Shook Partner Dan Rogers, Partners and Public Policy Group Co-Chairs Phil Goldberg and Victor Schwartz, and Of Counsel Chris Appel have filed an amici brief with the Utah Supreme Court in a case involving certified questions as to whether the state’s categorical bar to design defect liability for prescription drugs extends to implanted medical devices. The Court previously adopted Comment k of the Restatement (Second) of Torts § 402A to bar design liability claims related to prescription drugs that are “unavoidably unsafe,” primarily on public policy grounds. The amici brief explains that the same public policy basis applies with equal force to implanted medical devices, products that have beneficial and potentially life-saving attributes but also may involve serious risks.
Specifically, the brief discusses the importance of encouraging innovation in the manufacture of medical devices, and ensuring the continued availability of these products, through a clear rule barring design liability. The brief also examines the rationales of other states that apply Comment k categorically to medical devices. The brief further details the comprehensive regulatory scheme governing clearance to market medical devices under either the FDA’s Premarket Approval (PMA) or 510(k) processes, which require the same type of risk-benefit determinations as prescription drugs.
Shook attorneys submitted the brief on behalf of Advanced Medical Technology Association, American Tort Reform Association, BioUtah, Chamber of Commerce of the United States of America, National Association of Manufacturers and Pharmaceutical Research and Manufacturers of America.
The case is Burningham v. Wright Med. Grp., Inc., No. 20180143 (Utah Sup. Ct.).