Uploaded by devonfagel

*Flucker Opp to MSJ

advertisement
I. STATEMENT OF FACTS
II. WHETHER A LAB TECHNICIAN AND/OR SUPERVISOR EMPLOYED BY KAISER IS SUBJECT TO
LIABILITY FOR FAILURE TO PROPERLY PERFORM THE PLAINTIFF’S NEWBORN SCREEN AS
MANDATED IS A QUESTION OF FACT………….....…...
III. CREASON IS DISTINGUISHED FROM FLUCKER BASED ON WHICH TYPE OF ENTITY WAS
ALLEGEDLY NEGLIGENT; WHAT DUTY WAS BREACHED; WHEN THE ALLEGED BREACHES
OCCURRED; AND WHO WAS INJURED …………………………………………………..….......
A. Public Versus Private Entity……………………………………………...……...……….
B. Discretionary Versus Mandatory Duty…………………………....……………………..
C. Breach Before Versus During Negligent Act……………………………………...……..
D. Public Harm Versus Individual Injury………………………………………........…..…
IV. EVEN IF KAISER IS A PUBLIC ENTITY, IT IS STILL NOT IMMUNE FROM SUIT UNDER THE
CALIFORNIA TORT CLAIMS ACT …………………………………………………..……....
A. Kaiser’s Mandatory Duty to Perform the Plaintiff’s Test in Accordance with the Standards Set
Forth by the State, Precludes Protections Under §820.2………………..……..…...
B. Kaiser’s Mandatory Duty to Perform the Plaintiff’s Test for the Purpose of Treatment Through
Medical Intervention, Precludes Protections Under §855.6…………………..................
C. Kaiser’s Mandatory Duty to Perform the Plaintiff’s Test in Order to Protect Against the Risk of
Disabilities, Imposes Liability Under §815.6……….......................................................
V. THE PLAINTIFF HAS EXCEEDED THE REQUIREMENT TO OVERCOME SUMMARY JUDGEMENT
GIVEN THEIR WELL-CREDENTIALED EXPERTS HAVE PRESENTED OPPOSING OPINIONS GIVING
RISE TO MATERIAL ISSUES OF FACT FOR TRIAL
1
I. STATEMENT OF FACTS
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), Mrs. Flucker was not given that option.
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 LAMC as well as other Kaiser medical centers in southern California (Ex K14 at p. 5570).
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). 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 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...”
2
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 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...”
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.”
On October 6, 2017, at 11:45 AM, Mrs. Flucker saw Mary Ann Tsutsumi for a breasfeeding 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.).
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 follow-up weight check, to
any of the newborn clinic staff as no appointment was ever made (Ibid.).
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,
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).
3
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 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.
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).
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 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).
4
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).
On October 13, 2017, Mrs. Flucker took Ayden to the PHFE WIC in Irwindale where they were seen by
lacation 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).
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 murmer (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 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 reults 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,
5
the Fluckers were reassured 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 further.
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 IV (Ibid.).
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 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).
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).
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
6
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, 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, 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 meconiumlike 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).
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.).
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 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
7
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).
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.).
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-ofrange” 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.”
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.).
“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.”
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
8
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.).
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, 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 tests and been 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.
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 depositon that the State does not own the equipment Kaiser used to run Ayden’s newborn screening specimen.
9
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))
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
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.
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.).
II. WHETHER A LAB TECHNICIAN AND/OR SUPERVISOR EMPLOYED BY KAISER IS SUBJECT TO
LIABILITY FOR FAILURE TO PROPERLY PERFORM AYDEN’S NEWBORN SCREEN AS MANDATED IS
A QUESTION OF FACT
Kaiser previously argued, “whether one is an employee or independent contractor is usually a question of
fact.” (See Defendant’s Opposition to Plaintiff’s First Demurrer). Kaiser also insists, “[a] private entity is an
artificial person who can only function through its agents, and here, those agents were acting as servants of the
State.” Then stated, “the immunities that protect the State also apply to State employees and servants, and if the
State has immunity, then the employees and servants of the State have immunity.” There are very clear legal
distinctions between employee, independent contractor, agent, and servant, however the Defendant apparently
believes, no matter the label, Kaiser was immune.
