In PLIVA v. Mensing, 131 S. Ct. 2567 (2011), the Supreme Court held that FDA regulations governing the labeling of prescription drugs preempt state-law failure-to-warn claims against generic drug manufacturers -- meaning that people harmed by mislabled generic drugs cannot recover damages against their manfacturers under state law. Just a couple years earlier, in Wyeth v. Levine, 555 U.S. 555 (2008), the Supreme Court held that the same kind of suit against manufacturers of brand-name prescription drugs is not preempted by federal law. Along with Dena Feldman, I just wrote this article on PLIVA and its implications. The article is published at 39 Prod. Safety & Liab. Rptr. (BNA) 972 (Sept. 5, 2011), and 26 Toxics Law Rptr. (BNA) 1062 (Sept. 8, 2011).


Comments