DECLARATION OF JOHN HARRY SAMSON M.D.
I,
John Harry Samson, M.D., declare and state as follows:
1.
I am licensed to practice medicine in California. I have been board-certified in Pediatrics
by the American Board of Pediatrics since 1966. I am currently a Clinical Professor of Pediatrics
at USC School of Medicine and UCI School of Medicine. This declaration is based upon my own
personal knowledge, and I can competently testify thereto if called to do so.
2.
I obtained my medical degree from the Creighton University Medical School in 1961. I
completed my rotating internship at Memorial Hospital of Long Beach in 1962. I completed my
Pediatric residency at Children’s Hospital of Los Angeles in 1965. I have held professional
positions such as: Chief Attending Physician, I.C.U. Long Beach Children’s Hospital; Secretary
of Staff, Long Beach Children’s Hospital, Chairman of the Pediatric Intensive Care Unit
Committee at Long Beach Children’s Hospital, President of Staff at Long Beach Children’s
Hospital, a Trustee of the Board of Miller Children’s Hospital, and the Assistant Director of
Pediatric Intern Resident Training Program at UCI School of Medicine.
3.
I am familiar with the standard of care for pediatricians in Southern California at all times
pertinent to the care provided to Plaintiff Ayden Flucker. A true and correct copy of my CV is
attached.
4.
In forming the opinions expressed herein, I was provided and have personally received and
relied upon the following materials:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k.
l.
m.
n.
o.
p.
q.
Deposition Transcript of Brejeque Flucker, Guardian ad Litem K
Deposition Transcript of Christopher Gadomski, M.D.
Deposition Transcript of Nicole Morris, M.D.
Deposition Transcript of Nader Bishara, M.D.
Deposition Transcript of Jacqueline Nguyen, M.D.
Deposition Transcript of Joshua Allen May, M.D.
Deposition Transcript of Kara Brink, R.N.
Deposition Transcript of Michael Aguinaldo, M.D.
Ayden’s Medical Records from Kaiser
Kaiser On Call Interaction 30266132 Audio
Ayden’s Medical Records from Huntington Memorial Kaiser
Ayden’s Medical Records from WIC Program
CDPH Anomalous Report
Declaration of Jean lake, M.D.
Declaration of Donald Chace, M.D.
Declaration of Edward Wassman, M.D.
Declaration of Arlene Alikian, M.D.
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DECLARATION OF JOHN HARRY SAMSON M.D.
r. Ex K1 – Newborn H&P Note
s. Ex K2 – Care Planning Note
t. Ex K3 – NBS Order/Report Scan
u. Ex K4 – Progress Note
v. Ex K5 – Kaiser NBS Request Form
w. Ex K6 – Newborn Discharge Summary
x. Ex K7 – Care Plan Event Log
y. Ex K8 – Patient Education
z. Ex K9 – Breastfeeding Record
aa. Ex K 10 – Discharge Time
bb. Ex K 11 – Discharge Instructions
cc. Ex K 12 – Scan of Neonatal Transport Record
dd. Ex K 13 – CHLA NBS Request Form
ee. Ex K 14 – NBS Original
ff. Ex K 15 – NBS Scans
gg. Ex K 16 – Breastfeeding Assessment Follow-Up
hh. Ex K 17 – Newborn Care Clinic Note
ii. Ex K 18 – Breastfeeding Follow-Up
jj. Ex K 19 – Kaiser Advice Line Call
kk. Ex K 20 – KPOnCall Interaction
ll. Ex K 21 – WIC Note
mm.
Ex K 22 – Appt Check-In
nn. Ex K 23 – Growth Chart
oo. Ex K 24 – Kaiser Urgent Care Note
pp. Ex H 1 – Progress Note
qq. Ex H 2 – MRI Report
rr. Ex H 3 – Discharge Note
ss. Ex K 25 – Pediatric Progress Note
tt. Ex K 26 – Patient Instructions
uu. Ex K 27 – Transfer Note
vv. Ex K 28 – EPRP Encounter Report
ww.
Ex K 29 – Kaiser Transport Note
xx. Ex D 1 – Investigation Case Comments
yy. Ex D 2 – NBS
zz. Ex D 3 – Anomalous Inconsistent Results Investigation Form
aaa.
Ex C 1 – NBS Accession and Reporting at the NAPS Lab
bbb.
Ex C 2 – Newborn Screening Supervisor’s Daily Review and Release
ccc.
Ex C 3 – MS/MS Newborn Screening Supervisor’s Daily Review and Release
ddd.
Ex C 4 – Kaiser Contract
eee.
Ex R 1 – Kaiser Policy – Discharge Mom, Antepartum
fff.
Ex R 2 – Kaiser NBS Website / Booklet
ggg.
Ex R 3 – APA Newborn Screening Fact Sheets
hhh.
Ex R 4 – AAP Introduction to NBS
iii.
Ex R 5 – Increased Leucine Algorithm
jjj.
Ex R 6 – Newborn Screen – Increased Leucine
kkk.
Ex S 1 – 125000 Accepted Medical Practices
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DECLARATION OF JOHN HARRY SAMSON M.D.
lll.
mmm.
nnn.
ooo.
ppp.
5.
Ex S 2 – 124980 Accurate, Maximum Information
Ex S 3 – 124975 Legislative Findings and Declarations
Ex S 4 – 6503 Newborn Screening Laboratory Requirements
Ex S 5 – 125001 Mass Spectrometers
Ex S 6 – 6500-39 Newborn’s Physician Definition
Based on my education, training and experience, and my review of the medical records set
forth above, I made the opinions set forth in this declaration. Based upon my review of these
materials, I believe the following to be true and correct:
a. On October 4, 2017, at 11:59 AM, Ayden Flucker was born via normal spontaneous vaginal
delivery at 39 and 6/7 weeks-gestation at Kaiser Los Angeles Medical Center (Ex K1 at p. 5490).
