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On July 20, the 3d U.S. Circuit Court of Appeals ruled that a patient allegedly injured by a medical device that had been through a rigorous Food and Drug Administration (FDA) approval process could not sue the manufacturer under state tort law. Horn v. Thoratec Corporation, No. 02-4597. By itself, that is not surprising. The 6th, 7th and 8th circuits reached the same conclusion as far back as 1997. Only the 11th Circuit-in 1999′s Goodlin v. Medtronic, 167 F.3d 1367-has held that state tort law is not pre-empted. But Horn marks something of a departure for the FDA. On its own initiative, the agency submitted a friend-of-the-court brief urging pre-emption, while under prior administrations the agency had stood aloof in such cases or, if invited to intervene, often argued for giving consumers the protection of state tort law. Barbara E. Horn sued Thoratec Corp. after a malfunction in its HeartMate pump allegedly led to the death of her husband in 1998. The PMA process Before being marketed, the HeartMate had been through the FDA’s most rigorous regimen for medical devices, “pre-market approval” (PMA). The PMA process was mandated by a 1976 statute authorizing the FDA to regulate medical devices and creating a multitiered system of approvals. Manufacturers could sell products with minimal FDA review provided they were already on the market in 1976 or were the “substantial equivalent” of pre-1976 products. New devices, however, had to go through the PMA process. As explained by the 11th Circuit in Goodlin, “the PMA process is rigorous because it permits the FDA to demand the submission of detailed information regarding the safety and effectiveness of the product under review.” Once approval is granted, the court added, “the manufacturer may not change the approved labelling, product design, or manufacturing process in any way that would affect the safety or effectiveness of the device.” The 1976 statute contains an express pre-emption clause, codified at 21 U.S.C. 360k(a). It nullifies any state or local safety or efficacy requirements “different from, or in addition to, any requirement applicable under [the 1976 statute] to the device.” The touchstone for medical-device pre-emption is 1996′s Medtronic v. Lohr, 518 U.S. 470, in which the high court was so fractured that its holding has to be pieced together from multiple opinions. Lohr indisputably held that there was no pre-emption for a device that had only been through the comparatively lax substantial equivalence process. The 3d Circuit, like most circuits to have considered the issue, read Lohr as hinting that the more rigorous PMA process would trigger pre-emption. The 11th Circuit, by contrast, focused on language in Lohr emphasizing that the federal requirement must be specific to a particular device. Though more rigorous, the PMA process is ultimately no less “generic” than the substantial-equivalence test, since it applies to most post-1976 devices, the court concluded. As 3d Circuit Judge Julio M. Fuentes noted in his Horn dissent, there is a circuit split over another related issue. The 7th and 9th circuits have held that only the federal requirement need be specific with respect to a particular device, whereas the 10th Circuit has said that only device-specific state requirements are pre-empted, thus leaving most general tort laws untouched. Young’s e-mail is gyoungnlj.com.

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