July 2017: A Duo of Appellate Victories for Pfizer in Zoloft Birth Defect Litigation

As long-time national and lead counsel for Pfizer Inc. in various product liability matters, the firm led a defense team that secured two important appellate rulings in a mass tort litigation in which it was alleged that the use of Zoloft, an antidepressant sold by Pfizer, caused children to be born with birth defects.

One appellate decision stems from the federal multidistrict litigation In re Zoloft (Sertraline Hydrochloride) Products Liability Litigation, which involved lawsuits filed by several hundred plaintiffs. The plaintiffs proffered Professor Nicholas Jewell, a biostatistician from the University of California, Berkeley, as their expert on general causation (i.e., that Zoloft is capable of causing particular types of birth defects in the general population).

The firm helped to expose the many methodological flaws in Professor Jewell’s causation opinion and secure the exclusion of his opinion under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), and its progeny. Pfizer pointed out that by applying divergent methods in an unscientific manner to conform to his pre-ordained litigation opinions, Professor Jewell was engaging in “situational science” – a term coined by the firm, adopted by the MDL court in its decision, and now part of the Daubert lexicon. The MDL court agreed and excluded Professor Jewell’s opinion, leaving the plaintiffs without admissible and sufficient evidence of causation, an essential element of their claims. Accordingly, the MDL court entered summary judgment in favor of Pfizer.

The plaintiffs appealed to the United States Court of Appeals for the Third Circuit, arguing that the MDL court committed legal error by requiring statistically significant findings for a causation opinion and abused its discretion in excluding Professor Jewell. The Third Circuit disagreed and unanimously affirmed summary judgment for Pfizer in a precedential opinion.

Among many other important rulings, the Third Circuit rejected Professor Jewell’s efforts to diminish the importance of statistical significance, holding that statistical significance “remains an important metric to distinguish between results supporting a true association and those resulting from mere chance.” The Third Circuit also rejected the plaintiffs’ attempt to water down Daubert by recognizing that it is not enough to mechanically parrot in rote fashion the steps contained within the correct methodology–an expert must reliably apply the methodology.

Pfizer’s victory in the Third Circuit came on the heels of another appellate victory in the Pennsylvania Superior Court. In Porter v. SmithKline Beecham Corp., as in the federal litigation, the firm led the effort in getting the plaintiffs’ general and specific causation experts excluded under the Pennsylvania Rules of Evidence (which adopts the standard for expert evidence set forth in Frye v. United States, 293 F. 1013 (D.C. Cir. 1923)), and in obtaining a summary judgment on the eve of trial. Notably, in excluding the plaintiffs’ experts, the court recognized the importance of statistical significance when analyzing causation: “Generally accepted methodology considers statistically significant replication of study results in different populations because apparent associations may reflect flaws in methodology.” The Pennsylvania Superior Court, in rejecting the plaintiffs’ appeal, affirmed the decision and held that the plaintiffs failed to prove that their experts’ methodologies were generally accepted as reliable in the relevant scientific community.

These decisions are notable developments in the law on the admissibility of expert evidence under the Daubert and Frye tests. They correctly hold plaintiffs to their burden of proffering reliable or generally accepted scientific evidence of causation and will help to keep unfounded scientific testimony out of the courtroom. The firm remains a leader in successfully litigating the admissibility of expert testimony at the trial and appellate court levels in state and federal courts across the country. For example, in its continuing representation of Pfizer in other mass tort litigations, the firm also led the effort in convincing another MDL court to exclude the plaintiffs’ expert causation evidence and enter summary judgment in all of the several thousand cases in that MDL and is currently defending those decisions in an appeal brought by the plaintiffs before the United States Court of Appeals for the Fourth Circuit.

As long-time national and lead counsel for Pfizer Inc. in various product liability matters, the firm led a defense team that secured two important appellate rulings in a mass tort litigation in which it was alleged that the use of Zoloft, an antidepressant sold by Pfizer, caused children to be born with birth defects.One appellate decision stems from the federal multidistrict litigation In re Zoloft (Sertraline Hydrochloride) Products Liability Litigation, which involved lawsuits filed by several hundred plaintiffs. The plaintiffs proffered Professor Nicholas Jewell, a biostatistician from the University of California, Berkeley, as their expert on general causation (i.e., that Zoloft is capable of causing particular types of birth defects in the general population).The firm helped to expose the many methodological flaws in Professor Jewell’s causation opinion and secure the exclusion of his opinion under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), and its progeny. Pfizer pointed out that by applying divergent methods in an unscientific manner to conform to his pre-ordained litigation opinions, Professor Jewell was engaging in “situational science” – a term coined by the firm, adopted by the MDL court in its decision, and now part of the Daubert lexicon. The MDL court agreed and excluded Professor Jewell’s opinion, leaving the plaintiffs without admissible and sufficient evidence of causation, an essential element of their claims. Accordingly, the MDL court entered summary judgment in favor of Pfizer.The plaintiffs appealed to the United States Court of Appeals for the Third Circuit, arguing that the MDL court committed legal error by requiring statistically significant findings for a causation opinion and abused its discretion in excluding Professor Jewell. The Third Circuit disagreed and unanimously affirmed summary judgment for Pfizer in a precedential opinion.Among many other important rulings, the Third Circuit rejected Professor Jewell’s efforts to diminish the importance of statistical significance, holding that statistical significance “remains an important metric to distinguish between results supporting a true association and those resulting from mere chance.” The Third Circuit also rejected the plaintiffs’ attempt to water down Daubert by recognizing that it is not enough to mechanically parrot in rote fashion the steps contained within the correct methodology–an expert must reliably apply the methodology.Pfizer’s victory in the Third Circuit came on the heels of another appellate victory in the Pennsylvania Superior Court. In Porter v. SmithKline Beecham Corp., as in the federal litigation, the firm led the effort in getting the plaintiffs’ general and specific causation experts excluded under the Pennsylvania Rules of Evidence (which adopts the standard for expert evidence set forth in Frye v. United States, 293 F. 1013 (D.C. Cir. 1923)), and in obtaining a summary judgment on the eve of trial. Notably, in excluding the plaintiffs’ experts, the court recognized the importance of statistical significance when analyzing causation: “Generally accepted methodology considers statistically significant replication of study results in different populations because apparent associations may reflect flaws in methodology.” The Pennsylvania Superior Court, in rejecting the plaintiffs’ appeal, affirmed the decision and held that the plaintiffs failed to prove that their experts’ methodologies were generally accepted as reliable in the relevant scientific community.These decisions are notable developments in the law on the admissibility of expert evidence under the Daubert and Frye tests. They correctly hold plaintiffs to their burden of proffering reliable or generally accepted scientific evidence of causation and will help to keep unfounded scientific testimony out of the courtroom. The firm remains a leader in successfully litigating the admissibility of expert testimony at the trial and appellate court levels in state and federal courts across the country. For example, in its continuing representation of Pfizer in other mass tort litigations, the firm also led the effort in convincing another MDL court to exclude the plaintiffs’ expert causation evidence and enter summary judgment in all of the several thousand cases in that MDL and is currently defending those decisions in an appeal brought by the plaintiffs before the United States Court of Appeals for the Fourth Circuit.