He weighed 3625 g (7 lb. 15.9 oz.) and his APGAR scores were 8 and 9, at one and five minutes
of life, respectively (Ibid). At 1:00 PM, nurse Thuy Tran began assisting with breast feeding (Ex
K2 at p. 5502). At 1:10 PM, Dr. Jacquelin Nguyen ordered a newborn screening panel specimen
to be collected prior to discharge (Ex K3 at p. 5508). At 6 hours of life, Dr. Rebecca Demaria
admitted Ayden and began planning his discharge for the following day (Ex K1 at p. 5494). She
recommended “feed[ing] frequently in newborn period, lactation consult..., [n]ewborn screen...
[and d]ischarge home when discharge criteria met and follow-up per hospital protocol” (Ibid.).
Even though it was the policy of Kaiser Southern California Hospitals in 2017 to offer mothers
the option of staying up to 48 hours for uncomplicated normal spontaneous vaginal deliveries
(Ex R1 at p. 1).
b. On October 5, 2017 at 5:58 AM, nurse Rhodora Demesa listed Ayden’s primary problem as,
“breast feeding,” but noted that a LATCH score of 7 was achieved during her shift (Ex K2 at p.
5501). At 11:50 AM, Dr. Maya Rosen noted, “Mom [is] working on breastfeeding..,
[r]eassurance provided.., [and] Baby A Brejeque Collins... to be discharge[d] home with follow
up in 1 days in Newborn Clinic” (Ex K4 at p. 5500). At 12:00 PM, the newborn screen specimen
was collected (Ex K5 at p. 1). The California Newborn Screening Test Request Form listed the
baby’s name as, “Boy Collins,” the inpatient/ordering physician as, “Maya Rosen” and the
outpatient physician (community primary care provider) as, “Joshua May” (Ibid.). However, in
2017 Dr. Joshua May did not function as an outpatient physician for newborns but rather as the
recipient for all newborn screening reports on all babies born at Kaiser Los Angeles Medical
Center as well as other Kaiser medical centers in southern California (Ex K14 at p. 5570).
c. At 3:55 PM, Dr. Demaria filed Ayden’s Discharge Summary noting “Boy A Brejeque Collins...
[will be d]ischarged home after receiving appropriate newborn screening” (Ex K6 at p. 5487).
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DECLARATION OF JOHN HARRY SAMSON M.D.
Ayden’s weight had remained relatively stable at 3590 g (7 lbs. 14.6 oz.), which represented less
than 1% weight loss since birth (Id. at p. 5485). At 4:04 PM, nurse Lida Hayrpatian added the
following problems to Ayden’s chart: “Provide Support During Feeding Sessions, Effective
Breastfeeding, and Breastfeeding (Pediatric, Newborn, NICU) (Ex K7 at p. 5532). At 4:05 PM,
she completed the aforementioned tasks and indicated that his breastfeeding problem had
resolved (Ibid.). At 4:06 PM, nurse Hayrpatian noted Mrs. Flucker verbalized an understanding
of the following signs/symptoms and to call the Advice Line “to seek assistance in further
assessing your baby,” should they occur (Ex K8 at p. 5513, 5517, 5528):
“When to Seek Medical Attention... Poor weight gain for a baby is when they lose more
than 10% of his or her birth weight in the first week, hasn't reached their birth weight by 2 weeks
of age, or gains weight too slowly after 2 weeks of age. Poor weight gain in an infant may be due
to poor breastfeeding technique, not breastfeeding often enough or long enough, not feeding the
baby on demand, not breastfeeding from both breasts, poor let-down reflex, a limited milk supply
because of tobacco use, alcohol use or certain types of medicines or birth control pills...”
“Feeding Readiness Cues... A baby who is hungry will latch on to the breast or bottle and
suck continuously. When getting full during a feeding the baby will take longer pauses between
sucking. A baby who is full will turn away from the breast or bottle and not want to suck...”
“When to Seek Medical Attention... If your baby shows signs of decreased urine
output, increasing jaundice, and sleepiness, your baby needs to be assessed...”
Feeding Tolerance Decreased... Certain feeding difficulties may indicate potential
problems or illness in the infant not feeding well, very sleepy or lethargic, not waking up to eat...”
“Infection Signs/Symptoms... Signs of potential problems or illness in the newborn
include the following, which require immediate medical evaluation: persistent rapid breathing or
working hard to breathe...”
“Persistent Crying... You will learn your baby’s patterns and recognize behaviors that
seem unusual...”
d. At 4:50 PM, Elaine Robertson conducted a breastfeeding consult, noting that Mrs. Flucker was
expressing copious amounts of colostrum, had placed Ayden on her breast 7 times in the previous
24 hours and that he had 3 urinations since birth (Ex K9 at p. 5504). She recommended ad-lib
breast-feeding every 2-3 hours and at early signs of hunger, at least 8-12 times every 24 hours
(Id. at p 5505). At 4:59 PM, nurse Hayrpatian noted that a follow-up appointment had been made
and Ayden was this discharge home (Ibid.). Nearly 5 hours after his newborn screen (which was
ordered to be drawn before discharge) was drawn, Mrs. Flucker and her son were discharged
home (Ex K10 at p. 5483). Upon being sent home, she was handed a sheet which instructed her
to “Call Your Baby’s Provider for:.. Behavior:.. excessive sleepiness... Breathing: difficult
inhaling or exhaling. Cry: cries in an unusual way... Feedings:.. loss of appetite...” (Ex K11 at p.
