MEMORANDUM
TO:
Karin Mika
FROM:
1111
DATE:
October 19, 2006
RE:
Dr. Arliss Sedgewick (lack of informed consent)
ISSUE
WHETHER A DIABETES PATIENT HAS A CAUSE OF ACTION FOR
LACK OF INFORMED CONSENT WHEN THE DOCTOR FAILED TO
INFORM THE PATIENT OF THE RISK OF KIDNEY FAILURE
ASSOCIATED WITH AN EXPERIMENTAL TREATMENT.
STATEMENT OF FACTS
Plaintiff, Jared Morton (“Morton”), is a 37 year-old male suffering from Type I
diabetes that, until recently, was controllable with daily insulin injections. In 2003, Morton’s
diabetes became increasingly uncontrollable and he inquired of one of his physicians, Dr.
Edgis Parkinson, whether there were alternative treatments available. Dr. Parkinson
suggested an experimental islet cell transplant treatment being conducted as part of a study
by the Defendant, Dr. Arliss Sedgewick (“Sedgewick”). Sedgewick is a diabetes researcher
at the University Hospital Diabetes Clinic in Cincinnati.
Upon consultation, Sedgewick made clear to Morton that he was over the age allowed
for the study, but would be willing to include Morton as a favor to Dr. Parkinson. Morton
was also provided a number of medical consent forms spelling out risks associated with the
treatment and requiring Morton to assent to the judgments of the physicians overseeing his
treatment. Morton, however, was not furnished the Phase I documentation concerning the
experimental treatment, which detailed a 7% mortality rate, a majority due to renal failure,
among lab mice that had undergone the treatment. Sedgewick disclaims any prior knowledge
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of the mortality among lab mice due to her lack of familiarity with the research and lack of
expert knowledge of the contents of the Phase I documentation. Additionally, at the time of
commencing treatment on Morton, Sedgewick had no prior knowledge of renal failure
among other patients in the study.
In November 2004, Morton underwent the experimental procedure with seeming
success. However, his diabetes returned by the seventh month following treatment, and
Morton’s kidney functions began declining by the eighth. Within a year, Morton’s renal
functions were failing and he was placed on the kidney transplant list.
Morton filed suit in the spring of 2006 against our client, alleging medical
malpractice and battery, on the grounds that he did not give informed consent to undergo the
experimental treatment.
DISCUSSION
The general rule in Ohio concerning informed consent is that a physician must
adequately disclose to his patient the probable consequences, material risks and anticipated
benefits of a medical procedure. Congrove v. Holmes, 37 Ohio Misc. 95, 101 (Ct. Com. Pl.
Ross County 1973). Actionable offenses for lack of informed consent have been further
explicated by the Ohio Supreme Court in Nickell v. Gonzalez, 477 N.E.2d 1145, 1148 (Ohio
1985) as requiring three criteria be met:
(a)
The physician fails to disclose to the patient and discuss the material risks and
dangers inherently and potentially involved with respect to the proposed therapy, if
any;
(b)
The unrevealed risks and dangers which should have been disclosed by the
physician actually materialize and are the proximate cause of the injury to the patient;
and
(c)
A reasonable person in the position of the patient would have decided against
the therapy had the material risks and dangers inherent and incidental to the treatment
been disclosed to him or her prior to the therapy.
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“[M]aterial risks” are such that a reasonable person “would be likely to attach significance to
the risk of cluster of risks in deciding whether or not to forego the proposed treatment.” Id.
at 1149; accord Bedel v. Univ. of Cincinnati Hosp., 669 N.E.2d 9, 14 (Ohio Ct. App. 1995).
Concurrently, the specific determination of proximate cause must be assigned through expert
medical testimony, demonstrating that there was greater than 50% likelihood that the
prescribed medical procedure produced the injuries. Klein v. Biscup, 673 N.E.2d 225, 232
(Ohio Ct. App. 1996). In order for Mr. Morton to successfully bring a lawsuit against our
client, he must prove that disclosure of the risks in the mouse study was mandatory under law
and that the islet cell transplant was the proximate cause of his injuries. It is unlikely that
Mr. Morton will succeed in adducing such evidence and, as a result, our client will not be
liable for performing a medical procedure without informed consent.
Several cases in Ohio demonstrate how courts respond where patients have brought
actions for informed consent. For example, in Nickell v.Gonzalez, 477 N.E.2d 1145, 1149
(Ohio 1985), the Ohio case credited with establishing the modern day test for informed
consent, the court held that the patient gave her informed consent for a throat operation. In
Nickell, the plaintiff saw her surgeon for a throat operation. Id. at 1147. After surgery, she
was left with throat paralysis characterized as an “extraordinarily rare” occurrence. Id. at
1147-48. In finding consent sufficient, the court reasoned that a doctor was not obligated to
anticipate every possible complication of an operation. Id. at 1148. The court additionally
noted that it was unclear that the operation was the proximate cause of the paralysis. Id. at
1149.
