Products Liability Law Reporter

The Fourth Circuit Court of Appeals held that a district court had erred in excluding the testimony of a plaintiff expert based on an erroneous interpretation of West Virginia law regarding strict liability design defect claims that embraced the Elimination Mandate.

Judith Shears underwent surgery to treat stress urinary incontinence, and her physician placed a synthetic surgical mesh sling called tension-free vaginal tape (TVT mesh) beneath her urethra. She developed complications and subsequently underwent surgery to remove eroded mesh and an attached bladder stone. She and her husband sued Ethicon, Inc., the manufacturer of the TVT mesh, and parent company Johnson & Johnson. The lawsuit was transferred to federal district court, which addressed pretrial motions, including Daubert motions regarding the parties’ expert witnesses. The so-called Elimination Mandate of West Virginia Pattern Jury Instructions for Civil Cases §411 holds that to prove a design is defective, a plaintiff must prove that there was an alternative, feasible design that eliminated the risk that caused the injury. The court, relying on the Elimination Mandate, barred the alternative mesh design testimony of the plaintiffs’ design and materials expert Uwe Klinge. It then granted Ethicon’s motion for judgment as a matter of law on the plaintiffs’ design defect claim at the close of the plaintiffs’ case in chief. The jury found for the defense. The plaintiffs appealed.

The Fourth Circuit requested that the Supreme Court of Appeals of West Virginia resolve a certified question of law on whether a plaintiff alleging a West Virginia strict liability design defect claim is required to prove the existence of an alternative, feasible product design, existing at the time of the product’s manufacture, to establish that the product was not reasonably safe for its intended use, and, if so, whether the alternative design must eliminate the risk of harm the plaintiff suffered or whether a reduction of that risk is sufficient. The Supreme Court of Appeals held that as part of a prima facie case of strict products liability based on design defect, a plaintiff must prove that an alternative, feasible design existing at the time the subject product was made would have substantially reduced the risk of the specific injury the plaintiff suffered.

Adopting the Supreme Court of Appeals’s opinion, the Fourth Circuit considered the plaintiffs’ challenge to the federal trial court’s adoption of §411 and to the court’s Daubert ruling regarding Klinge’s expert testimony, which relied on §411 and its Elimination Mandate. The court found that the trial court had abused its discretion by relying on an erroneous legal principle. Citing the Supreme Court of Appeals’s response to its certification order, the court here found no support in West Virginia law for §411’s requirement for an alternative feasible design that eliminated the risk that injured the plaintiff. Rather, the court said, a plaintiff asserting a strict products liability claim based on defective design need only show that an alternative, feasible design was available to the manufacturer at the time the product was manufactured and that such a design would have substantially reduced the risk of the plaintiff’s injury.

The trial court’s exclusion of Klinge’s testimony was not harmless error, the court concluded, noting that the ruling essentially required the plaintiffs to pursue their products liability claim using only circumstantial evidence under a “malfunction” theory of liability, and that this resulted in judgment for Ethicon.

Consequently, the court vacated the trial court’s judgment and remanded the case.

Citation: Shears v. Ethicon, Inc., 2024 WL 3490742 (4th Cir. July 22, 2024).

Plaintiff counsel: AAJ member Jason P. Foster, AAJ member Scott S. Segal, and Robin J. Davis, all of Charleston, W. Va.