Congress enacted the Medical Device Amendments of 1976, in the words of the statute's preamble, "to provide for the safety and effectiveness of medical devices intended for human use." 90 Stat. 539. The question presented is whether that statute pre-empts a state common-law negligence action against the manufacturer of an allegedly defective medical device. Specifically, we must consider whether Lora Lohr, who was injured when her pacemaker failed, may rely on Florida common law to recover damages from Medtronic, Inc., the manufacturer of the device.
Throughout our history the several States have exercised their police powers to protect the health and safety of their citizens. Because these are "primarily, and historically, . . . matter[s] of local concern," Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 719 (1985), the "States traditionally have had great latitude under their police powers to legislate as to the protection of the lives, limbs, health, comfort, and quiet of all persons," Metropolitan Life Ins. Co. v. Massachusetts, 471 U.S. 724, 756 (1985) (internal quotation marks omitted).
Despite the prominence of the States in matters of public health and safety, in recent decades the Federal Government has played an increasingly significant role in the protection of the health of our people. Congress' first significant enactment in the field of public health was the Food and Drug Act of 1906, a broad prohibition against the manufacture or shipment in interstate commerce of any adulterated or misbranded food or drug. See 34 Stat. 768; Regier, The Struggle for Federal Food and Drugs Legislation, 1 Law & Contemp. Prob. 1 (1933). Partly in response to an ongoing concern about radio and newspaper advertising making false therapeutic claims for both "quack machines" and legitimate devices such as surgical instruments and orthopedic shoes, in 1938 Congress broadened the coverage of the 1906 Act to include misbranded or adulterated medical devices and cosmetics. See Federal Food, Drug, and Cosmetic Act of 1938 (FDCA), §§ 501, 502, 52 Stat. 1049-1051; Cavers, The Food, Drug, and Cosmetic Act of 1938: Its Legislative History and Its Substantive Provisions, 6 Law & Contemp. Prob. 2 (1939); H. R. Rep. No. 94-853, p. 6 (1976).
While the FDCA provided for premarket approval of new drugs, Cavers, 6 Law & Contemp. Prob., at 40, it did not authorize any control over the introduction of new medical devices, see S. Rep. No. 93-670, pp. 1-2 (1974); H. R. Rep. No. 94-853, at 6. As technologies advanced and medicine
In 1970, for example, the Dalkon Shield, an intrauterine contraceptive device, was introduced to the American public and throughout the world. Touted as a safe and effective contraceptive, the Dalkon Shield resulted in a disturbingly high percentage of inadvertent pregnancies, serious infections, and even, in a few cases, death. Id., at 8; Regulation of Medical Devices (Intrauterine Contraceptive Devices), Hearings before a Subcommittee of the House Committee on Government Operations, 93d Cong., 1st Sess. (1973). In the early 1970's, several other devices, including catheters, artificial heart valves, defibrillators, and pacemakers (including pacemakers manufactured by petitioner Medtronic), attracted the attention of consumers, the Food and Drug Administration (FDA), and Congress as possible health risks. See Medical Device Amendments, 1973, Hearings before the Subcommittee on Health of the Senate Committee on Labor and Public Welfare, 93d Cong., 2d Sess., 270-361 (1973).
In response to the mounting consumer and regulatory concern, Congress enacted the statute at issue here: the Medical Device Amendments of 1976 (MDA or Act), 90 Stat. 539. The Act classifies medical devices in three categories based on the risk that they pose to the public. Devices that present
Before a new Class III device may be introduced to the market, the manufacturer must provide the FDA with a "reasonable assurance" that the device is both safe and effective. See 21 U. S. C. § 360e(d)(2). Despite its relatively innocuous phrasing, the process of establishing this "reasonable assurance," which is known as the "premarket approval," or "PMA" process, is a rigorous one. Manufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200 hours on each submission. Hearings before the Subcommittee on Health and the Environment of the House Committee on Energy & Commerce, 100th Cong., 1st Sess. (Ser. No. 100-34), p. 384 (1987) (hereinafter 1987 Hearings); see generally Kahan, Premarket Approval Versus Premarket Notification: Different Routes to the Same Market, 39 Food Drug Cosm. L. J. 510, 512-514 (1984).
