In re Zoloft (Sertralinehydrochloride) Prods. Liab. Litig., MDL NO. 2342

• Decision Date: 05 April 2016
• Docket Number: MDL NO. 2342,12-MD-2342
• Citation: 176 F.Supp.3d 483
• Parties: In re: Zoloft (Sertralinehydrochloride) Products Liability Litigation This Document Relates to: All Actions
• Court: U.S. District Court — Eastern District of Pennsylvania

176 F.Supp.3d 483

In re: Zoloft (Sertralinehydrochloride) Products Liability Litigation

This Document Relates to: All Actions

MDL NO. 2342

12-MD-2342

United States District Court, E.D. Pennsylvania.

Signed April 5, 2016

Sheila L. Birnbaum, Mark S. Cheffo, Bert L. Wolff, Jonathan S. Tam, Quinn Emanuel Urquhart & Sullivan, LLP, Pamela J. Yates, Bert L. Slonim, Aaron H. Levine, Kaye Scholer, LLP, New York, NY, James E. Hooper, Jr., Andrew H. Myers, Wheeler Trigg O'Donnell LLP, Denver, CO, Robert C. Heim, Judy L. Leone, Dechert, LLP, Philadelphia, PA, for Pfizer.

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(sertralinehydrochloride), "a prescription medication approved for the treatment of depression and other ailments, causes birth defectsin 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 Steering 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 factfinder could determine, by a preponderance of the evidence, that Zoloftcaused 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, an 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. Bérard's methodology involved a rejection of the importance of replicated statistically significant epidemiological findings demonstrating an association between Zoloftand a pattern of birth defects, substituting a novel technique of drawing conclusions by examining 'trends' (often statistically non-significant) 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 excluded in part the opinions of the PSC's three other general causation 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 Zoloftcaused birth defectsin 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 Zoloftduring pregnancy has been the subject of many large epidemiological studies designed with the goal of identifying any associations between maternal SSRI /Zoloftuse 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 biostatistics 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 Zoloftwas capable of causing plaintiffs' injuries—is a prerequisite to recovery by every plaintiff herein."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 cases, 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. Sadler essentially applied his earlier opinions to the individual Plaintiffs. By stipulation of counsel approved by the Court, Plaintiffs agreed to withdraw the reports and reserved "the right to file supplemental reports from Dr. Levin and/or Dr. Sadler at a later date to address any new evidence relevant to their opinions which may come to light, and the right to offer their testimony" in the cases set for initial trials.²⁶ Defendants reserved "all of their rights to file objections or motions challenging any report and/or opinion of" these experts.²⁷

By opinion and order dated December 2, 2015, the Court excluded Dr. Jewell's report and testimony pursuant to Federal Rules of Evidence 403and 702.²⁸ The Court concluded after hearing testimony over several days that Dr. Jewell failed to consistently apply the scientific methods he articulated, deviated from or downplayed certain well-established principles of his field, and inconsistently applied methods and standards to the data so as to support his a priori opinion.²⁹ Significantly, the Court found that Dr. Jewell failed to address adequately all of the available epidemiological studies, particularly more recent studies that did not replicate the results in earlier studies, even though these studies included and expanded upon the populations in the earlier studies.³⁰ The Court also concluded that Dr. Jewell improperly attempted to rely upon internal Pfizer documents because such partial literature reviews are not the kinds of information generally relied upon by statisticians, and because to the extent that the documents expressed Pfizer's preliminary concerns about product safety, warranting further investigation, and were not final conclusions drawn by Pfizer (as Pfizer argued), Dr. Jewell's use of them would potentially be misleading to a jury.³¹ Pfizer moved for summary judgment immediately after this ruling.

II. LEGAL STANDARDS

A court will award summary judgment on a claim or part of a claim where there is "no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law."³² A fact is "material" if resolving the dispute over the fact "might affect the outcome of the suit under the governing [substantive] law."³³ A dispute is "genuine" if "the evidence is such that a reasonable jury could return a verdict for the nonmoving party."³⁴

In evaluating a summary judgment motion, a court "must view the facts in the light most favorable to the non-moving party," and make every reasonable inference in that party's favor.³⁵ Further, a court may not weigh the evidence or make credibility determinations.³⁶ Never...