Supreme Court Holds that FDA Regulation Does Not Preempt State Tort Claim
By Caitlyn Ross – Edited by Miriam Weiler
Wyeth v. Levine
Supreme Court of the United States, March 4, 2009, No. 06-1249
On March 4th, the Supreme Court of the United States affirmed the judgment of the Vermont Supreme Court, holding that federal drug labeling regulations do not preempt state failure-to-warn lawsuits. The Supreme Court held that compliance with FDA labeling requirements did not preempt Levine’s failure-to-warn claim based on what she alleged was defective labeling of Wyeth’s anti-nausea drug Phenergan. In so holding, the Court concluded that Congress did not intend to preempt state-law failure-to-warn actions. It also rejected Wyeth’s claim that the Court should defer to an FDA statement, made in the preamble to a 2006 regulation, that state tort suits threatened the FDA’s statutory mandate.
Briefs and relevant court documents are available here at the SCOTUS wiki. The SCOTUS Blog provides an overview of the case. Drug and Device Law Blog suggests that the decision does not eliminate preemption alcims, but does make them far more difficult to win. The Wall Street Journal Law Blog features an analysis of the decision. The Volokh Conspiracy notes a decrease in deference to agencies.