5538). For advice, she was instructed to call “800-954-8000.”
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DECLARATION OF JOHN HARRY SAMSON M.D.
e. On October 6, 2017, at 11:45 AM, Mrs. Flucker saw Mary Ann Tsutsumi for a breastfeeding
assessment follow-up in clinic the day after Ayden’s discharge (Ex K16 at p. 276). She noted
that Mrs. Flucker had breastfed 18 times in the previous 24 hours and reported the baby had been
“sleepy post circumcision and did not nurse for very long” (Ibid.). Nurse Tsutsumi performed
various interventions to improve his feeding, ultimately noting however, “infant swallows
increased and may need further feeding evaluation” (Id. at p. 277). It does not appear nurse
Tsutsumi voiced her concern about Ayden needing any further feeding evaluation to the newborn
clinic staff as the family medicine resident, Dr. Camille Clefton, who saw Ayden later that day
simply noted, “see lactation notes in mother’s chart for additional information” (Ex K17 at p. 6).
Nurse Tsutsumi’s lactation note, in which she mentions the possibility of a further feeding
evaluation, was never copied over to Ayden’s chart (Ibid.).
f. At 12:14 PM, Ayden was seen in the newborn clinic by Dr. Clefton with Dr. Nicole Morris
(Ibid.). His weight had dropped to 3300 g (7 lb. 4.4 oz.), which was down 325 g from his birth
weight of 3625 g or a decreased of 9% (Id. at p. 7). Thus, by October 6, 2017, Ayden had dropped
from the 71st percentile for weight at birth to the 40th percentile, just 2 days later (Ibid. and Ex
K23 at p. 1). Dr. Clefton planned for Ayden to return to clinic in 1-2 days for a weight check and
in 2 weeks for a well-baby check (Ibid.), yet the only future appointment listed in Ayden’s chart
was not until October 20, 2017, two weeks from the newborn clinic visit (Id. at p. 8). It does not
appear that Dr. Clefton voiced her concern about Ayden’s weight loss or the need for a followup weight check, to any of the newborn clinic staff as no appointment was ever made (Ibid.).
g. At 1:14 PM, Mrs. Flucker was seen by another lactation consultant, Jennufer Lezak, as she still
had concerns about breastfeeding (Ex K18 at p. 283). It appears lactation consultant Lezak
thought Ayden was showing signs of sleepiness as she, “[e]courage[d] mother to keep baby
stimulated while at the breast” (Ibid.). Unfortunately, lactation consultant Lezak does not appear
to have been aware of nurse Tsutsumi’s concern about Ayden needing another feeding
evaluation, as she simply wrote, “follow plan given by previous LC [lactation consultant]” (Id.
at p. 284).
h. On October 11, 2017, Mrs. Flucker called the Kaiser Advice Line (800-954-8000) as instructed
to report “breathing difficulty inhaling or exhaling” (Ex K11 at p. 5538). She called 3 times
between 12:48 PM and 1:41 PM, and was on the line with the Advice Line for a total of 48
minutes, according to Mrs. Flucker’s phone records (Ex K19 at p. 1). The interaction history call
#30266132 indicates the patient’s name to be “LA MED CENTER UNKNOWN” and the
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DECLARATION OF JOHN HARRY SAMSON M.D.
MRN/Patient ID as “0.” The caller’s name was listed as “BREJEQUE FLUCKER” (Ex K20 at
p. 1), not Brejeque Collins as it was listed in the newborn screening request form and elsewhere
in Ayden’s chart (Ex K5 at p. 1). The call was first triaged by Peggy Sue Mountain who noted,
“SOUNDS LIKE HAVING TROUBLE BREATHING,” and transferred the call to a nurse with
a priority of “STAT” at 1:06 PM.
i.
Despite requests of Kaiser to produce any and all recordings, transcripts, or documentation of
Mrs. Flucker’s 4 phone calls which she placed to the Kaiser Advice Line between October 11,
2017 and October 13, 2017, totaling more than 73 minutes (Ex K19 at pp. 1-2), they only
produced a single 4 minute and 42 second recording (Ex K20 audio file). At the start of the call,
one Kaiser receptionist is heard calling advice line nurse Mountain and indicating that a mother
was calling to report her baby “making noises like the baby’s having difficulty breathing” (Id. at
00:17). The receptionist claimed that Mrs. Flucker did not have the baby’s information (Id. at
00:22) and thus it appears, no name, nor MRN was listed on the interaction call log (Ex K20 at
p. 1). This also explains why there were “no notes” listed under “Call Documentation” when
Mrs. Flucker rushed Ayden to the pediatric urgent care clinic two days later (Ex K24 at p. 20),
with complaints of worsening difficulty breathing, as well as excessive sleeping, difficulty
feeding, “issue with tongue... [and] movements that are stiff” (Ex K22 at p. 22). It is unclear why
Mrs. Flucker’s October 11, 2017 calls were not documented in Ayden’s chart properly, given
that Mrs. Flucker read Ayden’s correct MRN (000025265516) to the advice line nurse (Ex K20
at 00:57). She also spelled both her and Ayden’s first and last names, nevertheless, the patient’s
name was listed as “UNKNOWN” in the interaction history (Ex K20 at p. 1).
j.
