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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 Breyer, concurring in part and concurring in the judgment.

This case raises two questions. First, do the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetics Act ever pre-empt a state law tort action? Second, if so, does the MDA pre-empt the particular state law tort claims at issue here?

My answer to the first question is that the MDA will sometimes pre-empt a state law tort suit. I basically agree with Justice O'Connor's discussion of this point and with her conclusion. See post, at 2-4. The statute's language, read literally, supports that conclusion. It says:

"[N]o State . . . may establish . . . with respect to a device . . . any [state] requirement . . . which is different from, or in addition to, any [federal] requirement . . . ." 21 U.S.C. § 360k(a) (emphasis added).

One can reasonably read the word "requirement" as including the legal requirements that grow out of the application, in particular circumstances, of a State's tort law.

Moreover, in Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992), the Court made clear that similar language "easily" encompassed tort actions because "[state] regulation can be as effectively exerted through an award of damages as through some form of preventive relief." Id., at 521 (plurality opinion) (internal quotation marks omitted); see id., at 548-549 (Scalia, J., concurring in judgment in part and dissenting in part). Accord CSX Transp. Inc. v. Easterwood, 507 U.S. 658, 664 (1993). This rationale would seem applicable to the quite similar circumstances at issue here.

Finally, a contrary holding would have anomalous consequences. Imagine that, in respect to a particular hearing aid component, a federal MDA regulation requires a 2 inch wire, but a state agency regulation requires a 1 inch wire. If the federal law, embodied in the "2 inch" MDA regulation, pre-empts the state "1 inch" agency regulation, why would it not similarly pre-empt a state law tort action that premises liability upon the defendant manufacturer's failure to use a 1 inch wire (say, an award by a jury persuaded by expert testimony that use of a more than 1 inch wire is negligent)? The effects of the state agency regulation and the state tort suit are identical. To distinguish between them for pre-emption purposes would grant greater power (to set state standards "different from, or in addition to" federal standards) to a single state jury than to state officials acting through state administrative or legislative lawmaking processes. Where Congress likely did not focus specifically upon the matter, see ante, at 14-19, I would not take it to have intended this anomalous result.

Consequently, I believe that ordinarily, insofar as the MDA pre-empts a state requirement embodied in a state statute, rule, regulation, or other administrative action, it would also pre-empt a similar requirement that takes the form of a standard of care or behavior imposed by a state law tort action. It is possible that the plurality also agrees on this point, although it does not say so explicitly.

The answer to the second question turns on Congress' intent. See, e.g., Barnett Bank of Marion Cty., N. A. v. Nelson, 517 U. S. ___, ___ (1996) (slip op., at 4); Allis Chalmers Corp. v. Lueck, 471 U.S. 202, 208 (1985); ante, at 13. Although Congress has not stated whether the MDA does, or does not, pre-empt the tort claims here at issue, several considerations lead me to conclude that it does not.

First, the MDA's pre-emption provision is highly ambiguous. That provision makes clear that federal requirements may pre-empt state requirements, but it says next to nothing about just when, where, or how, they may do so. The words "any [state] requirement" and "any [federal] requirement," for example, do not tell us which requirements are at issue, for every state requirement that is not identical to even one federal requirement is "different from, or in addition to" that single federal requirement; yet, Congress could not have intended that the existence of one single federal rule, say, about a 2 inch hearing aid wire, would pre-empt every state law hearing aid rule, even a set of rules related only to the packaging or shipping of hearing aids. Thus, Congress must have intended that courts look elsewhere for help as to just which federal requirements pre-empt just which state requirements, as well as just how they might do so.

Second, this Court has previously suggested that, in the absence of a clear congressional command as to pre-emption, courts may infer that the relevant administrative agency possesses a degree of leeway to determine which rules, regulations, or other administrative actions will have pre-emptive effect. See Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 721 (1985); cf. Smiley v. Citibank (South Dakota), N. A., 517 U. S. ___, ___ (1996) (slip op., at 3-5); Lawrence County v. Lead-Deadwood School Dist. No. 40-1, 469 U.S. 256, 261-262 (1985); Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842-845 (1984). To draw a similar inference here makes sense, and not simply because of the statutory ambiguity. The Food and Drug Administration (FDA) is fully responsible for administering the MDA. See 21 U.S.C. § 393. That responsibility means informed agency involvement and, therefore, special understanding of the likely impact of both state and federal requirements, as well as an understanding of whether (or the extent to which) state requirements may interfere with federal objectives. See Hillsborough, 471 U. S., at 721. The FDA can translate these understandings into particularized pre-emptive intentions accompanying its various rules and regulations. See id., at 718. It can communicate those intentions, for example, through statements in "regulations, preambles, interpretive statements, and responses to comments," ibid., as well as through the exercise of its explicitly designated power to exempt state requirements from pre-emption, see 21 U.S.C. § 360k(b); see also ante, at 24 (noting that FDA's authority to exempt state requirements from pre-emption necessarily requires FDA to assess federal laws' pre-emptive effect).

