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Drake v. Allergan, Inc.

United States District Court, D. Vermont

October 23, 2014

KEVIN DRAKE and LORI DRAKE, individually and as next friend of J.D. Plaintiffs,
ALLERGAN, INC., Defendant.



Plaintiff J.D. is a minor with cerebral palsy whose parents, Kevin and Lori Drake, filed claims individually and as next friend of J.D. against Defendant Allergan, Inc. ("Allergan"), the manufacturer of Botox. Plaintiffs' claims arise from injuries J.D. sustained that allegedly resulted from a Botox injection administered to treat his lower limb spasticity. Both parties have submitted pre-trial motions to exclude expert testimony under Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).

For the following reasons the Court denies Plaintiff's Motion to Exclude Defendant's Expert Michael S. Duchowny, M.D., ECF No. 91, grants in part and denies in part Defendant's Motion to Exclude Expert Testimony of David A. Kessler, M.D., ECF No. 92, and grants in part and denies in part Defendant's Motion to Exclude Expert Testimony of Anna Hristova, M.D., ECF No. 93.

I. Legal Standard

Admissibility of expert testimony is governed by Federal Rule of Evidence 702, which states:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if: (a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case.

Rule 702 requires a district court to ensure that scientific or technical evidence is both relevant and reliable. Kumho Tire v. Carmichael, 526 U.S. 137, 147 (1999); Daubert, 509 U.S. at 589. The evidentiary reliability of the proposed testimony depends on its scientific validity. Daubert, 509 U.S. at 590 n.9. The subject of an expert's testimony must be "scientific knowledge." Id. at 590. "Scientific" implies grounding in the methods and procedure of science while "knowledge" connotes more than subjective belief or unsupported speculation but need not be certainty. Id. In assessing reliability, in addition to the factors set forth in Rule 702, a district court may consider:

(1) whether a theory or technique has been or can be tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) the technique's known or potential rate of error and the existence and maintenance of standards controlling the technique's operation; and (4) whether a particular technique or theory has gained general acceptance in the relevant scientific community.

United States v. Williams, 506 F.3d 151, 160 (2d Cir. 2007) (internal quotation omitted).

As for relevance, in order to assist the trier of fact proposed expert testimony must be sufficiently tied to the facts of the case to "make the existence of any fact that is of consequence to the determination of the action more or less probable than it would be without the evidence." Fed.R.Evid. 401. The question of relevance has also been described as "fit." Daubert, 509 U.S. at 591. Expert testimony that does not relate to any issue in the case is not relevant and, therefore, not helpful. Id.

The court must make a preliminary assessment of whether the reasoning and methodology underlying the testimony is scientifically valid and whether that reasoning or methodology can properly be applied to the facts in issue. Id. at 592-93. The inquiry envisioned by Rule 702 focuses solely on principles and methodology, not on the conclusions they generate. Id. at 595.

The party proffering expert testimony has the burden of establishing its admissibility by a preponderance of proof but the court is the ultimate gatekeeper. Id. at 592 n.10; United States v. Williams, 506 F.3d 151, 160 (2d Cir. 2007). The Supreme Court emphasized the "liberal thrust" of the Federal Rules of Evidence, favoring admissibility of expert opinion testimony. Daubert, 509 U.S. at 588. "Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence." Id. at 596.

Nevertheless, expert testimony should be excluded if it is "speculative or conjectural." Major League Baseball Props., Inc. v. Salvino, Inc., 542 F.3d 290, 311 (2d Cir. 2008) (quoting Boucher v. U.S. Suzuki Motor Corp., 73 F.3d 18, 21 (2d Cir. 1996). Neither Daubert nor the Federal Rules of Evidence requires a district court to admit opinion evidence that is "connected to existing data by only the ipse dixit of the expert" if the court concludes that "there is simply too great an analytical gap" between the data and the proffered opinion. Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997).

II. Plaintiffs' Motion to Exclude Defendant's Expert Michael S. Duchowny, MD

Plaintiffs move to exclude Dr. Michael S. Duchowny's testimony entirely[1] for three reasons: 1) his opinion that Botox injections cannot cause seizures is based on a misreading of selected literature and ignores a significant amount of evidence to the contrary, 2) his opinion that J.D. has not suffered seizures but instead experienced an allergic reaction is unsupported by the evidence and is contrary to the opinion of every treating doctor and every other medical expert designated by either party, and 3) Dr. Duchowny is not qualified to diagnose allergic reactions.

A. Dr. Duchowny's Opinion Concerning the Causal Relationship Between Botox and Seizures

Plaintiffs argue that Dr. Duchowny's opinions about general causation are so far removed from the underlying facts and the available scientific literature that they are unreliable and therefore inadmissible. Plaintiffs suggest Dr. Duchowny's opinion regarding the causal relationship between Botox and seizures in general is based "almost entirely" on three sources: 1) the Cote article, 2) letters to the editor written on behalf of Allergan to criticize the Albavera-Hernandez epidemiology study, and 3) the Naidu article. Plaintiffs criticize Dr. Duchowny's reliance on and interpretation of these articles and claim he failed to address a plethora of evidence contrary to his opinion that Botox cannot cause seizures.

Allergan counters that this characterization of the source of Dr. Duchowny's opinions is false. According to Allergan, Dr. Duchowny actually relies on a number of studies Plaintiffs ignore in addition to his significant clinical experience with Botox, spanning more than ten years and thousands of patients. Allergan also argues Dr. Duchowny's experience is similar to that of other witnesses in this case, including Dr. Scott Benjamin, J.D.'s physiatrist who injected J.D. with Botox, and Dr. Janice Brunstrom-Hernandez, another expert who has treated over one thousand children with cerebral palsy with Botox injections. Finally, Allergan points out that Dr. Duchowny actually received and considered all but one source Plaintiffs identify and argue the source he did not consider was unremarkable.

Plaintiffs do not dispute and the Court agrees that Dr. Duchowny is well-qualified as an expert in neurology. Dr. Duchowny is a Senior Staff Attending Physician in Neurology at the Miami Children's Hospital and Professor of Clinical Neurology at the University of Miami Leonard Miller School of Medicine. He directs the Comprehensive Epilepsy Program and the Neurology Training Programs at Miami Children's Hospital. Dr. Duchowny has over thirty years of clinical experience in the diagnosis, prognosis, and management of children with cerebral palsy ...

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