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Horn v. Thoratec: FDA's Bold New Position on the Pre-emptive Effect of Product Approvals

By Bert W. Rein, Karyn K. Ablin, and Sarah E. Botha
April 28, 2005

By and large, the FDA has confined its participation to cases where it had specifically considered ' and rejected ' the plaintiffs' claims that a product's labeling or advertising should have included different language from that which was used. See Daniel E. Troy, FDA Involvement in Product Liability Lawsuits, Update: Food & Drug. L., Reg. & Educ. (Food & Drug Law Inst., Wash., D.C.), Jan./Feb. 2003, at 1. In 2004, however, the FDA submitted a brief in a state products liability action that signals the agency's willingness to be much more aggressive in protecting its jurisdiction from lay judge and jury determinations concerning a product's risk-benefit balance that conflict with the FDA's own determination of where that balance lies. See Br. of Amicus Curiae U.S. Dep't of Justice, Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir. 2004) (No. 02-4597) (“FDA Br.”).

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