title: 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.
authors.affiliation: Villanova University School of Law, USA. moreland@law.villanova.edu
authors.forename: Michael P
authors.initials: MP
authors.lastname: Moreland
mesh_terms: D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D018166:Health Care Reform / Q000331:legislation & jurisprudence*; D006801:Humans; D016365:Liability, Legal; D013219:State Government; D014481:United States; D014486:United States Food and Drug Administration