues during
their testimony and their review of relevant documentation, the discussion of that testimony has
been grouped, as much as possible, in order to understand the experts’ analyses of these
concerns. As such, the following is a description of the experts and some information as to their
qualifications.
Complainant’s Experts
Robert Segal, M.D., a pathologist licensed as a physician in New Jersey for thirty years,
has served as the Camden County Medical Examiner for fifteen years. He has also served in the
medical examiner’s offices in Philadelphia, Atlantic and Burlington Counties. He is certified by
the Board of Pathology. He now lectures at the University of Pennsylvania. Doctor Segal was
admitted as an expert in clinical, forensic and anatomical pathology qualified to give opinions as
to the findings at autopsy and the cause(s) of death. The cause of death is determined by
investigation into what happened to the individual, the autopsy findings, laboratory studies,
consultations and special examinations. Dr. Segal, who has performed thousands of autopsies,
does approximately fifty a year that are drug related.
Lori Karan M.D., is a Board Certified internist licensed in the State of California. She
was admitted as an expert in addiction medicine. Dr. Karan serves as an assistant adjunct
professor with a dual appointment in the Departments of Medicine and Psychiatry at the
University of California in San Francisco (“UCSF”), with emphasis in the Department of
Chemical Pharmacology and Experimental Therapeutics. Dr. Karan is a Fellow of the American
College of Physicians and has extensive experience detoxifying addicts in clinical settings at a
facility associated with Johns Hopkins. She has held previous academic positions at the Medical
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College of Virginia and has trained medical students, residents and post-doctoral fellows in
addiction medicine.
Dr. Karan has served on national committees and published articles concerning addiction
medicine. She is an executive board member and active participant in the American Society of
Addiction Medicine (“ASAM”). She has received a research award from the National Institutes
of Health. She is currently affiliated with the Haight-Asbury Clinic.
Reng-Lang Lin, Ph.D., Chief Toxicologist and Laboratory Director for the New Jersey
State Toxicology Laboratory, was admitted as an expert in toxicology, the ingestion, elimination
and absorption rates of drugs and their lethality or toxicity. He has been employed at the New
Jersey State Toxicology Lab since 1983. The witness holds a Ph.D. in Biochemistry from
Oklahoma State University and served a post-doctoral fellowship at the University of WisconsinMadison.
He also served in the Illinois Department of Health and was assistant chief of
toxicology in the Cook County Medical Examiner’s Office. Dr. Lin has served as a clinical
professor in forensic toxicology at the University of Medicine and Dentistry of New Jersey
(“UMDNJ”).
Dr. Lin is not a pathologist and he described himself as “somewhat familiar with
physiology.” He can determine whether a drug is lethal or not, but he is not the person who
performs the testing. A pathologist is the medical expert who determines the lethality of a
particular dose to a person with a particular condition. The lethality of a dose for a particular
individual can be affected by genetic and other factors.
Clifford M. Gevirtz, M.D., was admitted without objection as an expert in
anesthesiology and the UROD procedure. Dr. Gevirtz is a Board Certified anesthesiologist
licensed in New York State since 1981. He specializes in anesthesiology and pain management.
He holds a Bachelor of Science from Rochester, a Masters in Public Health from Tulane and a
M.D. degree from Tulane. He is a clinical associate professor of anesthesiology at Mt. Sinai
Medical School in New York City. He consults on hundreds of pain management matters a year
and is involved in the clinical practice of anesthesiology, participating in about 800-1,000
procedures a year.
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Dr. Gevirtz has directly performed 185 UROD procedures at Metropolitan Hospital
Center in New York City and has supervised and proctored another seventy procedures. He was
involved in creating a protocol for UROD procedures for the Center for the Investigation and
Treatment of Addiction (“CITA”) and he modified the protocol several times during the years
1996-97. He has taught the UROD procedure in several hospitals in the United States and in the
Commonwealth of Puerto Rico.
Dr. Gevirtz is currently associated with UltraMed, which acts as a referral service for
candidates for the UROD procedure. He has also been involved in research and development of
medical patches. He proctors and trains the personnel at new sites established by UltraMed.
UltraMed referred about fifty clients for UROD in the past year and was compensated for these
referrals. If, because of an adverse outcome of this case for the respondents, UltraMed were to
receive as 600 additional referrals a year, it would naturally stand to gain significant additional
compensation.
Herbert D. Kleber, M.D., is a professor of psychiatry and the director of the Division of
Substance Abuse at Columbia University College of Medicine. As all of the experts for both
parties attested, Dr. Kleber is a recognized authority on the treatment of drug abusers. The
doctor served as an expert consultant to the Board of Medical Examiners in connection with its
investigation of the Gooberman/Bradway UROD practice and was a participant in the
investigative hearing conducted by the Board on September 2, 1999, at which hearing Dr.
Gooberman testified and during which Dr. Kleber asked some of the questions posed to
Gooberman. The doctor first became involved in the Attorney General's and State Medical
Board’s activities regarding Doctors Gooberman and Bradway when he was contacted by Deputy
Attorney General Harper, who was then seeking advice on how to interpret certain findings. He
first provided written material in a report of September 10, 1999.
Dr. Kleber was first licensed in New York State in 1961. Dr. Kleber was associated with
Yale University from 1966 through June 1989, at which time President George H.W. Bush asked
him to become the Deputy Director of the White House National Office on Drug Policy. He
served in that capacity until November 1991 when he joined the faculty at Columbia University.
His current responsibilities at Columbia include clinical, research and academic functions. He
founded the Division on Drug Abuse, which now has a staff of 100 and currently is running
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between 18 and 20 research projects and receives $12 million a year in federal grants. Dr.
Kleber is in charge of training on substance abuse for the medical school and for psychiatric
residents and post resident fellows.
Until recently, Dr. Kleber was also the Executive Vice President of the National Center
on Drug Abuse.11 He is an author, co-author or editor of numerous publications. He is a
member of the National Academy of Sciences’ Institute on Medicine and is a Fellow of the
American College of Neuropsychopharmocology. He received an award from the ASAM in
spring 1999 in recognition of his research to advance substance abuse treatment. However, Dr.
Kleber is not a member of ASAM, and has chosen not to take ASAM’s examination for
certification in addiction therapy. He is also not Board Certified in psychiatry and is not a
pharmacologist.
Dr. Kleber has been treating addicted individuals for over thirty-five years. His textbook
is widely used and one of the best selling for students.
He has personally detoxified or
supervised the detoxification of over 3,000 individuals. By detoxification, he means to refer to
the process of ridding the body of a substance(s) to which the person has become dependent.
Another term for this process is “withdrawal.” While at Yale he formulated protocols for the
detoxification of opioid dependent persons.
Lawrence Gerald Kushins, M.D., testified as an expert in anesthesia and the dangers
associated therewith. Dr. Kushins is a licensed physician and professor of anesthesiology at
Robert Wood Johnson Medical Center, where he serves as chief of the anesthesia service and as
acting department chairman, in which capacity he supervises nurse-anesthetists and
anesthesiologists. He is Board Certified in anesthesiology and critical care medicine. Kushins
conducts an active clinical practice in which he administers anesthesia approximately 1,000
times per year. During the last five years, he has conducted a full-time clinical practice while
also teaching at Robert Wood Johnson Medical School. He has previously served in academic
positions at the State University of New York, Stony Brook, Long Island Jewish Medical Center
and New York University Medical School, as well as at the University of Florida. He has
published approximately ten articles and six book chapters.
11
In addition to his research, the doctor treats addicts and sometimes detoxifies addicts. He devoted himself full-time to his work at the medical
school in bio-medical research. He has a grant and will need to enroll a number of addicted patients into his study. It is possible that the grant
would be terminated if not enough addicts were obtained.
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Defense Experts
Dr. David E. Smith, M.D., was admitted as an expert in pharmacology, toxicology and
addiction medicine, also known as addictionology. Dr. Smith holds an M.D. degree from the
University of California, San Francisco (“UCSF”) and holds a Masters from that institution in
pharmacology and psychopharmacology. In 1967 he started the Haight-Ashbury Free Clinic in
San Francisco and is now its president and medical director.
The clinic is a non-profit
organization with twenty-two sites in the Bay Area, to which 50,000 clinic visits are made yearly
by uninsured individuals. It provides primary medical care and addiction treatments services,
including detoxification and aftercare. It has an active research program and is part of the NIDA
Clinical Trials network. In this role, it is involved in on-going work on medicines being tested
for their efficacy in addiction treatment, such as buprenorphine and long-acting naltrexone.
Dr. Smith has also served as the medical director of the Betty Ford Center’s Professional
Program. His time is spent one-third in treating addicts, one-third in research and one-third in
teaching. He has published nearly 350 articles and has been the author, co-author or editor of
fifteen books. He served as the president of ASAM from 1995-97. He has also served part-time
as the director of the State of California’s own addiction programs. He has testified as an expert
witness over 250 times.
Dr. Smith has never personally performed a UROD procedure. However, he has referred
people to others for UROD.
John T. Cooper, Jr., M.D., an expert in anatomic, clinical and forensic pathology, holds
a medical degree from the University of Texas Health Sciences Center. He has served as a
hospital pathologist and as a medical examiner in Phoenix, Arizona. Dr. Cooper also has worked
as a coroner’s pathologist in a private pathology group in Stockton California and has conducted
a private practice in which he has performed many “second look” forensic autopsies. He has
testified as an expert witness in both criminal and malpractice cases. Dr. Cooper is Board
Certified in each of the areas in which he was accepted as an expert.
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While serving in Phoenix, Dr. Cooper performed an autopsy on a young female who died
a few hours after undergoing ROD/UROD.
David Lew Simon, M.D., a licensed physician practicing in Mansfield, Connecticut, was
accepted as an expert in addiction medicine, anesthesiology and UROD. Dr. Simon graduated
from the Medical College of Virginia in 1987. He is Board Certified in anesthesiology and
practiced in that specialty until 1992, when he shifted his focus to addiction medicine. He is
certified in addiction medicine by ASAM and is a Fellow of the National Academy of Medical
Examiners. At one time, Dr. Simon was a member of the ASAM Public Policy Committee. He
has published an article on the rationale of naltrexone therapy.
Dr. Simon is both a colleague of Drs. Gooberman and Bradway in the field of addiction
medicine and a competitor of the respondents in the provision of UROD, providing an anesthesia
assisted detoxification that he calls Intensive Narcotic Detoxification, or “IND,” which he
characterized as being basically the same procedure as UROD. Dr. Simon’s practice was
conducted as Nutmeg Intensive Rehabilitation Center in Connecticut. Simon personally
performed about 250 UROD procedures between November 1996 and April 2000. During these
procedures, either he supervised the services of an anesthesiologist working as an independent
contractor or had a nurse anesthetist perform the anesthesia service in another 250 procedures.
His organization does not now perform UROD. Instead, it refers candidates for the procedure to
hospitals and to other providers.
Frank T. Maziarski, CRNA, testified as an expert witness for the respondents
concerning the duties and responsibilities of Certified Registered Nurse Anesthetists (“CRNAs”),
including their responsibilities in the area of critical care nursing and the maintenance of patients
and their discharge. Maziarski, a CRNA for over thirty-five years, licensed in New York State
and the State of Washington, holds a B.S. and a Masters in Physiologic Psychiatry from the
University of Nebraska. He served as Director of Anesthesia Education at the United States
Army Academy of Health Sciences at Fort Sam Houston and Director of Anesthesia at Madigan
Army Medical Center in Washington State. He was associate Director at Walter Reed Army
Medical Center and Director of Anesthesia at Beaumont Army Medical Center in El Paso, Texas.
He has recently been accepted into the American College of Forensic Examiners, an organization
of legal nurse consultants dedicated to the study and advancement of forensic examination of
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patients’ charts, legal documents and court proceedings. He has taught in the residency program
at the University of Washington and as an associate professor at Drake and at Nebraska
Wesleyan. He has testified as an expert for both the government and the defense in malpractice
cases in Washington State and North Carolina.
Mr. Maziarski acknowledged that he was not familiar with the specifics of the certifying
process for CRNAs in New Jersey. However, he described a CRNA as an advanced nurse
practitioner. A nurse anesthetist has critical care responsibilities and is required to know cardiac
function, how to read an EKG, how to intubate and use various types of equipment and advanced
life support procedures.
Maziarski conducts a private practice in clinical anesthesia and consults on legal matters
regarding nursing. He is not certified as a critical care nurse, but was trained in that field thirty
years ago and has experience in operating rooms and has directed critical care nurses in recovery
rooms. He also is required by state law and his professional organization to take review courses.
Jennifer Richards, R.N., is a registered nurse now employed as a Medicare nurse case
manager, but she was formerly employed as a critical care nurse in Dr. Gooberman’s office. Ms.
Richards worked as an operating room nurse at Kennedy Hospital and eventually went to work
for Gooberman. She was involved in both the monitoring of patients during UROD and in
bringing the patients out from under anesthesia and in discharging them. She also was involved
in interviewing patients prior to their undergoing the procedure.
Rosemary Capelli, R.N., a teacher at the Nursing College of New Jersey and a licensed
nurse with a master’s degree in Arts and additional course work towards a Ph.D., was requested
by former counsel to Dr. Gooberman to review the protocols and nursing resumes of those who
worked at the Gooberman clinic.
Frank Ragone, R.N., served as a critical care nurse in the Gooberman clinic from 199799. Mr. Ragone is licensed by the States of New Jersey and Pennsylvania. He holds an
associates degree from Camden County College.
He started to work part-time for the
respondents in 1997 and later worked full-time. He had first met Dr. Gooberman at Lady of
Lourdes Hospital and was interested in the work that the doctor was doing. He began to train
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with Gooberman three days a week for two weeks, first observing the procedures. He spoke to
the nurses, CRNAs and doctors. He then started to participate. He assisted with medications and
basic care and monitoring. He was advised of protocols and guidelines utilized in the facility
and was given much to read. He received written dosing orders for each patient. Standing
orders were in place. He compounded anesthesia drugs, mixing them together.
In addition to these responsibilities, Mr. Ragone explained that after the patients were
discharged he called them on a daily basis, preferring to speak to the patient, although he often
ended up speaking to the caretakers. These calls continued on a once-a-day basis for a week and
then three times a week or whatever was needed as a follow-up. When patients had complaints,
he worked from the standing orders and prescribed drugs.
Rebuttal Witnesses
Complainant’s rebuttal expert was Bunyad Haider, M.D., a cardiologist licensed by the
State of New Jersey. Dr. Haider has served as a full professor of Medicine at New Jersey
Medical School in the Department of Cardiovascular Diseases for approximately eighteen years
and is vice chair of the Department of Medicine. He conducts research, teaches and conducts a
clinical practice, in which he specializes in interventional cardiology. Dr. Haider is Board
Certified in Internal Medicine and Cardiovascular Diseases.
textbooks and published many papers.
He has authored chapters in
He has performed research on cardiac related
hypertension. The doctor has no experience in performing UROD, although he is familiar with
the procedure.
Respondent’s sur-rebuttal expert was Robert Katz, M.D., a clinical cardiologist licensed
in Pennsylvania and California, is associated with Presbyterian Medical Center in Philadelphia,
which is a part of the University of Pennsylvania Health Systems. Dr. Katz has thirty-one years
of experience as a cardiologist. He cares for patients, reads angiograms, echocardiograms and
does clinical noninvasive work, but not catheterizations, which are invasive. He is a graduate of
Middlebury College and Howard University Medical School and is Board certified in internal
medicine and cardiology. He has served as an assistant professor of clinical medicine at the
University of Pennsylvania.
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In addition to these experts, the respondents each were qualified as experts in the field of
addiction treatment and UROD. Each explained about their background and experience in these
areas.
Lance L. Gooberman, M.D., was admitted as an expert in UROD. He received his
M.D. degree in Juarez, Mexico. He is not Board Certified in Internal Medicine, but practiced in
that field until 1996.
He then practiced primary care medicine and worked nights in the
emergency room in West Jersey Hospital’s Eastern Division in Berlin. His interest in addiction
medicine emerged in 1987. He has been certified in addiction medicine by ASAM since 1990
and ultimately converted his practice to that field. He is himself a recovering methamphetamine
addict, having used drugs until February 1987.
In the early 1990’s, Dr. Gooberman began to see a reduction in emergency room cases
involving methamphetamines and a rise of heroin cases. Traditional detoxification methods
were expensive, programs were hard to get into, especially as managed care limited admissions
and durations thereof, and the programs were not very successful. He did a lot of reading on
what could be done for these addicts and attended conferences. He was advised of work
performed in Austria by Dr. Loimer, which involved precipitated withdrawal.
Thereafter,
Gooberman helped to form a committee at West Jersey Hospital Detox Center where he had
been precipitating some patients’ withdrawals. The procedure involved the use of naltrexone to
precipitate withdrawal, basically, the method utilized by Dr. Kleber at Yale. Prior to this,
Gooberman had been using sedatives such as phenobarbital and clonidine and he tried to make
the patients’ withdrawal comfortable, which it was not. The success rate was low, more than
half signed themselves out and of those who made it through the withdrawal, they usually
relapsed within a day or two due to their discomfort.
Dr. Gooberman detailed other experiences with precipitating withdrawal at Cooper
Hospital, where even heavily sedated patients would “come off the bed” and require “a lot” of
people to control them. The situation proved too nursing-intensive and, based upon suggestions,
the patients were then admitted to ICU or the intermediate care floor, rather than the regular
floors. Additional suggestions were made that if the patients were intubated the need for so
many nurses would be alleviated.
One nurse could handle two, rather than one patient.
However, there were complaints that these patients were not in extremis and did not belong in
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ICU beds. In addition, some had severe diarrhea, and the smell was bothersome. Nurses also
had bad “attitudes” toward drug addicts.
Dr. Gooberman was aware that Medicaid was paying $3,200 per patient and the hospital
was making a 50% profit on the procedures. He thought that if he could get the necessary
equipment, personnel and drugs he could do the procedures in an office setting. Although he
found that Medicaid would only pay $45 for procedures done in the office, he proceeded to set
up the office with all the proper equipment, essentially establishing an ICU. He then tried some
procedures in this setting. While no one in ASAM had previously done this procedure, he did
speak to Colin Brewer in England, a well-known addiction specialist who was performing
precipitated withdrawals and who had determined that octreotide would stop the severe diarrhea.
This produced a major change, as it assisted with maintaining proper electrolyte and fluid
balances.
David Bradway, M.D., who was the attending physician on five of the seven mortality
cases and for the two morbidity cases, has been licensed as a physician in New Jersey since
1977. For a time in the early 1980s he voluntarily surrendered his license to practice medicine as
a result of an opiate addiction problem and sequelae related thereto. Prior to his suspension, he
attended UMDNJ and had a residency in nuclear medicine at the University of Pennsylvania. He
served as an emergency room physician for one and one-half years. He worked as a software
engineer from 1982-89 at RCA in Moorestown. His medical license was at first partially
restored and he practiced internal medicine in 1984 and 1985. The license was fully restored in
1987. He practiced with Dr. Gooberman in the general practice of internal medicine from 198789 while also receiving a masters degree in mathematics from Drexel University. In 1990, he
opened his own practice in Magnolia, New Jersey. He now practices full time in the fields of
general medicine and family practice. He is on staff at West Jersey Hospital.
Dr. Bradway began to perform UROD in November 1995. Dr. Gooberman called,
explained the procedure and invited him to witness it. His own history peeked his interest in a
possible mode of detoxification. He had had some training before 1995 in anesthesia, in medical
school for two months at Beth Israel Hospital in Newark. He also read texts on pharmacology
and had learned in medical school between 1972 and 1976 how to intubate, extubate, evaluate
and do histories, physicals and follow-ups after anesthesia. While he served as an emergency
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room physician, his skills in anesthesiology were frequently needed. However, after 1985 and
until 1995 he did not have any experience with anesthesia. He has been re-certified in advanced
cardiac life support on several occasions. He is not Board Certified in Emergency Medicine, as
it was not a Board Certified specialty at the time that he was doing that work.
Dr. Bradway testified that after observing the UROD as performed by Dr. Gooberman
and determining that it was a reasonable procedure, he began to train in the procedure under Dr.
Gooberman’s supervision. Gooberman employed him to perform URODs sometime in late 1995
or January 1996. He was paid by the hour. He was trained in the various medicines and their
administration and purpose. On several occasions, an anesthesiologist was present when the
procedure was performed. Bradway understood that, as a licensed physician, he would be
supervising a CRNA. He was trained in the array of equipment used in UROD. The work was
performed in what was essentially an intensive treatment unit. He did perform some of the
intubations himself, although in general these were done by the CRNA. He first performed a
UROD procedure on his own in February or March 1996 and thereafter did them regularly on his
own, although at times both he and Gooberman were present. His role as the attending physician
was to oversee all aspects of the procedure and be primarily responsible both before and after
and to follow-up on discharge.
Detoxification and the NIDA Report
The unofficial NIDA report, issued on February 23, 1996 during the earlier phase of Dr.
Gooberman’s 1995-99 provision of UROD, is a key element in the conclusions about UROD
asserted in the Complaint and a discussion of its conclusions and significance played a prominent
role in the hearings. However, as UROD, whatever its efficacy, safety and/or acceptability,
purports to be only a means of detoxification, it is first helpful to relate some of the evidence
presented regarding the several approaches to treatment for opioid addicted individuals,
including the necessary element of detoxification.
Dr. Herbert Kleber explained that there are both “maintenance” and “drug-free”
approaches to treatment.
12
Maintenance can involve switching a person from the drug of
Although he had no role in writing the NIDA report, Dr. Kleber was consulted by Barbara H. Herman, Ph.D., the Director of NIDA’s Clinical
Opioid Medications Program, Clinical Trials Branch, an author of the report who asked him some questions and to whom he provided some
articles from the literature. The other author of the Report was Dorynne Czechowicz, M.D., associated with the Treatment Research Branch at
12
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dependency to an opioid considered safer for maintenance. Such a drug may be methadone, or
recently, buprenorphine. However, if, the goal is to allow a person to abstain from opioids,
rather than to maintain one on a “safer” opioid, then there are several approaches to the
detoxification of an addicted person. Detoxification is considered the preliminary or first step in
treatment of the addiction. Generally, the method of detoxification having the least risk for the
patient should be chosen. This is determined by what Kleber referred to as both “theoretical”
and “practical” considerations. The theoretical consideration involves an assessment of the
patient’s state of health, looking at, among other factors, his/her liver and heart function. Certain
means of detoxification are more stressful than are others. There is no single rule about what
method to use. The practical considerations include cost and availability of a modality of
treatment in the community. One method involves abstinence from the drug. Another involves
giving the addicted person a narcotic antagonist, such as naltrexone. A third method involves the
entry of an addicted person into an in-patient treatment facility or attendance at Narcotics
Anonymous (“NA”) meetings. The bulk of the treatment process is aimed at allowing an
addicted person to refrain from the use of opioids. The adage regarding opiate addiction is “easy
to get off/hard to stay off.” Relapse prevention tools include psychiatric counseling, “12-step”
and cognitive approaches. All these are part of the treatment of the addiction.
The witness described the process of withdrawal from opiates.
Heroin is diacetyl
morphine, meaning morphine with two acetyl groups attached. Withdrawal from morphine starts
about twelve hours after the last dose and peaks after about thirty-six until about seventy-two
hours after its start. It generally lasts for from five to seven days with lingering aspects thereafter
sometimes lasting over a period of weeks or months. These can include trouble sleeping and
irritability. Withdrawal from methadone generally peaks at four to six days and lasts for eight to
ten days, but the symptoms of withdrawal may linger for quite a long time thereafter.
Dr. Kleber explained that there are three main categories of detoxification protocols. One
of these involves the use of the drug clonidine, which alleviates 80% of the symptoms of opioid
withdrawal, but which, if used alone, does not shorten the period of withdrawal. A second
protocol involves the use of buprenorphine. This drug is not yet on the market for use in drug
withdrawal.
NIDA. Several consultants are listed as well. These include three professors of psychiatry and two other physicians, whose areas of specialty are
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A third protocol involves the use of clonidine and naltrexone.
detoxification method, or ROD.
This is a rapid
Naltrexone is used to precipitate withdrawal after a
pretreatment with clonidine, a drug that diminishes the withdrawal symptoms.
In effect,
naltrexone binds to the mų receptors in the brain, thereby not allowing the opiate to do so, and in
fact displacing morphine already on the receptors, thereby inducing withdrawal. Clonidine is
commonly used here and abroad, but naltrexone is not and the ROD process is not commonly
employed. By the end of the 1980’s, a naltrexone precipitated withdrawal lasted for two days.
This procedure, which Dr. Kleber initiated at Yale, did not employ general anesthesia. On the
other hand, UROD, as employed by the respondents and by some other practitioners, does
employ general anesthesia.
The theory behind UROD arose because of limitations that Kleber and his associates
found in their experiments with the clonidine/naltrexone process. The use of antagonists in
detoxification is impacted by the rate at which the antagonist can be given, due to the severity of
withdrawal symptoms that are by administration of the antagonist. At first naloxone, naltrexone
and clonidine were used in a two-day procedure, however, Dr. Colin Brewer, working in
London, reduced the time to a day-and-a-half by sedating the patient with clonidine. However,
the more naltrexone given to the patient, the more severe were the withdrawal symptoms. It was
Dr. Loimer, practicing in Austria, who first used anesthesia.
He used large doses of
benzodiazepine and anesthesia. This was the first ROD procedure. Over the past ten years,
those employing anesthesia in detoxification have used different methods of anesthetizing the
patient, some using propofol, some barbiturates, some ketamine, and some nitrous oxide. The
theory behind the anesthetized withdrawal was that by stripping the opiates off the receptors
while the patient was anesthetized, the detoxification could be accomplished within one to one
and one-half days.
However, according to Dr. Kleber, experience now shows that severe
withdrawal symptoms can be experienced for up to two weeks.
Naltrexone is an FDA approved drug for withdrawal. It has 140 times the affinity for the
mμ receptor that heroin has, thus, if naltrexone binds to a receptor 140 times the usual amount of
heroin needed to bind to the cell is necessary for it to overcome the effect to the naltrexone. Oral
naltrexone is a relatively quick acting drug that is approved for maintenance treatment.
However, naltrexone does not work very well if injected.
Another drug, naloxone, is an
not designated.
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injectable drug used mainly in the treatment of drug overdoses, since it works faster than oral
naltrexone.
Turning to the NIDA Report, Dr. Kleber explained that NIDA is a part of the National
Institutes of Health, charged to research the causes and prevention and treatments for all forms of
addiction. It funds 85% of all research on drug abuse in the world. Dr. Kleber’s understanding
is that the NIDA report was produced after the Israeli Ambassador to the United States asked
NIDA for information about UROD and for its position regarding UROD. One of the leading
proponents of the UROD technique has been Dr. Andre Waismann, M.D., from Israel.
Reportedly, the procedure was being utilized in Israel to treat soldiers.
Initially, the authors of the NIDA Report acknowledge that “the major problem” in
assessing UROD and “rendering a firm scientific opinion” about UROD is the lack of
randomized, single or double-blind controlled studies and the limited database as to the
procedure. In addition, different practitioners utilized different medications in the procedure,
thus it is “difficult to systematically determine which medication may be responsible for
alleviation of opiate withdrawal symptoms.”
In the absence of significant research, the
possibility that UROD might be useful for detoxifying opiate dependent individuals relatively
quickly, that is, within one to four days, must “remain a ‘medical impression.’ ”
Significantly, the authors report that there is a risk of death from UROD. They conclude
such because they state that death can occur either directly, from inadvertent overdose of the
anesthetic agent, or indirectly, due to aspiration of emesis during naloxone-precipitated
withdrawal. They then state “opiate detoxification has no known mortality risk in uncomplicated
cases,” and, as there is such a risk from UROD, “it is our view that such additional studies
should be undertaken only in very carefully considered and rigorously designed studies.”13
The authors of the NIDA study conclude that there is no evidence that UROD is superior
to any other detoxification technique in preventing relapse and that it is not a cure for opiate
addiction. While they concede that if UROD is proven safe and effective it may be beneficial for
“very high risk patients who would refuse longer detoxification procedures (I.e. 2 versus 5 days),
13
Among the sources for the conclusion that there is no risk of death in uncomplicated detoxification utilizing methods other than UROD are Dr.
Kleber’s letter to Dr. Hermann, dated February 7, 1996, and page 99 of an article by R. Mattick and W. Hall, Are detoxification programmes
effective? The Lancet 347: 99-100 (1996).
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to serve as a bridge towards longer term relapse prevention,” they conclude that on a risk/benefit
analysis UROD is unacceptable as a detoxification procedure.
The authors’ review of the literature regarding naloxone-induced reversal of high-dose
anesthesia led them to studies that they assert demonstrated “a small but significant incidence in
cardiovascular complications including cardiac arrest and pulmonary edema following
intravenous (i.v.) administration of naloxone to surgical patients.” The authors highlight (in bold
letters) a report of a “life threatening adverse event (pulmonary edema) when UROD was used
involving i.v. administered high dose naloxone.” This event was reported in 1995 by San, et al.14
In addition to the conclusions already stated, the authors of the NIDA report also
concluded that UROD was an “elaborate” procedure and that there were “less elaborate” and
“less expensive” detoxification methods available. The “elaborate nature” of the procedure was
its need for intensive care or operating room inpatient facilities “equipped with appropriate
medical and nursing staff and equipment . . . especially if anesthesia (versus moderate doses of
sedative) is used.” Other detoxification procedures do not require these types of personnel and
equipment. Cost-wise, the report states that a one to two day UROD procedure with six month
follow-up was $5,000, or, as reported by Dr. Kleber, about $7,500 in New Jersey. Costs for a
thirteen-day period of inpatient therapy with stabilization from other substances and methadone
treatment is said to be $3,705 and for inpatient detoxification about $285 a day, and rapid
detoxification using clonidine and naltrexone is reported to cost $1,425 for five days.
The NIDA report also concludes that there are no double-blind studies indicating that
UROD procedures are more successful in decreasing relapse than are longer duration treatments.
In summarizing their conclusions, the authors of the NIDA Report conclude that “based
on the available information, it appears that the UROD anesthesia method is currently without
ethical, medical, scientific, or financial justification as a clinical detoxification treatment at the
present time. . . .” (Italics added.) It concedes the possibility that if proven safe and effective
UROD might be of some use in the treatment of “extremely high risk” opiate addicted persons
who would turn down other, more conventional procedures . . .,” but suggests that “additional
14
The conclusion drawn by the authors of that report and the adoption of it as an example of the risk associated with UROD will be the subject of
further analysis and criticism later in this opinion.
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research evaluating UROD should be undertaken only in very carefully considered and
rigorously designed studies.”
Dr. Kleber agreed that as of February 1996 the conclusions expressed in the NIDA
Report accurately reflected his views regarding UROD. He acknowledged that as of that date he
had not observed or participated in a UROD detoxification. He denied that the report was
“hastily prepared,” after the Israeli inquiry was passed on to NIDA by the State Department.
In 1998, Dr. Kleber surveyed all of the literature on UROD and has tried to keep up with
the literature since then. There are only about twelve scientific articles on the process. Dr.
Kleber opined that ROD does not as yet have a widespread acceptance and asserted that
“recognized addiction experts” are “generally in agreement” that UROD is considered an
“experimental procedure” and will be so until research is done that allows for a full consideration
and assessment of the risks and benefits of the procedure. There have been no good controlled
studies of it and no good long-term study with outcomes. There is not yet any way to define the
benefits of the process and compare them to its risks.
In September 1998, Dr. Kleber submitted a grant application to NIDA and was eventually
awarded the grant that funds the Columbia University study, which is intended to provide the
study and test of UROD that has been up to now lacking. The grant funds a comparison study by
means of a random assignment of three methods of detoxification: 1) by use of clonidine; 2) by
use of clonidine, buprenorphine and naltrexone; and 3) by accelerated rapid opioid
detoxification, or AROD, another name and acronym for the procedure employing general
anesthesia that is also known as UROD. According to Kleber, this study will be the first
controlled study of the safety and efficiency of these procedures, as well as the risk/benefit ratio
and related studies as to the effects on the body, such as hormonal changes and the effect of sleep
while undergoing withdrawal. The portion of the study involving AROD was to involve thirty
patients, however, that study was delayed by Columbia’s Institutional Safety Board due to
reports concerning deaths occurring in relation to withdrawal under anesthesia. Dr. Kleber has
personally observed a UROD procedure, one of the two just performed at Columbia.
As a form of detoxification, ROD can be performed on an outpatient basis, although the
first day can be difficult. Opioid withdrawal is inherently stressful. Complications may be
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associated with pre-existing disease, such as certain cardiac problems, acute hepatitis or
pneumonia. Significantly for issues addressed later in this case, Dr. Kleber described persons
with such conditions as “already compromised.”
As noted earlier, Dr. Kleber was listed in the NIDA Report as a source for the proposition
that there was no risk of death associated with other methods of detoxification in uncomplicated
heroin withdrawal. He testified that there were no mortalities reported in the English language
literature. Before 1995, there was also no mortality associated with UROD. However, as the
UROD procedure has been spreading worldwide, in the period between 1995 and 1999 reports
have emerged regarding increasing numbers of deaths associated with UROD. The major risks
associated with the procedure are cardiac problems, including arrhythmias and dysrhythmias. In
addition, pulmonary problems are common, including irregular breathing patterns. In addition,
there can be a persistence of severe withdrawal symptoms for one to two weeks, including
persistent vomiting and diarrhea. Electrolyte abnormalities and decreased potassium could affect
the heart rhythm. Each of these risks poses a possibility of death. While the total of such visits
is unknown, these risk elements have led to emergency room visits.
Dr. Kleber identified and discussed a number of papers and articles written since the
NIDA Report. Some of these looked at the physiological changes that occur during UROD. A
1999 article by Pfab, Hirtl and Zilker, Opiate Detoxification under Anesthesia: No Apparent
Benefit but Suppression of Thyroid Hormones and Risk of Pulmonary and Renal Failure,
published in Clinical Toxicology 37(1), 43-50 (1999), (hereinafter referred to a as the “Pfab
article” or “Pfab”), based on a study of twelve patients, concluded that opiate detoxification
using anesthesia and high, repetitive doses of opiate antagonists had no obvious benefits and
high risks. According to the Abstract of that report, all of the patients had moderate to severe
opiate withdrawal symptoms and none completed detoxification within the first forty-eight
hours. The method used suppressed thyroid hormones and there was one pulmonary failure and
two renal failures.
Dr. Kleber discussed another article, Profound Increase in Epinephrine Concentration in
Plasma and Cardiovascular Stimulation after μ-Opioid Receptor Blockade in Opioid-addicted
Patients during Barbiturate-induced Anesthesia for Acute Detoxification, authored by Kienbaum
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et al.15 This article discussed UROD performed in a different manner than that practiced by Dr.
Gooberman or, for that matter, in Dr. Kleber’s study, as the anesthesia employed by the authors
was a barbiturate. The key conclusions of the study were that UROD produced a very large
increase (30-fold) in the catecholamine epinephrine in plasma, and “profound” cardiovascular
alterations. The authors suggested that due to the attendant cardiovascular changes, UROD
“should be handled by trained anesthesiologists or intensivists.”
Summarizing the literature since the issuance of the NIDA Report, Dr. Kleber concluded
that the consensus is clear. Practically every paper issued since the NIDA Report, even those
most favorable to UROD, has concluded that there are no controlled studies of UROD and a
definitive long-term study is needed. Additionally, more and more papers are concluding that,
contrary to the prevalent thinking in the early 90’s that UROD was a safe and effective
procedure, in fact the procedure is much riskier than originally thought. This is due to the
growing evidence that significant hormonal changes take place during the procedure.
In
addition, even UROD advocates such as Colin Brewer have shown that the withdrawal
symptoms continue for at least a couple of weeks after the procedure.
Kleber summarized several issues regarding UROD by indicating that persons providing
UROD either are or should be aware of the risks associated with the procedure. This is because
of the publication in reputable journals of the several reports and the fact that persons using new
procedures should have been trying to keep abreast of the developments in the area so as to know
what is going on. Given the “evolving” and “experimental” nature of the UROD procedure
during the period 1995 to 1999, the different methods, procedures employed, and the potential
for mortality and morbidity, a practitioner of UROD should have had the highest level of concern
regarding the safety of his or her patients. There was a need for heightened awareness and care.
The prudent practitioner, knowing of these deaths, had to have a heightened concern to carry out
the process as safely as possible. In addition, during this latter period there were more reports
regarding the changes in stress hormone levels and the persistence of withdrawal symptoms for
as late as several weeks after the procedure. In the absence of rigorous long-term studies
regarding the safety of the UROD procedure and the risk/benefit analysis related thereto, we
have no idea scientifically of the benefits of the procedure. Gooberman has no way of knowing
the ultimate outcomes for his 2,300 patients and therefore no conclusions can be drawn regarding
15
Anesthesiology, Vol. 88, No. 5 May 1998.
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the mortality rate of those who undergo Gooberman’s procedure as against the accepted death
rate of heroin addicts generally. He noted that the respondents had no idea of the mortality and
morbidity of their 2,300 patients within six, nine or twelve months after undergoing UROD. In
addition, we have inadequate knowledge of the risks involved because we have very little
information about what happens to the body in the twelve to seventy-two hours post-procedure.
Dr. David Simon has spoken at length with two of the authors of the NIDA Report,
Barbara Herman, Ph.D., and Dorynne Czechowicz, M.D., neither of who is an expert in
anesthesiology. He first learned of the report before it was published, in December 1995, when
he was calling around trying to find information about UROD for a review article he was
preparing.
The authors told him that NIDA was consulted by an agency in the Israeli
government about NIDA’s view of UROD, a procedure that was then being administered in
Israel. As he understood, “NIDA had not heard of it either. NIDA scurried to do a report.”
Simon’s general criticism of the NIDA report is that the authors did not speak to anyone
who performed UROD before they published their report. His own comments to the two authors
about the procedure were ultimately ignored. As for the report itself, Simon disagrees with it. It
is “biased,” the data quoted is “in many cases, factually wrong,” and, in addition, he believes that
the authors are judging UROD by a standard to which they did not hold themselves. The
“anecdotal reports” they used were “unsubstantiated, not peer reviewed and misinterpreted to
base their conclusion and their conclusion is that everything about UROD is anecdotal.”
Simon addressed the risk/benefit issue in more specific terms. To say that there is no
known mortality risk in detoxification of uncomplicated patients is a simplistic statement. To
him, it seems that they are saying that whenever someone dies “it was a complicated case.” In
fact, death is “not uncommon.” People die “from being on methadone maintenance.” Death can
occur in unassisted withdrawal, “even in uncomplicated cases, although that’s rare.” He added
that in fact the decedents in the present case were “all complicated.” Indeed, given the fact that
withdrawal induces stress and therefore causes the heart rate to go up and the blood pressure to
increase, a person with cardiovascular disease can experience a heart attack. “It’s the stress of
withdrawal that causes the risk in complicated cases, not the stress of the method.”
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Dr. Simon next addressed the report’s characterization of the death rate in anesthesia
procedures, which it states is 1 in 15,000, a figure that Simon suggested may have been accurate
at the time when Peter Cohen, a medical doctor and attorney who works for NIDA and is “long
retired” from anesthesia, actually practiced anesthesia. According to Simon, the authors of the
report called Dr. Cohen and he quoted them this figure. However, Dr. Kushins testified to a
figure of one in 250,000. Thus, Dr. Simon contended that the authors of the report have
exaggerated the risk from anesthesia, while at the same time discounting that the UROD
procedure has any benefit. Simon noted that the UROD procedure that he performed was very
similar to that performed by the respondents. He described the technology employed in his
procedure and noted that, with the use of two monitors and electrocardiogram and pulse
oximetry, as well as an end-tidal CO2 machine attached to the endotracheal tube, the risk of
dying from anesthesia has been reduced, depending on the publication that the figures are drawn
from, to 1 death in 200,000 or 1 in 250,000 to as low as 1 in 400,000. These figures stand in
stark opposition to the 1 in 15,000 figure used in the NIDA report.
On cross-examination, Dr. Simon agreed that the report actually refers to the rate of
“serious adverse events including death.” Therefore, his figures are not directly comparable to
that description.
However, he would nevertheless maintain that the NIDA figure is
“misleading.”
Continuing his critique of the NIDA Report, Dr. Simon addressed its reference to what it
characterized as a “very recent report” of a life-threatening adverse event involving pulmonary
edema following anesthesia in a procedure involving the administration by i.v. of high dose
naloxone. This report was contained in a letter to the editor of the American Journal of
Psychiatry dated June 1995, known in this record as the “San” report.16 It consists of a letter
written by four doctors in Spain about a complication that they experienced with a patient who
they treated. Simon characterized this “report” as an “anecdotal finding,” published without any
peer review. No cause and effect is described. According to Simon, the authors of the NIDA
Report interpreted this case as a situation in which San administered an opiate antagonist to a
patient, who then developed pulmonary edema. The authors then determined from this that the
UROD procedure could be “dangerous.”
However, the report does not stand up for this
conclusion. In the case reported, a thirty-eight-year old man with an opiate addiction was treated
16
San L. Puig M, Bulbena A, Farre M: High Risk of Ultrashort Noninvasive Opiate Detoxification. Am J Psychiatry 152:956 (1995).
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in 1995. He received an oral regimen of midazolam of sixty milligrams, which Dr. Simon
characterized as “a lot.” He also received .3 milligrams of clonidine and zofran, which is an
antidiarrheal, followed by fifty milligrams of naltrexone. The patient was not intubated; instead,
all of this was administered orally. After fifteen minutes, he was given an i.v. dose of .4
milligrams of naloxone, which was expected to induce withdrawal. The patient had severe
withdrawal symptoms, including rhinorrhea, dilated pupils, gooseflesh and restlessness.
According to Simon, “this happened before their sedation kicked in that they gave the pills.” He
was sedated with very high doses by mouth, “enough to knock out a horse. That is figuratively.
It had to be absorbed to work and then they gave him i.v. narcan fifteen minutes afterwards.
That, in and of itself, is medically ridiculous.”
The doctor continued his analysis of the incident. The details are such that it is best to
quote him at length.
These symptoms of withdrawal persisted for hours. To treat this
guy who is in and out of consciousness, having these bad
symptoms, they start giving him i.v. midazolam, benzodiazepine.
The amount of i.v. midazolam is a dose to induce general
anesthesia. They didn’t know it. They were sedating him. Thirty
milligrams produces general anesthesia in a seventy kilogram
male. They anesthetized him. Five hours after they started all of
this, they noticed that the heart rate was going down and saturation
on the pulse oximeter was going down. There was a problem.
They required oxygen therapy. They didn’t intubate him, which is
a standard of care. They put an oxygen mask on him. At that
moment he started vomiting fecaloid material, which is vomit that
looks like feces. He vomited, had an unprotected airway, was
anesthetized, lying there. They had a good sense to suction him
and even intubated him after all the damage was done from puking.
The conclusion was i.v. narcan caused pulmonary edema in this
case. What really happened was the patient either had aspiration
pneumonia or the patient developed laryngospasm, which the vocal
cords close, which you can’t get air back and forth, an obstruction
in the throat, which leads to a whole concept of negative
intrathoracic pressure pulmonary edema. . . .
What we have found in the anesthesia literature, which the
psychiatrists and the consults in the NIDA report clearly didn’t
understand, is that one of the ways which pulmonary edema could
be caused, I take a deep breath, when I do that, my rib cage goes
out and I generate inside my rib cage. The negative pressure
compared to the outside pressure draws air in. I’m stuck here, I
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just swallowed a marble. My vocal cords are closed or I vomited
and my acid from my stomach irritated the vocal cords. My
protective airways closed the vocal cords. I’m panicking. I have
to take a breath. I’m trying to breath. I use all my might to try to
suck with a closed glottis. You create great negative pressure from
the muscles of respiration. Here are the walls of the rib cage and
the muscles. This is pulling out, causing negative pressure. This is
one container. This negative pressure translates here, and now
there’s a negative pressure in the alveolus. Guess what happens.
Fluid is in there. Its called negative intrathoracic pressure
pulmonary edema. That’s what happened in this case. What the
doctors did to this guy is blatant malpractice. Blatant malpractice
is what these people did, and that’s what caused this problem. It
cannot be attributed to- -that he got narcan. He ran into problems
before they gave him the narcan.
Dr. Simon also commented upon the three references listed in the index to the NIDA
Report under the heading “Side Effects.”17 Simon argued that in each of the instances discussed
in these articles in which there was an episode of respiratory distress, the distress occurred before
the patient received the opiod antagonist. The implication drawn in each case was that the
pulmonary edema was caused by or associated with the opiod antagonists. However, in Simon’s
opinion, in each case the “much more plausible explanation” was that the distress was unrelated
to the administration of the antagonist.
Simon also discussed other published materials, including a “very biased article” by Pfab,
Hirtl and Zilker; Opiate Detoxification under Anesthesia; No Apparent Benefit But Suppression
of Thyroid Hormones and Risk of Pulmonary and Renal Failure18. This 1999 article, published
after the NIDA Report, discussed alleged side effects of opiate detoxification under anesthesia.
It concluded that there was a suppression of thyroid hormones; however, according to Simon,
except for one hormone, the levels were all normal. The other levels were merely decreased, but
still lie within the normal range. This result is a normal physiological response mechanism to
stress. The “Suppression” in the title of the article really refers to a response to the stress of
opiate withdrawal, constituting secondary hypothyroidism, which is a normal response. The
article is therefore misleading.19
17
Partridge BL, Ward CF: Pulmonary edema following low-dose Naltrexone administration, Anesthesiology Vol. 65: 709-710 (1986); San L,
Puig, M, Bulbena A, Farre M: High Risk of Ultrashort Noninvasive Opiate Detoxification, American Journal of Psychiatry 152: 956 (1995); Taff
RH: Pulmonary edema Following naloxone administration in a patient without heart disease Anesthesiology 59: 576-577 (1983).
18
Published in Clinical Toxicology, 37(1), 43-50 (1999)
19
The authors concluded that there was “no obvious benefit” from opiate detoxification using anesthesia and high, repetitive doses of opiateantagonists and that the “risks are high.” In addition, they found that, contrary to what they claimed to be the contentions of supporters of the
method, withdrawal symptoms continued after 48 hours.
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The witness also reviewed two additional “case reports” from Australia, each published
well before the issuance of the NIDA Report and, incidentally, before Dr. Gooberman began to
utilize UROD to treat addicts.20 He opined that the cause of the complications reported in each
case report as having been experienced by patients who received naloxone was not the use of that
drug. In the case reported in the “Wride” note, the patient had experienced facial trauma and
surgery was necessary. The patient was intubated twice and then again for a third time. The
patient then went into laryngospasm. The intubations were made easier by the use of a muscle
relaxant, succinylcholine, a “very dangerous” drug when given in repeated doses. In Simon’s
opinion, the death of this patient was the result of a phenomenon attributable to the multiple use
of the succinylcholine and the pulmonary edema was of the negative intrathoracic type and was
caused by poor airway management, not by the use of naloxone. Neither case proved anything
about the alleged relationship of the complications to the use of naloxone. There is simply no
mechanism proposed for that drug to have caused these complications. Indeed, Simon reviewed
the alleged causative effect between naloxone, nalmefene and naltrexone and “could find no
correlation between pulmonary edema and any of those antagonists.”
Simon also commented upon the “Brimacombe” note, which reports on a patient with a
gangrenous appendix, a condition which itself can cause sepsis and “all kinds of problems in
anesthesia.” The patient was reversed from anesthesia, but did not appear to be in sufficient
condition for extubation. Naloxone was administered. The tube was removed and the patient
went into laryngospasm, a not uncommon complication of anesthesia caused when the vocal
cords are “tickled” and the protective reflexes shut down and close. In his opinion, this process
caused negative intrathoracic pressure pulmonary edema, which would have occurred even if the
naloxone had not been administered.
In the second case reported by Brimacombe, a 69-year old man with a mass in his lung,
angina and ischemic cardiac disease, presented in cor pulmonale, basically pulmonary edema
caused by heart failure. He was given an opiate antagonist and still had pulmonary edema. In
Simon’s view, it is “absolutely ridiculous” to conclude that the naloxone caused the edema. The
The first case note, authored by Wride, Smith and Courtney, is entitled “A Fatal Case of Pulmonary Oedema in a Healthy Young Male
Following Naloxone Administration.” Anesthesia and Intensive care, Vol. 17, No. 3, August 1989. The second case note, authored by
Brimacombe, Archdeacon, Newell and Martin, is entitled, “Two Cases of Naloxone-Induced Pulmonary Oedema, The Possible Use of
Phentolamine in Management.” It was published in Anesthesia and Intensive care, Vol. 19, No. 4, November 1991.
20
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patient had it anyway, and there is no cause and effect between the pulmonary edema and the
opiate antagonist.
Addressing other aspects of the NIDA report, Dr. Simon argued that the authors’
criticism that UROD was not a cure for addiction showed their bias, as it most assuredly is not a
cure and there is no suggestion of a claim that it is a cure. However, detoxification is a first step
to rehabilitation, indeed, it is a “required first step. You can’t do the other parts without going
through the detoxification first.”
Another criticism voiced in the Report is that UROD is not justified due to the existence
of several other less expensive and less elaborate detoxification methods. This position fails to
take into account that Dr. Gooberman was charging $3,600 in a free-standing clinic, rather than
the cost that is charged with a hospital setting and using anesthesiologists, where in Connecticut
one hospital charges $5,300 and another $6,000. He believes that this criticism is at least
symptomatic of a “turf war” between practitioners of different approaches to addiction treatment,
psychiatrists who “make their money through the behavioral health care therapy” and medical
people “doing detoxification [who] make their money on the front part.” All of this is occurring
at a time when “money is drying up for behavioral health, especially for substance abusers.”
Simon noted that while the NIDA Report complains of the lack of any randomized,
controlled double-blind study of UROD, it would be very difficult ethically to perform any such
study. Simon conceded that he does not know how to do it. Dr. Kleber’s application for a grant
also addresses this problem, and his conclusion is the same.
In summation, Simon does not agree with the NIDA Report’s conclusion that, based upon
available information, UROD is “currently without ethical, medical, scientific or financial
justification.” He contends that the authors relied on outdated data, misrepresented the mortality
rate for alternative forms of opiate detoxification and misrepresented the risks of anesthesia. The
major risk identified was pulmonary edema, however, “they totally missed the boat” on this
subject.
The mortality rate for non-UROD detoxification is “very low.” In fact, Simon’s clinic
has never had a fatality, although there have been overdoses after detox, “because they are at a
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high risk for overdose.” However, he is unaware of any systematic study regarding this question
in regards to opiate detoxification. As for UROD, no outcome study exists to demonstrate
whether it has medical efficacy. As to those patients who died who did not take any illicit drugs
post-procedure, in the absence of a well-designed study that could demonstrate scientifically that
the procedure induced greater stress than other methods of detoxification, it is not possible to
determine whether they died within this relatively short time because of anything relating to the
procedure. Further, Simon disagrees with the allegation in paragraph fourteen of the Complaint
that the alternative methods of opiate detoxification without complication have established
mortality rates of zero. This also is not accurate.
Dr. Simon does not consider that UROD, as practiced by the respondents, constitutes “a
dangerous medical procedure,” with the caveat that “every medical procedure had risks and
benefits. There are risks to the procedure. The risks are acceptable.”
Dr. Simon contended that there is a known mortality risk in opiate detoxification and the
fact of medical complications in some of the instances was unrelated to the deaths. He believes
that the withdrawal syndrome that is related to opioids carries a risk of mortality. He does not
know what the phrase “virtually no risk” means in the context in which it is used in this sentence.
However, in so-called “uncomplicated patients” the risk is “very slight.”21
The language
identifying a risk of pulmonary edema associated with naloxone has been in the PDR since at
least 1996.
Dr. Simon believed that between 1995 and 1999 there were approximately thirteen
providers of UROD in the United States. He believes that four provided the procedure on an
outpatient basis, one of which was his own practice and another was Dr. Gooberman’s. An
anesthesiologist either directly provided the procedure from start to finish or supervised and
directed a CRNA or other health care provider in probably eleven of these thirteen. The
exceptions were the respondents’ practice and that of Dr. Alan Kazan in Arizona.22
The only professional organization in the United States that has formally approved
UROD is ASAM.
There is an organization in London, with a name something like
The sentence reads: “The withdrawal syndrome with opioids—including those that have been therapeutically administered in an opioid
maintenance treatment program—can be protracted and intensely symptomatic, even if it ultimately carries virtually no risk of mortality.”
21
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“International UROD Providers,” that provides the procedure through doctors located in London,
Hong Kong and some in the United States. The procedure is a relatively uncomplicated and
relatively benign one, with a low likelihood of morbidity or mortality.
Based on his experience, Dr. Simon opined that, while there is as yet no consensus in the
scientific community on the risk/benefit of UROD, in the case of most patients the benefits of the
procedure outweigh the risks. The deaths that occurred were, in general terms, primarily the
result of stress occurring due to the withdrawal from opiates that is precipitated by a
detoxification procedure.
These decedents were patients who had preexisting, underlying
conditions which, when subjected to the stress of withdrawal, caused the patients to expire. He
cannot say whether these individuals would have died from withdrawal precipitated by any other
form of induced detoxification.
In testimony, Dr. Simon summarized the benefits of UROD thusly:
If you do a method like Dr. Kleber where you do naltrexone and
clonidine while the patient is awake, what happens is as the patient
receives naltrexone, they are sicker and sicker and they are
consciously experiencing that.
That causes psychological
aversion. Here is the beauty of UROD. When the patient wakes
up, they don’t feel well. Let’s make no mistake about that. They
feel rotten. This is the beauty of it. Despite taking naltrexone,
they continue to get better. They are more likely to take the
naltrexone. There’s no aversion to it. That’s an enormous benefit.
...
Dr. Simon testified that many addicts have “detox phobia.” This is the result of their
having attempted to detox and therefore having knowledge of the severe difficulties withdrawal
causes. They do not want to go through those again. To the extent that UROD brings into
therapy for detoxification those who would not ordinarily approach the system for treatment, it is
also a benefit. In theory, it would also have a lower rate of recidivism and a higher rate of
persons who would remain drug free. However, even if the recidivism rate were the same,
UROD is a more humane, compassionate method of detoxification.
22
Simon believed that there might have been another provider, Dr. Waisman, in Los Angeles. This is apparently the same Israeli physician
referred to earlier as utilizing UROD to treat soldiers in Israel.
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Addressing the efficacy of UROD, Dr. Simon explained that he had made a presentation
in 1998 concerning two follow-up studies done by telephone on the first 162 patients treated by
his organization. This showed that 73% of those in the first study were opiate-free at an average
of 92 days after the procedure; 75% were opiate free 108 days out. At face value, this is a very
high success rate. In traditional detoxification, 50% relapse by three and one-half to four months
out. In addition, 54% of those detoxed engaged in an ongoing program of behavioral health care.
Simon was surprised to find that the relapse rate was the same whether the patients were
counseled or not.
Dr. David Bradway first became aware of the NIDA report in or after 1996 when Dr.
Gooberman gave it to him. He understood that it was a non-official document evaluating
UROD. He believed that its conclusion was that the risk of general anesthesia was high for some
patients when weighed against the benefit for those patients and that this conclusion was only
applicable to a certain population of patients. Both he and Gooberman felt that the report
expressed the opinion of one group of doctors who had prepared the report and neither
necessarily agreed with it.
Dr. Gooberman testified that he probably became aware of the NIDA Report in
April/May 1996 and filed a rebuttal to the document within days. The report made him “angry.”
He felt that the document was an unofficial paper, produced by a group of persons who had
never even seen UROD. The chairperson of the committee was not a physician. The report was
“unfair” and “self serving.” While he would not suggest that such consultants for the reports as
Drs. Kleber or O’Brien were themselves “shoddy,” nevertheless, he felt that the report produced
by the authors and consultants was “shoddy work,” that was based upon a couple of papers from
Europe. The research called for in the Report “had to be by them,” that is, by the authors or
consultants, who were NIDA affiliated researchers who were saying that NIDA should pay for
research. Indeed, some of the persons responsible for the report had been invited by him to
witness the procedure at his office, but they had not come. Additionally, although by the time of
its issuance Gooberman had done several hundred URODs, they did not choose to talk to him.
Gooberman explained that, as opposed to the analysis presented in the unofficial report,
UROD was at the time of its issuance and thereafter, and is today, a safe procedure if performed
by properly trained individuals. The idea that UROD is not an established or accepted method is
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quite wrong, as it has been performed in Europe for about thirteen years and is “pretty well
established.” There are many physicians performing the procedure both in the United States and
overseas.
An “Alternative” Assessment of UROD: The ASAM Public Policy Statement
Dr. David Smith characterized NIDA, as “just one professional organization that had
reviewed” UROD. Another organization, the American Society of Addiction Medicine, or
“ASAM,” has also considered UROD and has taken a position regarding this detoxification
method. Smith described ASAM as an organization that is “the nation’s specialty society of
physicians that specialize in addiction,” a constituent element represented in the American
Medical Association House of Delegates.
In 1996, during Dr. Smith’s presidency of ASAM, the organization was contacted by the
New Jersey Attorney General’s Office to inquire as to its views on the legitimacy of UROD and
whether the group had a policy on the procedure. Triggered by this inquiry, the group initiated a
study by its Practice Parameters Committee. The purpose of the review was to determine
whether the procedure was “evidence based,” a term used in medicine to denote that there is
“literature that supports . . . the procedure.”
As a result of the ASAM review, David Simon, considered by those at ASAM
responsible for dealing with the issue of UROD as the “most knowledgeable” about
UROD/ROD, prepared a review article. Chris Kasser, a “well-known physician in addiction
medicine” associated with the Departments of Psychiatry and Medicine at the University of
Tennessee and a member of the ASAM Board of Directors, prepared an editorial. These were
each published in the Journal of Addictive Diseases, Vol. 16 (1) 1997.23 In his article, Dr. Simon
attempted to review some of the controversies surrounding UROD, its safety, efficacy, cost, etc.
Dr. Kasser’s editorial criticized his methodology and use of analogies, and stated that, while
there was substantial literature worldwide regarding UROD, nevertheless there were deficiencies
in the research that had been performed regarding the procedure. There had been no doubleblind, controlled, randomized test, which is the highest level of scientific testing used. There
Simon’s article is entitled, Rapid Opioid Detoxification Using Opioid Antagonists: History, Theory and the State of the Art, J. Addict Dis.
1997; 16(1): 103-122. Kasser’s editorial, Current and Future Prospects for Rapid Opioid Detoxification with Opioid Antagonists, is at J. Addict
Dis. 1997; 16(1): 1-4.
23
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also had not been randomized treatment outcomes studies to determine whether the claims made
with regard to the long-term outcome were valid or not. Kasser wrote
In conclusion, a body of knowledge related to opioid withdrawal
management is emerging from clinical and basic research.
However, we are just beginning to sort out the incredibly complex
issues related to rapid opioid detoxification using opioid
antagonists. It appears that there is a critical need to provide
further assistance to clinicians and patients by objectively
determining what is known and what is not known about potential
risk and benefits of particular procedures. Dissemination of
relevant evidence-based guidelines for anesthesia administration
could be helpful now. There is also a need for well designed
research to provide more answers and information related to these
interventions.
Enhanced treatment for patient with opioid
dependence and other substance use disorders will only come
through the collaborative efforts in scientific research and clinical
addiction medicine.
Characterizing the difference between Kasser’s call for more information and research
and the somewhat similar sounding words in the unofficial NIDA Report, Dr. Smith criticized
the NIDA Report’s “jumping to the conclusion that this method is without ethical, medical,
scientific or financial justification and then call for more research. The NIDA report is like let’s
have a trial and hang them rather than talking about the research . . . .”
The ASAM Public Policy Statement on Opioid Antagonist Agent Detoxification Under
Sedation or Anesthesia (OADUSA) was finally approved in April 2000. Dr. Smith explained that
the title expresses simply another label for the procedure also known as AROD or UROD. The
Policy Statement takes a different position as to the procedure from that contained in the
unofficial NIDA Committee report.
ASAM considers UROD to be one of a number of
acceptable alternatives in the treatment array, although it is not considered a comprehensive
treatment. In summing up its views, ASAM elaborates the following:
1.
