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.
Supreme Court of the United States
Argued December 4, 2007 Decided February 20, 2008
Full case name	Charles R. Riegel, et ux. v. Medtronic, Inc.
Docket no.	06-179
Citations	552 U.S. 312 (more) 128 S. Ct. 999; 169 L. Ed. 2d 892
Argument	Oral 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
Majority	Scalia, joined by Roberts, Kennedy, Souter, Thomas, Breyer, Alito (in full); Stevens (all except for III-A and III-B)
Concurrence	Stevens (in part)
Dissent	Ginsburg

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

See also

• Eli Lilly & Co. v. Medtronic, Inc.
• FDA Preemption
• List of United States Supreme Court cases, volume 552

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)