474
Opinion of the Court
Justice Stevens announced the judgment of the Court and delivered the opinion of the Court with respect to Parts I, II, III, V, and VII, and an opinion with respect to Parts IV and VI, in which Justice Kennedy, Justice Souter, and Justice Ginsburg join.
Congress enacted the Medical Device Amendments of 1976, in the words of the statute's preamble, "to provide for the safety and effectiveness of medical devices intended for human use." 90 Stat. 539. The question presented is whether that statute pre-empts a state common-law negligence action against the manufacturer of an allegedly defective medical device. Specifically, we must consider whether Lora Lohr, who was injured when her pacemaker failed, may rely on Florida common law to recover damages from Medtronic, Inc., the manufacturer of the device.
F. Easley of North Carolina, Heidi Heitkamp of North Dakota, Theodore R. Kulongoski of Oregon, Mark Barnett of South Dakota, Charles W. Burson of Tennessee, Dan Morales of Texas, and Darrell V. McGraw, Jr., of West Virginia; for the American Association of Retired Persons et al. by David Halperin; for the American Insurance Association et al. by Victor E. Schwartz, Joseph N. Onek, Robert P. Charrow, Mark A. Behrens, and Jan S. Amundson; for the Association of Trial Lawyers of America by Jeffrey Robert White and Pamela A. Liapakis; for the Center for Patient Advocacy et al. by John G. Roberts, Jr.; for Collagen Corp. by Joe W. Redden, Jr., Keith A. Jones, and Frederick D. Baker; for General Motors Corp. by Kenneth W. Starr, Richard A. Cordray, Paul T. Cappuccio, David M. Heilbron, Leslie G. Landau, and James A. Durkin; for the Health Industry Manufacturers Association et al. by Bruce N. Kuhlik, Paul J. Maloney, and William J. Carter; for the Medical Device Manufacturers Association by Stephen S. Phillips and James M. Beck; for the National Conference of State Legislatures et al. by Richard Ruda and Lee Fennell; for the Plaintiffs' Legal Committee in MDL Docket No. 1014 by Stanley M. Chesley, John J. Cummings III, Calvin Fayard, Jr., Wendell Gauthier, Darryl J. Tschirn, and Michael D. Fishbein; for the Product Liability Advisory Council, Inc., by Robert N. Weiner and Hugh F. Young, Jr.; for Trial Lawyers for Public Justice, P. C., by Jonathan S. Massey and Arthur H. Bryant; for the Washington Legal Foundation by Daniel J. Popeo and Richard A. Samp; and for Two Products Liability Law Professors by Richard N. Pearson, pro se.
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