Treatment of addiction is a complex process that involves
management of substance use, relapse potential, denial, treatment
acceptance, treatment engagement, treatment retention and, when
necessary, the treatment of withdrawal symptoms.
2.
Any method of opioid detoxification is only a first step, and
is not in itself an effective treatment of opioid addiction. ASAM
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does not support the initiation of opioid detoxification
interventions when these are not a part of a continuum of services
that promote ongoing recovery from addiction.
3.
Opioid detoxification using antagonist agents along with
either oral or intravenous sedation or general anesthesia may be
referred to as ‘Opioid Antagonist Agent Detoxification Under
Sedation or Anesthesia’, or OADUSA.
4.
OADUSA can be an appropriate withdrawal management
intervention for selected patients, provided that such services are
performed by adequately trained staff with access to appropriate
emergency medical equipment.
5.
All candidates for OADUSA should be informed about the
known benefits, risks, and financial costs of the proposed
procedure in comparison with the known benefits, risks, and
financial costs of other treatment options available in the
community. Women of childbearing age should have pregnancy
tests completed prior to the initiation of OADUSA. For patients
receiving opioid agonist maintenance therapy, risk of relapse to
addiction with the discontinuation of maintenance treatment should
be discussed.
6.
The patient’s written informed consent should be obtained
prior to any planned course of OADUSA.
7.
Patients treated with OADUSA, especially when it employs
general anesthesia, require a sufficient period of medical
monitoring of their clinical status by the medical detoxification
treatment team immediately subsequent to the procedure, in order
to address clinical issues of craving, acute relapse risk, and
accompanying agitation.
8.
Although there is medical literature describing various
techniques of OADUSA, more research is needed to better define
its role in opioid detoxification. Further studies of outcome are
needed, including both the safety and efficacy of OADUSA as
compared to other opioid detoxification modalities, as well as any
differential effects on the long-term rehabilitation of opioid
addicts.
9.
It is recognized that the methods of opioid detoxification
available in a given community will evolve over time with the
advancement of biomedical knowledge and treatment research, and
that efficacy, safety, and cost profiles will continue to change
along with the science and practice of addiction medicine.
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Dr. Smith cautioned that the fact that ASAM issued its policy statement does not connote
that it was attempting to establish therein any definition of the standard of practice. In fact,
according to Dr. Smith, ASAM is very cautious regarding the establishment of a standard of
care. There may be many variables, each of which may be an acceptable procedure allowable
within the standard of practice.
ASAM members were concerned that on occasion the
established standard of care can be improperly used when applied in the legal context. There is a
fear that any minor deviation from the announced standard of care may be deemed to violate the
standard, when in fact minor deviations are generally allowed. In fact, he noted that in the
medical community, there is a preference for the term “evidence based,” rather than “standard of
care.”
In Dr. Smith’s view, the NIDA study constituted just one more piece of information to be
factored into the debate regarding the legitimacy of UROD. Indeed, he noted that whereas
NIDA is more of a research-based organization, ASAM is actually a treatment-oriented group.24
In the case of a procedure such as UROD, while there may be a lack of double-blind studies,
there is nevertheless a population of addicts who need treatment and therefore the “problem is in
front of you.”
Studies are very expensive and if government and drug companies won’t
undertake them, doctors “in the field” still must treat patients. There is a “yawning gap” between
clinical practice and research. This creates “friction because the research is perceived, in many
cases, as isolated from front lines of addiction treatment, which is unfortunate because research
is necessary to gather new knowledge, to improve the quality of care and also makes the research
tend to be irrelevant if it’s not translated in clinical practice.”
In the doctor’s view, this
“yawning gap” may explain “differences of opinion among addiction specialists based on their
alliance with either research orientation or clinical orientation.”
Dr. Smith disagreed with the statements in Count One, paragraph 2, of the Complaint,
wherein it states that UROD/ROD is “neither a medically established or recognized addiction
procedure” and is “a relatively new, highly controversial procedure within the medical/scientific
community, which is neither approved nor recommended by a government or professional
body.” Commenting on the importance of UROD, Smith noted that the addict population is at
high risk and the addicts frequently have significant health-care problems.
The fear of
withdrawal itself is such that in many cases it will dissuade patients from even considering
24
There will be more said about the treatment orientation or the research orientation of physicians and experts later in this opinion.
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entering treatment. UROD provides an alternative means of withdrawal, which may assist
physicians and patients in bringing about withdrawal.
In addition, the dropout rate from
treatment is a “crucial outcome for consideration in assessment of overall efficacy.” This
procedure provides a “viable option,” in that “patients understand that they will be physically
detoxified from opiates after the completion of the procedure.”
Dr. Smith also denied the allegation at paragraph sixteen, page seven, that the provision
of UROD by these physicians “demonstrates a clear and imminent danger to the public’s health,
safety and welfare.” In fact, heroin addiction is a chronic, relapsing and potentially fatal disease.
The heroin epidemic is nationwide in scope. There are a “lower percentage of people with
heroin addiction in treatment than any other chronic, relapsing and potentially fatal disease in our
country and the procedure talked about here leads to an accepted method of treatment for heroin
addiction and they are basically saying that treatment creates addiction and treatment is a threat
to public health, which I believe is an extremely inaccurate statement and is part of a nationwide
public debate that’s going on between law enforcement and treatment.”
Dr. Smith testified that, although the FDA has not approved UROD as a procedure, just
as it has not approved clonidine for use in addiction treatment, nevertheless, during the 1990’s
UROD has become an accepted method of treatment within the addiction community. However,
Dr. Smith was unable to say just when that acceptance arose.
He is unsure how many
practitioners were using the procedure in one or another form between 1995 and 1999, although
he listed several of whom he was aware.
In determining the acceptability of the respondents’ practice, Dr. Smith relied extensively
upon the ASAM standards.
Dr. Gevirtz is not a member of ASAM, although generally familiar with the organization.
He is aware of its guidelines regarding UROD and its most recent policy statement.
He
explained that the ASAM standards contain significant differences from the standard he uses and
recognizes. He agreed that prior to 1996 UROD was thought to be a safe and uncomplicated
procedure.
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Dr. Gooberman played a role in the formulation of the ASAM Policy Statement as a
member of its Public Policy Committee. The chair of the Committee on Standards asked the
chair of the Public Policy Committee to develop standards regarding UROD. Dr. Simon was
also a member of the Committee; he and Gooberman being the only members who were familiar
with UROD. Gooberman was placed on subcommittees and the discussions went on for a
number of years.
The Committee had twenty to twenty-five members and held meetings
generally attended by ten to twelve members. The policy that was developed was sent to the
Board of Directors, a group of about twenty-five to thirty members; a board of which neither
Simon nor Gooberman was a member. The Board voted and adopted the policy. The ASAM
Policy Statement addresses UROD as an alternative method of treatment.
The Deaths of Seven Patients
With this background concerning detoxification and UROD, this opinion will now turn to
the evidence regarding the demise of the seven patients treated by the respondents.
Dr. Robert Segal was covering the Medical Examiner’s position in Burlington County on
July 4, 1998. As a result, he came to perform the autopsy on Lester Kindig, a known drug abuser
whose death shortly after he had been to a clinic for detoxification was, in Segal’s
characterization, an “unexpected death under unusual circumstances.” The findings on autopsy
were essentially negative and there was no obvious cause of death. Dr. Segal was puzzled by
this and did not understand why Kindig had expired. He expected that when he received the
toxicology report it would show a straightforward drug death. However, the toxicology findings
were “confusing,” which in itself was strange as these are usually quite understandable. Thus,
the situation surrounding Kindig’s death did not make much sense to Segal.
The toxicology findings suggested that after the procedure Kindig had obtained more
illegal drugs, as methadone and free morphine were detected. Free morphine takes four hours to
disappear from the system. However, the death occurred about six hours after the procedure.
When Segal spoke to Kindig’s significant other, Ms. Klein, she advised that there was “no way”
that Kindig had taken any heroin post-procedure. She advised that Kindig was “totally wiped
out.” To Segal, she sounded “fairly convincing,” and he “tends to believe” her statements of
“the truth as she knows it to be.” He asked that she write down all that she could think of, and he
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intended to try to determine if there was any other explanation for the death other than that
Kindig had ingested heroin after the procedure. He hired several persons to assist him, and then
he learned about other cases involving post-UROD deaths. He found these to be an, “ongoing
mystery that needed a solution.”
Because of the confusion presented by the toxicology, Dr. Segal consulted with other
physicians. He first approached a doctor specializing in pain management at UMDNJ Stratford
and a pharmacologist and pain expert at the Philadelphia College of Medicine. Neither was very
helpful. He then spoke to his former student, Dr. Karan. He could not understand the presence
of some of the substances discovered in the body fluids. Dr. Karan was able to “educate" him.
However, Segal is unable to say how much of her expertise provided anything more than
academic background for his own opinion.
The pathologist reviewed the records and autopsy reports for Messrs. Stavola, Beigelman,
M.J. and Kindig. He had the toxicology reports for all these except Stavola. After analysis, he
determined that, to a reasonable degree of medical certainty, the UROD procedure performed on
each of these decedents contributed to their demise. In explaining his conclusion, the doctor
noted that occasionally the cause of death of an individual is not obvious, as the causative
condition or factor only existed during the life of the patient. For instance, most of the time it is
not possible to tell if an arrhythmia killed a patient. Sometimes the medical history will allow
for a diagnosis of the cause of death. In the several cases under consideration here, a very
significant factor is that the patients each went in to the procedure “essentially healthy" and then
died relatively shortly thereafter. Each entered the procedure in “normal health,” although they
were each drug addicts. As best as he could determine none suffered from any incapacity. They
had no medical problems of consequence. Each was examined at the clinic by a doctor and was
apparently not found to have any negative condition or finding as regards the ability to undergo
the procedure. They each then had UROD performed upon them. After the procedure, they
were “no longer normal healthy” persons. Each was described to him as having been “pretty
wiped out,” unable to walk under their own power, and each had to be assisted out of the facility,
one of them having to be lifted into the car. Each went to bed and was unable to get out of bed.
Some slept most of the time. None became “better” or “well.” Each then succumbed. The
autopsy result for each was essentially negative. There was no obvious gross or microscopic
finding. Each had some toxicologic finding. There was no independent, intervening cause. In
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some instances, the toxicology findings could explain the death, except that each had been given
a drug antagonist. None had suffered an identifiable overdose. The deaths were not sudden,
although he conceded that in Stavola’s case the death might be so characterized, as the decedent
got up out of bed and fell over. Beigelman was sick before he died, and the death was not
sudden; Kindig was “pretty wiped out,” went to sleep and did not wake up. This death was
“sudden,” and yet it really was not, as Kindig had been in difficulty before he went to sleep. In
Segal’s opinion, given all of these circumstances, there was no way to say that the UROD
procedure did not contribute to the deaths.
The doctor was aware of the stress levels induced by anesthesia and considered these
stress levels in reaching his conclusions. While not an anesthesiologist, he has been under
anesthesia himself, has observed persons under anesthesia, and knows in the “broadest terms”
what occurs. All of the persons with whom he has had some contact involving anesthesia,
including his own experience, recovered. Most did so quickly and well. Statistics indicate that
without any other complicating factors this is the normal result.
Dr. Segal commented upon the stomach contents found in decedents Beigelman and
Stavola. In Beigelman’s case, morphine was found, along with fentanyl and ketamine. In
Stavola’s case, free morphine was found. Segal considered how they could have exhibited these
findings. One possibility was that they had ingested drugs by mouth after the procedure. The
other possibility was that they had been given the drugs, either intravenously or via intramuscular injection. Circulation of the blood could then lead to secretion of the drug into the
stomach, a routine finding. Certain agents can pass by osmosis across the membrane from the
stomach to the blood and from the blood to the stomach. The latter is a quite normal occurrence.
In addition, bleeding can occur into the stomach, perhaps induced by a tube introduced into the
area. As for ketamine, while he had never seen it injected, he acknowledged, “ a few screwballs
might” do so.
The doctor also reviewed the reports and records concerning Ms. Flowers, Mr. Melendez
and G.W. Again, his opinion is that, to a reasonable degree of medical certainty, the UROD
procedure contributed to the deaths of these three individuals. Again, as with the other four
decedents, these persons, while admittedly addicts, were generally healthy, received the
treatment and died shortly thereafter. All were ill when they left the Gooberman clinic. In each
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instance, Dr. Segal could determine no cause for the deaths unassociated with this illness
between the completion of the procedure and the deaths.
No independent causes were
identifiable.
The autopsy report for Victor Melendez, issued by the Office of the Chief Medical
Examiner for the City of New York, listed the cause of death as “persistent nausea, diarrhea, and
vomiting, with ulcerative esophagitis, gastric ulceration and gastrointestinal hemorrhage.” This
latter is “bleeding in the gastrointestinal tract.” There is no evidence known to the doctor that
would suggest that Melendez suffered from these gastrointestinal conditions prior to the
procedure, although he could have had some gastric reflux historically. He opines that the
evidence is of a classic Mallory-Weiss syndrome, involving “a tear of the esophagus at the
junction of the stomach from persistent vomiting, which he suffered from the time he left the
clinic to the time that he was admitted to the hospital.” In this decedent’s case, this condition
could have developed within two to three days. The condition is sometimes seen in chronic
alcoholics, who do not know when to stop. The description of coffee-colored material vomited
by Melendez indicates blood. If the person had a pre-existing condition, then the use of opiates
could mask the pain associated with this condition.
Dr. Segal assumes that Melendez ingested methadone after he was discharged. However,
this does not change his opinion as to the cause of death. When Melendez left the treatment
facility, he was nauseous and vomiting the whole time. The autopsy showed that he died of
complications, predominantly nausea, diarrhea and esophagitis.
These were ongoing
complications from the time of discharge until death. Thus, in Segal’s opinion, if he did ingest
methadone, it “certainly may have increased his chance of dying, but it did not kill a person who
wasn’t going to live anyway.”
Dr. Segal disagreed with the medical examiner who performed the autopsy on Mr.
Melendez. In Segal’s opinion, Melendez’s heart, which weighed 450 grams, was not a “heavy
heart” for a man who weighed 235 lbs. Nevertheless, he agreed that he did have an enlarged
heart muscle. The heart was not healthy. There was moderate to marked fibrosis, that is, scartype tissue. In addition, there was scarring within the arteriolars, a condition known as arteriolar
sclerosis. There were very significant degrees of blockage of arterioles. The heart pathology in
itself could be the cause for a person’s death. If a person with these conditions also had
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amphetamines in the system there would certainly be a higher probability that the cause of death
was a combination of the amphetamines and the underlying heart disease. The toxicology
reports for Mr. Melendez confirmed the presence of amphetamines.
The examiner also found evidence of dead liver cells, which is not a normal finding for a
man of thirty years old. Thus, Melendez presented as a man with significant signs of alcoholic
liver disease. Despite his earlier characterization of the patients who died, he agreed that a
person with Melendez’s profile was not “an otherwise healthy person.” However, despite his
liver disease, Melendez was still able to walk into the clinic and appear healthy enough to pass a
physical examination allowing him to go through detoxification. While he had underlying
disease, he was not a “sick” person at that time. Melendez did not have cirrhosis of the liver, and
the type of liver disease that he had is not usually associated with esophageal verises, in which
veins which pass along the stomach and the esophagus may bleed due to the scarring and back
pressure in the veins of the esophagus usually associated with cirrhosis.
Lisa Flowers’ heart weighed 300 grams. Dr. Segal characterized this as a little enlarged,
a condition known as hypertrophy. A 110-pound woman normally has a heart that ranges
between 250 to 270 grams and perhaps up to 300 grams. One would look for a reason if the
weight were above 270-275 grams. There was evidence of anterior papillary muscles showing
small foci of hemorrhage near the implantation of the chordae, that is, where the valve system
attaches to the heart wall. This finding was, “not uncommon but not normal."
The toxicology report noted the presence of free morphine in Flowers’ blood. There was
also 3.84 micrograms per liter of fentanyl. Flowers died eighteen hours and twenty minutes after
discharge. Her stomach contents included 9.81 micrograms per kilo of fentanyl. A liter of blood
is equivalent to one kg. The concentration of fentanyl in the stomach was higher then in the
bloodstream. While the doctor was not aware of any biological mechanism that was an active
transport for fentanyl from the blood to the stomach, nevertheless, he would be “shocked that
there was not such a thing." As for the cause of her death, the medical examiner who performed
the autopsy first stated that it was “bilateral pneumonia, pending studies,” and later amended the
finding to “myocardial infarction following rapid detoxification.” The evidence of chronic
interstitial pneumonia is different from aspiration pneumonia, and had nothing to do with her
death.
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Examining the records for Mr. Beigelman, Dr. Segal noted that the medical examiner
found cardiomegaly with biventricular dilatation. This means that the gentleman had an enlarged
heart. Both ventricles were abnormally swollen. The doctor described this condition as like a
balloon that is in enlarged, overblown, but the walls are not themselves thickened. There were
also deposits of fatty material within the heart muscle itself. The amended cause of death listed
by Dr. Ragasa, the medical examiner, was “multiple drug intake, post detoxification therapy." In
Segal’s opinion, to a reasonable degree of medical certainty death resulted from withdrawal, the
effects of the detoxification procedure and from the presence of a number of drugs in the body.
The next patient whose records were reviewed was Frank Stavola. Mr. Stavola had
hepatosplenomegaly, which means that both the liver and the spleen were enlarged. It is not
normal for these organs to be enlarged.
The toxicology report for this patient lists
benzoylecgonine, a metabolite that is a product of the breakdown of cocaine. Cocaine ingestion
can cause an abnormal rhythm of the heart. Abnormal rhythms can cause pulmonary edema.
The toxicology report showed .03 milligrams per liter of free morphine in the blood, and .22
milligrams of free morphine was found in the stomach contents. This is seven times as much
free morphine as was found in the blood. Morphine can also cause pulmonary edema. The
cause of death listed for Mr. Stavola is pulmonary and cerebral edema and the amount due to
drug use (morphine, cocaine, nordazepam).
The anatomical diagnosis for decedent M.J. reveals severe acute pulmonary edema.
There are many reasons why one might have fluid in the lungs and one of these can be
irregularities in the heart. Generally, with the exception of minor changes that might be seen
microscopically in the heart muscle and indicate a ventricular dilatation, one would generally not
be able to document an irregularity of the heart at autopsy. In addition, Mr. J. had mild
myocardial hypertrophy with ventricular dilatation. An enlarged heart can lead to the organ
experiencing abnormal electrical conduction, which can set off arrhythmias, the existence of
which can also lead to pulmonary edema and can be fatal by themselves.
Dr. Segal addressed questions about the toxicology finding that Lester Kindig had
ethanol, which is alcohol, in his body. The accepted rate for the burn-off of alcohol from the
system of an average sized man such as Kindig is .015% per hour. The procedure he underwent
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lasted for about four hours. He died eight hours and seventeen minutes after his discharge, a
total of twelve hours and seventeen minutes. The toxicology report showed his alcohol content
to be .03. An average sized person who presented to a doctor prior to the onset of his procedure
with enough alcohol in the system such that after approximately twelve hours of burn-off that
person still had a .03 alcohol content would have been obviously demonstrating signs of
intoxification visible to a trained physician, such as those who examined Mr. Kindig. However,
the doctor posited the possibility that the alcohol discovered was in fact formed after death and
prior to the autopsy, and was thus a “postmortem artifact.” He has seen levels as high as .10 and
.12 at postmortem and fermentation can continue in the test-tube if it sits too long. However,
Segal acknowledged that this might not be the correct explanation in this case.
Mr. Stavola had a normal size heart, not a big heart. The evidence of interstitial fibrosis
indicates a minor abnormality, not one that would have caused clinical problems. His liver
showed some mild, inconsequential changes. No fentanyl was reported in his stomach, although
there is no indication that any attempt was made to look for any.
Dr. Segal took into account “the whole big picture” in attempting to explain his reasons
for concluding that the UROD procedure employed by the respondents caused or contributed to
the deaths of these patients. He agreed that the UROD procedure did not itself kill them, and
neither did the anesthesia. As for the medications employed, the fentanyl employed during the
procedure might have contributed to the deaths. However, the opiate blockers used should have
blocked all opioid-type drugs. In this connection, Segal noted that he could not explain why one
giving a patient an opiate blocker would then simultaneously provide the patient with an opiate.
There is not a lot of post-mortem experience with this fentanyl. However, it is a potent drug, and
giving it, “doesn’t make sense and particularly in retrospect, when the possibility of an overdose
of a combination of opiates, narcotics is playing a role, the fentanyl is certainly a potential
contributor to that.” He had seen two or three decedents in his experience, who had received
lethal doses of fentanyl from patches. However, he added that, “I’m a pathologist, not a real
doctor . . . I’m having my problems with that, but I’m not bright enough to know the answer.”
In a summary of the reasoning for his opinion, Dr. Segal stated that the patients were not
shot, were not stabbed, were not hit by a car and “were not given a massive overdose of anything
that we can identify that caused the death. There is no way for me to say that these procedures
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did not contribute to the death.”
He took into account that they were not hospitalized
immediately after the procedure and did not have professional caregivers tending to them. This
played a significant role in the fact that, in my opinion, certainly
had these people been adequately monitored - - adequate is not
even the right word - - medically monitored, the fact that they were
getting into trouble may have been identified more rapidly.
Appropriate medical things might have been done, and their lives
might have been saved.
While the witness conceded that there could be no certainty that any one or all could have
been saved, he nevertheless said that
The chances would have been much, much better had they been in
an intensive care facility, who are used to following these people
and capable of providing the type of care of resuscitating,
monitoring and saving lives.
The witness agreed that the several cardiac problems affecting these individuals were not
of such a character that they would have known they had them, and were not conditions that
would have been detected by ordinary diagnostic testing. These were hearts of normal size, so
that even with a transthoracic echocardiogram, which could identify the size of the heart, that
finding would not have been significant. Even the most meticulous cardiac workup “would not
show anything.” These “were not sick hearts,” which he would describe as “a heart that has
disease in it. It’s a heart that has severe coronary artery disease, old infarction, new infarction, a
lot of scar tissue, a heart that’s obviously significantly large, a heart that is in congestive failure.”
People with these conditions “normally have symptomatology.” In these patients however, the
only such symptomatology that he is aware of was one who had hypertension.
Segal added that the stress that was “obviously” a part of the UROD procedure
“contributed” to the deaths. In answering the judge’s question with the summary described
above, Segal did not refer to the stress, as “[I]t obviously was stressful and obviously
contributed. That part is so obvious, I didn’t include it.” However, he could not identify to what
degree the stress contributed to the deaths. “It didn’t cause. The problem with these is that we
don’t have a single cause. We have a whole bunch of things piling up on top of one another.”
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Withdrawal is itself a stressful process and there is no question but that the whole idea of UROD
involves inducing withdrawal.
To a reasonable degree of medical certainty, none of the decedents other than Melendez
took illicit drugs after leaving the clinic. In Melendez’s case, Segal believes that if the laboratory
studies were correctly performed he must have gotten some methadone prior to hospitalization.
Melendez’ cause of death, as described by Dr. Milewski, does not implicate a live condition or a
cardiac condition.
Mediastinitis, which is an infection, was involved.
He died from
gastrointestinal hemorrhaging, lacerations of the stomach junction and the esophagus, caused by
vomiting resulting from the detoxification. To a reasonable degree of medical certainty, the
opioids, cocaine or benzodiazepines found contributed to the deaths, but Segal stressed that they
were not the only factors causing them. Stavola and Kindig died from the combined effects of
withdrawal, the stress of detoxification and the drugs found. The level of fentanyl discovered in
M.J. was within the lower end of that observed in dead bodies, which is not the same as in live
bodies. He also died from the combined effects of the stress of detoxification and withdrawal.
Ms. Flowers was cachectic, wasting away, emaciated. However, this was not a factor in her
death. He has “no doubt in his mind” that she died of an acute myocardial infarction caused by
the detoxification procedure. She had no coronary artery disease and only the stress and the
medications she was given. In G.W.’s case, death resulted from severe aspiration pneumonia
resulting from the aspiration of gastric fluids following UROD.
Dr. Lori Karan became involved in this matter because of a prior association with Dr.
Robert Segal, dating back to when she was a medical student at Hahnemann Medical School in
Philadelphia, where Dr. Segal taught. As previously noted, Segal had become involved in the
investigation of the deaths of Beigelman, Stavola, M.J. and Kindig. During a telephone call
about matters unrelated to these respondents, Segal told Karan that he could not explain the
cause of death of these persons and, knowing of her expertise in the addiction medicine field, he
asked her to review the records associated with the cases. Referring to UROD, he told her that
they had been treated with a “new procedure” and he wanted to find out about it. He sent Lester
Kindig’s fiancée’s letter to her, along with the consent forms, anesthesia records and toxicology
reports for the four decedents.
She reviewed these and consulted informally with an
anesthesiologist and a toxicologist at UCSF.
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Having reviewed the autopsy, toxicology and other medical records and applying her
expertise, including her knowledge of basic pharmacology, Dr. Karan opined that the UROD
procedure as practiced by the respondents caused or contributed to the deaths of the four patients.
Standard methods of detoxification for opiate addicts without co-morbidity (coexisting medical
conditions) have virtually no mortality attached thereto. In the subject cases, there was no
apparent intervening cause to point to as a cause for the deaths that occurred so proximately to
the procedure. However, Dr. Karan acknowledged that she and Dr. Segal “really did not know
what was going on,” as least as to the exact mechanism of these four deaths. It is not really
known what the potential causes of these deaths were. To the extent that the exact mechanism is
not known, one is left with theory and speculation as to what occurred. However, the deviations
from good medical practice could still be contributory, causally related factors in the deaths.
Further addressing her thoughts as to the possible causes of death, Dr. Karan noted that
the temporal relationship between the procedures and the deaths is very important.
The
significance of that relationship becomes less distinct (a “gray area”) from three to four days out
to two weeks from the procedure.
After two weeks, it is more likely that other factors
intervened.
Dr. Segal was concerned as to why free morphine was detected in the decedents’ blood.
Dr. Karan acknowledged that the presence of cocaine and morphine in the blood at autopsy
might be an important determinant as to the cause of death and, in assessing possible causes of
death, she took the presence of these substances into account. Nothing in Gooberman’s UROD
procedure put cocaine into the patients’ systems. In a living person, the presence of cocaine in
the blood means that the drug was taken within two to three days at the outside. Urine detection
could occur from three to five days after use. The half-life of a single dose of cocaine is very
short, less than two hours, and generally, the cocaine would be out of the system within five halflives, or two hours. The presence of the metabolite in the blood means that the drug could have
been used either before or after the UROD procedure.
Dr. Karan noted that there are different receptors (Mų, Kappa, Lambda, Sigma) and each
has subgroups. The effects of the antagonists may differ at different levels within the cell. In the
literature, it is presumed that naltrexone works primarily on the mų receptors, but our knowledge
of all of the brains’ receptors and pathways is limited. It is possible that not all of the opiate
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receptors are blocked. Thus, Dr. Karan questioned whether some of the fentanyl receptors
remain unblocked by the naltrexone and, if that were the case, it is possible that this might permit
the fentanyl to effect respiration. In addition, neither the interactive effects of the drugs used in
the procedure nor the time of their impact is clearly understood. Finally, increased levels of
agonists in the blood following the administration of an antagonist have been documented in the
literature25 and this finding makes sense, as after the antagonist frees up the agonist by knocking
it off of the receptor the agonist has to go someplace. Thus, it is possible that the morphine
found in the blood could be from this “knock off” effect, although the drug would “disappear” as
the half-lives played out. This said, there is no easy explanation for the finding of ketamine in
the blood.
The doctor opined that the levels of opioids found in the blood at autopsy could possibly
have contributed to these deaths, but cautioned that we do not know the tolerance and how the
effects of the opioids were blocked. She does not believe that they were contributory factors to
the deaths if the cocaine present was not taken after the procedure.
Dr. Karan also understood from the autopsy reports that there were no “gross or
microscopic anatomic causes of death.”
She could not comment upon the “normality” or
“abnormality” of the size of the patients’ hearts, although she acknowledged that cardiomegaly
was listed as a finding for Kindig, Beigelman and M.J., as was bilateral dilatation for Beigelman
and M.J. This latter finding means that both ventricles were enlarged, and she agreed that such a
finding was “not normal.” Persons with these conditions are more prone to heart irregularities,
such as ventricular defibrillations, which are arrhythmias that “kill people.” Cocaine could
precipitate such arrhythmias. She agreed that the increase in epinephrine levels circulating to a
dilated heart due to stress (cold turkey) could establish a greater likelihood of arrhythmia. She
noted that three of the four decedents suffered from serious to very serious pulmonary edema,
and as they tried to breathe harder and faster to overcome its effects, they could ultimately
smother from the effects of the extracellular fluid. However, death could also result from
respiratory depression.
Mr. Stavola had hepatosplenomegaly, a large liver and spleen, which is a pathological
finding.
25
Resnick RB, Kestenbaum RS, Washton A., Poole D: Naloxone-precipitated withdrawal: A method for rapid induction onto naltresone.
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Dr. Lin reviewed the toxicology reports filed in the several cases. Assuming the accuracy
of the times and dates provided and the toxicology reports, it is his opinion that to a reasonable
degree of scientific certainty it is more likely than not that in the cases of Beigelman, Flowers,
M.J., Stavola and G.W., these individuals did not use any illicit drug after they were discharged
from Dr. Gooberman’s facility. The toxicology reports reveal that either no opioid or other
lethal substances, or at most only trace amounts of such substances, were found in each of these
decedents. If they had used such drugs after they were discharged, the amount of such drug
present at the time of death should have been “much higher.”
In contrast to these four individuals, Dr. Lin agreed that Mr. Kindig could have ingested
either morphine or heroin after the discharge. It is not unusual for metabolization to occur even
after death.
Cocaine can continue to metabolize, because the body temperature keeps the
enzymes working. A habitual user of cocaine will metabolize the drug faster. In addition,
decomposition can affect the findings.
Dr. Lin determined that it was more probable that Mr. Melendez used methadone after he
was discharged. The level of methadone found in Melendez falls into the average lethal range.
All others had levels below the lethal dose. Methadone is a long acting drug, and it can kill
hours after it is taken.
Dr. Lin commented that he found fentanyl in the blood “pretty often,” usually in the
stomach. Questioned about the ability to detect a drug after the passage of a number of halflives, the witness explained that it depended upon the dose taken. Thus, if enough is taken, given
the sensitivity of the instruments at the State lab, cocaine could be detected even after five halflives. He agreed that if an average healthy person took two drugs, the lethal dosage of the drugs
for that person would be reduced by the interaction of the two drugs.
Dr. Herbert Kleber reviewed the records relating to the seven mortality and two
morbidity cases. These include the hospital records, the doctors’ records and guidelines and the
generic doctor’s orders covering August 1988 to September 3, 1999, and the orders written for
patients Flowers, Hendrix and Perez. He also considered the autopsy and toxicology reports.
Clinical Pharmacology Therapy, Vol. 21, 409-413 (1977).
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Dr. Kleber considered the fact that the majority of the deaths occurred within forty-eight hours
post procedure to be very significant. He explained that the State of New Jersey defines a
complication of anesthesia as anything occurring within forty-eight hours after the procedure,
and in his opinion, any complications occurring within that timeframe should be considered “a
possible complication of the anesthesia." It strains credibility to believe the patients dying within
this window died from anything unrelated to the procedure or the deficiencies related thereto.
He explained that the stress levels involved in the procedure play a part in this opinion. He
compared the UROD procedure to cardiopulmonary surgery, referencing studies regarding
epinephrine, ATCH and Cortisol.
Dr. Kleber opined that, in contrast to the position presented by Dr. Segal, these patients
were not, except for the fact of their addiction, healthy individuals. The doctor believed that
more extensive screening procedures would have kept some of these patients from undergoing
the procedure.
Dr. Kleber explained that there was a risk of pulmonary edema associated with the use of
the narcotic antagonists naloxone, which was used briefly in the Gooberman practice, and
naltrexone, which replaced naloxone. In the cases of Flowers, Perez and Hendrix, nalmephene
was used, rather than the other two antagonists. There are no published papers connecting this
drug with pulmonary edema.
The witness noted that the toxicology reports indicated significant factors. Of the seven
decedents, three had cocaine metabolites present at autopsy and two others had provided
histories of cocaine use. In Kleber’s opinion, these individuals’ use of cocaine was a major
contributory factor in their deaths. The human body does not produce measurable amounts of
the metabolites of cocaine or measurable amounts of ethanol. Therefore, if these substances are
found in the body, the individual has to have ingested them in some manner. The witness agreed
that, according to the standard textbook, Textbook of Pharmacology, by Goodman and Gilman,
the half-life of morphine is 1.9±05, or two to two and one-half hours, and of cocaine, forty to
sixty minutes. A half-life is the period that it takes before half of the substance is no longer
present in the blood. The pharmacological rule is that after five half-lives the substance is
considered absent from the system. As such, if morphine had been taken, after five hours, or the
outside limit of five half-lives of that substance, it would not be detectable by the usual means,
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and similarly, cocaine would be undetectable after ten to twelve and one-half hours at the
outside.
Although he acknowledged that the data is inadequate to assure his conclusion, Kleber
opined that in some cases, indeed perhaps in all, the postoperative care provided was inadequate.
Proper care provided to these patients might have prevented the deaths of some or all of them.
Dr. Kleber believes that because of the potential for morbidity or mortality the patients should
have been kept overnight. At a minimum, they should have been kept until they were able to
ambulate on their own without assistance. They should also have been coherent and been able to
void. The amount of time necessary for each patient to reach this stage would vary, but in his
view, in the majority of cases, it would be at least four hours and would be longer for many
patients.
Based upon his review of the records, Dr. Gevirtz opined that the respondents’ UROD
procedure contributed directly to the demise of individuals. He identified deviations from the
accepted standards of anesthesia practice, both in general and as related to the UROD procedure
itself. He listed the primary differences between the manner in which he performs UROD and
the manner that Doctors Gooberman and Bradway did the procedure:
1) different devices to titrate the propofol;
2) different styles of anesthesia;
3) naloxone challenge used by him for the first cohort of patients, but not
thereafter ; never used by them;
4) he employed a lot more blood screening;
5) he had a psychologist and a psychiatrist involved in screening, each an
addictionologist, they did not use such professionals;
6) the length of stay post-procedure;
7) his use of a lot of gastric prophylaxes, used to prevent upper GI bleeding and gastric
ulceration.
While acknowledging Dr. Kleber as a world recognized addictionologist, Dr. Gevirtz
disagreed with the doctor as to the existence during the years 1995-99 of a standard of care for
the performance of UROD. Gevirtz contended that there were indeed standards for UROD
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during that period, referencing the American Society of Anesthesiology (“ASA”) standards,
which he and the ASA each characterize as “minimum standards.
More specifically, Dr. Gevirtz opined that the use of the fentanyl patch was a deviation
from acceptable standards, as was the failure to employ clonidine. In addition, the manner in
which patients were discharged and the lack of skilled aftercare constituted deviations from
standards. In regard to the discharges, Gevirtz noted that there is no notation of Aldrete scores or
any indication that an Aldrete score was determined. The Aldrete score is determined from a
system used to evaluate the suitability of a patient for discharge. A patient who is not able to
stand, is unable to walk without assistance, to speak coherently and is somnolent is not ready for
discharge from an ambulatory care facility. Premature discharge of a patient can endanger the
patient, who may aspirate and may not have all of the protective mechanisms fully functioning.
Indeed, from 1995-99, the standard of care was to keep the patient slightly sedated after the
anesthesia wore off. There is a slightly increased risk of aspiration. If the blood pressure has not
returned to normal levels, the patient may have a stroke or heart attack.
Dr. Gevirtz explained that at the time that they were being discharged, Dr. Gooberman’s
patients were critically ill individuals who required critical care monitoring. The premature
discharge of those patients who died contributed to their deaths, as did the unavailability of
clonidine, as they could not tolerate vomiting. Gevirtz noted that clonidine, also known as
Catapres, is an Alpha two agonist drug that controls blood pressure and suppresses the release of
norepinephrine. When the drug is used, the catecholamine surge characteristic in detoxification
is not observed.
According to Gevirtz’s June 9, 2000, report, the use of clonidine in
detoxification has been “a standard of care in ultra-rapid opiate detoxification” and has been “an
integral part of detoxification for twenty years.” In addition, the failure to provide adequate
doses of clonidine “will lead to marked elevations of catecholamines . . . which in turn may lead
to cardiac dysrhythmias, pulmonary edema as well as upper gastrointestinal ulceration.”
Dr. Gevirtz acknowledged that while clonidine is generally acknowledged to lower blood
pressure, the FDA has not approved its use for opioid detoxification. Between 1995 and 1999, in
the CITA protocol for UROD, patients were given clonidine to take home and were instructed to
use it in 0.2 milligram doses twice a day (“BID.”) However, these patients were not instructed to
take their blood pressure before each dose was ingested, despite the fact that the drug “has the
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potential to have serious consequences in terms of blood pressure and cardiac effects.” Gevirtz
acknowledged that, like clonidine, benzodiazepines reduce the release of catecholamines.
However, he argued that they do so to a lesser degree than does clonidine.
Dr. Gevirtz opined that the inability of Mr. Melendez to control nausea and vomiting and
maintain hydration caused his death. A deviation from standards occurred in regard to post
procedure care standards. Melendez’s toxicology report did show amphetamines in the urine
samples, #s 8 and 9.
In addition, Gevirtz explained that Dr. Gooberman’s deviations from professional
standards directly contributed to the hospital admission of Messrs. Perez and Hendrix. Fentanyl
is an analgesic, good for control of pain. The witness explained that fentanyl identified in the
stomach contents might be explained by ulceration in the stomach and diffusion of the patch
reservoir across the skin and into the bloodstream. To a small degree, this blood-carried fentanyl
could enter the stomach, while additional amounts would be metabolized by the liver. In the
autopsy report for Marc Beigelman, there is no mention of any bleeding, only a reference to forty
milliliters (“ml”) of brownish liquid.
If there was submucosal hemorrhaging due to the
endotracheal tube, the thin brownish material observed could be partially digested blood.
Dr. Kushins discussed the pre-operative assessments that the Gooberman and Bradway
patients underwent. These included a history and physical examination, but did not appear to
include any extensive pre-anesthetic testing. The patients were drug users who might well have
heart, lung, liver, kidney and other problems. These patients might be cocaine abusers, and
cocaine use itself poses anesthesia risks.
Many abusers have episodes of coronary artery
vasospasm and constriction and some end up with resulting myocardial infarctions that damage
their heart, leaving the heart less able to handle the stresses of anesthetics and particularly the
stresses of opiate detoxification of this nature.
Based upon his review of the records of the patients in question in this matter, Dr.
Kushins opined that there had been significant increases recorded in blood pressure. Blood
pressure and heart rate increases followed upon the administration of the opioid antagonists.
These increases reflect a stress response caused by competitive antagonism for opioid receptors,
which results in a release of catecholamines, which are naturally occurring substances produced
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in the body, including epinephrine and norepinephrine. The increase in epinephrine was not
measured with respect to these patients, but the increase has been reported in the literature at
least since 1997. The effect of the surge of epinephrine and norepinephrine is to heighten blood
pressure and heart rate, causing increased pressure in the lungs or pulmonary circulation and the
release of various hormones and increased respiratory activity. If experienced, these conditions
pose anesthesia related dangers that can cause complications, such as myocardial infarction,
stroke, heart failure and pulmonary edema. The appropriate anesthesia response would be the
initiation of drugs that counteract the effects of the catecholamines.
The doctor was unable to quantify the level of stress which patients Kindig, Flowers and
G.W. experienced. However, he could say that in each case they had experienced a greater level
of stress then they would have had they gone about their daily lives. The fact that they received
anesthesia caused their heart rate and blood pressure to increase. Stress can cause different
reactions in different people.
The doctor acknowledged that he had used epinephrine to treat asthmatic attacks and then
allergic reactions and that such use would significantly raise epinephrine levels, increasing the
heart rate and at times blood pressure.
A rapid lowering of the blood pressure can cause cardiac arrhythmia all by itself.
Kushins suspects that each of the decedents in this case had experienced a cardiac and/or
respiratory event(s). The occurrence of one of these events can lead to the occurrence of the
other. Some reports indicate that there can be delayed cardiac symptomatology resulting from
recent cocaine use. Although probably most such events occur within one hour, they may occur
after a couple of hours.
Nevertheless, while most occur within this short time frame,
symptomatology can occur up to twelve to fourteen hours following use. Extended cocaine use
causes its own pathology. Kushins was not able to recall if any of the decedents had any
valvular problems. However, he did explain that Victor Melendez had some enlargement of cells
that was observable microscopically. There was some also obstruction of the smaller vessels in
the myocardium. This could be evidence of heart disease, however, while there may have been a
disease process occurring, it may not have been enough to damage the heart. The level and type
of activity for the patient would be an important factor in determining whether there was any
clinical symptomatology.
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Kushins commented upon the addendum to the Monmouth County Medical Examiner’s
Post-Mortem Report issued for Frank Stavola which changed the cause of death from the initial
“pulmonary and cerebral edema due to pending further examination” to “pulmonary and cerebral
edema due to drug use (Morphine, Cocaine, Fentanyl and Nordiazepam,” (this latter believed by
Kushins to be a metabolite of diazepam). The witness explained that the death “may or may not”
have been the result of pulmonary edema caused by cardiac disturbance. Kushins noted that
opioid antagonists can cause respiratory depression and, in addition, may pose a risk of
pulmonary edema, which has been reported in the literature. 26 However, he acknowledged that
while naltrexone does cause shortness of breath and heavy breathing causes pulmonary edema,
there are no literature references to naltrexone as a cause of pulmonary edema. The 1999 edition
of the Physicians Desk Reference, p. 936, which states that naltrexone has caused shortness of
breath and heavy breathing, does not say that it has caused pulmonary edema. Despite this fact,
he still maintains that naltrexone is the same as naloxone or nalmefene, each of which has been
linked to pulmonary edema. Naltrexone is an opioid antagonist and pulmonary edema has been
shown in reports to be extensively demonstrated with the use of these drugs.
In addition to these concerns, there are other anesthesia related concerns. These include
problems with intubation of the trachea, the possibility of the patient awaking from general
anesthesia too early and the removal of the tube, all of which can cause stress.
In his written report, Dr. Kushins explained that he believed the “lack of post-procedure
care may have contributed to the deaths of . . . G.W., Mark Beigelman, Frank Stavola, M.J.,
Lester Kindig, and Lisa Flowers.” However, he testified that he did not necessarily hold that
conclusion “to a degree of medical certainty.” Similarly, when he stated at page two, paragraph
three of his report that, “[O]ne must wonder whether in isolated patients after Naltrexone or
Nalmefene precipitated withdrawal if the Naltrexone pellet did not result in an adequate blood
level of antagonist that the fentanyl might have caused an opioid overdose,” he did not mean to
26
The witness explained that pulmonary edema involves an accumulation of fluid in the alveoli, where gas exchange takes place. There are many
possible causes for this condition. It is not regularly observed at autopsy, and if seen, it may not always be related to the cause of death. The use
of morphine and its derivatives and/or alcohol can cause it, however, it is also used to treat the condition. He believes that the use of cocaine
and/or amphetamines can cause it as well. Heart failure can cause pulmonary edema: as the heart muscle fails to pump an adequate supply of
blood, the blood backs up to the pulmonary circulation and fluid is exuded out into the alveolar spaces. Airway obstruction and certain central
nervous disturbances can also cause pulmonary edema. Pulmonary edema is a rare, but foreseeable risk of general anesthesia. When detected by
a reasonable practitioner of reasonable prudence it can be treated. If caused by heart failure, drugs can be used; if by excessive amounts of fluid,
then diuretics can be administered. The ease of diagnosis depends on circumstances and expectations. In a monitored setting, it is both
detectable and treatable.
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say that he had so determined “to a medical certainty.” Further, when he stated on page 1 of the
report that “Despite Dr. Gooberman’s extensive experience . . ., his procedure has resulted in at
least six post-procedure deaths,” he was making a distinction regarding post-procedure care
versus the procedure “as a whole.” His concern with the post-procedure care was with the lack
of ability of the caretakers to adequately understand and deal with issues that arose and the lack
of an ability in the post-procedure period to effectuate a “rapid rescue,” although he could not
say with certainty that any of the decedents could have been resuscitated. He explained that
despite this uncertainty, if patients were “rescued” earlier, they might have had a “better chance.”
However, he acknowledged that those who died following the procedure might nevertheless have
died in the same time frame. He further acknowledged that there was a potential that one or
more of the patients might have died even if the patient had been retained for a longer period at
the Gooberman facility and there was even a potential that a patient who underwent rapid
detoxification in a hospital setting might succumb. However, despite these several uncertainties,
he asserted that if a patient were retained, changes in his or her condition could be more readily
observed and acted upon and the situation might be salvaged.
Therefore, in his opinion,
retention for monitoring for twenty-four hours was appropriate. In his opinion, as practiced by
the respondents, the UROD procedure placed these patients at risk to an unacceptable degree.
Dr. David Smith testified that in his expert opinion there is no empirical evidence to
substantiate the claim that the procedure “and/or respondents’ aftercare and treatment or the lack
or inadequacy thereafter” directly or indirectly caused or materially contributed to the deaths of
G.W., M.J., Stavola, Beigelman and Kindig.” In the case of each of the listed decedents, the
procedure was performed and the patients were discharged, with the decision to discharge made
based both upon criteria developed by Dr. Gooberman and the exercise of clinical judgment.
Each had stable vital signs and exhibited no pathological signs or symptoms other than those that
were consistent with opiate withdrawal and therefore anticipated. Prior to their discharge, they
were each required to demonstrate that they could communicate with the doctors if questions or
concerns arose. More than 2,000 patients were successfully treated and discharged to immediate
family, friends or relatives. The mortality rate was equal to or less than .03 percent. While an
ideal outcome would be that there were no deaths following the procedure, Dr. Smith concurs
with the findings of Dr. Cooper (to be discussed below) that the patients’ deaths were not caused
by the procedure and there is no evidence to support the argument that they were so caused. In
fact, in several of these cases, there is evidence suggestive of post-operative non-compliance
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with written instructions; non-compliance that could be a contributing factor to the deaths.
While there is a temporal correlation existing between these individuals undergoing the
procedure and their subsequent demise, there is no proof of causation, and the suggestion that
there is such a causal relationship is the product of “very fuzzy” thinking.
Dr. Smith concluded that, to a reasonable degree of medical certainty, the causation of
the deaths of patients G.W., Stavola, M.J., Kindig, Beigelman and Melendez was unknown and
could not be proven scientifically to have been caused by the UROD procedure. Although he
emphasized that there were many unknowns about the cause of death, Smith explained that they
were not anesthetic deaths, but were all cardiac deaths. Dr. Smith noted that while implantation
of the naltrexone pellet was intended to block the physiological effects of the mų agonists, it is
possible that some of effects that are not mediated through the opiate receptor may still occur.
These effects may include the release of histamines, which could lead to a drop in blood pressure
and might cause a cardiac arrhythmia. In addition, histamine release can cause respiratory
system problems, which could affect cardiac function. Given that there were over 2,300 URODs
performed in which death did not occur shortly after the procedure, there is a “strong possibility
of another variable,” in these particular cases. That variable is noncompliance. Noncompliant
behavior of certain patients can lead to histamine related effects that might have led to their
demise.
Dr. Smith argued that medically unassisted withdrawal might prove fatal if a person had
an underlying cardiac disease. The withdrawal impacts upon pulse rate and blood pressure, and
the hypersympathetic discharge, which is adrenaline, could lead to fatal consequences.
Dr. Smith acknowledged that Dr. Cooper did a good job of summarizing the cases, but he
disagrees with Cooper’s comment that naltrexone is “most likely a significant contributing factor
in sudden death occurring during medically supervised opiate withdrawal.” (!Pick up comments
at page 123 of February 26 re: bias against doctors treating addicts).
Dr. John Cooper explained that Lisa Flowers was taken to a hospital before death and an
EKG indicated that she had suffered a myocardial infarction. The autopsy report revealed
bilateral pneumonia. The UROD procedure was not in itself causative of her demise. Indeed,
she, as well as all of the other individuals in question, “got through the procedure fine.” They
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had a normal post-procedure course. There were some post-procedure signs and symptoms, and
additional signs and symptoms, prior to Flowers’ death. She exhibited mild wheezing and
muscle incoordination. He attributed the wheezing to the fact that she was an asthmatic. The
muscular incoordination is normal in this setting and not of significance. After her discharge and
prior to her death, Ms. Flowers also experienced restlessness, vomiting and diarrhea, was
extremely cold and had convulsive activity. Each of these was a normal, expected sign of
withdrawal and was not relevant to the cause of death.
However, she also experienced
respiratory distress, which is not a normal and expected outcome with withdrawal. She also had
bradycardia, a slow heart rate and ECG abnormalities in the hospital that were consistent with a
myocardial infarction. These were harbingers of an undesirable outcome. The autopsy revealed
that Flowers was cachectic. She had a fentanyl patch in place, which to him meant that it had
been “left in place from the time that she left the treatment.” Cerebral edema was noted, but this
is a non-specific finding.
She exhibited definite heart pathology, identified from some
hemorrhage in the heart around the papillary muscles. He believed that there “may have been
some actual ischemia in the heart.” There was also some general congestion of blood in the
organs, which in itself is non-specific in nature and yet constitutes an abnormal finding. The
microscopic analysis showed well-established acute inflammation of muscle fibers of the heart,
which he labeled as “incontrovertible evidence of infarction.”
Cooper concluded to a medical certainty that Flowers’ death was caused by an acute
myocardial infarction due to acute opiate withdrawal. Contributing factors were malnutrition,
asthma, chronic cocaine and heroin abuse. While death can be the outcome of an opiate
withdrawal, it is not an expected outcome. However, in Ms. Flower’s case, her death was an
example of a death resulting from opiate withdrawal.
The death was neither caused nor
contributed to by the UROD procedures employed by the respondents.
Mark Beigelman was a heroin user and, at the time he presented for the UROD
procedure, was also a methadone addict. He came through UROD normally and was discharged
with routine signs of recovery from the procedure. Later he sweated profusely, which was to be
expected. He died eleven to twelve hours after extubation. The autopsy revealed that he had an
enlarged heart, with hypertensive type changes, dilatation of the ventricles, indicating acute heart
failure, and other nonspecific findings of generalized visceral congestion and cerebral edema.
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Cooper noted that the upper limit of normal weight for a heart in a man of Beigelman’s
size would be 380 grams. In Beigelman’s case, as with other of the decedents whose deaths are
at issue, their enlarged hearts displayed concentric left ventricular hypertrophy.
This is a
condition that results when the left ventricle, which is the main pump that creates systemic blood
pressure, thickens and the increased mass or heavier weight of the heart is a result of the
thickening of the wall of the left ventricle. This is generically referred to as hypertensive
cardiomyopathy.
In the absence of drug use, this condition is most commonly caused by
sustained high blood pressure. Presumably, the abuse of cocaine and amphetamines causes a
stimulation of the sympathetic nervous system and raises the blood pressure. The effect is the
equivalent of high blood pressure for a non-drug user. In Beigelman’s case, he had a long
history of high blood pressure, which was coupled with a history of cocaine abuse. To a medical
certainty, his death was caused by a cardiac dysrhythmia, or abnormal heart rhythm, resulting
from hypertensive cardiomyopathy. The UROD procedure did not have any role in his demise.
Referring to Dr. Segal’s report, Dr. Cooper stated that Segal’s opinion as to the cause of
Beigelman’s death was not “completely non-legitimate,” as one cannot be completely dogmatic
about characterizing a 400 gram heart as enlarged. This gentleman was 185 pounds, and to the
extent that the major textbooks place the upper level of normalcy at 380 grams, Cooper would
disagree that a 400-gram size was within the range of normalcy.
However, the point is
debatable. Segal’s report does not “give us any clues as to how” he reached his conclusion as to
the cause of death.
Cooper opined that there is no causative relationship of the UROD procedure and the
death of G.W. This is especially so due to the passage of three and one-half days before his
demise. G.W. died three and one-half days after discharge. He suffered from some mitral valve
abnormality that affected the flow of blood in the heart between the left and right ventricles.
This condition can lead to fatal arrhythmias. In addition, he had a very severe, very ferocious
and widely distributed pneumonia, an acute pneumonitis in both lungs, and this killed him. The
pneumonia was aspiratory in origin.
Aspiration pneumonia, in which gastric contents are
introduced into the lungs with bacterial and chemical consequences thereto, usually develops
within twelve hours of aspiration and can cause death within twenty-four to thirty-six hours,
although Cooper conceded that in perhaps 10% of the cases it might take three to four days. The
pneumonia can be detected by a physician listening to a patient’s chest within a few hours of the
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onset of the condition. Thus, if it is not detected by a competent physician listening to the chest,
then that “could only mean that the patient has not aspirated yet or it hasn’t been long enough to
develop physical findings.” Aspiration pneumonia is a possible complication with any anesthetic
procedure, however, if the decedent had gotten the pneumonia as a complication of the procedure
itself, it would have developed much sooner and symptoms of its development would have been
observed.
M.J. also passed through the UROD procedure and had the normally anticipated
symptoms of withdrawal. He then suffered from respiratory distress, an unexpected event. He
died some thirteen to fourteen hours after extubation. The autopsy showed nonspecific findings,
such as pulmonary edema and generalized visceral congestion. However, he also had mild left
concentric, left ventricular hypertrophy and dilatation of the ventricles, indicating acute heart
failure. His heart weighed 400 grams, higher than the normal outer limit of 380 grams. The
dilatation means that the left and right ventricles are large in diameter, a condition that “goes
along with an acute failure of the heart.” Before cardiac arrest, he would suffer an abnormal
rhythm and the heart would not pump efficiently. The blood would back up in the heart. The
size of the heart ventricles “is a reliable indicator of what the heart was doing before death.”
Pulmonary edema can result from many different causes and there is no pattern to its appearance.
It often is associated with circumstances in which people “die somewhat slowly,” and “most of
them have it.” It is often noted and classically is associated with drug overdoses, “but the reason
why is because people are laying there with a prolonged period of respiratory depression and
sluggish heart function for a period of time, long enough for these changes to set in.” The slow
nature of the death is the cause of the edema, not the heroin overdose as such.
Dr. Cooper commented upon the pathologist’s determination that M.J. died from fluid
overload due to rapid opiate detoxification with naltrexone implant due to acute and chronic drug
abuse. He responded that
The idea that this is somehow a fluid overload is - - frankly, it’s
ludicrous because he was - - the reason is you can get fluid
overloaded in a setting where you’re under anesthesia and you
have an I.V. in you, that’s true, but then to walk out and be okay,
respiratory-wise and be okay for some hours and then on top of
that to be really keeping anything down, you’re throwing up,
you’re sweating profusely and in effect doing all the things that a
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person can do to become dehydrated and die some twelve hours
later and then attribute that to fluid overload, it’s absurd.
Dr. Segal’s report advised that he believed that the pathologist who autopsied M.J. wrote
a “well-written cause and manner of death and I agree completely.” Dr. Cooper commented
upon this assessment.
As we talked about, I think that his opinion is completely in
opposition to the facts as we understand them . . . You cannot
justify a conclusion of fluid overload in this setting. So, I don’t
understand why anybody would, with forensic pathology
experience, would agree with a conclusion like that.
Cooper asserted that Segal was relying upon the interpretation of the examining
pathologist and, “when you’re analyzing a body of autopsy reports, it may be worthwhile to look
and see what the original examining pathologist thought, but it’s much more instructive to look
at the actual facts that they recorded, look at the descriptions of the individual organs.” Cooper
argued that, in reviewing the pathologist’s report for M.J., Segal was basically concurring with
his own assessment in the Kindig case and did not take into account the significance of the
naltrexone block.
He “completely brushed past” “the abnormalities in the hearts of these
people.”
Finally, we have - - the concern that he goes case by case stating
conclusions, but in each case he declines to explain what his
thought processes are in arriving at that conclusion and I think that
if you’re offering an expert opinion, it’s not enough just to say that
is my opinion. At some point you need to be willing to explain
how you arrived at it.
Nothing in Dr. Segal’s testimony in this hearing has changed Dr. Cooper’s critical assessment of
his report. As for the cause of death, in his opinion, to a reasonable degree of medical certainty,
M.J. died as a result of a cardiac dysrhythmia due to hypertensive cardiomyopathy. The UROD
procedure played no role in causing or contributing to the death.
Lester Kindig had a history of high blood pressure, heroin and methadone use. He also
emerged from UROD with normal withdrawal symptoms and never demonstrated other than
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typical symptoms. He was not closely observed by his caretaker. He died within ten to twelve
hours of extubation. His heart weighed 460 grams, indicative of a substantial hypertensive
cardiomyopathy. Dr. Cooper characterized Dr. Segal’s stated cause of death, an adverse reaction
to drugs and ROD, as “unfounded,” claiming that it failed to take into account the findings at
autopsy and the history and failed to fit the facts. Instead, Cooper found that the cause of death
was cardiac dysrhythmia resulting from hypertensive heart pathology. Opiate withdrawal was a
contributing factor; however, the procedure he underwent was not a contributing factor.
Cooper labeled the autopsy performed on Kindig, in which Segal participated, as “not
adequate.” The shortcomings included a missing clinical history and nothing is stated regarding
the circumstances of the death. Segal’s report does not indicate that he considered, at least to
any degree of completeness, the clinical history, or that he understood UROD. “Even more
importantly,” it did not appear that he was aware that Kindig was a fifty year old with chronic
hypertension. The report did not seem to suggest that much attention was paid to the “actual
clinical circumstances of death.” There is no mention of the enlarged heart, even though its 460gram weight is plainly stated, and this is a “very significant finding.” Dr. Segal apparently did
not recognize this as abnormal, so it was not included in the pathologic diagnosis. In addition,
this condition ties in with the hypertension. The report should both recognize the abnormality
and why it exists. As for the stated cause of death, it “just appears there,” but the report does not
explain, “how in the world he came to such a conclusion based on the autopsy findings or based
on clinical history.” In Cooper’s opinion, Segal was “possibly confused and possibly did not
have time to look into it or think about it, but, again, I have the advantage of hindsight and being
able to look at several different cases and when he did this case, presumably it was his first
exposure to the whole business of cardiac dysrhythmia in the court (sic) of opiate withdrawal.”
In his opinion, Segal reached a “convenient conclusion.” After all, the gentlemen had recently
undergone UROD and was now dead and “presumably he didn’t recognize the heart pathology
so he just made the convenient conclusion that since its - - since it seemed to be temporally
related to the procedure it must be the cause.”
Cooper noted that the Kindig autopsy report did not contain any reference to any
microscopic examinations. Such analysis is “absolutely” required in a so-called “mysterious”
death, one that is “medically related,” as opposed to a “violent death,” and its absence indicates a
breach of the standard of practice for pathologists. He added, “I don’t want to paint it with too
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broad of a sweep, but if you have an enlarged heart in a death which seems confusing to you,
then I think the standard of practice would most definitely include sections of the heart and
presumably the other organs while you’re at it.”
Cooper next discussed Frank Stavola. Mr. Stavola did well during the procedure and did
not exhibit any significant symptoms before his discharge. He was closely watched. He suffered
a sudden collapse after getting out of bed some nine to ten hours after extubation. The autopsy
revealed nonspecific findings, pulmonary and cerebral edema and generalized visceral
congestion, as well as myocardial fibrosis, the later typical of several different things and a
finding often seen in persons with coronary artery disease.
Cooper believes that due to Stavola’s ongoing cocaine use, his heart was rendered more
susceptible to abnormal rhythms. He disagrees with the pathologist’s report, which assessed the
cause of death as “pulmonary and cerebral edema due to drug use; morphine, cocaine, fentanyl
and nordiazepam.”
The edemas suggest that he did not die precisely when he collapsed.
However, the facts do not support a finding that the death was the result of a drug overdose. The
presence of the opiate receptor block would prevent an overdose with an opiate type drug. The
“sudden collapse” fits with a cardiac arrhythmia. It is true that he had cocaine metabolites in his
blood, and thus cocaine is surely a factor. However, the very presence of the cocaine metabolites
is indicative of a cardiac arrhythmia, which Cooper characterized as the “mechanism of death in
cocaine deaths.” His recent use of cocaine, within twenty-four hours of presenting for the
procedure by Cooper’s definition, in conjunction with his ongoing heart problems and cardiac
arrhythmia associated with withdrawal, are the contributing factors to the gentlemen’s demise.