Focusing mostly on the phrase, “servant of the State,” the Defendant seeks to create a legal category which
does not exist in the context of clinical laboratories and state-mandated screenings. Kaiser fails to cite a single case
which even contains the word, “servant,” no less defines its meaning. In fact, it only appears once in §810.2 of the
Government Claims Act, which defines “employee” to include, “an officer, judicial officer as defined in Section
10
327 of the Elections Code, employee, or servant, whether or not compensated, but does not include an independent
contractor.” According to Legislative Committee comments, “servant” was substituted for “agent” to restrict the
liability that public entities could face for “agents” who the State did not directly control. It was not meant to extend
immunity to any entity contracted with the State to provide mandatory screens.
The evidence in this case and the statutory scheme for newborn testing show, that at most, Kaiser was an
independent laboratory contractor performing mandated testing. Even so, according to the Supreme Court, the
relationship between Kaiser and the State bore no resemblance to that of servant-master (See State ex rel Dept of
CHP. V Superior Court, 60 Cal.4th 1002). In that case, the Court held a CHP Freeway Service Patrol (FSP) program
did not give rise to a special employment relationship between CHP and a private tow truck driver sufficient to
make the driver an “employee” of the CHP under the vicarious liability provisions of the Government Claims Act.
Under the statute, tow-truck operators contracted with the county transportation authority, CHP officers directed
tow-truck drivers to provide roadside assistance, and the tow-trucks were required to bear a CHP logo. Nevertheless,
since CHP did not select the tow-truck drivers, the Court held there was no “special employment relationship.”
Here, the State did not select the nurse who collected Ayden’s sample, nor the lab technician who ran the test, nor
the lab manager who authorized its reporting.
Kaiser also attempts to conflate state control of laboratories with mandated obligations for an independent
health care service plan that owns and operates its own private laboratories. While the state “sets quality controls
for the lab” as the Defendant points out, those are simply minimum standards that laboratories must follow. In the
Defendant’s first amended answer, Kaiser quoted the following from the state’s investigation report, that “[a]ll the
quality control parameters of the MSMS instrument at [Kaiser’s] NAPS Lab at the time of analysis of this specimen
was within acceptable range.” That simply means the machine was working properly, which leaves human error as
the only explanation for the contamination error. In other words, Kaiser was required to maintain the mass
spectrometer according to State standards, and the instrument appeared to have been working properly when
Ayden’s specimen was tested. Nowhere does the report say the instrument operator used it properly. There is no
support for Kaiser’s conclusory statements that its employees were “following all the protocols set by the state.”
And given it was not an employee of the State but an employee of Kaiser who contaminated Ayden’s sample and
reported erroneous results, Kaiser cannot claim immunity for a mistake that the State had nothing to do with.
In State ex rel Dept. of CHP, the Court held that even though the private tow-truck drivers were controlled
by the CHP as they were directed when and where to provide roadside assistance by public officers, the truck drivers
were not considered servants of the State, as the privately employed drivers ultimately controlled operation of the
vehicles. In this case, the State had no day-to-day control of the Kaiser NAPS laboratory’s operation, not to mention
control over the operation of each individual blood test, whether at bedside collection by the Kaiser nurse, bench
side analysis by the Kaiser lab technician, or results reporting by a Kaiser laboratory manager. Without some amount
of day-to-day operational control of Kaiser’s testing, it cannot be said to be acting as a servant of the State.
Kaiser states its laboratory employees, “are obligated to follow the protocols and parameters set by the
State...” and that “Kaiser South Biochemical Genetics Lab is not free to deviate from the contracts or the protocols
11
set forth by the State...” Yet, by contaminating the specimen and reporting an erroneous Leu/Ala ratio that was
below cutoff, Kaiser was clearly not complying with said “protocols and parameters.” Put differently, imagine that
Kaiser tested the wrong newborn and thus reported inaccurate results causing a missed diagnosis and permanent
brain damage. Should Kaiser be immune simply because the test was mandated by the State? That is what happened
here. Contamination errors are equivalent to testing the wrong blood from an “unidentified source.”
