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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 Realizing that existing devices could not be withdrawn from the market while the Food and Drug Administration (FDA) completed PMA analyses, Congress included a provision allowing pre-1976 devices to remain on the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.cralaw


Held: The judgment is reversed in part and affirmed in part, and the cases are remanded.

56 F.3d 1335, reversed in part, affirmed in part, and remanded.

JUSTICE STEVENS delivered the opinion of the Court with respect to Parts I, II, III, V, and VII, concluding that the MDA does not pre-empt the Lohrs' common-law claims. Pp. 484-486; 492-502; 503.

(a) While the Court need not go beyond § 360k(a)'s pre-emptive language to determine whether Congress intended the MDA to pre-empt at least some state law, see Cipollone v. Liggett Group, Inc., 505 U. S. 504,517, "the domain expressly pre-empted" by that language must be identified, ibid. Interpretation of the text is informed by the assumptions that the States' historic police powers cannot be superseded by a Federal Act unless that is Congress' clear and manifest purpose, Rice v. Santa Fe Elevator Corp., 331 U. S. 218, 230, and that any understanding of a pre-emption statute's scope rests primarily on "a fair understanding of congressional purpose," Cipollone, 505 U. S., at 530, n.27. Pp.484-486.

(b) The Lohrs' negligent design claims are not pre-empted. The FDA's "substantially equivalent" determination as well as its continuing authority to exclude a device from the market do not amount to a specific, federally enforceable design requirement that would be affected by state-law pressures such as those imposed here. Since the § 510(k) process is focused on equivalence, not safety, substantial equivalence determinations provide little protection to the public. Neither the statutory scheme nor legislative history suggests that the § 51O(k) process was intended to do anything other than maintain the status quo, which included the possibility that a device's manufacturer would have to defend itself against state-law negligent design claims. Pp. 492-494.

(c) Section 360k(a) does not pre-empt state rules that merely duplicate the FDA's rules regulating manufacturing practices and labeling. That the state requirements may be narrower than the federal rules does not make them "different" under §360k. Nor does the presence of a damages remedy amount to an additional or different "requirement"; it merely provides another reason for manufacturers to comply with identical existing federal law "requirements." This view is supported by the regulations of the FDA, to which Congress has delegated authority to implement the MDA. Pp. 494-497.

(d) The Lohrs' manufacturing and labeling claims are not pre-empted.

Although the statutory and regulatory language may not preclude "general" federal requirements from ever pre-empting state requirements, or "general" state requirements from ever being pre-empted, it is impossible to ignore its overarching concern that pre-emption occur onlycralaw

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