The witness argued that Dr. Segal’s conclusion that death was due to adverse reaction to
drugs does not fit the facts. Cooper related that the implanted naltrexone pellet, “would kind to
tend to preclude that this is a drug death and in the paragraph directly above he mentions
myocardial fibrosis.” In addition, Segal stated that he had not yet seen the toxicology report.
Thus, although Segal did not have all of the facts, he did recognize the heart pathology. The
facts simply did not fit Segal’s proffered conclusion.
Victor Melendez had hypertensive cardiomyopathy, a sign of cardiac pathology. His
heart was in the 450-460 gram range and had quite a bit of fibrous tissue in the heart muscle. He
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fit into the group that might be expected to die from this particular cardiac abnormality while
going through opiate withdrawal, regardless of how that process was initiated. He actually died
of intractable vomiting, which at some point resulted in a tear in the esophagus. He had an
inflammation of the mediastinum. These are serious conditions and carry a very high fatality
rate. His temperature was 104.3, which suggests that sepsis, an infection and bacteria throughout
the bloodstream, may have resulted from the esophageal tear and mediastinitis. While the
postmortem blood cultures were negative, this does not necessarily mean that he was not septic,
as false-negative post-mortem cultures do occur. Nevertheless, it is also true that Melendez had
an alcoholic liver pathology, that is, a liver with fatty infiltration and necrosis of liver cells and
the beginning of fibrosis. From these findings, Cooper can glean that Melendez was a heavy
alcohol user. He also experienced seizures at times and one could have occurred during the
withdrawal, that is, he could have suffered from delirium tremens, which does produce high
fever and seizures.
Cooper opined that one can never be sure exactly why Mr. Melendez died, but to a
reasonable degree of medical certainty he did not die as the result of undergoing UROD, which
procedure had no connection with these two possible causes of death.
Cooper disagreed with the proposition that people do not die from opiate withdrawal,
calling this idea a “myth.” For instance, people will go “cold turkey,” an excruciating procedure
in which, commonly, a “valiant attempt” ends in the person not being able to get through the
withdrawal and giving up and getting a fix, which kills them. “We see that over and over.” It is
not listed on the death certificate as a death due to withdrawal, but instead as due to heroin
overdose. However, it is “really withdrawal related because if they didn’t try to withdraw, they
wouldn’t have died.” In this case, we see patients who died as a result of causes, “fairly
representative of the kinds of death we see in opiate withdrawal through any method. They’ll
have heart attacks. They’ll have arrhythmias because of their cocaine damaged hearts or they’ll - I’ve seen cases where they have had hemorrhagic stroke because their blood pressure goes up.”
Along with these causes, there frequently is aspiration pneumonia, or other forms of pneumonia,
resulting from the patient’s resistance being weakened due to going through the procedure. In
addition, there can be the esophageal tear and mediastinitis, and finally, the large amount of
epinephrine in the system can cause people to have bleeds in their heads and stroke to death.
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The thirty-five year old woman who Dr. Cooper autopsied following her death after
undergoing UROD/ROD in Phoenix, Arizona, had an enlarged heart and had used cocaine
recently, as indicated by the presence of benzoylecgonine in her system. He believes that she
also had some myocardial fibrosis. She died around twelve hours after extubation. Cooper
opined that she definitely died of a cardiac arrhythmia while under direct medical care. At the
time Cooper was suspicious of the UROD procedure and felt that it was not “sound medicine.”
Dr. Kasen, the physician who performed that UROD, provided him with articles, and after
reviewing the hospital records, he determined that the death had not resulted from the procedure.
Instead, he determined that she had ventricular dysrhythmia due to cardiac hypertrophy, with
contributing factors being cocaine abuse and opiate detoxification, a term he was using
interchangeably with “withdrawal.” The patient was under medical observation, so that the
occurrence of the arrhythmia was clearly shown by the medical records. She had a grossly
abnormal heart and a microscopically abnormal heart, both enlarged and with an excess of
fibrous tissue. The mechanism for the occurrence of the arrhythmia would be the presence of
elevated levels of catecholamines, epinephrine (adrenalin) and norepinephrine (noradrenaline),
resulting from the withdrawal. These substances would sensitize the heart to abnormal rhythms,
rhythms well known to occur more likely when the heart is enlarged, even without the presence
of elevated levels of these catecholamines.
The witness agreed with the statement, “It’s fair to say that without regard to the method
of opiate withdrawal, the fact of opiate - - without regard to how it was done, would suggest that
opiate withdrawal played a part in their demise in relationship to the preexisting condition.” In
addition, he opined that “. . . I can see that these people and probably more would have died if
they had gone through opiate withdrawal through other methods. They would have just as surely
died or failed to withdraw. So it cannot be attributed to the procedure because we’re passed that
and its - - the cause of the death is the heart problem, opiate withdrawal. Saying nothing about
what procedure is involved, opiate withdrawal is a precipitating factor.”
Turning to his analysis of the morbidity cases, Dr. Cooper explained Mr. Hendrix
represents a complication of the UROD procedure.
He evidently aspirated enough gastric
contents during the procedure and before discharge that he developed aspiration pneumonia
within a day or so, although the records do not contain any reference to such aspiration. The
situation was handled appropriately. Aspiration is a foreseeable complication of any anesthetic
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procedure and is listed in the respondent’s consent forms. Aspiration of stomach contents can
occur during heroin use, however, it is unlikely that Hendrix would have experienced aspiration
pneumonia that very week had he not had the procedure that placed him into withdrawal. Thus,
there is a link, but not a causal link, between the use of anesthesia in the UROD procedure and
the death. As for Mr. Perez, this case fits the same pattern, respiratory distress, and in his case, a
heart attack within twenty-four hours.
On cross-examination, the witness explained that the statement in his report that the
UROD procedure had “no appreciable role” in the mortalities and morbidities that he examined
meant the same as “no causative role.” This means that if any causative relationship does exist it
does so to such a minimal extent as to be undetectable to anyone. As for post-discharge
ingestion of any drugs as a factor, when he first started to look into these deaths he considered
that possibility, indeed it was a “leading theory.” However, he did not find any evidence of such
use. Likewise, the fentanyl patch did not contribute to the deaths.
Dr. Cooper commented upon the stress levels inherent in the withdrawal process. He
noted that introduction of anesthesia mitigates the stress of withdrawal, here during the crucial
first three to four hours of that process. He denied that the anesthesia would heighten stress, and
commented, “logic dictates that it would be helpful.”
Dr. Cooper commented on the “ITU Record” for Lisa Flowers, Volume II, 0030. He had
reviewed this document “very superficially.” This is as close a document to an anesthesia record
as he found. He did not pay particular attention to the drugs administered in each individual
case, other than to look to see if they were relevant to the cause of death. He did not have any
concern that there was any synergistic effect with the combinations of drugs employed. He knew
that naltrexone, if used as an opiate blocker, would raise the level of catecholamines and thus
raise blood pressure and heart rate and make the patient more susceptible to arrhythmia. The rise
in epinephrine is “part and parcel” of the opiate withdrawal scenario.
Cooper agreed that hypotension is associated with fentanyl.
This condition can
contribute to or cause dysrhythmia.
Dr. Cooper stated in his report,
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Naltrexone administration is a cardinal feature of this particular
therapeutic plan, and it has elsewhere been established that opiate
receptor blockade - in the presence of opiate receptor agonists leads to elevation of circulating levels of catecholamines. In my
opinion, naltrexone is most likely a significant contributing factor
in sudden death occurring during medically supervised opiate
withdrawal.
Deputy Attorney General Harper asked Dr. Cooper to explain why this statement does
not mean that, in Mr. Stavola’s case, in which Cooper concluded that death was undoubtedly
connected to the increase in epinephrine levels, that UROD did not have a causal connection to
his demise. The witness explained that the use of naltrexone is “completely nonspecific,” “not
unique to this procedure” and merely a “common denominator,” in that it is a method used to put
patients into opiate withdrawal. He believes that all of five deceased Gooberman patients whose
cases he reviewed, as well as the lady in Phoenix, died as the result of cardiac arrhythmias
caused by excessive catecholamines acting upon heart tissue previously damaged by cocaine
abuse and, in addition, the situations were exacerbated by low serum potassium, a condition
known as hypokalemia. He would not rule out some contribution by naltrexone. He also
testified that there was currently no study or literature to support any conclusion that the
insertion of a naltrexone pellet could cause a new “burst” of catecholamine levels. Again,
“logic” dictates against such a conclusion.
Dr. David Simon testified that G.W. died as the result of aspiration pneumonia, which is
admittedly a potential complication of any anesthetic event. However, Mr. W. died some three
and a half days after undergoing UROD and his vomiting, and the resultant aspiration and
pneumonia was not caused by the anesthesia, but from a problem commonly associated with
substance abusers and alcoholics.
The general time frame for looking at an anesthetic
complication is forty-eight hours. If the problem occurs after that time, it is not something
having to do with anesthesia.
Frank Stavola’s death was neither caused by nor contributed to by either UROD or
aftercare. Based upon the information identified by the pathologist, there was physical evidence
of cirrhosis of the liver, indicative of alcohol abuse. Stavola had cardiac fibrosis that could be
secondary to the alcohol abuse. He may have had a cardiomyopathy, an enlargement of the heart
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muscle that also could be due to alcohol abuse. He also may have abused benzodiazepine, as he
had the metabolite of that drug in his system.
He was undergoing the stresses related to
withdrawal from opiates, and superimposed thereon may have been undergoing alcohol or
benzodiazepine withdrawal.
Withdrawal from either of these is well accepted to be life
threatening in and of itself. A high body temperature, such as 104.5 degrees, is a symptom of
alcohol or benzodiazepine withdrawal.
Commenting on Dr. Karan’s opinion regarding the relationship of fentanyl to the death of
Mr. Stavola, Simon declared that the only relationship that he saw was temporal, as this patient
did not die of a drug overdose, but instead of a heart arrhythmia occurring in association with
physiological stress related to opiate withdrawal.
If one were to die of a drug overdose
associated with opiates, one would suffer respiratory depression, but that condition did not occur
here. Also, in Simon’s professional opinion, the pharmacokinetics of fentanyl, that is, the
manner in which it works, and the dosage involved, added to the fact that he had received three
opiate antagonists, are circumstances which indicate that, the patient could not have overdosed
on fentanyl or on any opiate. Indeed, he had a tolerance for opiates, and given the time that the
antagonists were in the bloodstream compared to the amount of opiate that he could have
reasonably had in his system, it simply is not pharmacologically possible that he died of an
opiate overdose.
As for Mark Beigelman, this patient “unequivocally” had biventricular dilatation of the
heart, in itself a very significant cardiac pathology, even if it were not associated with
cardiomegaly. Again, he did not die of a drug overdose, and therefore the fentanyl had no
relationship to the death. The respondents could not reasonably have concluded before the
procedure that he suffered from this disease. The death was therefore not predictable. He went
home and experienced the stress of withdrawal which, given his diseased heart, led to his demise.
This is a logical, if not probable, cause of death.
Simon noted that a pathologist would have to draw any conclusions as to the influence of
fatty infiltration of the heart muscle that could lead to short-circuiting and arrhythmia. The
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witness acknowledged that he did not identify dysrhythmia due to cardiac myopathy as the cause
of death, but he is not a pathologist. 27
Dr. Simon’s differential diagnosis in the case of M.J. is that he possibly died as the result
of the stress of withdrawal from benzodiazepine. Simon is convinced to a degree of medical
certainty that UROD neither caused nor contributed to the death. The doctor noted that in his
practice of UROD the “only complication that I have seen.” has been seizure. He believes that in
those instances where seizure has occurred the patient was experiencing a benzodiazepine or
barbiturate withdrawal, superimposed on the opiate withdrawal. M.J. was an admitted abuser of
Xanax, a short-acting benzodiazepine, and his experience fits the description of seizures. While
acknowledging that he is not a pathologist, Simon believes that while the drug was not found at
autopsy, , the presence of the drug would be dependent upon its half-life, and with a short-acting
drug such as Xanax the drug rapidly goes away. In his opinion, when M.J. stopped taking it for
forty-eight hours, he experienced seizures due to withdrawal from the benzodiazepine. Indeed,
he recalls that cocaine was found in the blood, and as cocaine lowers the threshold for seizures, it
makes them more likely to occur.
Lester Kindig also may have died as the result of a benzodiazepine withdrawal or a
histamine release superimposed on the opiate withdrawal. His history reported that he took
Valium and restoril, each a benzodiazepine.
Metabolites of Valium, or diazepam, were
discovered in his blood on toxicologic examination. No better explanation of the reason for
Kindig’s death is apparent.
While Simon cannot state to a reasonable degree of medical certainty what exact process
caused the demise of Lisa Flowers, he can say that, to a reasonable degree of medical certainty,
the UROD procedure neither caused nor contributed to her death. The pathologist stated that a
myocardial infarction occurred. It is noteworthy that she had bilateral consolidation of the lungs,
and this suggests that she may have had an aspiration pneumonitis or pneumonia. She also had
metabolites of benzodiazepine in her blood, although she did not have any benzodiazepine itself.
She also had received sandostatin at home, and might have had an idiosyncratic drug reaction
27
Originally, Dr. Simon attempted to offer a differential diagnosis that Beigelman used morphine after the procedure, perhaps because he felt
sick, and this could have triggered a histamine release that could drop his blood pressure and bring on an arrhythmia, even though an opiate
blocker would prevent the morphine from working. He suggested that perhaps a loved one had supplied the drug. However, later in his
testimony, Dr. Simon advised that in presenting this alternative theory he had confused Beigelman with Kindig, and that it was Kindig who might
have taken the morphine, not Beigelman.
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thereto. This drug can cause a decrease in the heart rate. Simon cannot say whether Ms. Flowers
should have had a less “invasive” form of detoxification, but he has no problem with the use of
UROD to detoxify newly addicted persons; indeed, these are the safest patients upon which to
perform the procedure.
Without the hospital records regarding Victor Melendez,28 Dr. Simon cannot formulate
an opinion as to the actual cause of death. However, the extended time between discharge and
death is a significant factor in the doctor’s analysis that the UROD procedure did not cause or
contribute to his demise. The stress of opiate withdrawal was a key factor, associated with
underlying medical pathology. Melendez had a high methadone concentration in his blood. The
autopsy report states that on admission to the hospital Melendez had a fever of 104.3 degrees,
which “definitely” could be a sign of withdrawal from alcohol or benzodiazepine. In addition,
the autopsy found disseminated intravascular coagulation, which means that the blood clotting
mechanism had gone awry, and Melendez was hemorrhaging “from everywhere.” This can
signify that he suffered a seizure, which can bring on such a condition. In addition, seizures can
bring on the persistent tachycardia, hypertension and episodic bradycardia/electromechanical
disassociation and ventricular dysrhythmias that are noted on the autopsy report. Evidence of
end-stage alcoholic liver disease is also noted, suggesting that alcohol withdrawal is more likely
than withdrawal from benzodiazepine.
The evidence of interstitial fibrosis, which is only
identifiable on microscopic examination, and of other evidences of small vessel disease, indicate
that Melendez had small blood vessels coming off the major coronary arteries that were almost
totally occluded. These findings are “very abnormal” for a thirty year old man and therefore are
very significant.
The condition of the liver is a classic indication of a person who had
chronically abused that organ.
In Simon’s opinion, Mr. Melendez was a person who, because of the conditions affecting
him, could not withstand the stresses of withdrawal, such as the hormonal increase. His heart
“couldn’t withstand that stress.” The alcohol withdrawal would be the more significant event, as
it “most likely was responsible for the seizures.”
The parties stipulated that all attempts to obtain Mr. Melendez’ hospital records from Montefiore Hospital in New York were unsuccessful and
there is no mention in any expert reports about his case that suggests that those records were examined by any of the experts.
28
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Samuel Perez was found to have an ejection fraction of 20%.29 A normal ejection
fraction might be 50 to 60%. Thus, Perez had a very low fraction, one that Simon characterized
as indicating very significant heart disease. The care provided to Perez by the respondents met
the standard of care. Transfer of the patient to the hospital was appropriate.
Simon opined that the respondents did not violate the standard of care in Christopher
Hendrix’s case. He appears to have experienced an aspiration pneumonitis. This is a known
complication associated with substance abusers and anesthesia. Again, with reference to his own
experience described above, there is also evidence in this case of benzodiazepine intake and
alcohol abuse, and the description of Hendrix’ shaking is consistent with the possibility of
withdrawal from these substances. Further, the hospital notes reflect that he was caught selfadministering Xanax, and as a result, he was asked to leave the hospital. This instance of selfadministration bolsters Simon’s opinion that Hendrix was a regular user of benzodiazepine and
as such, he would go so far as to hold the opinion to a reasonable degree of medical certainty that
Hendrix was “most likely” undergoing withdrawal from the benzodiazepine, which may have
precipitated the aspiration.
Critical Care Nurse Jennifer Richards testified that she was on call and received more
than one telephone call from Anthony Reggio, who in his first call at about 1:00 or 2:00 p.m.
advised her that Lisa Flowers, trying to make herself feel better, had “done twenty bags” of
heroin. Richards told him to tell Lisa to stop, that the heroin would not make her feel better. He
also instructed Anthony that if Lisa experienced trouble breathing he should call 911. Ms.
Richards then spoke to Dr. Gooberman, but she does not believe that she made any note about
this call from Anthony and cannot recall why she did not, although it was probably because she
was so busy.
Richards believed that a majority of UROD patients tried to use heroin after the
procedure, indeed many told her that they had. She did not chart such information.
Dr. Bunyad Haider reviewed the records of decedents Stavola, Kindig, M.J., Beigelman,
Melendez and Flowers and Dr. Cooper’s report. His concentration was on the cardiovascular
aspects and their relationship to the adverse outcomes. He considered any cardiac abnormalities,
An “ejection fraction” refers to the ability of the person’s heart to contract and expel blood out through one of the chambers. The “fraction” is
the percentage of the blood that is in the chamber when the heart is relaxed and then contracts, and after the contraction, some of the blood
remains in the chamber.
29
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whether these existed before death, and the causal relationship, if any, of the abnormalities to the
death of the patients.
Dr. Haider divided the six decedents into two groups: Group A consisted of Beigelman,
Stavola and M.J. In his opinion, based upon the autopsies of these individuals, they did not have
any preexisting clinical, functional or structural cardiac abnormalities. Group B consisted of
Kindig, Melendez and Flowers, each of whom had such abnormalities, mostly of a structural
nature, although he could not ascertain whether and to what extent these abnormalities may have
caused clinical/functional impairments.
Mark Beigelman’s heart weighed 400 grams. Opining that the normal range for a male
was between 325 ±75 grams, Haider classified a heart of this size as in the upper range of
normalcy. He had cardiac thickening of the left ventricular wall. This finding appears in persons
who have hypertension and are subject to cardiac disease. If the left ventricle’s muscle is
thickened beyond normal limits it is considered abnormal, and indeed, he characterized the
importance that that muscle remain in the range of normalcy as “very critical.” The average
range is 0.8 to 1.5 centimeters. Beigelman’s measured at 1.5, the upper range of normal.
Stavola’s 350-gram heart had a ventricular wall thickness of 1.4 centimeters. M.J.’s heart
weighed 400 grams, but there is no finding as to the thickness of the ventricular wall. In
Haider’s opinion, none of these three decedents had cardiomegaly/hypertrophy. In addition, he
opined that in the case of these three, there was no relationship between any preexisting cardiac
disease and their eventual deaths.
Haider disagreed with Dr. Cooper, who claimed that M.J. had hypertensive
cardiomyopathy. He also disagreed with Cooper’s opinion that Group A member Beigelman had
this condition. In Haider’s opinion, M.J. did not have either cardiomegaly or hypertensive
cardiomyopathy.
As for Mr. Stavola, while Cooper concluded that his death resulted from cardiac
dysrhythmia due to opiate withdrawal, Haider, while agreeing that “obviously” the adverse
outcome resulted from the withdrawal, disputed that preexisting cardiac disease was related to
Stavola’s demise. He did agree that a person who had no underlying structural, functional, or
clinical cardiac disease and who went through opiate withdrawal could experience a cardiac
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dysrhythmia even without the presence of such preexisting cardiac conditions. Therefore, in
Stavola’s case, even though Haider was unable to detect any cardiac disease, it was nevertheless
possible that he did have a cardiac dysrhythmia.
Turning to Group B, Mr. Kindig did have an enlarged heart of 460 grams and
cardiomegaly. An overweight heart is considered a diseased heart. The condition is usually the
result of sustained high blood pressure and, indeed, Kindig had a history of hypertension. As for
Dr. Cooper’s conclusion that he died of a cardiac dysrhythmia due to hypertensive
cardiomyopathy, Haider characterized this opinion as “speculative.”
The range of normalcy for a female’s heart is 275±75 grams.30 The most striking finding
in regard to Ms. Flower’s heart was a contraction band necrosis and evidence of acute
inflammatory process. This was a damaged heart muscle. The inflammatory process means that
there are cells in the heart muscle that result from some acute process in the heart and this
occurred in the absence of any obstruction or narrowing of the coronary arteries. There was
evidence of damage to the myocardial cells, or acute myocardial infarction, despite the absence
of such blockage, which usually is the cause of most heart attacks. Some areas of hemorrhaging
were present as well, which is consistent with an acute injury to the heart muscle. Otherwise,
there was no evidence of any other significant cardiac abnormalities or disease is this twenty
year old. Dr. Haider agreed that she died of an acute myocardial infarction due to opiate
withdrawal, as Dr. Cooper had stated in his report. The withdrawal “clearly played a role in the
eventual outcome.”
The other findings about her condition indicate that she might have
eventually suffered such an infarction anyway.
Victor Melendez’s heart weighed 450 grams. The left ventricular wall thickness was 1.8
centimeters. Each measurement was beyond normal limits. In addition to the left ventricular
hypertrophy, he also had some interstitial and perivascular fibrosis and some occluded small
vessels. Melendez did not have a history of hypertension and there are many other causes for
these cardiac abnormalities. He did not report any history of alcohol intake to the respondents.
A good internist would order an EKG for a thirty-year-old patient prior to most procedures,
although he could not speak to what a general practitioner might do. He opined that where a
patient was being placed under general anesthesia, it “makes no sense not to do an EKG.”
30
The doctor accepted this statement as reported in Hurst, The Heart, at page 59. Dr. Haider referred to the text as the “Bible” in cardiology.
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Haider explained that hearts that exhibit these abnormalities are at high risk for
arrhythmias. However,
. . . based on the fact that none of these patients had any functional
impairment based on the clinical evaluation, I don’t think that that
was the primary cause of these patients’ deaths. Although, I must
emphasize, that the presence of cardiomegaly does place anyone at
somewhat of a high risk for arrhythmias but not the sole cause of
adverse outcome that these patients suffered within a few hours of
this procedure because, again, this cardiomegaly is preexistent for
sometime, although there was no clinical history of any symptoms
related to the fact that they had evidence of functional impairment;
meaning, symptoms related to the heart disease. So a cardiac
finding by itself would not be enough--sufficient to establish a
causal relationship between this heart, which is abnormal, and the
arrhythmias and the deaths.
In his report, Dr. Haider opined that the deaths under review were temporally related and
attributable to the UROD procedure and were potentially preventable complications that could
have been detected early and managed in a controlled hospital setting. In his testimony, the
doctor carefully defined a procedure related mortality as one in which the complications are
temporally related to the procedure. “After the patient walks into the doctor’s office and after
the procedure, died within hours.
So, that we call procedure related, if it is within the
meaningful period after the procedure.” However, there is no connotation of causation in this
term. The six deaths he examined were procedure related, and this is so not only because of the
temporal relationship, but also because, in addition to the obvious temporal relationship, the
decedents “suffered respiratory and cardiac depression following the procedures, which, in my
opinion, I put down here, related to the multiple drug effects.”
Elaborating on this last point during cross-examination, the witness noted that naloxone,
naltrexone and ketamine, the later an anesthetic drug, all have a known cardio-depressant impact.
These drugs, and the effects they produce, when combined with the effects of withdrawal,
especially the hormonal surge, caused the “initial insult which eventually led to arrhythmia.”
Haider could not ascribe a degree of importance to the part played by each drug or effect;
however, in combination they did contribute to the adverse impact. In regard to the anesthetic
drugs, “general anesthesia itself poses a degree of stress which you would not have in patients
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that are being treated without general anesthesia.” Just by itself, this stress results in a release of
catecholamines.
Dr. Haider opined that the deaths of the Group A patients were caused by or contributed
to by the UROD procedure. He does not believe that, absent their undergoing the UROD
procedure, these people would have died when they did. The procedure was performed under
general anesthesia and is then associated with opiate withdrawal. The withdrawal then continued
after the patient emerged from the anesthesia. The withdrawal symptoms are caused by multiple
factors.
That is partly because of the drug effect, blunted hypoxic drive,
patient after anesthesia not able--to able to respond to low oxygen.
In addition, there is the catecholamine surge and “also the effects
of multiple drugs in the system which is a result of the anesthetic
agents that the patients were exposed to and plus the drugs that the
patients were addicted to in the past. Multiaspects of this can
cause significant depression of the cardiac and respiratory
function, which some of these patients exhibited.
These breathing problems could lead to hypoxemia, which is low oxygen in the blood,
which may not have been detected or managed, and could then lead to a further depression of the
cardiopulmonary system and eventually arrhythmia and death. These factors, added to the
preexisting heart diseases by the UROD procedure, enhance the risk of fatal arrhythmias. “One
can postulate that these factors are responsible for determining the arrhythmias in these patients.”
He noted that the problems he identified, the hypoxemia, cardiopulmonary depression and
arrhythmias, could have been detected and managed in the post-procedure period.
The same answer applies to the Group B patients. Their structural abnormalities placed
them at high risk for adverse events such as arrhythmias. The abnormalities exhibited by the
Group B patients were medically detectable during the period of 1995-99. A 12-lead EKG could
have detected them. However, he conceded that some patients with cardiomegaly cannot be
diagnosed by this device.31 An echocardiogram, which is more sophisticated, could detect these
also.
31
Where the patient is very obese or has lung disease.
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The UROD procedure poses special risks to patients with cardiac related conditions.
Cocaine can cause spasm of the coronary artery and produce myocardial infarction, or ischemia,
a decreased blood flow to the heart muscle without infarction, and can also cause cardiac
arrhythmia. Heroin can cause problems that lead to pulmonary edema and cardiac abnormalities.
Together, these drugs can lead to cardio-depressive effects, which can lead to arrhythmias and
death. A physician possessing average skill and competence should have known of these risks
and the need for heightened care and caution. In the pre-screening, a physician of such average
competence should have identified those prospective patients with high, moderate or low risk
and a risk/benefit ratio must then have been applied to determine whether what one intended to
do to the patient would “harm the patient or get the patient better.” The “key to the entire
situation” is the pre-procedure assessment.
Appropriate post-procedure monitoring requires close monitoring of the heart, lungs and
brain function. This allows detection of early warning signs, which can then be assessed and
managed. “So, failure to detect those early warnings of – associated with those - - in these
situations can result in adverse outcome because it is then related to - - it progresses to a more
downward course, and the stage comes where it’s irreversible.”
Dr. Haider agreed that cardiac catheterizations are very invasive procedures. These
“routine” procedures have a mortality rate of .001% and the patient is generally discharged the
same day. A complication of bleeding from the site can occur, but the rate of such complications
is “extremely low.” Patients are retained for about six hours.
Haider acknowledged that Mark Beigelman had cocaine metabolites in his system at
autopsy. Nevertheless, he opined that it did not appear that the amount found reflected a large
dose of the drug. While cocaine could in and of itself cause ischemia and arrhythmia and is toxic
to the heart, he believed that these outcomes were usually the result of “unusually large doses”
and generally such cocaine-induced arrhythmias occur shortly after use of a large dose. He
disagreed with Dr. Ragasa’s assessment in the autopsy report that Beigelman had cardiomegaly
and that his 400-gram heart was large. He noted that while Beigelman weighed only 170
pounds, he was 6 feet tall. He also disputed that there was actually any biventricular dilatation.
While the autopsy report mentions it, there is “no data to support that,” as no dimensions are
provided and the doctor “eyeball[ed] it.” The heart will dilate terminally, “depending on how far
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resuscitated the patient, CPR, so on, the heart sometimes arrests in a state of dilatation.” It is
therefore a non-specific finding and a person who in life did not have biventricular dilation could
have, in death, a heart that is dilated. There is no way to tell post-mortem whether the decedent
had the condition while alive.
However, in life the condition could be detected by
echocardiogram.
Dr. Haider summed up his position regarding the factors that caused these deaths thusly:
Again, as I mentioned before, it’s a combination of factors.
Anesthesia played a role clearly and drugs on board and the
response of the body to withdrawal as manifested by, as I
mentioned before, the release of catecholamines in a person who
had just gone through withdrawal and had significant degree of
respiratory and CNS alteration. So, that combination certainly
together are very important, and that’s what I’m trying to allude to
and that is the phase post anesthesia before discharge.
...
Before discharge that needs to be monitored and after discharge,
clearly, these aspects of individual patients became worse clearly
and which got into a state that there was a downhill course and the
patient died.
Dr. Katz prepared a report after reviewing the autopsy reports and at least two opinions
from experts, as well as articles, including his own, published in the New England Journal of
Medicine, titled “Cardiovascular Complications of Cocaine Use.”
He has treated persons
addicted to opiate drugs, also about a hundred cocaine addicts, and a couple of hundred heroin
addicts, in addition to alcohol dependent persons. These persons are often multi-addicted. In
addition, he understands that many of the respondents’ patients were polysubstance abusers.
Dr. Katz explained the long-term effects of heroin abuse on the cardiac system and the
growing body of knowledge about the electrophysiology affecting the heart. Among the impacts
of heroin use over the long term can be fibrosis, which is the development of scarring on the
myocardium. Whenever there is scarring, there is a potential for malignant arrhythmias to occur
and, while the bigger the scar the more likely it is that such arrhythmias will occur, there can be
arrhythmias even when there is minuscule scarring.32
32
The doctor referred to a patient, a physician, who had an arrhythmia despite scarring that was “as small as you can get.”
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The doctor commented that M.J. was an intravenous heroin user who also used cocaine.
He had a stroke in 1996, purportedly caused by “bad drugs.” The physical and history workup
was adequate and up to the standard of care in medicine. The cause of death is listed as
hypertensive cardiomyopathy. There was no evidence of coronary artery disease. There were
signs of flattening of the trabeculae, that is, “like bands of muscle that line both ventricles.” To
Katz, this is a sign that the heart had sustained some damage. The reasons for such damage are
myriad, but it could possibly be the result of hypertension, although the doctor did not have
enough data to so conclude. The condition could also result from drug use, bacteria, or virus.
The complications that can result from these findings commonly include arrhythmia, which
results from pressure that develops and backs up throughout the left atrium down into the lungs
to the right side of the heart.
Lester Kindig had a history of hypertension, but was not on any medication for that
condition. He had undergone a rapid detoxification in London in 1996. His heart weight was
high. His death was labeled a hypertensive cardiomyopathy, but Katz finds the evidence of that
“vague.” Kindig would have been more prone to cardiac arrhythmia.
Lisa Flowers had a contraction band. The micro hemorrhaging that was discovered is
seen in cases of cocaine and heroin abusers, but adrenalin response can also cause it.
Contraction band irregularities could easily cause electrical problems and arrhythmias.
Mark Beigelman had a heart weighing in at the upper limits of normal. He also had heart
chamber dilatation and thickening of the heart muscle walls. Generally, the cause of this
condition is unknown, although it can be caused by high blood pressure, toxins or the narrowing
of the aortic valve. In such cases where the muscles do not work synchronously, the heart has to
work harder and this can cause thickening. Under stress, these cardiac problems could lead to
arrhythmia.
Dr. Katz found it is hard to come up with a cardiac related cause of death for Frank
Stavola, other than one caused by the impact of norepinephrine.
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Dr. Katz could not rule out the impact of the withdrawal process as a factor affecting
these patients. However, he “certainly think(s) most of these changes appear to be chronic
flattening of the trabecula, the glistening, thickness doesn’t occur overnight. It occurs over a
period of time.” He could not rule out the possibility that the UROD procedure played some role
in the abnormalities found, yet he could not pinpoint what drug used in UROD caused the
abnormalities, or what about the procedure did so. Reviewing the drugs used in UROD, he
identified propofol and fentanyl as drugs used in cardioversions; these are drugs that are fairly
safe even for persons with cardiac problems. Any drug can have a side effect, but these have
been found to be “probably safer than other groups of drugs” that surgeons and anesthesiologists
could have used. Ketamine and versed, which is a “fancy form of valium,” are also used by
cardiac surgeons and anesthesiologists.
The cardiac abnormalities that were found in these decedents would “probably not” be
detectable from a history and physical examination. They also would not likely produce any
information on a history and physical that would indicate the need for additional studies. An
echocardiogram might show thickening, an EKG or echocardiogram “possibly” would disclose
an enlarged, overweight heart. Had these abnormalities been revealed in some manner they
should not have led to a decision not to do the UROD, unless they were “very severe.” More
heart damage would result if the procedure was not performed and the prospective recipient
continued to use toxic drugs.
Left ventricular hypertrophy is mild if the thickness of the wall is in the range of 1.5,
even at 1.8. Such readings “wouldn’t . . . terribly upset” the witness. Except for Ms. Flowers,
Katz saw nothing about any of the other decedents’ conditions that would suggest that, absent the
UROD procedure being performed upon them, they had anything other than a normal risk of
death due to their cardiac conditions. None presented any indication of congestive heart failure,
and the damage to the hearts indicated by the flattening is cardiologically insignificant, although
there might be “all kinds of rhythm problems.” However, he agreed, “we can only assume that
perhaps there was an arrhythmia as opposed to a total cessation of the heart.”
The abnormalities exhibited at autopsy by Stavola, Kindig and M.J., while perhaps
indicative of some significant issues, were nevertheless not such as to suggest that they would
have died from these cardiac issues at the times that they in fact expired. In Flowers’ case,
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something acute is clearly indicated by the autopsy findings, and it is likely that that acute
occurrence happened within the twenty-four hours before death, in fact, his “educated guess”
would be that it happened within the last six to twelve hours. While the probability is that she
too would not have died when she did absent the UROD, it is “more probable” that she would
have than it is that the other decedents would have died when they did.33
Dr. Katz disagrees with Dr. Cooper’s opinion that M.J. died of hypertensive
cardiomyopathy. As for Beigelman, he does not totally disagree with Cooper’s assertion that he
too died of hypertensive cardiomyopathy. Katz testified that Beigelman might have had some
evidence of that condition, although in his written report he denied that he saw any such
evidence. In fact, he had some mild dilatation of both ventricles and might have had a mild form
of hypertensive cardiomyopathy, as well as the right ventricular dilatation. He acknowledged
that he was “waffling on the cause. I’m not sure that he did or did not have it.” In his
laboratory, a 1.7-centimeter reading for wall thickness would be referred to as hypertensive. He
could not give a direct linkup between this mild hypertensive myopathy and death, given that
“anybody who goes through a withdrawal long-term without medications or short-term has a
possibility of dying.” The witness found it “difficult to discern whether or not hypertensive
cardiomyopathy was present” in Kindig’s case.
In Stavola’s case, Katz would “have to say that cardiac dysrhythmia” was the cause of
death, although there were no findings at autopsy or otherwise to indicate that such a
dysrhythmia occurred. In the withdrawal setting, with the adrenalin rush that occurs, a person
with any damage to the heart muscle is at higher risk than is the average withdrawal patient. He
added, “but the average withdrawal patient certainly doesn’t have a zero mortality.” This
determination is not based upon any objective medical fact in Stavola’s history, but on the
doctor’s analysis of surrounding factors and his best medical judgment.
Dr. Katz acknowledged that in all of the cases, except Ms. Flowers, the pathologists
involved in the autopsy did not assign the cause of death as cardiac related. However, he offered
that these were patients who came in with abnormal myocardials and, while he cannot give a yes
or no answer as to whether the patient class served by the respondents were such that it was
foreseeable that they would present with such abnormalities, he suspects that they would,
33
Dr. Katz has seen about fifteen to twenty persons of about twenty years of age who have had heart attacks; two of these were cocaine abusers
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although he was not sure of the percentage. He also would think that it would and should be
foreseeable that in a class of polysubstance abusers there would be cardiac problems.
In
addition, he agreed that any of the drugs involved in the procedure, including the anesthetic
drugs, “have a certain propensity to aggravate arrhythmia,” by which, according to his testimony,
he means a “minor” “inclination of tendency.” Finally, he agreed that in the cases of Beigelman,
Stavola, Kindig and Flowers, each was found to have in their system at autopsy drugs such as
morphine, methadone, cocaine, or heroin that can pose a cardiac risk.
Pulmonary edema can occur from drugs such as heroin, although this is not a cardiac
pulmonary edema, but one caused when the oxygen level falls and the carbon dioxide level rises,
causing a “vicious cycle.” It can happen in one to two hours, or even as much as twenty-four
hours, after use. After that time it is not common, but he could not rule out such a later
occurrence of the condition. If one underwent UROD, heroin used shortly after the procedure
should be blocked by the naltrexone, if that drug in fact is blocking all of the receptor sites.
However, heroin toxicity might occur and not be fully blocked.
Dr. David Bradway noted that, based upon the information available to them regarding
the seven decedents, the only link that he and Gooberman could find was the temporal link. The
occurrence of seven deaths during four years and out of 2,356 procedures was clearly a lower
rate of deaths than the expected mortality rate for heroin users of between 2 and 5% a year.
After each death, the doctors discussed the case, and where available, reviewed the toxicology
reports, which were often only available to them four, six or eight weeks after the death. As for
patients in general, nurses made follow-up telephone calls to them every day for the first week,
every other day the second week, then biweekly, monthly or every six months. Given the
expected rate of mortality for this population of addicts, the respondents concluded that it was
possible that these seven deaths could “just have happened, or in other words, could have
occurred randomly.” There was no link to anesthesia, as the propofol was out of the patients’
systems within one hour. The literature was not helpful in attempting to understand the causes of
the deaths.
Dr. Lance Gooberman testified that he performed the UROD on G.W. Mr. W. was one
of the “early” cases treated by Gooberman. Mr. W. had an objection to the “photo” section on
who may have suffered vasospasms.
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the Consent Form and it was redacted in accordance with his wishes. A caretaker who identified
herself to Gooberman as Mr. W.’s “mate” was present.
Gooberman confirmed that neither on the written consent form nor in the oral review
thereof was death mentioned as a possible risk, as at that time in 1995, Gooberman did not think
of death as a possibility, nor did anyone else with whom he had spoken about the procedure.
G.W. “woke up slow” and was “very lethargic.”
34
He experienced some post-procedure
vomiting with blood therein, but, given the use of tubing, this was expected. While medications
were given for the vomiting, it did not abate as quickly as the doctor had hoped. As Gooberman
was “a little more guarded back then,” he requested that the caretaker take W. to a hotel room
and he paid for the stay. It happened that this procedure was performed on the weekend that Dr.
Colin Brewer was visiting from London and Brewer and Gooberman both went to the motel to
see W. W. was not very animated, was “just laying there,” and, according to his caretaker, was
still vomiting, although Gooberman did not see this occurring. His lungs were clear and the
doctor determined that W. was “responsive,” “arousable, but he wasn’t real participatory.” The
patient was given two injections to decrease the vomiting.
Gooberman thinks that he later returned by himself to check on W. He found W.
essentially unchanged, and, according to his note prepared on October 17, 1995, W. was resting
comfortably. The lungs were still clear.
The next morning Dr. Brewer and a member of Gooberman’s staff stopped by and this
time found W. “somewhat improved.” Gooberman then saw W. later that day and he was more
responsive. He appeared to be more alive, “coming out of it.” Further telephone conversations
with the caretaker indicated that he had begun to take fluids and was able to keep them down.
He last saw W. at the hotel on a Sunday morning at 7:00 a.m., forty-eight hours after W. had
arrived for his UROD. He was communicative and was taking fluids, his lungs were clear, and
he was lethargic. When he then spoke to the caretaker on Sunday afternoon she reported that
they were checking out to return to Pottstown, Pennsylvania. She reported that he was doing
better, occasionally breathing rapidly (a breathing pattern sometimes seen with naltrexone).
Parenthetically, this was also the weekend when “Joe,” the patient in the video played at hearing, was treated. He and G.W. were treated at
about the same time and, in recalling W.’s “lethargic” state, Gooberman noted, “He did not wake up like Joe.”
34
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There was no evidence of fever and as far as he can recall, no indication that he was continuing
to vomit.
Following many attempts to make further contact with the caretaker or W., on October 16
a staff person was told by the caretaker that W. had died and that the office should not call
anymore. Gooberman was stunned and called back. He was told that W. had died of a cardiac
arrest and had also developed pneumonia. The reason for death reported by W.’s caretaker did
not make sense to Gooberman, and he reported the possibility that someone who had had
undergone UROD had died to the Board of Medical Examiners and provided the Board with the
chart.
The cause of death listed for W. is acute necrotizing pneumonia, an inflammatory
bacterial infection that destroyed lung tissue. Depending on the stage, symptoms of this illness
would be primarily a cough, shortness of breath and fever. The time in which this condition
would develop would depend in part on the ability of the patient to fight off the infection and it is
hard to estimate how long it would take pneumonia to develop. When he examined W. at the
motel, Gooberman had specifically been concerned about the possibility of aspiration
pneumonia, but he had discovered no signs of an infection and heard no “rales,” which is a
characteristic sound that could signal fluid in the small airways. However, in the early stages the
infection might not be detectable. The doctor drew a distinction between “chemical” aspirative
pneumonia, which he said was more likely if the aspirated material was vomitus, and “bacterial”
aspirative pneumonia, more likely caused by saliva and bacteria contained normally within the
mouth that get down into the lungs.
Reviewing the drugs listed in the toxicological report, Gooberman noted that he did not
prescribe any benzodiazepines for W., and yet diazepam (valium), nordazepam (a product of the
breakdown of valium) and Temazepam (Restoril) were found in his system. These are all
sedative type drugs and could affect W.’s ability to wake up and could exacerbate his lethargy,
situations which could make aspiration pneumonia a more likely occurrence. It appears that W.
took these drugs either before or after UROD. There are several possibilities regarding the
development of this aspiration pneumonia, which ultimately caused the death some thirty-six
hours after he last saw Mr. W:
(1) W. was somewhat dehydrated. He came in for UROD without
having eaten or drank enough. He was hydrated during the
procedure, but he then was nauseous and vomited, leaving him dry,
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a condition in which it is harder to hear lung consolidation or rales.
It is possible that an x-ray would not have shown any problem, as
it is always heard before it is seen on an x-ray. Thus, when he
examined W., he might have missed the pneumonia due to the
dryness;
(2) the pneumonia was not there when he examined W. It was a
virulent strain that developed after he last saw the patient;
(3) despite the fact that he was looking for signs of pneumonia, Dr.
Gooberman simply missed the signs. Indeed, this also means that
Dr. Brewer, who was also looking for it and listened to W.’s lungs,
missed the signs as well.
Dr. Gooberman also treated Frank Stavola. Stavola had “been through the wars,” that is,
he admitted to a fifteen bag a day heroin habit and, while he did not tell Gooberman during their
meeting, he told the staff during his initial interview that he had used cocaine. Gooberman
learned of his death later that night. A CRNA was making follow-up telephone calls from
Gooberman’s house where there was a staff Christmas party taking place and he told the doctor
that the paramedics had gone to the motel because Stavola had gotten up and collapsed. On
March 13, Gooberman received a verbal report of the toxicological report. It showed the
presence of cocaine metabolites and Gooberman believes that Stavola probably tried to make
himself feel better by using cocaine. He also had some interstitial fibrosis. This heart disease is
not unusual in people who use cocaine.
The stress of withdrawal could have caused an
arrhythmia, especially if there was any degree of cardiomyopathy.
Gooberman believes that Stavola was one of a group of 515 patients who were given a
fentanyl challenge before they left the office to make sure that the naltrexone pellet was working.
Due to the information available to him after Stavola’s death and during 1997, Gooberman
believed that his death had resulted from cocaine use.
Mr. Beigelman’s UROD was performed by Dr. Bradway, but Gooberman went over the
caretaker instructions with his parents, assisted by another patient or a caretaker who happened
to be there and spoke Russian. The doctor felt satisfied that they could adequately take care of
their son.
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A call from Garden State Hospital later advised Gooberman of Beigelman’s demise. It
seemed that he had died a “sudden death,” as at the hospital his mother said to Gooberman that
her son had “just started gurgling.” He later learned that there was evidence of cocaine in the
system and he believed that this death, like Stavola’s, was attributable to cocaine use. With the
information he later learned of, the possibility of an arrhythmia must be acknowledged, with the
stress of withdrawal potentially impacting on abnormalities indicative of heart disease.
According to Dr. Ragasa, Beigelman had an enlarged heart.35 Ordinary and prudent medical
examinations and the history and physical did not give any indication of this problem.
Additional testing would probably not have led to the discovery of this problem. Even an
echocardiogram might not appreciate the existence of an enlargement in a heart of 400 grams.
Dilatation was not that gross as to be picked up either, even by echocardiogram. Further, as his
cardiac consultant group told him, these conditions are not in and of themselves necessarily
contraindications for UROD. No reasonable person would do a cardiac catheterization or test
pulmonary artery pressure as a pre-screening device, as these carry their own additional risks.
Neither the standard of care with regard to addiction medicine nor for the performance of UROD
required that these additional tests be performed. Indeed, the stresses would be the same for
other forms of detoxification and withdrawal brought about thereby, and in the case of UROD,
by the time the patients had emerged from anesthesia they had been through the worst stresses of
the withdrawal.
Beigelman’s death, understood to be the second cocaine-related death, caused
Gooberman to enact procedures to try and limit cocaine use, by telling patients up front, when
they first called and again when they came in for and were instructed about the procedure, that it
was very important that they not use cocaine. However, he did not employ the dipstick test when
it became available because he believed that it was an unreliable indicator of recent cocaine use.
Prospective patients were also turned away if they had used cocaine before the procedure,
despite the fact that its half-life is such that pre-procedure use really was not a contra-indicator
for UROD.
Dr. Bradway performed UROD on M.J. The records concerning his death confirm
hypertrophy (400-gram heart) and ventricular dilatation. Gooberman believes that the death
resulted from cardiomyopathy and the stress of withdrawal on this heart. M.J. was a past abuser
35
During testimony, Gooberman identified a man’s heart of less than 350 grams as “normal.”
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of cocaine and had experienced a previous CVA. There was no evidence of fluid overload.
Indeed, to the contrary, he had to be turned upside down to fill his blood vessels when he arrived
and his lungs were dry, without rales. He received only about 1,500 cc’s of fluid and this was
perhaps a bit low for him. He went to the bathroom twice. All this points to the absence of such
an overload. The family never suggested any shortness of breath.
Lester Kindig’s death was indicative of hypertensive cardiomyopathy, an enlarged heart
of 460 grams going through the stresses of withdrawal. He had alcohol in his blood, but
Gooberman had not provided him with any. Based upon computations, it does not appear likely
that the bottle of beer Kindig drank before the procedure (as per his caretaker) would have
resulted in the blood alcohol reading found, as had he had enough before to lead to that result it
would have been noticeable to Dr. Bradway and to the doctor or nurse who did the pre-procedure
interview. Gooberman also noted that benzodiazepines were found in his system, which again
had not been provided by Bradway, and there is a possibility that he took benzodiazepines after
the procedure. The report that Kindig was found “the way that he left that night . . . his hands
folded on his chest on top of the covers that was pulled over him” after supposedly “nobody
checked on him” was suspicious. In Gooberman’s experience, after having observed “literally
hundreds or thousands of patients go through withdrawal and none of them lay still . . . My
experience is they never have covers on top of them. They kick them off because they are
kicking the habit. They kick the covers off and more often than not, they don’t even have a sheet
on the mattress because they toss and turn so much that it comes off.”
Based on these factors, Dr. Gooberman concluded to a reasonable degree of medical
certainty that Kindig died from an arrhythmia caused by withdrawal stresses and a very large
heart.
The respondent opined that, to a reasonable degree of medical certainty, the cause of Lisa
Flowers’ death was an arrhythmia that occurred in a person undergoing withdrawal and the
accompanying stresses; a person with cardiomyopathy and also possibly a person who used
cocaine post-procedure. Gooberman characterized Flowers’ 300-gram heart as “large,” due to
her small stature, at 5’3, 105 pounds. The toxicology report shows the presence in her system of
free morphine. Gooberman testified that Anthony Reggio, Flower’s caretaker, told Jennifer
Richards, a nurse on his staff, that he had told Flowers that she should not have used “about
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twenty bags” of heroin post-procedure. He argued that the presence of the morphine suggested
post-procedure, as opposed to pre-procedure, use of heroin, as in all probability heroin taken preprocedure would have metabolized. He posited, as “just a possibility,” that, while the naltrexone
would have blocked the effect of the heroin, she may have also taken some cocaine, which
metabolized and therefore was not found in the system, but which may have caused a myocardial
infarction. Evidence that she did use cocaine (although not necessarily post-procedure) is that at
twenty years of age she had myocardial fibrosis, which is not a normal finding for someone her
age, except that it does occur in cocaine abusers.
In Gooberman’s opinion, Victor Melendez was a man in the terminal stages of addiction,
an “old guy inside,” with a 450-gram heart and small vessel disease, for which not much can be
done and which is both frequent in diabetics and hard to determine pre-mortem. He also had
multiple ulcers in his stomach; a hemorrhage at the top of the esophagus extended 2/3’s of the
way down to the junction and, upon microscopic analysis of the liver, marked fatty infiltration
that the doctor felt suggested an alcoholic liver of hepatitis C.
The doctor explained that the standard of care is to perform an EKG for a patient over the
age of forty, and not to do so for a person of thirty years of age. It is possible that an
echocardiogram might have shown the enlargement of the heart, but even if it had, this is not
necessarily indicative of a low ventricular output, or ejection fraction, and even such a low
output “would still be only a relative contraindication.” In Gooberman’s opinion, to a reasonable
degree of medical certainty, Melendez was septic when he died and had “quite a bit wrong with
him,” making it hard to “tease out everything that was going on.”
However, he had
cardiomyopathy and some degree of withdrawal and this could have precipitated an arrhythmia.
Additional Issues
While the cause(s) of death for the various decedents are a central concern in this case,
another set of issues, admittedly in many ways directly related to possible reasons why patients
did not survive, address the question of whether the respondents, in their practice of UROD,
deviated from the standard of care applicable to their activities. It is important to note that the
experts who addressed these issues did not necessarily agree on what standards were applicable
to UROD. In fact, some suggested that there was no standard of care for the procedure, or at
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least was not at the time that the two respondents were providing the procedure. It also is posited
that Dr. Gooberman, as the person either performing or responsible for such a large percentage
of the URODs, was by his own activities establishing, many of the standards. It seems that the
experts did acknowledge that at the very least, any standards for UROD were evolving over the
period 1995-99, and indeed, to the extent that any future UROD practice occurs, they continue to
evolve. In its particulars, the “standards” issue touches on many of the Complaint’s allegations
of improper and negligent conduct and therefore speaks to such issues as the intake and
screening procedure, the drugs used in UROD, the discharge criteria and practice, aftercare and
post-UROD rehabilitation.
Standard of Care
Dr. Karan testified that that there is a large amount of experience existing in the field of
addiction treatment medicine and a fairly standard set of medical procedures is applicable,
although at the present time there is some notion concerning changes in some of the techniques,
such as the use of methadone and buprenorphine. As for UROD, there are no standards of care
as of yet for ROD or UROD procedures as such, but the absence of a complete set of standards
for ROD “doesn’t mean complete anarchy” exists. There are clearly recognized standards of
care for good medical care and, therefore, there are at least minimum standards that are
applicable to the ROD procedure. Further, as information on this procedure has developed over
the past five or more years, ASAM has developed some standards. Such standards as now exist
are not more restrictive than they were five years ago. Yet, at the same time, as far as the
definition of acceptable standards of care is concerned, it is true that at present ROD is
something of a “moving target,” so that, for instance, while she firmly believes that the absence
of a supervising anesthesiologist is a violation of what the standard should be, the standard is
evolving and changing.
Taking her thoughts on this standards issue into account, Dr. Karan concluded that as
practiced by the respondents, the detoxification element of the UROD procedure deviates from
accepted standards of practice and the standards for the detoxification of opioid dependents.
Dr. Kleber acknowledged that as of 1995 UROD was a “very experimental procedure
with no one set of standards." Different antagonists were used as well as different anesthetics.
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There were controversies regarding whether the procedure should be performed under full
anesthesia, or only under sedation. No published standards existed before 1995. Indeed, this
lack of published mandatory standards continued in 1996. The standards were “evolving.”
Dr. Gevirtz published a case study in the Journal of Addictive Diseases regarding some
123 UROD procedures that he and another physician performed. He acknowledged that UROD
is an evolving procedure; nevertheless, he insisted that there are standards of care applicable to
it. The standards he utilized were taken from the American Society of Anesthesiology (“ASA”).
These standards did not actually address UROD as such, but did address the anesthesia elements
of the procedure.
Dr. Smith first learned of UROD in the early 1990’s. Dr. Gooberman, who Dr. Smith
characterized as an important member of ASAM, would make presentations about the procedure.
In addiction medicine, Dr. Herbert Kleber was doing “more experimental” work at Yale. The
process was evolving.
As a practitioner of addiction medicine, Dr. Smith was interested in ways to treat the
disease. Detoxification is not treatment of the disease. However, Dr. Smith had been looking at
naltrexone as a possible drug of interest in the treatment of opiate addiction since the 1970’s. In
considering the possibility of implantation of this drug in opiate users, the question that had to be
answered was, why do it? However, while there were questions to be answered, nevertheless, he
characterized the implantation of naltrexone as a treatment modality.
At the request of former counsel for Dr. Gooberman, the witness prepared a report in
which he reviewed the series of allegations made in the Attorney General’s Complaint. In
connection with the analysis of their practice and its conformity to such standards of care, Dr.
Smith cautioned against judging the respondents based upon a standard of care that did not exist
when they were treating patients. Instead, as the ASAM Policy Statement No. 9 notes, they must
be judged “based upon the science and practice of addiction medicine relevant at the time.” The
ASAM Statement emphasizes that the methods of opioid detoxification that are available in a
given community will evolve over time as biomedical knowledge and treatment research
advances.
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Addressing the charge in subparagraph two of the Complaint that, in their practice of
UROD, the respondents have “regularly deviated from accepted standards of medical care which
exist in the medical practices of addiction treatment and anesthesiology,” Dr. David Simon
explained that while there are central issues of standard of care in this case, “people are talking
about different standards.” He identified four standards of care. The first is that expected in
addiction medicine. The second is that relating to addiction psychiatry, that is, that which would
be expected by Board certified psychiatrists with a specialty Board in addiction psychiatry. The
third standard of care is that for anesthesia, subdivided into that applicable in the operating room
and that applicable in other settings. Finally, there is a fourth standard, that being the standard
applicable in UROD. As to the latter, it is Simon’s position that in the time frame 1995-99 there
was no standard for UROD. There were not many practitioners using the procedure, they were
using different protocols, and in some cases, these protocols were protected as proprietary
information. “Different practitioners were using different methods and most of the practitioners,
for whatever reasons, be they altruistic or selfish, most of them were secretive about what they
were doing.” Indeed, Dr. Gooberman was pioneering the procedure in the United States; he was
setting the standard. There was no previous standard against which he could be judged. Dr.
Gevirtz worked for CITA, an organization which kept its work secret, and therefore, “[H]ow
would we know what the standard was that he used?”
In Dr. Simon’s opinion, Dr. Kleber is really speaking to standards applicable for
addiction psychiatry, and it is not fair to hold these non-psychiatrists to those standards. Neither
of the respondents is a psychiatrist and therefore the standards for addiction psychiatry are not
applicable to them. Addiction psychiatry is only one area of practice dedicated to treating
addicts, and persons such as Simon and the respondents are addiction medicine specialists, not
addiction psychiatrists. Simon does not believe that the respondents deviated from the standards
applicable to addiction specialists. Even as of the time of his testimony, Simon argued that there
is no definitive UROD standard of care; it is evolving.
As for anesthesia, the anesthesia
standards applicable to a particular operating room setting are not directly applicable to UROD
procedures conducted in an outpatient setting. However, in his view, there is no deviation from
the ASA standards in the Gooberman/Bradway practice, except perhaps regarding the standard
for monitoring every five minutes, where the respondents apparently monitored every fifteen
minutes (more about this later in this opinion). However, the witness argued that the machinery
used during the procedure can be set to established parameters automatically and can monitor
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and sound alarms, recycling on a five, ten or fifteen minute cycle. Thus, it would be acceptable
to set the monitors to meet the continuous monitoring standards.
Reflecting on Count Two, paragraph 2.I, subparagraph j., which alleges that the
respondents failed “to provide safe and effective procedures and personnel to ensure safe and
effective patient recovery and continuation of appropriate addiction treatment,” Simon testified
that, in his opinion, based upon his knowledge of how drug addicts are treated in communities
across the country, there was no deviation, “from what was done in the many hospitals and
treatment programs.” Further, having reviewed “some of the expert testimony” presented in this
hearing, he opined that
what the experts speak to of the standard, in my opinion, is the
gold standard, platinum standard but not the minimally required
standard that’s out there. You can get a 2 ½ million dollar grant,
spend all that money buys, you can deliver a maximum level
standard of care. It’s not reasonably expected of a practitioner in
private practice to be able to deliver that same level of standard of
care. . . On some of the issues, certainly not all, Dr. Gooberman
might not have met the gold standard, but he met the acceptable
standard, the standard that’s out there in practice. . . Dr.
Gooberman’s practice did not, in any way, deviate from the
standard that’s practiced in treating addicted individuals
throughout the country in many, many programs.
Dr. Bradway explained that the NIDA report did not lead to any specific changes in Dr.
Gooberman’s protocols. Nevertheless, the two were always seeking to improve the procedure
and give the patients the “best care possible,” and, to the extent that it was appropriate, changes
in the protocols were made to meet individual circumstances. In addition, some general changes
were made in the protocol over the three years. The formulation of the naltrexone pellet
changed, the antagonist utilized changed, the pharmacological regime changed and screening
criteria were changed so that more stress testing and pulmonary function testing was done in the
wake of deaths that were unexplained to the doctors, at least in terms of any objective data to
understand why exactly the deaths had occurred. Because they had some toxicology reports that
implicated cocaine, over time they excluded patients who had taken cocaine within twenty-four
hours of the procedure, and the number of persons denied the procedure increased as the doctors
became more cognizant of heavier users and cross-dependencies. Thus, the doctors’ standard of
care evolved with the implementation of new policies and procedures. As for cocaine use,
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Bradway did use the dipstick on occasion when his clinical judgment led him to believe it
necessary.36 His clinical determination was based in part on his knowledge of addictions and
experience with the addict population.
Discussing the standard of care applicable to the UROD procedures and associated care
he rendered, Dr. Gooberman stated that the standard did not really change over the years 1994
through 1997, as the “basics were still the basics.” There were “nuances in terms of the
practitioners throughout the world and what they thought would be preferential and that was
changing and, I guess, it’s still changing.” He was active in bringing people together to discuss
the issues in a public forum and he reviewed the literature and attended forums. In addition, “I
exposed what I did to scrutiny by my peers at every opportunity.”
Pre-Procedure
Dr. Karan found further deviations from accepted standards of care in regard to a lack of
proper assessment of the patients before UROD and in the medication and follow-up provided.
As for the assessments, a much fuller assessment than that which Drs. Gooberman and Bradway
required was appropriate. The assessment was needed to determine both the indications for and
any contraindications against the use of UROD for the particular patient.
In a “regular”
detoxification, a very detailed history of the patient’s addiction is obtained, including the type of
drugs used, the frequency and level of use and the method of administration. A urine drug
screen, a physical assessment, including breath sounds, a breathalyzer examination, a history as
to any delirium, seizures, infectious diseases, underlying medical problems, is also obtained, so
that the physician knows what he or she is dealing with.
