Legal Opinion
Riegel v. Medtronic, Inc.
Supreme Court of the United States
Decided February 20, 2008No. 06-179PublishedCited by 712 opinions
1Opinion of the CourtJustice Scalia
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…
2Cases cited8 opinions
- Skidmore v. Swift & Co.Supreme Court of the United States · 1944
- Connecticut National Bank v. GermainSupreme Court of the United States · 1992
- United States v. Mead Corp.Supreme Court of the United States · 2001
- Cipollone v. Liggett Group, Inc.Supreme Court of the United States · 1992
- Auer v. RobbinsSupreme Court of the United States · 1997
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3Cited by712 opinions
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- Gorman v. Wolpoff & Abramson, LLPCourt of Appeals for the Ninth Circuit · 2009
- Bausch v. Stryker Corp.Court of Appeals for the Seventh Circuit · 2010
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