Kumra v. Abbott Laboratories

Filing 124

ORDER re: 70 84 and 110 . For the reasons set forth in the attached Opinion and Order, Defendant's motions to strike the specific causation testimony of Drs. Lewis, 84 , and Stodgell, 70 , are GRANTED; Defendant's motion for Summary Judgment, 110 , is GRANTED. Ordered by Magistrate Judge Ramon E. Reyes, Jr on 5/22/2017. (Naidich, Zachary)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF NEW YORK
_____________________
No 14-CV-4875 (RER)

_____________________
N.K. AN INFANT BY HIS MOTHER AND NATURAL GUARDIAN,
TANJA BRUESTLE-KUMRA,
Plaintiff,
VERSUS

ABBOTT LABORATORIES,
Defendant.
___________________
OPINION & ORDER
___________________

May 22, 2017

RAMON E. REYES, JR., U.S.M.J,
70, 84). Upon review of the proposed
testimony and witness qualifications, I
conclude that neither of the proffered
witnesses may testify as to specific causation.
Because Plaintiffs are incapable of offering
any other admissible evidence on this
required element of their claims, I find
summary judgment appropriate and grant
Abbott’s motion.

Tanja Bruestle-Kumra (“BruestleKumra”) and her infant child N.K.
(collectively “Plaintiffs”) commenced this
action
against
Abbott
Laboratories
(“Abbott”) in May of 2014, alleging that
Abbott failed to adequately warn of the
teratogenic effects of its drug, Depakote,
which caused N.K. to suffer from a
constellation of severe birth defects. (Dkt.
No. 1-2). Following removal to Federal Court
and the close of discovery, Abbott moved for
summary judgment pursuant to Fed. R. Civ.
P. 56, on the grounds that: (1) Plaintiff had
failed to offer admissible evidence regarding
either specific causation or labeling
deficiency; and (2) Plaintiffs’ claim was
precluded by federal law. (Dkt. No. 111).
Intimately related to this motion are two of
Abbott’s pre-trial motions to exclude witness
testimony on specific causation. (Dkt. Nos.

BACKGROUND
Abbott produces and distributes
Depakote, an anti-epileptic drug whose
active ingredient, valproic acid, is a known
teratogen linked to increased incidents of
certain birth defects if taken during
pregnancy. (Dkt. No. 1-2 (“Complaint”) ¶ 4;
Dkt. No. 1-3 (“Answer”) ¶ 4; Dkt. No. 113
(Abbott’s Rule 56.1 Statement (“Df. R.
1

56.1”)) ¶ 23; Dkt. No. 116 (Plantiffs’ Rule
56.1 Reply (“Pl. R. 56.1”)) ¶ 23 (agreeing
that Depakote was teratogenic but disputing
the level of risk)). Plaintiffs contend that the
warning label provided for Depakote was
inadequate. (Complaint ¶ 14).

evidence in support of each element of their
claims. (Dkt. No. 111 (Memorandum in
Support of Defendants Motion for Summary
Judgment (“Df. MSJ Br.”) at 4)).
Under Rule 56, the party seeking
summary judgment bears the burden of
proving that “there is no genuine dispute as
to any material fact” and that it is “entitled to
judgment as a matter of law.” Fed. R. Civ. P.
56(a); see also Goenaga v. March of Dimes
Birth Defects Found, 51 F.3d 14, 18 (2d Cir.
1995). Where the nonmoving party “will bear
the ultimate burden of proof at trial” the
movant may satisfy its burden by “point[ing]
to an absence of evidence to support an
essential element of the nonmoving party’s
claim.” Goenaga, 51 F.3d at 18; see also
Celotex Corp. v. Catrett, 477 U.S. 317, 32223, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). If
the movant satisfies its burden, it then falls to
the nonmoving party to identify a genuine
dispute of material fact that calls the
movant’s right to judgment into question.
United States v. Rem, 38 F.3d 634, 643 (2d
Cir. 1994). Doing so requires actual evidence
in the form of “depositions, documents…or
other materials[.]” Fed. R. Civ. P.
56(c)(1)(A); see also Celotex Corp., 477 U.S.
at 324.

