Judge Cites Clearer View of FDA Regulations in Vacating Preemption Ruling



DOCUMENTS
  • Opinion


INDIANAPOLIS - A federal judge has reconsidered and vacated his prior decision that dismissed as preempted failure-to-warn claims brought by the sister of a former priest who killed himself after taking Paxil. Tucker v. SmithKline Beecham Corp., No. 04-1748 (S.D. Ind.).

Judge David F. Hamilton of the U.S. District Court for the Southern District of Indiana said July 18 that his prior ruling deserved a closer inspection of FDA regulations and failed to consider whether the agency's involvement in Paxil label changes ordered in 2007 conflict with allegations five years earlier that the warnings were inadequate.

Hamilton previously awarded summary …






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