While we do not have access to the 43-minute call that followed the first two initial calls on
October 11, 2017 (Ex K19 at p. 1), during the brief recording that was produced, Mrs. Flucker
can be heard telling the nurse that her son is “struggling to breath,” and was concerned that he
“can’t breath,” while making a sound as if he is gasping for air (Ex K20 at 02:50). Even more
concerning, she reported after giving Ayden oral Tri-Sol which had been prescribed at the
newborn clinic, “he started to breath like that [gasping for air] even more” (Id. at 03:15). In
response, nurse Mountain simply stated she would have to ask a series of “yes or no” questions
(Id. at 03:43). First, she asked if Ayden was “hard to wake up,” to which Mrs. Flucker responded,
“yeah.” Nurse Mountain spoke over her response and listed other symptoms including, “staring
or shaking” to which Mrs. Flucker responded, “he sleeps a lot, and he falls asleep in the middle
of me feeding him, and yeah, he is hard to wake up” (Id. at 03:50). While she denied seeing him
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DECLARATION OF JOHN HARRY SAMSON M.D.
shake, she did report staring episodes when he was awake (Id. at 04:12). These responses were
apparently documented as the nurse’s keyboard can audibly be heard clicking, while Mrs.
Flucker spoke (Id. at 04:16), however under the section entitled “CSS Screening Questions” from
the interaction history sheet, no questions or responses are listed (Ex K20 at p. 1).
k. During the 43-minute phone call that followed the first two, Mrs. Flucker was apparently told to
place her cell phone’s receiver up against the baby so she could listen to him breath, yet according
to the declaration of defense expert, Dr. Arlene Alikian, “it was determined that there were no
apparent issues with his breathing” (Alikian Declaration at p. 4, lines 19-20). Yet, Ayden’s
symptoms continued to worsen and by October 13, 2017, unable to get a physical evaluation with
Kaiser through the advice line service, Mrs. Flucker went to the closest Women, Infants, and
Children (“WIC”) location to have her son properly evaluated (Ex K21 at p. 1).
l.
On October 13, 2017, Mrs. Flucker took Ayden to the PHFE WIC in Irwindale where they were
seen by lactation consultant, Celia Sanchez who recommended immediate “[a]ction neede by the
HCP [Healthcare Provider] and wrote, “baby hypertonic, baby has a disorganized suck and hard
time grabbing breast. Possible ENT referral. Babies (sic) breathing and crying sounds different.
Baby very sleepy. Try nipple shield - did not [breastfeed]” (Ibid.). She indicated that Mrs.
Flucker had the correct latch-on, positioning and hand expression technique as well as a good
milk supply (Ibid.). On the PHFE WIC “Physician Report for Breastfeeding Infant,” consultant
Sanchez wrote both Dr. Nicole Morris (who saw Ayden on October 6, 2017) and Dr. Michael
Aguinaldo (who was scheduled to see Ayden on October 20, 2017) on the report so that it would
be directed to his listed providers at Kaiser (Ibid.). After failing to feed Ayden and growing
increasingly concerned over his signs and symptoms, the staff at WIC recommended Ayden,
immediately be taken to the hospital for an emergent evaluation (Ex K22 at p 1). Mrs. Flucker
called ahead to inform Kaiser of what she was told at WIC and spoke with someone at the advice
line for 25 minutes beginning at 4:27 PM (Ex K19 at p. 2).
m. At 5:51 PM, Tim Moreno scheduled an urgent care office visit with Dr. Christopher Garomski
at Kaiser Baldwin Park for 6:15 PM that evening (Ex K22 at p. 1). Mr. Moreno documented an
arrival time of 5:52 PM and under scheduling notes, wrote, “difficulty breathing, sleeping a lot.
hardly eating. issue with tongue. movements are stiff. heart murmur (sic)” (Ibid.). At 6:08 PM,
Ayden’s weight was documented to be 3407 (7 lb. 8.2 oz.) and thus he had now fallen from the
71st percentile in weight at birth to the 30th percentile at 9 days of age (Ex K23 at p. 1). Ayden’s
BMI was calculated to be 13.1 kg/m2 and he was tahcycardic to 149. While he was afebrile and
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DECLARATION OF JOHN HARRY SAMSON M.D.
not hypoxic (SpO2 100%), the reason for the visit was listed as “DIFFICULTY BREATHING
while feeding and when not feeding [and] SLEEPINESS.” Yet, Dr. Gadompski’s note makes no
mention of the hypertonia, disorganized suck, and “crying differently” as noted by WIC
consultant Sanchez (Ex K21 at p. 1). His note makes mention of the stiff movements and tongue
issue as documented by Kaiser representative Moreno (Ex K22 at p. 1). Instead, Dr. Gadomski
lists a boilerplate normal exam and under assessment, simply enders the diagnosis code Z71.1 or
“PERSON W FEARED COMPLAINT, NO DIAGNOSIS MADE” (Ex K24 at p. 21). Under
plan, Dr. Gadomski gave “reassurance” and instructed “[r]eturn to clinic if worsens” (Ibid.). No
orders were placed. (Ibid.). No tests or nursing assessments were ordered. (Ibid.) At his
deposition, Dr. Gadomski admitted that he made no effort to look up Ayden’s newborn screening
results and further testified that he did not know where or how to access such results. Thus, no
diagnosis was given for complaints covering several organ systems including neurological
(hypertonia, disorganized suck), metabolic (sleepiness, difficulty feeding), respiratory (difficulty
breathing) (Ibid.). In the end, the Fluckers were reassured that there was nothing to fear, advised
to return home, and told to keep trying to feed Ayden (Ibid.). They did as instructed, and waited
until their first appointment with Ayden’s pediatrician to discuss their concerns further.