In addition, in Klein v. Biscup, 673 N.E.2d 225, 232 (Ohio Ct. App. 1996), a more
recent Ohio Court of Appeals case, the court held that the defendant had sufficiently
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disclosed material risks related to a performed spinal surgery. In Klein, the plaintiff
underwent spinal fusion surgery to alleviate lower back pain. Id. at 227. The plaintiff had
signed a consent form. Id. However, the defendant failed to reveal that he would be using
bone plates and screws “off-label” (not according to FDA approval). Id. The surgery was
unsuccessful, causing fractured vertebra, pain and incontinence in the plaintiff. Id. The court
emphasized that the doctrine of informed consent in Ohio does not require a physician to
specifically disclose the use of a medical material in a non-FDA approved manner. Id. at
231. Furthermore, the court noted that without expert medical testimony of a 50% likelihood
of the spinal surgery producing the patient’s injuries, a material fact of proximate cause was
not established. Id. at 232.
In another Ohio case on informed consent, in Turner v. Children’s Hosp., Inc., 602
N.E.2d 423, 433 (Ohio Ct. App. 1991) the court held that a specialist at a hospital did not
have a duty to inform other doctors that a child’s seizure disorder was related to adverse
reactions to DPT vaccinations. In Turner, a child was administered DPT vaccinations by a
series a physicians, leading to seizures and retardation. Id. at 426. A specialist at the
hospital, overseeing the seizures exclusively, failed to note a connection between the DPT
vaccinations and the seizures. Id. at 425. In finding adequate disclosure, the court reasoned
that the specialist was not obligated to inform other doctors of material risks of which he was
not aware and did not arise in his diagnosis. Id. at 433. Moreover, the court in Turner, noted
that the specialist had not “proposed” the administration of the DPT vaccination. Id. at 431.
The case law on informed consent in Ohio makes it clear that we will be able to assert
a valid defense against the lawsuit brought by Mr. Morton. The baseline rule regarding
informed consent in Ohio is that three elements must be met before a patient can bring an
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action: (1) failure to disclose material risks, (2) the unrevealed risks were the proximate
cause of injury and (3) a reasonable person would have elected not to undertake the
procedure if the risks had been revealed. Nickell, 477 N.E.2d at 1148. As a further
elucidation of the first element, doctors must reveal to patients reasonable material risks and
benefits associated with the medical procedure. Congrove, 37 Ohio Misc. at 101.
The legal rules governing disclosure of reasonable material risks do not extend
revelation to every possible risk. In Nickell, the court held that “extraordinarily rare” risks do
not need to be disclosed to a patient. 477 N.E.2d at 1148. It may similarly be argued that the
renal failure risks can be construed as “extraordinarily rare” on the grounds that Sedgewick
had no prior knowledge of the risk in mice or human subjects. The facts indicate that
Sedgwick had no role in the mouse study and that renal failure only affected a small
percentage of lab mice.
This point of view is strengthened by the holding in Turner, in which the court held
that doctors would not be held liable for failing to inform patients of risks that require going
beyond basic medical duty, especially when more than one doctor is involved in the overall
treatment. 602 N.E.2d at 433. Likewise, here, a court may find that Sedgewick should not
be required to undertake additional research to discover such risks that were not medically
apparent, especially given that she was not part of the initial study. Similar to Turner, it
appears that the law in Ohio does not require doctors to consult extensively with previous
physicians in order to determine potential risks. An argument could be made that this is
especially true of a practitioner who implements a research protocol because she would not
be in the position to know all of the nuances involved in the previous research.
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Our position is further supported by the court in Klein, which emphasized that ‘offlabel use’ of a medical device, as part of a medical procedure, is not a material risk requiring
disclosure. 673 N.E.2d. at 231. Analogous to Klein, it can be argued that the experimental
treatment carried out on Morton was ‘off-label use’ since he was not of appropriate age for
the study and therefore was not a designated research subject. As a result, our client may not
have been required to disclose risks associated with the procedure, as its performance was
‘off-label’ and its corresponding risks were therefore not material according to Ohio law.
We can sustain our defense more explicitly on the grounds that Sedgewick did not
actually propose the treatment to Morton. In Turner, the court stated that the “duty to inform
arises only when the physician in fact proposes some mode of treatment giving rise to a
patient decision.” 602 N.E.2d at 431. The facts show that Sedgewick did not propose the
treatment, but rather performed the treatment as a favor to Morton’s diabetes specialist, Dr.
