Preemption Defense: Is Inaction by the FDA Enough?
A seeming contradiction between two recent federal district court rulings on preemption and the U.S. Food and Drug Administration’s oversight of pharmaceuticals creates some uncertainty about whether evidence submitted by the drug manufacturer of inaction by the FDA is enough to establish that the FDA would not have approved a heightened warning to the drug’s label.
Preemption is a demanding defense which will not succeed without “clear evidence” that the FDA would not have approved an enhanced drug warning label. Wyeth v. Levine, 555 U.S. 555, 571 (2009). Noting that Wyeth does not define what constitutes clear evidence, and that the application of that standard is necessarily fact specific, in November 2015 a United States District Court Judge from the Southern District of California granted summary judgment on behalf of Merck Sharp & Dohme Corp., Eli Lily & Co. and others on plaintiffs’ state law failure-to-warn claims, finding that the FDA would have rejected earlier pancreatic cancer warning labels for those drugs. [Read full article]