Courts are starting to “get” the design defect preemption argument. That makes sense because the argument is simple. Any major changes in the design of a drug or a medical device require the prior approval or permission of the FDA. And if FDA approval or permission is required, PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), requires implied preemption.

Barcal v. EMD Serono, Inc., No. 5:14-cv-01709-MHH, 2016 WL 1086028 (Mar. 21, N.D. Ala. 2016) involved alleged heart birth defects from a fertility drug – Serophene. The drug’s labeling included a statement about congenital heart defects being observed in children of mothers whose pregnancies had been induced by the drug, but the plaintiff claimed the risk was higher than indicated. To read the blog post on Barcal and its effect on the preemption issue, click here.