Parkinson, who actually recommended the experimental treatment. It can be asserted that
Sedgewick’s role in Morton’s treatment was akin to that of a technician rather than the
primary physician diagnosing, recommending and carrying out treatments for a patient. As
such, Ohio law may not assign a duty to Sedgewick to reveal any material risks, let alone the
results of the lab mice study.
Alternatively, we may utilize another line of defense. The court in Nickell
promulgated a three part rule for actionable failures to disclose appropriate medical risks.
477 N.E.2d at 1148. The rule specifically requires that unrevealed material risks “are the
proximate cause of the injury in the patient.” Id. In the case at bar, given the temporal lag of
eight months between the islet cell transplant and the injuries sustained by Morton, it can be
argued that the medical procedure was not the proximate cause of the injuries. The facts
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signify that Morton’s diabetes was under control following the procedure and it is more
likely that an intervening cause was to blame for his renal failure.
A defense by lack of proximate cause is further supported by the court’s decision in
Klein. There, in order to meet the proximate cause rule, the court required the plaintiff to
produce expert testimony of a 50% likelihood of the procedure being the cause of the injuries
sustained. Klein, 673 N.E.2d at 232. In the case at bar, the mortality rate in the mouse study
was merely 7% and not all deaths were attributable to renal failure. Given these facts, and
that renal failure is not an uncommon consequence of uncontrollable diabetes, Denise Grady,
A Diabetes Treatment Fails to Live Up to Early Promise, N.Y. Times, Sept. 28, 2006 at A16,
there is a strong likelihood that the renal failure will not be attributed, at 50% likelihood, to
the experimental treatment carried out by our client. Consequently, having not satisfied all
three criteria promulgated in Nickell, our client is not liable for the tort of lack of informed
consent.
However, Morton’s counsel may proffer a number of counterarguments that Morton
did not give informed consent to the treatment. For example, in Nickell the court applied the
reasonable patient standard. 477 N.E.2d at 1149. Morton may argue that a reasonable
patient would have assigned significant risk to the information withheld by our client
regarding mortality in mice. A risk that upon incidence inherently results in death, regardless
of the likelihood, would likely be of import to a patient. Thus, Dr. Sedgewick should have
informed him of any information that may have influenced his decision to assent to the
procedure. Additionally, in Turner, the court stated that patients must be informed of all
risks that a “reasonably prudent physician would disclose.” 602 N.E.2d at 432. Morton may
also argue that Sedgewick failed to inform herself prudently of serious and reasonable risks
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associated with the procedure and, thus carelessly failed to disclose reasonable risks to
Morton.
To further counter our defenses, Morton may distinguish the facts in the case at bar
from those in Nickell. In Nickell, a physician was not required to disclose “extraordinarily
rare” risk of paralysis. 477 N.E.2d at 1148. Morton may assert that the mortality risk among
mice in the collateral mouse study could not be construed as “extraordinarily rare.” A seven
percent mortality rate, where one in every fourteen mice died as a result of the treatment,
may be more readily classified as a probable risk than an “extraordinarily rare” occurrence.
Consequently, Sedgewick had a legal duty to disclose the results of the mouse study to
Morton.
Even with the arguments presented by opposing counsel, we still have a strong
position and can counter their arguments. The courts have held that a doctor is not required
to inform a patient of all risks. Turner, 602 N.E.2d at 431; see also O’Brien v. Angley, 407
N.E.2d 490, 495 (Ohio 1981). As mentioned above, this disencumbers the physician of the
duty to disclose material risks, specifically where the medical procedure is ‘off-label.’ Klein,
673 N.E.2d. at 231. It also likely protects the physician from undertaking onerous additional
research. Turner, 602 N.E.2d at 433. While our client may have had an ethical imperative to
investigate deeply into the risks associated with his research, she is likely only legally bound
to inform the patient of such risks as a reasonable physician would be aware.
CONCLUSION
As a rule of law in Ohio, informed consent requires a physician to reveal relevant and
reasonable risks associated with a particular medical procedure. Congrove, 37 Ohio Misc. at
101. Failure to fulfill this requirement, however, is not actionable as a tort unless there was
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an injury and a reasonable sense that the injured party would not have consented to the
procedure had the relevant risks been revealed. Nickell, 477 N.E.2d at 1148. In the case at
bar, our client was not legally bound to disclose the result of the mouse study. Dr.
Sedgewick was not aware of the mouse mortality data and is not legally required to disclose
material risks of which she is not cognizant. Even if Dr. Sedgewick had known the risks, she
would not have been required to disclose them since she was performing the medical
procedure ‘off-label,’ on an individual not involved in the actual study. Additionally, is it
unlikely that Morton will be able to prove the islet cell transplant as the proximate cause of
his injuries. Therefore, in the case at bar, we should be able to defend our client from the
action brought by the plaintiff.
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