Not all, nor even most, Class III devices on the market today have received premarket approval because of two important exceptions to the PMA requirement. First, Congress realized that existing medical devices could not be
Although "substantially equivalent" Class III devices may be marketed without the rigorous PMA review, such new devices, as well as all new Class I and Class II devices, are subject to the requirements of § 360(k). That section imposes a limited form of review on every manufacturer intending to market a new device by requiring it to submit a "premarket notification" to the FDA (the process is also known as a "§ 510(k) process," after the number of the section in the original Act). If the FDA concludes on the basis of the § 510(k) notification that the device is "substantially equivalent" to a pre-existing device, it can be marketed without further regulatory analysis (at least until the FDA initiates the PMA process for the underlying pre-1976 device to which the new device is "substantially equivalent"). The § 510(k) notification process is by no means comparable to the PMA
Congress anticipated that the FDA would complete the PMA process for Class III devices relatively swiftly. But because of the substantial investment of time and energy necessary for the resolution of each PMA application, the ever-increasing numbers of medical devices, and internal administrative and resource difficulties, the FDA simply could not keep up with the rigorous PMA process. As a result, the § 510(k) premarket notification process became the means by which most new medical devices—including Class III devices—were approved for the market. In 1983, for instance, a House Report concluded that nearly 1,000 of approximately 1,100 Class III devices that had been introduced to the market since 1976 were admitted as "substantial equivalents" and without any PMA review. See Medical Device Regulation: The FDA's Neglected Child (Committee Print compiled for the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce), Comm. Print 98—F, p. 34 (1983). This lopsidedness has apparently not evened out; despite an increasing effort by the FDA to consider the safety and efficacy of substantially equivalent devices, the House reported in 1990 that 80% of new Class III devices were being introduced to the market through the § 510(k) process and without PMA review. H. R. Rep. No. 101-808, p. 14 (1990); see also D. Kessler, S. Pape, &
As have so many other medical device manufacturers, petitioner Medtronic took advantage of § 510(k)'s expedited process in October 1982, when it notified the FDA that it intended to market its Model 4011 pacemaker lead as a device that was "substantially equivalent" to devices already on the market. (The lead is the portion of a pacemaker that transmits the heartbeat-steadying electrical signal from the "pulse generator" to the heart itself.) On November 30, 1982, the FDA found that the model was "substantially equivalent to devices introduced into interstate commerce" prior to the effective date of the Act, and advised Medtronic that it could therefore market its device subject only to the general control provisions of the Act, which could be found in the Code of Federal Regulations. See Respondent's Memorandum in Support of Motion for Summary Judgment in No. 93-482 (MD Fla., Nov. 1, 1993), Exh. A to Exh. 1 (Declaration of Charles H. Swanson) (hereinafter FDA Substantial Equivalence Letter). The agency emphasized, however, that this determination should not be construed as an endorsement of the pacemaker lead's safety. Ibid.
Cross-petitioner Lora Lohr is dependent on pacemaker technology for the proper functioning of her heart. In 1987 she was implanted with a Medtronic pacemaker equipped with one of the company's Model 4011 pacemaker leads. On
In 1993 Lohr and her husband filed this action in a Florida state court. Their complaint contained both a negligence count and a strict-liability count. The negligence count alleged a breach of Medtronic's "duty to use reasonable care in the design, manufacture, assembly, and sale of the subject pacemaker" in several respects, including the use of defective materials in the lead and a failure to warn or properly instruct the plaintiff or her physicians of the tendency of the pacemaker to fail, despite knowledge of other earlier failures. Complaint ¶ 5. The strict-liability count alleged that the device was in a defective condition and unreasonably dangerous to foreseeable users at the time of its sale. Id., ¶ 11. (A third count alleging breach of warranty was dismissed for failure to state a claim under Florida law.)
Medtronic removed the case to Federal District Court, where it filed a motion for summary judgment arguing that both the negligence and strict-liability claims were preempted by 21 U. S. C. § 360k(a). That section, which is at the core of the dispute between the parties in this suit, provides:
"(a) General rule
The District Court initially denied Medtronic's motion, finding nothing in the statute to support the company's argument that the MDA entirely exempted from liability a manufacturer who had allegedly violated the FDA's regulations. See App. to Pet. for Cert. 5d. Not long after that decision, however, the United States Court of Appeals for the Eleventh Circuit concluded that § 360k required pre-emption of at least some common-law claims brought against the manufacturer
The Court of Appeals reversed in part and affirmed in part. 56 F.3d 1335 (CA11 1995). Rejecting the Lohrs' broadest submission, it first decided that "common law actions are state requirements within the meaning of § 360k(a)." Id., at 1342. It next held that pre-emption could not be avoided by merely alleging that the negligence flowed from a violation of federal standards. Id., at 1343. Then, after concluding that the term "requirements" in § 360k(a) was unclear, it sought guidance from FDA's regulations regarding pre-emption. Those regulations provide that a state requirement is not pre-empted unless the FDA has established "`specific requirements applicable to a particular device.' " Id., at 1344 (citing 21 CFR § 808.1(d) (1995)). Under these regulations, the court concluded, it was not necessary that the federal regulation specifically deal with pacemakers, but only that the federal requirement "should, in some way, be `restricted by nature' to a particular process, procedure, or device and should not be completely openended," 56 F. 3d, at 1346 (footnote omitted), and that the specific device at issue should be subject to its requirements.