Kaiser is also conflating “protocols and parameters,” which are two entirely different concepts in laboratory
medicine. Protocols refer to how a test is performed, namely how the newborn’s specimen is collected, logged,
transported, and analyzed in order to ensure accurate results. Those results are then interpreted using predetermined
parameters which are carefully defined by the State to ensure accurate diagnosis. Relying on expert opinions as
defined by the Hereditary Disorders Act, the State defines said testing protocols and diagnostic parameters in order
to minimize false positives and false negatives as much as possible. Given the discretionary or quasi-legislative
nature of making these determinations or judgment calls, the State is immune from liability, should a newborn be
misdiagnosed due to their blood results falling outside the predetermined parameters. In Ayden’s case, Kaiser failed
to follow the State’s testing protocols by contaminating his blood sample and reporting erroneous results. While
Kaiser did follow the State’s diagnostic parameters and not initially diagnose Ayden as presumptively positive for
MSUD, doing so was meaningless as it was based on inaccurate results from Kaiser’s mistake.
This confusion of testing protocols with diagnostic parameters explains why Defendant’s reliance on
Creason v. Department of Health Services, is unfounded. Rather, Ayden’s case is consistent with Smith v. County,
20 Cal.App.4th 1826. In Creason, the State’s diagnostic parameters were alleged to have caused injury, however the
Defendant Department of Health Services was deemed to be immune from liability given the discretionary nature
associated with setting diagnostic parameters. In Smith, the Defendant state employee performed the wrong test
causing injury due to the lack of accurate results and thus was deemed liable for failing to follow testing protocols.
This case is about contamination, similar to Smith. It is not about cut-offs, thus Creason is inapplicable.
III. CREASON IS DISTINGUISHED FROM FLUCKER BASED ON THE TYPE OF ENTITY WHICH WAS
ALLEGEDLY NEGLIGENT; WHAT DUTY WAS ALLEGEDLY BREACHED; WHEN THE ALLEGED
BREACHES OCCURRED; AND WHO WAS INJURED
A. Public Versus Private Entity
In Creason, the Plaintiffs sued the State Department of Health Services for its alleged failure to exercise
reasonable care in formulating testing and reporting standards when the Department had previously determined
only newborn screening tests resulting in an elevated TSH and a low T4, met criteria for hypothyroidism. The child
was misdiagnosed because both her TSH and T4 were high. The Court held the State exercised its discretionary or
quasi-legislative duty to define appropriate standards and that the formulation of said standards was not done for
examination or diagnosis. (See Creason v Department of Health Services, 18 Cal.4th 623)
Here, Ayden is suing Kaiser, a private entity for breaching its mandatory duty to perform his newborn
screening with accurate results and minimum misinterpretation. The Plaintiff has made no allegation against the
State claiming high cut-off values for the Leu/Ala ratio caused his misdiagnosis. Rather, the Plaintiff alleges Kaiser
12
breached its mandatory duty, contaminating Ayden’s specimen and causing his misdiagnosis. As explained in detail
above, Kaiser and its employees are not State employees, which distinguish this case from Creason.
B. Discretionary Versus Mandatory Duty
This case is also distinguishable from Creason, based on the nature of the duty which was allegedly
breached, and more consistent with the facts in Smith v County, 20 Cal.App.4th 1826. In Smith, the Plaintiff, a police
officer, was exposed to a person’s blood raising concerns of exposure to HIV. Yet, the County employee who tested
the blood, mistakenly performed a hepatitis rather than an AIDS test, resulting in anguish over the uncertainty of
his HIV status. Performance of the AIDS test was not discretionary, once the public employee collected and tested
the person’s blood. Likewise, here, Kaiser’s duty to perform an accurate newborn test was mandatory. However, in
Creason, the alleged breach involved a discretionary act in determining testing standards. This distinction is critical,
as “immunity is usually extended to the ‘planning’ rather than the ‘operational’ levels of decision-making,”
demonstrated by comparing when the negligence in each case occurred. (See Johnson v. State of California (1968)