n. On October 20, 2017, Ayden was seen for the first time by his assigned pediatrician, Dr. John
Aguinaldo at 16 days of age for his well-baby check (Ex K25 at p. 28). In his note, he wrote,
“[p]atient not feeding well. Patient taking ½ oz every 2 hour. Patient was seen at urgent care on
10/13/17 and diagnosed with fear complaint. Parents state that patient never fed well since before
the discharge from hospital” (Id. at p. 27). Ayden’s weight had fallen to 2955 g (6 lb. 8.2 oz)
which represented the 2nd percentile for his age (Ibid.). On exam, Ayden was lethargic,
dehydrated with cap refill >3 seconds, unable to open his eyes, appeared to have oral thrush, was
bradycardic, and had a weak tone (Ibid.). Dr. Aguinaldo spoke with “Dr. Schram from inpatient”
but there were no beds available for admission, thus 911 was called for transport to the closest
emergency department (Ibid.). He was given Glucagon intramuscularly by the EMTs for a blood
glucose of 53, as he was so dehydrated, they could not place an intravenous line (Ibid.).
o. The Fluckers were given Kaiser Permanente’s Child’s Well Visit Care Instructions advising
parents to, “call your doctor or other clinician if you see signs that your child is having problems..,
your baby cries in an unusual way, your baby is rarely awake and does not wake for feedings,
seems too tired to eat, or is not interested in eating” (Ex K26 at pp. at 38-39). Elsewhere it
instructs them to “call for help [when] concerned that your baby is not getting enough to eat or
8
DECLARATION OF JOHN HARRY SAMSON M.D.
is not developing normally.” (Id. at p. 41). Kaiser’s instructions further state, “[i]t’s also a good
idea to know your child’s test results (Id. at pp. 39-40). Elsewhere it states, “[f]ollow-up care is
a key part of your children’s treatment and safety.., be sure you know the results of all tests and
labs ordered as part of your child’s care” (Ex K26 at p. 38).
p. At 4:45 PM on October 20, 2017, Dr. Lucy Schram documented that Ayden presented to clinic
with poor feeding and an 18% weight loss since birth, appeared lethargic, dehydrated, and
“minimally responsive” (Ex K27 at p. 45). Dr. Schram noted there would be no bed availability
until later that evening, thus she recommended sending him to the closest emergency department
(Ibid.). At 6:28 PM on October 20, 2017, Dr. Duane Hansen noted even after being given
Glucagon, Ayden was, “still altered and very dehydrated” and thus was declared unstable for
transfer and admitted to the NICU at Huntington Memorial Hospital (Ex K28 at p. 52).
q. On October 22, 2017, Huntington Memorial neonatologist, Dr. Nader Bishara, wrote a NICU
progress note with the following relevant history (Ex H1 at p. 48); “Admitted on DOL 16 with
history of very poor PO intake, dehydration with hypernatremia and hyperchloremia, mild
metabolic acidosis, hypercalcemia (total serum Ca was 14.8 with Ca 2.14), possible seizures..,
hypotonia, and severe oral thrush.” On physical exam, Ayden exhibited, “slightly posteriorly
rotated [ears], macroglossia and the mouth appear[ed] somewhat wide and the chin appear[ed]
small... Breathing pattern [was consistent with] kussmaul respirations.., exaggerated inspiration
and moderate retractions, occasional inspiratory stridor.., liver edge is palpable 2 cm below
RCM... Lethargic with little spontaneous movement, is hypotonic, has decreased response to
tactile stimuli, occasional weak whimpery cry, as well as periodic rhythmical pedaling involving
both legs or left leg with alternating swinging arms... Mongolian spots noted on buttocks and
right lower back” (Ibid.). It should be noted that none of the Kaiser nurses or physicians that saw
Ayden up until his admission to Huntington Memorial had identified any of the congenital
anomalies listed by Dr. Bishara including the rotated ears, large tongue that protruded from a
small mouth, and Mongolian spots on his back and buttocks (Ibid.). While not specifically
identified as having “macroglossia,” the WIC lactation consultant did report Ayden’s
disorganized suck and the need, in her opinion for an ENT referral (Ex K21 at p. 1). She also
identified the weak whimpery cry and the Kussmaul respirations that “sound[ed] different”
(Ibid.). In fact, Dr. Bishara’s description of Ayden’s breathing as an exaggerated inspiratory
stridor, is precisely what Mrs. Flucker described over the phone with the advice line nurse on
October 11, 2017 (Ex K20 at 02:50). Despite what the Fluckers, lactation consultant Sanchez,
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DECLARATION OF JOHN HARRY SAMSON M.D.
and Dr. Bishara reported between October 11th and October 22nd, Dr. Gadomski noted normal
breath sounds, respiratory effort, no palpable liver edge (Ex K24 at p. 21). He also made no
mention of Ayden Mongolian spots, nor neurological complaints as the only neurological exam
performed was to note Ayden was alert (Ibid.). There was no comment about Ayden’s primitive
reflexes, nor his rhythmical pedaling (i.e. “stiff movements”), nor hypotonia, all of which were
noted before and after Dr. Gadomski’s urgent care exam.
Dr. Bishara was also able to obtain a more complete history from Ayden’s parents, noting:
“[Ayden] was alert and feeding well on day of birth, but became less active after the
circumcision [which was performed at approximately 20 hours of life] and had not been feeding
well since... Per parents, they were not assigned a pediatrician when they were discharged from the
hospital and were told to follow-up with the Kaiser Peds Clinic at 2 weeks of age which was the
day of admission to our NICU. Infant was seen by Kaiser Lactation the day after discharge from
nursery (DOL 2) and one other time and parents were told they needed to keep the baby awake and
feed him more. Parents were very concerned about his weight loss and lack of interest in feeding,
thus took him to Kaiser Urgent Care an 10/13, and were again told they needed to try harder to get
the baby to eat. Parents followed up at the Peds Clinic as scheduled an 10/20... He was still passing
meconium-like stook on 10/21 (DOL 17)... Per parents, the stridor has been present since birth and
would get louder with crying or agitation... Parents showed Dr. Yang a note from a lactation
consultant who noted her concern that infant was ‘hypertonic.’” (Ex H1 at pp. 50-52).
