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 <i>amicus</i> briefs in which the FDA provides further guidance on the proper scope of pre-emption in prescription drug litigation.
Eric G. LaskerPart 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.
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