Riegel v. Medtronic, Inc.

2008 United States Supreme Court case
Riegel v. Medtronic, Inc.
Argued December 4, 2007
Decided February 20, 2008
Full case nameCharles R. Riegel, et ux. v. Medtronic, Inc.
Docket no.06-179
Citations552 U.S. 312 (more)
128 S. Ct. 999; 169 L. Ed. 2d 892
ArgumentOral argument
Holding
The MDA's pre-emption clause bars common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA.
Court membership
Chief Justice
John Roberts
Associate Justices
John P. Stevens · Antonin Scalia
Anthony Kennedy · David Souter
Clarence Thomas · Ruth Bader Ginsburg
Stephen Breyer · Samuel Alito
Case opinions
MajorityScalia, joined by Roberts, Kennedy, Souter, Thomas, Breyer, Alito; Stevens (except Parts III–A and III–B)
ConcurrenceStevens (in part)
DissentGinsburg

Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), is a United States Supreme Court case in which the Court held that the pre-emption clause of the Medical Device Amendment bars state common-law claims that challenge the effectiveness or safety of a medical device marketed in a form that received premarket approval from the Food and Drug Administration.[1]

It modified the rule in Medtronic, Inc. v. Lohr.[2]

See also

References

  1. ^ Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).
  2. ^ Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).

Further reading

  • Korobkin, Russell (2007). "Who Should Protect the Public? The Supreme Court and Medical Device Regulation". New England Journal of Medicine. 357 (17): 1680–1681. doi:10.1056/NEJMp078142. PMID 17960010.

External links

  • Text of Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) is available from: Findlaw  Justia  Oyez (oral argument audio) 


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