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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.



Isaac Gorodetski
Project Manager,
Center for Legal Policy at the
Manhattan Institute

Katherine Lazarski
Press Officer,
Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.