Under this approach, the court concluded that the Lohrs' negligent design claims were not pre-empted. It rejected Medtronic's argument that the FDA's finding of "substantial equivalence" had any significance with respect to the pacemaker's safety, or that the FDA's continued surveillance of the device constituted a federal "requirement" that its design be maintained. Id., at 1347-1349. On the other hand, it concluded that the negligent manufacturing and failure to warn claims were pre-empted by FDA's general "good manufacturing practices" regulations, which establish general requirements for most steps in every device's manufacture, see id., at 1350; 21 CFR §§ 820.20-820.198 (1995), and by the
Medtronic filed a petition for certiorari seeking review of the Court of Appeals' decision insofar as it affirmed the District Court and the Lohrs filed a cross-petition seeking review of the judgment insofar as it upheld the pre-emption defense. Because the Courts of Appeals are divided over the extent to which state common-law claims are pre-empted by the MDA,
As in Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992), we are presented with the task of interpreting a statutory provision that expressly pre-empts state law. While the pre-emptive language of § 360k(a) means that we need not go beyond that language to determine whether Congress intended the MDA to pre-empt at least some state law, see id., at 517, we must nonetheless "identify the domain expressly pre-empted" by that language, ibid. Although our analysis of the scope of the pre-emption statute must begin with its text, see Gade v. National Solid Wastes Management Assn.,
First, because the States are independent sovereigns in our federal system, we have long presumed that Congress does not cavalierly pre-empt state-law causes of action. In all pre-emption cases, and particularly in those in which Congress has "legislated . . . ina field which the States have traditionally occupied," Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947), we "start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress." Ibid.; Hillsborough Cty., 471 U. S., at 715-716; cf. Fort Halifax Packing Co. v. Coyne, 482 U.S. 1, 22 (1987). Although dissenting Justices have argued that this assumption should apply only to the question whether Congress intended any pre-emption at all, as opposed to questions concerning the scope of its intended invalidation of state law, see Cipollone, 505 U. S., at 545-546 (Scalia, J., concurring in judgment in part and dissenting in part), we used a "presumption against the pre-emption of state police power regulations" to support a narrow interpretation of such an express command in Cipollone. Id., at 518, 523. That approach is consistent with both federalism concerns and the historic primacy of state regulation of matters of health and safety.
Second, our analysis of the scope of the statute's preemption is guided by our oft-repeated comment, initially made in Retail Clerks v. Schermerhorn, 375 U.S. 96, 103 (1963), that "[t]he purpose of Congress is the ultimate touchstone" in every pre-emption case. See, e. g., Cipollone, 505 U. S., at 516; Gade, 505 U. S., at 96; Malone v. White Motor Corp., 435 U.S. 497, 504 (1978). As a result, any understanding of the scope of a pre-emption statute must rest primarily
With these considerations in mind, we turn first to a consideration of petitioner Medtronic's claim that the Court of Appeals should have found the entire action pre-empted and then to the merits of the Lohrs' cross-petition.
In its petition, Medtronic argues that the Court of Appeals erred by concluding that the Lohrs' claims alleging negligent design were not pre-empted by 21 U. S. C. § 360k(a). That section 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 this chapter 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 this chapter." Medtronic suggests that any common-law cause of action is a "requirement" which alters incentives and imposes duties "different from, or in addition to," the generic federal standards that the FDA has promulgated in response to mandates under the MDA. In essence, the company argues that the plain language of the statute pre-empts any and all common-law claims brought by an injured plaintiff against a manufacturer of medical devices.
