Riegel v. Medtronic, Inc.

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]

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 (in full); Stevens (all except for III-A and III-B)
ConcurrenceStevens (in part)
DissentGinsburg

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.


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