If done properly, this detailed
assessment takes an hour without any laboratory work, at least a half-hour to an hour and a half
depending on complications.
The standard of care for assessing an addicted individual
oftentimes requires a urinalysis. These details are not evident in the records of the respondent
doctors.
While Dr. Karan stated that the failure to obtain a knowledge of the length of drug use
and the possible use of multiple drugs were not, as such, deviations from the standard of care,
nevertheless, her review of records did not reveal that there was enough information obtained
36
He recalled that the standard testing for cocaine and other abused drugs became available in 1998 or 1999.
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regarding co-morbidity, that is, the use of other drugs. There was an insufficient medical history
obtained and a lack of appropriate diagnostic radiology. There is no evidence of any cardiac
workup, which she described as standard practice prior to surgery and the administration of
anesthesia.
The witness commented that, given that the patient’s came for the treatment on one day
and often from a distance, there was a great deal invested in making sure that the entire
assessment and treatment occurred that day.
Dr. Kleber was involved in the formulation of the anesthesia protocol for the Columbia
study, but has not supervised anesthesia use for the past five years. Therefore, the protocol was
prepared with the assistance of a Board Certified anesthesiologist who is an assistant professor of
anesthesia at Columbia. Physical examinations of the study participants are conducted by others.
Cardiologists are used to review EKGs. Internists and anesthesiologists then determine whether
a participant can continue in the study.
Dr. Kleber testified that a doctor must screen potential patients to determine their
suitability for a particular procedure, given the status of the patient and the risks and benefits of
the possible treatment. The exclusion criteria utilized by the respondents did not exclude persons
who had abused cocaine; this in spite of the fact that there is a known relationship between
cocaine use and heart damage and the fact that the stress involved in certain procedures could
lead to a bad outcome if cocaine were in the system. The presence of cocaine in the body during
a UROD procedure may heighten risks. Cocaine is known to sensitize the heart. As UROD is
known to lead to large increases in certain internal hormones and neurotransmitters, such as
cortisol, ACTH and epinephrine, cocaine use should have been considered. Indeed, as Kleber
pointed out, at the September 1999 hearing Dr. Gooberman acknowledged that he believed that
some of the deceased patients had used cocaine after the procedure, yet he did not test before the
procedure despite the warning provided by these deaths. Addicts are desperate people who often
lie and testing is needed to determine is they have in fact used recently, that is, within twelve to
twenty-four hours. In addition, although the consent form does state that cocaine use after the
procedure may kill the patient, evidence that, even after the warning given on the telephone in
initial contact calls, the patient used cocaine increases the risk that the patient will be noncompliant with this direction after the procedure. The screening procedures did not test for
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cocaine use immediately prior to carrying out the UROD procedure.
A dipstick test was
available and only took a few moments to administer. It produces a result that would indicate
whether cocaine was ingested within twenty-four hours of the test. In addition, the history taken
from the patient can also assist in this task. As far as Kleber could determine from the material,
the doctors did not assess the length of use of drugs of abuse by potential UROD patients. In his
opinion, if the length of use was shorter, then less risky detoxification procedures should have
been employed.
The screening did not appear to consider benzodiazepine use in assessing the suitability
of the patient, nor did the exclusion criteria appear to exclude alcohol dependence, which
increased the risks due to possible delirium tremens. The presence or dependency upon other
drugs could complicate withdrawal. As a result, there is a need to know if a potential patient is
dependent upon alcohol and/or sedatives. Dr. Kleber opined that a breathalyzer test was an
appropriate and necessary screening tool.37
Another exclusion criteria is pregnancy, yet the respondents did not do a pregnancy test.
Guidelines adopted by ASAM in 2000 specify that pregnancy testing be done. This testing is
particularly important, as some heroin addicts are well known to experience irregular
menstruation or have stopped menstruating without being pregnant. Additionally, naltrexone is
not approved for use during pregnancy.
A patient affected by serious cardiac problems should also be excluded. Some of these
conditions cannot be detected by means of physical examinations, history and EKG. Once
deaths had occurred following UROD treatment, there was a particular need to screen those with
cardiac changes.
Dr, Gervirtz discussed the protocol that he put into place in 1996. The basic outlines
were those established by CITA in Europe. Prior to undergoing the procedure, a detailed consent
form was used, which was reviewed line-by-line, page-by-page. No candidates received the
procedure on the same day they first came to the site. The candidates had a face-to-face
interview with a Board certified psychologist, who reviewed both medical and addiction history.
37
Although the doctor noted in his September 10, 1999, report that dependence on alcohol or benzodiazepines was not listed as an exclusion
criteria or even cautioned against in the screening procedure, nevertheless, none of the patients who died exhibited any symptoms of delirium
tremens.
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Each then had a history and a physical examination for the anesthesia. A Board certified
psychiatrist also saw the candidates, in order to determine if they were suitable. Each candidate
had a SMA 7 and SMA 22 test, electrolytes were checked, and a chest x-ray and EKG were
performed. A urine dipstick test was performed on intake and again on the morning of the
detoxification.
Not all of the candidates were accepted for the procedure; some being
disqualified due to medical status, based upon findings relating to cardiac, liver or pulmonary
status. Pre-anesthesia assessment standards of the ASA were fulfilled. If the candidate was a
chronic cocaine user, a more elaborate cardiac evaluation was performed. Most of the candidates
for UROD are multi-abusers, that is, they use more than one illicit drug, and “speedballs,” a
combination of cocaine and heroin, are commonly used.
Gevirtz agreed that it is conceivable that testing for cocaine use will present a false
reading. Therefore, it is conceivable that a UROD procedure could be performed on a client who
had in fact used cocaine recently and should not have undergone the procedure.
Dr. Kushins testified that the standard of care requires that appropriate evaluation of
myocardial function occur and the witness opined that in the period from 1995 to 1999 transthoracic echocardiograms were readily available to assist in this function. These provide an
excellent non-invasive method for examining the condition of the heart. This equipment is
sophisticated and expensive and is part of a hospital-based practice.
Dr. Kushins emphasized that in his opinion, if a patient admitted to cocaine abuse within
a recent period of time, the standard of care applicable in 1995 through 1999 required that the
physician order an echocardiogram prior to allowing the patient to undergo UROD. The doctor
defined “cocaine abusers” as persons abusing cocaine and admitting that they are abusing
cocaine. Such abusers are persons who had used cocaine on repeated occasions, not once in their
lifetime. Those who repeatedly use cocaine should have an echocardiogram. Indeed, if a patient
has used cocaine with any regularity, then the patient should have a trans-thoracic
echocardiogram, which is usually read by a cardiologist in the hospital. Such examinations are
not 100 percent accurate regarding underlying cardiac pathology and can miss these pathological
signs. Such additional tests as a trans-esophageal echocardiogram and a thallium stress test offer
a small additional yield of information and are not routinely required.
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The doctor acknowledged that a doctor generally has to take at face value what a patient
says during a pre-anesthesia interview. If the patient denies using illicit drugs, then the doctor
must accept that statement. The doctor also acknowledged that the standard of care is that
persons under age of forty with no known history and without any significant medical problems
receive surgery without first having an electrocardiogram. Kushins explained that for a patient
under thirty-five years of age without any symptomatology, there would be no indication for an
EKG or an echocardiogram during a workup prior to anesthesiology.
Dr. Kushins observed that if Lisa Flowers, who suffered from asthma, had experienced
recent exacerbations of her asthmatic condition, then, in the case of elective surgery such as
UROD, the patient should have been advised to wait at least one to two weeks and then return if
she had normal symptomatology, confirmed by examination. He also noted that Ms. Flowers
had been wheezing before the procedure and in such an instance, the procedure should have been
deferred for a week or two until the wheezing cleared up. While some people do experience
these symptoms on an almost continual base, in Ms. Flowers’ case, she had a recent respiratory
infection. Persons with such conditions are at risk if they use heroin, as the drug has respiratory
effects of a negative nature. Thus, it is beneficial for such a person to stop using heroin.
Dr. Smith disagreed strongly with the charge that the respondents had failed to establish
“inclusion and exclusion criteria for those patients undergoing the procedure.” While “precise
research criteria for inclusion or exclusion” were not employed, Dr. Gooberman “was not bound
to a research standard.” Regarding this issue, Smith noted that the “ ‘very broad evidence’ is that
the group who are in treatment do better than those who are not,” and, in the words of the
California Society of Addiction Medicine, there are “many doors to addiction-based treatment
and none of them are bad.” In treating his patients, Dr. Gooberman responded to the selection of
his approach by persons who had, in many instances, either rejected or failed at other approaches
to treatment. “The goal of the addiction medicine doctor is to get the patient in treatment.
There’s not one set of treatment, nor is there one set path of treatment.”
Dr. Simon did not recall that he had seen any written document containing the inclusion
and exclusion criteria applied by the respondents to determine which candidates for UROD were
acceptable.
However, it was clear to him that patients were appropriately evaluated and
judgments made as to their acceptability for undergoing the procedure. An individual medical
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judgment as to the acceptability or lack of acceptability for inclusion in a treatment program is
perfectly within the standard of care in the addiction community.
Addressing the criticism that the respondents failed to distinguish between those
candidates for whom an alternative form of detoxification was appropriate, Dr. Simon opined
that the respondents did not breach any standard of care. However, he also noted that UROD is
itself an alternative form of treatment for seriously addicted persons who, in the great majority of
cases, have already attempted detoxification and/or treatment by other means, such as “cold
turkey,” hospitalization, methadone maintenance, etc. Simon had difficulty with the concept that
it was inappropriate to detoxify somebody in need of detoxification, by whatever method. If a
patient were not a good candidate for UROD, it is not clear to Simon that the patient would be a
good candidate for any alternative method of detoxification.
Dr. Simon rejected the allegation in Count Two, Paragraph 2. II, subparagraph c, that the
respondents failed “to adequately pre-operatively assess patients” cardiac, respiratory, hepatic
and renal systems to determine their ability to tolerate the exceptional stresses of the
UROD/ROD procedure.” Disagreeing in part with the characterization of the stresses involved
in UROD as being “exceptional” in comparison to those he said were encountered in some other
surgical procedures, he also defended the assessment forms and interview and intake forms
utilized by the respondents as “very similar [to those] that are in many surgery centers,” although
he did not believe that the “higher standard” for “typical surgery center[s]” was the standard to
which the respondents should be held. 38 Additionally, the Complaint seems to assume the need
for renal and hepatic assessments, when a review of the ASA standards for laboratory testing for
anesthesia finds that the standards do not contain such a requirement. In his opinion, the
respondents provided for an adequate physical examination prior to a surgical/anesthetic
procedure conducted in an ambulatory surgery setting. The respondents’ procedure met the
standard of care.
Discussing the screening mechanisms that he employed at Nutmeg between 1996 and
1999, the witness testified that, as recommended by colleagues in the addiction medicine field,
he used a urine test. He utilized this test, not as a prescreening device, but as an aide in aftercare,
38
Dr. Simon referenced a monograph, Cardiopulmonary Bypass: Current Concepts and Controversies, edited by Tinker (D-84), to illustrate the
“significantly higher” levels of stress involved in that procedure. Further, citing the Textbook of Medical Physiology, by Guyton, he noted the
effect of “mental” stress, which can raise the level of stress hormones, such as cortisol, up to twenty fold.
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so that he could determine what drugs a patient was using. This was especially so with a multiaddicted person, so that Simon could write prescriptions for appropriate medications. He wanted
to be able to exclude causes of symptoms other than opiate withdrawal. In his view, this was
“good medicine.” In addition, he used this information as a part of an outcome data analysis.
Blood tests were done on a case-by-case basis. This was good medicine, as well as a part of his
market and business strategy, impressing other providers.
Men over forty years old were given a twelve-lead EKG, as were those about whom he
had any clinical suspicion of some medical concern. No echocardiograms were performed, but
“less than ten” candidates for UROD were referred out for clearance, a step that he characterized
as a form of defensive medicine. The ASA standard for general surgery requires that men over
forty undergo a twelve-lead EKG before the surgical procedure. In the present matter, the
records do not indicate that the respondents did such testing, but when queried as to whether this
constituted a violation of the standard of care, Simon questioned whether the added
complications of a surgical procedure, as opposed to UROD, were such that the ASA standard
was inapplicable to UROD. He performed the twelve-leads because it was the standard and also
good medicine, but he was “very, very conservative and I wanted to cover all bases. I wanted to
dot all the I’s, cross all the T’s. So, in that respect I followed all the guidelines that I could.” He
never excluded anyone over forty from UROD based upon a twelve-lead test.
Dr. Simon commented that the standard of care applicable in anesthesia, addiction
medicine and the practice of the UROD procedure does not require the administration of an
echocardiogram prior to the administration of UROD. “If you ask a patient, by history, if he has
a heart problem or not and the patient says no and your exam of him doesn’t lead you to believe
that he has a significant heart problem, there’s unequivocally no reason to get an
echocardiogram.” If the patient has used cocaine, there is still no such standard in effect. Dr.
Simon “quite strongly disagrees” with Dr. Kushins “absurd” opinion that if a person used
cocaine twice in a year it was then necessary for the patient to undergo an echocardiogram in
order to comply with the standard of care. It is simply not reasonable that someone who used
cocaine twice in a calendar year would exhibit any significant cardiac pathology that would
warrant an echocardiogram or that would show up on one. The age of the patient and the degree
of any cocaine use are factors that a physician must take in to account in making judgments as to
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the tests to order in specific cases. However, “I don’t believe that the heart disease caused by
cocaine is the type that will be revealed by a cardiac echogram.”
Simon advised that he had used dipsticks for testing for cocaine. He “supposed” that the
general wisdom was to use them, however, while he would defer to Dr. Karan’s opinion, in
prescreening 162 patients in his clinic, 20 percent were found to use other drugs and no
correlation was found with relapse rates. As for the opinion expressed by some practitioners of
UROD that they recommend that the procedure not be performed on someone who uses cocaine,
he “respectfully disagrees, based on my data, which shows that we had a positive cocaine in the
urine and it has made no difference. We have done it safely and effectively. . . To me it doesn’t
make sense, when I think about the pharmacology involved, to discriminate against cocaine. We
can’t do anesthesia with cocaine, but we can do it with a tricyclic antidepressant. That probably
doesn’t make pharmacological sense.”
Simon argued that this reluctance to perform this
detoxification procedure on persons who use cocaine is another manifestation of the bias against
drug abusers that he has encountered in the field. This bias arises from social values, something
like the feeling that these drug abusers are not from the “better” class of persons, although in his
practice he treats lawyers, doctors, executives, etc. The bias carries over to addiction treatment
specialists, in that there seems to be a bias against drug addicts vis a vis those who need
psychiatric treatment or pain management for other reasons.39
The doctor did not believe that it was appropriate for patients to come to the UROD
procedure, “comfortable.” If a patient where to ask over the telephone, “how should I come,”
“we would always try to hedge . . . because we never wanted to recommend somebody to use an
illegal substance . . . it was inappropriate . . . .” However, while this was a valid medico/legal
concern, the witness added that “[F]rom a medical standpoint, I didn’t have a problem with a
patient coming in with opiates.”
Mr. Maziarski could not say what the standard of care was regarding the testing of
patients for cocaine use prior to a UROD procedure, although he knew that the CRNAs did not
test patients pre-operatively. He would not test unless the protocol established for the procedure
required such testing, and he knew of nothing special about this patient population that would
require such pre-assessment.
39
Dr. Smith also addressed issues of bias regarding the treatment of drug addicts and of doctors who treat such persons.
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In his report, Dr. Katz stated that he “would have liked to have seen an electrocardiogram
and echocardiogram performed, full history and physical including blood work for the
procedure” and “would also liked to have seen this done in the hospital.” During his testimony,
he clarified that he was referring to a twelve-lead EKG. Because of his training and practice as a
cardiologist, he likes to have as much information as possible before he makes a diagnosis. As a
cardiologist, he feels the electrocardiogram is a “crucial part of the examination.” Again, he
further clarified his written thoughts, specifying that if he could do the history and physical and
felt that there was a need, in a cardiologic sense, for an EKG or thereafter for other tests he
would want these performed. “In other words, if a patient had some signs that I didn’t like or
some symptoms that I wanted to pursue then I would have pursued them.” In the years 1995-99,
medical prudence for a physician about to perform UROD might have required the physician to
contemplate these four elements, yet he could not say that he was “clear that all of them are
critical in making the decision as to whether or not to do the procedure.” However, he agreed
that, as the EKG does provide the practitioner with the “best available information upon which
clinical judgment can be made,” and, “to the extent that there is an established and recognized
test or diagnostic procedures that provides information that’s necessary to the clinical judgment,
the failure to do that test ‘might be’ something of an impropriety, if not actually a deviation of
standard of practice.”
Dr. Katz agreed with counsel for Dr. Bradway that no test, be it electro or echocardiogram or stress test, is 100% determinative of whether the patient has heart disease. Tests
such as stress tests and procedures such as cardiac catheterization carry risks, even the risk of
death. However, weighed against their benefits, the EKG and the blood test carry either no risk
or a very small one. A physician must rely upon personal judgment, and in that realm, personal
contact with the patient is “crucial” in making decisions. The more cases one does, the more
knowledgeable one becomes. Yet there are misses, and “if you don’t miss anything, you haven’t
done anything.”
Not all drug abusers have clinical heart disease. Dr. Katz would not give stress tests or
an echocardiogram to all abusers. There is no deviation from the standard of care in not doing
these tests. Yet, he acknowledged that his standard as a cardiologist is to perform an EKG, and
said, “its prudence in the evaluation of any patient,” or, at least, “most.” With the population that
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the respondents were treating between 1995 and 1999, as a cardiologist Katz would have
preferred to have seen an EKG performed. However, while he did not have any idea as to the
standard of treatment to be provided by an addiction treatment specialist providing UROD
during the years 1995-99, he noted that during those years increased suspicions as to the
relationship between the abuse of heroin, cocaine and alcohol and diseases of the heart
developed into an understanding that there is a definite relationship between these toxins and
heart damage. He believes that an individual practicing in the addiction treatment field during
that period “should have known” the state of medical knowledge as to this relationship. This
should have created a greater sense of caution as to patients and UROD. The UROD procedure
had certain already recognized consequences, such as the heightened stress of general anesthesia,
with its risk of morbidity and mortality, and withdrawal, with its accompanying adrenalin rush
that effects a patient even when anesthetized, but more so when that patient is withdrawing from
opiates.
Katz opined that if there was no specific standard of care in existence for addictionology,
then the exercise of reasonable medical prudence in evaluating and diagnosing the patient
population that the respondents were treating would have required, at a minimum, the
performance of a twelve-lead EKG. Depending upon the results of the EKG, other tests might
then be required. An EKG might possibly show cardiomegaly and has a 50/50 chance of
revealing hypertrophy, particularly of the left ventricle, although it might miss the condition on
the right side. This finding would show that there was some cardiac disease and lead to
questions about what exactly was causing the condition. An echocardiogram would be “better”
for detecting cardiomegaly, although “not perfect” at doing so. An echo might show a heart of
450/460 grams. A basic blood test, blood counts with differentials and chemistries, might not
reveal cardiac problems, but could detect anemia, elevated white blood counts and infections.
Dr. Bradway explained that the interview process involved screening the prospective
patient. When he first started to perform URODs, the general office practice was to obtain a
series of tests that were a part of the screening process. These tests included a complete blood
count (“CBC”) with differential, hepatitis profile, pregnancy screen for a female of fertile age,
HIV screen, urine analysis and TB skin test. In describing the office practice, Bradway did say
that these tests were “recommended,” which he clarified to mean that tests could be waived at
the doctor’s discretion, but were generally required, and if a patient had not had the tests done, it
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“was up to the physician to exempt them from it. . . but as a general rule, they were required - - a
recommended - - I don’t know how to phrase this exactly.” After about one year, Gooberman
decided to discontinue the battery of blood tests, because the experience of several hundred
UROD procedures indicated that it made no difference whatsoever to the outcomes whether
these were performed or not.
Bradway conservatively estimates that in his first year he performed 100 URODs. He
performed the histories and physicals himself. Information gathered in a telephone interview
constituted a part of this history. He felt comfortable having the prescreening tests done, as the
procedure was still relatively new to him. On several occasions, he put off a UROD because the
tests had not been done. He frequently called for a stress test or for an echocardiogram,
however, with the population they were treating, which averaged thirty-four years of age, it was
not routine to order an EKG or stress test unless the physician was presented with symptoms. If
someone had asthma, a chest x-ray was ordered.
Dr. Bradway personally performed over 1,000 URODs by the time he disassociated with
Gooberman in 1999 when the consent order was entered.
He also did 150 more when
Gooberman was also present. In one in ten, or perhaps one in twenty, cases he declined to do the
procedure pending additional medical clearance. Many of the patients had come in from out of
town; however, if there were “any hint of a medical problem” he would not do the UROD. He
had some accommodation from other doctors as to getting pulmonary or cardiac tests and exams
performed. About 50-100 patients were declined altogether, although some of those who were
declined were later detoxified by UROD or by other methods. Gooberman also turned down
patients in Bradway’s presence, as when there was a left axis deviation detected by cardiogram,
and for a variety of other medical reasons.
Dr. Bradway recalled that in the early stages of his work with Dr. Gooberman, no screen
for cocaine use was performed; indeed, Bradway does not think that at that time any commercial
test was available. Later, the screening process evolved, partly in response to the fatalities, and a
dipstick urine analysis was used for some patients. These were chosen based on Bradway’s
clinical judgment, his knowledge of addictions and of the population of people, “in sum total my
experience in using—in—in understanding their problems.”
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By December 1996, 671 URODs had been performed by the two doctors. This was the
point at which Frank Stavola died. Bradway noted that over the period 1996-99 he cancelled
patients who he determined were on excessive doses of a drug. These decisions resulted from an
exercise of clinical judgment. Over time, he became more conservative as to the level of a
prospective patient’s methadone addiction and whether he would not do the procedure. For the
most part, the people who came to the clinic were persons using heavier doses of illicit drugs,
and he considered the information that he obtained as to drug use and the amount thereof as a
factor in his screening process. However, the decision was a clinical one and was not made on
any strict numbers approach, that is, that a particular milligram usage in a given period was an
automatic disqualifier. When the deaths of patients occurred he and Gooberman had information
about the causes of deaths that was “severely . . . constrained.”
Dr. Gooberman testified that the primary inclusion criteria for UROD were a history of
opiate dependency and previous attempts to overcome dependency. Exclusion criteria included
pregnancy, and at first any history of cardiac problems, although later on he required that such
potential patients consult with a cardiology group. Gooberman specifically recalled that he
discussed with the prospective patients whether they had any history of arrhythmias. “If there
was any history whatsoever we would freely ask for a consultation.” There also was a Board
Certified pulmonary consultant available for consultation. There were psychiatric illnesses that
might negate doing the procedure. In addition to these criteria, the physicians’ own clinical
judgment was used “in terms of who you wanted to do and who you didn’t want to do.” The
personnel who answered the telephones did a lot of screening regarding these issues. Further, if
the caretaker was not deemed adequate, the procedure was not done, unless some other
arrangements was established, such as paying for a caretaker.
Pre-procedure use of cocaine was not at first an exclusion factor. However, after the
deaths of Stavola and Beigelman, each of whom had a history of using speedballs (heroin and
cocaine together) and, in Stavola’s case, a pathologist’s oral report that he had used cocaine,
Gooberman added warnings about cocaine use to the consent form and the telephone personnel
were advised to tell prospective patients of the risk. This precaution was not based upon “hard
evidence” that cocaine use had caused these deaths, but it “seemed like the most likely
possibility based on the evidence that I had.” Gooberman recalled that dipsticks were used
“early on,” but they “weren’t very good early on” and they check for benzoylecgonine, not
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cocaine. Cocaine lasts for only an hour, but the benzoylecgonine could last in the system and
produce a positive reading two days later. Such a positive reading would not have been helpful.
He was not sure that cocaine use before the UROD made a difference and patients were being
monitored during the UROD. “In reality, it would not have made a difference if they had used
that morning because we were equipped to handle a problem if it developed.”
Dr. Karan addressed the allegation contained in Count Two, paragraph 2 I. k. of the
Complaint, which charges that the respondents created and implemented “what was an
experimental procedure without adequate disclosure of the experimental nature to patients and
without obtaining their informed consent.” She contended that the respondents failed to fully
disclose to the patients that the UROD procedure was investigational in nature. This is a very
new procedure, the guidelines for which indicate that it was “patent pending.” The patients were
not told just how new it was. This is a “definite” deviation from the standard of care.
Dr. Kleber testified that the purpose of the consent form is to provide the patient with
some informed means of understanding what he/she is about to undergo. Serious risks must be
spelled out. Kleber agreed with Karan that the consent forms did not reveal to potential patients
that UROD was experimental and that drugs were being used for “off label” purposes.
Additionally, the consent forms did not list death as a possible risk. Since, by the time of Lisa
Flowers death in July 1999, the doctors knew of six to seven deaths that had occurred among the
patients who had undergone their UROD procedure, it was incumbent that they list death as a
risk and thereby give their prospective patients the ability to make an informed judgment as to
the procedure and its implications.
Another deviation existed concerning the waiver of confidentiality and privacy contained
in the consent form. The form provided that the patient agreed to “be photographed, videotaped
or otherwise recorded before, during and after treatment,” and that the resulting material was the
property of Lance L. Gooberman, M.D., P.C. and could be used “as deemed appropriate for
scientific and/or educational purposes.
In addition, the consent encompassed permitting
Gooberman, P.C. to use the patient’s appearance for use on television or radio “in any and all
manner and media throughout the world in perpetuity.” It further allowed the use of any
recording “in connection with any publicity and institutional promotion campaigns, . . . but not
as an endorsement of any product or service.” It purported to release Gooberman, P.C. and those
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associated with it from any claims of invasion of privacy, defamation, or other causes of action
“arising out of production, distribution, broadcast or exhibition . . . .”
Dr. Kleber explained that there are specific federal confidentiality guidelines that are
frequently stamped on such forms or otherwise spelled out, and in the addiction community the
use of a waiver such as the respondents included constituted a deviation from standards.
Dr. Smith asserted that the allegation regarding a failure to disclose the “experimental” or
“investigational” nature of the procedure must be based on inaccuracies. In his view, UROD is
not, and was not in 1995-99, experimental, but is and was instead an established procedure. An
“experimental” procedure has a “very specific meaning,” in science and medicine. It has a
protocol, informed consent and methodology, and the technique for statistical evaluation. In
connection with the process undertaken by the respondents, the use of the term “experimental
procedure,” constitutes a “misuse of the term. He contrasted the situation existing in his own
clinic, where clonidine is used for opiate detoxification.
Literature exists to support the
treatment and there is a collection of case studies. Despite the existence of these elements, such
a body of support does not rise to the level of a study and his use of the drug would still be
considered “unapproved use, but not experimental.” In contrast, his clinic also has a NIDA
grant, involving a randomized comparison of the use in detoxification of buprenorphine versus
clonidine, which is the “conventional therapy.” In this comparison, there exists a protocol and a
Human Risk Committee. This is an “experimental” procedure.
Further explaining his definition, Smith stated that the use of a drug such as clonidine,
which is approved for treating hypertension, for an unapproved use, is not an experiment, even in
the absence of randomized, double-blind studies with respect to that unapproved use. In the case
of UROD, all of the drugs used are approved for a medical use. Therefore, the fact that the
UROD procedure uses approved drugs takes the procedure out of the experimental realm.
Dr. Simon explained that the consent form employed in 1996-97 was used at a time when
UROD was viewed as an extremely safe procedure. Death was not thought to be a risk factor
greater than in any other surgical procedure utilizing anesthesia.
Methadone maintenance
involves more deaths by number than does UROD, and yet, as far as Simon is aware, the consent
forms used for that maintenance do not mention death. If the lack of reference to death as a risk
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accompanying the administration of methadone is representative of the standard of care in
addiction medicine, the lack of reference in the respondents’ consent form to death as a possible
risk was not a violation of the standard of care.
Simon agreed that insistence on a waiver of patient confidentiality in the informed
consent form would constitute a violation of the standard of care. However, Simon recalled that
he had seen a consent form completed by one of the patients whose cases are here under review
in which the waiver was crossed out.
This indicated that such a choice was available to the
patients and therefore no violation of the standard occurred.
Mr. Ragone was sometimes present in the doctors’ office or the examination room when
patients were given the consent forms to sign. Typically, the procedure was explained to them,
including a discussion of risks and the need for follow-up treatment. Patients generally asked
questions. Sometimes Ragone went over the form with the patient and then the doctor spoke to
the patient.
Dr. Bradway testified that after deaths occurred, changes were made in the consent form
and patients were advised orally that people had died and death was a possibility. Some people
actually walked out when told this. After the third death occurred, Bradway, by then aware that
cocaine metabolites or cocaine had been discovered in the blood of two decedents, began to tell
prospective patients about deaths having occurred, but he did not say that the procedure was “in
any way” related to the deaths, that it would cause death, or that there was any direct link to
fatality from the procedure. He only related that the ingestion of other drugs was related to the
deaths and compliance with the instructions regarding medications given to the patients was
necessary. It was Bradway’s practice as a physician to “always” go over the consent form,
especially if the procedure needed a consent form. Such verbal discussion of the form is rarely
documented.
Dr. Gooberman related that the consent form and the caretaker form were drafted by an
attorney, who was a former member of the New Jersey Board of Medical Examiners. These
were each reviewed in the office before the procedure was started, and patients “heard what they
wanted to hear.” He would go through each of the listed conditions that the patient might
experience after completing the procedure, that is, post-extubation. Included in this discussion
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was the abnormal breathing that frequently occurred, which was either fast and/or slow breathing
that might be caused by naltrexone. In addition, he would advise the patients about what could
happen if they reverted to opiate use, as if they used the same dose as they had used before
having UROD they could very easily die from an overdose. Likewise, he advised that a couple
of people had died and that it was thought that they had used cocaine and that it had caused them
to expire and therefore any subsequent use of cocaine was “a problem.” They were told that if
they felt the need to use opiates they could come back for another pellet. They were also told
about the duragesic patch and that if it came off they should just stick it back on.
Peri-Operative Concerns
In addition to her concerns about screening and pre-procedure diagnostic testing, Dr.
Karan related her concerns about deviations from the standard of care in regard to practices
occurring peri-operatively. One of these is in regard to the drug clonidine, or Catapres, which as
previously related, is used by the medical community, including practitioners of ROD, to
substantially reduce withdrawal symptoms. Dr. Karan described these symptoms as including
anxiety, agitation and piloerection, or “gooseflesh.” Karan used clonidine in her own practice,
which did not include the provision of ROD. Clonidine is an FDA-approved drug, but it is not
approved for use in detoxification.
In a letter dated January 9, 2000, Dr. Gevirtz stated that “Clonidine has been an integral
part of detoxification for 20 years and its use is a standard of care in” UROD. “Failure to utilize
it during detoxification is a clear deviation from the standard of care, which may result in
tachycardia, hypertension, nausea and vomiting.” Gevirtz testified that while the standards that
he first employed for peri-operative aspects of UROD were originally provided by CITA,
modifications were made in the drugs employed. The procedure lasted from four to six hours.
Among the several drugs employed during the procedure, Gevirtz felt that clonidine was
particularly important because of its anti-hypertensive quality and because it suppresses
norepinephrine. The UROD procedure is very stressful for the patient, especially if clonidine is
not used or if there is “not enough on board.” A study by Kleinman demonstrated that there is “a
very dramatic increase” of catecholamines during withdrawal, which is “very dangerous during
anesthesia” and this can dramatically increase blood pressure, a very dangerous reaction that can
trigger arrhythmias and hypertensive crisis.
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Dr. Gevirtz acknowledged that clonidine has the potential for causing serious blood
pressure and cardiac effects. He opined that benzodiazepines, which are sometimes used in place
of clonidine, do not accomplish the suppression of catecholamines to the same level as clonidine
does. Dr. Gooberman’s protocol identified Atropine as the drug to be utilized if it became
necessary to reverse the paralytic condition induced during the intubation stage. Atropine is used
in conjunction with neostigmine or prostigmin and is used if the patient’s heart rate slows down.
If clonidine has been used during the early stage of the procedure, it may be necessary to
administer a higher dose of atropine to achieve the desired effect, although the clonidine does not
prevent the atropine from working.
Dr. Simon, who utilized clonidine to minimize the effects of withdrawal symptoms, was
not prepared to say that providing UROD without clonidine did not constitute the practice of
good medicine. Simon noted that Dr. Gooberman, who had “vast” experience, may have found
that fentanyl worked as well as clonidine did.
In his testimony, Dr. Gooberman at first explained that while he used clonidine for every
patient, over time he changed the point at which he administered it, due to some difficulty with a
patient’s blood pressure which caused him to consider possible drug interactions. He discussed
the issue with Dr. Michael N. D’Ambra, Associate Professor of Anesthesia at Harvard Medical
School and Director of the Cardiac Anesthesia Group at Massachusetts General Hospital, who
confirmed Gooberman’s suspicions about the possibility of such interaction.40 As a result,
Gooberman decided to change the point at which he administered clonidine.41 However, in later
testimony, Gooberman corrected these statements, as after reviewing his records he realized that,
while he employed clonidine “every day” as he uses clonidine in other forms of detoxification,
he realized that he did not use clonidine in every UROD case. He had utilized this drug in the
first half of the UROD cases and then phased it out as a regular medication, as he felt that there
were better drugs to use to achieve the purpose. Gooberman argued that the absence of clonidine
did not constitute a violation of the standard of care, as there are a variety of methods used
In a letter dated August 30, 1999, addressed to Dr. Gooberman’s former counsel, Dr. D’Ambra writes that he is personally aware of Dr.
Kleber’s protocol at Columbia University “in which he will compare opiate antagonist reversal of opiate dependence in Clonidine-sedated
patients and patients under general anesthesia, also to be given clonidine. We halted the use of Clonidine at MGH after the second patient
because of its dangerous cardiovascular side effects.”
41
The interaction that was problematic was between clonidine and atropine, which drug was administered to increase the pulse and maintain
blood pressure at a time when neostigmine is used to reverse the effect of paralytic agents administered earlier in the procedure. This interaction
was explored with Dr. Gevirtz during his cross-examination.
40
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within the standard. The decision as to which drugs to use is a clinical decision that is made
based upon the training and experience of the clinician. Different clinicians used different drugs,
and based on his experiences he understood that “a lot of practitioners of” ROD do not use
clonidine.
As an example, he noted that clonidine is not used by Massachusetts General
Hospital, and they do not use it due to the experience that he had discussed with Dr. D’Ambra.
Count Two, paragraphs I.i. and II.d., each contain an allegation that the respondents’ use
of the fentanyl transdermal patch constituted an investigational or experimental risk and that the
patients were exposed to this risk without appropriate patient consultation and informed consent.
Dr. Karan characterized the respondents’ use of the fentanyl patch as a clear deviation from the
standard of care. The use of this patch did not make sense medically, as the employment of
fentanyl, an opiate agonist, seemed contrary to the goal of the UROD procedure, which was to
knock opiates off the receptors by use of opioid antagonists. As she understood, Dr. Gooberman
had explained that the fentanyl was used to modify withdrawal symptomatology and make the
patient more comfortable, but the witness believed that this was medically “inconsistent.” There
was nothing in the medical literature supporting the safety and efficacy of the procedure.
Dr. Kleber also identified the use of the fentanyl transdermal patch as a deviation from
the standard of care. Fentanyl is an ultra short-acting analgesic, up to now utilized in operative
procedures. The purpose of the UROD procedure was to rid the patient’s system of opiates, not
to put opiates such as fentanyl into the system.
In addition, if the theory of UROD and
antagonist block therapy is correct, then the fentanyl should not be effective. The use of fentanyl
carries risks of overdose and/or respiratory depression.
Dr. Gevirtz noted that fentanyl is not used in his UROD procedure, as it is a narcotic
agonist and contraindicated for one being detoxed under consent. Dr. Kushins was likewise
troubled about the use of the fentanyl patch. The patients received opioid antagonists, and there
was no surgical intervention that would require an analgesic such as fentanyl. There seemed to
be no indication for the use of fentanyl, which is normally used for relief of pain or to decrease
the doses of other anesthetic drugs given during a general anesthetic procedure. Ketamine is an
excellent analgesic and there is no indication of a need for a second analgesic. In addition, if the
purpose of providing the patients with all of the antagonists was to induce withdrawal, there
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seemed to be no logical reason to administer an opioid such as fentanyl during this procedure.
Dr. Kushins has never administered fentanyl by a transdermal medium.
Dr. Simon has reviewed the literature on the uses of transdermal patches and is convinced
that whether or not the fentanyl patch is an efficacious treatment mechanism, it played no part in
the deaths of the patients. He argued that it was pharmacologically impossible for the decedents
to have suffered from a fentanyl overdose. Use of the patch does not breach any standard of
care. Indeed, their use may have some potential advantages. The use of a patch avoids a
concern, noted by Dr. Kleber, that a subcutaneous implant might dissolve or release more than
the intended amount of drugs. Additionally, as an antagonist of naltrexone, fentanyl may be
protective against the possibility of a naltrexone drug burst. While Dr. Simon does not himself
use the patch in his practice, he concluded that based upon his “vast experience,” Dr. Gooberman
may have concluded that use of fentanyl was more efficacious than use of clonidine to treat
residual withdrawal symptoms, a conclusion that Simon characterized as “reasonable.” As
providers of UROD tend to closely guard their protocols, Simon could not be sure if any others
use fentanyl.
Dr. Gooberman explained that the theory behind his employment of the fentanyl patch
was based upon the research of Dr. Jed Rose, who, working at the Duke University Nicotine
Research Center, examined the nicotine antagonist patch. He spoke to Dr. Rose and read his
papers. Rose believed that when someone goes through withdrawal from nicotine, some of the
withdrawal symptoms are not blocked by the antagonist mecamylamine, and therefore if you
gave both the antagonist and the agonist together, the nicotine and the mecamylamine, the patient
would not get the effects of the nicotine, but at the same time will not necessarily feel as bad.
Rose’s studies had shown that it was easier to get people off nicotine this way. This theory
coincided with what some of Gooberman’s patients were telling him, that they were experiencing
muscle aches and pains after UROD and that, as a result, “a lot of them did heroin and they said
the heroin made them feel better, helped them through it.” Since he would not encourage his
patients to use heroin, Gooberman perceived that a steadily delivered low dose of the agonist
fentanyl infused through the skin might help and “certainly couldn’t hurt.” The patients had
naltrexone on board via the pellet, which would block any respiratory depression, and therefore
he believed that the low dose of fentanyl provided via the patch to persons used to high doses
was “worth a try.” Even if the naltrexone did not work, the dose of fentanyl was not dangerous.
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Count Two, paragraph 2. I.a. alleges that the respondents’ use of the naltrexone pellet,
without knowledge as to the duration of its action and how much heroin and other opiates it
would block on a daily basis, constituted a deviation from standards. Dr. Karan testified to her
doubts about the naltrexone implant. The formulation was not approved by the FDA. While
naltrexone is approved for certain routes of administration, there was no pre-trial data and a lack
of a research background for this method of administration.
Dr. Kleber also has concerns regarding the use of naltrexone, given what he described as
its link to pulmonary edema. There is a concern that when a patient receives this drug, there may
be an “ immediate burst” release that may cause pulmonary edema. According to Kleber, the
study that he has been conducting at Columbia regarding an injectable form of naltrexone has
demonstrated that until a “steady state” is reached, which can last for three to five weeks, “you
get a rapid burst of naltrexone released into the bloodstream.” While he himself did not know if
this were also the case with Gooberman’s pellet, he questioned whether Dr. Gooberman knew if
the implantation of the naltrexone pellet had a similar potential effect. As in the immediate
postoperative period, breathing is often irregular and the heart may be under strain, if the system
then becomes flooded with a narcotic antagonist that has been associated with pulmonary edema,
such as naltrexone, there is a danger of potential morbidity and mortality. In addition, he could
not recall seeing any reports or documentation regarding the duration of the possible blockading
effect of the pellet over a period of one to three weeks. However, as one of the normally
expected consequences of a withdrawal precipitated by UROD is abnormal breathing, giving the
patient a substance (in the pellet) that could worsen such breathing abnormalities and that has
been shown to cause pulmonary edema and that has not yet been adequately tested is troubling.
Dr. Smith commented that characterizing the respondents’ practice as at “substantial
variance” from the standard of care presupposes such a conflict. This is particularly troublesome
in an area that involves an evolving standard, and one is therefore required to evaluate the
outcome which, “in Dr. Gooberman’s procedures I felt were very positive because he was
emphasizing the implanting of the naltrexone pellet.” In fact, this aspect of the procedure may
represent an improvement in treatment procedure. The biggest issue involved with regard to
addicts’ early relapse is noncompliance with the recommended treatment. The theory of the
implant is the same as that represented by the issuance of oral naltrexone to patients, but it may
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be an improvement because the oral medication has to be taken once a day and many addicts did
not comply with that dosing regimen.
The fact that naltrexone injection is not approved by the FDA does not mean its use
constitutes a violation of the standard of care. Indeed, clonidine is also used in addiction
medicine, but its use has not been approved by the FDA for the detoxification of addicts either.
Manufacturers do not want to “taint” their products by associating them with this field.
Additionally, many treatment modalities are not accepted by “mainstream medicine.” In more
conventional forms of detoxification, it is necessary to wait for from seven to ten days before
administering naltrexone.
This is necessary in order to assure that there is no residual
dependence, because if the drug is administered early it can precipitate withdrawal. A narcan
challenge can be used to test for any residual dependence.
Smith noted that the use of naltrexone on a long-term basis has been advocated by Dr.
Charles O’Brien, who authored a chapter in Dr. Kleber’s textbook. Dr. O’Brien is one of the
world’s leading experts on the drug and a consultant to the study being undertaken on developing
Naltrel, a long-acting form of naltrexone.
Queried on cross-examination as to the relationship between naltrexone, nalmefene and
naloxone and pulmonary edema, Dr. Simon agreed that there is a relationship, however, in his
opinion there is not a “cause and effect.” The Physician’s Desk Reference (“PDR”) reflects
reports of adverse incidents of pulmonary edema with the administration of naloxone. However,
Simon commented that the PDR is nothing more that a
compilation of information submitted by individual drug
companies for doctors and in many cases, the drug companies take
a very conservative approach for medical/legal reasons so that they
don’t get sued for liability and they are very apt to mention small
degrees of actions. . . the statement in that book is derived from the
same inaccurate data and footnotes that draw the wrong
conclusions that I spoke of yesterday. . . [The doctor is referring to
his comments on the NIDA report, the San report and other
articles, reported above] This is a typical example of garbage in;
garbage out.
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Dr. Gooberman related that naloxone is a short-acting opiate antagonist. It was used by
Dr. Loimer when he started to employ UROD. Gooberman utilized the drug and then added
naltrexone at the end.
Naloxone is used all over the world in emergency rooms and by
paramedics to combat a heroin overdose. However, there were rumors that naloxone might be
associated with pulmonary edema and therefore Gooberman switched to the more expensive
nalmefene, which was used in later URODs, sometimes in conjunction with naloxone.
Discussions with Dr. Simon and a Dr. Gonzales, both anesthesiologists, and a search of the
literature led Gooberman to understand that the consensus was that the edema was not caused by
the naloxone, so he went back to using it, while all the time he was also employing naltrexone.
Several studies indicate that naltrexone, while not itself a very long lasting drug, is, however, an
effective drug to use in opiate addiction treatment.
As it breaks down in the system, its
metabolite of 6 beta naltrexol is long lasting. The UROD procedure provides a means to make
naltrexone an effective tool, as without the rapid procedure the need to wait to initiate the drug’s
use for seven to ten days after withdrawal is a substantial drawback to the successful utilization
of the drug.
The next problem that had to be overcome was that of patient noncompliance, for patients
would not take the daily pills required for oral administration. What was needed then was to
provide a means of keeping patients on naltrexone after they emerged from the withdrawal.
Administration by means of depo-naltrexone, an off-label pellet preparation of the drug,
provided the means to accomplish this end, using a drug already approved for opiate
detoxification.
The FDA has not evaluated the safety and efficacy of the naltrexone pellet, however,
Gooberman insisted that the agency had approved what they were doing “under certain
regulations regarding compounding and that we were free to do that for as long as we wanted, to
the degree that we wanted.” In support of Gooberman’s position, Dr. Simon stated that it is not a
breach of the standard of care in medicine for a physician to compound a drug and use it for offlabel use.
Specifically addressing the allegations of the Complaint concerning the naltrexone pellet,
Gooberman denied that he did not know, “by objective data, the duration of action of the
antagonist provided . . . and how much heroin or other opiates are blocked on a daily basis.”
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While he argued that the standard of care does not require that he know these answers by
objective data, nevertheless, he did know from both objective and subjective data. His office
conducted a study in approximately 1996 of post-implant effectiveness, using a fentanyl
challenge to determine if the implant was providing the necessary level of drug to block the
effects of the fentanyl. A fentanyl challenge is a so-called “provocative testing” mechanism that
is used to determine whether the treatment is adequate. Fentanyl is administered to see if the
naltrexone is blocking its effects, which, if the drug is indeed working, results in the fentanyl
having virtually no effect on the patient. Blood samples were collected. It was determined that
the duration varies from patient to patient, as is frequently the case with medications, but while
the number of days ranged from twenty-one to seventy after implantation, in general the testing
demonstrated that the pellets worked for about thirty-five days. Gooberman has seen the pellet
be effective for as long as two, even three months, after implantation. Additionally, the office
surveyed patients who had received oral naltrexone following UROD, and patients who received
the pellet after Gooberman began using it, and determined that with the pellet, almost 100% of
the recipients reported that they had not resumed using heroin after thirty days following the
implant. This was an increase from about 66% reporting such success after thirty days following
receipt of oral naltrexone. (D-59).42
A series of charges are made that relate to the alleged impact of the UROD procedure
upon the physiology of the patients and concerns, arising at least in part from this issue, of the
manner in which drugs are used in the procedure and the qualifications of the physician and staff
who provide the procedure. Count One, paragraph 7 of the Complaint contends that the UROD
“procedure, because of the combined effects of the anesthetic agents and the antagonist and other
drugs, produces a high level of physiological stress upon patients. Count Two, paragraph 2 II. b.
asserts that the respondents deviated from standards because UROD involved “the administration
of anesthetic agents so as to produce unconsciousness during a highly stressful period without
appropriate knowledge of the effects of said drugs and their interactions with other drugs
administered.” Count Two, paragraph 2. II. e. alleges a deviation from standards resulting from
“the simultaneous provision of a procedure which is the medical equivalent of general anesthesia
in an outpatient setting for as many as six patients through CRNAs and critical care nurses
42
Interesting observations regarding the role of naltrexone are contained in an article (P-46) by Hoffman, Berkowitz, McDonald and Hass, UltraRapid Opioid Detoxification Increases Spontaneous Ventilation, Journal of Clinical Anesthesia 10:372-376 (1998), which reports, in light of
“interest in the success of the detoxification procedure to treat opioid addiction,” that UROD achieved 100% opioid detoxification and that the
improvement noted in long-term relapse rates in a national treatment outcome study (Treatment Outcome Prospective Study) of 2,280 patients
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subject to overarching medical supervision by a non anesthesiologist and without the presence of
a critical care physician.”
Dr. Lawrence Kushins noted that the respondent’s UROD procedure induced heightened
levels of stress for the patients, who manifested increases in blood pressure and heart rate after
the administration of the opiate antagonists. The medical literature and research studies have
shown that there are measured increases in catecholamine and epinephrine and norepinephrine in
patients undergoing ROD, but these levels have not been measured in the respondents’ patients.
These substances, which are naturally produced in the body, have differing effects at receptor
sites within the body and affect circulation, respiration, hormone secretion and other functions.
Within an anesthetic procedure, epinephrine and norepinephrine can cause increased blood
pressure, heart rate, and the pressure within the pulmonary or lung circulation and can affect
respiratory frequency. Patients who experience these changes may have complications from
heart failure, myocardial infarction, stroke, or from pulmonary edema.
patient’s vital signs and other indications is thus vital.
Monitoring of the
Following the procedure itself,
monitoring must continue during the recovery period from general anesthesia.
In addition to these stresses, additional stress can occur as a result of the induction of
general anesthesia and intubation of the trachea.
Emergence from general anesthesia can
likewise be stressful, as can the removal of the endotracheal tube.
Dr. Kushins compared the stress level of UROD as against that of a non-UROD
procedure from the point of view of anesthesia administration. The difference is that in UROD,
the patient is exposed not only to the normal stresses of anesthesia procedures, but, in addition,
to the major surge of catecholamines. He concluded that the level of risk of danger in the UROD
procedure is “significant” in comparison to anesthesia administered for some non-UROD
surgical procedure. There are other such procedures that cause less stress, a comparable level of
stress or even greater levels of stress. However, the doctor conceded that in such examples of
what he believed to be low stress procedures, such as partial mastectomies and arthroscopy of the
knee, the catecholamine levels have not been measured.
treated in conventional detoxification programs versus 113 patients treated with UROD “may be related to long-term compliance with Naltrexone
in the after-care program. Thus, “Naltrexone compliance in the after-care program may improve abstinence.” Id. at 375.
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Dr. Kushins acknowledged that a person undergoing unaided withdrawal from heroin
definitely undergoes a stressful event.
The anesthetics used in the Gooberman procedure,
propofol, ketamine and midazolam, do not cause nausea or vomiting, and it can be presumed that
any nausea or vomiting or diarrhea mentioned in the orders or the instructions from Dr.
Gooberman would be precipitated by the withdrawal.
Dr. David Smith characterized the predicate allegation concerning the alleged “high level
of physiological stress,” as “meaningless in itself.” Addiction produces high levels of stress, as
does any form of opiate withdrawal. In Dr. Smith’s opinion, UROD produces stresses that are
consistent with or even less stressful than do other forms of detoxification. In fact, the doctor
argued that the high-level physiological stress involved was produced not by the procedure itself,
but by opiate withdrawal.
Dr. Simon also disagreed with this allegation. He believed that the person who wrote this
does not understand the physiology. Contrary to the paragraph’s implications, Simon posited
that, in fact, “anesthesia is a treatment to lessen the physiological stress.” Opiate withdrawal
causes the stress, not the anesthesia, which instead “treats the stress.” The increase in hormonal
levels that does occur is normal and does not reach dangerous levels. Simon noted that the
discussion of stress and of increases in epinephrine and norepinephrine must be placed in
context. According to Guyton, Textbook of Physiology, mental stress and anxiety can cause a
twenty-fold increase in such stress hormones as cortisol. Further, Simon referred to the article
by Keinbaum, et al., which addressed the “profound increase in epinephrine” (measured at thirtyfold) resulting from opioid receptor blockade in barbiturate-induced anesthesia for acute
detoxification.” The doctor argued that the levels of epinephrine and norepinephrine identified
in this article are “nowhere that approached during open heart surgery.” Further, while the
increase in cardiac output of 74 percent may sound high, in fact it is not when compared with the
increase in cardiac output attained by running around the block, which he said was 500 percent.
Further, the catecholamine levels reached during UROD peak during the first couple of hours
while the patient is monitored in an Intensive Care Unit. The levels then return to normal. If a
heart attack were going to occur due to the increased hormonal levels, it would be anticipated
that it would occur during these early hours. It is an indication of how safe the procedure is that
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these heart attacks have not happened. Indeed, the articles demonstrate that the responses are
“normal physiologic responses.” 43
Once again, Dr. Simon disagreed that the respondents administered “anesthetic agents to
produce unconsciousness during a highly stressful period without appropriate knowledge of the
effects of said drugs and their interactions with the other drugs administered.” Contrary to this
assertion, Simon contended that there is no evidence that they did not understand the drugs that
they employed. The misleading element of this allegation is that, again contrary to its assertion,
the use of anesthesia actually decreases stress. Based upon his review of the charts, the vital
signs remained in the acceptable ranges and the course of the patients’ experience under
anesthesia was “uneventful and I didn’t see anything that happened during the procedure that
was causative of any detrimental effect to a patient . . . . I can only conclude that he knew what
he was doing.” In addition, from his own interaction with Gooberman, he believed that the
doctor had adequate knowledge to perform the procedure, which was a “very simple procedure”
from an anesthetic point of view. Simon offered that Gooberman is the most experienced
physician in the country performing UROD, and the fact that the number of deaths is seven out
of over 2,300 procedures, “tells me the man must know what he’s doing.”
Mr. Maziarski, who has published a paper on hypotension and histamine release,
commented on the release of histamine that can occur when opiates, or other substances such as
muscle relaxants or blood products, are introduced into the body. There is no way to tell in
advance how significant this histamine release will be in any one individual; sometimes people
do not experience it at all, other persons do. It can be severe, even leading to anaphylactic shock
and severe hypotension, arrhythmias and tachycardias. To the witness’ knowledge, propofol,
midazolam, naltrexone, nalmefene and naloxone are not drugs that cause histamine release. In
fact, none of the drugs that Gooberman and Bradway utilized in the UROD process would
ordinarily cause a histamine release, unless the patient had an allergy to the drug.
The witness also reviewed the article “Ultrarapid opioid detoxification: effects on cardiopulmonary physiology, stress hormones and clinical
outcomes,by Eman, D’Ambra, et al., published in Drug and Alcohol Dependence 61 (2001) 163-172. In this article the authors, associated with
Harvard Medical School and Massachusetts General Hospital, reviewed data concerning UROD, referred to in the article as URD, performed on
seven patients. The authors, who credit Dr. Gooberman for assistance in the design of the anesthesia protocol employed, report that while
hemodynamic and respiratory functions did not change significantly during the anesthesia phase of URD, plasma ACTH and cortisol levels did
increase “robustly.” The authors state that reports such as that by San in 1995, Seoane in 1997 and Pfab in 1999 “underscore the evolving
awareness that URD is far from being a benign procedure and that any patient entering URD is being subjected to a potentially iatrogenic risk.
While they conclude that “URD may have a role in the armamentarium of treatments for opioid dependence,” p. 171, the authors also state, “In
accordance with other investigators (Kienbaum . . . 1998) we suggest therefore that because of potential respiratory complications, URD and
acute post-anesthesia monitoring should be handled by experienced M.D. anesthesiologists.” Id. at 170.
43
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Picking up on the theme of stress as a significant element in UROD, Dr. Kleber
expressed his opinion that the procedure causes such severe stress that significantly effects the
patient’s hormone levels and carries with it such risks of mortality and morbidity that it should
only be carried out by a trained anesthesiologist.
In his understanding, the overwhelming
majority of UROD practitioners are anesthesiologists. His opinion on this point is premised
upon his understanding that involvement of anesthesiologists was in fact the standard in the field
and that the articles he had read and the physicians with whom he had discussed the procedure
supported this view.
Dr. Gevirtz testified that, in the years 1996-99, there were an average of seven sites in the
U.S. and Puerto Rico in which UROD was performed. Most of these had more than one
anesthesiologist performing procedures. Gevirtz trained personnel at four of these sites. The
only location where an anesthesiologist did not perform the UROD procedures was Dr.
Gooberman’s facility.
In Gevirtz’ opinion, in general, a critical care trained physician or
anesthesiologist is required to perform a UROD procedure. However, Gevirtz acknowledged
that Gooberman could legally administer anesthetics. The use of a nurse-anesthetist is permitted
in other outpatient procedures, although such use conflicts with the ASAM standard. Thus, the
use by Gooberman of a nurse-anesthetist is “an issue.”44
Dr. Kushins cited the fact that multiple patients were anesthetized by nurse anesthetists
who were not supervised by an anesthesiologist or physician and who were not directly
monitoring all the patients simultaneously. This nurse anesthetist would intubate a patient and
then move on to the next patient and at the appropriate time extubate the tracheal tube. Dr.
Kushins nevertheless acknowledged that during the period 1995 to 1999 there was no law that
required that a nurse anesthetist had to be supervised by an anesthesiologist in an office setting.
He also understood that critical care nurses were present and that they were responsible for
monitoring the patient.
Monitoring of the patient's condition is a component part of the
anesthesia procedure and is vital to the well being of the patient.
Dr. Kushins’ opinion is that UROD should not be performed as an outpatient procedure.
He also contends that it is “prudent” for an anesthesiologist to administer the procedure. He does
not believe that having a CRNA administer the anesthetic is ideal, but if that is to occur than at
44
He denied any knowledge of a movement in New Jersey to curtail the use of CRNA’s in ROD procedures.
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least an anesthesiologist should be supervising. However, and significantly, in contrast to what
Dr. Kleber presented as a basis for his testimony on the subject, Dr. Kushins acknowledged that
the standard of care does not automatically require that an anesthesiologist be involved. In his
opinion, the standard of care is that in rural areas it is acceptable for a CRNA to be supervised by
any other type of doctor; however, in other settings the standard would be for an anesthesiologist
to supervise. Thus the definition of the applicable standard of care may depend upon the
characteristics or factors taken into account, i.e., the ideal standard; the standard that
accommodates economic realities; the location where the standard is being applied.
He
cautioned that the failure to meet this standard is not per se malpractice, and if the procedure is
properly conducted, there is no malpractice.
Kushins explained that the issue of what requirements government may impose on the
relationship of CRNAs and anesthesiologists is a matter of debate and controversy at the Federal
level. Currently, all states except New Hampshire require that “a doctor” supervise the work of
CRNAs. Kushins described the issue as in a “tremendous state of flux.” Regulations that were
proposed by the Board of Medical Examiners in New Jersey in 1998 for office surgery have been
challenged and are not at this time in force.
Dr. Simon did not agree that there was any violation of the standard of care regarding the
provision of multiple UROD procedures presided over by a non-anesthesiologist. Considering
the ASA standards, which are applicable to surgery in an operating room and therefore speak to a
standard higher than that that he believes is applicable to Gooberman and Bradway in their
provision of UROD, Simon noted that their activities did not breach those standards. When he
observed the facility, it was adequately staffed and the records that he has reviewed “appeared to
meet the standard. The documentation seemed appropriate.” He was aware that a UROD
provider in Miami Beach’s Mt. Sinai Hospital, Dr. Harold Whittles, who is an anesthesiologist
working under the direction of Dr. Gevirtz and affiliated with CITA, “routinely anesthetized four
patients at a time.”
Dr. Simon commented on the role played by anesthesiologists in UROD. As opposed to
their more usual role as “invited guests” in other surgical procedures, in UROD the
anesthesiologist could be “the whole show. ” Attempts to limit the use of CRNAs have been
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made; indeed, he referred to a “chronic battle” over who should administer anesthesia.45 During
cross-examination, Simon testified that he had first thought of becoming involved in UROD in
1995. When he first encountered Dr. Gooberman in April 1996 at an ASAM convention, he
believed that Gooberman was a “quack.”
This impression arose because of Simon’s own
background as an anesthesiologist. However, at that time Simon knew “nothing” about the
UROD procedure. He came to Gooberman’s office to view the procedure. Simon performed his
first UROD in November 1996.
Dr. Simon also believes that the competition for available dollars in the health care field
makes persons practicing in one field, such as psychiatry, “hesitant to refer patients out of their
treatment system because if they do there will be repercussions.” The persons “who have been
running the show or have been very influential in the substance abuse community have been
psychiatrists and internists.” Now along comes UROD, a procedure that requires a level of care
that “the other doctors don’t feel comfortable administering.” While by no means the only factor
in the bias against UROD and its practitioners, or at least certain of them, it is nevertheless a
factor. In addition, Simon commented on the motivation of some of the practitioners in the
UROD field to “knock out” other practitioners. Simon related that he had spoken a couple of
years ago to David Yerushalmey, then the CEO of CITA at a time that it was owned by a prior
group. At that time, UROD was a procedure that was viewed by some doctors as “kind of out
there.” It was necessary to get referrals from doctors, counselors, etc., and these people had to
feel “comfortable that this is a legitimate treatment . . . .” Yerushalmey told Simon that “a
distinct goal of his was to put Dr. Gooberman out of business . . . ,” as Gooberman was seen as a
major competitor of CITA. Dr. Oppenheim and Dr. Gevirtz were both associated with CITA at
that time. Dr. Oppenheim later on expressed a similar objective to Simon, around April 2000.