69 Cal.2d 782, 793-794).
In Creason the Court first had to determine whether the alleged duty was mandatory or not. Under
Government Code §815.6, “a public entity is liable for an injury proximately caused by its failure to discharge a
mandatory duty designed to protect against the risk of a particular kind of injury...” (Morris v County of Marin
(1977) 18 Cal.3d 901, 904.) Whether a particular statute is intended to impose a mandatory duty, rather than a mere
obligation to perform a discretionary function, is a question of statutory interpretation for the courts. (Nunn v. State
of California, 35 Cal.3d. at p. 624.) In Creason, the Court interpreted the Hereditary Disorders Act as having given
the State “substantial discretion in formulating and reporting appropriate testing standards.” The statute granted the
Department of Health the authority to “establish appropriate regulations and testing methods.” Under the reasoning
in Johnson, the Court held that, “drafting of rules, regulations and standards by the governmental agency charged
with that responsibility would unquestionably fall in the category of discretionary basic policy decisions for which
governmental agencies usually are insulated from civil liability.” The Court further stated, “immunity is usually
extended to the ‘planning’ rather than the ‘operational’ levels of decision making, i.e., “those areas of quasilegislative policy-making...”
In this case, the rules, regulations and testing methods did not cause Ayden’s injury. Rather, his permanent
brain damage was proximately caused by Kaiser’s failure to follow said rules, regulations and testing methods. The
alleged breach occurred at the operational level whereby the specimen was contaminated by a Kaiser employee and
Ayden’s Leu/Ala ratio was erroneously reported to be below the cutoff value for diagnosing MSUD. This distinction
is clarified by comparing the timing of events.
C. Breach Before Versus During Negligent Act
In Creason, the alleged negligence occurred before the newborn test took place, when the state established
criteria for hypothyroidism. In Smith and Flucker, the alleged negligence occurred during the actual tests, both of
which were performed for the purpose of diagnosis and treatment. This second distinction, namely the purpose of
each Defendant’s respective undertaking, involves Government Code §855.6, which provides that a public entity
13
may not be held liable for failing to perform a physical or mental examination, “except for an examination or
diagnosis for the purpose of treatment.” As Creason points out, “the ‘purpose of treatment’ exception was intended
to be narrowly applied to cases involving negligent treatment of particular individuals in doctors' offices or
hospitals, rather than to the initial development of testing and reporting standards governing laboratory tests given
to help detect.” Here, the negligent performance of Ayden’s newborn testing is at issue, no matter how much Kaiser
wishes to make this case about the State’s formulation of testing standards/cutoffs, which occurred well before
Kaiser’s negligent act(s).
In Creason, the Court explained that, “any negligence on defendant's part occurred not while testing Sierra
but earlier, during the formulation of the standards designed for interpreting and reporting the results of the tests
ultimately given.” As in Smith, negligence on the part of Kaiser occurred during the performance of Ayden’s actual
test. In Creason, the Court further explained, “although the state-mandated test here was properly performed under
the testing procedure established by the State.., plaintiffs allege the Department negligently determined not to report
certain test results as indication of possible hypothyroidism.” In Ayden’s case, the state-mandated test was
performed improperly due to contamination error and had nothing to do with the State’s discretionary duty in
formulating cutoffs. The distinction between Kaiser’s contamination error and the State’s cutoff value for Leu/Ala,
is of particular importance when comparing public burden with individual injury and when considering the ultimate
legislative intent.
D. Public Burden Versus Individual Injury
The Legislative findings and declarations in §124975 of the Hereditary Disorders Act state the following,
which are particularly pertinent in cases of MSUD:
(b) Hereditary disorders, such as sickle cell anemia, cystic fibrosis, and hemophilia, are often costly, tragic, and
sometimes deadly burdens to the health and well-being of the citizens of this state.
(c) Detection through screening of hereditary disorders can lead to the alleviation of the disability of some
hereditary disorders and contribute to the further understanding and accumulation of medical knowledge about
hereditary disorders that may lead to their eventual alleviation or cure.
(d) There are different severities of hereditary disorders, that some hereditary disorders have little effect on the
normal functioning of individuals, and that some hereditary disorders may be wholly or partially alleviated
through medical intervention and treatment.