Concerned about a possible metabolic disorder, Dr. Bishara planned to [f]ollow-up on Newborn
Screen Result (parental consent for release of information faxed to NB screen on 10/20 - Done
at Kaiser Sunset #31-485-756-31 under last name Collins DOB 10/4/17 (Mom's first name
Brejeque, DOB 12/04/92) (Ex H1 at p. 53).
r. On October 23, 2017 at 11:19 AM, Ayden underwent an MRI Brain for possible cerebral edema
(Ex H2 at p. 373). The clinical history included poor feeding, dehydration, and hypotonia. At
2:38 PM, Dr. Jimmy Kang discussed his findings of “[s]ymmetric profound diffusion restriction
within the brain as described above concerning for inborn error of metabolism. The appearance
is compatible with maple syrup urine disease [“MSUD”]” (Ibid.).
s. On October 24, 2017 at 2:54 PM, Dr. Bishara filed a NICU Transfer Summary/Discharge Note
as Ayden was required by Kaiser to be transferred back to LAMC (“Kaiser Sunset”) as they now
had bed availability (Ex H3 at p. 11). Dr. Bishara had already inquired about the initial newborn
screen that was collected on October 5, 2017 and was informed that it was “negative” (Ibid.)
Nevertheless, given the suspicion for a metabolic disorder and the radiographic confirmation on
October 23, 2017, Ayden was made NPO and Dr. Bishara attempted to ensure Ayden remained
NPO through the transfer back to Kaiser (Id. at p. 13), however he was unable to speak directly
with Ayden’s Kaiser physicians and thus, Ayden was restarted on feeds upon being transferred
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DECLARATION OF JOHN HARRY SAMSON M.D.
back to Kaiser on October 24, 2017. Dr. Bishara noted in his transfer summary the plan for a
metabolic disease consult and to follow-up on urine organic acids and plasma amino acids, which
had been ordered to confirm the MSUD diagnosis (Id. at p. 15). On October 26, 2017, the
Handoff Report/Acute Interfacility Neonatal Transport Record which documented Ayden’s
transfer from Huntington Memorial to Kaiser LAMC two days prior, was scanned into Kaiser’s
electronic medical record system and was indexed in Ayden’s chart the following day (Ex K12
at p. 73).
t.
While it only took 2 days for Kaiser to scan the transport record into Ayden’s chart, it took more
than 6 weeks for Ayden’s Newborn Screening Results to be scanned by Kaiser’s medical records
department and another 2 days to get indexed into Ayden’s chart (Ex K15 at p. 5572).
Furthermore, it took more than 2 months for the results to be sent to the “Newborn’s Physician:
JOSHUA MAY, MD and said copy to be scanned into Kaiser’s system, which did not occur until
December 14, 2017 (Ex K3 at p. 5509). The Newborn Screening Panel order indicates that
Kaiser’s Genetic Testing Laboratory also known as Kaiser South Biochemical Genetics or the
NAPS laboratory performed the analysis of Ayden’s blood specimen on October 7, 2017 at 7:19
AM (Ibid.). It also states that “[r]esults and interpretation will be mailed out to all providers by
the California State Genetic Disease Branch... Note: The results and interpretation are not
available at Kaiser Genetic Testing Laboratory” (Ibid.). Thus, even though Ayden’s newborn
specimen was collected by a Kaiser nurse, analyzed by a Kaiser lab technician, reviewed for
holding and further testing or release by Kaiser’s lab supervisor, Kaiser’s physicians did not have
access to the data until more than 2 months after it was initially analyzed (Ibid.).
u. Had that data been made available to Ayden’s providers by October 11th and October 13th, then
advice line nurse Mountain and urgent care pediatrician, Dr. Gadomski would have seen that
even the initial results (which were subsequently discovered to have been highly inaccurate due
to laboratory error), showed several “out-of-range” analytes including a total Leucine/Isoleucine
level of 474.5 and a Valine:Phenylalanine ratio of 5.2 (nearly twice the upper cutoff of 250
umol/L for Leucine/Isoleucine and nearly 50% above the upper cutoff of 3.5 for the
Valine:Phenylalanine ratio) (Ex K14 at p. 2). These values were flagged in red highlight as
“High.”
v. On the same page as the aforementioned flagged analytes of Leucine, Isoleucine, and Valine (the
three branched chain amino acids that cannot be metabolized by those with MSUD) the report
states: (Ibid.).
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DECLARATION OF JOHN HARRY SAMSON M.D.
“Test interpretations are based on the Birth/Collection Information provided above and
subject to disclaimer below. Due to biological variability of newborns and differences in detection
rates for the various disorders in the newborn period, the Newborn Screening Program will not
identify all newborns with these conditions. While a positive screening result identifies newborns
at an increased risk to justify a diagnostic work-up, a negative screening result does not rule out
the possibility of a disorder. Health care providers should remain watchful for any sign or
symptoms of these disorders in their patients. A newborn screening result should not be
considered diagnostic, and cannot replace the individualized evaluation and diagnosis of an
infant by a well-trained, knowledgeable health care provider.”
