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Article: August 2017: Product Liability Litigation Update

Business Litigation Reports

Hot Topic: Plaintiffs’ Efforts to Evade the Burden of Supporting Products Liability Claims with Expert Testimony. The core allegations in many product liability cases are that the manufacturer failed to adequately warn of its product’s risks and that the product caused an injury. To meet their burden, the plaintiffs usually proffer expert testimony on issues such as causation and the adequacy of the product warnings. Recently, however, where courts have excluded the plaintiffs’ expert evidence as unreliable under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), or analogous state standards, the plaintiffs have tried to pivot from proffering expert evidence to arguing instead that they can meet their burden of proof without expert evidence, and survive summary judgment, by relying on non-expert evidence and so-called “admissions” that are taken from the defendant’s company documents.

The appeal of these arguments for plaintiffs is obvious. If allowed, plaintiffs would be allowed to sidestep Daubert, avoid the expenses associated with expert discovery and briefing, and proceed to trial more quickly and with a lower burden of proof. These issues are front and center in appeals arising out of mass tort litigations that are currently pending before federal and state appellate courts across the country.

For example, in In re Mirena IUD Products Liability Litigation, 202 F. Supp. 3d 304 (S.D.N.Y. 2016), appeal pending, No. 16-2890(L) (2d Cir. 2016), it was alleged that an intrauterine birth control device, Mirena, caused secondary perforation in the uterus. The multidistrict litigation (MDL) court excluded the plaintiffs’ causation experts and granted summary judgment for the manufacturer, Bayer, because the plaintiffs lacked admissible and sufficient evidence of causation—an essential element of all their claims. As the MDL court observed, courts have long held that “[e]xpert testimony is required in cases involving complex causation issues” outside common knowledge and lay experience. Id. at 311. The plaintiff argued that no expert testimony was needed because non-expert evidence sufficiently established causation, including FDA-approved labeling for Mirena and Bayer’s labeling for another intrauterine product, letters to doctors about Mirena, employee statements, and internal documents.

The MDL court addressed each of these documents and rejected the plaintiffs’ arguments, holding that “no court has held that admissions can substitute for required expert testimony, and this Court will not be the first. Such a ruling would disregard the purpose of the requirement for expert testimony, leaving jurors to speculate, and would chill free and frank discussion by manufacturers of drugs or devices.” Id. at 320. The MDL court added that it “need not go so far as to say that admissions can never substitute for expert testimony.” Id. But “if such statements could ever suffice,” they would have to be “clear, concrete or detailed” enough for a jury to find a causal nexus without speculating. Id. at 320, 327. The non-expert evidence cited by the plaintiffs, the MDL court found, was far too “ambiguous.” Id. at 320.

Mirena is currently on appeal in the U.S. Court of Appeals for the Second Circuit where the court will decide whether the non-expert evidence can sufficiently take the place of expert evidence of causation.

Likewise, in In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices and Products Liability Litigation, --- F. Supp. 3d. ---, 2017 WL 87067, at *13-17 (D.S.C.), appeal pending, No. 17-1140(L) (4th Cir. 2017), the MDL court held that expert testimony was required to establish the plaintiffs’ claims that Lipitor causes diabetes. The court rejected the plaintiffs’ arguments that non-expert evidence, such as an internal email and foreign Lipitor labeling, amounted to “admissions” of causation, and granted summary judgment for the defendant manufacturer, Pfizer, because the plaintiffs lacked expert evidence of causation, among other reasons. Lipitor is now on appeal in the U.S. Court of Appeals for the Fourth Circuit, where Quinn Emanuel is lead counsel to Pfizer.

Whereas Mirena and Lipitor illustrate attempts to move away from the requirement of expert evidence on causation, the plaintiffs in another mass litigation, In re: Zoloft Litigation, 2017 WL 665299, at *8 (W.Va. Cir. Ct.), appeal pending sub. nom J.C. v. Pfizer, Inc., No. 17-0282 (W. Va. 2017), attempted to make the same argument to avoid the need for expert testimony on whether prescription drug labeling was adequate to apprise physicians of the supposed potential side effects.

Zoloft was litigated before a West Virginia mass litigation panel and involved claims that maternal use of Pfizer’s antidepressant, Zoloft, during pregnancy caused children to be born with heart defects. The plaintiffs were unable to present expert evidence to show that Zoloft’s labeling failed to adequately warn of the alleged risk of birth defects and sought to rely instead on the defendant’s internal documents concerning scientific interpretations of observational data, animal studies and toxicology reports, adverse event reports on birth outcomes, and foreign labeling language regarding use during pregnancy.

The Panel reviewed each of the documents and held that they could not substitute for expert testimony. To the contrary, the court reasoned that the parties’ differing interpretation of these internal scientific or medical documents “clearly illustrates the complexity of the issues presented by Plaintiffs’ failure to warn claims,” putting the issues “beyond the knowledge and experience of the average juror such that expert testimony is required.” Id. at *17. The plaintiffs appealed this decision, which is currently pending before the Supreme Court of Appeals of West Virginia, where Quinn Emanuel is lead counsel to Pfizer.

Mirena, Lipitor, and Zoloft are recent examples of tactics by plaintiffs in complex mass tort cases to forestall summary judgment by pivoting from using expert evidence when that evidence is otherwise inadmissible and instead relying more heavily on company documents. For manufacturers faced with products liability exposure, these will be important appellate cases to watch.