Furthermore, if Congress intended to preclude all common-law causes of action, it chose a singularly odd word with which to do it. The statute would have achieved an identical result, for instance, if it had precluded any "remedy" under state law relating to medical devices. "Requirement" appears to presume that the State is imposing a specific duty upon the manufacturer, and although we have on prior occasions concluded that a statute pre-empting certain
The pre-emptive statute in Cipollone
Other differences between this statute and the one in Cipollone further convince us that when Congress enacted § 360k, it was primarily concerned with the problem of specific, conflicting state statutes and regulations rather than the general duties enforced by common-law actions. Unlike the statute at issue in Cipollone, § 360k refers to "requirements" many times throughout its text. In each instance, the word is linked with language suggesting that its focus is device-specific enactments of positive law by legislative or administrative bodies, not the application of general rules of common law by judges and juries. For instance, subsections (a)(2) and (b) of the statute
An examination of the basic purpose of the legislation as well as its history entirely supports our rejection of Medtronic's extreme position. The MDA was enacted "to provide for the safety and effectiveness of medical devices intended for human use." 90 Stat. 539. Medtronic asserts that the Act was also intended, however, to "protect innovations in device technology from being `stifled by unnecessary restrictions,' " Brief for Petitioner in No. 95-754, p. 3 (citing H. R. Rep. No. 94-853, at 12), and that this interest extended to the pre-emption of common-law claims. While the Act certainly reflects some of these concerns,
The legislative history also confirms our understanding that § 360(k) simply was not intended to pre-empt most, let alone all, general common-law duties enforced by damages actions. There is, to the best of our knowledge, nothing in the hearings, the Committee Reports, or the debates suggesting that any proponent of the legislation intended a sweeping pre-emption of traditional common-law remedies against manufacturers and distributors of defective devices. If Congress intended such a result, its failure even to hint at it is spectacularly odd, particularly since Members of both Houses were acutely aware of ongoing product liability litigation.
Medtronic asserts several specific reasons why, even if § 360k does not pre-empt all common-law claims, it at least pre-empts the Lohrs' claims in this suit. In contrast, the Lohrs argue that their entire complaint should survive a reasonable evaluation of the pre-emptive scope of § 360k(a). First, the Lohrs claim that the Court of Appeals correctly held that their negligent design claims were not pre-empted because the § 510(k) premarket notification process imposes no "requirement" on the design of Medtronic's pacemaker. Second, they suggest that even if the FDA's general rules regulating manufacturing practices and labeling are "requirements" that pre-empt different state requirements, § 360k(a) does not pre-empt state rules that merely duplicate some or all of those federal requirements. Finally, they argue that because the State's general rules imposing common-law duties upon Medtronic do not impose a requirement "with respect to a device," they do not conflict with the FDA's general rules relating to manufacturing and labeling and are therefore not pre-empted. Design Claim
The Court of Appeals concluded that the Lohrs' defective design claims were not pre-empted because the requirements with which the company had to comply were not sufficiently concrete to constitute a pre-empting federal requirement. Medtronic counters by pointing to the FDA's determination that Model 4011 is "substantially equivalent" to an earlier device as well as the agency's continuing authority to exclude the device from the market if its design is changed. These factors, Medtronic argues, amount to a specific, federally enforceable design requirement that cannot be affected by state-law pressures such as those imposed on manufacturers subject to product liability suits.
The company's defense exaggerates the importance of the § 510(k) process and the FDA letter to the company regarding
The FDA stressed this basic conclusion in its letter to Medtronic finding the 4011 lead "substantially equivalent" to devices already on the market. That letter only required Medtronic to comply with "general standards"—the lowest level of protection "applicable to all medical devices," and including "listing of devices, good manufacturing practices, labeling, and the misbranding and adulteration provisions of the Act." It explicitly warned Medtronic that the letter did "not in any way denote official FDA approval of your device," and that "[a]ny representation that creates an impression of official approval of this device because of compliance with the premarket notification regulations is misleading and constitutes misbranding." FDA Substantial Equivalence Letter.
Thus, even though the FDA may well examine § 510(k) applications for Class III devices (as it examines the entire medical device industry) with a concern for the safety and effectiveness of the device, see Brief for Petitioner in No. 95-754, at 22-26, it did not "require" Medtronics' pacemaker to take any particular form for any particular reason; the agency simply allowed the pacemaker, as a device substantially equivalent to one that existed before 1976, to be
Identity of Requirements Claims
The Lohrs next suggest that even if "requirements" exist with respect to the manufacturing and labeling of the pacemaker,
Nothing in § 360k denies Florida the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements. Even if it may be necessary as a matter of Florida law to prove that those violations were the result of negligent conduct, or that they created an unreasonable hazard for users of the product, such additional elements of the state-law cause of action would make the state requirements narrower, not broader, than the federal requirement. While such a narrower requirement might be "different from" the federal rules in a literal sense, such a difference would surely provide a strange reason for finding pre-emption of a state rule insofar as it duplicates the federal rule. The presence of a damages remedy does not amount to the additional or different "requirement" that is necessary under the statute; rather, it merely provides another reason for manufacturers to comply with identical existing "requirements" under federal law.
