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.
The U.S. Food & Drug Administration’s (FDA’s) Least Burdensome Provisions: Concept and Principles: Guidance for Industry and Food and Drug Administration Staff, February 5, 2019, states that “medical device regulation should be least burdensome across the total product life cycle.” This means that manufacturers are expected to provide “the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time.” The FDA observed that this approach should “ensure that patients have access to high-quality, safe and effective medical devices.”