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Nos. 95-754 and 95-886


on writs of certiorari to the united states court of appeals for the eleventh circuit

[June 26, 1996]

Justice O'Connor, with whom the Chief Justice, Justice Scalia, and Justice Thomas join, concurring in part and dissenting in part.

Section 360k(a), the pre-emption provision of the Medical Device Amendments of 1976 (MDA), provides that no State may establish or continue in effect "any requirement" "which is different from, or in addition to," any requirement applicable under the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) to the device. As the Court points out, because Congress has expressly provided a pre-emption provision, "we need not go beyond that language to determine whether Congress intended the MDA to pre-empt" state law. Ante, at 12. We agree, then, on the task before us: to interpret Congress' intent by reading the statute in accordance with its terms. This, however, the Court has failed to do.

The case requires us to determine whether the Lohrs' state common law claims survive pre-emption under §360k. I conclude that state common law damages actions do impose "requirements" and are therefore pre-empted where such requirements would differ from those imposed by the FDCA. The plurality acknowledges that a common law action might impose a "requirement," but suggests that such a pre-emption would be "rare indeed." Ante, at 31. To reach that determination, the opinion--without explicitly relying on Food and Drug Administration (FDA) regulations and without offering any sound basis for why deference would be warranted "imports the FDA regulations interpreting §360k to "inform" the Court's reading. Accordingly, the principal opinion states that pre-emption occurs only "where a particular state requirement threatens to interfere with a specific federal interest," ante, at 28, and for that reason, concludes that common law claims are almost never pre-empted, ante, at 30-31, and that the Lohrs' claims here are not pre-empted. This decision is bewildering and seemingly without guiding principle.

The language of §360k demonstrates congressional intent that the MDA pre-empt "any requirement" by a State that is "different from, or in addition to," that applicable to the device under the FDCA. The Lohrs have raised various state common law claims in connection with Medtronic's pacemaker lead. Analysis, therefore, must begin with the question whether state common law actions can constitute "requirements" within the meaning of §360k(a).

We recently addressed a similar question in Cipollone, where we examined the meaning of the phrase "no requirement or prohibition" under the Public Health Cigarette Smoking Act of 1969. Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992). A majority of the Court agreed that state common law damages actions do impose "requirements." Id., at 521-522 (plurality opinion), id., 548-549 (Scalia, J. and Thomas J., concurring in judgment in part and dissenting in part). As the plurality explained:

"The phrase, `[n]o requirement or prohibition' sweeps broadly and suggests no distinction between positive enactments and common law; to the contrary, those words easily encompass obligations that take the form of common law rules. As we noted in another context, `[state] regulation can be as effectively exerted through an award of damages as through some form of preventive relief. The obligation to pay compensation can be, indeed is designed to be, a potent method of governing conduct and controlling policy.' San Diego Building Trades Council v. Garmon, 359 U.S. 236, 247 (1959)." Id., at 521.

That rationale is equally applicable in the present context. Whether relating to the labeling of cigarettes or the manufacture of medical devices, state common law damages actions operate to require manufacturers to comply with common law duties. As Cipollone declared, in answer to the same argument raised here that common law actions do not impose requirements, "such an analysis is at odds both with the plain words" of the statute and "with the general understanding of common law damages actions." Ibid. If §360k's language is given its ordinary meaning, it clearly pre-empts any state common law action that would impose a requirement different from, or in addition to, that applicable under the FDCA--just as it would pre-empt a state statute or regulation that had that effect. Justice Breyer reaches the same conclusion. Ante, at 1-3 (opinion concurring in part and concurring in the judgment).

The plurality's reasons for departing from this reading are neither clear nor persuasive. It fails to refute the applicability of the reasoning of Cipollone. Instead, in Part IV, the plurality essentially makes the case that the statute's language, purpose, and legislative history, as well as the consequences of a different interpretation, indicate that Congress did not intend "requirement" to include state common law claims at all. The principal opinion proceeds to disclaim this position, however, in Parts V and VI and concludes, rather, that a state common law action might constitute a requirement, but that such a case would be "rare indeed." Ante, at 31. The Court holds that an FDCA "requirement" triggers pre-emption only when a conflict exists between a specific state requirement and a specific FDCA requirement applicable to the particular device. See ante, at 26-30. But see ante, at 28 ("[W]e do not believe that this statutory and regulatory language necessarily precludes `general' federal requirements from ever pre-empting state requirements, or `general' state requirements from ever being pre-empted . . . .") The plurality emphasizes the "critical importance of device specificity" in its understanding of the pre-emption scheme. Ante, at 31.

