470
OCTOBER TERM, 1995
Syllabus
certiorari to the united states court of appeals for the eleventh circuit
No. 95-754. Argued April 23, 1996—Decided June 26, 1996*
Enacted "to provide for the safety and effectiveness of medical devices intended for human use," the Medical Device Amendments of 1976 (MDA or Act) classifies such devices based on the risk that they pose to the public. Class III devices pose the greatest risk and, thus, are subject to a rigorous premarket approval (PMA) process. However, most Class III devices on the market have not been through the PMA process due to two statutory exceptions. Realizing that existing devices could not be withdrawn from the market while the Food and Drug Administration (FDA) completed PMA analyses, Congress included a provision allowing pre-1976 devices to remain on the market without FDA approval until the requisite PMA is completed. The Act also permits devices that are "substantially equivalent" to pre-existing devices to avoid the PMA process until the FDA initiates the process for the underlying device. The FDA uses a "premarket notification" submitted by all manufacturers (§ 510(k) process) to determine substantial equivalence for Class III devices. Petitioner Medtronic, Inc.'s pacemaker is a Class III device found substantially equivalent under the § 510(k) process. Cross-petitioners, Lora Lohr and her spouse, filed a Florida state-court suit alleging both negligence and strict-liability claims in the failure of her Medtronic pacemaker, but Medtronic removed the case to the Federal District Court. That court ultimately dismissed the complaint as having been pre-empted by 21 U. S. C. § 360k(a), which provides that "no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement (1) which is different from, or in addition to, any requirement applicable under [the MDA] 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 device under [the Act]." The Court of Appeals reversed in part and affirmed in part, concluding that the Lohrs' negligent design claims were not pre-empted, but that their negligent manufacturing and failure to warn claims were.
*Together with No. 95-886, Lohr et vir v. Medtronic, Inc., also on certiorari to the same court.
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