Tort Reform by Regulation: FDA Prescription Drug Labeling Rules and Preemption of State Tort Claims

Abstract

In 2006, the Food and Drug Administration (FDA) asserted in the preamble to a revised physician labeling rule for prescription drugs that FDA labeling requirements preempt state common law failure to warn claims. The FDA's action reflects a wider effort of administrative agencies to preempt conflicting state law requirements. The debate over preemption raises a set of difficult issues, including the sufficiency of agency safety review, the scope of administrative deference, and federalism. This article surveys the background to the 2006 FDA labeling rule and the Supreme Court's recent preemption jurisprudence in leading cases such as Cippollone v. Liggett Group, Inc., and Geier v. American Honda Motor Corp.

Keywords: tort law, product liability, preemption

JEL Classification: K13,K32