In
mid-1997
Bruestle-Kumra
suffered two seizures, resulting in her
hospitalization. (Df. R. 56.1 ¶ 2; Pl. R. 56.1 ¶
2). As a result of her seizures, BruestleKumra was prescribed Depakote. (Df. R.
56.1 ¶ 3; Pl. R. 56.1 ¶ 3). She became
pregnant in 2004, (Df. R. 56.1 ¶ 19; Pl. R.
56.1 ¶ 19), and continued taking Depakote
throughout her pregnancy. (Df. R. 56.1 ¶14;
Pl. R. 56.1 ¶ 14).
Bruestle-Kumra’s son N.K. was born
in March of 2005. (Df. R. 56.1 ¶ 19; Pl. R.
56.1 ¶ 19). N.K. suffers from a number of
physical and developmental impairments
including “cleft palate, hypospadias…,
hypoplastic
thumbs,
micrognathia…,
microcephaly, wide-set nipples, low-set ears,
and facial dysmorphologies[,]” as well as a
host of “cognitive developmental delays” and
“autistic-like traits[.]”(Df. R. 56.1 ¶ 20; Pl. R.
56.1 ¶ 20). These wide-ranging and severe
physical and mental injuries have caused
great hardship for N.K. and his family and are
the subject of this lawsuit. (Complaint).
Plaintiffs allege that it was N.K.’s prenatal
exposure to Depakote that caused his injuries,
and they now seek just compensation.
(Complaint).

To prevail at trial, Plaintiffs must
prove the element of causation by presenting
“admissible expert testimony regarding both
general causation, i.e., that [Depakote]
exposure can cause the type of [injury
suffered]; and specific causation, i.e., that
[Depakote] exposure actually caused” N.K.’s
injuries. Amorgianos v. National R.R.
Passenger Corp., 303 F.3d 256, 268 (2d Cir.
2002). Plaintiffs intend to meet their specific
causation burden through the testimony of
Dr. Rachel Lewis, M.D. (“Dr. Lewis”) and
Christopher Stodgell, Ph.D. (“Dr. Stodgell”).
(Dkt. No. 114 (Memorandum in Opposition

DISCUSSION
I.

Summary Judgment
1.

Legal Standard

Abbott has moved for summary
judgment, advancing several arguments
including that Plaintiffs are unable to present

2

to Summary Judgment (“Pl. MSJ Br.”)) at 34).
Abbott has filed multiple motions in
limine seeking to exclude witness testimony
pursuant to Fed. R. Evid. 702 and Daubert v.
Merrell Dow Pharm. Inc., 509 U.S. 579, 113
S.Ct. 2786, 125 L.Ed.2d 469 (1993). Among
them are Abbott’s motions to strike the
specific causation testimony of Drs. Lewis
and Stodgell. (Dkt. Nos. 70, 84). Absent this
testimony Plaintiffs will be unable to meet
their burden as to an essential element of their
claims, entitling Abbott to judgment as a
matter of law. 1
2.

According to Dr. Lewis’ expert report
pursuant to Rule 26(a)(2), “[N.K.’s]
condition is a result of his prenatal valproate
exposure.” (Lewis Aff. at 5).
Dr. Stodgell is an associate professor
at the University of Rochester School of
Medicine and Dentistry in the Obstetrics &
Gynecology department. (Dkt. No. 74-1 (Dr.
Stodgell’s Expert Report (“Stodgell
Report”)) at 1). He has a B.A. in biology, a
M.S. and Ph.D. in pharmacology and
toxicology, and has received post-doctoral
training in genetics. (Id; Dkt. No. 74-2
August Deposition Testimony of Dr. Stodgell
(“Stodgell Depo.) 55:14). However, he is not
a medical doctor. (Id.)

Proposed Witnesses

Dr. Lewis is a pediatrician licensed to
practice in New York. (Dkt. No. 88-2
(Affidavit of Dr. Lewis (“Lewis Aff.”)) ¶¶ 12). She received her Medical Degree from
Harvard Medical School and completed her
residency at Morgan Stanley Children’s
Hospital of New York-Columbia University
in 2003. (Lewis Aff. ¶ 3-5). She has been
N.K.’s treating pediatrician since he was
twelve days old. (Dkt. No. 88-3 (Deposition
Testimony of Dr. Lewis (“Lewis Depo.”))
69:8-9).

