United States District Court, E.D. New York
N.K. an infant by his mother and natural guardian, TANJA BRUESTLE-KUMRA, Plaintiff,
Abbott Laboratories, Defendant.
OPINION & ORDER
E. REYES, JR. United States Magistrate Judge.
Bruestle-Kumra (“Bruestle-Kumra”) 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. 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
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. 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).
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, Bruestle-Kumra 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
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).
has moved for summary judgment, advancing several arguments
including that Plaintiffs are unable to present 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)).
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, 322-23, 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
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 to
Summary Judgment (“Pl. MSJ Br.”)) at 3-4).
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.
Lewis is a pediatrician licensed to practice in New York.
(Dkt. No. 88-2 (Affidavit of Dr. Lewis (“Lewis
Aff.”)) ¶¶ 1-2). 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).
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).
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).
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.)
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
Dr. Stodgell's opinion that N.K.'s injuries were
caused by in utero exposure to valproic acid. (Stodgell
Admissibility of Expert Testimony