w. Due to the Kaiser lab’s error in measuring and reporting an inaccurate Alanine level of 460.68
umol/L (474.5 umol/L / 1.03 = 460.68 umol/L), when the true and accurate level was measured
by the state to be 256.48 umol/L (407.8 umol/L / 1.59 = 256.48 umol/L) (Ex D3 at p. 2), the initial
results analyzed and reported by the Kaiser lab on October 7, 2017, did not flag as presumptively
positive because the Alanine was falsely elevated by nearly double the accurate value later measured
by the State’s lab when they retested the newborn screening specimen collected on October 5, 2017
(Ibid.). Nevertheless, even the erroneous results initially reported by Kaiser only missed one of the
three cutoffs by approximately 6.5% (Lecine:Alanine ratio was initially measured by Kaiser’s NAPS
lab at 1.03, when the accurate value later measured by the State’s lab was reported to be 1.59, far
above the cutoff of 1.1, which would have flagged Ayden’s newborn screen as presumptively positive
and avoided everything that happened after October 7, 2017 (Ibid.).
x. However, even the erroneous results, had they been made available to Ayden’s providers in their
original color form with red highlights for out-of-range values (Ex K14 at p. 2), would have triggered
an investigation into a possible metabolic disorder, either by ordering an amino acid panel or other
diagnostic tests such as the presence of alloisoleucine which is considered pathognomonic for MSUD
(Ex D1 at p. 1). Instead, a black and white faxed copy of the report is scanned into Kaiser’s EMR
system more than 6 weeks after the results were finalized (Ex K15 at p. 85 and p. 87). There is no red
highlight flagging Leucine, Isoleucine, and the Valine/Phenylalanine ratio as “High.” (Ibid.).
Furthermore, the report misidentifies the “Newborn’s Physician [as] Joshua May” (Ibid.). Addressing
the results to Dr. May who was never intended to be the physician caring for Ayden, either in the
nursery, the NICU or the outpatient community setting, violates the State’s Newborn Screening
Program protocols which defines the ‘Newborn’s physician’ [as] the physician caring for the newborn
or infant in the perinatal licensed health facility’s normal newborn nursery or neonatal intensive care
unit or in the outpatient community after discharge” (17 CCR §6500.39). Dr. May fulfilled none of
those rolls and admitted at his deposition that he only occasionally looked at the second page of the
thousands of newborn screening results that were mailed to him in 2017 for all babies born at Kaiser
LAMC, and only for his own personal patients that he saw for endocrine disorders. In other words,
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DECLARATION OF JOHN HARRY SAMSON M.D.
had the TSH had been flagged as high, he might have noticed it, but since he was not a metabolic
specialist, not only was he not aware of the significance of an elevated Leucine, he did not bother to
check since MSUD was not his specialty. However, unlike all the other physicians who have been
deposed in this case who have personally ordered newborn screening tests and been mailed or
provided the complete results (including the second page), those at Kaiser who cared for Ayden, did
not have the knowledge of how to access or the ability to access said results.
y. Ultimately however, if Kaiser had properly performed the initial newborn screening from the start
and reported the values that the State eventually measured on November 7, 2017, then Ayden’s
specimen would have been flagged as presumptively positive, he would have been placed on a protein
restricted diet, and Ayden’s neurological injury would have been averted (Ex D3 at p. 2). According
to the state’s investigator, Dr. Partha Neogi, “this anomaly may be due to possible contamination of
the particular well from an unidentified source.” Instrument to instrument variation was also put
forward as a possible explanation for the discrepancy between the Alanine value measured by Kaiser
to be 460.68 umol/L and not the accurate value measured by the State to be 256.48 umol/L.
(Ibid.). Despite Kaiser’s claim that the deviation was simply due to acceptable standard error or
variation and that “contamination in a lab can happen absent negligence,” Kaiser’s expert, Dr.
Donald Chace, puts forth no evidence or basis for such an opinion (Chace Declaration at p. 10,
line 9). He also makes several other erroneous statements. For example, he and all of the other
defense experts claim that the State of California owns the MSMS instruments and equipment
that Ayden’s sample was run on (Chace Declaration at p. 9, lines 14-15), however this is
contradicted by the Division Chief of the Genetic Disease Screening Program, Dr. Richard
Olney, who testified at deposition that the State does not own the equipment Kaiser used to run
Ayden’s newborn screening specimen. Furthermore, the statute creating the genetic disease
testing program states, “If the department determines that contracting for these services is more
cost effective, and meets the other requirements of this chapter, than purchasing the tandem mass
spectrometry equipment themselves, the department shall contract with one or more public or
private laboratories.” (§1250001(b))
z. Kaiser’s experts correctly state that the Kaiser South Biochemical Genetics Lab was, “not free
to deviate from the contracts or the protocols set forth by the State of California.” (Chace
Declaration at p. 4, lines 21-22). However, by analyzing and reporting an Alanine level that was
nearly twice as high as its actual and accurate measurement, Kaiser violated the contracts and
protocols set forth by the State (Ex D3 at p. 2). For example, the statute provides, “the
information, tests, and counseling for children shall be in accordance with accepted medical
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DECLARATION OF JOHN HARRY SAMSON M.D.
practices... and shall follow the standards and principles specified in Section 124980,” which
states in part, that “clinical testing procedures established for use in programs, facilities, and
projects shall be accurate, provide maximum information, and the testing procedures selected
shall produce results that are subject to minimum misinterpretation.” By definition, the initial
Alanine level measured by Kaiser’s lab was not accurate, did not provide maximum information
and the results were subsequently misinterpreted by the State as “no follow-up required.” Had
Kaiser initially reported the accurate Alanine level, Ayden’s sample would have been
automatically flagged as presumptively positive.
aa. However, even despite the initial error, Kaiser’s laboratory supervisor had complete oversight
and was charged with evaluating each and every MS well to judge on his/her own whether the
sample should be scored as green for release, yellow for hold, or red for further testing (See
“Kaiser’s Newborn Screening Supervisors Daily Review and Release Using Specimen Guide”
and the “MS/MS Newborn Screening using NeoBase Supervisor’s Daily Review and Release”).
