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April 14, 2008

FDA Drug Regulation Preempts Failure-to-Warn Claim

The U.S. Court of Appeals for the Third Circuit ruled that the Food & Drug Administration's long history of regulating anti-depressants and its explicit rejection of a suicidality warning for the drugs Paxil and Zoloft preempts state-law based failure-to-warn claims.  The divided and narrowly-tailored opinion is limited to circumstances in which the FDA has actively monitored the drug's risk and publicly rejected the need for the warning that plaintiffs argue state law requires.  The court did not decide whether preemption would be appropriate in other circumstances such as where the FDA had not rejected the substance of the warning sought or where the FDA had only stated its legal postition after the litigation had begun.  See Shannon Duffy's article for The Legal Intelligencer.


April 14, 2008 | Permalink


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