by Michael A. Walsh
Washington Legal Foundation
May 20, 2013
Working Paper Series
Because the Food and Drug Administration may not have the stranglehold it once had over the dissemination of information, new theories and approaches to state tort liability are emerging. None is more potently poised than tort claims related to unapproved new uses or off-label uses. Similarly emergent are theories claiming “parallel” state court tort damages based upon violation of the Food and Drug Cosmetic Act.

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