Prescription drug manufacturers have unsuccessfully asserted pre-emption as a defense to product liability claims for decades. A new FDA final rule and the first federal case interpreting that rule indicate that the tide may be turning.
Colacicco v. Apotex: A New Era in Prescription Drug Pre-emption
Prescription drug manufacturers have unsuccessfully asserted pre-emption as a defense to product liability claims for decades. A new FDA final rule and the first federal case interpreting that rule indicate that the tide may be turning. On May 25, 2006, Judge Baylson of the U.S. District Court for the Eastern District of Pennsylvania issued his opinion in <i>Colacicco v. Apotex, Inc.</i>, 432 F. Supp. 2d 514 (E.D. Pa. 2006). The decision is the first federal court opinion discussing the pre-emptive effect of the preamble to the FDA's final rule on prescription drug labeling (the 'preamble'). <i>See</i> 71 Fed. Reg. 3922, 3934 (Jan. 24, 2006).
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Donald C. Le GowerThis premium content is locked for LawJournalNewsletters subscribers only
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