Dr. Stodgell’s research focuses on
teratology and autism; he is a member of the
Teratology Society and is chair of the Autism
Research Program. (Stodgell Report at 1). He
has conducted extensive testing on the effect
of in utero exposure to valproic acid on
animals. (Id.) However, Dr. Stodgell has
never conducted human testing and has never
diagnosed valproate exposure in a human
patient. (Stodgell Depo. 42:23-43:2).
It is Dr. Stodgell’s opinion that N.K.’s
injuries were caused by in utero exposure to
valproic acid. (Stodgell Report 9-13).

Dr. Lewis has never conducted
research on Depakote or valproic acid.
(Lewis Aff.) Nor has she researched the
effects of in utero exposure to valproic acid
(“valproate exposure”). (Lewis Aff.). Prior to
N.K.’s first visit, her knowledge of Depakote
was limited to refilling prescriptions for
epileptic patients. (Lewis Depo. 23:12-23).
Since that initial visit, she has conducted little
to no additional research on Depakote,
valproic acid, or valproate exposure. (Id.
11:4-7, 23:3-7).

II.

Admissibility of Expert Testimony
1.

Legal Standard

When a litigant seeks to introduce the
opinion testimony of an expert witness,
courts assume the active and important role
of gatekeeper. Daubert, 509 U.S. at 589. In
fulfilling this gatekeeper function, the
Second Circuit requires courts to determine:

1

To the extent that the expert report of Timothy
Anderson, M.S., M.B.A., could be read as addressing
specific causation, his testimony is inadmissible as he

is unqualified to proffer a medical diagnosis. (Dkt. No.
77).

3

qualified to testify in the specific…or
specialized area at issue.” Bourassa, 2015
WL 4715250, at *3.

“(1) whether the witness is qualified as an
expert to testify as to a particular matter, (2)
whether the opinion is based upon reliable
data and methodology, (3) whether the
expert’s testimony on the particular matter is
relevant…and (4)” whether the proposed
testimony complies with Fed. R. Evid. 403.
Glowczenski v. Taser Intern., Inc., No. 04-cv4052 (SJF) (WDW), 2012 WL 976050, at *4
(E.D.N.Y. Mar. 22, 2012). If the expert
cannot satisfy these requirements, their
testimony must be excluded. Nimely v. City
of New York, 414 F.3d 381, 396-97 (2d Cir.
2005). The party seeking to introduce expert
testimony bears the burden of proving by a
preponderance of the evidence that these
requirements have been met. United States v.
Morgan, ---Fed.Appx.---, 2017 WL 129902,
at *1 (2d Cir. 2017).
2.

a)

Dr. Lewis

Dr. Lewis is not qualified to testify
that Depakote caused N.K.’s injuries. While
undoubtedly qualified as an expert in general
pediatric medicine, Dr. Lewis has no
experience qualifying her to testify on the
subject of specific causation. She has no
training in teratology. (Lewis Depo. 23:2-6).
She has never prescribed Depakote, only
refilling prescriptions when her patient’s
prescribing doctors were unavailable. (Id at
23:12-23). Indeed there is no indication that
she has any expertise, training, or experience
that would qualify her to testify that
Depakote was the cause of N.K.’s injuries.

Qualifications
Deficiencies in knowledge or
experience may be overcome through “a
review of other studies and scientific
literature[, which] can be enough to qualify
experts to testify and to make that proposed
testimony reliable.” In re Mirena IUD
Products Liability Litig., 169 F.Supp.3d 396,
412 (S.D.N.Y. 2016). There is no indication
that Dr. Lewis conducted such research. Her
familiarity with current medical literature on
valproic acid and Depakote is limited to its
use “in treating epileptic children.” (Lewis
Deop. at 23:24-24:7; 11:4-7 (“Q. In addition
to your medical records, was there anything
else you relied on in forming your opinion?
A. In forming them, no.”). Dr. Lewis did not
perform any research or make any additional
investigation that might qualify her as an
expert on valproate exposure. (Id at 25:3-7).
Her attempts to understand the cause of
N.K.’s injuries were limited to a single
review of a single medical book, the day of
his first visit. (Id at 146:2-9). This is
insufficient to qualify her as an expert and as
such she may not testify to specific causation.

