Product Liability & Mass Torts Digest

Under both strict product liability and negligence theories, plaintiffs must establish proximate causation where there is a reasonable certainty that the defendant’s acts caused the injury. Several recent cases have emphasized the Daubert requirement that expert testimony supporting proximate cause for product liability claims must be non-speculative and backed by reliable, reproducible, scientific methodologies.

The California Supreme Court has recognized a new path for plaintiffs to prove causation in failure-to-warn cases against manufacturers of prescription drugs and medical devices. Under the learned intermediary doctrine, such manufacturers have a duty to warn physicians of the risks associated with their products but do not have a duty to warn patients.

In a recent decision, the Eleventh Circuit affirmed the summary judgment victory of Zeltiq Aesthetics, Inc. in a failure-to-warn and design defect lawsuit regarding its CoolSculpting medical device and found that a health care provider’s misunderstanding of an adverse effect did not bear on the adequacy of the product’s warning.

The Fourth Circuit recently reversed a decision to admit expert evidence in a products liability matter involving the packaging of garage doors/hoods in Sardis v. Overhead Door Corp.

In two recent cases involving medical device implants, two federal courts ruled on defendants’ summary judgment motions on failure to warn claims—one court granting and the other denying.

Last month, the U.S. Court of Appeals for the Fifth Circuit affirmed two summary-judgment decisions in In re Taxotere (Docetaxel) Products Liability Litigation, a coordinated multidistrict litigation (MDL) that is centralized in the Eastern District of Louisiana.

It goes without saying that in a failure-to-warn case, the plaintiff must establish that the defendant’s failure to warn of a specific adverse event caused the plaintiff’s injury.

On June 26, 2020, GlaxoSmithKline LLC (GSK) filed a Petition for Writ of Certiorari regarding “the first—and, to date, only—appellate decision interpreting” the “fully informed” prong of the pharmaceutical preemption analysis in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019). Pet. 2.

A California appeals court recently reversed the dismissal of a failure to warn claim based on preemption in the Risperdal and Invega Product Liability Cases, suggesting that in the wake of the Supreme Court’s decisions in Wyeth v. Levine, 129 S.Ct. 1187 (2009) and Merck Sharp & Dohme Corp. v. Albrecht, 139 S.Ct. 1668 (2019), drug manufacturers will continue to face challenges in establishing a preemption defense.