In re Zoloft (Sertralinehydrochloride) Products Liability Litigation

176 F. Supp. 3d 483, 2016 WL 1320799
CourtDistrict Court, E.D. Pennsylvania
DecidedApril 5, 2016
DocketMDL NO. 2342; 12-MD-2342
StatusPublished
Cited by15 cases

This text of 176 F. Supp. 3d 483 (In re Zoloft (Sertralinehydrochloride) Products Liability Litigation) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Zoloft (Sertralinehydrochloride) Products Liability Litigation, 176 F. Supp. 3d 483, 2016 WL 1320799 (E.D. Pa. 2016).

Opinion

Rufe, Judge.

OPINION

By Order filed April 17, 2012, the United States Judicial Panel on MultiDistrict Litigation transferred to this Court, for coordinated or consolidated pretrial proceedings, cases alleging that Zoloft (sertraline hydrochloride), “a prescription medication approved for the treatment of depression and other ailments, causes birth 'defects in children when their mothers ingest the drug while pregnant.”1 In rejecting arguments opposing centralization of the cases, the Panel determined that “while the specific birth defects alleged vary somewhat among the plaintiffs, all actions will share discovery relating to general medical causation; factual discovery will overlap concerning Pfizer’s research, testing, and warnings; and expert discovery and Daubert motions will overlap to some degree.”2 These events common to the litigation having occurred, the Court now is presented with Defendants’ motion for summary judgment in all pending cases.3 Plaintiffs, through the Plaintiffs [487]*487Steering Committee (“PSC”), oppose the motion.4 The motion puts the following two questions before the Court: First, have Plaintiffs produced sufficient admissible evidence from which a reasonable factfin-der could determine, by a preponderance of the evidence, that Zoloft caused Plaintiffs’ injuries? Second, if they, have not, what next?

I. BACKGROUND

Early in the MDL, the parties agreed to a schedule to govern proceedings in the MDL.5 The schedule included discovery from Pfizer, the exchange of expert reports regarding general causation and hearings as to the admissibility of the expert testimony pursuant to Daubert v. Merrell Dow Pharmaceuticals.6 At the initial hearings, the PSC offered the testimony of four expert witnesses7 on the issue of general causation in an effort to establish that Zoloft, when used at therapeutic dose levels during human pregnancy, is a teratogen capable of causing a range of birth defects.8 Plaintiffs primarily relied upon Dr. Anick Bérard, ah epidemiologist.9 By opinion dated June 27, 2014, the Court found that Dr. Bérard had failed to base her opinion upon scientifically valid methodology and reasoning such that it could not be considered by a jury.10 The Court determined that “Dr. Berard’s methodology involved a rejection of the importance of replicated statistically significant epidemiological findings demonstrating an association between Zoloft and a pattern of birth defects, substituting a novel technique of drawing conclusions by examining ‘trends’ (often statistically nonsignificant) across selected studies.”11 The Court also held that Dr. Bérard failed to address adequately those epidemiological studies that did not support her opinion.12

By opinion and order dated August 12, 2014, the Court excludéd in part the opinions of the PSC’s three other general cau[488]*488sation witnesses, Dr. Robert Cabrera (a teratologist), Dr. Michael Levin (a molecular developmental biologist), and Dr. Thomas Sadler (an embryologist). The Court concluded that these experts could not testify that Zoloft caused birth defects in humans but could testify as to the limited question of the existence of plausible biological mechanisms by which altered concentrations of serotonin in a developing embryo could cause birth defects.13 The Court held that “when epidemiological studies are equivocal or inconsistent with a causation opinion, experts asserting causation opinions must thoroughly analyze the strengths and weaknesses of the epidemiological research and explain why that body of research does not contradict or undermine their opinion.”14 These experts did not address the epidemiological evidence, and because Dr. Bérard’s report and testimony had been excluded they could not rely on her conclusions or testify as to human causation.15

The PSC filed a motion for partial reconsideration of the opinion excluding Dr. Bérard only. The Court denied this motion by opinion and order dated January 23, 2015, rejecting the argument that the Court erred by requiring replicated, statistically significant epidemiological findings to establish general causation.16 The Court explained that:

medical experts, and especially physicians opining as to specific rather than general causation, may rely on data other than statistical evidence from epidemiological studies, such as a differential diagnosis, which is a “technique generally accepted in the medical community.” In re Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Products Liab. Litig., 890 F.Supp.2d 552, 561 (E.D.Pa.2012) (citing Heller v. Shaw Industries, Inc., 167 F.3d 146, 155 (3d Cir.1999)). However, Dr. Bérard is an epidemiologist, not a physician, and the Court has evaluated the reliability of her methods accordingly. Moreover, the Court notes that, unlike the association at issue in In re Diet Drugs, which had not been the subject of any epidemiological study, the use of Zoloft during pregnancy has been the subject of many large epidemiological studies designed with the goal of identifying any associations between maternal SSRI /Zoloft use and a broad range of birth defects. Even so, the Court has evaluated Dr. Bérard’s methods according to the Daubert principles, and did not apply any bright-line exclusionary rules to her causation analysis.17

While seeking partial reconsideration, the PSC also filed a motion for leave to introduce Nicholas Jewell, Ph.D., a biosta-tistics professor, as an additional expert witness on general causation with regard to cardiac defects.18 The PSC argued in support of its motion that “Dr. Jewell’s testimony is critically important to the plaintiffs in this litigation. Proof of general causation — that exposure to Zoloft was capable of causing plaintiffs’ injuries — is a prerequisite to recovery by every plaintiff [489]*489herein.”19 By opinion and order dated January 7, 2015, the Court .granted the motion after balancing the interests of all parties to the MDL and weighing heavily “the indisputable fact that the evidence is of critical importance to Plaintiffs.”20 After these rulings, many cases alleging non-cardiac injuries were dismissed without prejudice by stipulation of the parties.21

Defendants raised a Daubert challenge as to the admissibility of Dr. Jewell’s testimony and report.22 After this motion was filed, the parties stipulated to the dismissal without prejudice of additional eases, including some alleging both cardiac and non-cardiac defects.23 Defendants also filed a motion to strike new expert reports by Dr. Levin and Dr. Sadler, arguing that Plaintiffs were improperly attempting to re-litigate the admissibility of these experts’ reports and testimony.24 These reports purported to be case-specific to the two trial-ready cases,25 although Dr. Levin did not address any opinions specific to these Plaintiffs, and Dr.

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Bluebook (online)
176 F. Supp. 3d 483, 2016 WL 1320799, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-zoloft-sertralinehydrochloride-products-liability-litigation-paed-2016.