Mr. Maziarski noted that there has always been some tension between anesthesiologists
and nurse anesthetists, who are competitors, and that some anesthesiologists will not work with
CRNAs. When a CRNA is working, a physician must be present. Although some hospitals may
require that that physician be an anesthesiologist, the standard of care does not require it.
Maziarski opined that there is no deviation from the standard of care in an outpatient
setting for a CRNA to administer the drugs used in UROD, including ketamine and midazolam
45
He noted that this battle has even reached the Presidential level, as then-President Clinton had issued HCFA regulations permitting nurse
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rather than for an anesthesiologist to do so. Nurse anesthetists are trained to provide general
anesthesia and resuscitate patients and to provide a resource to the attending physician. The
CRNA is expected to be able to advise the doctor on what the drugs will do to the patients, and
there is no difference in the standard of care applicable to an anesthesiologist and to a CRNA.
The CRNA must be able to prepare and implement an anesthesia plan for the patient and the
procedure, and manage the airway and pulmonary status. New Jersey’s regulations governing
the practice of CRNAs require that they practice to the standards of the American Nurses
Association (“ANA”).
Count Two, paragraph 2, II. f. alleges that the respondents failed to provide adequately
for the management of possible anesthesia emergencies such as difficult airways. Addressing
this issue, Dr. Kushins noted that if there was difficulty in administering anesthesia there were
various types of equipment available that could be used to intervene. The doctor acknowledged
that in the cases he reviewed such difficulties did not appear to have occurred. There was also
no clear provision made for dealing with difficult airways and no obvious plan to handle
situations that could arise where there might be an inability to intubate or ventilate a patient.
Some patients present with a difficult anatomy, causing problems with intubating the patient.
The standard of care requires that appropriate equipment, including a number of different
devices, be present at the facility and that there be a plan to manage such difficulties. The doctor
explained that in order to be able to manage any difficult airway, it is necessary that the facility
have at least a half-dozen pieces of equipment on hand, including a laryngeal mask, combitubes,
a cricothyrotomy kit, and depending upon the skill of the persons doing the intubation, perhaps
three different kinds of very advanced laryngoscopes.
Dr. Kushins did not recall that
Gooberman had any of these types of equipment, however, he did not recall if he asked about
each one specifically.
Dr. Simon explained that problems could arise due to anatomical peculiarities that
prevent the insertion of a tube in the trachea. Normally a facemask can be used in such
circumstances and this allows the patient to breath adequately. However, in a situation that he
labeled as the “dreaded can’t intubate, can’t ventilate scenario,” the tongue falls back in the
throat, or for other reasons air cannot be moved and the patient cannot breath. This must be
fixed quickly or the result can be serious trouble for the patient. A relatively new device, the
anesthetists practice just before he left office.
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laryngeal mask airway, or LMA, provides a means of ventilating the patient in such emergencies.
The recommendation now is that if anesthesia is to be given, an LMA should be present.
Gooberman had such a device. In addition, when Gooberman was asked about this type of
problem during another hearing, he responded that if he could not intubate the patient, he would
abort the procedure. Simon has visited the Gooberman clinic and observed the equipment
utilized. He characterized the equipment as “appropriate.”
Mr. Maziarski visited the Gooberman clinic the day prior to his testimony. He reviewed
the methods, instrumentation and staffing, and reviewed the charts of seven of the patients at
issue in this case. He is familiar with UROD from his reading of medical literature, but has
never participated in the procedure. He issued an expert report, D-59, which addressed the first
four of the cases, the others having been reviewed later. The medical equipment and furnishings
that he observed were substantial in scope and the facility very well equipped. In addition, he
was advised that the equipment he saw was present at the time that he wrote his report.
Mr. Ragone was familiar with the equipment maintained on site and nothing that he
needed to properly monitor the patients during the UROD was missing. David Monzo, a CRNA
for six years who worked for Gooberman for about three years and was involved in between
eight hundred and one thousand procedures, testified that the Gooberman facility was “better
equipped” than a ITU for airway equipment, with all sizes and types of blades. Monzo never
encountered an airway problem.
Addressing Count 2, II. a., which alleges that ketamine, midazolam and propofol were
administered in doses that were not related to the patient’s weight as well as titrated to the
patient’s response to the drugs,” Dr. Kushins expressed concern that patients were given drugs in
accordance with “standing orders.” According to the monitoring or flow sheets, these drugs
were not administered according to the patient’s weight. The ITU sheets and flow sheets for
these patients indicated that the same doses had been provided regardless of the size of the
patient. This constituted a significant and important deviation from the standard of care. In
addition, markings on some of the flow sheets indicated that the dose of medicine provided to the
patient was not consistent with the orders of Dr. Gooberman.
According to the witness,
anesthetic drugs and muscle relaxants are given to a patient based on weight, a certain number of
milligrams or micrograms by body weight. They are also administered according to the patient's
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responses to those doses, which are observed by the anesthesiologist or the nurse anesthetist,
who may then determine to provide additional doses as needed.
Dr. Simon commented on this allegation of a deviation from the standard of care for
anesthesiology. The doctor argued that the statement in subparagraph a. was “misleading.”
There are guidelines in anesthesia that provide for “a very large latitude in dosing.” These are
usually expressed in terms of a range of medication per weight of the patient, such as with
propofol, where the guideline might be dosed at 2.5 to 3.5 milligrams per kilogram of the
patient’s weight. However, in the witness’s opinion, it is more prudent to titrate the dosage to
the patient’s response. This is in part due to factors such as the inherent genetic differences
between patients and the age of the patient.
In summarizing his review of the patient’s charts in this case, Simon opined that in every
case the vital signs were in the normally expected range for someone going through
detoxification. “Indeed, the blood pressure is probably lower and better maintained than it would
be if they were awake.” He observed no deviation from standards in the manner in which
dosages of these drugs were administered.
Mr. Maziarski opined that there were no violations of standards in the protocol utilized
by the respondents regarding the dosing of patients during UROD. Dr. Gooberman had a
protocol that was based upon his research and experience. The patients were given a stick
(syringe) of drugs and propofol mixtures were given to the patient based upon the patient’s
response. Anesthesia is an inexact science. Students are taught that drugs are administered in
doses of so many milligrams per kilogram of weight, but in practice the witness does not do
these calculations because he knows from experience what a man or woman of a particular
weight requires. In addition, even if the calculation is used, particular conditions affecting the
patient may require that he or she be given less or more of the anesthetic for it to be effective. In
general, dosing starts in the middle of the range of the likely need of the patient and then one
titrates to response. Not every individual patient is treated in the same manner.
Questioned about the dosage of the induction agent diprivan (propofol) administered to
persons of significantly different sizes (a 5’3”, 150 pound woman and a 5’10”, 240 pound man),
Maziarski stated that it was necessary to know the nature of the patients before he could
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determine whether any deviation from standards occurred if they received the same level and
amount of diprivan. While a standard baseline is appropriate for use, after that is used it is then
necessary to titrate to the need of the individual.
Mr. Maziarski noted that once patients were stabilized following intubation and the
passage of an appropriate amount of time, their continued monitoring by a critical care nurse was
appropriate, with extubation later carried out by the CRNA or the physician.
Dr. Bradway explained that from intubation through extubation, the attending physician
supervised the CRNA and staff. The CRNA, who was stationed at the head of the bed, usually
intubated and extubated. Bradway rarely performed the intubation and did not extubate the
patient. He induced the anesthesia, using syringes of propofol and ketamine. The doctor was on
one side of the gurney and another CRNA was stationed on the other side of the gurney, handing
medications to the doctor. Sometimes the nurse did inject the medications.
Bradway further explained that the doctor decided the amount of anesthesia to be given.
There were standard quantities, based on body weight and surface area, measured in milligrams
per kilogram. However, clinical judgment was involved, as more or even less of the drug(s)
might be used within the therapeutic window. Naltrexone and other opioid antagonists were
generally injected and the dosage was generally not determined by body weight. Usually one
dose was given, and for withdrawal, the therapeutic range and latitude of efficacy were wide.
The standard protocol drawn up by Dr. Gooberman determined the amounts of the antagonists to
use. What was given was more or less determined by the posted standing orders, but the
determination also involved clinical judgment and observation by experienced doctors. If more
than the measured amount was needed, a little more was added. The standing orders were “good
estimates,” however, the clinical decision as to how much was necessary was almost an
“intuitive thing” and was not a difficult decision. The decision as to whether to administer any
other drugs was always made by Bradway, although the actual administration was performed by
the CRNA.
Dr. Gooberman explained that he developed the anesthesia protocol based upon his
experiences at Cooper Hospital, including consultations with that hospital’s chief of
anesthesiology, critical care nurses and residents. Gooberman explained that there is a range of
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drugs that are given based upon the patient’s weight and then further adjustments are made,
based upon the patient’s response to the medications. Over time, the anesthesia plan was
modified, based upon conversations with other practitioners and information garnered from the
literature.
Count Three of the Complaint alleges that the records maintained by the respondents
failed to record all of the anesthetic agents administered, the amounts thereof and the route and
timing of administration. Dr. Kushins noted that when he reviewed Mr. Melendez's chart he
could not tell when naltrexone was administered. Further, the standing orders did not indicate
the timing for administration, only a sequence. Intubation of the patient and administration of
anesthesia each cause stress and the blood pressure, heart rate and heart rhythm all increase
within minutes of these events. Dr. Kushins also noted that records created during the anesthetic
procedure did not indicate appropriate monitoring, or at least did not record that monitoring of
vital signs was occurring every five minutes. Instead, the records indicate that after the first
three sets of vital signs were taken, monitoring was recorded only every fifteen minutes, in
violation of the standard of care, which required the monitoring and recording of vital signs
every five minutes during general anesthesia. The records themselves appeared, "somewhat
different from the usual records that anesthesiologists or nurse anesthetist keep in hospital or
ambulatory surgical centers." As an example, the doctor discussed propofol, which is also
known by the brand name diprivan. The manner, or route, by which diprivan was administered,
was not clearly recorded and the doctor therefore had to assume that it was administered
intravenously, although it was not specifically recorded in that fashion.
Referring specifically to the records for Lisa Flowers, Volume IV, page 169, Dr. Kushins
opined that they demonstrated these deviations. During the first half hour of the procedure, the
vital signs were recorded every five minutes and then every fifteen minutes thereafter. The
record shows that propofol was administered, as was aminophylline and vecuronium, the latter a
muscle relaxant.
The anesthesia records do not show whether opioid antagonists were
administered and do not show the initial drugs given to anesthetize the patient, which would
generally be ketamine, propofol and the initial muscle relaxant. Other flow charts maintained for
other patients similarly do not show this information. It is therefore difficult to infer that doses
were given and when they were administered, and it is impossible to tell which drugs were
initially administered.
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Dr. Simon argued that the respondents are properly held to the standards of care
applicable to addiction medicine, but there are no standards per se for UROD. Except perhaps
for the five-minute monitoring requirement, they did meet the applicable ASA standards as well,
although as non-anesthesiologists, he does not think that they apply to them.
As for the
monitoring standard, he believes that the standard for such monitoring in the UROD context may
be evolving to a fifteen- minute requirement. As for records of anesthesia administered, a nonanesthesiologist administering anesthesia must keep a record, but he does not believe that the
standard of record keeping for an non-anesthesiologist is the same as that applicable to an
anesthesiologist, where the ASA standards are very specific about what must be included in the
record. There is no written document that purports to set the standard for non-anesthesiologists
performing anesthesiology. A proper anesthesia record would include the drugs administered,
how much was given and by what route of administration, although if there is only one route
possible it is not necessarily the standard to show this and, perhaps, it is not even required to
show the route even where there are possible choices in the method of administration. From the
records, one could also determine when the drugs were administered, although in practice one
could not always tell to the minute when that occurred. He conceded that the respondents’
record keeping were at times “sloppy,” however; he did not think there was a violation of
standards to which the doctors should be held.
Dr. Simon also reviewed the anesthesia record maintained for Lisa Flowers. This ITU
record does not meet the typical format utilized by a Board Certified anesthesiologist practicing
in accordance with the ASA guidelines. However, the form exceeds the records that a dentist
would use in an anesthesia procedure. Nevertheless, upon examination Simon agreed that this
document is “sloppy,” because it does not note the drugs that were administered, other than
diprivan, aminophylline and oxygen. The narcotic protagonists are not listed. If considered in
conjunction with the Standing Orders, it might be clear which drugs were given, however, under
the ASA standards a Standing Order is not part of the anesthesia record. Nevertheless, while he
is not sure what standards apply, the Orders do exist and they list the medications and doses
given. While Simon characterized the records as not “optimal,” and while they make for “very
sloppy record keeping,” he believes the ITU records and the Orders should be evaluated in toto.
This said, Simon agreed that he was assuming from the existence of the Order that the drugs
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were actually administered to Flowers in the course of her UROD, an assumption that “probably
I should not make.”
Frank Maziarski testified that the standards of care governing CRNAs require that an
appropriate record be maintained of the drugs administered, the amount given, the route of
administration and the time administered. The anesthetist only records what he or she gives. If
any other person administers a drug, that person should record the information. Considering the
records for Lisa Flowers, Maziarski saw the bronchodilator aminophylline recorded, as well as
propofol and vecuronium. Other than these, no other drugs are listed. Referring to the orders
written by Dr. Bradway for Flowers, there is no recording on the anesthesia records of the
administration of fentanyl via a patch, or of the induction agents octreotide or glycopyrrolate, or
of ketamine or midazolam or of naloxone, nalmefene or naltrexone. This failure to record the
information regarding these drugs is a deviation from standards, indeed in this particular example
a “certainly obvious” omission. It is axiomatic that there must be a recordation of everything
that is induced. If a CRNA knew that drugs were administered and that there was no recording
of that fact, the CRNA had a duty to tell the person who administered the drugs to record them.
Failure to do so and to follow up and make sure that it took place would be a violation of the
standard of care.
Similar omissions appeared in other patients’ records. For example, in Kindig’s records,
the major anesthetic drugs are not shown, nor are the opioid antagonists. While this record is “a
little more complete,” there are still major omissions. Again, neither the antagonists nor some of
the induction agents recorded are in the record for M.J. Other serious deficiencies are found in
the Perez, Melendez and Stavola charts. The Beigelman record is quite different, with a host of
listed agents. While there is some omission of information as to when some of the listed drugs
were given, overall this is a more appropriate record.46
Maziarski acknowledged that he had noticed that the omissions were present in the record
when he reviewed it, but he did not note this deviation in his written report, as he thought that the
protocol was being used as “a check list.” He did not advise counsel for the respondents about
46
Ronald Kumar, Associate Vice President of Pennsylvania Hospital and a CRNA who worked at the Gooberman facility during the years 199498, also testified that the records did fail to record medications that were administered. He noted that despite these omissions, the procedures
were “pretty much standardized,” and the omission of a drug did not mean that it had not actually been given to the patient.
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his knowledge of these deviations prior to his testimony, terming his failure to do so “an
omission.”
Maziarski agreed that the records do not contain an “anesthesia plan,” which he described
as a plan formulated after assessment of the patient as to how the anesthetist intends to conduct
the anesthesia. A CRNA is both competent and expected to prepare such a plan if he or she is
involved in a procedure. The “plan” might simply be a note, such as “general anesthesia with
sedation,” or “local with sedation.” While such notations are not shown on the records, the plan
would be the same in every case, following the protocol. While the records should ideally have
the plan noted, there may be “slippage.”
Reviewing the standards for monitoring vital signs, Maziarski testified that during a
surgical procedure they are to be monitored every five minutes from beginning to end. However,
there are two parts to this procedure: that part where the nurse anesthetist is involved with the
critical portion of UROD and that part where the patient has been stabilized and is passed on to
the critical care nurse. The critical care nurse takes blood pressure and pulse readings every
fifteen minutes or even longer. Maziarski viewed the critical first portion as lasting fifteen,
twenty or thirty minutes. There was no problem with the longer time period between readings
during the second phase of the procedure up to extubation. Monitoring every fifteen minutes
after extubation has occurred is okay, as long as the patients have been determined to have
recovered their reflexes, secretions and saliva and are breathing normally. The written standards
for monitoring require the five-minute interval monitoring as long as the patient is anesthetized
in the operating room, and then the culture of the institution involved determines how they will
carry out maintenance of the patient in the I.C.U., where the policy might allow for monitoring
on a reduced schedule. New Jersey regulations governing the induction and procedures for
general anesthesia administered by a CRNA in a private outpatient setting under the supervision
of a doctor or a physician’s assistant would supersede any other standards. Monitoring of the
patient between intubation and extubation was done by the CRNAs and other critical care nurses.
Once the patient was stabilized and the antagonist was administered the patient was in
withdrawal. All of the monitoring equipment was alarmed according to established parameters
and if an alarm sounded it was called to his attention. He recalled that there was one critical care
nurse assigned to one or two patients.
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Gooberman identified forms used to chart medications and vital signs, forms which
evolved over the time he performed UROD. The CRNAs brought to him a “busy” document
(Volume II, page 175) that they were commonly used to, which contained superfluous
information. The form was eventually changed. Dr. D’Ambra recommended using a form used
in the Post-Anesthesia Unit at Massachusetts General, a setting that Gooberman saw as “more
analogous” to his own setting. D’Ambra suggested fifteen-minute intervals for recording signs
during the intubation and extubation periods and then a different period during the time the
patient was under I.C.U. type care “although the extubation is still under I.C.U. type care.” A
new form was designed that Gooberman named the “Intensive Treatment Unit,” a name
reflecting the British designation for an I.C.U. His re-designed record was intended to more
closely reflect the I.C.U. records with which Gooberman was familiar. In doing so he deleted
superfluous information and also
unfortunately I left out one of the things I added to this form and . .
. in doing the new form, I thought I added it, but I missed it . . .
where we would list the induction medications. When I modified
this form, the one on Page 175, I added a box to be checked when
the induction medications were given to note the time and to note
what the induction medications were. When I developed a new
form, for some reason, I failed to add that box and not noticing
that, when we did the procedures we assumed that the nurses were
checking that box and it wasn’t there.
Gooberman explained that it had been his practice that charting was left to the nurses
“and I had not provided them with an area in which to chart that and their assumption was that I
would chart what I gave. However, I can determine when those drugs were given based upon the
rest of the ITU record.” There is no question that the induction drugs were given, basically
within the first five minutes of the procedure,” but he acknowledged that the failure to provide
for and assure the proper charting of the induction medications was his “mistake.”
Post-Procedure Issues
Count Two, Paragraph 2. II. f., charges that the respondents deviated from the standard of
care by permitting patients to be discharged prematurely after they underwent UROD. This
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charge is significantly related to additional issues regarding the reasons for the demise of the
patients.
Dr. Kleber advised that N.J.A.C. 13:35-4A.7 regulates discharge of patients by a
physician who administers or supervises the administration of anesthesia in an office setting.
Subsection (g) provides that such physician “shall ensure” that, prior to discharge,
1) a practitioner is present on the premises until the patient is
discharged;
2) the patient is given a written and verbal instructions for followup care and advice regarding complications;
3) before the patient leaves the office, he/she is evaluated by the
physician and the physician reviews and signs the post-anesthesia
record; and
4) the patient is discharged “only into the company of a
responsible individual.”
The witness’ concern regarding the manner in which patients were discharged by the
respondents arose from what he read in accounts provided by the caretakers of patients who
claimed that at the time of discharge the patients were unable to walk, had to be totally
supported, were barely coherent and/or were confused. Kleber explained that if a patient were
drifting in and out of sleep, this fact could affect the determination as to whether to discharge the
patient. A patient who exhibited these characteristics would be in danger of falling, of aspirating
and might have trouble sustaining adequate respiration.
Where, as in the case of the
respondents’ practice, discharge is to the outside world as opposed to an intensive care unit, the
patient could be at risk for serious complications. This is particularly so where discharge is into
the company of caretakers who are not adequately trained regarding what constitutes abnormal,
as opposed to normal, breathing. The instructions provided to the caretakers about the possibility
of the patient experiencing abnormal breathing patterns were “totally inadequate.” They set the
caretaker up for trouble, as they could not be expected to understand from these instructions how
to distinguish between abnormal and normal breathing, and to understand those breathing
changes that will normalize and those that will not. Thus, Dr. Kleber advocated that in order to
comply with the regulation’s requirement that a patient be discharged into the care of a
“responsible person,” that person must of necessity be someone who has seen a number of
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persons with breathing difficulties and can identify deviations from normally expected patterns,
someone such as a practical nurse, a nurses’ aide, or some such trained individual.
Dr. Gevirtz testified that in his opinion premature discharge of patients played a role in
the deaths of these patients. “They are critically ill patients. They need to be monitored in a
critical care setting, and discharging them to a hotel room is not a critical care setting.”
Gevirtz explained the modified CITA protocol that he put in place for the case series of
123 patients treated at Pascack Valley Hospital and elsewhere between August 1996 and
December 1996.
This protocol was drafted to fulfill the standards of the ASA.
Gevirtz
explained that after about six hours the anesthesia had worn off. If a patient was retained
overnight, some sedation was maintained and the patient was monitored on telemetry in the
intensive care-type setting until the next day. The median stay was thirty hours. Patients were
not discharged if they still were experiencing nausea and, if vomiting, they were not released.
Patients were not discharged in eight hours simply because they can ambulate. Upon discharge a
whole litany of medications were perscribed to protect the stomach, to control diarrhea, to
control abdominal cramps and back pain, nausea and vomiting. However, nausea should not
persist for days.
Gevirtz discussed the use of a scoring system that he deemed essential for the proper
determination of a patient’s suitability for discharge. The Aldrete scoring system, (P-57), is, in
Gevirtz’ estimation, “the standard.” This system, in the 1995 version published in the New York
State Society of Anesthesiology’s Sphere Magazine, is used in ambulatory surgery centers and
outpatient settings. In his review of the respondent’s records regarding the several patients
whose cases are under review, he saw no notations regarding the Aldrete score.
Patients
appeared to have been discharged prematurely, “not having fully recovered from the anesthetic
and from the detoxification procedure.” Using the Aldrete system, Gevirtz opined that a patient
who is discharged while somnolent would score a one or a zero on the score. Under the
procedure he followed, a patient could not be discharged until he or she scored a two, that is,
until they were awake. A patient who is unable to stand without assistance, unable to walk
without assistance, unable to speak coherently and is somnolent cannot be properly discharged
from an ambulatory facility, as that patient may have an impaired airway and is at risk of death if
they vomit when not fully awake and aspirate the vomitus. If their blood pressure is “not all the
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way back,” they may suffer a stroke or heart attack “or something of that ill-being.” “You have
to meet the scores to discharge people safely.” Referring to the possibility of vomiting after
discharge, the witness explained that if an inadequate amount of clonidine was given and if the
patient has not yet fully recovered from the anesthesia, the patient may not be able to tolerate
vomiting and protect the airway fully. “[I]f you don’t quantitate with the Aldrete scoring system
you don’t know whether they can do that.”
While there may be another scale used for such
determinations, Gevirtz is unfamiliar with any such scale.
Dr. Kushins also determined that deviations from the standard of care occurred when
patients were discharged despite not yet being sufficiently recovered to warrant their release
from the clinic. The discharge procedures utilized were not in accordance with appropriate
standards for patients who have undergone an ambulatory procedure in which they have been
anesthetized. The respondents’ patients were not appropriately monitored before discharge and
should have been kept at the facility for a longer time, until they were more awake and stable.
Patients were discharged while continuing withdrawal and were not ready to be discharged to a
family member.
In Dr. Kushins’ opinion, if the patient has been discharged from a licensed health-care
facility and has been awake and stable for more than twenty-four hours it is all right to discharge
the person to his family. Acknowledging that the determination as to suitability for discharge is
ultimately a clinical judgment made by a physician, he nevertheless argued that for a patient to
be ready for discharge from recovery it is necessary that the patient be awake, relatively free of
pain, able to follow commands and oriented, and have a stable blood pressure and heart rate
within approximately twenty percent of the patient’s baseline. In addition, although some delete
consideration of color due to its less than objective nature, those who use it feel that the patient
should have appropriate skin color that is pink, not dusky or cyanotic, thus indicating a good sign
of oxygenation. Finally, they should be moving all four extremities on command. The patient
should be awake, coherent, not be experiencing protracted nausea or vomiting and should be able
to take fluids, stand and walk unassisted, and be able to call for help if necessary and should have
someone with them after they go home.
Dr. Kushins also referenced the Aldrete score, which he said was used to evaluate a
patient's suitability for discharge from a recovery room or a post-anesthesia care unit. The
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Aldrete score is used to allow nurses and anesthesiologists to assess a patient's readiness for
discharge from the recovery room or post recovery. Among the issues considered are the ability
of the patient to move his or her extremities, skin color, blood pressure, heart rate, state of
awareness, and respiration. Although the ability of a patient to urinate is not a factor considered
in the Aldrete score, depending upon the nature of the procedure to which the patient has been
subjected, the ability to void may be a proper criteria respecting dischargeability. As for the
patient's ability to walk, this capacity must be assessed in terms of how the patient was able to
walk, that is, did the patient walk independently or with someone standing next to them for
safety. If the patient could not stand up and could not do so by him or her self, then the doctor
did not believe that this was an appropriate criterion for discharge. According to the witness, if a
patient is unable to satisfy the Aldrete score the patient should not be released to go home.
The witness said that the same standards could be applied in either a hospital or
ambulatory surgery setting, or even in an office-based practice. However, the doctor was
unaware whether there were any standards applicable to office-based surgery in New Jersey prior
to 1998.
Based upon his review of the seven patients, Kushins concluded that they had not been
appropriately discharged from the Gooberman facility. The patients were somnolent, too sleepy
and therefore unable to summon help if necessary. They were incapable of independent motor
activity and were at risk for a variety of complications due to their somnolent state. These
complications could include obstruction of the airway, which could result in aspiration. The
patient also might suffer from respiratory depression. If a patient was somnolent, unable to walk
without assistance and was not able to pass an Aldrete, in either its original or expanded version,
then the patient was not suitable for discharge.
Commenting upon notes found in the Lisa Flowers chart, Dr. Kushins stated that
evidence of a positive hand grip and positive head lift, as well as spontaneous ventilation,
seemed like criteria to consider for extubation of the trachea, but these are not really criteria
related to discharge. Extubation of the patient by a CRNA in the presence of the supervising
physician is appropriate. Evidence such as is found in the Beigelman chart, that a patient
ambulated with assistance, does indicate signs of recovery, but the question in his how much
assistance the patient needed to walk. If the patient has to be dragged around, then the patient is
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not ready for discharge. However, if someone simply has to stand next to the patient for safety
reasons, then the patient may well be sufficiently ambulatory to be discharged. Kushins related
that he recalled seeing a caregiver’s report about a patient being “dragged” around the recovery
room and this comment “stuck with him.” He believed that there were reports about patients
being dragged, but the nurses’ notes do not reflect such activity. In addition, Dr. Gooberman did
not say anything about patients having to be dragged.
The doctor criticized the lack of information on the Kindig chart, which did not show
oxygen saturation on room air nor did it indicate vital signs, which should be measured before
discharge. There was not enough information on the chart to allow him to determine if Mr.
Kindig should have been discharged when he was. The doctor based his opinion on whether the
patients were dischargeable or whether they were conscious enough to go home or go to their
hotel.
Dr. Kushins also expressed concern that if the caretaker did not fill all of the variety of
prescriptions provided before arriving at the motel or other location where the patient was going
to begin recovery, the caretaker might have to leave the patient alone in order to go out and fill
additional prescriptions that might be needed. According to the protocol, the caretaker was to
remain with the patient for forty-eight hours and therefore, if the caretaker had to leave the
patient for this purpose, the caretaker would not comply with the protocol.
In addition,
caretakers were expected to possibly administer injected medications to patients without specific
training, and nurses employed by the doctors were called upon to make diagnoses of changing
situations over the telephone and then instruct non-licensed, inexperienced caretakers on what to
do to treat the patient.
In conclusion, Dr. Kushins testified that in his opinion, patients were inadequately
assessed before discharge. However, in the absence of sufficient information, he could not say
whether they were in actuality discharged prematurely.
Dr. David Smith was asked to comment specifically as to the acceptability within the
standard of care of the discharge of a patient fifteen minutes after the completion of a four to six
hour UROD procedure. In response, he commented, “it’s a non-question,” because, regardless of
the procedure involved, “the trained physician makes a judgment,” that is, a clinical judgment
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based upon the circumstances with regard to the individual patient.
Clinical judgment
“dominates in standard of practice.” Assessing the Lisa Flowers case, Dr. Smith agreed that as
of the time of discharge, the only written note relating to the suitability of the patient for
discharge is a nurse’s note. In his opinion, the discharge of this patient at the time when she was
allowed to leave the facility was appropriate.
Smith did not see any deviation from standards arising from the lack of any indication
that the respondents employed the Aldrete System in determining suitability for discharge. His
understanding of Gooberman’s discharge criteria, as determined by his discussions with the
doctor, is that the patient must be stable, the catheter removed, vital signs stable, and the
caregiver informed of the necessary information. In Smith’s opinion, using analogy, if a patient
were unable to stand and/or walk without assistance, unable to speak coherently and was
somnolent, the patient could still be dischargeable, subject to clinical judgment. However, if the
patient were comatose, unable to ambulate at all, unable to sit up, and might aspirate vomitus,
they would not be dischargeable. Ability to void is an essential characteristic for one to be
dischargeable.
Smith was questioned as to whether the simultaneous existence of four factors at the time
of discharge of the deceased individuals would not link the procedure causally to their deaths.
These factors were identified by the deputy attorney general as follows: they were unable to
walk, to stand without assistance, to speak coherently and were somnolent. He replied that even
assuming all of these individual conditions to be present, they would not be “a medical fact that
would be appropriate to link the procedure and causation.” Neither would the additional fact that
within twenty-four hours of discharge two patients were required to go to the emergency room,
each exhibiting respiratory distress and each having to be intubated and placed on ventilators for
approximately one week before being discharged. Smith explained that for the linkage to be
made, the patients would “have to be dead on the table.”
Dr. Simon identified the issues of concern in general anesthesia regarding the suitability
of a patient for discharge as whether the patient was cognizant, is able to answer questions
appropriately, exhibits stable vital signs, has stable oxygenation and respiration and can ambulate
without much assistance.
There are standards published by the American Society of
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Anesthesiologists (“ASA”) in 1998.47 However, criteria for UROD patients may not be the same
as for other patients, and aspects of the ASA standards are not applicable to the UROD
procedure as practiced in Gooberman’s freestanding clinic. UROD patients are physically weak
and do not feel well. They do not look “healthy” and to some degree may appear to be
“debilitated.” There is “something going on in that center of the brain that affects muscular
coordination.”48 In addition, these people are emotional and are very needy people. “They look
different and act differently.” As a result, the standards that generally apply for discharge from
anesthesia do not automatically apply for discharging patients from UROD. Simon opined that
in the UROD setting, if the vital signs are stable, the patient is coherent, can walk while assisted,
can talk and communicate, if the airway is protected and if there is hand strength, then the patient
can be discharged. On the other hand, although he did not recall any such cases, if a patient was
somnolent, the patient probably would not be dischargeable. However, in some instances of
somnolence, depending upon the degree, discharge might even be acceptable.
Dr. Simon had heard of the Aldrete score, but he has never used it at any time during his
training or practice. The Aldrete score is not mentioned in the ASA standards and it does not
constitute the standard of care.
Ultimately, the question of suitability for discharge is a
clinician’s decision. In his own practice, Dr. Simon made a decision regarding discharge after
“eyeballing” each patient, even those whose procedures he did not personally perform. While he
never discharged anyone within fifteen minutes of extubation, there were, perhaps, five patients
who were allowed to leave thirty minutes after extubation, and there were some “quick
recoveries.”
Based upon his review of the respondents’ UROD procedures, Mr. Maziarski did not find
that they failed to provide a safe procedure. The nurse anesthetist was in the recovery area with
the patients, as was a critical care nurse. Standards existed for determining the suitability of
patients for discharge; such as head lift capability, muscle tone, consciousness, ability to
maintain the airway and hand squeeze. The Aldrete Score is used as an evaluative device in
many instances, but there are other protocols and there is no violation of the standards of care if a
facility employs its own procedure, so long as it considers the necessary elements. The failure to
utilize the Aldrete is not a deviation from the standard of care. Ultimately, the determination to
discharge is left to the sound discretion of the doctor in charge, and a nurse can utilize the
47
According to the witness, these standards are probably more stringent than those that were in existence in the 1995-99 period.
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applicable protocol and decide if discharge is appropriate. In Gooberman’s practice, the critical
care nurse/CRNA and the doctor determined if discharge was appropriate.
Maziarski’s review of the charts of six of the patients revealed expected variances in the
vital signs of the patients, but no significant hypotension. Prior to discharge, the patients were
stabilized and were able to walk, talk and breathe appropriately, as well as urinate. CRNAs
came to the facility with the knowledge and training to perform the safe and proper
administration of anesthesia and management of the anesthesia patients. The ratio of nurses to
patients met the proper standards for critical care. The CRNAs stayed at the facility until the last
patient left. There were no deviations regarding the post discharge procedures and protocols. As
far as the standards of anesthesia care were concerned, the UROD procedure was safe. He
concluded that to a reasonable degree of nursing and medical certainty, it did not deviate from
standards of care for anesthesia care.
The files that Maziarski examined do not include discharge notes prepared by the nurse
anesthetist. A discharge note is required for the discharge of a patient, and should include
information about the time of extubation, respirations, vital signs and the condition of the patient
and that the patient is able to maintain his or her airway. The determination to allow the patient
to be discharged is a function of another person other than the CRNA. A patient who cannot
stand without assistance is not stable enough for discharge, nor is a patient who cannot walk
without assistance or who is incoherent. If the patient can walk and talk but is somnolent,
discharge is allowable, but not if the patient drifts in and out of consciousness. Mr. Maziarski
concluded that, as he understood it, the discharge protocol in use by the respondents was
adequate. The patient had to be able to hold a dialogue, understand, walk without assistance for
a distance of about 300 feet, urinate, not exhibit nausea and be able to hold down fluid. CRNA
and ANA standards require that there be a discharge protocol, but they do not require that it be
the Aldrete formulation.
The Lisa Flowers file does not contain a suitable discharge note. The note therein is
“minimal.” There is nothing recorded thereon as to vital signs, nothing about color of the
patient, nothing about whether she was talking. The note does state that the patient ambulated,
urinated twice, and was taken to the door in a wheelchair. Discharge fifteen minutes after
48
This area is thought to be the nucleus accumbens, which Simon said is thought to be related to muscle strength.
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extubation following a three-hour procedure is “rare,” but if the patient meets the discharge
criteria, it is allowable. However, the witness acknowledged that in his thirty-five years of
experience he had never seen this happen or heard of it from someone else.
Frank Ragone was given guidelines as to what to expect of patients when they emerged
from the anesthetic. He was taught how to assess their condition, including their strength and
mental status. They would be positioned sitting on the side of the bed, dangling their feet and
raising their arms. They would be told to push against his hands, and would be assisted in
walking as needed. An assessment was made as to the patient’s level of consciousness and
ability to ambulate. The patient was helped to the bathroom. If the patient was ready, he or she
was then taken out to see the caretaker, or if not yet ready, was taken back to a bed and Ragone
would go out and speak to the caretaker.
Dr. Simon also disputed the accuracy of the allegation in paragraph thirteen that the
aftercare and treatment or lack thereof either directly or indirectly caused or contributed to the
deaths and/or morbidities at issue in this case. As for persons undergoing detoxification, Simon
sees no problem with discharge to caretakers, giving them prescriptions for medications and
instructions as to their use. In Canada, detoxification is routinely done on an outpatient basis. It
is also routine for nurses to call the night of the detoxification and the next day to check on the
patient. Further, there is no breach of the standard of care if a nurse is permitted to prescribe
medications pursuant to a protocol established by the doctor. If there is any deviation in the
symptoms identified by the patient or the caretaker then the nurse is required to speak to the
doctor. This is a very standard procedure and indeed, it is a part of the licensing requirement for
nurses to understand the need to call a doctor. In the present case, it appears to Simon that the
staff followed the orders and the practice regimen.
Nurse Jennifer Richards commenting upon the discharge phase, noting that when patients
awoke they generally lay for about one hour. However, some wanted to go to the bathroom
immediately. Some vomited after the procedure. A critical care nurse would assess the patient
and determine if they appeared to be ready for discharge, and then a doctor would look at the
patient and decide if discharge should occur.
In making her assessment, Richards would
consider whether the patient was able to talk to her, would assess the pulse oximetry and blood
pressure and would determine that the patient was not experiencing any distressful breathing.
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Although she did not consider the ability to stand up by oneself as criteria for discharge, the
patient did have to be able to walk around the hallways twice, sometimes needing assistance to
do so. Patients uniformly commented that they “felt like shit.”
Ms. Richards viewed herself as a patient advocate. When she was employed at Kennedy
Hospital, she sometimes found herself arguing with physicians when the doctor determined that a
patient could be discharged and she, in her professional opinion, did not believe that the patient
was actually ready for discharge. In her professional opinion, none of the patients she assessed
at the Gooberman clinic was discharged prematurely.
Questioned as to whether a somnolent patient who could not walk without assistance,
could not speak coherently and was unable to stand without assistance, was nevertheless
dischargeable, Richards opined that one in such a condition was not “dischargeable from
anywhere,” and insisted that she never observed any patient discharged from the clinic with all
four of these characteristics. Although she noted that there had been discussions in the office
about the efficacy of having patients go home before they started to hurt, she insisted, “it didn’t
have anything to do with being somnolent.” She considered that state in which a patient should
be when discharged from UROD to be the same as if they were to be discharged from same day
surgery.
Ms. Richards had heard of the Aldrete score, but she could not say what it was. She was
not aware of any criteria employed for determining dischargeability in a hospital setting based
upon a requirement that a patient be able to walk some specific number of feet.
Ms, Richards recalled that she learned of visits to emergency rooms by post-UROD
patients. Queried as to such visits occurring within three days after the procedure, she recalled
that she would get calls from emergency rooms about patients who wanted the pellet removed
and the emergency room physician would call to find out “what’s going on, what’s this incision.”
She “guessed” that she had received about twenty such calls. Some people who went to the
emergency room were sick with diarrhea and/or vomiting. Three or four had excessive vomiting
and were given I.V. fluids and sent home. None of the twenty or so patients she received calls
about were admitted to the hospital. She believed that 95% of them went to have the pellet
removed.
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Paula Chalphin, R.N., a registered nurse for sixteen years, who worked for Gooberman
and is now a nurse recruiter, confirmed that prior to a patient’s discharge a doctor would assess
the patient to determine if he or she was ready to go. She too was “vaguely familiar” with the
Aldrete score, but she never employed it nor was she ever required to use it. Each institution had
its own standards for discharge. These were similar to those employed by Gooberman and
Bradway.
David Monzo, a CRNA who worked for Dr. Gooberman for three years beginning in
1996 and was involved in between 800-1,000 UROD procedures, recalled that after Lisa
Flowers’ procedure was completed, she practically extubated herself and “jumped out of bed” to
the bathroom. She was definitely not somnolent, and “she could probably have carried him on
her own.” She was very agitated and was “trying to make time with the patient in the next bed.”
No one had ever seen a patient act quite this way and he would term her as having an “unusual”
recovery.
Rosemary Capelli, R.N., teaches nurses how and what to assess in order to determine if a
patient is ready for discharge. The parties stipulated that Ms. Capelli’s testimony regarding
discharge issues was of a general character and was not intended to address the specific
morbidity and mortality cases under scrutiny in this case. According to Ms. Capelli, it is
absolutely appropriate for nurses to make the decision as to the suitability of a patient for
discharge, although typically a doctor sees the patient before discharge actually occurs and the
doctor always makes the actual determination to discharge. The nurse will take the last set of
vital signs and observations prior to the doctor’s review. Ms. Capelli is not familiar with the
Aldrete scores, although she knew of the Glasgow Loma score, another scoring system that can
be used for discharge determinations, although it is not typically employed. What is typical in
practice is for the nurse to employ his or her observational skills. The patient must be awake,
alert enough to respond to another person and, although not as important as these criteria, should
be oriented as to person, place and time. The nurse can decide whether to employ a more
specific score system or whether there is a need for the doctor to see the patient again before
discharge.
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Ms. Capelli opined that if certain characteristics are typical and expected of patients who
have undergone a particular type of procedure, such as somnolence, an inability to stand or walk
without assistance or incoherence, then discharge with those characteristics present could be
permitted.
Commenting on the discharge procedures for patients, Dr. Katz noted that while everyone
should be monitored for an hour or so, if they were up and around, walking and talking and
coherent and there were no significant arrhythmias, then discharge to home would be okay; in
fact, he added that, “we do it everyday. Unfortunately today we send people home the same day
for all kinds of crazy surgeries.” As for the outpatient, non-hospital setting, the doctor explained
that while he was “very comfortable with an inpatient setting” and his prejudice is to keep
overnight if I can,” given insurance issues, often that cannot be done.
Dr. Bradway testified that determinations to discharge a patient were based on the
standard of care, which he described as being based upon the clinical judgment of the doctor in
charge. While the doctor could not recall if there were any written discharge standards, he
described his actual procedure. Cardiovascular stability, including heart rate, blood pressure,
oxygenation as registered by pulse oximetry and ventilation, were all considered. The Aldrete
score was not used per se, as it contained factors not pertinent to the UROD procedure, being
more attuned to the release of patients from emergent anesthesia to a recovery room and not for
discharge from an outpatient facility.
Dr. Bradway emphasized that it is important to recognize that persons who had just
undergone UROD were in withdrawal, were weak, looked sick, did not appear stable, sometimes
were curled in the fetal position, had hair that on occasion might be standing on end and they
also might be twitching. People are often not used to seeing persons in this condition. In
addition, these patients also exhibit many symptoms for secondary gain, but this is where a
trained clinician can determine how the patient is actually doing. In fact, Bradway suggested
that nearly all of the caretakers for the over 2,300 patients treated with UROD would assert
similar concerns about the appearance and condition of their patient as did the testifying
caretakers of the mortality and morbidity patients. As a part of determining the suitability of the
patient for discharge, the patient had to demonstrate that he or she could ambulate at least 300
feet around the perimeter of the premises. The doctor would look at the coherence demonstrated
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by the patient, the ability to walk, with or without assistance, and the ability to void at least once.
The patient could not be experiencing refractory vomiting and diarrhea, or be unable to respond
to appropriate questions.
Dr. Bradway acknowledged that he did not create or sign a discharge note or a postanesthesia note for patients Melendez, Beigelman, Flowers, M.J. or Kindig. In fact, “it was not
our custom” to write such a note, not part of the protocol. He believed that nurses would record
the vital signs and information in the record. He did identify notes regarding the ambulatory
status at time of discharge placed in the notes of M.J. and Victor Melendez.
Dr. Gooberman commented that generally patients were uncomfortable when they first
awoke after undergoing UROD. They suffered from nausea and less often from vomiting,
yawned a lot and stretched, twitched and exhibited spastic movements, and were often weak.
Sometimes for a while, they were autistic in appearance, or they grunted or even exhibited signs
of Tourette’s type activity. Some, such as the gentlemen shown in the video played at hearing,
were far more comfortable when they emerged.
Gooberman had never heard of the Aldrete score before it was mentioned at the
September 1999 Board proceeding.
Not all of its criteria were applicable to the UROD
procedure performed outpatient. For instance, the vital signs were affected by the fact that the
patient was still in withdrawal. Additionally, there was some advantage to the fact that the
patient was not necessarily “fully” awake.
The withdrawal sometimes caused patients to
experience low back and leg pain. Most were nauseated and therefore were not “encouraged” to
drink. Most voided in the bed or went to the bathroom. He did not compute any scores. He
explained that in determining the criteria for discharge he felt that if a patient could walk with
assistance for 300 feet, or even 150 feet at a time, such would demonstrate a certain sufficient
amount of strength, respiration, and maintenance of blood pressure to allow discharge. The
physiological parameters that such activity required one to exceed were of the sort that one
would ordinarily have to demonstrate following a surgery performed with anesthesia. Many
doctors, including anesthesiologists, came to the clinic and saw what he was doing in respect to
discharge. What he did was “just basic common knowledge and common standard of care and
what I had always done as a physician and seen what other physicians do in terms of making a
clinical judgment.”
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We had patients that before that they fully got up, were fully
monitored with respect to their blood pressure. It was charted,
their pulse oximetry and it was charted, their pulse and it was
charted. They were obviously moving if they were walking . . .
They were talking or a lot of times just groaning but they were
communicative. Most of the times they weren’t most happily
communicative, but they were communicating. These are all basic
knowledge for a physician.
Gooberman’s discharge determinations were not made in a manner that was specific to
UROD, but based upon his treatment of patients for years, including in ICUs and discharging
them from hospitals.
He commented on the testimony of persons who said that they had observed patients
dragged around prior to their being discharged. To a limited extent, this characterization is true.
Patients often “flopped” when they were in view of other people. This is a “secondary gain”
mechanism, one that this group of patients was particularly prone to use. In addition, this group
did seem to have some difficulty getting their legs under them. Heroin addicts often have a
certain ambivalence as to whether they want to be helped. They come in for treatment, they get
up to walk to the office, but they “cannot get there” and walk back. Some, as a means of
canceling the scheduled UROD, even lied that they used cocaine the night before. As a group,
they are more prone to lying than is the general population.
Some of the charts indicate that a handgrip was assessed. Some CRNAs used a nerve
stimulator to see how much movement there was after the use of paralytic agents. These were
largely matters of style rather than substance. Other factors looked at were whether the patients
were sneezing, which required the use of a lot of muscle, whether they were moving their head,
their color, respiration, and EKG results. They were also taken to the bathroom, which, while
not a specific discharge criterion, was nevertheless done.
Each patient was “absolutely”
examined by a physician before release. Lisa Flowers’ discharge fifteen minutes after extubation
was “not unusual,” as a lot of the patients were able to leave in a shorter period of time.49 In fact,
after Flowers died, he reviewed the charts of the other patients who had UROD the same day as
she did and discovered that two others were also discharged within fifteen minutes of extubation.
Gooberman cited one patient, a very well-known rock musician, who, in less than fifteen minutes, “was in the elevator and I had to run after
him . . . I couldn’t keep him there.”
49
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Mr. Maziarski agreed that there was a dearth of discharge notes in the patient records that
he examined.
Drs. Gooberman and Bradway acknowledged that they had not included
discharge, or post-anesthesia, notes in the records of patients. Gooberman acknowledged that he
became aware of pending Board regulations regarding record requirements, including the need
for intra-procedure records of drugs administered, and he contended that he had instructed his
then attorney to work with the staff to assure that the requirements were complied with. His
testimony is less than clear as to whether he was actually personally aware of the requirement for
a discharge summary, but again, he wanted the attorney and staff to be sure that the facility
functioned in conformity with the rules. Nevertheless, Dr. Bradway candidly conceded that
while a physician such as himself would evaluate a patient for discharge,
it was not our custom to write a note of discharge. I don’t believe
it was part of the protocol. So, I never did it. It doesn’t mean that
I didn’t do it. Of course, I did it. My concern is with the patient
and I know you can never write enough for patients- -For lawyers
and things but the fact is I rather - - my attention was to the patient,
not to making a large number of notes available for looking at
afterwards.
Count Two, paragraph 2. I.h. alleges a deviation from standards based upon “the
establishment of an aftercare, post-discharge protocol which contemplates non-physicians
prescribing or dispensing multiple medications in response to patient complaints without prior
consultation with a physician.” Additionally, Count Two, paragraph 2. II. i. similarly charges a
deviation because of the “establishment of a protocol and practice which contemplates non
physicians, namely critical care nurses, receiving telephone calls from care givers and deciding
whether additional, or different, medications should be prescribed based on presented
symptomatology without prior physician consultation.” Addressing these charges, Dr. Kleber
commented about the “laundry list” of medications listed on the orders, with, for instance, five
medications listed for sleep, two for anxiety and other such multiple listings for various listed
symptomatology. Apparently, the nurse was to choose the appropriate medication from the list,
but Kleber did not see anything in writing that appeared to guide or direct the nurse as to which
of the listed medications to choose in any given situation. This constitutes a deviation from
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accepted standards. If a doctor is not to personally prescribe, then there must be very clear
instructions as to when and what to prescribe.
Dr. Smith testified that there is no violation of the standard of care involved in having
nurses prescribe medications pursuant to standing orders or protocols. Indeed, he related that
practicing in California, he has a nurse practitioner working under him and has a protocol in the
pharmacy and the nurse practitioner can prescribe. While unfamiliar with the law in New Jersey,
he explained that practice by protocol is part of the health care and treatment team approach.
Likewise, Mr. Maziarski opined that there was no deviation from the standard of care in
the use of medication orders and the determination by nurses utilizing those orders of the
medications to use. This procedure is done in the ICU, with the decision as to which medication
to utilize based upon the symptomatology exhibited by patients.
The doctor prepares the
protocols and the medical staff approves them.
Gooberman identified post-discharge orders (Vol. IV, 169-170a) prepared for specific
patients. These were not a protocol. There had been previous versions of these “Standing
Orders.” At first, they were posted at the nurses’ station and reviewed in in-service training;
later they were written out and incorporated in individual orders. In 1995, he might have been
doing these himself. Later, as he brought Dr. Bradway on board, he formalized the orders,
however, he is not sure when that occurred. The orders were administered by the RNs, who were
free to choose the medications from the list based upon the symptoms and the in-service training
they received. All of the nurses had worked in critical care units. No written directions were
prepared to explain these orders.
The doctor explained that in-service discussions were conducted about the twenty-six
PRN drugs listed on the Orders. If a patient complained about a symptom, the nurses had a
group of medicines to use for the particular symptom. Often these had more of a placebo effect
than a real one, as the medications were frequently not very helpful, but the patient at least felt
that something was being done for them. They would feel better after the passage of some time.
Gooberman insisted that the use of a list of medications for nurse guidance was a typical hospital
routine.
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A series of allegations address the alleged deviations from the standards of care in regard
to the determination by the respondents not to require or provide for an overnight stay for their
patients in a carefully monitored, supervised medical setting. Count Two, paragraph 2. I.g.
criticizes “the failure to adequately provide for patient aftercare with appropriately trained health
care personnel.” Count Two, paragraph 2. I.k. both criticizes “the failure to provide safe and
effective procedures and personnel to ensure safe and effective patient recovery” and expands
this to include “the continuation of appropriate addiction treatment.” Count Two, paragraph 2.
II.g. speaks of a failure to provide “safe and adequate patient care post discharge through
adequately trained health care professionals and appropriate safeguards.” Finally, Count Two,
paragraph 2. II.j. alleges that the respondents’ failed “to provide safe and adequate post discharge
procedures and personnel to ensure safe and effective patient recovery from anesthesia and
detoxification procedures.”
Discussing the provision of UROD on an outpatient basis, Dr. Kleber stated that he knew
of no other provider of UROD besides the respondents doing the procedure on an outpatient
basis, although he agreed that there might be others.
In his understanding, everyone else
providing UROD does so with the patient staying overnight following the procedure. Indeed,
although the process was evolving, he understood that in 1998-99 there was more of a move to
in-patient treatment. However, he could not say whether this was the standard of care.
Dr. Gevirtz identified the issue of overnight retention as one of the several significant
differences in his approach to UROD from that of Dr. Gooberman. He retained patients for an
absolute minimum of twenty-four hours and believed that the mean stay was thirty hours.
Dr. Smith disagreed that the respondents’ failure to provide for patient retention
overnight constituted a violation of the standards of care, nor did he agree that they had violated
standards by failing to “adequately provide for patient aftercare with appropriately trained health
care personnel.” He likened UROD to other “similar anesthetic procedures,” such as liposuction,
where it is an accepted practice for that procedure to be performed on an outpatient basis with
the outpatient released to a caregiver. Noting the cost factors involved in retaining patients
overnight, he contended that this critique implicates significant “health-care system” issues. If
the patient was required to stay overnight, the cost would increase by two to three times and
there is serious doubt as to whether insurance companies would pay for such overnight stays.
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This same comment also addresses the previously discussed allegations that criticize the
“establishment of an aftercare, post-discharge protocol which contemplates non physicians
prescribing or dispensing multiple medication in response to patient complaints without prior
consultation with physicians.” As in the case of liposuction, medicines are dispensed and
instructions are given to the caregivers and, in the doctor’s view, the standard of care in the field
of addiction medicine for this method is the release of patients to caregivers. The practice is
accepted not only in this particular instance, but also in medicine in general.
Smith recalled that during 1995-99 he reviewed Dr. Simon’s protocol, as well as those
used by Dr. Kazen in Arizona and Dr. Colin Brewer in London, England. Dr. Kazen is not an
anesthesiologist. These protocols contributed to his general fund of knowledge in preparing his
opinion regarding the Gooberman/Bradway practices. He was unable to recall how long Dr.
Kazen retained his patient’s after the completion of the procedure, and was aware that both Drs.
Simon and Brewer kept patients overnight.
Smith further disagreed with the Complaint’s statement that the UROD procedure was
not provided, except in limited locations where its provision is “under conditions believed to be
at substantial variance from those under which respondents provide the procedure, including but
not limited to direction by an anesthesiologist, patient retention overnight and immediate
availability of critical care physicians.”
In his opinion, what the Complaint refers to as
“substantial variance,” and which it converts into allegations of violations of the standards of
care, he would call “minor variation with the framework of accepted standards of practice.”
According to the AMA, a physician can use clinical judgment as long as it’s evidence-based. . .
.” Therefore “any variation should not be considered a violation of the standard of practice….”
While he cautioned as to the reluctance of ASAM to be seen as setting the standards of care, Dr.
Smith noted that in the course of formulating ASAM’s policy statement on UROD, there was
extensive discussion on the issue of whether patients should be retained overnight. Cost factors,
trends in medicine and “analogous” procedures such as liposuction were considered. There were
advocates for requiring overnight retention, although he could not specifically recall who
advocated this position.
The policy statement ultimately incorporated an accommodation
between the two viewpoints. (There also was considerable discussion regarding whether the
policy should advocate the need for anesthesiologists to perform the procedure or whether to
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allow that other physicians could do so. While not specifically stated in the policy, there was a
clear interest in assuring that a physician was in control).
The perhaps three or four
anesthesiologists he spoke to advised that the longer that a patient can spend in the hospital the
better the safety. However, they added that a stay “is not necessary and the trend is towards the
outpatient and that’s where the liposuction example came up.” Thus, release without overnight
retention was “not ideal but acceptable.” Smith was himself surprised to learn how much
surgery was being performed in an outpatient setting.
Dr. Smith did not consider the retention of patients overnight for monitoring purposes to
be a “major difference” in procedure vis a vis the respondents’ practice of not retaining the
patients overnight. In his opinion, the standard of care contemplates both approaches. Indeed,
while he said, “there’s no standard at that level,” he conceded that his methodology might be
flawed, that is, as Dr. Kasser argues, relative to scientific validity, analogy thinking, such as the
analogy to liposuction, “does not rise to the highest level of scientific thinking.” Nevertheless,
while there are no studies on this issue, that does not mean that one position or another is not
true, it merely means that there are no studies. In determining whether Gooberman’s approach
violated the standard of care, Smith, knowing that there were no scientific studies to evaluate
whether the retention or the outpatient approach was better, concluded that he did not violate the
standard of care. In making this assessment, Smith was not guided by what other practitioners
did, given the many scientific and other variables affecting the choice, such as cost and
insurance, and the lack of studies as to what was the better approach. In fact, to the extent that
he relied upon the analogy to liposuction and other procedures that are routinely performed
outpatient, and as he was informed about these by anesthesiologists and surgeons at UCSF with
whom he consulted, the advice was that there would have to be proof, that is, scientific studies,
to justify the higher costs necessitated by hospitalization.
Dr. Cooper testified that the UROD procedure was a “very, very valuable treatment
modality” that needed to be the subject of “ongoing studies associated with ongoing therapy.”
(He also suggested that heightened screening for patients might be appropriate, a suggestion that
“should be considered as a possibility of people who are better qualified to consider it than I
am.”) He also would advise further study regarding overnight stays with telemetry and serum
potassium monitoring. The witness affirmed that there is no way to have predicted at what point
in time a post-UROD patient might suffer a fatal arrhythmia. “Once you have a cocaine
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damaged heart you can go at any time.” If the withdrawal process were reversed “in time,” the
arrhythmia might be prevented. One would have to remove the opiate block and administer
opiates. In addition to reversing the withdrawal procedure, it is also possible that in the case of
these cardiac dysrhythmias, they could have been effectively treated by immediate
hospitalization and emergency intervention. “It may be possible, and that’s why I think it needs
further study.” In addition, the doctor acknowledged that if an individual had been retained
under telemetry, the dysrhythmias would have been discovered and perhaps that would have
made a difference, although the witness pointed out that in the case in Phoenix where the woman
was at least hospitalized, (although he was unsure if she was in an ICU) it did not. Given the
assumption that Dr. Gooberman’s clinic was the equivalent of a ICU, it is fair to assume that had
the patients been retained that the abnormal rhythms would have been discovered and that
medical intervention by a qualified medical person would have been available and that if
necessary immediate transfer to a hospital for specialized assistance would have occurred. Thus,
with those assumptions, that logic would suggest that the failure to have the retention in place
provides a link to the causation of the deaths. However, the doctor could not say how much
better the patient’s chances of survival would have been in such circumstances, as further studies
would be required and the exact type of arrhythmias involved would have to be known. He
denied that there was a linkage between the “constricted period of time (the limited postdischarge period of retention at the clinic) and the deaths here, . . .”
Acknowledging, “hindsight is always 20/20,” Dr. Simon argued that in the area of patient
aftercare, what was predictable and expected had been appropriately provided for. It is clearly
the established practice in the United States to routinely discharge post-anesthesia/surgical
patients to lay persons. In addiction medicine, persons go through withdrawal and “are in
psychosocial support with lay people. That’s the foundation of AA and NA.” The discharge of a
UROD patient to a non-medically trained person is not a breach of the standard of care, either in
the case of a patient who has undergone general anesthesia or UROD.
Dr. Simon described the routine model in the United States as that described in an article
published in the quarterly edition of “Problems in Anesthesia,” Volume II, No. 1, a wellrespected authoritative journal that, although not peer reviewed, is nevertheless “analogous to a
textbook.” It describes an appropriate caretaker as “a responsible person,” defined as someone
who is physically and intelligibly capable of taking care of the patient at home,” a person who, in
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Simon’s word, “must be relied upon to care for the patient, to be aware of problems should they
occur and to access help if necessary.” Simon contended that this authoritative article points out
that the standard of care does allow the discharge of a patient who has undergone surgery with
anesthesia to the care of a layperson. Indeed, while in past years the length of the surgery was
considered a factor that would prohibit such discharge, that factor is no longer considered a
negating factor.
In the case of persons who undergo plastic surgery, patients who have
experienced from four to six hours of anesthesia and four to six hours of surgery are released to
laypersons.
Simon is not aware of any instance in which the respondents breached the standard of
care by discharging patients to non-medically trained individuals.
In addition, there was
“probably not” any instance in which any patient was prematurely discharged. Further, it is his
opinion that none of the morbidities or mortalities were related to premature discharge in any
context relating to anesthesia. In this context, Simon disputed that one could suggest that had
these patients been hospitalized for the UROD procedure, they would not have died. Patients
who have been observed in hospitals have in fact expired. While there is a reasonable general
assumption in medicine that the more care the better, it is nothing more than that, “a general
assumption,” but one cannot jump to that conclusion with a certainty.
Dr. Simon expressed concern about an aspect of the Victor Melendez case, in which Dr.
Bradway performed the UROD. He thinks that there may have been “miscommunication” of
information associated with the visit to the motel by Mike Bortnicker, who reported to the
practice that Melendez was “stable.” Simon did not know the causes of the miscommunication;
he thinks that Melendez could have been treated and his outcome could have been improved. He
is uncertain whether this miscommunication rose to the level of a violation of the standard of
care, but it is nevertheless a concern. He was “troubled” that the patient, who was vomiting, was
not given an I.V. and evaluated in person by a physician or even by a registered nurse.