To reach its particularized reading of the statute, the Court imports the interpretation put forth by the FDA's regulations. Justice Breyer similarly relies on the FDA regulations to arrive at an understanding of §360(k). Ante, at 3-5. Apparently recognizing that Chevron deference is unwarranted here, the Court does not admit to deferring to these regulations, but merely permits them to "infor[m]" the Court's interpretation. Ante, at 23. It is not certain that an agency regulation determining the pre-emptive effect of any federal statute is entitled to deference, cf. Smiley v. Citibank (South Dakota), N.A., slip op. at 8, but one pertaining to the clear statute at issue here is surely not. "If the statute contains an express pre-emption clause, the task of statutory construction must in the first instance focus on the plain wording of the clause, which necessarily contains the best evidence of Congress' pre-emptive intent." CSX Transp., Inc. v. Easterwood, 507 U.S. 658, 664 (1993). Where the language of the statute is clear, resort to the agency's interpretation is improper. See Chevron U. S. A. Inc., v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842-843 (1984). Title 21 U.S.C. § 360k(a)(1) directs the pre-emption of "any [state] requirement" "which is different from, or in addition to, any requirement applicable under [the FDCA] to the device." As explained above, and as Justice Breyer agrees, ante, at 1-3, the term "requirement" encompasses state common law causes of action. The Court errs when it employs an agency's narrowing construction of a statute where no such deference is warranted. The statute makes no mention of a requirement of specificity, and there is no sound basis for determining that such a restriction on "any requirement" exists.

I conclude that a fair reading of §360k indicates that state common law claims are pre-empted, as the statute itself states, to the extent that their recognition would impose "any requirement" different from, or in addition to, FDCA requirements applicable to the device. From that premise, I proceed to the question whether FDCA requirements applicable to the device exist here to pre-empt the Lohrs' state law claims.

I agree with the Court that the Lohrs' defective design claim is not pre-empted by the FDCA's §510(k) "substantial equivalency" process. The §510(k) process merely evaluates whether the Class III device at issue is substantially equivalent to a device that was on the market before 1976, the effective date of the Medical Device Amendments; if so, the later device may be also be marketed. Because the §510(k) process seeks merely to establish whether a pre-1976 device and a post-1976 device are equivalent, and places no "requirements" on a device, the Lohrs' defective design claim is not pre-empted.

I also agree that the Lohrs' claims are not pre-empted by §360k to the extent that they seek damages for Medtronic's alleged violation of federal requirements. Where a state cause of action seeks to enforce an FDCA requirement, that claim does not impose a requirement that is "different from, or in addition to" requirements under federal law. To be sure, the threat of a damages remedy will give manufacturers an additional cause to comply, but the requirements imposed on them under state and federal law do not differ. Section §360k does not preclude States from imposing different or additional remedies, but only different or additional requirements.

I disagree, however, with the Court's conclusion that the Lohrs' claims survive pre-emption insofar as they would compel Medtronic to comply with requirements different from those imposed by the FDCA. Because I do not subscribe to the Court's reading into §360k the additional requisite of "specificity," my determination of what claims are pre-empted is broader. Some if not all of the Lohrs' common law claims regarding the manufacturing and labeling of Medtronic's device would compel Medtronic to comply with requirements different from or in addition to those required by the FDA. The FDA's Good Manufacturing Practice (GMP) regulations impose comprehensive requirements relating to every aspect of the device manufacturing process, including a manufacturer's organization and personnel, buildings, equipment, component controls, production and process controls, packaging and labeling controls, holding, distribution, installation, device evaluation, and record keeping. See 21 CFR §§ 820.20-820.198 (1995). The Lohrs' common law claims regarding manufacture would, if successful, impose state requirements "different from, or in addition to" the GMP requirements, and are therefore pre-empted. In similar fashion, the Lohrs' failure to warn claim is pre-empted by the extensive labeling requirements imposed by the FDA. See, e.g., 21 CFR § 801.109 (requiring labels to include such information as indications, effects, routes, methods, frequency and duration of administration, relevant hazards, contraindications, side effects, and precautions). These extensive federal manufacturing and labeling requirements are certainly applicable to the device manufactured by Medtronic. Section 360k(a) requires no more specificity than that for pre-emption of state common law claims.

To summarize, I conclude that §360k(a)'s term "requirement" encompasses state common law claims. Because the statutory language does not indicate that a "requirement" must be "specific," either to pre-empt or be pre-empted, I conclude that a state common law claim is pre-empted if it would impose "any requirement" "which is different from, or in addition to," any requirement applicable to the device under the FDCA. I would affirm the judgment of the Court of Appeals that the Lohrs' design claim is not pre-empted by the MDA, and that the manufacture and failure to warn claims are pre-empted; I would reverse the judgment of the Court of Appeals that the MDA pre-empts a common law claim alleging violation of federal requirements.