The FDA regulations interpreting the scope of § 360k's pre-emptive effect support the Lohrs' view, and our interpretation of the pre-emption statute is substantially informed by those regulations. The different views expressed by the Courts of Appeals regarding the appropriate scope of federal pre-emption under § 360k demonstrate that the language of that section is not entirely clear. In addition, Congress has
The regulations promulgated by the FDA expressly support the conclusion that § 360k "does not preempt State or local requirements that are equal to, or substantially identical
Finally, the Lohrs suggest that with respect to the manufacturing and labeling claims, the Court of Appeals should have rejected Medtronic's pre-emption defense in full. The Court of Appeals believed that these claims would interfere with the consistent application of general federal regulations governing the labeling and manufacture of all medical devices, and therefore concluded that the claims were preempted altogether.
The requirements identified by the Court of Appeals include labeling regulations that require manufacturers of every medical device, with a few limited exceptions, to include with the device a label containing "information for use, . . . and any relevant hazards, contraindications, side effects, and precautions." 21 CFR §§ 801.109(b) and (c) (1995). Similarly, manufacturers are required to comply with "Good Manufacturing Practices," or "GMP's," which are set forth in 32 sections and less than 10 pages in the Code of Federal Regulations.
While admitting that these requirements exist, the Lohrs suggest that their general nature simply does not pre-empt claims alleging that the manufacturer failed to comply with other duties under state common law. In support of their claim, they note that § 360k(a)(1) expressly states that a federal requirement must be "applicable to the device" in question before it has any pre-emptive effect. Because the labeling and manufacturing requirements are applicable to a host of different devices, they argue that they do not satisfy this condition. They further argue that because only state requirements "with respect to a device" may be pre-empted, and then only if the requirement "relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device," § 360k(a) mandates pre-emption only where there is a conflict between a specific state requirement and a federal requirement "applicable to" the same device.
The Lohrs' theory is supported by the FDA regulations, which provide that state requirements are pre-empted "only" when the FDA has established "specific counterpart regulations or . . . other specific requirements applicable to a particular device." 21 CFR § 808.1(d) (1995).
Although we 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, see Part VI, infra, it is impossible to ignore its overarching concern that pre-emption occur only where a particular state requirement threatens to interfere with a specific federal interest. State requirements must be "with respect to" medical devices and "different from, or in addition to," federal requirements. State requirements must also relate "to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device," and the regulations provide that state requirements of "general applicability" are not pre-empted except where they have "the effect of establishing a substantive requirement for a specific device." Moreover, federal requirements must be "applicable to the device" in question, and, according to the regulations, pre-empt state law only if they are "specific counterpart regulations" or "specific" to a "particular device." The statute and regulations, therefore, require a careful comparison between the allegedly pre-empting federal requirement and the allegedly pre-empted state requirement to determine whether they fall within the intended pre-emptive scope of the statute and regulations.
Similarly, the general state common-law requirements in this suit were not specifically developed "with respect to" medical devices. Accordingly, they are not the kinds of requirements that Congress and the FDA feared would impede the ability of federal regulators to implement and enforce specific federal requirements. The legal duty that is the predicate for the Lohrs' negligent manufacturing claim is the general duty of every manufacturer to use due care to avoid foreseeable dangers in its products. Similarly, the predicate for the failure to warn claim is the general duty to inform users and purchasers of potentially dangerous items of the risks involved in their use. These general obligations are no more a threat to federal requirements than would be a state-law duty to comply with local fire prevention regulations
In their cross-petition, the Lohrs present a final argument, suggesting that common-law duties are never "requirements" within the meaning of § 360k and that the statute therefore never pre-empts common-law actions. The Lohrs point out that our holding in Cipollone is not dispositive of this issue, for as Part IV, supra, suggests, there are significant textual and historical differences between the Cipollone statute and § 360k, and the meaning of words must always be informed by the environment within which they are situated. We do not think that the issue is resolved by the FDA regulation suggesting that § 360k is applicable to those requirements "having the force and effect of law" that are "established by . . . court decision," 21 CFR § 808.1(b) (1995); that reference, it appears, was intended to refer to court decisions construing state statutes or regulations. See 42 Fed. Reg. 30383, 30385 (1977); Brief for Petitioners in No. 95-886, p. 26, n. 7.