Third, the FDA has promulgated a specific regulation designed to help. That regulation says:

"State . . . requirements are preempted only when . . . there are . . . specific [federal] requirements applicable to a particular device . . . thereby making any existing divergent State . . . requirements applicable to the device different from, or in addition to, the specific [federal] requirements." 21 CFR § 808.1(d) (1995) (emphasis added).

The regulation does not fill all the statutory gaps, for its word "divergent" does not explain, any more than did the statute, just when different device related federal and state requirements are closely enough related to trigger pre-emption analysis. But the regulation's word "specific" does narrow the universe of federal requirements that the agency intends to displace at least some state law.

Insofar as there are any applicable FDA requirements here, those requirements, even if numerous, are not "specific" in any relevant sense. See ante, at 25-26, 29-30. Hence, as the FDA's above quoted pre-emption rule tells us, the FDA does not intend these requirements to pre-empt the state requirements at issue here. At least in present circumstances, no law forces the FDA to make its requirements pre-emptive if it does not think it appropriate.

I cannot infer a contrary intent from Justice O'Connor's characterization of the federal standards applicable here as "comprehensive" and "extensive," post, at 6-7, both because that characterization is questionable, see ante, at 25-26, 29-30, and because this Court has previously said that it would "seldom infer, solely from the comprehensiveness of federal regulations, an intent to pre-empt in its entirety a field related to health and safety." Hillsborough, supra, at 718. It therefore seems to me that the better indicator of the FDA's intent is its pre-emption related regulation. And that regulation's word "specific" would seem a reasonable exercise of the leeway that statutory language and practical administrative circumstance suggest Congress intended to grant to the agency.

Fourth, ordinary principles of "conflict" and "field" pre-emption point in the same direction. Those principles make clear that a federal requirement pre-empts a state requirement if (1) the state requirement actually conflicts with the federal requirement--either because compliance with both is impossible, Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-143 (1963), or because the state requirement "stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress," Hines v. Davidowitz, 312 U.S. 52, 67 (1941)--or (2) the scheme of federal regulation is "so pervasive as to make reasonable the inference that Congress left no room for the States to supplement it," Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947). See, e.g., Barnett Bank, 517 U. S., at ___ (slip op., at 4-5); Gade v. National Solid Wastes Management Assn., 505 U.S. 88, 98 (1992) (opinion of O'Connor, J.); Wisconsin Public Intervenor v. Mortier, 501 U.S. 597, 604-605 (1991); English v. General Elec. Co., 496 U.S. 72, 79 (1990).

It makes sense, in the absence of any indication of a contrary congressional (or agency) intent, to read the pre-emption statute (and the pre-emption regulation) in light of these basic pre-emption principles. The statutory terms "different from" and "in addition to" readily lend themselves to such a reading, for their language parallels pre-emption law's basic concerns. Without any contrary indication from the agency, one might also interpret the regulation's word "divergent" in light of these same basic pre-emption principles.

Insofar as these basic principles inform a court's interpretation of the statute and regulation, they support the conclusion that there is no pre-emption here. I can find no actual conflict between any federal requirement and any of the liability creating premises of the plaintiffs' state law tort suit; nor, for the reasons discussed above, can I find any indication that either Congress or the FDA intended the relevant FDA regulations to occupy entirely any relevant field.

For these reasons, I concur in the Court's judgment. I also join the Court's opinion, but for Parts IV and VI. I do not join Part IV, which emphasizes the differences between the MDA and the pre-emption statute at issue in Cipollone, because those differences are not, in my view, relevant in this case. I do not join Part VI, because I am not convinced that future incidents of MDA pre-emption of common law claims will be "few" or "rare," ante, at 31.