OCTOBER TERM, 2007
NOTE: Where it is feasible, a syllabus (headnote) will be released, as is
being done in connection with this case, at the time the opinion is issued.
The syllabus constitutes no part of the opinion of the Court but has been
prepared by the Reporter of Decisions for the convenience of the reader.
See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337.
SUPREME COURT OF THE UNITED STATES
RIEGEL, INDIVIDUALLY AND AS ADMINISTRATOR OF
ESTATE OF RIEGEL v. MEDTRONIC, INC.
CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR
THE SECOND CIRCUIT
No. 06–179. Argued December 4, 2007—Decided February 20, 2008
The Medical Device Amendments of 1976 (MDA) created a scheme of
federal safety oversight for medical devices while sweeping back state
oversight schemes. The statute provides that a State shall not “es-
tablish or continue in effect with respect to a device intended for hu-
man use any requirement—. . . (1) which is different from, or in addi-
tion to, any requirement applicable under [federal law] to the device,
and . . . (2) which relates to the safety or effectiveness of the device or
to any other matter included in a requirement applicable to the de-
vice under” relevant federal law. 21 U. S. C. §360k(a). The MDA
calls for federal oversight of medical devices that varies with the type
of device at issue. The most extensive oversight is reserved for Class
III devices that undergo the premarket approval process. These de-
vices may enter the market only if the FDA reviews their design, la-
beling, and manufacturing specifications and determines that those
specifications provide a reasonable assurance of safety and effective-
ness. Manufacturers may not make changes to such devices that
would affect safety or effectiveness unless they first seek and obtain
permission from the FDA.
Charles Riegel and his wife, petitioner Donna Riegel, brought suit
against respondent Medtronic after a Medtronic catheter ruptured in