Pursuant to Rule 702, “[a] witness
who is qualified as an expert by knowledge,
skill, experience, training, or education may
testify in the form of an opinion[.]” Fed. R.
Evid. 702. The witness’ qualifications do not
need to be perfectly on point, and testimony
is permitted where the witness’ “educational
and experiential qualifications in a general
field closely related to the subject matter in
question.”
Davids
v.
Novartis
Pharmaceuticals Corp., 857 F.Supp.2d 267,
276 (E.D.N.Y. 2012).
However, “[a]n expert, although
generally qualified, may not be competent to
render opinions under the circumstances of a
particular case which are outside the expert’s
area of expertise.” Bourassa v. Black &
Decker (U.S.) Inc., No. 12-CV-1476
(FJS/CFH), 2015 WL 4715250, at *3
(N.D.N.Y. Aug. 7, 2015). The court retains
“the screening function traditionally played
by trial judges[,]” Nimely, 414 F.3d at 395-9),
and must determine whether “the expert [is]

4

b)

substances, such as valproic acid, in animals
generally. (Id). This is insufficient to qualify
him as an expert on the specific cause of
N.K’s injuries.

Dr. Stodgell

Dr. Stodgell has a more substantial
background in the effects of valproate
exposure. He is undoubtedly qualified to
testify as to general causation, but just
“because a witness qualifies as an expert with
respect to certain matters or areas of
knowledge, it by no means follows that he or
she is qualified to express expert opinions as
to other fields.” Nimely, 414 F.3d at 399 n.13.

2.

Methodology

Even if they possessed the necessary
expertise, Drs. Lewis and Stodgell may not
testify to specific causation because their
opinions are not based upon reliable data and
methodology, as required under Rule 702.
Glowczenski, 2012 WL 976050, at *4. Courts
are charged with “ensur[ing] that ‘any and all
scientific testimony or evidence admitted is
not only relevant, but reliable.’” Nimely, 414
F.3d at 396 (quoting Daubert, 509 U.S. at
589). Rule 702 seeks to ensure reliability by
requiring expert testimony to be “based on
sufficient facts or data” and be “the product
of reliable principles and methods” that “the
expert has reliably applied[.]” Fed. R. Evid.
702.

In the context of medical opinions,
courts have consistently drawn a distinction
between the qualifications of medical and
non-medical doctors, noting that non-medical
doctors who are qualified to diagnose a
medical condition may be unable to reliably
determine its cause. Plourde v. Gladstone, 69
Fed.Appx. 485, 487 (2d Cir. 2003) (Witness
who was “a toxicologist and not a medical
doctor” was not qualified to opine on specific
causation in humans); Coene v. 3M Co., 303
F.R.D. 32, 55 (W.D.N.Y. 2014) (“Although a
toxicologist may be qualified to testify as to
causation, a toxicologist is generally not
qualified to offer a medical diagnosis.”);
Munafo v. Metropolitan Transp. Auth., No.
98-CV-4572 (ERK)(RLM), 00-CV-0134
(ERK)(RLM), 2003 WL 21799913, at *20
(E.D.N.Y. Jan. 22, 2003) (finding a
phsychopharmocologist, who diagnosed and
prescribed medication to treat conditions was
not qualified to opine on the cause of said
condition.”).

Under the facts of this case, reliable
methods require a differential diagnosis, in
which doctors assess the patient’s symptoms,
create “a list of possible causes[,]” and then
seek to eliminate possible causes “to identify
the most likely cause[.]” Ruggiero v. WarnerLambert Co., 424 F.3d 249, 254 (2d Cir.
2005).
Courts have consistently found
specific causation opinions reached without
the aid of a differential diagnosis to be
unreliable and requiring exclusion. Israel v.
Spring Industries, Inc., No. 98 CV 5106
(ENV)(RML), 2006 WL 3196956, at *10
(E.D.N.Y. Nov. 3, 2006) (Causation
testimony
“will
satisfy
Daubert’s
prerequisites for reliability only if the expert
conducted a meaningful differential
diagnosis ruling out other possible
contributing factors.”); see also Davids, 857
F.Supp.2d at 278 (“[E]ven though an expert