These contracts require the Kaiser lab director to utilize critical judgement in analyzing
specimens and quality control parameters to ensure that such contamination errors do not occur
(Ibid.).
6.
It is my opinion based upon my review of the materials in this case, and further based on my
education, training, and experience, that the care provided to Ayden Flucker from his birth to his
transfer to Huntington Memorial Hospital on October 20, 2017, fell below the standard of care. First,
Kaiser’s expert, Dr. Arlene Alikan claims that it was not a breach in the standard of care to be
influenced by the State’s newborn screening results that the results were negative and did not require
follow up because the pediatricians and on call nurse conducted their own independent evaluation.
Putting aside for the moment, my opinion that said evaluations, fell below the standard of care given
the severity, consistency, and progressive nature of the complaints reported by Mrs. Flucker on
October 11, 2017 and again on October 13, 2017. The simple fact that Kaiser reported a falsely
elevated Alanine level that was nearly twice the actual measurement by the state and due to
contamination from an unidentified source (either the MSMS instrument on which Ayden’s sample
was run, consistently reported elevated Alanine levels for several runs/days or another specimen in
an adjacent well which was run at the same time and had a spike in the Alanine level, caused Ayden’s
sample to be falsely elevated), means that Kaiser violated the State’s statute to report accurate results
subject to minimum misinterpretation. Putting aside, Kaiser’s negligence in performing the mandated
newborn screen properly, from a clinical perspective, by sending the results to an endocrinologist
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DECLARATION OF JOHN HARRY SAMSON M.D.
who was not Ayden’s physician, Kaiser ignored the State’s requirement that the newborn’s physician
actually be the provider caring for the patient. Such a system fell below the standard of care because
it prevented the provider from utilizing all of the available data. Because the results indicating an
elevated Leucine, Isoleucine, and Valine were never sent to Ayden’s care providers, they were falsely
led to believe there were no metabolic issues.
7.
It is my further opinion based upon my review of the materials in this case, and further based
on my education, training, and experience, that the care provided to Ayden on October 6, 2017 fell
below the standard of care as nurse Tsutsumi failed to voice her concern about Ayden needing any
further feeding evaluation to the newborn clinic staff and failed to make an appointment for a weight
check. Had nurse Tsutsumi done so, this would have provided another opportunity for a clinician to
perform a physical exam and intervene before October 20, 2017.
8.
It is my further opinion based upon my review of the materials in this case, and further based
on my education, training, and experience, that the care provided to Ayden on October 11, 2017 by the
Kaiser advice line nurses, fell below the standard of care. First, Mrs. Flucker described Ayden gasping
for air, having difficulty breathing, difficulty awakening - answering all of nurse Mountain’s screening
questions in the affirmative. This should have triggered a recommendation that Mrs. Flucker take
Ayden in to be seen urgently. Second, it is certainly below the standard of care for a nurse to use a
telephone receiver as a stethoscope to evaluate stridor. While it is true that upwards of 87% of all cases
of stridor in infants and children is due to a congenital anomaly of the airway, not all of these conditions
are benign. Stridor is caused by turbulent air flow in the larynx or lower in the bronchial tree and is a
sign of a narrowed or obstructed airway. Inspiratory stridor often occurs in children with croup or it
may be cause by a foreign body lodged in the airway. While Dr. Alikan claims there was no breach in
the standard of care to perform such an assessment of stridor over the phone, because he was
subsequently diagnosed with Congenital Laryngeal Stridor, “which is a common newborn issue that
does not require further intervention.” (Alikian Declaration at p. 9, lines 16-17). Ayden was also
diagnosed with Kussmaul respirations with inspiratory stridor (Ex H1 at p. 48). Had nurse Mountiain
recommended Mrs. Flucker take Ayden so a provider could listen to his breathing, this would have
provided another opportunity for a clinician to perform a physical exam and intervene before October
20, 2017.
9.
It is my further opinion based upon my review of the materials in this case, and further based
on my education, training, and experience, that the care provided to Ayden on October 13, 2017 by the
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DECLARATION OF JOHN HARRY SAMSON M.D.
Kaiser advice line nurse and Dr. Gadomski, fell below the standard of care. At less than 2 weeks of
age with such a constellation of symptoms including difficulty breathing, lethargy, stiff movements,
hypertonia, disorganized suck, difficulty feeding, weight loss from the 71 st percentile at birth to the
30th percentile at 9 days of life, the advice line nurse and Dr. Gadomski should have had a high
suspicion for neonatal sepsis, which he was eventually diagnosed with, seven days later. At that time,
Dr. Bishara noted several congenital anomalies which were never identified by any of the Kaiser staff
at any point prior to October 20, 2017. It was below the standard of care for Dr. Gadomski not to
perform a complete physical, including a neuro exam given the reports of hypotonia, stiff movements,
and lethargy. It was below the standard of care for Dr. Gadomski not to inquire or attempt to retrieve
Ayden’s newborn screening results. Had Dr. Gadomski done so and seen the elevated Leucine level,
this should have triggered at least some further investigation, and at a minimum a blood glucose as
hypoglycemia would have been simple to diagnose and treat as it was on October 20, 2017 when
Ayden’s glucose was measured to be 53. Had any of the aforementioned tests been ordered, it is my
opinion that Ayden Flucker would have been diagnosed with MSUD before October 20, 2017, in order
to prevent or substantially limit Ayden’s neurological injuries.
I declare under penalty of perjury under the laws of the State of California that the foregoing
is true and correct. Execute this 23 day of February, 2022, at Long Beach, California.
_______________________________
JOHN HARRY SAMSON M.D.
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DECLARATION OF JOHN HARRY SAMSON M.D.