Dr. Simon provided such knowledge as he had on other providers of the UROD
procedure in the United States, including his organization, Intensive Narcotic Detoxification
Centers of America (“INDCA”), and his Connecticut practice, Nutmeg, which managed patients
at Milford Hospital in Milford, Connecticut and in Winchester, Tennessee, San Leandro,
California and Seattle, where the procedure was administered on an outpatient basis, outside a
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hospital setting. Some of the hospitals his organization contracts with treat the procedure as
“somewhat an ambulatory procedure with a twenty-three-hour observation period.” Others call
it “in patient administration.”
The patients treated by Dr. Simon at his Nutmeg facility were “strongly encouraged” to
stay overnight after the procedure in a non-skilled respite area, consisting of three rooms run by a
not-for-profit foundation separate from INDCA and his practice. Eighty to ninety percent of
them did stay. He considered the patients “street-ready” after the procedure and, rather than
going to a motel, as many of the respondents’ clients did, his simply went across the hall to the
respite area. Patients who were in this area were not always monitored, although volunteer
EMTs did monitor patients at first and blood pressures were eventually taken overnight. In fact,
the State of Connecticut would not allow him to medically monitor them overnight. Those who
stayed overnight were then readmitted to the practice the next morning, reevaluated and then
discharged if appropriate. Commenting on the reasons for the overnight stays and monitoring,
Simon said that while he was not sure that he made a judgment that such overnight stays were
medically necessary, at the time he was aware of Gooberman’s case and wanted to stay out of
trouble. In addition, he was a competitor of Gooberman’s and he saw this “overnight stay” as a
marketing tool.
The witness does not presently directly provide the UROD procedure, having entered into
licensing agreements, or as he called them, “cooperative service agreements,” with three
providers.50 His company, INDCA, of which he is the sole owner and chief executive manager,
contracts with anesthesiologists to perform the procedure in hospitals, although he was hazy as to
whether the language of the agreements restricts licensing to only those providers who will do
the UROD in a hospital setting. His intent was that the procedure be performed in a hospital.
One reason for this choice is that the providers are not experienced in UROD and his
organization trains the providers and staff. In addition, in the current climate surrounding
UROD, which is partially the result of this case, it is best from a marketing and public relations
standpoint not to do the work outside of a hospital. When the company is comfortable with the
skill and experience level of the providers, it leaves them on their own.
50
Simon holds several patents for the use of pharmaceutical agents. He did not acquire any of these from Gooberman.
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Dr. Bradway testified that during the summer of 1999 the two respondents discussed the
possibility of retaining their patients overnight or for a longer period. They would then have
nurses monitor them. They did not reach a conclusion as to what was the appropriate thing to do.
He also stated that the issue “may have been discussed periodically” from 1996, after each of the
deaths, although not in the same degree for each and depending on the information they had
available to them. They wondered whether it would have made a difference if the patient had
been kept overnight and observed or placed in a cardiac unit in a hospital. “We’re always second
guessing ourselves and trying to determine other factors that are involved. I think we’re our own
worse critics in that regard, and I think we’re always soul searching for answers.”
Dr. Gooberman acknowledged that dozens of UROD recipients went to the emergency
room sometime after receiving the procedure. However, he did not concede that these people
had to go to the ER, only that they went. He testified that he was aware that some people went to
the ER because they wanted the naltrexone pellet removed. He was not sure how many of those
who presented themselves to the ER following UROD had been hospitalized, although he
personally placed three or four patients in the hospital himself. When he characterized the
number of persons who went to the hospital before the Medical Practitioner Review Board, he
used the phrase “dozens,” to contrast with “hundreds,” however, the figure stated was a general
one, as he did not count the number of calls he had received over the years about persons being
hospitalized.51
As noted previously, Count Two, 2.I.j., alleges that the respondents violated standards of
care in that they failed “to provide safe and effective procedures and personnel to ensure safe and
effective patient recovery and continuation of appropriate addiction treatment.” Count Two,
The actual exchange was as follows: “DR. ROKOSZ: What about hospitalizations within 72 hours of rapid opiate detox treatment?
DR. GOOBERMAN: Hospitalizations are more common. We, of course, mentioned the ones that we had hospitalized from the center. Patients
do frequently go into emergency rooms in the first couple days to try to have their pellets removed. Caretakers certainly do take people to the
emergency room and for a variety of reasons; sometimes they are just dumping them.
DR. ROKOSZ: How many were admitted to the hospital, though?
DR. GOOBERMAN: I don’t know the number; but there are patients that are admitted. Usually the admission is because most of them occurred
in the beginning, when the emergency rooms were not aware of what was going on. And now, realizing what’s going on, they might give them
some fluids and sent them out again.
DR. ROKOSZ: How many approximately do you think it would be? Are we talking about dozens? Are we talking about a couple?
DR. GOOBERMAN: I think we are talking about dozens.
DR. ROKOSZ: Do you know if any of those were intensive care unit admissions?
DR. GOOBERMAN: Yes, they were intensive car unit admissions. If the ER doctor calls me and we have a patient that’s flopping around and
having muscle problems, I usually would recommend at this point just reintubate them, put them in the unit; they will be okay in the morning.
What happens is when they get to the emergency room, the first thing they do, because they are flopping around, is they tie them down. Once
they tie them down, they get combative because they can’t stand to be restrained. Or they will give them sedatives, which can sometimes also
make them combative. If they don’t do anything and just let them relax, they will get better. It’s just a matter of waiting, but it’s not a pretty
thing to watch. And it’s somewhat disturbing to an emergency room, so I say, if you have to do something, protect their airway, put them on a
drip; and they will be okay in the morning.”
51
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2.I.b. asserts that the respondents violated standards of practice by failing to “affirmatively
arrange for post-detoxification counseling as an essential component for rehabilitation.”
Witnesses discussed the topic from the standpoint of UROD as a detoxification process and the
need for ongoing recovery efforts thereafter.
UROD is not Dr. Smith’s detoxification method of choice. Narcotics addicts have a very
high relapse rate: 25% in the first three months, 50% in the first six months and 80% will get to
one to five years. He prefers to use medication as a carrot to get people to attend twelve-step
meetings. Smith does not see UROD as easily transitioning into the psychosocial treatment
mode, which he described as the treatment model that “works the best, which is the integration of
pharmacotherapy and recovery.”
In Gooberman’s procedure, abstinence is being induced
pharmacologically with the use of the implanted naltrexone pellet.
Despite his personal
preference, the doctor is familiar with Dr. Gooberman’s protocols, which he found contained a
“strong orientation” and “major commitment on the psychosocial in participation of a twelvestep program.” The twelve-step group does better in the long-term than those not in a twelvestep program.
He noted that the standards for office-based treatment are evolving. While Dr. Smith has
a recovery group and counseling available in his own clinic, “if you want to mobilize the mainstream of medicine in an office-based setting, then you have to refer and “Dr. Gooberman is very
strongly oriented to twelve-step recovery, refers to twelve-step recovery, and in fact, he has even
taken some of his patients to twelve-step recovery.” Again, Dr. Smith criticized the charge
contained in Count Two, 2.I.d., which alleges that the respondents failed to distinguish between
patients for whom alternative forms of detoxification would be appropriate. Individuals who
were seeking UROD are people who have tried and failed at other methods of treatment. Dr.
Gooberman is well schooled in the broader issues of addiction medicine and has a strong twelvestep orientation. His use of the naltrexone implant as a narcotic agonist, leading to abstinence
and recovery, particularly impressed Smith.
Dr. Simon opined that it is a perfectly acceptable approach to post-detoxification
rehabilitation to encourage participation in a twelve-step recovery program and even to arrange
for an appointment with a counselor. Due to the confidentiality inherent in such programs, there
[Transcript of investigative inquiry of 9/2/99, pages 240-242.]
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is no acceptable procedure for affirmatively confirming whether a patient has attended such
programs, other than through the patient him/herself.52
He recalled that he had seen
documentation and, in addition, from his general knowledge of Gooberman’s practice, he knew
that the respondents did affirmatively recommend participation in such programs to their UROD
patients.
Dr. Gooberman identified the standard of care in the addiction medicine field to require
that patients be referred to twelve-step programs, and his patients were referred to psychiatrists
and those from outside the South Jersey area to ASAM certified physicians. In addition, patients
were sometimes actually taken to meetings.
Discussion and Analysis
Authority of the Board
Pursuant to authority granted by the Legislature in The Uniform Enforcement Act
(“UEA”), N.J.S.A. 45:1-14 et seq., the State Board of Medical Examiners may
. . . suspend or revoke any . . . license issued by the board upon
proof that the . . . holder of such . . . license
...
c. Has engaged in gross negligence, gross malpractice or gross
incompetence which damaged or endangered the life, health,
welfare, safety or property of any person;
d. Has engaged in repeated acts of negligence, malpractice or
incompetence;
e. Has engaged in professional or occupational misconduct as may
be determined by the board;
...
h. Has violated or failed to comply with the provisions of any act
or regulation administered by the board;
52
The Attorney General stipulated that twelve-step recovery programs are a recognized form of addiction treatment.
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Violations of professional standards and/or regulations adopted by the Board and
applicable to the licensee(s) must be established by a fair preponderance of the credible
evidence.
In re Polk, 90 N.J. 550, 560 (1982). The Attorney General of New Jersey is
designated by law to serve as the complainant in cases in which sanctions against a licensee’s
privilege to practice medicine are sought.
A State Board licensing proceeding addresses concerns that go beyond the issues and
concerns relevant in a civil malpractice case. In contrast to litigation conducted through the civil
tort system, the State Board, as the administrative body charged by the Legislature to regulate the
practice of medicine, is concerned not only with the remediation of specific wrongs done to
individuals in the past by physicians who engaged in malpractice, but is also charged with the
overall supervision of the profession. The concomitant obligation therefore rests on the Board to
protect the public from those who are unable or unwilling to practice in accordance with the
interests of public health and safety. It therefore must both deter and punish those “who risk the
health and lives of patients through gross malpractice. Polk, supra., at 565; In re Suspension of
De Marco, 83 N.J. 25, 30 (1980). As such, while the evidence necessary to establish tort liability
in a civil malpractice case must necessarily establish that the physician’s conduct not only
violated the degree of care, knowledge and skill ordinarily possessed by and exercised in similar
situations by the average member of the profession practicing in the field and that the physician’s
failure to have and use such skill and care resulted in the patient suffering damage, Schueler v.
Strelinger, 43 N.J. 330, 344-45 (1964), in a Board proceeding, the Board can consider the
demonstrated failure to comply with standards of care, knowledge and skill and the competence
or incompetence of the physician, even where demonstrated deviating conduct has not been
proven to have damaged a patient.
Medicine is not an exact science.
The law recognizes that the physician is not a
guarantor of a satisfactory or successful outcome to treatment that he or she renders. “The fact
that a good result may occur with poor treatment, and that good treatment will not necessarily
prevent a poor result must be recognized.” Id. at 344. However, as Schueler, supra, notes, the
law imposes standards to which a practitioner must adhere, standards intended to insure that the
care and treatment rendered to a patient meets a level of professionalism. However, Schueler
also recognizes that there is often not only one, specific means of conduct by which a physician
can practice in his field without straying beyond the accepted limits.
Thus, as has been
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repeatedly pointed out here in connection with the practice of addiction medicine and the
provision of treatment to addicted individuals,
A physician must be allowed a wide range in the reasonable
exercise of judgment. He is not guilty of malpractice so long as he
employs such judgment, and that judgment does not represent a
departure from the requirements of accepted medical practice, or
does not result in failure to do something accepted medical practice
obligates him to do, or in the doing of something, he should not do
measured by the standard above stated. Id.
As noted, the Board of Medical Examiners can sanction a physician who has engaged in
“gross” negligence and “gross” malpractice. In re Kerlin, 151N.J.Super.179 (App. Div. 1977)
discussed the definition of these terms.
It is obvious that the terms “neglect” and “malpractice,” standing
alone, import a deviation from normal standards of conduct.
“Gross neglect” or “gross malpractice” suggest conduct beyond
such wrongful action - - how far beyond has been left to the
judgment of the Board, subject, of course, to judicial review.
See also In re Jascalevitch License Revocation, 182 N.J. Super.
455, 467 (App. Div. 1982).
In addition, the Board can sanction for “professional incompetence,” a term which the
court in Kerlin, supra, defined as “any inability to conform with proper standards of professional
conduct, . . . .”
Standard of Care
The record substantiates the fact that during the period from 1995 through 1999 UROD
was a relatively new procedure. The record developed here identifies a very limited number of
practitioners in this country, with some others also performing UROD in other parts of the world.
Additionally, the record demonstrates that during those years, there was no clearly recognized
single standard of care for the practice of UROD qua UROD. However, while that may have
been the case, as Dr. Karan wisely noted, the lack of any single, identifiable UROD standard
does not mean that the practice of UROD was left to “complete anarchy,” to a state of chaos.
UROD was, and remains, a medical procedure used by medical practitioners to treat medical
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conditions. These practitioners are charged by their oath, their code of conduct and ethics, and
their status as licensees granted the privilege to act as physicians, to practice “good medicine” in
the best interest for their patients. Further, the UROD procedure, as a means of detoxifying
addicts through a process involving anesthesia, necessarily implicates for those providing it, that
they do so in accordance with the applicable elements of those standards that govern the practice
of both addiction medicine and anesthesiology. To the extent that the practice is carried out in an
outpatient setting, such standards as apply to that type of practice are also applicable. Thus,
while during the period 1995-99, there was not as such a standard of care for UROD, the several
elements of medicine and medical practice that are involved in the provision of this procedure
dictate that a practitioner providing UROD do so to the level of the average member of the
profession practicing in those fields, that is, the average practitioner of both addictionology and
of anesthesiology.
Of course, the specific standards to which the UROD provider is held may depend upon
the applicability of specific practices and standards existing within those areas of practice as they
reasonably apply to the needs and demands of the UROD process.
Aspects of anesthesia
procedure and practice may have to be understood in the context of the actual processes involved
in UROD. But, suffice it to say, while the evolutionary process has, and no doubt will, continue
to define the exact parameters of acceptable UROD practice, the fact that in the mid-to-late 90s
the procedure was such a new method does not mean that those who practiced it were free to do
as they pleased and were not answerable to any standards.
As for Dr. Gooberman’s
acknowledged significant role as perhaps the most prolific practitioner of the procedure in that
period, it is entirely possible that someone in his role could have established the standard of care
by which the community of UROD providers would be judged. However, for that to occur, his
practices would have to be both accepted by the general community of practitioners of UROD
and, even more importantly, be in accord with the aforementioned “good practice of medicine”
and the reasonably applicable provisions of the practice of both addiction medicine and
anesthesiology. That he and Dr. Bradway were not anesthesiologists is a point of real concern to
the complainant, but, even if the record demonstrates that the provision of UROD by and under
the supervision of a non-anesthesiologist physician is not a per se violation of the standards of
care properly applied to UROD, they nevertheless, and then especially so, must have conducted
the anesthesia component of UROD in accordance with an understanding of the anesthesiarelated concerns inherent in the use of anesthesia in any procedure and, more particularly, in
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connection with the use thereof on persons addicted to opiates and possibly other drugs. They
must then have utilized acceptable uses and practices necessary to assure that the recipients of
UROD received the level of skill and care that would serve to both protect them and deliver to
them the benefits of UROD at the least possible reasonable risk to their health and safety. They
also had to assure the utilization by others under their authority of these practices.
Applying this understanding about the standard of care to which these practitioners were
reasonably held during the years 1995-99 allows an examination of the many specific claims that
they violated those standards, and ultimately, the question of why the seven decedents died and
whether these respondents have any professional liability for those deaths. However, before
reviewing these issues, the foundational question posed by the Complaint as to whether UROD
was an acceptable medical procedure at the time it was practiced by the respondents from 199599, must be considered. Was UROD “beyond the pale,” a procedure of such dubious worth that
in the years in question its performance constituted a per se violation of standards, or,
alternatively, was its performance allowable, at least so long as it was provided in accordance
with appropriately applied standards of care determined in line with the preceding discussion?
The Unofficial NIDA Report
The Attorney General initially filed his complaint on October 1, 1999. The Complaint
asserts that UROD is not an “accepted” procedure. Instead, it asserts that it is, at best, an
“experimental procedure,” the worth of which can and must be assessed only after appropriate
rigorous testing and evaluation. Indeed, the Complaint cites the unofficial 1996 NIDA report
and asserts the lack of “medical, ethical, moral, and financial justification” for the procedure.
This quotation of this highly condemnatory phrase from this document is a seeming indictment
of UROD that serves as an opening theme to the Attorney General’s condemnation of the
respondents’ practices. Yet, while the Complaint goes on at length about these specific issues,
the opening volley seemingly amounts to an independent allegation of improper practice,
separate and apart from the specifics of charges that in their practice of UROD, Doctors
Gooberman and Bradway engaged in specific violations of standards of care and caused or
contributed to deaths and morbidities. The concept that UROD was, and perhaps still is, a highly
suspect, or even a morally bankrupt procedure, or, at least that until it is subjected to rigorous
scientific analysis and testing it cannot be practiced by any physician, whether an
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anesthesiologist or not, without that practitioner violating the dictates of good, ethical practice, is
a stinging assertion that regardless of the care with which the respondents may have acted, they
were nevertheless utilizing a procedure that they should not have even undertaken. 53
It is evident that addiction to heroin and other opiate drugs is a veritable plague. To the
extent that any responsible physician or scientist can develop a safe, reliable, and, given the
dictates of medical need and financial realities, relatively inexpensive means of assisting those
caught in the vice of such addiction, such doctor or scientist can perform a major, indeed, even
an heroic act for the betterment of his or her fellow humans. To a significant extent, the question
posed here is whether the respondents have attempted to do that or have instead simply acted
irresponsibly and outside the limits of professionalism. This question must be considered with
the recognition of the limitations of medicine in general and of UROD in particular.
In its best light, UROD is offered by these respondents as an effective means of
detoxification and as a means of entrée, an opening to abstinence for potential recovering
addicts. It is neither a cure for addiction nor a guarantee of successful abstinence. However,
whatever UROD’s promise may be, it may be that here the respondents, acting for either good or
possibly tainted motivations, have offered to unsuspecting, at risk persons only a procedure of
dubious worth, a serious peril to those who so desperately need both an assist and a hope.
The circumstances of the preparation of the NIDA Report have been the subject of some
discussion and, frankly, some speculation, in this hearing. As the Report was written some six
years ago, an assessment today of the strong language used in the Report at that time to deny the
worth of UROD must be performed with an awareness of the developments since that time. In
considering the status of UROD in 2002, if the evidence now supports the efficacy and safety of
the procedure, practiced either in its “abstract” form, or, for the purposes of this case, as
practiced by the respondents, it matters little what NIDA’s unofficial report concluded in 1996.
Of course, it also does not matter if the NIDA Report’s more sweeping conclusions are found to
be unsupportable on this record if the record nevertheless establishes that the respondents’
53
The Attorney General has argued during the hearing and as recently as in his response to the October 2002 motion to reopen the record that the
Complaint does not target UROD per se, but only the manner in which the respondents practiced UROD. I respect the Attorney General’s offer
that the issue of UROD’s ethical, moral, financial and medical worth is not at issue, but the tenor and character of the evidence presented, as well
as the specific element in the NIDA Report, have significantly raised the question as to whether, at least during the 1995-99 period, a practitioner
could utilize any form of UROD in his practice. Perhaps the real thrust of the argument is that only someone performing “serious research” could
do so, but in resolving the issues in this case, I have decided that it is best to meet head on the questions, and the implications, posed by the
Report and the testimony.
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practice of that otherwise “acceptable” procedure was tainted by impropriety, negligence and
malpractice. Yet, it seems apparent that at its foundation, the Complaint posits the idea that
these respondents used an inappropriate means of treatment, and while the specific manner in
which they provided UROD may yet be found herein to be deficient, it is also necessary to
consider the foundational question of whether any practice of UROD by these doctors between
1995 and 1999 could have been appropriate. Indeed, the Attorney General posits that the real
interest in the NIDA Report is that it should have served as a warning and a notice to the
respondents at the time that they should not have been providing UROD.
Although the UROD concept is apparently not entirely new, the modern development of
ROD, or UROD, has largely taken place during the 1990’s. It seeks to answer a difficult
challenge in the initial phase of removing opiate addicts from the grasp of addiction. As the
record amply reflects, the initial phases of withdrawal are quite difficult, extremely unpleasant
and, to many who attempt to withdraw, too much of a hurdle to overcome. Dr. Loimer and the
others who have followed him, including quite prominently Dr. Gooberman, have sought,
through the development of the rapid detoxification approach, to overcome this initial high
hurdle by allowing the patient to “experience” the initial phase of withdrawal while anesthetized.
Perhaps it might be better to say that they offer the patient the opportunity to withdraw while not
“experiencing” the harshest elements of withdrawal. In its conception, this approach is clearly a
very humane means of encouraging those seeking to stop opiate use to enter the long, never
ending battle of the recovering addict.
Whatever may have been the cause for NIDA to get involved in informally considering
UROD in 1996, one fact is clear. This report, while prepared at the behest of the appropriate
authorities within NIDA, was never officially published. It is therefore “informal,” and while
this does not mean that the worth of its judgments are necessarily any less, nevertheless, at least
as far as this record reveals, it has not been formally adopted as the official position of the
prestigious National Institute. It is therefore best seen as an early assessment by the writers of a
rather new procedure. It is somewhat disturbing that in putting together this assessment, the
authors did not seem to feel it worth their effort to speak to practitioners of the procedure, most
especially to Dr. Gooberman, then certainly one of the most involved practitioners of UROD,
indeed, perhaps the most involved. In determining what impact the NIDA Report has in this
case, that is, what does it mean in assessing the performance of these two licensees, it is also
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important to note that the authors of the Report were not called to testify. The Report, its
statements and conclusions, have been supported and attacked, but the authors have not appeared
(at the behest of whichever party) to be examined and cross-examined as to how and why they
drew the conclusions that they did.
There can be no denying that at the time of the Report, and for all of the time after its
issuance during which the respondents practiced UROD, there was no comprehensive, doubleblind study of the procedure and its effects and effectiveness. Indeed, the Report calls for such
an evaluation.
The Report states that there is a risk of death from UROD and that, apparently opposed to
that risk, there is no known mortality risk “in uncomplicated cases” of opiate detoxification. It is
not exactly clear what the authors mean by “uncomplicated” cases, but the proposition expressed
in both the Report and by experts for the Attorney General that opiate detoxification does not
carry the risk of death is probably an overstatement of the actual situation. The reason for this is
that credibly testified to by Dr. Simon. Some deaths that occur to persons addicted to opiates
may appear to have been the result of heart attacks, yet the deceased may have suffered that
attack while detoxifying and the death may not have been reported as related to detoxification.
Further, as well explained in this record, the persons who died temporally close to undergoing
UROD were decidedly not “uncomplicated” patients. Many, if not all, had an underlying cardiac
disease, condition or defect. Those who underwent the process as performed by the respondents
and did not die may or may not have been “complicated” or “compromised” in similar fashion,
yet of those over 2,300 patients, none died in such a temporal frame as to cause the complainant
to include them in this complaint. In addition, to the extent that a morbidity event could turn into
a mortality event, the record here is largely barren as to the actual reasons for the alleged
“dozens” of hospital visits and/or admissions of recipients of these practitioners’ UROD
services. Thus, the record does not allow us to determine whether any of these visits (many of
which were purportedly requests of the patients for the removal of the naltrexone pellet for
reasons not spread on this record and therefore only determinable by rank speculation) are
instructive regarding the impact of the procedure on others, possibly “uncomplicated.” Given
the record here, and the uncertainties and strongly differing views of highly competent
professionals, including pathologists, regarding the cause of these deaths of persons who had
UROD, it is certainly probable that some deaths, of an unknown number or percentage, not
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attributed to opiate withdrawal and its effects, did indeed result from those non-UROD
withdrawal processes. In addition, we cannot tell whether the authors of the Report would
consider the cases of the decedents herein “uncomplicated,” and apparently, they would agree
that there have been deaths in “complicated” opiate withdrawal.
The authors of the Report suggest that death from UROD could occur from “inadvertent
overdose” of the anesthetic agent or from aspiration of emesis during naloxone-precipitated
withdrawal. Either could no doubt occur, but assuming competent management of the process
and the patient, the likelihood of such events occurring and leading to death is surely very
limited. The record demonstrates quite clearly that aspiration of vomitus by persons addicted to
opiates is a concern and does occur, and that is true even without it being related to a UROD
procedure.
Indeed, the respondents were very aware of this, and they listed aspiration
pneumonia as a potential risk in their consent forms. To suggest that there might possibly be a
risk from an “inadvertent” overdose of anesthesia is to state the obvious, and that risk is not
limited to this particular anesthesia procedure, but presumably to all to some extent.
The authors make a risk/benefit assessment and conclude that the benefit that UROD may
offer to a small group of persons “very high risk” in nature and who would refuse longer
detoxification procedures is outweighed, at least pending further rigorous study, by the risk
posed of cardiovascular complications including cardiac arrest and pulmonary edema, citing the
San letter. Several of the expert witnesses have addressed the importance of UROD as a tool in
the armamentarium of addictionologists and other practitioners seeking to help an often
desperate and in many instances endangered patient population. It does seem that the very
possibility of a procedure that allows those addicted to opiates a chance at an easier early stage
of detoxification and withdrawal offers a great benefit, and the risks identified, and especially the
limited and anecdotal nature of the support for those risks, fail to present a very convincing
argument that even in 1996, UROD was so “without ethical, medical, scientific or financial
justification as a clinical detoxification treatment . . . .” On the other hand, the lack of any
rigorous studies of its efficiency, safety and benefits was, and is, troubling. To the extent that the
unofficial 1996 NIDA Report identifies the need for study and raises some concerns that needed
to be considered and analyzed, it certainly served a purpose. However, to the extent that the
Report’s rather strongly negative, even condemnatory, summation served to spark a licensing
body, acting in its investigatory capacity, to cite the Report as a foundational broadside at
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practitioners, I believe that that body, and in the first instance this judge, must push aside any
serious reliance on what the authors of the report concluded and must instead concentrate the
assessment of these licensees’ actions on the evidence produced relating directly to their practice,
the patients they treated and the expert and lay evidence directly relevant to the circumstances of
this practice, these decedents and patients.
At the same time, it is of course important to recall that while in 1996 the unofficial
NIDA Report represented the only identified statement regarding UROD by a governmental or
professional organization, since that time ASAM, a group directly involved in the battle against
addiction, has spoken. Its recognition of UROD as an “appropriate withdrawal management
intervention for selected patients,” presented within the context of its call for appropriately
trained staff and emergency equipment and the other conditions and qualifications incorporated
in its nine point elaboration, constitutes a statement of “acceptance” of the procedure that
recognizes the need for significant caution and control, yet also concludes that it is an allowable
“first step” process, useful for initiation of ongoing recovery in a “continuum of services.”
Of course, both the NIDA Report and Chris Kasser’s 1997 editorial recognize that UROD
had not then been the subject of a double-blind, controlled, randomized study. Ideally, it would
no doubt be more acceptable scientifically and, from a public policy view, perhaps more
comforting, if such a study had occurred before Dr. Gooberman and others started to undertake
any significant provision of UROD. However, even Dr. Kleber appears to accept the difficulty
in designing and implementing such a test in this particular context.
In summary, the unofficial NIDA Report raises issues and concerns, but I CONCLUDE
that the focus of this case cannot, and should not, be heavily influenced by that 1996 Report’s
broad attack on UROD’s alleged lack of “medical, ethical, moral and financial” justification. It
is far better to concentrate upon the details of what the respondents did, or did not, do.
Specific Charges
Moving on to the Complaint’s assertions about the means and manner of practice
employed by the respondents in their provision of UROD, both the Complaint and the evidence
adduced at hearing suggest that the Attorney General’s allegations of wrongdoing relate to three
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distinct, and yet of course highly integrated, aspects of that practice. First, the Complaint
condemns actions and practices, or in some cases the lack of proper action, regarding the period
of time starting with the first contact of a prospective recipient of UROD through the time when
that person was taken into the operating area, the so-called “pre-operative” phase. This includes
the initial information provided to prospects and the screening given, or in some instances, not
given to these candidates to determine their fitness for UROD, or their lack thereof. Second, the
Complaint questions the specific use of drugs and combinations thereof employed by the
respondents to anesthetize the patients, induce withdrawal and manage them during the period
prior to extubation. In addition, also in dispute is the nature and responsibilities assigned to the
members of the team providing UROD, the doctors themselves, the CRNAs and critical care
nurses, and the equipment available to these professionals. Further, the Complaint alleges that
the process and decision making regarding the fitness for and the timing of discharge from the
facility was flawed, and this includes the fundamental question as to the possible need for
overnight retention. This second group of issues falls within the perioperative phase, the last
issue of which leads into the third aspect of the Complaint, that is, the procedures and
arrangements for post-operative, post-procedure care and monitoring and the impact of the
decision not to retain patients overnight in a monitored facility. Finally, in some sense overlying
these aspects, is the question of whether the doctors made the proper efforts to consider
alternative means for patients to detox and whether they made the appropriate provisions to at
least attempt to help the UROD patients move beyond detoxification to twelve-step or other
means of supporting and strengthening their continued recovery efforts.
One “issue” that surfaced during the hearing is the “definition” of the UROD procedure,
or better yet, what part of the events from the time that persons first contacted the respondents’
office until the time that an individual either moved on in life or, in the case of the patients
focused upon herein, either expired or were hospitalized, is properly deemed as part of the
UROD. In other words, is there some part of this continuum that lies outside of the UROD
process? This is important to the extent that the allegation made here is that persons died
because either UROD caused or UROD contributed to their demise.
It is clear that the
“perioperative” of the UROD procedure began with intubation and lasted through extubation.
There is also no question that the intake procedures, post-extubation period until proper
discharge and some period thereafter also must be considered connected to the procedure itself.
Any death occurring therein must be looked at carefully to see if something about the way
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persons were “allowed in” to the procedure and/or how they were treated after extubation is
relevant to the reasons for their death. The evidence may show that the actions of the physicians
and staff during the intubation-extubation, perioperative period, including the use of the drugs
involved, did not involve any element of negligence, and that the theory and practice of the
“technical” procedure itself was without fault. Nevertheless, the evidence may demonstrate that
the pre-procedure “intake and screening” of candidates was flawed, thus leading to the exposure
of inappropriately selected persons to what for most candidates was an otherwise safe and
efficient process. Additionally, or possibly alternatively, the evidence may show that the postextubation care was seriously flawed. Problems with this care may include both the process
leading to discharge, the decision not to retain patients overnight, or other aftercare issues, such
as the nature of caretakers and the instructions given to them. Thus, it is possible that the
evidence in this case might vindicate UROD per se, but condemn one or both practitioners for
other aspects of their conduct vis a vis the decedents.
Turning to specific allegations of deviation from the standard of care to which the
respondents are properly held, approximately 2,350 persons underwent UROD under the
direction and control of either, or in some cases, both respondents. Each of these patients had to
make a difficult decision to do so. It is certainly reasonable to conclude that each one knew that
by undergoing UROD they would undergo withdrawal from the opiate drug(s) to which they
were addicted. However, a series of charges are made against the respondents, alleging that in
regard to several aspects of their practice they failed to adequately advise their prospective
patients of risks involved in UROD and/or of the investigational or experimental nature of the
procedure itself or of aspects thereof.
The law requires that a prospective recipient of medical treatment receive sufficient
information about the proposed course of treatment to enable that patient to make an “informed
consent” to the treatment. In 1999, the Supreme Court of New Jersey addressed the requirement
thusly:
. . . New Jersey has long since abandoned the objectively-prudentpatient rule, recognizing the informed role of the patient in health
care decisions (auth. omitted). Accordingly, a patient must be
informed of material risks, which exist “when a reasonable patient,
in what the physician knows or should know to be the patient’s
position, would be ‘likely to attach significance to the risk or
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cluster of risks’ in deciding whether to forego the proposed therapy
or to submit to it.
[Perez v. Wyeth Laboratories, 161 N.J. 1, 20-21.]
The Court continued, with words that, while stated in a case involving a somewhat
different context concerning the mass marking of the contraceptive implant Norplant, are
nevertheless applicable here, as the record reflects the marketing efforts of Dr. Gooberman to
publicize the availability of his UROD treatment through billboards and mass-media
presentations and appearances.
When a patient is the target of direct marketing, one would think,
at a minimum, that the law would require that the patient not be
misinformed about the product. It is one thing not to inform a
patient about the potential side effects of a product; it is another
thing to misinform the patient by deliberately withholding potential
side effects while marketing the product as an efficacious solution
to a serious health problem. Id.
In Gilmartin v. Weinreb, 324 N.J. Super. 367 (App. Div. 1999), the court wrote that “the
physician must only disclose the ‘risks associated with the proposed treatment’ and ‘dangers
associated with . . . [the] proposed course of treatment.” He is “ ‘not responsible for failing to
disclose a risk’ which is ‘not inherent in the procedure’ and a physician ‘need not discuss a risk
of the improper performance of an appropriate procedure.’” Gilmartin, supra, at 375, quoting
Calabrese v. Trenton State College, 162 N.J. Super. 145, 156-57 (App. Div. 1978), aff’d, 82 N.J.
321 (1980) and 61 Am.Jur.2d Physicians, Surgeons, and Other Healers § 191 (1981). In the
case of a medical procedure, a “‘risk inherent in the medical procedure performed’ means that
the ‘risk is one which exists in and is inseparable from the procedure itself.’” Gilmartin, supra,
at 376, quoting Jones v. Papp, 782 S.W.2d 236, 240 (Tex. App. 1989).
Count I, paragraph 2. I. e., charges that the respondents failed to “clearly and
appropriately identify death as a risk factor in the informed consent form signed by patients.” In
his proposed findings of fact, the Attorney General presents the “cumulative” assertion that no
warning was provided “despite knowledge of at least six patient deaths.”
Of course, in
considering this charge, it must be recalled that despite the Attorney General’s “cumulative”
assertion, the issue must be examined by placing it in context.
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At the start of Dr. Gooberman’s UROD practice in 1994, there had been no deaths
identified as being causally related to UROD. In fact, the evidence from witnesses such as Drs.
Kleber and Simon is that at that time UROD was considered a safe procedure. It is important to
remember that Dr. Kleber was the source for the assertion in the NIDA Report that death was not
a risk in uncomplicated heroin withdrawal. Dr. Smith agreed that the mortality rate from nonUROD detoxification was “very low,” but added that the high risk of overdose following
detoxification had lead to some deaths. Thus, given these understandings within the profession,
it would seem from this evidence that at the start there would have been no duty to warn of a risk
of death. The death of G.W, the first known death of a Gooberman/Bradway UROD patient
occurring in a temporal relationship to the decedent’s UROD procedure, occurred on September
29, 1995. The second, of Frank Stavola, occurred over one year later on December 23, 1996, by
which date, according to Dr. Bradway, the respondents had already performed 671 procedures.
It has been the consistent position of the respondents that they did not then, and, in fact, do not
now, believe that these deaths and the deaths of the other five patients were in any way casually
related to UROD. Thus, early on in the period from 1994 through September 1995 and even
perhaps through December 1996, based upon their understanding and assessment of the situation
and of their experience in performing UROD many hundreds of times, the doctors saw no reason
to begin to advise their prospective patients that death was a specific or inherent risk of UROD.
The primary source for the allegation of a deviation incorporated in this charge came in
testimony presented by Dr. Kleber. He actually did not state his charge in such a temporally
unlimited manner as the complaint does. Kleber commented that to his knowledge, by the time
of the last death in July 1999, the respondents had not warned their patients that there was a
possibility of death resulting from undergoing UROD. He specifically said, “Since - - at that
time the physicians knew of at least six deaths or seven deaths. I believe it was incumbent upon
them to warn . . . .” He did not pinpoint at what point in time, or after how many of the deaths
had occurred, this responsibility to warn their patients came to rest upon the respondents.
Importantly, the evidence adduced at this hearing from all the experts affirms that death,
which did not occur to any of these patients “on the table,” also did not occur directly from the
anesthesia or directly from the inducing drugs, although perhaps the combination did have an
adverse impact. During the years 1995-99, the respondents could not see any linkage of the
deaths to the anesthesia used, and they thought that given the small number of deaths and the
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known death rate for heroin addicts generally, that these passings might have been unfortunate,
yet “random,” occurrences, not the result of something inherent in UROD. Further, to the extent
that they had some reason to believe that the death of Stavola resulted from post-procedure
intake of cocaine, which drug was found in his system, they might also have determined that the
cocaine, and not UROD itself, was the likely contributing factor to death. Even the third death,
that of Marc Beigelman in March 1997, involved evidence of cocaine metabolites found in his
system. This again suggested possible use of cocaine post-procedure, and the respondents again
may have believed that UROD was not the culprit, but that instead post-procedure usage of
cocaine posed a threat to the well being of UROD recipients. Once they saw the possibility that
post-UROD cocaine use might be fatal, they did advise potential recipients that death could
occur if cocaine were used after UROD. Indeed, as Dr. Bradway testified credibly, after each
death he and Gooberman reviewed the facts to the extent they knew them and over time made
some changes in their procedures and protocols.
The Attorney General points to the NIDA Report, noting that the Report discusses the
death reported by San and arguing that it should have served as an early warning to the providers
that there might be a risk of death associated with UROD. However, it is not clear that an
anecdotal report of a single death that might have been causally related is enough to trigger the
need to warn patients, particularly when a practitioner who was even then perhaps the most
experienced provider of the procedure in the world did not find any basis for concluding that
death was actually a risk.
It should be further noted that while there is a responsibility to warn patients of possible
inherent risks and side effects from a procedure, in the case of these patients, given their histories
of addiction and their attempts at other methods of detoxifications and treatment and their likely
desperation, there can be no certainty whatsoever that the disclosure of a possible, even of a
remote, risk of death from UROD would have dissuaded them from undergoing the procedure.
Indeed, although Dr. Bradway did testify that some people walked out when told that people had
died following UROD, there is probably not much likelihood that it would have dissuaded them.
This is especially so when, even based upon an approach to the proofs in this case most favorable
to the complainant, that inherent risk would most likely occur if the patients suffered from
conditions that might not be detectable pre-procedure. “A patient must be informed of material
risks, which exist ‘when a reasonable patient, in what the physician knows or should know to be
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the patients’ position, would be ‘likely to attach significance to the risk or cluster of risks in
deciding whether to forego the proposed therapy or to submit to it’”
Perez v. Wyeth
Laboratories, supra., at 20-21. In the case of most, if not all, of the seven decedents and the two
morbidities, I am persuaded that the great likelihood is that each would have gone through with
the UROD procedure even if death had been a listed possible risk.
If the deaths of these patients were for the most part the result of the stress of withdrawal
upon their systems, which were in some cases undetectably compromised, it may be that these
persons died as a result of a risk that is inherent in any withdrawal process, including, and maybe
even more so, UROD. A sufficiently damaged or compromised cardiac system may be a time
bomb that the stress of withdrawal will ignite in certain persons. If the underlying cardiac
problems are not reasonably detectable pre-operatively, that is, by use of equipment and testing
during the screening process that is appropriately used given the specific circumstances of the
patient and the application of the physician’s clinical judgment, then there is a risk inherent in
the induction of withdrawal that certain patients will experience serious, even fatal, cardiacrelated incidents. While the discussion of the findings and conclusions as to the causes of death
of the patients will follow, to the extent that these deaths may have shown that deaths can occur
after UROD even in the absence of patient non-compliance because it induces withdrawal and
because some persons’ systems cannot manage the stress, then it would seem that the law would
require that the patients be advised in advance that there is a risk that they could die or otherwise
experience serious morbidity, even if they appear to the physician to be medically able to
undergo UROD after having undergone reasonable screening procedures. However, in the
context of this series of deaths ,which posed such a mystery to even such an experienced expert
pathologist as Dr. Segal, and which are the subject of such controversy amongst experts as is
reflected in this record, I cannot find that the respondents were at fault for not listing death as a
specific risk.
Based upon the totality of the evidence, I am persuaded that the respondents did not act
improperly when they did not list death as a possible risk, as they had no reason to believe that it
was a risk inherent in the procedure. Therefore, the charge is DISMISSED.
In Count Two, paragraph 2 I. k. the Attorney General charges that the respondents
deviated from professional standards when they failed to disclose to prospective patients that
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UROD was “effectively” an “experimental procedure” and to obtain their informed consent to
undergoing such an “experiment.” Count Two, Paragraph 2. I. i., alleges a further deviation
arising from “the use of fentanyl transdermal patches which were not established as either a
necessary or appropriate drug within the UROD/ROD procedure provided by the respondents
which accordingly introduced an experimental risk into said procedure without appropriate
patient consultation and informed consent.” Finally, Count Two, paragraph 2 II. d. charges
that “the administration of fentanyl” by the respondents was provided “in a fashion such that the
procedure was rendered investigational or experimental in nature without appropriate patient
disclosure and consent.”
Interestingly, none of the parties has addressed these alleged violations to any degree in
their written submissions. Whether this is an indication that one or more parties see this as a
weak point in their case is unclear, nevertheless, despite this seeming disinterest in arguing the
point, it having been raised, it must perforce be resolved.
Each of the alleged deviations from the purported standard of care that centers upon the
use of the fentanyl patch is framed in regard to the issue of notice and informed consent, and is
posited upon the concept that as employed by the respondents, the fentanyl patch constituted an
experimental usage. In the sense that these claims are expressed, there is no suggestion that the
use of the drug did any actual harm to anyone, and presumably, even if the complainant agreed
that it did not (which is not to imply that the complainant so agrees), the charge would still lie,
based as it is on the nature and status or classification of the usage, rather than its result. In the
record, Dr. Segal posited that while theoretically the antagonist naltrexone, on board the patient
through the implant, should have blocked any, or at least any significant, effect of the opiate
fentanyl, nevertheless perhaps the fentanyl “may have contributed” to the deaths, and there are
some “mysterious” findings of fentanyl within the blood or the stomach of some decedents and
speculation as to how that substance could have reached the stomach. Ultimately, considering
the evidence adduced on this point, I FIND that the evidence does not support a conclusion to a
reasonable degree of medical certainty that fentanyl did cause or contribute to any of the deaths.
This said, whether fentanyl should have been used as it was provided, via a patch medium,
whether such use deviates from accepted professional standards or is simply a “difference” in
methodology without pejorative impact or implication, are matters that need not be resolved in
order to determine the outcome regarding the stated charge that the respondents violated
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applicable standards because they did not disclose that their use of fentanyl was experimental.
Thus, as with the overall charge as to UROD itself, these fentanyl issues will be addressed as
questions of “consent” and “experiment.”
The consent forms utilized by the respondents did not state that the UROD procedure was
experimental. They did state that the procedure of opiate withdrawal under general anesthesia
“is a procedure first developed in Vienna in 1989,” perhaps a fair indication that the procedure
was rather “new” and had no long history behind it. The consent form also addresses the
implantation of the naltrexone pellet.
As this implantation was a part of the
Gooberman/Bradway approach to UROD, it presumably is also part of the allegation of deviance
from standards governing consent that its use was also not labeled “experimental.” The form
noted that naltrexone was a medically accepted drug for the treatment of drug addiction and that
the implantation method was a medically accepted method of administering many drugs, adding
“however, implanting naltrexone under the skin is a new way to deliver naltrexone” and
“Naltrexone has not been approved by the Food and Drug Administration (FDA) for use in
pellets.” It also cautioned that while oral administration of naltrexone had no side effects, “[I]t is
possible . . . that implanting the Naltrexone will result in new side effects.”
As previously described, Dr. Kleber testified that “recognized addiction experts”
generally agreed that, until the research identified in the NIDA Report was done to “carefully
delineate risks and benefit,” the procedure “should still be considered an experimental
procedure.” Dr. Karan characterized the failure to advise prospective recipients of this as a
“definite” deviation from standards. However, Dr. Smith, an addictionologist who does not
practice UROD, emphatically denied that UROD was experimental. He pointing out the “very
specific meaning” attached to that term within medicine and the undisputed fact that the UROD
procedures performed by the respondents were not a part of any established study of UROD,
were not conducted in a university or research center setting, were not the subject of a research
protocol, were not conducted pursuant to a grant issued for the purpose of conducting a study of
the procedure, and were not being performed by the respondents as a part of a planned study of
the procedure for publication. Additionally, the medications used were all approved by FDA,
although their use in some instances was off-label. He specifically noted that if an approved
medicine were used for a non-approved use, the usage was not “experimental,” even in the
absence of a randomized, double-blind study.
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Dr. Simon, who, of course, was a practitioner of UROD and still has a significant
monetary interest in the procedure, testified that the procedure was “recognized” before ASAM’s
policy statement, however he also said that there were “recognized” procedures that are
nevertheless “experimental.”
Dr. Gooberman attempted to address this question, as, when speaking about the fentanyl
patch, he related, “there was no experiment going on. Experimenting is done for the sake of
knowledge. What I was doing was taking care of patients and trying to relieve their suffering.”
While I do not suggest that he is necessarily correct, Gooberman’s comment may reflect some
distinction, at least in his mind, between the academic study of a medicine or procedure and the
day-to-day work performed “in the trenches” by non-academic practitioners seeking to find new
means of treatment for the patients they see and attempt to treat every day. This dichotomy is
also seen in some of the cases and articles discussed below.
Interestingly, when Dr. Kleber was questioned by Deputy Attorney General Harper about
his attachment of the “experimental” label to the procedure, he said that he “believe(d) that the
procedure is still experimental.” However, while that statement of seeming uncertainty may
have referred to the status of UROD at the time of his testimony in 2001, rather than in the
period 1995-99, when Kleber spoke further, he said
If the doctors who performed it say it’s not experimental - - they
don’t put it in their consent form. So, the question is who decides
whether something is experimental or accepted and that may be a
legal question rather than a medical one. (Emphasis supplied).
Kleber then posited his understanding that if he was performing a procedure or using a
drug for an indication not approved (later defined by Kleber as meaning not approved by the
FDA, or in other words, “off label”) - -that may be the most relevant thing here. . .”
If I’m using Sipramine, an antidepressant, to treat cocaine use and
it’s not an approved use of the Sipramine, I need to inform my
patients that this is not an approved use, this is an experimental use
and it’s my understanding that if I don’t that there’s been
numerous malpractice cases where judgments were rendered
because a physician had not informed the patient that the use of
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this drug was not accepted. I am more aware of that than I am of
procedures.
Dr. Smith noted that all of the drugs used in UROD are approved by the FDA, although,
as with clonidine, not specifically approved for use in detoxification. Thus, UROD involves offlabel usage. Seeming to disagree with Dr. Kleber’s characterization, Smith stated that the fact
that drugs are used for other than their FDA-approved uses does not make an experiment out of
such usage, at least in the technical terminology applicable to medical experimentation.
Dr. Smith refers to the technical meaning of an “experiment,” and makes some valid
points regarding the lack of a “research” context for Gooberman’s work. At the same time, it
may be said that if a procedure is used by a doctor that has not been attempted before, or has had
only limited use, and the drugs used therein are used for a purpose not yet approved by FDA, and
they are used in a manner and for a purpose intended to reach a goal that it has not yet
demonstrated that such usage and procedure can both effectively and safely achieve, then there is
certainly a measure of “experimentation” or “investigation” involved, albeit not perhaps the
formal “experiment” or “research” of which Dr. Smith speaks. It is also true that at the time that
Dr. Gooberman first began to use UROD it was a “new,” “cutting edge” process with a limited
and evolving history. At least for some period, if not for the whole time during which they
provided the procedure, the respondents really had a limited basis for predicting if it would lead
to better long-term outcomes for addicts (more on this later). As will be seen from the discussion
below, I believe that Dr. Smith’s comments more properly address what constitutes “research”
than what constitutes “experimental.” Thus, as Smith suggests, the question is how to define an
“experimental procedure.”
One court has described the responsibility of a health care provider to advise a patient
that a procedure or treatment that the provider is offering to the patient is experimental.
With experimental procedures the “most frequent risks and
hazards” will remain unknown until the procedure has been
established. If the health care provider has a duty to inform of
known risks for established procedures, common sense and the
purposes of the statute equally require that the health care provider
inform the patient of any uncertainty regarding the risks associated
with experimental procedures. This includes the experimental
nature of the procedure and the known or projected most likely
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risks. . . . The underlying tort principles of rationality that require
informing before operating clearly demand more information when
the proposed procedure is new and untested.
[Estrada v. Jaques, 321 S.E.2d 240, 254 (N.C. Ct. of App. 1984)]
The controversy over how or what to define as “experimental” in the field of medicine is
not new. Indeed, in Pilot v. State Health Benefits Commission, 95 N.J.A.R.2d (TYP) 226 (1995),
a decision on remand issued in a case involving a dispute over coverage by the State Health
Benefits Program for the drug Sabril, used for controlling intractable temporal lobe epilepsy in
Europe and legally imported into the United States, but not yet approved by the FDA for use in
this country, I noted a report issued in July 1990 by the Health Insurance Association of America
(“HIAA”) entitled “MEDICAL PRACTICE ASSESSMENT REPORT
Coverage for
Unapproved Drugs: A Framework for Decision Making. In that report, the authors, who were
concerned about “the dissatisfaction among providers and patients regarding reimbursement
policies for drugs that are still in varying stages of clinical investigation,” wrote in their
Executive Summary that, “key issues” requiring resolution included “especially the conflict that
exists in medical practice over the designations “experimental,” “investigational” and “generally
accepted medical practice.” Pilot, supra at 227.
The issue of what constitutes an “experimental” use in medicine has been the subject of
some discussion in both case law and medical literature. In a leading case, Rush v. Parham 625
F.2d 1150 (5th Cir. 1980), the Fifth Circuit Court of Appeals, in a case in which it determined
that the Georgia State Department of Medical Assistance should have been allowed at trial to
show that it had a ban against paying for experimental treatment because such treatment is not
“medically necessary,” and that transsexual surgery was experimental, discussed in footnote 11
at page 1,156 what it deemed at that time to be “the clearest articulation of the considerations
that go into determining whether a particular service is experimental . . . .” This discussion was
found in a letter, entitled Enclosure #2 to Intermediary Letters Nos. 77-4 & 77-5, (1976 Transfer
Binder) Medicare and Medicaid Guide (CCH) P 28, 152 (1976), which was at that time used by
Medicare to explain to its clients and providers why a service was ineligible for reimbursement.
In making such a decision (whether to provide payment for a
particular service) a basic consideration is whether the service has
come to be generally accepted by the professional medical
community as an effective and proven treatment for the condition
for which it is being used. If it is, Medicare may make payment.
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On the other hand, if the service or treatment is not yet generally
accepted, is rarely used, novel or relatively unknown, then
authoritative evidence must be obtained that it is safe and effective
before Medicaid may make payment.
Other courts have cited this excerpt in discussing the “experimental” question. These
discussions clearly establish that a procedure “generally accepted by the professional community
as an effective and proven treatment for the condition which it is being used,” is not
“experimental.” In this case, the more relevant issue is whether a procedure, not yet accorded
such wide acceptance, nevertheless may, be classified as not “experimental.” Recognizing that
there are new and “as a result, relatively unknown,” procedures, the Eighth Circuit Court of
Appeals said in Weaver v. Reagen, 886 F.2d 194, 198-99 (8th Cir. 1989), that in the absence of
general acceptance, one must turn to “authoritative evidence [ ] that attests to a procedure’s
safety and effectiveness” in order to demonstrate that the procedure is not experimental. This
approach is also followed in Peterson o/b/o Peterson v. Utah Dept. of Health, Div. of Health
Care Financing, 969 P.2d 1, 6 (Utah Ct. App. 1998).
Research has not identified case law that has addressed the issue of exactly what
constitutes such “authoritative evidence” in the context of “rarely used, novel or relatively
unknown” procedures. In a law review article published in 1995, Melody L. Harness, What is
Experimental Medical Treatment? A Legislative Definition is Needed, 44 Clev. St. L. Rev. 67,
95-96 (1995), (hereinafter “Harness”) the author writes that, in the insurance context in which so
many issues regarding the status of a procedure or the use of a medication come up,
there is no consensus definition of experimental treatment.
Policies often define experimental treatment as treatment not
commonly and customarily recognized by the medical community,
treatment connected with medical or other research, or treatment
that has no proven medical value. Frequently, however, policies do
not specify the information the insurer will consider in determining
whether the treatment is commonly and customarily recognized by
the medical community, is connected with medical or other
research, or has no proven medical value.
The author suggests a definition for when a drug, device or medical treatment is
“experimental” and, in addition, addresses what constitutes the type of proof that she terms as
“reliable evidence,” useful for establishing the “experimental” status of the procedure. Her first
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category, not relevant to the respondents’ UROD practice (although perhaps to Dr. Kleber’s
grant) involves those drugs, devices or procedures that are the subject of on-going phase I, II or
III clinical trials. Her second category seems more relevant to UROD during the period 1995-99
and to the respondents’ activities:
(2) If Reliable Evidence shows that the consensus of opinion
among experts regarding the drug, device or medical treatment or
procedure is that further studies or clinical trials are necessary to
determine its maximum tolerated dose, its toxicity, its safety, its
efficacy, or its efficacy as compared with the standard means of
treatment or diagnosis.
Reliable Evidence means published reports and articles in
the authoritative medical and scientific literature; the written
protocols used by the treating facility or the protocol(s) of another
facility studying substantially the same drug, device or medical
treatment; or the written informed consent used by the treating
facility or by another facility studying substantially the same drug,
device or medical treatment or procedure.
In New Jersey, the Appellate Division considered the issue of what “experimental” meant
in Murray v. State Health Benefits Commission, 337 N.J. Super 435 (App. Div. 2001). Murray
was a state college employee seeking reimbursement from the State Health Benefits Plan for
colonic hydrotherapy. Murray asserted that the treatment was “thought to be safe and effective
by complementary or alternative physicians.” As part of his initial decision rendered in the
contested case hearing before the OAL, Administrative Law Judge R. Jackson Dwyer determined
that colonic hydrotherapy was not considered safe and effective within the “appropriate
specialty” of gastroenterology, but he determined that the procedure could not be considered
experimental or investigational under the applicable State Plan definition. On review, the State
Health Benefits Commission reversed Judge Dwyer on this latter point, concluding that the
procedure was experimental and therefore not “medically necessary,” a required condition for
reimbursement. The Commission determined that, while there did
not appear to be any ongoing clinical trials or research studies, the
procedure is nevertheless investigational or experimental. Colonic
hydrotherapy is prescribed only by a few doctors practicing
integrative or alternative medicine. Since it is not deemed safe and
effective by the appropriate specialty, it follows that the procedure
needs further evaluation before it would be accepted as appropriate
treatment.
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[Murray, supra, at 442.]
In addressing the case on appeal, the Appellate Division, in an opinion written by Judge
Steven Lefelt, J.A.D., noted that the litigation before it was “a poor vehicle” for determining
whether such a non-traditional, alternative treatment should be reimbursable “like treatments that
are prescribed by traditional doctors.” Id. at 39. While the appellate panel applied longrecognized standards of appellate review which greatly limited its role in reaching the merits of
the dispute and upheld the Commission’s decision, Judge Lefelt nevertheless addressed the
court’s concerns about the Commission’s approach to dealing with the determination of the
“experimental” or “non-experimental” nature of procedures such as that for which Mr. Murray
sought reimbursement.
Judge Lefelt noted that the Commission, in addition to looking at
“published reports in authoritative medical literature and governmental regulations, publications
and evaluations,” could also consider “prevailing medical opinion that regards a particular
treatment as experimental.” He further commented upon the Commission’s evaluation that
“traditional gastroenterologists constituted the ‘appropriate specialty of the United States medical
profession’” to which the Commission would look in assessing the “experimental” or
“investigational” nature of the procedure. Id. at 445.
New alternative medical treatments should not be excluded from
coverage without careful consideration. ‘Insurer inclusion of
alternative and complementary therapies is likely to expand as
therapies gain acceptance and credibility, and gain support by data
showing that such treatments can contribute to health so as to
minimize insurer’s overall costs.” See Michael H. Cohen, Holistic
Health Care: Including Alternative and Complementary Medicine
in Insurance and Regulatory Schemes, 28 Ariz.L.Rev. 83, 156
(1996). . . . As more and more doctors become familiar with
alternative practices, we can anticipate the availability and
increasing utilization of unstudied alternative treatments.
[Kathleen M. Boozang, Western Medicine Opens the Door to
Alternative Medicine, 24 Am.J.L. & Med. 185, 186-187 (1998).]
To some degree, the Commission’s approach relating to
colonic hydrotherapy could be applied to any future alternative
treatment that is not generally recognized or prescribed by
traditional doctors. We urge the Commission not to do so
routinely. Let us try to explain our concerns. In essence, the
Commission has stated that because few to no traditional doctors
prescribe this treatment, then the alternative practices must be
experimental or investigational.
And, therefore, under this
rationale, the converse is true, that a treatment will be non197
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experimental only when traditional doctors begin prescribing or
become supportive of the treatment. “Organized medicine, since
its inception, has fought to maintain a firm grip on the philosophy
of health care generally, as well as on the specific treatments
patients should have available to them.”
[Id. at 186.]
When other alternative treatments are presented for
reimbursement, we hope that the Commission will determine with
an open mind which “appropriate specialty” should be searched for
“prevailing opinion.” Assuming there are no ongoing or planned
trials or tests, the Commission should carefully consider whether
the “appropriate specialty” should be alternative licensed medical
practitioners of the proposed treatment rather than whatever
traditional medical specialty may be related to the treatment.
[Murray, 337 N.J.Super. 435, 445-446.]
An interesting and very recent analysis of the issues relating to consent and
“experimental” activity, that also touches on the issue of academic “research” vis a vis the every
day practice of clinical medicine addressed by Dr. Gooberman and the formal definition of
research and experimentation addressed by Dr. Smith, is found in Anchef v. Hartford Hospital,
799 A.2d 1067 (Supreme Ct. Conn. 2002). In this case, a medical malpractice action was
brought against Hartford Hospital and physicians. The defendant’s successfully defended the
suit at trial. On appeal, the principal issue dealt with whether the trial court had properly
excluded the report of a federal commission regarding the protection of human subjects of
biomedical and behavioral research, entitled, “The Belmont Report: Ethical Principles and
Guidelines for the Protection of Human Subjects of Research.” The plaintiff claimed that he had
been injured as a result of an improperly administered program involving a drug known as
gentamicin, a drug known to be nephrotoxic and ototoxic.
54
He claimed that the hospital had
failed to inform him that he was a participant in a clinical trial or procedure and had failed to
inform him of the experimental nature of his course of treatment with the drug. The hospital did
not dispute that it had not informed the plaintiff that he was a part of a program that constituted
medical research and did not ask him for informed consent to being a subject of a program of
medical research.
In fact, the hospital “vigorously” contended that the program did not
constitute research. It argued that its use of the drug to treat the patient’s suspected enterococcal
osteomyelitis, a potentially life-threatening form of bone infection, was instead “the
implementation of a program or practice of medical therapy, which, in turn, was aimed, not at
54
That is, toxic to the kidneys (nephrotoxic) and ears (ototoxic).
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validating an untested theory or hypothesis, but at using the available literature, including prior
research and clinical data, for the improvement of patient care and safety.” Significantly, the
issue of whether or not the use of the drug by the hospital constituted medical research or the
implementation of a therapeutic program for patient care and safety was litigated as a question of
fact.
The plaintiff produced evidence that in 1993 Hartford Hospital was the only hospital in
the country that provided a level dose of seven milligrams per kilogram of body weight
(7mg/kg), a dosage not previously tested on humans. The conventional dosage approved by the
FDA was three mg/kg. The hospital had itself described the seven-mg/kg dosage and the one
daily injection by which it was delivered as “radical.” In addition, the hospital utilized a
“protocol,” which meant that if a doctor failed to prescribe the dosage at seven mg/kg as called
for in the protocol, the hospital’s pharmacist would change the dosage automatically. The
hospital had stated in publications to the medical community how its Gentamicin program was a
“radical change from standard
. . . administration schedules” and that their program was
different from most other hospital-based programs, involving “a radical change in both the
conventional dosing and administration of the” drug. Data was collected on each patient at the
hospital apart from the patient’s medical record and the doctors at the hospital who were
responsible for enacting the program lectured to the medical community on the findings of the
program. The plaintiff’s expert witness, a physician, identified four reasons for his conclusion
that the Gentamicin program constituted research:
(1) it was “a systematic application to many patients of a given
regime, rather than individualization for the patient and the
infection”;
(2) it involved “the systematic collection of data”;
(3) the data was collected “not in the [patient’s medical] chart, but
in a research office”; and
(4) the purpose of the program “was to be able to publish [its
results] in the medical literature and in newsletters for the hospital
staff . . . .”