As a teratologist and toxicologist, Dr.
Stodgell may be qualified to testify that
Depakote exposure can cause N.K.’s injuries.
However, by his own testimony he has never
evaluated children, has never been called
upon to diagnose dysmorphic features or
autism in a child, and is not a clinician.
(Stodgell Depo. 42:23-44:14). His expertise
is limited to the teratogenic effect of

5

testified that immediately after N.K.’s first
appointment she came to believe his injuries
were caused prenatal valproate exposure. Id
at 144:20-22). She reached this conclusion
before eliminating any genetic causes, based
only on a review of N.K.’s symptoms in a
medical textbook – Smith’s Congenital
Human Malformations. Id at 146:2-9.

need not rule out every potential cause in
order to satisfy Daubert, the expert’s
testimony must at least address obvious
alternative causes and provide a reasonable
explanation for dismissing specific alternate
factors identified by the defendant.”)
(internal quotations omitted); Glowczenski,
2012 WL 976050, at *5 (listing additional
factors courts consider, including “whether
the expert has adequately accounted for
obvious alternative explanations.”); Munafo,
2003 WL 21799913, at*18 (“To the extent
that [expert] testimony touches upon matters
of causation, it will satisfy Daubert’s
prerequisites for reliability only if the doctor
conducted a meaningful ‘differential
diagnosis’ ruling out other possible
contributing factors.”).
a)

Not only did Dr. Lewis fail to
eliminate alternative causes before reaching
her initial conclusion, she lacked the
knowledge to independently rule out genetic
causes. She has no background in genetics
and has never treated patients with the
genetic disorders capable of causing N.K.’s
constellation of injuries. (Id at 23:2-6, 62:610, 76:7-11). As such, her initial opinion was
reached through improper methodology.

Dr. Lewis
Subsequent to the formation of her
opinion, additional but ultimately insufficient
testing was conducted.

Plaintiffs argue that Dr. Lewis
“arrived at her conclusion by using a
differential diagnosis” because she initially
determined that N.K.’s condition was either
genetic or the result of valproate exposure
and then eliminated the potential genetic
causes.
(Dkt.
No.
87
(Plaintiff’s
Memorandum in Opposition to Motion to
Strike the Testimony of Dr. Lewis (“Pl.
Lewis Opp”)) at 17). Plaintiffs are only
partially correct. Dr. Lewis’ records and
deposition testimony confirm that she viewed
N.K.’s condition as either genetic or the
result of prenatal valproate exposure. (Lewis
Depo. 145:13-20). However, it is clear that
Dr. Lewis failed to adequately investigate or
eliminate potential genetic causes before
arriving at her opinion.

In 2005 N.K. was sent to Dr. Yebao,
a geneticist, who ran tests for Pierre Robin,
Smith-Lemli-Opitz (“Opitz”), DiGreorge,
and Fanconi. (Dkt. No. 88-4 (Dr. Lewis’
Notes on Phone Call With Dr. Yebao
(“Yebao Call”)); Stodgell Depo. 159:6-17).
Following testing, Dr. Yebao informed
Bruestle-Kumra and Dr. Lewis that N.K.’s
results were normal, but he called for a “reevaluation in Genetics in six months” to
determine if any additional testing was
warranted. (Dkt. No. 88-6; Dkt. No. 88-5
(Yebao Report) at 2). Dr. Lewis is not sure if
this re-evaluation ever occurred. (Lewis
Depo. 95:13-23). She did testify, however,
that Dr. Yebao did not believe N.K.’s
condition was the result of valproate
exposure. (Id at 99:2-9; Yebao Call).

By Dr. Lewis’ own admission, both in
her deposition and her medical records,
N.K.’s condition might have been caused by
prenatal valproate exposure or have resulted
from genetic factors. (Lewis Depo. 144:2022, 145:13-20). Despite this, Dr. Lewis

Dr. Lewis disagreed with this
conclusion. (Lewis Depo. 81:15-18).
However, she lacks the expertise to challenge

6

genetic tests were ever conducted. (Lewis
Depo. 124:8-23).

Dr. Yebao’s assessment. With regard to
Pierre Robin, she stated that the disorder was
“not my area of expertise[.]” Id at 62:6-10.
She has never treated a patient with Opitz or
Fanconi. Id at 76:7-11. When asked if she
was sure these causes had been ruled out, Dr.
Lewis testified “DiGeorge, for sure. They did
that specific FISH. And DiGeorge they did a
specific test. Fanconi and Opitz, you would
have to ask the geneticist….But I think it is
implied by their testing.” Id at 78:5-24.

