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

By and large, the FDA has confined its participation to cases where it had specifically considered &mdash; and rejected &mdash; the plaintiffs' claims that a product's labeling or advertising should have included different language from that which was used. <i>See</i> Daniel E. Troy, <i>FDA Involvement in Product Liability Lawsuits,</i> Update: Food &amp; Drug. L., Reg. &amp; Educ. (Food &amp; 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. <i>See Br. of Amicus Curiae U.S. Dep't of Justice, Horn v. Thoratec Corp.</i>, 376 F.3d 163 (3d Cir. 2004) (No. 02-4597) ("FDA Br.").

25 minute read April 28, 2005 at 09:24 AM

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Bert W. Rein, Karyn K. Ablin, And Sarah E. Botha