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Wyeth v. Levine – U.S. Supreme Court Rejects FDA Preemption in Pharmaceutical Cases

Date: Apr 22, 2009

On March 4, 2009, the Supreme Court issued its long-awaited decision in Wyeth v. Levine, the controversial case addressing whether the Food and Drug Administration's (FDA) approved labeling of prescription drugs shields drug manufacturers from state tort suits.[1] In a 6-3 opinion, the Court held that FDA's approval of a prescription drug label did not preempt state-law failure to warn claims given the facts of this case, although it left open the door open for a finding of preemption under different circumstances. As a result of this decision, pharmaceutical companies should thoroughly document their interactions with FDA with respect to product labeling decisions and work to obtain clear FDA responses on whether proposed labeling changes are, or are not, acceptable.

The Wyeth decision is part of a trilogy of FDA preemption cases taken up by the Supreme Court in the last year and signals a move towards limited availability of the implied preemption defense in the context of FDA regulated drugs. The case has also sparked speculation that the Court's decision may potentially be applied in other contexts of agency regulation, impacting consumers who are suing for injuries caused by motor vehicles, chemicals, pesticides, and household products, etc.[2] As stakeholders begin to assess the impact of the decision, reviewing the issues raised in Wyeth and other recent FDA preemption cases, as well as possible future congressional action, may provide important clues for what is to come regarding FDA's regulation of the safety of products covered by the Federal Food, Drug, and Cosmetic Act (FDCA).

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[2] Thomas N. Tiedt, "Pharmaceutical Safety is Not Served by Federal Supremacy," The Food and Drug Law Institute Update (September/October 2008) at 47; see also Adam Liptak, "No Legal Shield in Drug Labeling, Justices Rule" NY Times (March 4, 2009); see also High Court Hears Arguments on Limiting Drug Company Lawsuits," The Online NewsHour with Jim Lehrer (November 3, 2008).