In 2015, John T. Wells, M.D. (“Dr.
Wells”) conducted a neurological evaluation
of N.K. related to his academic difficulties.
(Dkt. No. 86-5 (“Wells Report”) at 5). Dr.
Wells was aware of the original genetic
testing, but in felt N.K. should “have a follow
up genetics evaluation.” (Id at 6).
Later that year N.K. was evaluated by
Arthur Mandel, M.D. (“Dr. Mandel”) for
attention problems. (Dkt. No. 86-6 (“Mandel
Report”) at 2). Like Dr. Wells, Dr. Mandel
stated that “genetics ha[ve] advanced and it
may be helpful to see genetics again in order
to get more advanced testing.” (Id at 6). No
further tests were performed and Dr. Lewis
did not consult with a geneticist regarding the
possibility of new testing. (Lewis Depo.
134:15-17).

In addition to Dr. Yebao’s call for
more testing, at least four other treating
physicians have recommended further
genetic testing to determine the cause of
N.K.’s injuries.
In
2013
N.K.
received
a
dermatological examination from Kimberly
Morel, M.D. (“Dr. Morel”). (Dkt. No. 88-7
(“Morel Report”) at 1). Dr. Morel
recommended that N.K. be sent to Dr. Yebao
to be tested for NF1. Id at 3. Dr. Lewis has no
record of additional genetic testing following
Dr. Morel’s recommendation. (Lewis Depo.
113:23). She did not believe further testing
was necessary as she disagreed with Dr.
Morel’s assessment that N.K. met the clinical
criteria for NF1. (Id at 114:3-8).

Five doctors, including Dr. Yebao,
recommended additional genetic testing at
some point in N.K.’s treatment. Dr. Lewis,
however, has conducted no additional testing.
Rather, she has neglected to explore
alternative potential causes such as NF1.
Dr. Lewis has also ignored
improvements in genetic testing over the past
decade which might yield more concrete
results. As noted above, Dr. Yebao was
unable to definitively determine causation
and he, along with four other treating doctors,
recommended renewed testing. However,
when asked if improvements in genetic
testing over the past decade might lead to
more conclusive results, Dr. Lewis stated that
“what they would add to a child I saw ten
years ago who couldn’t have had that test, I
don’t know. They are very specific genetic
tests. I have never ordered them myself[.]”
(Id at 48:17-25).

In 2014 Dr. Murray Engel, M.D.
(“Dr. Engel”) provided Dr. Lewis with a
report on N.K. in connection with reported
staring spells. (Dkt. No. 86-4 (“Engel
Report”) at 1-2). Like Dr. Morel, Dr. Engel
recommended further genetic testing for “the
possibility of NF1 or other genetic diagnosis
in addition to [N.K.’s] in utero exposure to
anti-epileptic medication.” Id at 7. According
to Dr. Engel, Bruestle-Kumra declined
further testing because she believed N.K.’s
condition was the result of Depakote
exposure. (Id at 6). Despite a second opinion
citing NF1 as a potential cause, no additional

7

74-9 (November Deposition Testimony of
Dr. Stodgell (“Stodgell Depo. 2”)) 41:17-19).
Dr. Stodgell relied entirely on Plaintiffs’
counsel to determine which records were
relevant and which did not need to be
provided or reviewed. (Stodgell Depo 2
41:22-42:3). It is also clear that he did not
have access to all the relevant reports when
he produced his expert report. (Stodegll
Depo. 2 22:1-23:3) (“I saw those documents
after I prepared my report” referring to
multiple pediatric records and notes). As
such, his report suffers from the same defects
as Dr. Lewis’.

