In Shears v. Ethicon, Inc., the U.S. Court of Appeals for the Fourth Circuit vacated a judgment entered in favor of Ethicon and its parent company Johnson & Johnson following a jury trial in a pelvic mesh products liability action. The July 22, 2024, decision underscores an important clarification in West Virginia products liability law — to succeed on a strict product liability claim premised on a design defect, a plaintiff must prove a feasible alternative design that substantially reduces the risk of the specific injury that the plaintiff suffered, but the plaintiff need not prove that the alternative design would eliminate that risk.
According to the court’s opinion, plaintiffs Judith and Gary Shears sued Ethicon and Johnson & Johnson after a surgical mesh sling implanted to treat Mrs. Shears’ urologic and abdominal conditions partially eroded, causing other medical difficulties and requiring a second operation to remove the mesh. One of Mrs. Shears’ claims was a strict product liability claim alleging the mesh was defectively designed. To prove her case, Mrs. Shears relied on an expert witness who identified two alternative designs that in the expert’s opinion reduced the risk of erosion.
The district court excluded Mrs. Shears’ expert based on Section 411 of the West Virginia Pattern Jury Instructions for Civil Cases, which states that a plaintiff must prove a feasible, alternative design that “eliminated the risk” of her specific injury. Mrs. Shears’ expert only identified designs that reduced risk. The court’s ruling effectively precluded Mrs. Shears from pursuing her strict liability claim based on a design defect. Following a jury trial, the district court entered judgment in the defendants’ favor.
On appeal, the Fourth Circuit vacated the judgment and remanded the case to the district court. After oral arguments, the Fourth Circuit certified questions to the Supreme Court of Appeals of West Virginia regarding whether Section 411 of the pattern jury instructions accurately reflected West Virginia law. On June 11, 2024, the West Virginia court unanimously ruled that Section 411 was incorrect. West Virginia law does not require that the alternative design eliminate the risk of the plaintiff’s specific injury. Instead, “a plaintiff is required to 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 suffered by the plaintiff.”
The Fourth Circuit resolved the Shears’ appeal based on this ruling. By faulting Mrs. Shears’ expert for failing to identify alternative designs that eliminated the risk of Mrs. Shears’ injury, the district court held the expert to a standard not recognized by West Virginia law. And because the ruling prejudiced Mrs. Shears’ ability to put on her case at trial, the district court’s error warranted vacating the judgment and remanding for further proceedings. The decisions of the Fourth Circuit and the Supreme Court of Appeals of West Virginia clarify that a plaintiff seeking to recover on a strict product liability claim for a design defect must only prove a feasible, alternative design that substantially reduces the risk of injury.
McGuireWoods provides advice and representation to companies navigating products liability issues and litigation. For questions about the potential impacts of the Fourth Circuit’s decision, please contact the authors of this alert, your McGuireWoods contact or a member of the firm’s Product Liability & Mass Tort team.