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N.K. v. Abbott Laboratories

United States District Court, E.D. New York

May 22, 2017

N.K. an infant by his mother and natural guardian, TANJA BRUESTLE-KUMRA, Plaintiff,
Abbott Laboratories, Defendant.

          OPINION & ORDER

          RAMON E. REYES, JR. United States Magistrate Judge.

         Tanja 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 Abbott's motion.


         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. 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).

         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, 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 ¶ 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).


         I. Summary Judgment

         1. Legal Standard

         Abbott 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)).

         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, 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 324.

         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 to Summary Judgment (“Pl. MSJ Br.”)) at 3-4).

         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. Proposed Witnesses

         Dr. 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).

         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).

         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.)

         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).

         II. Admissibility of Expert Testimony

         1. Le ...

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