Within any statute, the Legislature often indicates more than one type of duty and purpose underlying the bill. For
example, in the Hereditary Disorders Act, the State Department of Health was charged with utilizing its expertise
when exercising its discretionary duty regarding where to set cutoff values. Too many false positive can raise testing
costs and cause unnecessary parental anxiety surrounding follow-up tests. However, while there will always be
some false negatives, the Department also formulates mandatory licensing and regulatory standards for laboratories
conducting such important tests, because as this case demonstrates, a single misdiagnosis due to lab error, can have
such devastating results. In striking the right balance, the Department exercises its quasi-legislative duties involved
in “planning” and developing the testing program, for which the State cannot be held liable. However, regardless
of its classification as a private entity or “State servant,” the Act also established mandatory duties for laboratories
such as Kaiser as they carry out the day-to-day “operational” testing requirements.
14
Likewise, the Act also indicates multiple purposes as it screens all newborns or the public at-large for
hereditary disorders which may be wholly or partially alleviated by an accurate diagnosis and treatment. Doing so
was meant to identify those with hereditary disabilities in order to intervene before it effects the “normal functioning
of [these] individuals.” Screening was also meant to reduce costs to the “citizens of this state” and “contribute to
the further understanding and accumulation of medical knowledge.” Yet, all of those goals whether for an individual
patient or for the accurate knowledge about this rare disorder, are not achievable if the tests are contaminated.
In Creason, the Court had great concern that by removing immunity protection afforded to the State for
carrying out its discretionary duty to balance the public costs with individual harms, “may well threaten the
continuation of a generally beneficial statewide program that has screened millions of California babies for disabling
congenital disorders.” That concern is not at issue in this case. Here, Kaiser’s failure to carry out its mandatory
screening requirements and adhere to accepted standards of laboratory practice, should impose civil liability, even
if it is deemed to be a public “servant” for their devastating injury to an individual later found to have MSUD.
V. THE PLAINTIFF HAS EXCEEDED THE REQUIREMENT TO OVERCOME SUMMARY JUDGEMENT
GIVEN THEIR WELL-CREDENTIALED EXPERTS HAVE PRESENTED OPPOSING OPINIONS GIVING
RISE TO MATERIAL ISSUES OF FACT FOR TRIAL
Based on their review of the relevant medical records, as well as their education, training, and experience
treating patients like Ayden Flucker, Plaintiff’s experts have laid out their opinions that Kaiser, its physicians,
nurses, laboratory technicians/supervisors failed to meet the standard of care with regard to the treatment of Ayden
Flucker between October 4, 2017 and when he was eventually diagnosed more than three weeks later, thereby
proximately causing Ayden Flucker’s severe neurological injuries that he suffered as a result of not being flagged
as presumptively positive for MSUD on October 7, 2017 due to Kaiser’s laboratory error causing the supervisor to
report an inaccurate Alanine value that was nearly double the true measurement as determined by the State. By
definition, the inaccurate Alanine value violated the contract and protocols set forth by the State which mandate
that all laboratories follow accepted medical practices and produce accurate testing results subject to minimum
amount of confusion. But for Kaiser’s laboratory error, Ayden’s specimen would have been flagged as
presumptively positive for MSUD and he would have been placed on a restricted protein diet before substantial
neurological injury had occurred. While Dr. Chace claims that such an error may happen in the absence of
negligence, he provides no basis for such an opinion.
Based on their review of the relevant medical records, as well as their education, training, and experience
treating patients like Ayden Flucker, Plaintiff’s experts have laid out their opinions that Kaiser failed to meet the
standard of care on October 6, 2017, 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 to prevent Ayden’s neurological injuries.
Based on their review of the relevant medical records, as well as their education, training, and experience
treating patients like Ayden Flucker, Plaintiff’s experts have laid out their opinions that Kaiser failed to meet the
15
standard of care on October 11, 2017. 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
Congentical 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. 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.
Based on their review of the relevant medical records, as well as their education, training, and experience
treating patients like Ayden Flucker, Plaintiff’s experts have laid out their opinions that Kaiser failed to meet the
standard of care on October 13, 2017. 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 71st 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 congential 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.
16
Download