The hospital countered that the program did not constitute medical research. The doctors
in the hospital’s department of infectious diseases, pharmacy and therapeutics committee,
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antibiotic subcommittee and medical executive committee approved the Gentamicin program
before its enactment by the hospital. Their approval was based upon “voluminous data and
known principles of pharmacokinetics and was found by the committees to embody sound policy
for the well-being of the patients and not to constitute medical research. In addition, the program
had been “widely studied for many years before it was implemented,” and was not implemented
to test the drug’s safety. The program was not a clinical trial, there were no control groups or
randomization or double-blinding.
The primary consideration behind the program was the
“efficacy of outcome and patient safety.”
The hospital’s expert witness concluded that the hospital’s Gentamicin program was not
research, as the hospital had implemented, “a program rather than a research protocol,” and had
“reviewed all the literature that was available at the time, what had been done in the laboratory,
what had been [done] in animals, [and] the published information on clinical trials [and] research
trials that had been done in Europe and were starting to be done in the United States.” One of
the trials had “indicated that the program was ‘ready for patient use.’ ”
One of the experts, a doctor who was responsible for the implementation of the program
at the hospital, defined the Gentamicin program as “an aspect of clinical practice,” which he
defined as
Understanding . . . what work was done in the past and how this
will affect the patients, especially their outcome in the treatment of
diseases, and . . . adopting what was done by others and applying
that to the care of patients. That’s what clinical practice basically
is. This differs from research in that if you have a question that
you can’t find an answer to in the literature of sufficient magnitude
that you want to find out what the answer to the question is, then
you have to in a systematic, organized way investigate that issue
and find out the answer to the question. They’re two completely
separate things.
The Connecticut Supreme Court ultimately did not rule on the issue of whether the
Gentamicin program constituted research. It reserved that determination for the jury. It upheld
the exclusion of the Belmont Report, because the trial court found that it was more prejudicial
than probative, in part due to references to war crimes and the Nuremberg Code. The Court
noted that on the probative side, the Belmont Report contained a definition of research and an
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explanation of the line between practice and research.
That discussion is perhaps worth
consideration in this case. The Report acknowledged
the distinction between research and practice is blurred partly
because both often occur together (as in research designed to
evaluate a therapy) and partly because notable departures from
standard practice are often called ‘experimental’ when the terms
‘experimental’ and ‘research’ are not carefully defined. . . . For the
most part, the term ‘practice’ refers to interventions designed
solely to enhance the well being of an individual patient or client
and that have a reasonable expectation of success. The purpose of
medical or behavioral practice is to provide diagnosis, preventative
treatment or therapy to particular individuals. By contrast, the
term ‘research’ designates an activity designed to test a hypothesis,
permit conclusions to be drawn, and thereby to develop or
contribute to generalized knowledge (expressed, for example, in
theories, principles, and statements of relationships). Research is
usually described in a formal protocol that sets forth an objective
and a set of procedures designed to reach that objective.
When a clinician departs in a significant way from standard
or accepted practice, the innovation does not, in and of itself,
constitute research. The fact that a procedure is ‘experimental,’ in
the sense of new, untested or different, does not automatically
place it in the category of research. Radically new procedures of
this description should, however, be made the object of formal
research at an early stage in order to determine whether they are
safe and effective. . . .
Another insight on the status of “new” treatments and whether they are necessarily
“experimental” is discussed in Miller v. Whitburn, 10 F.3d 1315 (7th Cir. 1993), where the court
noted that
Clearly, the best indicator that a procedure is experimental is its
rejection by the professional medical community as an unproven
treatment. The quoted passage [from Rush v. Parham, supra.]
suggests, however, that different definitions of “experimental” may
be necessary depending on the notoriety of the treatment under
review. Indeed, certain procedures may be so new and, as a result,
relatively unknown, that the medical community may not yet have
formed an opinion as to their efficacy. [ ] We agree with the court
in Rush that such procedures are not per se experimental. If
“authoritative evidence” exists that attests to a procedure’s safety
and effectiveness, it is not “experimental.
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The above discussion highlights the quagmire that exists regarding the terminology used
to classify the status of medical procedures and other uses of medically related items such as
drugs and the considerations that are involved in attempting to identify the proper category.
While much about this process is cloudy, I FIND that the evidence here is at least clear that the
respondents were not conducting any formalized “research” program involving UROD. There
was no randomization, no double-blinding, no comparative study, no grant, and no oversight
committee, none of the attributes of academic research. Instead, the respondents were clearly
conducting a “practice,” and were utilizing UROD for the express purpose of treating individuals
and attempt to enhance their well-being. The procedure was used to treat with the intention of
providing the individuals with a significant, indeed, a crucial first step on the long road to
continuing abstinence.
At the same time, I FIND that while during the years 1995-99, there were a small number
of practitioners of UROD, the acceptance of UROD amongst the wider world of medicine during
those years and more particularly of addiction medicine, has not been demonstrated. Further, I
FIND that there is controversy amongst the several experts called to testify in this hearing as to
whether it was, at least at that time, properly deemed “experimental.” In the period 1995-99, the
procedure was still quite new and relatively rare, apparently practiced by a limited group of
physicians at various localities in the United States, Europe, the Middle East and perhaps
elsewhere. There is no evidence that up to the time of the 1999 issuance of the ASAM Policy
Statement any governmental or medical professional group had placed its stamp of acceptance
on the procedure. Additionally, as the NIDA Report detailed, there was no evidence of any
randomized, double-blind study, any phase I, II, or III clinical trails or other academic studies
going on at the time. Thus, according to the categories set up by Harness, supra, if the “reliable
evidence” shows a consensus of opinion among experts that the procedure needs further study or
clinical trials to determine its safety, efficacy or efficiency, as well as perhaps the maximum
tolerances for the dosages of medication used in UROD, the procedure is experimental.
Similarly, according to the Miller court, the question is whether “authoritative evidence” affirms
the procedure’s safety and efficacy. In the absence of the studies and research analysis, the issue
of the existence of such “authoritative” and “reliable” evidence rests mostly upon the opinion of
experts.
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The ultimate determination of whether UROD was “experimental” during these years is
made more difficult by the fact that over that time the experience of the respondents in utilizing
the procedure went from the very limited experience that Gooberman had in the hospital setting
to the experience garnered over hundreds and hundreds and then again hundreds more
procedures. It may be that when he first began to offer UROD that Gooberman should have
advised his patients that there were no studies of UROD’s safety and efficacy, that the outcome
vis a vis other forms of detoxification was as yet unclear, and that there was an “experimental”
aspect to the procedure. Later on, when his own experience and follow up indicated that the
procedure was safely applied to hundreds of patients and that the procedure did detoxify and
with implantation of the pellet offered a thirty to sixty day period during which opiates were
blocked, it may have then been appropriate and ethical for Gooberman to stop using the
“experimental” tag. In this vein, an important question that must be asked is at what point a
procedure that properly fits within the category of an “experimental procedure” no longer must
be considered experimental. This question must arise because, while the evidence in this case
does suggest that in 1995-99 there were experts who viewed UROD as experimental, Dr.
Gooberman, who was generally conceded to be not only an expert, perhaps even the expert, on
UROD, but also with his associate its most active practitioner, was actively performing the
procedure hundreds and hundreds of times, with occasional refinements but in essentially the
same manner each time. If the purpose of UROD was that it serve as a means of providing
accelerated detoxification via the placement of the patient under anesthesia, the induction of
withdrawal by means of the introduction of opiate antagonists, followed by extubation and then
discharge to continue withdrawal and, hopefully, to continue abstinence, then it would appear
that their UROD procedure was overwhelmingly successful. In this instance, the success or
failure of a patient to continue to abstain cannot properly be considered a measure of the success
or failure of the procedure, for UROD could only promise or reasonably be expected to detoxify
the patient and give him or her a “fighting” chance to advance ahead in time as a recovering
addict, rather than as an active one. The question is then, if a physician/expert in a new or
relatively new and rarely tried procedure tries out that procedure, repeats it over and over and
over, hundreds of times, and finds it to be successful and then continues to employ it, can the
procedure move from the “experimental” category, despite the lack of generalized acceptance
within the appropriately defined medical community, Murray, supra, or even the consensus of
opinion among experts that more study is needed?
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In M.K. v. Division of Medical Assistance and Health Services, 1992 WL 280789 (N.J.
Adm.), Judge Tolomeo quotes at length from an article entitled, “Transsexual Healing: Medicaid
Funding of Sex Reassignment Surgery (1991)
When a new medical treatment is introduced, it must be considered
experimental because its safety and efficiency are unknown. As
experience with the treatment is documented, its risks, side effects,
and success rate are detailed. At this point, the medical
community decides whether the benefits of the treatment outweigh
the risks (taking into account alternative treatments and the natural
course of the disease untreated). If the medical community
continues to offer the treatment, it can no longer be considered
experimental. Subsequent research in the field is directed toward
increasing the success rate by developing a method of identifying
prospectively those applicants for treatment who will likely have a
negative outcome and/or those who may respond to an alternative
treatment. Continuing advances in this area of investigation does
not, however, mean that the treatment continues to be
experimental; rather, it represents the continuing refinement of an
established treatment. . . .
As the above discussion of what constitutes an “experimental procedure” amply
demonstrates, the courts, commentators and medical profession have all struggled with defining
the proper classifications and have recognized the confusion surrounding this medical and legal
issue. In determining whether the respondents violated their ethical and professional standards, I
am persuaded that at least in the early stages of Dr. Gooberman’s practice of UROD, there was
an experimental aspect to his use of the procedure. In the mid-90’s UROD was still a very new
and largely unaccepted procedure, which did not have much of a literature and did not have any,
or at least any significant, research to support its efficacy and safety. While his consent form did
mention that the procedure had only originated in Vienna in 1989, he did not choose to advise his
potential patients that it was not only very new, but largely untested. Although I believe that
there may well have been a point in time during the period 1995-99 when Gooberman, and
therefore, Bradway’s experience with the procedure had become such that there was no longer a
need to advise candidates for UROD that the procedure was experimental, I CONCLUDE that,
at least for the first few hundred procedures, the consent form should have advised the prospects
that the procedure they were agreeing to have was just that, “experimental,” new and not yet
significantly tested, Estrada, supra. It is probably true that this would not have deterred many;
indeed, very few of the desperate persons who sought Gooberman’s help would likely have
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declined to undergo UROD even had they been so informed. However, at least when dealing
with the major aspects of a new and largely untested procedure, a physician has an obligation to
provide full disclosure to a patient as to the risks and benefits of that procedure and that
obligation cannot be avoided because ultimately the information may not make a difference to
the patient.
Thus, I am constrained to CONCLUDE that Dr. Gooberman did violate
professional obligations and standards on each of these occasions. Given the uncertain nature of
the point in time when Gooberman’s experience was such as to permit him to ethically dispense
with the experimental label, I decline to conclude that Dr. Bradway acted in violation of these
requirements.
Turning to the use of fentanyl patches, Dr. Gooberman explained his rationale for
utilizing this opiate drug and the delivery mechanism he employed. He believed that it might
serve to modify some of the unpleasant effects of withdrawal, while being provided at so low a
dose as to pose no risk to the patient. While the record contains expert criticisms of the basic
theory and some speculative and unproven concern that fentanyl could perhaps have played a
role in the demise of patients, in this specific context neither the record nor common sense
supports a finding that Gooberman’s patients were at all likely to have considered information
about the fentanyl and the patch as a material factor that might have dissuaded them from
proceeding with the UROD procedure. Further, there is no significant evidence that Gooberman
should have foreseen any risk in using the drug as he did. He cited literature and experiments
with the patch modality for the delivery of therapeutic drugs and appears to have had a
reasonable medical basis for what he did. While it may be that his use did constitute an
experiment, a first attempt to see if the patch method could help ameliorate some discomfort for
his patients, nevertheless, I fail to see that it is reasonable to condemn him for a violation of the
consent requirements. The charges are therefore DISMISSED.
Count Two, paragraph 2. I. f. charges, “the creation and implementation of a complete
waiver of patient confidentiality including, but not limited to, an acknowledgement of the right in
Dr. Gooberman to publicize medical data and treatment provided to the patient within the public
media. Said waiver, when viewed in relation to Dr. Gooberman’s media (billboard) advertising
stating the procedure offered is confidential, is both a deviation from accepted practice standards
and a deceptive and misleading practice.” Even Dr. Simon has acknowledged that the inclusion
in the consent form of a waiver of confidentiality was a deviation from standards. The fact that
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there is evidence in the record that at least one, patient crossed out the waiver is insufficient to
eliminate any violation of the standard by the respondents. If the standard does not allow for
such a waiver, than the possibility that an alert and sufficiently offended patient or advising
caretaker accompanying the patient might see fit to object and to even physically eliminate the
waiver by crossing it out is not a defense to a finding of a violation. This is especially so given
that there was at least some evidence that at the time that patients arrived for their treatment and
received the standard preliminary information they were occasionally already under the influence
of drugs, and in addition, the patients and their caretakers were often quite desperate and looking
to the respondent(s) for some last measure of hope. It was, and remains, the responsibility of the
provider to assure that his practice is conducted in accordance with the proper legal and ethical
standards, and it is most assuredly not the responsibility of the patients to do so.
I CONCLUDE that the inclusion of a waiver of confidentiality in the consent form
constituted a violation of the standards to which these professionals are properly held.
Obviously, there were multiple instances of this violation being repeated in connection with over
two thousand patients.
Count Two, paragraph 2. I. c., charges that the respondents failed “to properly establish
inclusion and exclusion criteria for patients undergoing” UROD. Count Two, paragraph 2. II.
c. charges that the respondents failed to “adequately preoperatively assess patients cardiac,
respiratory, hepatic, and renal systems to determine their ability to tolerate the exceptional
stresses of the UROD/ROD procedure.” In analyzing these charges, it must first be remembered
that the procedure was offered as a means of detoxification for persons addicted to the use of
opiates, persons who, in many, if not in most, cases were long-term users who had tried other
means of detoxification and were not successful in achieving a “permanent” end to their opiate
use, but had reverted to active use. Clearly, each of the persons who sought to obtain UROD
from the respondents and who fit this profile was a potentially appropriate recipient. Dr. Smith
noted that it is generally believed that those who are treated do better than those who are not and
Dr. Simon expressed his concern about the need to treat people and his discomfort with the
notion of not detoxifying someone in need of detoxification. However, granting that a procedure
that theoretically offered some hope of a less difficult withdrawal and a new start on the path to
abstinence would ideally be available to all addicts, the issue of criteria for “inclusion,” that is,
who is a suitable candidate for UROD, and “exclusion,” that is, who is not, implicates such
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issues as prior cocaine use/abuse, pre-existing cardiac or other serious health problems, the
truthfulness of potential patients about their experiences and the need, if any, for screening
patients for the existence of evidence of existing serious medical conditions, pregnancy or recent
use of cocaine. While the need to obtain treatment by those addicted to opiates is clearly a
pressing concern, exposure of an individual with medical or other conditions or activities that
contra-indicate the use of UROD as the means of treatment is not, one presumes, in the best
interests of even such a desperate person, at least unless it could be shown, as Dr. Simon
wondered, that the prospective UROD recipient would be in at least as much potential peril from
other forms of detoxification as he or she would be from UROD. However, as the evidence
shows, not all of the experts agree as to what exactly are the appropriate exclusion criteria.
While pregnancy is accepted by all as an exclusionary condition, there is significant dispute as to
whether subjecting cocaine users to UROD is a violation of the appropriate standards and, as to
at least some cardiac issues, there is much dispute as to whether reasonable means of prescreening patients for the existence of such conditions would be likely to reveal their existence.
Further, as several witnesses stressed, there is an overriding “clinical judgment” factor that
cannot be overlooked or denigrated. With at least some of the factors favoring exclusion, the
reasonable and studied judgment of the clinician experienced in the procedure may properly lead
to an appropriate conclusion to go ahead despite the risks posed by the existence of the
exclusionary factor.
I FIND that in general the expert evidence supports the conclusion, on the one hand, that
there is no standard of care that requires that patients under the age of forty be given a twelvelead EKG before surgery if they have no known history or significant medical problems. On the
other hand, those over the age of forty should be given such an EKG. Further, there is no
standard generally requiring an echocardiogram for these patients. Dr. Kushins acknowledged
that the standards do not require such testing prior to the application of anesthesia to a patient
under forty. The respondents testified that they did not universally employ twelve-lead EKGs, or
EKGs generally, in pre-screening patients, except where there was some indication that caused
them to specially require one, which might be done as part of a consultation with their cardiac
consultants.
The testimony of Dr. Katz was particularly interesting.
Katz explained that as a
cardiologist he wanted to have as much information as possible and felt that an
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electrocardiogram was a “crucial part of the examination.” However, he clarified that, as a
cardiologist, he would want these tests performed when he saw signs or symptoms that he did
not like and that he “wanted to pursue.” He hedged on whether the lack of an EKG was a
deviation from standards, although suggesting that it was perhaps “something of an impropriety.”
He also stressed that the physician must use “personal judgment.” Significantly, while given the
nature of the patient population for UROD in 1995-99, he would have preferred to see an EKG,
he did not know what the standard of care was for this in addictionology at that time. In
summary, despite what I think can fairly be characterized as a good bit of “hedging,” he did
conclude that the physician who was “reasonably prudent” would have required at least a
minimum of a twelve-lead EKG.
Dr. Katz’s testimony is significant, and not only because his testimony, while presented
as a witness for the respondents, may be read as somewhat adverse to their position and interest.
It demonstrates perhaps the difference in approach of a self-described, “very cautious”
cardiologist and a non-cardiologist toward testing, and perhaps it is true that Dr. Katz has, in
assessing this issue, the benefit of hindsight that the respondents did not have in 1995-99. Yet,
as he emphasized, the nature of the patients these physicians were treating cannot be overlooked.
Given the makeup of this patient population and the good chance of multi-drug abuse and
cocaine abuse by the respondents’ prospective patients, it may not have been too much to ask or
to expect of the respondents that they routinely employ twelve-lead EKG’s. However, to say
that Dr. Katz’s comments as to the desirability of such “universal” testing regardless of the age
of the patient represents the state of the practice in addictionology or anesthesiology during the
1995-99 period, during the acknowledged evolution of standards applicable to UROD, is, I
suspect, to give it too much weight. Hindsight is a valuable assist to those seeking to determine
mistakes after the fact; however, it is not available in time to those who are later subject to
criticism. Additionally, what someone may find preferable, or what one may do in order to be
extra-cautious or conservative, is not always what one is required to do in order to meet the
generally accepted standard of care within the profession. Based upon the record adduced here, I
FIND that there was no applicable standard of care for either anesthesiology or addictionology in
1995-99 that required that prospective UROD patients be given a twelve-lead EKG as a routine
pre-screen if they were under forty years of age and did not present any other evidence of cardiac
disease. However, for patients over forty years of age who were to undergo a procedure with the
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screening. As the respondents did not routinely require this, and as the records do not reveal that
any such testing was performed for patients Kindig, who was 50, M.J., who was 44, Stavola,
who was 43 and G.W., who was 40, I CONCLUDE that they breached the standard of care
when they did not insist on an EKG.
Most of the expert witnesses discussed in some detail the problems and challenges
presented by the fact that a percentage of the opiate addicted individuals seeking UROD were
also cocaine users/abusers and often used other drugs or alcohol. In criticizing the respondents’
inclusion/exclusion criteria (or lack thereof), Drs. Kleber, Karan, Gevirtz and Kushins each
commented on the need to establish co-morbidity, cocaine use, etc. This led to additional
criticisms concerning the lack of use of cocaine dipsticks and/or trans-thoracic echocardiograms,
the later specifically due to concerns that cocaine usage could have caused cardiac problems. Of
course, all agree that the primary source of information as to a patient’s past or present drug
usage is the patient him/herself. Yet, such information from persons who are often severely
addicted to illegal drugs is not necessarily reliable. The need for the use of screening devices
such as the dipstick, and the reliability of such devices, was a point of some disagreement.
Of course, the cocaine testing/screening issue must also consider the history of the first
temporally related deaths that occurred to Gooberman and Bradway’s UROD recipients.
Gooberman explained that he used dipsticks early on, but he stopped using them when he found
that they were unreliable. After they learned of the first deaths, and given their suspicions that
these resulted from post-procedure use of cocaine, they started to strongly warn prospective
patients about the serious danger arising from such post-procedure use and the risk that death
could occur if their warning were not heeded. The fact that they started to see the danger of such
activity and the devastating results that could occur to a post-UROD patient might well have
served as a warning to them, a warning that at a minimum required that they be sure to institute,
or re-institute, some measures to screen for cocaine users.
The record does support the concern that significant cocaine use may lead to cardiac
problems, and, given the stresses inherent in withdrawal, if not in UROD itself, the existence of
underlying cardiac conditions is therefore a matter of concern. Dr. Gevirtz testified that under
the CITA protocol a dipstick test was performed both on intake and again on the morning of the
procedure. Dr. Simon posited that there was not necessarily a good case for denying UROD to
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all those who did use cocaine, as he apparently believed that such an attitude was both
pharmacologically unsupportable and reflective of a bias against drug users on the part of some
practitioners. However, Simon acknowledged that he did use dipsticks, and he “supposed” that
this was the “general wisdom” and deferred to Dr. Karan’s opinion. She said that requiring a
urine test was “good medical practice,” which she assumed was the standard of care.
It is not clear that the medical evidence supports a conclusion that if a patient used
cocaine prior to the UROD, even shortly before, that such use would necessarily have a negative
impact on the patient during or even shortly after the procedure was concluded. The half-life of
the drug is sufficiently short that if used before UROD, cocaine is not likely to still be in the
system as cocaine.
However, benzoylecgonine might remain for a longer time. The real
problem about cocaine appears to be, first, the possible impact on the patient’s heart resulting
from significant prior involvement with the drug (although exactly how much or how often such
use must have been to impact the heart is not clear) and, second, use after UROD. To the extent
that knowledge of previous use might lead to an understanding that a patient might have a
compromised cardiac system, even despite the inability to easily detect such by such tests as
EKG or echocardiogram, or that a patient might be more likely to ignore warnings about postUROD use, such information might be “helpful” to the practitioner and ultimately beneficial to
the patient. Yet, Simon and Gooberman both said that even with such knowledge, previous use,
at least prior to twenty-four hours before procedure, was not an appropriate exclusionary factor.
It is not entirely clear from this record that it should be, but at the same time, the evidence does
appear to establish that there existed at some time during the 1995-99 period both dipsticks for
testing for cocaine and a practice among practitioners of the procedure to make use of such in the
screening procedure. The question then is whether the respondents’ decision not to use them
regularly is a violation of the standard of care, or alternatively, simply an acceptable variation in
practice that does not rise to the level of a violation of standards.
Patients who presented themselves for UROD were generally addicted users of opiates.
Continuation of their “habit” presented them with significant dangers. If they were to stop using
opiates altogether, some process of withdrawal inevitably had to occur. If a multi-abuser had a
compromised cardiac system, it is certainly possible that a prudent practitioner of addiction
medicine in general and UROD in particular might advise that some other means of withdrawal
other than UROD was preferable for that patient. The practitioner’s clinical judgment would be
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an important factor, even a determining one, in advising the patient. Of course, to the extent that
the practitioner realized that one with a compromised cardiac system might still be subject to the
stresses of withdrawal post-procedure and might therefore be at risk for arrhythmia or other such
complications even despite the ability to successfully manage the patient perioperatively, the
knowledge that one was a cocaine abuser would no doubt play a significant factor in the
application of such clinical judgment.
Practitioners in the addiction treatment field during the years 1995 through 1999 with the
experience of a Dr. Gooberman certainly were aware of the potentially damaging effects of
cocaine on the cardiac system. While ultimately the decision as to whether to include/exclude a
prospective UROD patient who has used/abused cocaine rests upon the clinical judgment of such
a practitioner, it is not unreasonable that he arm himself with reasonably available information
before making final decisions. The generally accepted practice was for UROD providers to
utilize the dipsticks once they became available. As acknowledged in the record, they were not
by any means a perfect solution to the need or desire to “know” whether someone had a cocaine
history, but they did offer a useful tool and practitioners of UROD such that Gevirtz and other
CITA providers under its protocol, and Simon, used the dipsticks. I FIND that such use was the
“standard.” The respondents’ decision to abandon the use of such pre-screening testing deviated
from the standard practice.
Perioperative Issues
Count Two, Paragraph II. f. alleges that the respondents failed “to provide adequately
for the management of possible anesthesia emergencies such as difficult airways.” The chief
support for the charge came from Dr. Kushins, but while he explained the need for certain
equipment, he did not recall if he had ever ask about specific pieces of equipment. His testimony
on this allegation was general and vague in nature. Other evidence regarding this charge was
limited.
Dr. Simon and Mr. Maziarski each attested that, based upon their visits to the
Gooberman facility and the information available to them, the appropriate equipment to allow
proper management of difficult airways was present on site during the years in question. I
CONCLUDE that the complainant has failed to establish this charge by a preponderance of the
credible evidence.
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Additional charges are made concerning other aspects of the operative procedure.
Particularly significant in the context of the complainant’s overarching contention that the
decedents’ deaths were caused by or contributed to by UROD is the conclusion stated in Count
One, paragraph 7, that UROD, “because of the combined effects of the anesthetic agents and
the antagonist and other drugs, produces a high level of physiological stress upon patients.” This
purported “high level of physiological stress” is then a foundational fact in Count Two,
Paragraph II. b., which alleges deviations from applicable anesthesiology standards resulting
from
[t]he administration of anesthetic agents so as to produce
unconsciousness during a highly stressful period without
appropriate knowledge of the effects of said drugs and their
interactions with other drugs administered.
The conclusion asserted in the first of these allegations regarding the level of stress to
which patients were subjected during UROD is very much related to the question, addressed
extensively by the expert witnesses, of whether that stress played a predominate role in causing
the demise of patients whose systems simply could not handle that level of stress and suffered
fatal arrhythmias as a result. However, as the second charge is worded, the claimed violation of
standards is not dependent on whether the stress led to anyone’s demise. Instead, its thrust
appears to be that the respondents’ employed anesthetic agents in a process that caused certain
physiologically significant biological responses and consequences when they did not really have
the knowledge to understand what was going to occur as a result of their administration of the
anesthetics, particularly when these were to be used in conjunction with other drugs. This
second charge necessarily ties in with the assertions of some of the complainant’s experts, such
as Dr. Kleber, who opined that because of the stresses that arise from anesthesia-induced
withdrawal, UROD must be performed by an anesthesiologist. While the Complaint does not
specifically charge the respondents with violating their professional responsibilities because
they, as non-anesthesiologists, undertook to provide this anesthesia based procedure,
nevertheless that allegation has been made at trial and therefore appears to be asserted by the
complainant as an additional failure on the part of the respondents to comply with their
professional responsibilities. The closest to a definitive allegation of this purported violation of
professional standards is contained in Count Two, paragraph 2. II. e., where the complaint
objects to the respondents’ practice of “the simultaneous provision of a procedure which is the
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medical equivalent of general anesthesia in an outpatient setting for as many as six patients
through CRNAs and critical care nurses subject to overarching medical supervision by a non
anesthesiologist and without the presence of a critical care physician” as a deviation from
accepted medical practices for addiction medicine and anesthesiology. This allegation seems to
mix the issue of multiple procedures with the absence of an anesthesiologist and/or a critical care
physician.
What is interesting about the charge that these respondents employed a procedure that
allowed the use of anesthetic drugs, antagonists and other drugs and did not possess the
“appropriate knowledge of the effects of such drugs and their interactions. . .” is that the charge
very specifically alleges a violation of standards in the administration of anesthetic drugs, yet it
is not clear whether the allegation is based solely on the alleged experimental nature of UROD,
or, perhaps alternatively, on the fact that these practitioners were not anesthesiologists. The
Complaint seems to contend, and surely at least some of the complainant’s experts allege, that
the respondents should not have been performing UROD, even if other physicians who are
anesthesiologists might properly perform it. If the issue is the experimental nature of UROD,
then, in a larger sense, it may be true that, given the lack of formal study and research in the area,
those performing the procedure, at least in its early days, were “operating” in, if not the dark,
then at least in the twilight, at least as to these questions regarding the effects and impacts of the
induction of withdrawal via administration of antagonists to anesthetized patients. However, if
the basis of the allegation is instead the fact that the respondents were not anesthesiologists, then,
despite the claims that their involvement in UROD violated standards, and while a reasonable
preference for the involvement of anesthesiologists has been shown in the record and even
though the actual participating physicians at most sites have been shown to be anesthesiologists,
the claim that their involvement deviated from established standards has not been sustained.
Again, considering the first possible reading of the charge, I am readily convinced by the
evidence that the UROD procedure does cause a significant level of physiological stress, and that
the catecholamine surge is substantial. I am also convinced that, at least to some degree, that
stress is dampened or ameliorated by the use of anesthesia. On this record, it is impossible to
conclude by a preponderance of the credible expert evidence that the administration of the
anesthetic drugs and the production of unconsciousness in these patients was itself a significant
cause or contributing factor to their deaths or morbidities. In addition, while the withdrawal
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induced in the patients as the result of the introduction of antagonists and the resultant surge of
catecholamines to physiologically significant levels may have played its part in their demise,
there appears to be little, if any, evidence that the respondents did not appreciate the effects of
the anesthetic drugs and their interactions. They knew that the purpose of the anesthesia and the
state of unconsciousness it induced was, in significant part, to reduce the stress that would
impact the patient if he or she were induced into withdrawal while awake or only slightly
sedated. On the record, they had no significant reason in the period 1995-99 to be concerned that
the administration of anesthetic drugs themselves, or the use of these drugs in combination with
antagonist drugs, was a danger to their patients. If they failed to appreciate anything it was the
impact of the induction of withdrawal by means of the introduction of antagonists and the
“critical” level of stress that the withdrawal might cause for some limited number of their
patients. The theory of UROD, that patients could better tolerate withdrawal in its earliest stages
by “experiencing” that withdrawal while anesthetized, may have been “correct.” The question is
whether, in practice, the impact of a sudden thrusting of the patient into withdrawal proved too
much for some limited number of patients to manage. This question will be addressed below.
Dr. Segal candidly testified that the anesthesia drugs did not kill any of the patients.
However, several experts for the complainant, citing studies and reports and their own
understandings, related that the level of physiological stress during the UROD process was very
significant. They pinpointed the significant increase in catecholamine release during UROD and
the possible impact that such may have on patients physiological response as of the greatest
concern to them. This testimony was countered by respondents’ witness Simon, who insisted
vigorously that the whole purpose and consequence of using anesthesia is to reduce stress. He
denied that there was anything untoward about placing persons under anesthesia prior to
inducing withdrawal: indeed, he claimed that to the extent that withdrawal was stressful, the
anesthesia would act as a counter, reducing the level of stress. In addition, he argued that the
catecholamine levels found were not all that extraordinary when compared to other activities that
also lead to an increase of significant size.
I CONCLUDE that whatever may have been the impact of the antagonists and the
catecholamine surges upon patients and however that may have impacted upon their deaths and
serious medical consequences, the administration of anesthesia drugs was not a factor in what
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killed these persons. The respondents have not been proven to have committed a violation of
standards in their administration of anesthesia.
While Dr. Kleber, himself a psychiatrist and not an anesthesiologist, claimed that the
stresses resulting in UROD were such as to require that only an anesthesiologist carry it out, Dr.
Kushins, who is an anesthesiologist, quite candidly admitted that a qualified CRNA, such as
those employed by the respondent, could legitimately provide the anesthesia services necessary
for UROD. While he believed that an anesthesiologist should supervise the CRNA, at least in
urban and suburban areas, as opposed to the lesser level of supervision that would be acceptable
in at least some rural areas, he nevertheless acknowledged that even if a non-anesthesiologist
physician did supervise the CRNA in non-rural settings, it was not per se malpractice. While Dr.
D’Ambra expressed in his letter to Gooberman’s prior counsel that he and Gooberman had
disagreed “as to the role of CRNA vs. Anesthesiologist,” he nowhere suggests that any per se
malpractice existed because Gooberman had chosen to use CRNAs rather than anesthesiologists
in his procedure.
The issue of the relationship between anesthesiologists and CRNAs, and between
anesthesiologists and non-anesthesiologist doctors, was a topic given some attention by the
defense experts. Questions of economic competition and perhaps professional jealousy evidently
are alive and well in this area, purportedly impacting all the way to the very highest levels of
activity within the Federal government. Mr. Maziarski convincingly presented the qualifications
and skills possessed by appropriately trained and certified CRNAs. The preponderance of the
credible evidence leads me to CONCLUDE that there is no violation per se in CRNAs
providing anesthesia services during a UROD procedure, and also no professional misconduct,
negligence or malpractice per se if a competent non-anesthesiologist supervises a competent
CRNA who does so. To the extent that Count Two, Paragraph 2, II. e. addresses the “nonanesthesiologist” issue, that charge is DISMISSED. However, still to be considered is the
question of whether the process itself causes such levels of stress that provision of it by these
doctors, even with competent assistance from certified CRNAs, placed their patients in danger
and therefore constituted professional misconduct.
Drs. Karan and Gevirtz described the failure to employ clonidine as a violation of the
standard of care. It is not clear exactly where in the Complaint this alleged deviation is charged,
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if at all, but it may fairly fall within the allegations of Count Two, paragraph 2. I. j. and 2. II.
j., each of which addresses, in part, alleged failure of the respondents to “provide safe and
effective procedures . . . to ensure safe and effective patient recovery . . .” and “safe and adequate
post discharge procedures . . . to ensure safe and effective patient recovery from anesthesia and
detoxification procedures.”
Dr. Simon, who utilized the drug in his UROD procedure, nevertheless would not
characterize the failure to use it as a violation, deferring to Dr. Gooberman’s expertise and
assuming that Gooberman was satisfied that other drugs could adequately address the symptoms
for which he and others used clonidine. For his part, Gooberman defended his choice to change
from his early use of clonidine in every case to the use of other drugs, at least for the most part.
It is clear enough from this record that the majority of practitioners of UROD use
clonidine to combat the effects caused by withdrawal. However, as Dr. Gooberman correctly
stated, the “standard” of practice does not necessarily require that one and only one drug be
chosen for a task if there are other drugs that will provide a similar, if perhaps not identical,
effect. While Dr. Gevirtz argued that alternatives such as benzodiazepines simply do not work
as well as clonidine, Dr. Gooberman’s credible statements about his contacts with Dr. D’Ambra
regarding the concern that clonidine carries certain risks if interacting with atropine, risks that
were acknowledged by Dr. Gevirtz, and Dr. D’Ambra’s written confirmation regarding
Massachusetts General’s discontinuance of the use of clonidine in UROD, are sufficient to
support the conclusion that Gooberman’s determination had some legitimate basis in science and
in practice. As such, without at this time considering the possibility that in the individual cases
under consideration the lack of clonidine may have played a role in the death or serious
morbidity of a specific patient, I CONCLUDE that there was no per se deviation from and
violation of the applicable standards of practice.
Count Two, Paragraph 2. I. a. alleges that the respondents deviated from the accepted
standards of addiction medicine by
The implantation of a Naltrexone pellet without knowing by
objective data the duration of action of the antagonist provided
under the circumstances and how much heroin or other opiates are
blocked on a daily basis.
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While this charge is specifically directed at the alleged lack of “objective data” regarding
duration of effect and the extent to which the amount of antagonist provided will effectively
block what amount of opiate, the concern of complainant’s experts was more broadly stated in
their testimony. They spoke of the possibility of a “burst effect” of the pellet and the possibility
that the drug might cause pulmonary edema.
Initially, both Dr. Smith and Dr. Gooberman well explained the theory behind the use of
a naltrexone pellet, the desire to find a way to overcome the problem of patient non-compliance
and provide a long-lasting block to opiates that did not require that the patient be responsible for
taking a medication on a daily or perhaps weekly basis, and also avoid some of the discomfort
involved in the deep intramuscular (i.m.) injection used by others such as Dr. Kleber. Dr. Smith,
a highly respected and qualified expert in the addiction medicine field, felt that the use of the
pellet was perhaps a most important improvement in treatment method. Indeed, as noted in
footnote 53 at page 249, the authors of the article cited therein report the apparent positive
impact of naltrexone on long-term relapse rates, and presumably, if the pellet does indeed allow
for more easily tolerated long-term dosing of naltrexone, that might have a significant impact on
the prospects for long-term abstinence for those treated with the pellet.
Of course, it is true that the pelletized means of providing the drug was innovative, was
something new that did not have a history of use upon which Dr. Gooberman could draw to
support his usage of the pellet. Additionally, given this, the use of a naltrexone pellet clearly was
not a standard in addiction medicine before he began using it. Naltrexone is an FDA-approved
drug, but it was not approved as an implant in 1995-99. This fact does not alone condemn the
user, as indeed the evidence shows that clonidine is likewise not approved for use in the manner
it is employed by the several highly expert physicians utilizing it in connection with
detoxification procedures.
Dr. Gooberman also insisted that through his own follow-up study he had observed that
the pellet lasted as long as two months in some patients, but that as with many other drugs, the
duration of action varied. Thus, contrary to the allegation, he insisted that he did have some
knowledge of the duration of action, albeit not from some outside study or other “objective”
source. He further insisted that there was no requirement in the standard of care that he
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“objectively” know such information. In fact, no source has been cited for the idea that a
physician must have such “objective” sources of support for the use of a procedure, as opposed
to other information that may support the use.
The complainant’s experts’ attack on the use of the naltrexone pellet is based largely on
the concern about “burst” and pulmonary edema. Dr. Kleber speculated about the possibility of
burst based upon some experience with the injectable form of naltrexone, however, he could not
pinpoint any evidence that that concern was actually transferable to the pellet and there is no
other evidence in the record that a “burst” effect is a real concern regarding this medium of
delivery. Presumably, unless “burst” occurs, the limited release of the encapsulated naltrexone
over a period of many days and even a few months is not what concerns Dr. Kleber in respect to
the possibility of pulmonary edema occurring. If, absent “burst,” naltrexone is in fact associated
with that condition, an idea that Dr. Simon vigorously challenged, Dr. Kleber never said so.
It is true that “objective” “outside” academic or manufacturer’s research studies and trials
on this method of providing this lawful drug to patients have not occurred. There is apparently
nothing illegal about doing what Dr. Gooberman decided to do, in a good faith effort to assist his
patients in the difficult task of avoiding opiates after completion of withdrawal. His evidence as
to the findings regarding durational effect in a sampling of his patients is unchallenged. On the
record, I cannot fault his use of the naltrexone pellet based on the lack of such “objective” data.
As for the “threat” of pulmonary edema resulting from a rapid early release of the naltrexone
from the pellet in a patient already prone to breathing difficulties and cardiac concerns, as the
findings regarding the deaths of the seven patients do not support pulmonary edema as the cause
of their deaths, and as the record does not show that condition to have been a problem in other
patients among the many, many recipients of the pellet, and in the absence of more than
speculative concern on Dr. Kleber’s part, I CONCLUDE that the respondent’s use of the pellet
in the UROD procedure did not constitute any breach of professional standards. The charge is
DISMISSED.
Count Two, paragraph 2. II. a. charges that the respondents violated the standards of
care applicable for anesthesiology because they administered “ketamine, midazolam and
propofol in a manner in which doses were not related to the patient’s weight as well as titrated to
the patient’s response to the drugs.” The evidence on this issue is not substantial and, indeed,
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little attention has been paid to it in the briefs. Dr. Kushins insisted on the need to provide the
drugs in a manner that, at least initially, took into account the differing weights of the patients.
The defense witnesses acknowledged that, at least in concept, this dosage to weight relationship
was appropriate. However, as Mr. Maziarski explained and as Drs. Bradway and Gooberman
supported, the need to account for the individual patient’s response to the drug, to use clinical
judgment to assess whether the specific patient required more of the drug for it to have the
desired effect upon the patient, was at least as important, if not ultimately the paramount clinical
concern regarding the dosage of these drugs. Dr. Kushins’ testimony also supports the need for
clinical judgment to be applied to the subject of dosing, and in the end, I cannot determine from
this record that the respondent’s practice was tainted by a deviation from the standards applicable
to anesthesiology practice regarding the determination of the amount of these induction drugs
that were delivered to their patients. Therefore, I CONCLUDE that the charge has not been
proven by a preponderance of the credible evidence and it is DISMISSED.
Count Three of the Complaint alleges that, in connection with the anesthesia records for
decedents Flowers, Kindig, M.J., Melendez, and for patients Perez and Hendrix, the respondents
failed “to prepare appropriate patient records in accordance with established standards of
anesthesia practice and as required by N.J.A.C. 13:35-6.5 (b) and N.J.A.C. 13:35-4A.7(h) (3) and
(4).” More specifically, Paragraph 2 (a) charges a failure “to state all of the anesthetic agents
administered, the amounts administered and the time of administration, and subparagraph (b)
charges that “the records of anesthesia administration prepared after June 15, 1998 failed to
contain a post-anesthesia discharge note or summary as required by N.J.A.C. 13:35-4A.7 (h).”
Finally, subparagraph (c) contends that the respondents’ “records failed to identify the opioid
antagonists Naloxone, Naltrexone or Nalmefene administered and the amounts thereof.”
In the period 1995-99, the regulations of the Board of Medical Examiners required that
(b) Licensees shall prepare contemporaneous, permanent
professional treatment records. . . . All treatment records shall
accurately reflect the treatment or services rendered. . . . To the
extent applicable, professional treatment records shall reflect:
...
Treatment ordered, including specific dosages, quantities and
strengths of medications . . .if prescribed, administered or
dispensed . . . .
[N.J.A.C. 13:35-6.5 (b).]
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In addition, N.J.A.C. 13:35-4A.7 (h) (3) and (4) provided that
Physicians who administer or supervise the administration of
monitoring of anesthesia services in an office shall ensure that a
patient record is prepared which contains the following:
...
An intra-procedure record which includes anesthetic agents
and techniques used, any changes since the inception of anesthesia
in vital signs, oxygen saturation, electrocardiogram interpretation,
temperature and end-tidal carbon dioxide measurements when
required, as well as the volume and type of fluids administered.
A post-anesthesia note entered prior to the patient’s
discharge from the office which shall include at least such postprocedure data as the patient’s vital signs and general condition,
respiration, consciousness, circulation, special problems or
precautions and a summary of fluids received during surgery or
any complication or untoward event which occurred.
It cannot be doubted that there are legitimate concerns regarding the anesthesia records
maintained by the respondents. Besides the criticism of those records presented by Dr. Kushins,
even witnesses presented by the respondents themselves acknowledged, however grudgingly,
that the records were “sloppy,” and were not in accordance with the requirements of professional
standards, either as to the frequency of recording of the vital signs or the recording of the drugs
administered, or of the time of administration or the amounts administered. Dr. Simon, while
expressing some concern that the respondents not be held to a standard of surgeons or
anesthesiologists in an operating room and indicating that the existence of written orders
regarding the drugs administered during UROD could supply important information as to drugs
utilized and dosages thereof, acknowledged that he should not be assuming anything about
matters not properly recorded. Mr. Maziarski also agreed that deviations from the standard for
recording information in an anesthesia record existed, although he completely failed to note this
in his report or to acknowledge it in his direct examination. Dr. Gooberman acknowledged that,
as he reformulated charts, he had failed to provide for and assure proper charting of the drugs
given to the patient during the procedure.
I FIND and CONCLUDE, based on the records entered in evidence in this case and the
testimony of the experts, including the important admissions made by Dr. Simon, Mr. Maziarski
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and even Dr. Gooberman, that the anesthesia records maintained by the respondents for patients
Flowers, Kindig, Melendez, Stavola, M.J., Perez and, to a lesser extent, Beigelman, were not
adequate to meet professional standards, failed to relate the full range of drugs administered to
the patients during the UROD procedure, and violated N.J.A.C. 13:35-4A.7 (h) (3). Therefore, I
CONCLUDE that the complainant has proven the violations charged in Count Three,
paragraphs (a) and (c). Further, I CONCLUDE that the respondents did not comply with the
requirements of N.J.A.C. 13:35-4A.7 (h) (4) and did not prepare required post-anesthesia
discharge notes as deemed necessary by the Board’s adoption of this regulation.
Post-Operative Issues
A primary aspect of the Complaint and a focus of so much understandably emotional
testimony is the allegation at Count Two, paragraph 2. II. h., that the respondents allowed the
“premature discharge of patients.” This claim, that patients were allowed to leave the treatment
facility before they were suitably ready for release, necessarily ties in with the several variously
worded charges contained at Count Two, paragraph 2. I. g., “the failure to adequately provide
for patient aftercare with appropriately trained health care personnel;” Count Two, paragraph
2. I. j., “the failure to provide safe and effective procedures and personnel to ensure safe and
effective patient recovery and continuation of appropriate addiction treatment; Count Two,
paragraph 2. II. g., “the failure to provide safe and adequate patient care post discharge through
adequately trained health care professionals and appropriate safeguards;” and Count Two,
paragraph 2. II. j., “the failure to provide safe and adequate post discharge procedures and
personnel to ensure safe and effective patient recovery from anesthesia and detoxification
procedures.” While not directly stated, the issues raised in these several charges implicate the
decision made by Dr. Gooberman, and also carried out by Dr. Bradway, that the routine practice
and protocol for UROD patients under their care would be for them to be discharged from the
treatment facility without either being encouraged or required to any stay overnight in any
monitored and/or supervised special location. Ultimately, while these several charges require
independent consideration apart from the concerns regarding the reasons for the deaths and
morbidities and the contributive role of UROD thereto, it is also true that the complainant
believes that the combination of premature discharge, discharge to inadequate caretakers,
inadequate safeguards and inadequate supervision and monitoring was a significant factor in, or
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fostered the conditions that led to, the demise or serious illness of patients whose cases are under
review in this hearing.
Drs. Gooberman and Bradway each testified as to the discussions they had and the
reasons why they chose to not require an overnight stay in a monitored and closely supervised
setting. They apparently concluded that the recipients of UROD could leave their facility in
much the same manner as do others who undergo outpatient treatments, including various forms
of outpatient surgery, and that this could be done safely and in a manner that allowed them to
provide UROD at considerably less cost than they would have been required to charge had they
maintained the patients overnight. I FIND Dr. Gooberman’s explanation of his motivations to be
highly credible and there is no doubt in my mind that the ability to provide UROD at a cost that
was more readily manageable for a broader spectrum of opiate addicted persons was an
important factor for Dr. Gooberman and that Dr. Bradway agreed with this goal. Given the life
experience of these physicians and their genuine understanding and empathy with this patient
population, their goal was no doubt both understandable and, at least in theory, a good thought.
Whether in practice it was a legitimate, supportable and wise choice, or instead was a foolish,
risky and, indeed, perhaps a fatal choice for some is a question that is at the core of much in
dispute here. Had the doctors chosen to require an overnight stay, the issues as to the suitability
for discharge of these patients within a matter of minutes or hours of extubation would not be
issues. However, given the choice that was actually made, the patients were not retained, and
thus whether they were actually released too shortly after extubation is a serious matter of
contention. Further, it is readily understood that the decision not to retain also may have
foreclosed the possibility that some patients’ conditions, manifested during their overnight stay,
might have alerted the doctors that they were not yet ready to be removed from the direct care
and supervision of trained professionals, even if that meant hospitalization. Indeed, as will be
detailed below, in the case of patients Stavola, Beigelman, Kindig, M.J., Flowers, Perez and
Hendrix, an overnight stay would have encompassed the time frame within which they expired
or became seriously ill, although, of course, no one can be certain that had they stayed overnight,
they would have experienced a crisis during that stay, would have been saved or, despite the best
efforts by medical professionals to save them, would have nevertheless expired. As the experts
conceded, such is pure speculation, although the fact that certainty as to outcome is impossible
does not mean the decision not to retain cannot be assessed.
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N.J.A.C. 13:35-4A-7 established regulatory standards for “physicians administering or
supervising the administration of anesthesia services in an office,” including standards for
discharge from the office. Subsection (g) provides that “physicians who administer or supervise
the administration of anesthesia services in an office shall ensure the following prior to discharge
That at least one practitioner shall remain on the premises until the
patient is discharged to home or transferred to a special overnight
stay area;
That the patient shall be given written and verbal instructions for
follow-up care and advice concerning complications;
That before the patient leaves the office or is transferred to the
special overnight stay area, the physician shall evaluate the patient
and shall review and sign the post-anesthesia record; and
That the patient shall be discharged only into the company of a
responsible individual.
The respondents contend that they never discharged any patients prematurely. However,
the testimony of caretakers to whom the mortality and morbidity patients were released
presented a set of observations and descriptions of the perceived conditions that they believed
strongly indicated that their charges were by no means ready for discharge and were, in fact, in
no condition to be released from the treatment facility into the care of non-professional
caretakers who were expected to take the patients to hotels, motels or family homes, without any
stay in a “special overnight stay area” or other area where they would be watched, monitored or
otherwise professionally supervised. While this testimony may possibly establish that patients
were discharged too quickly and might lead to a conclusion that some delay in discharge for a
period of additional minutes or hours would have sufficed to allow the patient to recover
sufficiently to meet discharge standards and be released to the care of a caretaker, it also clearly
implicates the decision that patients would not be routinely retained overnight before discharge.
In assessing the respondents’ practices, the experts for the complainant were forced to
rely in part on the anecdotal information contained in statements made by caretakers. These
persons were without question caring persons with a particular love for, interest in and concern
about the patients released to their supervision.
However, it is true that they were not
professionally trained medical personnel and were no doubt neither entirely objective about what
they observed nor professionally trained to evaluate whether discharge was appropriate. That a
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patient may not “look” well, may not appear “healthy,” may seem “unstable,” to a non-physician
is not necessarily the proper criteria to decide that discharge was premature. That said, their
insights and input regarding the patients’ apparent conditions at the time of discharge are
extremely important and, despite their lack of training, not to be denigrated. They demand that
the charged professionals demonstrate that discharge determinations were made with proper
consideration of and respect for the proper standards.
In evaluating the propriety of the discharges, experts such as Dr. Kleber took into account
not only the described inability of patients at the time of discharge to walk without being
“dragged,” to speak coherently, to keep awake and alert, to demonstrate clarity of thought. They
also considered to whom these persons were being discharged; that is, they contended that
release to the caretakers involved in these cases of patients exhibiting these kinds of behaviors
and conditions and continuing to experience withdrawal did not amount to discharge to the
“responsible person,” required by above quoted regulation.
In determining whether a person was in fact ready for discharge, Dr. Gevirtz argued that
the use of the Aldrete scoring system was “the standard.” Yet, he acknowledged that there might
be other such scales in use, and therefore it is not clear that only the Aldrete Scoring System can
be used by a responsible practitioner to determine dischargeability. Indeed, while Dr. Kushins
also relied upon the Aldrete and urged its use, both Mr. Maziarski and Ms. Capelli, who despite
not being physicians nevertheless have significant background and training, related that there are
in fact other such systems or evaluative tools for discharge determinations. On this record, I
FIND that the Aldrete System is not the only evaluative system or tool that can be used to
evaluate readiness for discharge. However, it is abundantly clear that some criteria must be used.
A practitioner must be able to examine among several important criteria and then, applying the
clinical judgment essential to the practice of good medicine, determine if the time is ripe to let
the patient depart in the care of the “responsible person,” or alternatively, to keep the patient for
some additional time. The Aldrete and similar systems provide the doctor with such criteria,
with markers to consider and assess before making this vital decision. If the practitioner does
evaluate the important characteristics and apply his/her professional judgment, then the lack of
specific utilization of any one particular “system” is not a violation of the standard of care.
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In determining the proper standards to apply regarding discharge from an out-patient
UROD procedure, it would be appropriate for a physician to consider the general criteria for
discharge from an out-patient, anesthesia-related procedure and decide, given the nature of the
procedure involved and its anticipated aftermath, whether any modifications in the standard
criteria were appropriate. That is, there might be something about the particular procedure, the
persons receiving it, or what they were going to experience after leaving the facility that might
suggest that the normal concerns and criteria be modified, perhaps with the deletion or
adjustment of some criteria, or even with the addition of some criteria. In the case of UROD, the
known and expected result of UROD was to place the recipient into withdrawal. Even in the
beginning of the Gooberman UROD practice, and certainly as time went on, it was known that
withdrawal and its symptoms did not entirely cease upon extubation or even at the time of
discharge, but continued on for some period, measured in many hours and some days. Unlike
some outpatient, office-based procedures in which anesthesia is utilized, this particular procedure
started up a significant systemic response that was ongoing. While some such procedures do
carry with them some ongoing bodily responses and effects after discharge, it seems safe to
assume that ongoing withdrawal from opiates carried with it more of a likelihood of “significant”
post-discharge events than many other procedures. Thus, a practitioner contemplating discharge
after UROD had to take into account these potentials.
The respondents testified that, despite not computing scores with Aldrete or a similar
scoring system, they nevertheless utilized appropriate criteria and that, while the appearance of
post-UROD opiate addicted persons may well have been discomforting to their caretakers,
nevertheless, even in the case of Ms. Flower’s discharge fifteen minutes after extubation, each
patient met the reasonable and appropriate discharge criteria utilized by the clinic. Walking 300
feet with or without assistance, being able to communicate even if reluctant to do so, sufficiently
oxygenated and with stable vital signs, these were the primary criteria used by Gooberman.
Based upon the testimony and the expert opinion’s, I FIND that the respondents and
those they supervised did have an adequate understanding of the proper criteria for determining
whether to discharge their patients. They knew that the ability to communicate, to ambulate,
even if with assistance, to maintain stable signs and the absence of significant vomiting or
nausea, were key elements. Thus, I FIND that they had in place, albeit not in written form, the
appropriate knowledge necessary for them to properly assess their patients’ suitability for
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discharge. Whether they did so for the individuals specifically at issue herein and, importantly,
whether they should have even been assessing these, or any, patients for discharge so relatively
soon after extubation, as opposed to doing so only after an overnight stay, are still questions to
be determined.
The resolution of issues concerning the propriety of the decisions to discharge these
patients and of the decision made concerning any requirement for overnight retention are in
many ways related to the question of why these patients died and of whether the doctors’
procedures were directly or indirectly either the cause or a significant contributing factor in the
deaths. Therefore, it is necessary to determine, to the extent that this record and the state of the
scientific and lay evidence permits, the reason for the deaths and the apparent relationship, if
any, of the fact that these patients were not retained, but were instead discharged at varying
intervals following extubation.
Count I, paragraph 13 of the Fourth Amended Complaint presents the overarching
contention that each of the seven deaths was causally connected to UROD as practiced by these
doctors, claiming that, “[E]ach of the . . . . deaths was either directly or indirectly caused by the
UROD/ROD procedure . . .
and/or respondents’ aftercare and treatment or the lack or
inadequacy thereof.” Paragraph 16 then claims that the respondents’ conduct in “providing a
dangerous medical procedure and the improper and inadequate follow-up medical care incidental
thereto” constituted the gross and repeated malpractice, negligence and incompetence that must
be proven in order to sustain disciplinary action. Thus, in order to sustain discipline on this
charge, the complainant must have met its burden of proving a causal connection between
something either done by the respondent(s) or not done and the fact of the death, and also must
prove that some action or inaction on the part of the respondent(s) was negligent.
If the
respondents provided a safe procedure and performed it in accordance with the appropriate
standards of conduct, no negligence occurred and no fault lies. If negligence is proven, then and
only then must the determination be made as to whether the level and quality of the negligent
act(s) and incompetent practice is sufficient to permit the Board to exercise its statutory authority
and sanction the physicians.
To determine whether the complainant has proven the causal connection between UROD
and the respondents’ practice thereof and the deaths of these patients, it is necessary to first
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determine what medical condition, illness or disease caused them to die. In order to resolve
these most serious charges, it is necessary to both determine the actual physical mechanism of
death, that is, did they die because they suffered an arrhythmia, an infection, did they choke to
death or die of an overdose of a toxic drug, etc., and then to determine if anything about either
the actions or inactions of the respondents was either directly or indirectly responsible for the
development and existence of that condition or illness that caused the death(s). If the causal
linkage has not been proven for any of the decedents, then at least as to the claim that the
respondents were responsible for the deaths, the complainant’s case will fail.
There are certain findings and conclusions regarding the circumstances of the deaths of
the seven decedents that are clear and undisputed. The facts demonstrate that none of these
persons died “on the table,” that is, none expired during the period from initial exposure to
anesthesia and intubation through extubation. Additionally, none died for at least six and onehalf hours after being discharged from the Gooberman facility. Each of the decedents had
undergone UROD, thus each was, without question, placed into withdrawal from opiates, an
outcome which both they and the physician administering UROD anticipated and which was the
very purpose of the procedure.
Further, after their discharge, whether or not it occurred
prematurely, they continued to experience withdrawal for some time. Given the timing of their
demise after discharge, which ranged up to seventy-one and one-half hours, it is clear that each
was still undergoing at least some aspects of withdrawal, or at least the consequences of having
been in withdrawal, when they expired. As the intended goal of the UROD procedure was to
induce withdrawal, to that extent it must be said that the procedure worked as expected by both
physicians and patients.
The primary investigator involved in the initial stages of consideration as to the reasons
for the demise of a group of patients of Drs. Gooberman and Bradway who had undergone
UROD was Dr. Segal. While he professed that after he first became involved in the Kindig
matter he found the death “mysterious” and could not understand why the gentlemen had died
and even turned to Dr. Karan for assistance and support in his quest to understand the cause,
eventually Segal settled on a theory of causality that directly targeted UROD as a substantial
causal factor. He summed up his theory thusly: the decedents who came to the Gooberman
facility were, despite their addictions, in “normal health.”
After undergoing UROD, they
emerged as “no longer normal healthy persons,” but instead as persons who were wiped out, who
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did not get better and who eventually died. He perceived no other intervening cause(s) that
might explain the deaths. In view of the described pattern of events, he could not conclude
anything other than that the deaths were clearly contributed to by the UROD procedure.
If, as several of the experts posited, the deaths of most, or even all, of the patients
resulted from the stresses and strains of the withdrawal process impacting upon persons who,
despite Dr. Segal’s assessment that they were “normal healthy persons,” were, in fact, not nearly
as “healthy” as he suggested, but were instead persons whose cardiac systems were compromised
in one or another way, then, as Segal concluded, it is indeed true that the UROD process, as the
means by which they were placed into withdrawal, did, without any doubt, play a role in their
demise. A causal connection, a linkage of cause and effect, may be said to exist if by placing a
patient through UROD, the physician caused that patient to enter withdrawal and the stresses and
strains inherent in that withdrawal led to the patient experiencing a physiological effect that
caused the patient to die. In other words, in the time and place in which these decedents died the
likelihood is substantial that they would not have died at that very time, but for the fact that they
underwent UROD and thereby entered into withdrawal with its accompanying stresses. This
said, it is also within the realm of reasonable possibility that, had they somehow entered into
withdrawal at that very time by means other than UROD, they might very well have succumbed.
However, by itself, this causal link is not necessarily pejorative, either to UROD as a mode of
treatment or to the respondents as practitioners thereof. All of the more than 2,300 persons who
underwent UROD were similarly placed into withdrawal and all but seven survived the process
and, with some limited exceptions, did so without any significant medical complications. The
question then is: did the persons who died do so because they could not survive the stresses of
withdrawal under any circumstances, or instead, did something peculiarly involved in the UROD
process as practiced by the respondent physicians, whether it be the inducing and/or anesthesia
drugs used therein or the swiftness or impact of rapid withdrawal, cause these persons to
experience a withdrawal that involved a level of stress that proved fatal to them? Additionally,
or perhaps alternatively, did some aspect of the arrangements for aftercare place these persons,
some of whom were perhaps particularly vulnerable to the stresses of withdrawal due to
conditions not readily or reasonably ascertainable pre-procedure, in circumstances that were
inadequately geared to protect them during the early stages of their continuing post-extubation
withdrawal?
