Donna S. Riegel, Individually and As Administrator of the Estate of Charles R. Riegel v. Medtronic, Inc. (552 U.S. 312)
U.S. Supreme Court · decided February 20, 2008 · Supreme Court Database (Spaeth)
- Citation
- 552 U.S. 312 · 128 S. Ct. 999
- Decided
- February 20, 2008
- Term
- October Term 2007
- Vote
- 8–1
- Majority author
- Justice Scalia
- Issue area
- Federalism
- Disposition
- Affirmed
- Outcome
- Petitioning party lost
- Ideological direction
- Liberal
Opinion excerpt
Justice Scalia delivered the opinion of the Court. We consider whether the pre-emption clause enacted in the Medical Device Amendments of 1976, 21 U. S. C. § 360k, bars common-law claims challenging the safety and effectiveness of a medical device given premarket approval by the Food and Drug Administration (FDA). I A The Federal Food, Drug, and Cosmetic Act (FDCA), 52 Stat. 1040, as amended, 21 U. S. C. § 301 et seq., has long required FDA approval for the introduction of new drugs into the market. Until the statutory enactment at issue here, however, the introduction of new medical devices was left largely for the States to supervise as they saw fit. See Medtronic, Inc. v. Lohr, 518 U. S. 470, 475-476 (1996). The regulatory landscape changed in the 1960’s and 1970’s, as complex devices proliferated and some failed. Most notably, the Daikon Shield intrauterine device, introduced in 1970, was linked to serious infections and several deaths, not to mention a large number of pregnancies. Thousands of tort claims followed. R. Bacigal, The Limits of Litigation: The Daikon Shield Controversy 3 (1990). In the view of many, the Daikon Shield failure and its aftermath demonstrated the inability of the common-law tort system to manage the risks associated with dangerous devices. See, e. g., S. Foote, Managing the Medical Arms Race 151-152 (1992). Several States adopted regulatory…
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