Buckman Co. v. Plaintiffs’ Legal Comm. (U.S. Supreme Court)
Plaintiffs sought damages from our client for alleged misstatements made to the FDA in seeking its approval of a medical device. This so-called “Fraud on the FDA” theory of liability had been gaining traction in the lower courts and was endorsed in this case by a panel of the Third Circuit. We successfully petitioned for certiorari and the Supreme Court ruled unanimously in our client’s favor. The Court held that plaintiff’s Fraud-on-the-FDA claim amounted to private enforcement of the Food, Drug, and Cosmetic Act and, therefore, was impliedly preempted by a provision of the Act prohibiting private rights of action.