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After considering all of the evidence, I FIND that it is apparent that G. W. died from
aspirative pneumonia, a known hazard for heroin addicts and a known risk of UROD that was
included in the warnings that were a part of the consent process. This conclusion is in accord
with the view of the medical examiner, and of those expert witnesses who presented a conclusion
as to his cause of death.
Interestingly, other than Dr. Segal’s general assessment, outlined above, and Dr. Karan’s
general identification of the temporal relationship as “very important,” the complainant’s
witnesses largely refrained from any specific identification of W’s cause of death or, a
conclusion that the provider’s conduct caused or contributed to the death. Importantly, Dr.
Kushins, while suggesting that a lack of proper post-procedure care could have played a role,
nevertheless acknowledged quite candidly that he could not say to a reasonable degree of
medical certainty that the death of G.W. was caused by or contributed to by UROD.
In assessing this question, the most difficult question is whether Dr. Gooberman should
have been alerted to the onset of pneumonia. Mr. W. died sixty-eight and one-half hours after
discharge. Dr. Cooper noted that aspirative pneumonia is usually detectable by a physician
within a few hours of its onset. The evidence is that Dr. Gooberman visited W. at the motel on
several occasions before he and Ms. B. returned home. On these visits Gooberman, and also
apparently Dr. Brewer, examined W.’s lungs and, according to Gooberman, they were clear. He
claimed that he was specifically concerned about the possibility of aspirative pneumonia.
If, as Dr. Gooberman stated, he and his experienced British colleague did not detect
either rales or other signs of pneumonia, then it is very possible that it had not yet begun at the
time of these visits. Gooberman last saw W. thirty-six hours before his death. According to Dr.
Cooper, aspirative pneumonia can start as little as twelve hours after aspiration and then cause
death within twenty-four to thirty-six hours. It is therefore quite possible that at the time of this
last visit, the aspiration that led to the pneumonia had not yet occurred, or, quite possibly, the
event had occurred so close in time to the last visit that Gooberman could not yet have detected
it.
In my opinion, it is not likely that Gooberman simply missed the signs of concern. It is
also quite likely, indeed far more likely than not, that during the earlier visits there was nothing
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suspicious or indicative of aspiration pneumonia for he and Dr. Brewer to detect. Given the
length of time before W. died, the chances that he aspirated during the UROD, or at least that
any aspiration that may have occurred at that time resulted in the pneumonia is, at best,
extremely slim. It is also very doubtful that the onset of aspirative pneumonia would have been
detected had he been retained overnight in an ICU setting. In his case, he was examined several
times after discharge by physicians, and in the absence of any significant evidence that they were
negligent in their exams, the difference in outcome had he been retained as opposed to his being
examined at the motel cannot be identified. Vomiting was not an unforeseen prospect and, in
fact, the danger of aspiration pneumonia was identified in the consent form. If the aspirative
event occurred after W. left the motel, it is certainly possible that the onset of pneumonia might
have been detected by a physician or nurse at a hospital, but as Ms. B. candidly admitted, her
partner chose to reject her advice and refused to be taken to a hospital. Perhaps that choice
blocked identification in time of the start of a deadly process, but that question cannot be
answered.
I CONCLUDE that, while W. died because he aspirated vomitus and developed
pneumonia, there is no evidence to support a conclusion that either the UROD procedure or the
actions, or lack of action, by Dr. Gooberman, substantially caused or contributed to the death of
Mr. W. The complainant has failed to produce sufficient evidence to support such a close
connection, other than, as noted, the evident fact that UROD purposely induced withdrawal and,
as understood and disclosed, vomiting was a possible result of withdrawal. The connection
between the induction of withdrawal initiated through UROD, the vomiting and aspiration and
the pneumonia, ultimately leading to death, while a connection in fact, is not a connection that
supports a claim of negligence and of professional and legal responsibility. Further, based upon
the evaluation of evidence regarding the causes of death of the patient and the issue of overnight
retention, I CONCLUDE that the lack of overnight retention did not cause or contribute to the
death of Mr. G.W.
The medical examiner ultimately concluded that Frank Stavola died of “pulmonary and
cerebral edema due to drug use” listing several drugs, including morphine, cocaine, fentanyl and
nordiazepam. Aside from repeating his general comments regarding his assessment of the
relationship of UROD to the deaths of the several decedents, Dr. Segal agreed that Frank
Stavola’s death might be deemed “sudden.” He acknowledged that the benzoylecgonine found
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in the toxicologic screen could cause an arrhythmia by itself. He agreed that Stavola did not die
as the result of the UROD procedure itself or from the anesthesia. Instead, he attributes the death
to the combined effects of withdrawal, stress and the drugs found in his system.
While several experts (Kushins, Segal) questioned the use of fentanyl in Gooberman’s
version of UROD and posited that it could have been a contributor to the deaths of some patients,
I FIND that the necessary evidence to support a conclusion to that effect is clearly lacking. The
other experts called by the Attorney General were not able to identify specific evidence to tie Mr.
Stavola’s death to UROD. Neither Dr. Karan, who only referred to the temporal tie, Dr. Lin, Dr.
Kleber or Dr. Gevirtz had any specific information to offer regarding Stavola’s death. Dr.
Kushins’ opinion concurs with the arrhythmia theory, although he could not be sure if there was
an underlying cardiac disturbance. Dr. Cooper noted that the heart of a cocaine abuser was more
susceptible to arrhythmias; indeed, he saw it as the “mechanism of death” in the death of cocaine
users.
In addition, he too understood that the increased catecholamines resulting from
withdrawal here acted upon a damaged heart, one that was already susceptible to arrhythmias.
Even Dr. Haider, while finding no evidence in Stavola of pre-existing cardiac abnormalities and
classifying the death as “procedure related,” agreed that one could reasonably postulate that a
catecholamine surge was involved.
I FIND that the most medically reasonable conclusion as to the cause of Frank Stavola’s
death is that he succumbed to the effects of a cardiac dysrhythmia.
The cause of this
dysrhythmia was most likely the stress of withdrawal, however, based on the available evidence,
I FIND that at some point not very removed from his UROD, Stavola took cocaine. It is also
possible that the cocaine caused or contributed substantially to the occurrence of the arrhythmia.
Dr. Haider pointed out that if a patient suffers an arrhythmia in a hospital setting, that
condition can be immediately addressed, although that does not guarantee a successful outcome.
To the extent that a patient was retained overnight and the arrhythmia struck during that time,
overnight retention might result in the patient surviving. Stavola died six hours and thirty-seven
minutes after discharge. In his case, it cannot be denied that overnight retention might have led
to a different result for him.
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It must be added that overnight retention might also serve to prevent or at least
substantially reduce the likelihood of a patient taking cocaine or another drug in contravention of
the warning against such post-UROD usage. While the preventative or retardant effect of an
overnight stay would not have any impact once the patient was discharged the next day,
nevertheless, in the first critical hours following extubation, while the impact of the induced
opiate withdrawal continued to impact upon the patient, retention may serve a prophylactic
purpose.
Aside from those considerations, given that the death post-discharge of Frank Stavola
was the result of an arrhythmia, the question remains whether some aspect of UROD either
caused or enhanced the surge of catecholamines, such that the procedure exposed patients to
greater risk of arrhythmia, and if it did, whether that fact properly results in a conclusion that the
respondents’ actions are legally chargeable. Indeed, as with the next decedent, Mr. Beigelman,
whom Haider classified with Stavola (and M.J.) in Group A, (those whom he determined did not
have structural or functional cardiac abnormalities), it is this very point that is at the heart of
Haider’s identification of UROD as the causal or contributing factor in their deaths.
Mark Beigelman died nine hours and forty minutes after discharge; again well within the
time parameter for overnight retention. Dr. Ragasa concluded that he died from the effects of
multiple drug intake, post detoxification. His heart weighed 400 grams, which both Ragasa and
Dr. Segal classified as “enlarged,” although evidence from other experts placed a heart of this
size at the upper reaches of normalcy. In addition, the experts disputed whether he actually had
biventricular dilatation. Complainant’s expert Segal and defense experts Cooper and Simon
asserted that he did; complainant’s cardiologist Haider disputed this conclusion, arguing that the
data necessary to support the conclusion was lacking. Dr. Katz, the respondent’s cardiac expert,
was unsure, by his own description “waffling” on the issue.
The consensus of the experts suggests that this decedent had a heart that was on the
borderline of both “heaviness” and dilatation. It was a heart in the body of a heroin and cocaine
abuser (cocaine metabolites were present at autopsy, indicating recent use, whether before or
after UROD). Once again, UROD induced withdrawal and the concomitant hormonal surges.
These impacted upon this drug user’s “borderline” heart. The possibility, indeed, given the
stresses of withdrawal, the likelihood of arrhythmia as the cause of death is significant. Based on
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the preponderance of the credible evidence I FIND that Beigelman died due to an arrhythmia. It
is unclear whether post-UROD cocaine use was a factor.
Mr. Beigelman was taken to a motel after his discharge.
He eventually vomited
something described by his mother as a “very dark” substance. Whether the appearance of this
substance was indicative of something more than the usually expected vomit is not clear.
However, it is clear that from the time of his discharge until the time he died at the motel, no
professional medical person saw Beigelman. If he had been retained for an overnight stay, a
professionally trained person could have assessed his condition, and, if the nature of the vomitus
was such as to require any intervention, to have accomplished the same or to have arranged
transfer to a hospital. Without retention, this was not possible, or, at least, it would have required
that a professional visit the motel to assess the patient’s condition. Such a visit did not occur
here.
M.J. died sometime before 8:30 a.m. on April 17, 1998, at most eighteen hours after his
discharge. Again, his heart weighed 400 grams, at least on the high end of normalcy, if not
somewhat beyond that upper limit. I FIND that the most reasonable cause of death would
appear to be an arrhythmia, although what brought that event about is a matter of some
conjecture. Dr. Haider posits that the combination of anesthesia drugs and those used to induce
withdrawal causes a depression in both pulmonary and cardiac function that could lead to an
arrhythmia. Dr. Cooper takes note of the respiratory distress suffered by this patient, which he
identifies as an “unexpected event.” Mr. J. had a stroke in 1996. Dr. Katz argues that there is
some evidence that the heart was damaged, either by hypertension or drug use. He agrees with
Haider that M.J. did not suffer from hypertensive cardiomegaly, as Dr. Cooper believed, but
disagrees about the alleged impact of the induction drugs as creating a dangerous risk of
cardiopulmonary depression.
The credible evidence is that after Mr. J. arrived at home at about 3:30, he vomited at
about 4 p.m. and then, after being medicated with clonidine, he started to experience projectile
vomiting. He then received sandostatin injections. All of this occurred without the patient being
seen, monitored or assessed by a medical professional. When Dr. Bradway called at 10:15 p.m.
and heard what was occurring he replied that all was “under control.” An attempt to medicate
orally as per his direction in that phone call resulted in immediate vomiting. When J. shortly
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thereafter appeared to be in difficulty, a call placed to Bradway was at first unsuccessful in
reaching him. He did respond to a second call, but death occurred shortly thereafter.
It is obvious that had Mr. J. been retained overnight, he would have been seen by a
medically trained professional and, if deemed appropriate, measures could have perhaps been
taken of a different, or possibly of a more effective, manner than did in fact occur. That J. would
have survived is conjecture, but the chances of survival might well have increased.
The
arrhythmia that ultimately killed him might have been detected and managed.
Once again, in Lester Kindig’s case, I FIND that the evidence points most directly at an
arrhythmia as the cause of death. In Kindig’s case, the experts agree that his 460-gram heart was
well beyond the range of normalcy, and even Dr. Haider agrees that this was a diseased heart in a
person with a history of hypertension.
While he thinks that Dr. Cooper’s theory of the
dysrhythmia resulting from hypertensive cardiomegaly is speculative and again posits his own
cardiopulmonary depressant concept, the outcome of whatever process occurred caused an
arrhythmia that resulted in the patient’s death.
Kindig died some eight hours and seventeen minutes after discharge, which was itself just
over two hours after extubation. He too thus died within the period of overnight retention, had it
been in place. While nothing happened at the motel after he arrived there that leaps out as a sign
that retention would have afforded immediate attention or assessment to a manifest problem,
nevertheless, once again, the arrhythmia might have been detected by monitoring and might have
been managed successfully.
Assigning an exact cause for the death of Victor Melendez is difficult. By any definition,
he was not a healthy person, a fact that in itself reflects upon Dr. Segal’s “general theory.” His
heart was diseased, he had liver disease, and he had a history of hypertension. I FIND that the
stress of withdrawal was, without question, a major factor in his demise. Dr. Haider cited the
“surge” factor, as well as the possibility of hypoxemia; Dr. Simon also believes that he could not
stand the stresses. In addition, as Drs. Segal and Cooper generally agree, there is ample evidence
and reasonable medical certainty that the esophageal tearing and mediastinitis was at least an
additional, if not the primary, factor in the death. Added to all of this is the possibility that he
either took or was given methadone, although whether he did so before or after the procedure
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and whether he received it at the hospital is a subject of dispute. When all is considered, I FIND
that the preponderance of the credible evidence is that arrhythmia was a strong prospect for one
with this patient’s problems and that it, as well as mediastinitis, certainly played a very important
role in killing Mr. Melendez.
Mr. Melendez did not die until seventy-one hours and thirty minutes after discharge, and
about seventy-three hours and thirty minutes following extubation. Certainly, had he been
retained overnight and his course had not been different, he would not have died while being
retained and monitored or observed. However, while it is therefore much more difficult to say
that the failure to retain him lessened his chances of survival or contributed to his death, it must
be noted that when the Melendez family was at the motel the first night, he vomited regularly
and eventually appeared to throw up blood. Mike Bortnicker came to the scene that evening and
said that all was okay. It is a fact that Bortnicker, while having received some training from the
doctors, was nevertheless not a trained physician or nurse. It is at least possible that the nature of
Melendez’s symptoms during that first night would have alerted someone with medical training
monitoring him in retention that his distress was not what was considered “normal,” although, of
course, this is not certain.
The cause of Lisa Flowers’ demise, some eighteen hours and twenty-three minutes after
discharge and eighteen hours, twenty-eight minutes after extubation, is not disputed. Based upon
the clear evidence, I FIND that she suffered an acute myocardial infarction.
Dr. Cooper
concluded that the infarction was the result of acute opiate withdrawal, yet it was not caused or
contributed to by UROD. In essence, he concluded that, having been placed into withdrawal via
UROD, her system, with a heart that was at least a bit large and showed some abnormal signs,
could not stand up to the demands of withdrawal, which included some expected withdrawal
related stresses. Indeed, Dr. Haider largely agreed with Dr. Cooper’s assessment, and added that
an infarction might well have occurred regardless of whether Flowers underwent UROD,
although not necessarily at the time when it actually occurred. Whatever its exact cause, Ms.
Flowers’ infarction occurred early enough in the morning. Had she been retained, she would
presumably still have been at the retention site when she suffered the attack. Again, she might
have been saved, or she might have succumbed anyway.
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It is apparent from the above that the possibility exists that, had the respondents retained
their UROD patients overnight, five of the seven who died during the likely period of retention
might have been saved, or at least might have had a better chance of survival. However, while
this prospect may well result in a natural feeling of discomfort, concerning the respondents’
decision regarding the issue of retention versus non-retention of patients, it is still necessary to
determine if a requirement for overnight retention of patients actually constituted an accepted
standard in UROD practice in the years 1995-99, or for that matter, whether there was in those
years any standard regarding this issue with which the respondents had to comply in order to
conduct their practice safely and ethically. In examining this issue, it must be remembered that
while a very small number of non-retained patients died after receiving UROD, well over 2,300
recipients, or about 99.7% of those treated, did not55. Thus, despite the pressing concern as to
the fate of the five, it is nevertheless true that the vast majority of the non-retained patients were,
at least as far as this record reveals, not harmed by their discharge-without-retention, and there is
also really no way to determine whether, despite their non-retention, many of them were placed
in any actual danger.
The evidence indicates that while the respondents made a decision not to retain their
patients overnight, within the still quite limited community of UROD providers active during the
years 1995-99, the choice generally, if not unanimously, was to provide for some form of
overnight patient retention. Dr. Gevirtz retained patients as a standard procedure. Dr. Simon,
while quite deferential to Dr. Gooberman’s vast experience in UROD, acknowledged that when
he was providing UROD in his practice, he too made overnight accommodations available. His
patients were “strongly encouraged” to remain overnight in these facilities, where, while they
were not always “medically” monitored, they were nevertheless monitored by volunteer EMTs
and had their blood pressure checked. Significantly, they also were seen by a professional the
next morning before they were discharged. While Simon tried to present this process as, in part,
a marketing tool, and suggested that it was influenced by the pending disciplinary proceedings
against Dr. Gooberman, and while Simon also presented himself as acting conservatively,
nevertheless, the fact remains that his choice was to retain. As he put it, while the statement is
only based upon a “general assumption,” nevertheless, in medicine the belief is “the more care
the better.”
55
If the death rate is calculated based upon the idea that only these five patients out of 2,350 died when not retained overnight (as retention is
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The issue of overnight retention cannot be entirely separated from the costs associated
with such retention, the need for beds, support staff, and the like. The cost of health care, and in
particular of providing this perhaps promising detoxification procedure to the greatest number of
addicts at the lowest reasonable cost, was a significant factor in the thinking of the respondents.
Additionally, it was a key consideration mentioned by Dr. Simon and by Dr. Smith, who detailed
the controversy attending ASAM’s decision as to whether to include a requirement for overnight
retention in its 1999 Policy Statement. As Smith saw it, ASAM eventually decided that it
wanted to make it clear that ultimately the physician must remain in control of the treatment plan
for individual patients. ASAM’s Policy Statement ultimately provided that a patient who had
been anesthetized had to be provided with a “sufficient period of medical monitoring of their
clinical status by the medical detoxification treatment team immediately subsequent to the
procedure, in order to address clinical issues of craving, acute relapse risk, and accompanying
agitation.” It thus made no specific recommendation as to the need for any overnight stay, and at
the same time, acknowledged the dynamic and evolutionary stage in which the procedure stood,
which presumably might mean that experience would demonstrate the degree to which such
post-procedure monitoring might, or might not, need to be extended to an overnight stay.
I CONCLUDE that the evidence supports a finding that during the period 1995-99
overnight retention was certainly the manner of practice in the field of UROD. While the record
may not be sufficiently complete to assure that the only practitioners of UROD who did not
provide for such retention were these two respondents, as far as is revealed here, they do appear
to be, if not the only ones, then at least just about the sole providers so practicing at that time. If
the standard of professionalism to which these practitioners are held is then that which was
practiced and accepted as the norm by the average practitioners in the field, then it may be said
that the standard of care was to provide overnight retention. However, it must be remembered
that during 1995-99 this was a rather new procedure, with a very limited number of practitioners,
and the years in question may well be considered as a formative period during which the means
and methods of practice in this area were developing and evolving. Simply because most
practiced in a certain manner does not mean that every variation from that method was a
violation of a standard of care such that the alteration, adjustment, or difference in approach
constituted a chargeable violation of professional standards. Instead, a different, perhaps an
innovative manner or method, may also be medically and, perhaps more to the point, legally
unlikely to have been a meaningful factor in regards to the other two decedents), the survival rate increases slightly to 99.8%.
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acceptable, as even the medical/legal concept of the standard of care contemplates that not
everyone must necessarily practice the exact same way, following each and every step in a rigid,
lockstep pattern. Schueler v. Strelinger, supra, at 344.345. The question then is, whether the
evidence supports a conclusion that a variation from what most practitioners do is still within the
realm of acceptable practice, or, to the contrary, whether, the record supports a determination
that the undue level of risk and possible harm that the different approach subjects patients to is so
outside the reasonable range of acceptability that the different approach constitutes not only a
deviation from, but also a violation of, the acceptable standard of care to which a practitioner is
rightly held.
In considering whether the respondents’ approach to the issue of overnight retention
constituted an allowable difference from the accepted practices of others, it is not inappropriate
to state that, at least in the early stages of Gooberman’s UROD practice, the very “newness” of
UROD itself and even more so the manner in which the respondents performed the procedure
called for the utmost caution in their decisions as to how to proceed. Thus, in making a choice as
to whether to retain or not to retain at the onset of his UROD practice, Dr. Gooberman might
well have been wiser to retain patients and evaluate the effects of the procedure within the first
day, and then, if after analyzing the course of a reasonable number of patients he was satisfied
that their progress was predictable and safe and could be well-managed by non-professional
caretakers, to have then dispensed with any general requirement for retention. This would have
then allowed him to achieve the goal of providing the procedure at lower cost, while at the same
time assuring that the choice of non-retention was a safe one. This said, on the whole, looking at
the matter after nearly 2,350 procedures have occurred, it is difficult to conclude that the general
decision not to retain patients overnight after UROD was a professionally unacceptable decision
that violated the standard of care of good medicine, even though it did differ from the practices
of other UROD providers. This general statement does not mean that there was not always a
requirement that the doctors carefully evaluate the condition of each individual both immediately
after extubation and then during the post-extubation period at the clinic, most importantly, at the
time when a decision as to whether to allow the patient to leave the clinic was made. Thus, if a
patient exhibited sufficient characteristics to indicate the existence of a medically unacceptable
risk in releasing that patient to a non-medically qualified caregiver, the responsibility of the
respondents was surely to either retain that patient overnight, or, having made no provision for
such overnight stays and the needed monitoring at their clinic, to have assured that the patient
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was hospitalized.
With that all-important caveat, in general the experience of the
Gooberman/Bradway team was that patients who were not retained did not suffer any significant
post-discharge problems that suggest that their retention overnight would have had any
appreciable impact on their progress. Of course, for at least the five identified above, it may be
that an overnight stay would have proven life-saving, although of that we can never really be
certain and such a conclusion is at best conjecture. However, it must also be acknowledged that
an overnight stay would not likely have meant anything for the other two decedents, unless
perhaps they had been retained a second night.
I FIND on this record that the complainant has not established by a preponderance of the
credible evidence that the inclusion of an overnight stay in a professionally supervised and/or
monitored setting was a mandatory element of the acceptable professional practice of UROD
during the years 1995-99, and that these respondents violated the acceptable standards of practice
and of care by not requiring such. In a field as new as UROD was, in a time of evolution when
the parameters of acceptable practice were not clearly established, practitioners had to have some
freedom to choose between possible courses of action.
Here, starting out in a procedure
acknowledged by even now critical experts to have then been seen as involving the provision of
a rather benign process, and then having gathered a set of experiences that were the largest
amongst those practicing the procedure, the respondents had little evidence to support a need to
change what they were doing. Two of the first three deaths appeared to be either caused or
significantly influenced by non-compliance with instructions against post-UROD cocaine use.
During these early years of Gooberman’s, and later also Bradway’s UROD practice, the vast,
overwhelming number of non-retained patients did not succumb, or, as this record has it, need
hospitalization for actual problems related to withdrawal or, even more directly, to the UROD
procedure itself. The deaths of several persons were, as the record shows, “mysterious,” and yet
could be seen as coming within a range of expected deaths of opiate abusers.
Based upon these considerations and the totality of the evidence, I CONCLUDE that,
while certainly the more cautious thing to do would have been to retain patients overnight, as Dr.
Simon did, the complainant has not proven by a preponderance of the credible evidence that the
respondents engaged in malpractice, negligence or misconduct and certainly not in gross
malpractice, misconduct or negligence in the overall decision not to retain patients overnight. To
the extent that the several charges in the Complaint attack the respondents’ conduct regarding the
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provision of post-discharge care, and to the extent that the lack of retention was seen as an
element in their purported sanctionable conduct, that aspect of the charges is DISMISSED.
Since the respondents were not professionally negligent in not retaining the cohort of
patients overnight, the issue then devolves to whether they did prematurely discharge any of the
several patients who died or had serious post-discharge events requiring hospitalization. To the
extent that it is known from this record, it appears that the decedents were discharged between
approximately fifteen minutes and at most about three hours after extubation occurred. While
the testimony of the caretakers paints a picture of unresponsive, somnolent, weak, sick, nauseous
persons thrust out of the respondents’ facility, and while I do not for the moment doubt the
genuineness of their characterizations, given the nature of the withdrawal experience, the
emergence from anesthesia, the generally weakened condition that a person having spent hours
in an anesthetized condition would likely be in and the nature of the patients themselves, I cannot
conclude on this record that the respondents inappropriately allowed them to depart the facility.
They did not act either carelessly, negligently, without consideration for the condition of their
patients or without some sense of a professional and moral commitment to them. I have no
doubt that, as the caretakers said, their charges were often not very responsive to communication,
as they no doubt felt quite unwell and were naturally very tired, but at the same time I do not
believe that they were incapable of communication when the need truly arose. It was no doubt
quite disheartening and difficult for the caretakers to see their loved ones and friends in such a
state. However, while the testimonies do evoke both considerable and quite understandable
sympathy, on the record as a whole, and given the findings made above that the respondents well
understood the appropriate discharge criteria even though they did not use the Aldrete scoring
system, I CONCLUDE that they did not prematurely discharge these patients. The charge is
DISMISSED.
Count Two, paragraph 2. I. b. claims the existence of a deviation from standards
because of an alleged “failure to affirmatively arrange for post-detoxification counseling as an
essential component of rehabilitation.” The evidence in support of this charge is not convincing.
While it is certainly clear that UROD is, by itself, in no sense a sufficient step to provide an
addict with the necessary support and assistance to achieve rehabilitation, nevertheless, I FIND
from the evidence spread on this record that Drs. Gooberman and Bradway have taken
reasonable steps to try to assist and encourage their UROD patients to attend twelve-step
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programs after they complete withdrawal. As noted, it is not possible for them to assure that
their patients will continue in such efforts and in such programs, but several of the witnesses who
had some knowledge of the respondents and their program were quite confident that the
respondents did in fact seek to encourage such participation. While Dr. Smith expressed his
reservations as to the efficacy of the transition from UROD and naltrexone to psychosocial
methods of supporting rehabilitation, the issue here is not the ultimate success of the
rehabilitation efforts but, instead, the efforts of the respondents to at least reasonably encourage
and facilitate the entry into rehabilitation. I am satisfied that they have made a good faith
attempt to do so. I CONCLUDE that the complainant has failed to prove this charge by a
preponderance of the credible evidence and it is therefore DISMISSED.
Count Two, paragraph 2. I. h. and 2. II. i charge that the doctors breached standards of
care in regard to the aftercare, post-procedure protocol that provided a listing of medications for
nurses to prescribe based upon symptomatology described by patients and/or caretakers. Dr.
Kleber cited this as a problem without identifying any source for his conclusion other than his
own assessment. Competent witnesses for the respondents explained that contrary to Kleber’s
view, there was no violation of standards. The determination as to which of several medications
should be prescribed in a given circumstance was made by trained, certified medical personnel
acting based not only on the described symptoms, but also upon in-service training and their own
professional training and standards. The evidence does not suggest that the doctors were not
available for consultation where the trained professional was uncertain about which medication
to order. To the extent that the complainant claims that there was a violation of standards here,
the proof of such is far short of that necessary to establish the deviation. Therefore, these
charges of professional misconduct are DISMISSED.
SUMMARY
This case has presented a number of difficult issues that require consideration of the
proper role and limits of innovation and the weighing of risks and benefits of a potentially
beneficial procedure.
Two physicians whose prior life experiences have included serious
difficulties with addiction have sought to apply their understandings of this terrible affliction and
of emerging treatment possibilities to the treatment of others who need help. In doing so, Drs.
Gooberman and Bradway have in some instances pushed the envelope. Dr. Gooberman, as the
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physician who initiated the UROD practice and taught it to Bradway, and as the overall operator
of the treatment facility, no doubt bears the primary responsibility for the practice. However, Dr.
Bradway is, of course, responsible for the professional decisions he made and actions he took, or
failed to take.
I agree with Judge Lefelt’s thought, expressed in Murray v. State Health Benefits
Commission, supra, that litigation is indeed a “poor vehicle” for determining whether alternative,
innovative, non-traditional forms of medical treatment are medically sound. The litigation forum
is perhaps better suited to the more traditional determination of whether practitioners have
violated existing, well-understood and accepted standards of care then to a resolution of whether
a controversial new form of treatment is medically acceptable.
In medicine, evolving
understandings of the workings of medicines, physiology and other aspects of science will often
alter the perceptions and even the well-accepted understandings of what works, what does not
work, what helps and what harms. What is acceptable practice today may be found to be
unacceptable next week, next year.
Indeed, as this decision has been in preparation, new
information has emerged on such issues as replacement hormone therapy that may shake the
practice of medicine in regard to issues of women’s health. This is but one example of how
evolutionary medical science can be. Further, as this decision was all but completed, a new
report of a randomized study comparing forms of treatment was published and offered in
evidence by motion to reopen. No doubt other such studies will appear.56 Nevertheless, even in
regard to as new a method of practice as UROD, still in its infancy despite its growth and
acceptance by such organizations as ASAM, it is essential that the State, through the Board of
Medical Examiners, exercise oversight over the medical profession to assure, as much as it can
within the limitations of knowledge available at any given time, that the public is protected from
dangerous medical practice, while at the same time, being cautious to avoid applying too
stringent a control on innovation.
Here, the extensive record developed leads to some
56
The report, McGregor, Ali, et. al “A comparison of antagonist-precipitated withdrawal under anesthesia to standard inpatient withdrawal as a
precursor to maintenance naltrexone treatment in heroin users: outcomes at 6 and 12 months, Drug and Alcohol Dependence 68 5-14 (2002),
reports on a comparison between one-day precipitated withdrawal using naloxone under anesthesia and “current inpatient withdrawal treatment
using Clonidine plus symptomatic medication.” The study was randomized. It serves to point to the interesting possibilities offered by
naltrexone as a treatment modality, but also highlights the limitations of that drug and the interest in the development of a slow release depot
formulation of naltrexone. This study, published four years after the last of the respondent’s URODs, certainly demonstrates that others involved
in the treatment of opiate addicts see the potential advantages of a method of long term delivery of naltrexone that may help to increase the
chances of longer term participation in post-withdrawal therapy. The study also does point to some short-term advantage of the precipitated
withdrawal for retention in naltrexone treatment. Of course, the naltrexone treatment in the study started post-UROD and the interest in slow
release depot formulations is not stated as being sought for peri-operative application, indeed, the authors report that naltrexone was not induced
until withdrawal was completed, “in order to avoid severe reactions to naltrexone . . .” The study also recognizes that there have been reports of
risks associated with antagonist-precipitated withdrawal, and the study did involve participants who were in some cases discharged from the
hospital on the same day they received UROD. The study had other similarities and differences to the Gooberman procedure, such as the use of
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conclusions that favor the work of the respondents and some that do find their work deficient
when measured against appropriate standards.
I CONCLUDE that, as practiced by the respondents, UROD cannot be said to be a per se
inappropriate or especially dangerous procedure. Nevertheless, as with many other medical
procedures involving anesthesia and other medical procedures, some limited number of persons
will unfortunately die during or shortly after the procedure, despite its relative safety and the
performance of the procedure in a responsible manner. No doubt, not every decision a physician
makes as to method of practice during the early stages of the practice of a new, alternative
medical procedure will be either the most conservative or the most successful. Nevertheless, I
CONCLUDE that in this case the respondents acted in good faith and, except for the limited
exceptions noted, within the ambit of acceptable medical standards of care for both addiction
medicine and anesthesiology, as well as the new and evolving method they chose to offer to a
population highly in need of assistance. While there is sufficient evidence to persuasively
establish a number of violations of professional and regulatory standards, I CONCLUDE that,
on the whole, the practice of UROD by each doctor did not involve substantial negligence,
malpractice or professional misconduct, or gross negligence, malpractice or misconduct.
I CONCLUDE that the complainant has proven both a temporal link and a causal
relationship between UROD and the events that resulted in the deaths of some patients and the
serious non-fatal consequences that required the hospitalization of two patients. However, the
complainant has failed to prove by a preponderance of the credible evidence that the
respondents’ conduct in providing UROD, or their alleged failure to act in certain ways, was
substantially responsible for the deaths.
I CONCLUDE that these deaths occurred either
because some of the patients, acting in defiance of warnings, used cocaine after the UROD and
suffered fatal arrhythmias, or, in other cases, simply could not withstand the stresses of
withdrawal and suffered fatal arrhythmias, or died of aspirative pneumonia that occurred not as a
result of any improper conduct by the respondents. Thus, intervening events may well have
occurred in the Stavola and Beigelman cases. I further CONCLUDE that while the stress of
withdrawal did prove too much for a very limited number of compromised patients, the
complainant has not proven by a preponderance of the credible evidence that UROD as practiced
by Drs. Gooberman and Bradway involved the use of a combination of drugs that exposed
clonidine for all patients. On the whole, the report serves to highlight issues already addressed in this case and reviewed in this opinion. It serves
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patients to any undue risk of harm so long as they were properly managed during the procedure
and were appropriately discharged and, as necessary, provided with follow up support during the
ongoing withdrawal process.
Based upon the discussions above, I CONCLUDE that the complainant has established
by a preponderance of the credible evidence that the respondents’ practice of UROD has failed to
meet several requirements of the standard of good medicine. Additionally, they have violated
certain specific requirements of the regulatory code. More specifically, even though dipstick
screening was available, the respondents’ failed to continue to screen patients for cocaine use.
They improperly sought to have patients waive their rights to confidentiality as a part of the
consent form.
Dr. Gooberman failed for some indeterminate period to properly advise
prospective patients that UROD was an experimental procedure, so as to properly advise them
before they gave informed consent to being treated. They failed to prepare adequate records of
both anesthesia and antagonist administration, as well as post-anesthesia discharge notes, as
required after June 15, 1998.
neither to validate nor reject precipitated withdrawal under anesthesia, and as such, is not in any way dispositive of any of the issues in this case.
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Penalty
N.J.S.A. 45:1-21 permits the Board of Medical Examiners to revoke or suspend any
license issued by it to a physician if the preponderance of the credible evidence establishes the
physician has engaged in acts or practices that involve gross negligence, gross malpractice or
gross incompetence, or repeated acts of negligence, malpractice or incompetence, or actions that
constitute professional misconduct or are in violation of any act or regulation administered by the
Board. In addition to such penalty or as an alternative, N.J.S.A. 45:1-22 provides that any person
who violates any provision of an act or regulation administered by a professional board may
receive a letter of warning, reprimand, or censure, may be assessed civil penalties and may be
ordered to cease and desist from future violations or take affirmative corrective action with
regard to any act or practice found unlawful. N.J.S.A. 45:1-25 provides that any person who
violates any provision of an act or regulation administered by the Board shall, in addition to any
other sanctions provided, be liable to a civil penalty of not more than $2,500.00 for a first offense
and not more than $5,000.00 for a second and each subsequent offense. Each separate transaction
shall constitute a separate offense, but “a second or subsequent offense shall not be deemed to
exist unless an administrative or court order was entered in a prior, separate and independent
proceeding.” In addition, in any action that is brought pursuant to the statute, the Board “may
order the payment of costs for the use of the State.”
I CONCLUDE that there is no basis for the imposition of the ultimate sanction of
revocation of either physician’s medical license. The extremely serious allegations regarding the
employment of a purportedly unethical and medically unwarranted procedure and the charge that
these respondents’ grossly negligent and/or repeatedly negligent and/or incompetent practices
and misconduct caused or contributed to the deaths of seven persons and the serious illness of
“dozens” of persons have not been proven by the requisite standard of proof. The suggestions
and implications that they were simply grinding out ethically tainted UROD procedures and then
were not seeking to reasonably assist their patients post-procedure in the attempt to stay abstinent
have been demonstrated to be incorrect charges.
Despite the failure of the complainant to prove the most serious charges, clearly several
violations have been established. There are obvious failures in regard to the records produced
and a failure to comply with medical record requirements.
The respondents were each
245
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OAL DKT. NO. BDS 10905-99S
responsible, as professionals and as supervisors, to assure that they and those under their
authority properly recorded the events required to allow a complete and understandable record of
the treatment rendered. It is vitally important that the records of a patient’s treatment, including
and perhaps especially so those relating to surgical and anesthetic procedures, clearly indicate the
drugs utilized, the method of administration, the dosage and the timing of such administration.
While there is apparently no firmly established formulation for the records that identify these
matters, the doctors were responsible to see that these matters were properly recorded. The
failure to do so, while not shown here to have contributed to or to have disguised any negligence,
nevertheless is a serious failure. Each respondent shall pay a civil penalty of $2,500 for this
violation.
The attempt to publicize the procedure through the possible use of patients’ identities,
even if for wholly positive reasons to alert the public that UROD was available (and no doubt
also to bolster Dr. Gooberman’s, and later also Dr. Bradway’s practice), may have gotten in the
way of the doctors’ responsibility to properly protect the confidentiality of their patients. The
patients should never have been placed in the position of having to affirmatively opt out of
possible future use of their experience, and perhaps their identity, at a time when they were quite
likely not at their sharpest and no doubt under some emotional and physical strain. Again, this
violation has not been shown to have had any affect upon patient care. Each physician shall pay
a civil penalty of $1,500 for this offense.
While the record does not allow for a definitive determination, I strongly believe that Dr.
Gooberman’s failure to advise the early patients of the “experimental” nature of UROD did not
actually lead to anyone undergoing the procedure who would not have otherwise done so.
Further, at some time during the four years and over 2,000 procedures, the need to refer to it as
an experiment ended. Nevertheless, given the importance of fair and open dealings with patients
and prospective patients, Dr. Gooberman shall pay a civil penalty of $2,500 for this offense.
Violations regarding EKGs for patients over forty and even for not continuing the use of
dipsticks to screen for cocaine use are important failures. On this record, it is impossible to
determine with any degree of probability that any particular patient was harmed by the failure to
perform these tests; however, the failure may have increased the risk to which individuals were
subjected. As such, each respondent shall be liable for a civil penalty of $2,500 for failure to use
246
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OAL DKT. NO. BDS 10905-99S
dipsticks and $2,500.00 for failure to perform EKG’s on patients over the age of 40 as a routine
pre-screening device.
While in the overall scope of the charges, the charges that were sustained are limited,
nevertheless, they occurred multiple times and denote a less than completely careful approach to
the serious work involved. Based upon the findings and conclusions and in view of the violations
of good medical practice and appropriate standards of care, I CONCLUDE that each respondent
shall be suspended from practice for a period of six months. In addition, Dr. Gooberman shall
pay a total of $11,500.00 in civil penalties. As the record of this case demonstrates that Dr.
Bradway was previously sanctioned by the Board for serious violations of its rules and
regulations, an additional penalty of $5,000.00 is imposed. Dr. Bradway shall pay a total of
$14,000 in civil penalties. In addition to these sanctions, each respondent must enroll and
successfully complete class(es) or course(s) designated by the Board that address issues of
informed consent, patient confidentiality, screening procedures for anesthesia procedures and
record keeping requirements. Further, upon the completion of their suspensions, each physician
shall be placed on administrative probation for a period of two years, during which they may be
subject to review of their record keeping, and should they resume UROD or any other anesthesia
based procedures, their pre-procedure screening protocols.
Each physician will be equally responsible for the payment of costs of investigation.
However, the bulk of the most serious charges have not been sustained. Without doubt, these
charges constituted the greatly substantial elements that were the subject of the Board’s
investigation and were the driving forces behind a very long and highly complex trial.
I
CONCLUDE that it would be manifestly unfair and inequitable for the respondents to have to
pay all of the Board’s costs. Instead, the respondents shall pay one-third of the Board’s costs and
attorneys fees. It is SO ORDERED. Counsel for the Board shall file affidavits with the Board
regarding costs and fees and the Board will presumably make a final order regarding the
allocation of costs.
I hereby FILE my initial decision with the BOARD OF MEDICAL EXAMINERS for
consideration.
247
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OAL DKT. NO. BDS 10905-99S
This recommended decision may be adopted, modified or rejected by the BOARD OF
MEDICAL EXAMINERS, which by law is authorized to make a final decision in this matter.
If the Board of Medical Examiners does not adopt, modify or reject this decision within fortyfive (45) days and unless such time limit is otherwise extended, this recommended decision shall
become a final decision in accordance with N.J.S.A. 52:14B-10.
Within thirteen (13) days from the date on which this recommended decision was mailed
to the parties, any party may file written exceptions with the EXECUTIVE DIRECTOR OF
THE BOARD OF MEDICAL EXAMINERS, 140 East Front Street, 2nd Floor, Trenton,
New Jersey 08608, marked "Attention: Exceptions." A copy of any exceptions must be sent to
the judge and to the other parties.
DATE
JEFF S. MASIN, ACTING CHIEF ALJ
Receipt Acknowledged:
DATE
BOARD OF MEDICAL EXAMINERS
Mailed To Parties:
DATE
mjm
OFFICE OF ADMINISTRATIVE LAW
248
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OAL DKT. NO. BDS 10905-99S
EXHIBIT LIST
(Bolded exhibits are in evidence)
JOINT EXHIBITS
J-1
J-1
Stipulation
Amended as of 3/20/01
FOR THE COMPLAINANT:
P-1
P-2
P-3
P-4
P-5
P-6
P-7
P-8
P-9
P-10
P-11
P-12
P-13
Consent For Treatment, M.J., contained at Volume 2, Pages 76-79
Towne Pharmacy Description of Clonidine, Sandostatin Syringe & Trazodone
Prescription bottle labeled Trazodone (Beigelman)
Prescription bottle labeled Clonodine (Beigelman)
Prescription bottle labeled Sandostatin Syringe (Beigelman)
Towne Pharmacy bills for Beigelman prescriptions-4 pages
Prescription bottle labeled Baclofen 50 mg (Melendez)
Prescription bottle labeled Baclofen 10 mg (Melendez)
Prescription bottle labeled Trazodone 50 mg (Melendez)
Prescription package labeled Sandostatin Syringes
Dr. Gooberman’s records concerning Lisa Flowers, Volume II, pages 3-46
Hospital records for Lisa Flowers, Volume II, pages 47A-1 to 47A-70
Doctor’s records for Les Kindig, Volume II, pages 48-73
P-14
P-15
P-16
P-17
P-18
P-19
P-20
P-21
P-22
P-23
P-24
P-25
P-26
P-27
P-28
P-29
P-30
P-31
P-32
P-33
P-34
P-35
P-36
P-37
P-38
EMS chart for Lester Kindig- Volume II, pages 72-73
Doctor’s records for M.J.- Volume II, pages 74-101
Doctor’s records for Mark Beigelman- Volume II, pages 107-129
Doctor’s records Frank Stavola- Volume II, pages 130-161
Doctor’s records for Samuel Perez – Volume II, pages 186-210
Hospital Records for Samuel Perez- Volume II, pages 211-375
Doctor’s records for Christopher Hendrix- Volume II, pages 376-408
Hospital records for Christopher Hendrix- Volume II, pages 409-595
Doctor’s records for Victor Melendez- Volume II, pages 596-633
Doctor’s records for G.W.-Volume II, pages 162-185
Orders and Guidelines- Volume IV, pages 169-262
Death Certificate for M.J.-Volume II, page101
Death Certificate for Victor Melendez-Volume II, page 632
Death Certificate for Lester Kindig-Volume IV, Pages 88-89
Post Mortem Examination Report for Mark Beigelman-Volume I, pages 47-51
Post Mortem Examination Report for Frank Stavola-Volume I, pages 53-58
Post Mortem Report for Lester Curtis Kindig-Volume I, pages 60-64
Post Mortem Report for M.J.-Volume I, pages 66-69
Autopsy Report for Lisa Flowers-Volume I, page 72-77
Autopsy Report for G.W.-Volume I, pages 85-89
Autopsy Report for Victor Melendez-Volume I, pages 111A-119
Toxicology Report for Mark Beigelman-Volume I, Pages 100-105
Toxicology Report for Frank Stavola-Volume I, Pages 94-95
Toxicology Report for Lester Kindig-Volume I, pages 106-108
Toxicology Report for M.J.-Volume I, pages 96-99
249
- -
OAL DKT. NO. BDS 10905-99S
P-39
P-40
P-41
P-42
P-43
P-44
P-45
P-46
P-47
P-48
P-49
P-50
P-51
P-52
P-53
P-54
P-55
P-56
P-57
P-58
P-59
P-60
P-61
P-62
P-63
P-64
P-65
P-66a
P-66b
P-67
P-68
P-69
Toxicology report for Lisa Flowers-Volume I, Pages 78-83
Toxicology Report for G. W.-Volume I, pages 109-111
Toxicology Report for Victor Melendez-Volume I, pages 122-126
Death Certificate for G.W.-Volume I, page 84
Excluded (Book Cover and Table of Contents)
Curriculum Vitae for Dr. Herbert Kleber Volume I, pages 145-166
“Opiate Detoxification Under Anesthesia: No Apparent Benefit but Suppression
of Thyroid Hormones and Risk of Pulmonary and Renal Failure, Clinical
Technology, (1999), contained in Volume 4, pages 135-142
Ultra-Rapid Opiod Detoxification Increases Spontaneous Ventilation, Journal
of Clinical Anesthesia 10:372-376 (1998), contained at Volume 4, pages 154158
Profound Increase in Epinephrine Concentration in Plasma and Cardiovascular
Stimulation after μ-Opioid Receptor Blockade in Opiod-addicted Patients
during
Barbiturate-induced
Anesthesia
for
Acute
Detoxification,
Anesthesiology, Vol. 88, No. 5, May 1998, Volume 4, Pages 159-166
NIDA Scientific Report of Ultra Rapid Detoxification with Anesthesia
(UROD): Opinion of the Consultants and Criteria Relating to Evaluating the
Safety and Efficacy of UROD, Unofficial Report, Volume 4, pages 123-134.
Journal of the American Medical Association (JAMA) article
Not In Evidence-Three Methods of Opiod Detoxification in a Primary Care
Setting, Annals of Internal Medicine 127:526-530 (1997), Volume 4, pages 143147
Dr. Lawrence G. Kushin’s report, September 7, 1999, Volume 1, pages 33-36
Curriculum Vitae of Lori D. Karan, M.D., Volume I, pages 127-144
Letter dated September 28, 1999 from Lori D. Karan, M.D. to Douglas J.
Harper, Volume 1, pages 13-14
Letter dated September 27, 1999 from Lori D. Karan, M.D. to Douglas J.
Harper, Volume 1, pages 15-16
Ultra-Rapid Opioid Detoxification An Analysis of 4 Cases of Mortality, Lori D.
Karan, M.D., F.A.C.P., Volume 1, pages 0017-0032
Curriculum Vitae of Dr. Gevirtz, Volume I, pages 181-191
Aldrete Scoring System
NOT IN EVIDENCE
Curriculum Vitae for Dr. Lawrence Kushins, Volume I, pages 167-177
Chart
Curriculum Vitae for Reng-lang Lin, Ph.D.
Report of Dr. Lin dated May 30, 2000
Letter from Jan Klein dated October 18, 1998
Prescription written on Dr. Gooberman’s pad for seven tests
Sketch of Dr. Gooberman’s office suite in 1996
Letter from Michael N. D’Ambra, M.D. to Alma Saravia, Esq., dated August
30, 1999
Letter to Koski
Depo-Naltrexone-an Adjunct to Opiate Abstinence after Detoxification,
Unpublished article by Drs. Gooberman, Bradway and Bartter
Transcript-In The Matter of State Board of Medical Examiners In Re: Lance
Gooberman, M.D.-October 20, 1995
Report of Dr. David Smith with attachments
250
- -
OAL DKT. NO. BDS 10905-99S
P-70
P-71
P-72
P-73
P-74
P-75
P-76
P-76a
P-77
P-78
P-79
P-80 a & b
P-81 a, b & c
P-82 a, b & c
P-83
P-84
P-85
P-86
P-87
P-88
P-89
P-90
P-91
P-92
P-93
P-94
Letter dated 5/2/00 from Herbert D. Kleber, M.D. to Douglas J. Harper, Esq.
Letter dated May 14, 1997 from Alan I. Leschner, Ph.D., to Dr. Colin Brewer
Response to NIDA Report, revised January 1997
Report of Dr. Kleber, dated September 10, 1999
Report of Dr. Gevirtz dated June 9, 2000
Report of Dr. Segal, dated May 12, 1999, Volume I, pages 1-12
Records for D. Floyd (admission limited to establishing knowledge)
Chart (part of D-59)
Chart-Aspirative Pneumonia
Chart
Letter dated March 16, 1999 from Cynthia G. McCormick, M.D. to Lance L.
Gooberman, M.D.
Excerpts for 1996 Physician’s Desk Reference (PDR)
Excerpts from 1997 PDR
Excerpts from 1999 PDR
Letter dated 12/3/00
David L. Simon, M.D., Rapid Opioid Detoxification Using Opioid Antagonists:
History, Theory and the State of the Art, Journal of Addictive Diseases, Vol.
16(1) 103-122 (1997)
Brochure issued by Nutmeg Intensive Rehabilitation Centers © 2000 INDCA
Editorial: Chris Kasser, M.D., Current and Future Prospects for Rapid Opioid
Detoxification with Opioid Antagonists, Journal of Addictive Diseases, Vol
16(1) 1-4 (1997)
Elman, D’Ambra, et al., Ultrarapid opioid detoxification: effects on
cardiopulmonary physiology, stress hormones and clinical outcomes, Drug and
Alcohol Dependence 61 163-172 (2001)
Letter dated January 24, 2001 from David R. Black, Esq., to John Sitzler, Esq.
Letter dated April 25, 2000 from David L. Simon, M.D. to Herbert Kleber,
M.D.
Curriculum Vitae of Bunyard Haider, M.D.
Medical Report, dated May 9, 2001 issued by Bunyard Haider, M.D.
Letter dated April 6, 2001 from Douglas J. Harper, D.A.G. to Bunyard Haider, .
M.D.
Additional Report, dated October 28, 1999, issued by Reng-lang Lin, Ph.D.
Letter dated May 11, 2001from Frank Vocci, Ph.D., to John Farmer, Jr.,
Attorney
General
FOR THE RESPONDENTS:
D-1
D-2
D-3
D-4
D-5
Intake Form for M.J., completed 4/11/98, at Volume 2, page 0075
Unsigned statement regarding M.J. marked “Privileged Information; Personal
and Confidential, at Volume 2, pages 0102-0105
Medical History for M.J., dated 4/10/98, Volume 2, 0080
Consent for Treatment re: Frank Stavola, dated December 23, 1996, Volume 2,
0139-0141
Consent for Treatment re: Lester Kindig, dated September 2, 1998, Volume 2,
0050-0053
251
- -
OAL DKT. NO. BDS 10905-99S
D-6
D-7
D-8
D-9
D-10
D-11
D-12
D-13
D-14
D-15
D-16
D-17
D-18
D-19
D-20
D-21
D-22
D-23
D-24
D-25
D-26
D-27
D-28
D-29
D-30
D-31
D-32
D-33
D-34
D-35
D-36
D-37
D-38
D-39
D-40
D-41
EMS Patient Chart for Lester Kindig, Volume 2, 0072
U.S. Detox, Inc. ITU Record re: Lester Kindig, Volume 2, 0065
Letter dated October 19, 1998 from Jan Klein (Kindig) to Dr. Seigal, Volume 2,
pages 0067-0071
Medical History of Mark Beigelman
Consent for Treatment for Christopher Hendrix, dated July 13, 1999, Volume 2,
0401
Untitled document regarding Christopher Hendrix, Volume 2, 0383
Medical History of Christopher Hendrix, dated July 6, 1999, Volume 2, page
0381
Medical History of Samuel Perez, Jr., dated June 9, 1999, Volume 2, page 01950196
Consent for Treatment for Victor Melendez, dated May 26, 1999, Volume 2,
pages 0599-0602
Rapid Opioid Detoxification During General Anesthesia, A Review of 20
Patients, Anesthesiology, vol. 91, No. 6 (Dec. 1999)
Echocardiography for Assessing Cardiac Risk in Patients Having Noncardiac
Surgery, Educational Reviews, Inc. 1996
Nurse’s Notes re: Lisa Flowers, Volume 2, 0033
Notes made by Dr. Karan after toxicology consult
Blood Toxicology Chart following Dr. Karan’s report, version number 1 with
two entries below the chart
Echocardiography for Assessing Cardiac Risk in Patients having Noncardiac
Surgery, Annals of Internal Medicine, Volume 125, No. 6, pages 433-441
Report of Dr. Smith
Summary of Preoperative Test Recommendations, Underwood-Memorial
Hospital Medical-Dental Staff
Drawing showing effects of drug over time
Drawing of cellular effects
American Society of Addiction Medicine Public Policy Statement on Opioid
Antagonist Agent Detoxification Under Sedation or Anesthesia (OADUSA)
Page 233 of American Psychiatric Press textbook of Substance Abuse
Treatment
Goodman and Gilman, Pharmacological Basis of Therapeutics, page 1732
Goodman and Gilman, Pharmacological Basis of Therapeutics, page 1762
(In evidence as P-73) Report of Dr. Gevirtz
Letter from Dr. Kleber to Mr. Harper, May 2, 2000
Photo
Photo
Photo
Memorandum dated August 5, 1998 from Deputy Executive Director Charles A.
Janousek to Executive Director Judith I Gleason
Face SheetLetter to the Editor of Anesthesiology, dated November 2000
Dr. Kleber’s grant proposal
Patent
Philadelphia Magazine article, January 2000
E-mail to Dr. Gooberman
E-mail
252
- -
OAL DKT. NO. BDS 10905-99S
D-42
D-43
D-44
D-45
D-46
D-47
D-48
D-49
D-50
D-51
D-52
D-53
D-54
D-55
D-56
D-57
D-58
D-59
D-60
D-61
D-62
D-63
D-64
D-65
D-66
D-67
D-67A
D-68
D-69
D-70
D-71
D-72
D-73
D-74
D-75
Filing with Securities and Exchange Commission by Ultramed International,
Inc.
Not in evidence
Pulse regarding rule concerning Nurse-Anesthetists
Letter from Douglas Harper, D.A.G. to Dr. Lin
Consent form for Lester Kindig
(also P-66a) Letter from Michael N. D’Ambra, M.D. to Alma Saravia, Esq.,
dated August 30, 1999
Physician notes regarding Victor Melendez-Supplemental Case Information
Preliminary Report regarding Lisa Flowers
Curriculum Vitae of Dr. David E. Smith
Dr. Smith’s report
Chart depicting “Withdrawal” (Intensity and Duration) via UROD procedure
Letter from Richard Millstein, Deputy Director, NIDA, to Richard Walling,
Office of International Health, DHSS
Letter from Dr. Colin Brewer to Barbara H. Herman, PhD., Director, Opiod
Medications Programs, NIDA, dated May 9, 1996
Letter from Dr. Kleber to Dr. Brewer
Curriculum Vitae of Frank T. Maziarski,, CRNA. M.S.
Report of Frank T. Maziarski, M.S., dated May 31, 2000
LAM
Photo Album
Video Cassette of Gooberman UROD procedure
Letter from Alan I. Leshner to Dr. Colin Brewer, date stamped “RECEIVED 21
May 1997”
Professional Services Agreement, Administrative Office of the Courts and US
Detox
Curriculum Vitae of John T. Cooper, Jr., M.D.
Report of Dr. Cooper
Autopsy Report regarding decedent K.K-S.
Letter from Charles A. Janousek to Alma Saravia, Esq., dated 2/11/97
Statement by Gibbs, Esq.
Depo-Naltrexone-An Adjunct to Opiate Abstinence after Detoxification”
Gooberman, Bradway & Bartter
Curriculum Vitae of David L. Simon, M.D.
Report of Dr. Simon, dated June 15, 2000
Supplemental Report of Dr. Simon, dated July 23, 2000
Paper regarding 162 patients treated by Dr. Simon presented at 1998 ASAM
Conference
Diagram
Diagram-Normal/Dependent/After Opioid Antagonists
EXCLUDED-tape of Simon procedure
Leshner, “Managing Heroin Addiction: A Look at the Options,” Behavioral
Health Management, January/February 1998
253
- -
OAL DKT. NO. BDS 10905-99S
D-76
D-77
D-78
D-79
D-80
D-81
D-82
D-83
D-84
D-85
D-85A
D-85B
D-85C
D-85D
D-85E
D-85F
D-86
D-87
D-88
D-89
D-90
D-91
D-92
D-93
San , Puig, Bulbena & Farre, “High Risk of Ultrashort Noninvasive Opiate
Detoxification,” Letter to the Editor of American Journal of Psychiatry Volume
152(6) (June 1995)
Drawing illustrating Negative Intra-thoracic Pressure Pulmonary Edema
First page of article by Wride, Smith and Courtney, A Fatal Case of Pulmonary
Oedema
in
a
Healthy
Young
Male
Following
Naloxone
Administration,Anaesthesia and Intensive Care, Vol. 17 (3) 374 (August, 1989)
Brimacombe, Archdeacon, Newell and Martin, Two Cases of Naloxone-Induced
Pulmonary
Oedema-The
Possible
Use
of
Phentolamine
in
Management,Anaethesia and Intensive Care, Vol. 19 (4), (November, 1991)
American Society of Anesthesiologists (“ASA”) standards for discharge from
PAC-U (to another unit)
Problems in Anesthesia, Outpatient Anesthesia, Vol. 2(1) 13-16 Jan-March
1988
Chart identifying four standards of care
Page 750-Substance Abuse-A Comprehensive Textbook, 3rd edition, pages 433,
749, 750, 790, 792
Monograph-- Cardiopulmonary Bypass: Current Concepts and Controversies
(Tinker, editor)
ASA Guidelines for Office-Based Anesthesia (Approved, October 13, 1999)
ASA Statement on Routine Preoperative Laboratory and Diagnostic Screening,
approved, October 14, 1987 and last amended October 13, 1993
ASA Statement on Qualifications of Anesthesia Providers in the Office-Based
Setting, approved October 13, 1999
ASA Guidelines for Ambulatory Anesthesia and Surgery, Approved October
11, 1973 and last amended October 21, 1998
ASA Statement regarding Documentation of Anesthesia Care, approved,
October 13, 1988, approved October 12, 1988
ASA Basic Standards for Pre-anesthesia Care, approved October 14, 1987
ASA Guidelines for Non-operating Room Anesthetizing Locations
Department of Health and Human Services Food and Drug Administration
form: Consent to Treatment with an Approved Narcotic Drug
Point/Counterpoint: Should rapid opiate detox be performed by
nonanesthesiologists, Physician’s Weekly, Vol. XV, No. 14 (April 13, 1998)
Note: Methadone-related deaths in New Zealand, published in New Zealand
Medical Journal, page 303 (1999)
Bentley AJ, Busuttil A, Deaths Among Drug Abusers in South-east Scotland
(1989-1994, Med. Sci. Law Vol. 36 (3) 231-236
Zanis & Woody, Brief Communication: One-year mortality rates following
methadone treatment discharge, Drug and Alcohol Dependence 52 257-260
(1998)
Zador & Sunjic, Death in methadone maintenance treatment in New South
Wales, Australia 1990-95, Addiction 95(1) 77-84 (2000)
Cooper, Seymour, Cassidy & Oliver, A Study of Methadone in Fatalities in the
Strathclyde Region 1991-1996, pages 233-241
Steentoft, et al., Fatal poisonings in young drug addicts in the Nordic countries:
a comparison between 1984-85 and 1991, Forensic Science International 78 2937 (1996)
254
- -
OAL DKT. NO. BDS 10905-99S
D-94
D-95
D-96
D-97
D-98
D-99
D-100
D-101
D-102
D-103
D-104
D-105
D-106
D-107
D-108
D-109
D-110
D-111
D-112
D-113
D-114
Payte, Opioid Maintenance Pharmacotherapy (OMP), presented at ASAM’s
Review Course in Addiction Medicine, October 22-24, 1998
Not in evidence
Not in Evidence
Not in Evidence
Letter and Report from Rosemary Capelli, MA, RN, June 14, 2000
Curriculum Vitae, Rosemary Capelli RN, MA
Not in evidence
Not in evidence
Not in evidence
Not in evidence
Not in evidence
Not in evidence
Not in evidence
Curriculum Vitae of Robert I. Katz, M.D.
Not in evidence
Not in evidence
Not in evidence
Picture
Picture
Picture
McGregor, Ali, et. al, A comparison of antagonist-precipitated withdrawal
under anesthesia to standard inpatient withdrawal as a precursor to
maintenance naltrexone treatment in heroin users: outcomes at 6 and 12
months, Drug and Alcohol Dependence 68 5-14 (2002)
255
- -