A West Virginia federal court ruled that Texas courts would not apply comment k to Section 402A of the Restatement (Second) of Torts in design defect cases not involving prescription drugs. The case, Jenkins v. Bostin Scientific Corp., 2016 WL 1448867 (S.D. W.Va. Apr. 12, 2016), is part of an MDL proceeding involving claims for injury caused by transvaginal surgical mesh.
A majority of states apply comment k in barring strict liability claims against certain “unavoidably unsafe” products (i.e., products “which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use.”). Such unavoidably unsafe products, “are especially common in the field of drugs.” But comment k is not limited on its face to prescription drugs. A number of states apply comment k to medical devices, either categorically or on a case-by-case basis. For example, in Hill v. Searle Laboratories the Eighth Circuit predicted that Arkansas courts would adopt comment k and would determine whether a product was within the scope of comment k on a case-by-case basis. See Hill v. Searle Laboratories, 884 F.2d 1064, 1067-70 (8th Cir. 1989).
The Jenkins court rejected defendant’s argument that comment k barred plaintiff’s design defect claim. The court acknowledged that, under Texas law, “all FDA-approved prescription drugs are unavoidably unsafe as a matter of law.” However, the court declined to apply comment k beyond the category of prescription drugs, finding that “the products are neither FDA-approved nor prescription drugs.” See Jenkins, 2016 WL 1448867, *5. This analysis is perfunctory, and at least one commentator argues it is also incorrect. See Michelle Yeary, Don’t Mess With Texas, Drug and Device Law (May 6, 2016, 3:20 PM) http://druganddevicelaw.blogspot.com/2016/05/dont-mess-with-texas_6.html.
The full Jenkins decision can be found here.