Still, Dr. Lewis “ha[s]n’t reached the
conclusion that genetic testing, more
detailed, more recent…would come back
normal.” (Id at 149:6-9). Based on the lack of
adequate results, she is unable to rule out
genetic causes. (Id at 135:10-12) (“Q. Are
you able to rule out a genetic underlying
cause of NK’s cognitive and physical
disabilities?...A. If we must provide ‘yes’ or
‘no answer, I guess I have to say no.”).
Despite her own admission that renewed
testing might indicate genetic causes, she has
made no effort to explore this possibility.
In addition to potential genetic
factors, Dr. Mandel also referenced a
possible structural brain lesion. (Mandel
Report). Dr. Lewis could not testify as to any
testing done to explore Dr. Mandel’s
concerns. (Lewis Depo. 132:21-133:7). She
did reference an MRI conducted prior to Dr.
Mandel’s evaluation, but noted that it “might
not be a perfect study” because of problems
with the original test. (Id at 133:3-7). She was
also unable to “make a conclusion” as to
whether cerebral hemorrhaging was the cause
of N.K.’s mental or emotional problems or
whether it might be caused by valproate
exposure. (Id at 160:7-12).

Further, a no time prior to forming his
opinion did Dr. Stodgell view pictures or
videos of N.K., personally examine N.K., or
otherwise interview N.K. (Id at 36:4-14). Nor
did Dr. Stodgell speak directly with any of
N.K.’s treating doctors or relatives. (Id at
36:24-37:6). He also lacked key facts, like the
results of N.K.’s MRI evaluation, which
revealed hemorrhaging. (Id at 79:4-5). As a
result, Dr. Stodgell does not possess adequate
facts on which to base his causation opinion.
Nor did he apply proper methodology
to the facts he did possess, failing to conduct
a differential diagnosis. Dr. Stodgell’s
attempt to rule out potential alternative
causes of N.K.’s condition is plagued by the
same problems as Dr. Lewis’. He relied on
Dr. Lewis’ flawed report in ruling out genetic
causes. (Id at 41:9-18) (“A. There was
comment that genetic testing was done,
chromosomal analysis and those were
negative for known genetic defects or
chromosomal abnormalities. So to me that
was the major rule-out. Q. All right. Who was
the geneticist…who ruled out genetic
causes…A. This was a comment that was
made in the medical record by the
pediatrician[.]”).While an expert witness
may rely on the treating physician’s reports
and
records,
where
the
“treating

Dr. Lewis has not adequately
explored or eliminated viable alternative
causes. Because she failed to order tests
necessary for an accurate diagnosis and did
not apply reliable methods to assessing the
limited information she did possess, Dr.
Lewis’ opinion is incapable of satisfying the
requirements of Rule 702.
b)

Dr. Stodgell

Dr. Stodgell did not conduct his own
independent investigation. His opinion is
based entirely on reviewing existing reports
provided to him by Plaintiffs, such as that of
Dr. Lewis. (Stodgell Depo. 40:4-12; Dkt. No.

8

(“Treating physicians may be treated as fact
witnesses not required to provide an expert
report[.]”); Turner v. Detla Air Lines, Inc.,
No. 06 CV 1010 (NGG)(CLP), 2008 WL
222559, at *1 (E.D.N.Y Jan. 25, 2008) (“[I]f
a treating physician is asked to render opinion
testimony based on the physician’s
specialized skill and knowledge that falls
within Federal Rule of Evidence 702, the
treating physician may be entitled to an
expert fee.”).

physicians…have not been shown to satisfy
the requirements of Rule 702” the expert’s
testimony is deemed similarly flawed.
Mallozzi v. EcoSMART Technologies, Inc.,
No. 11-CV-2884 (SJF)(ARL), 2013 WL
2415677, at *13 n.8 (E.D.N.Y. May 31,
2013).
He did not consider other genetic
causes because “[he] was under the
assumption that genetic causes had been
ruled out or were not being considered.”
(Stodgell Depo 163:3-7). Even if he had
wanted to conduct a differential diagnosis, he
could not have because he did not know
which tests had been conducted and was
unfamiliar with key genetics reports such as
Dr. Yeboa’s initial clinical notes or follow-up
genetic summary. (Id at 42:18-19, 148:7-14,
158:7-159:8, 160:9-14).

However, “the testimony of a treating
physician…is not without bounds,” Ali v.
Connick, No. 11-cv-5297 (NGG) (VMS),
2016 WL 3002403, at *7 (E.D.N.Y. May 23,
2016), and “treating physicians who are
designated as non-retained experts…are
not…permitted to render opinions outside the
course of treatment and beyond the
reasonable reading of the medical records.”
Davids, 857 F.Supp.2d at 280. Dr. Lewis
testified that, during her treatment of N.K.,
she concluded that his condition was caused
by valproate exposure. However, such a
conclusion is not reflected in her medical
records.