Nevertheless, we do not respond directly to this argument for two reasons. First, since none of the Lohrs' claims is pre-empted in this suit, we need not resolve hypothetical cases that may arise in the future. Second, given the critical importance of device specificity in our (and the FDA's) construction of § 360k, it is apparent that few, if any, common-law duties have been pre-empted by this statute. It will be rare indeed for a court hearing a common-law
Accordingly, the judgment of the Court of Appeals is reversed insofar as it held that any of the claims were preempted and affirmed insofar as it rejected the pre-emption defense. The cases are remanded for further proceedings.
This action raises two questions. First, do the Medical Device Amendments of 1976 (MDA) to the Federal Food, Drug, and Cosmetic 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 510-512. The statute's language, read literally, supports that conclusion. It says:
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 preemption 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 486-491, 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
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. 25, 30 (1996); Allis-Chalmers Corp. v. Lueck, 471 U.S. 202, 208 (1985); ante, at 485-486. 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. 735, 739-741
Third, the FDA has promulgated a specific regulation designed to help. That regulation says:
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
Insofar as there are any applicable FDA requirements here, those requirements, even if numerous, are not "specific" in any relevant sense. See ante, at 497-498, 501. 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 513, 514, both because that characterization is questionable, see ante, at 497— 498, 501, 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" preemption 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
It makes sense, in the absence of any indication of a contrary congressional (or agency) intent, to read the preemption 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 action. 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 502.
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 484. 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 cases require 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 502. 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 500, and for that reason, concludes that common-law claims are almost never pre-empted, ante, at 502-503, and that the Lohrs' claims here are not pre-empted. This decision is bewildering and seemingly without guiding principle.
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., at 548-549 (Scalia, J., joined by Thomas, J., concurring in judgment in part and dissenting in part). As the plurality explained:
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
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 commonlaw 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 502. 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 498-502. But see ante, at 500 ("[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 502.
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,
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 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,
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.
"Upon application of a State or a political subdivision thereof, the Secretary may, by regulation promulgated after notice and opportunity for an oral hearing, exempt from subsection (a) of this section, under such conditions as may be prescribed in such regulation, a requirement of such State or political subdivision applicable to a device intended for human use if—
"(1) the requirement is more stringent than a requirement under this chapter which would be applicable to the device if an exemption were not in effect under this subsection; or
"(2) the requirement—
"(A) is required by compelling local conditions, and
"(B) compliance with the requirement would not cause the device to be in violation of any applicable requirement under this chapter."
To carry out this grant of authority, the FDA has issued regulations under the statute which both construe the scope of § 360k(a) and address the instances in which the FDA will grant exemptions to its pre-emptive effect. See 21 CFR § 808.1 (1995); n. 18, infra .
We note that although it is the FDA that exercises this authority, the Act gives that authority directly to the Secretary of Health and Human Services, who subsequently delegated her authority to the FDA. See, e. g., 21 U. S. C. § 360k(b) ("the Secretary may" exempt state requirements), § 321(d) ("Secretary" defined as "the Secretary of Health and Human Services"). Under the FDCA, the Secretary is vested with "[t]he authority to promulgate regulations for the efficient enforcement of" the Act. 21 U. S. C. § 371(a).
"(d) State or local requirements are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific Food and Drug Administration requirements. There are other State or local requirements that affect devices that are not preempted by section 521(a) of the act because they are not `requirements applicable to a device' within the meaning of section 521(a) of the act. The following are examples of State or local requirements that are not regarded as preempted by section 521 of the act:
"(1) Section 521(a) does not preempt State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices (e. g., requirements such as general electrical codes, and the Uniform Commercial Code (warranty of fitness)), or to unfair trade practices in which the requirements are not limited to devices.
"(2) Section 521(a) does not preempt State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the act.
. . . . .
"(6)(i) Section 521(a) does not preempt State or local requirements respecting general enforcement, e. g., requirements that State inspection be permitted of factory records concerning all devices . . . .
"(ii) Generally, section 521(a) does not preempt a State or local requirement prohibiting the manufacture of adulterated or misbranded devices. Where, however, such a prohibition has the effect of establishing a substantive requirement for a specific device, e. g., a specific labeling requirement, then the prohibition [may] be preempted." 21 CFR § 808.1(d) (1995).
If anything, the language of the MDA's pre-emption statute and its counterpart regulations require an even more searching inquiry into the relationship between the federal requirement and the state requirement at issue than was true under the statute in Cipollone.