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Prescription Drug Litigation Pre-emption: A Status Report from the Defense Perspective

By Eric G. Lasker
October 30, 2006

Part Two of a Two-Part Series

The Food and Drug Administration's ('FDA') pre-emption analysis in the preamble to its Jan. 24, 2006 drug-labeling rule has resulted in a significant shift in judicial recognition of pre-emption in prescription drug litigation. While only a handful of courts had upheld prescription drug pre-emption arguments prior to the FDA preamble, a solid majority of courts informed by the FDA's preamble analysis have found state law claims pre-empted. Part One of this series discussed key battlegrounds upon which future FDA pre-emption arguments will be fought. This second installment reviews recent case law and also discusses two new FDA amicus briefs in which the FDA provides further guidance on the proper scope of pre-emption in prescription drug litigation.

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