Because he has relied on Dr. Lewis’
flawed analysis and took no independent
steps to conduct his own differential
diagnosis, Dr. Stodgell’s testimony does not
satisfy the requirements of Rule 702.
III.

Admissibility
Testimony

of

Fact

Witness
In her initial assessment, following
N.K.’s first visit, Dr. Lewis wrote “?
Valproate embryopathy” which she testified
meant “possible valproic embryopathy[,]”
but never expressly wrote that N.K.’s injuries
were caused by Depakote or valproic acid.
(Lewis Depo. 70:3-5, 161:7-24). She further
testified that at that time she could not
definitively determine that N.K.’s injuries
were the result of valproate exposure. (Id at
70:12). In her subsequent reports she makes
reference to valproate exposure, but
consistently writes “unknown etiology.” (Id
at 99:2-100:6). The conclusion that N.K. was
the victim of valproate exposure is simply not
reflected in Dr. Lewis’ medical records.

Plaintiffs argue that “since Dr. Lewis’
opinion as to the cause of N.K.’s injuries was
formed during the course of her treatment of
N.K., such opinion testimony is considered
factual in nature, and therefore not subject to
Daubert exclusion.” (Pl. Lewis Opp. at 15).
Plaintiffs cite multiple cases in support of this
proposition. (Id. at 16-17). Plaintiffs’ cases
focus on the fact verses expert distinction for
the purpose of compliance with Fed. R. Civ.
P. 26’s disclosure requirements and payment
of fees, not with motions to exclude
testimony under Rule 702 and Daubert. e.g.
Puglisi v. Town of Hempstead Sanitary Dist.
No. 2, No. 11-CV-0445 (PKC) (GRB), 2013
(WL 4046263at *1 (E.D.N.Y. Aug. 8, 2013)

9

Even if such an opinion could be read
into her records, classifying Dr. Lewis as a
fact expert does not relieve this Court of its
duty to ensure she utilized reliable methods
in reaching her opinion. Munafo, 2003 WL
21799913, at *18 (Daubert’s “requirements
are not diminished merely because the expert
witness is a ‘treating physician’ rather than an
expert retained solely for the purposes of
litigation.”); see also In re Zypreza Products
Liability Litig., 489 F.Sup.2d 230, 282
(E.D.N.Y. 2007) (noting that fact witnesses
may also be experts, subject to the
requirements of Rule 702).

GRANTED. As a result, they will be unable
to testify that Bruestle-Kumra’s use of
Depakote during pregnancy caused N.K.’s
injuries. Plaintiff can offer no other
admissible evidence of specific causation.
Therefore, I find that they will be unable to
meet their burden of proof at trial and
GRANT Abbott’s motion for summary
judgment.
SO ORDERED.

Ramon E. Reyes, Jr.
RAMON E. REYES, JR.
United States Magistrate Judge

Courts in this district have found that
“when [a] treating physician seeks to render
an opinion on causation, that opinion is
subject to the same standards of scientific
reliability that govern the expert opinions of
physicians hired solely for the purposes of
litigation.” Davids, 857 F.Supp.2d at 280
(internal quotations omitted); see also
Mallozzi, 2013 WL 2415677, at *13 n.8
(“[T]he deficiencies in Dr. Levy’s testimony
cannot be overcome by his reliance upon
causation opinions of plaintiff’s treating
physicians that have not been shown to
satisfy the requirements of Rule 702.”);
Deutsch v. Novartis Pharm. Corp., 768
F.Supp.2d 420, 472 (E.D.N.Y. 2011) (finding
a treating physician’s causation opinion to be
limited by the reliability requirements of
Rule 702).

Dated: May 22, 2017
Brooklyn, New York

For the reasons discussed above, Dr.
Lewis’ flawed methodology is unreliable.
Therefore, she is unable to testify as to
causation regardless of how Plaintiffs seek to
characterize her.
CONCLUSION
For the reasons set forth above,
Defendant’s motions to strike the causation
testimony of Drs. Lewis and Stodgell are

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