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SCOTUS answer to FDA preemption question?

The Vermont Supreme Court ruled in Levine v. Wyeth, 2006 WL 3041078, that a jury could award millions of dollars of damages for failure to warn, notwithstanding the fact that the label for the drug, Phenergan, already included an FDA-approved warning of the possibility of the adverse side effect that Ms. Levine suffered; the Court announced that FDA warnings were a floor, rather than a ceiling, despite the explicit statement of the FDA that its approval of a label reflected both a floor and a ceiling. (Beck and Herrmann had a post last week that did a wonderful job refuting Levine.)

The certiorari petition to the Supreme Court has attracted amicus attention from the U.S. Chamber of Commerce and PhRMA (brief doesn't appear to be online), and a cert opposition from Public Citizen. Now the Supreme Court has asked for the opinion of the Solicitor General, which is a good opportunity for the Bush Administration to seek clarification of this important issue of state-court and plaintiffs' bar attempts to override federalism and have state laws trump FDA regulation to stick it to out-of-state defendants. [early word from Beck/Herrmann; WSJ via SCOTUSblog; Pharmalot; Supreme Court Today]

Update: The SCOTUSblog site has some other certiorari briefs.



Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.