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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 ' 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.”).
Background
The medical device at issue in Horn was a HeartMate heart pump. After extensive review and numerous communications with the manufacturer, the FDA approved the pump in 1994 pursuant to the Pre-Market Approval (“PMA”) process set forth in 21 U.S.C. '360e(c). See Horn v. Thoratec Corp., 376 F. 3d 163, 164-65, 169-70 (3d Cir. 2004). The plaintiff brought design defect and failure to warn claims against the device manufacturer following her husband's death a few days after the HeartMate implanted into him became disconnected from his heart. Id. at 165. The district court granted summary judgment in favor of the device manufacturer, finding that such claims were pre-empted by the Medical Device Amendments' (“MDA's”) express pre-emption provision set forth in 21 U.S.C. '360k(a). Id. That provision prohibits states from establishing or maintaining any safety or effectiveness requirement for a medical device that is “different from, or in addition to, any requirement applicable” under the FDCA. 21 U.S.C. '360k(a)(1). The plaintiff appealed the ruling to the U.S. Court of Appeals for the Third Circuit. Horn, 376 F.3d at 165.
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