For at least two decades, Pennsylvania law has recognized an exemption from strict liability for prescription drug manufacturers based on the state Supreme Court’s interpretation of the Restatement (Second) of Torts Sec. 402A cmt. k. Comment k carves out an exception to traditional strict product liability claims for “unavoidably unsafe products,” or those which bear inherent risks—such as medicines which must be prescribed by a doctor. A less settled question is whether that exemption extends to manufacturers of prescription medical devices, specifically regarding manufacturing defect claims. On June 25, 2019, Judge Robreno of the U.S.D.C. Eastern District of Pennsylvania asked the Third Circuit to answer it.
In Kim v. Toyota Motor Corp., No. S232754 (August 27, 2018) the California Supreme Court broke with 40+ years of intermediate court of appeal precedents barring manufacturers from using evidence of their compliance with industry custom and practice to prove their design was not defective. Rather, the Court held, such evidence is no longer categorically inadmissible, but neither is it categorically admissible. Admissibility depends on the nature of the evidence and the purpose for which it is offered.
Recap: Part 1 (here) discussed the background of the consumer expectations test (CET) and part 2 (here) described the California Supreme Court’s seemingly definitive decision in Soule v. General Motors Corp., 8 Cal.4th 548 (1994) explaining the types of cases where CET can be applied.
Recap: The background and prior post for this multi-part series can be found here.
In 1994, the California Supreme Court took up Soule v. General Motors Corp., 8 Cal.4th 548 (1994), to provide much-needed guidance as to when it is and is not appropriate to allow a jury to decide the design defect issue based on the consumer expectations test (CET). “Much-needed” may be an understatement – trial courts routinely allowed plaintiffs freely to elect what design defect standard the jury would consider, often both CET and the risk-benefit test (RBT), gaining the proverbial two bites at the apple, and the courts of appeal had not prescribed any meaningful limiting theory or principle. Continue reading
In the 50-plus years since the inception of the doctrine of strict products liability in tort, a vexing issue for product manufacturers has been how to evaluate and defend against accusations of design defect. Manufacturing defects are relatively easy to evaluate – something either did or did not go wrong on the assembly line, the product either did or did not conform to specifications. But except for the rare and extreme cases where, in hindsight, the design is so clearly misguided that no reasonable engineer would consider it safe, courts, commentators and lawyers have hotly debated the proper benchmark to judge the alleged defectiveness of an entire product line.