Medtronic, Inc. v. LohrMedtronic, Inc. v. Lohr
Lead Opinion
аnnounced the judgment of the Court and delivered the opinion of the Court with respect to Parts I, II, III, V, and VII, and an opinion with respect to Parts IV and VI, in which Justice Kennedy, Justice Souter, and Justice Ginsburg join.
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 Med-tronic, 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.,
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 mis-branded 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 Daikon Shield, an intrauterine contraceptive device, was introduced to the American public and throughout the world. Touted as a safe and effective contraceptive, the Daikon 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 pre
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
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 “pre-market 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, &
II
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
Ҥ360k . State and local requirements respecting devices
“(a) General rule
“Except as provided in subsection (b) of this section, 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.” 5
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
The Court of Appeals reversed in part and affirmed in part.
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;
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,
Ill
As in Cipollone v. Liggett Group, Inc.,
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 ... in a field which the States have traditionally occupied,” Rice v. Santa Fe Elevator Corp.,
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,
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.
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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
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
An examination of the basic purpose of the legislation as well as its history entirely supports our rejection of Med-tronic’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
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 regard
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; thе 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 pace
Nothing in
The FDA regulations interpreting the scope of
The regulations promulgated by the FDA expressly support the conclusion that
Manufacturing and Labeling Claims
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.”
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
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.”
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 deviсe 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 regula
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In their cross-petition, the Lohrs present a Anal argument, suggesting that common-law duties are never “requirements” within the meaning of
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
VII
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.
It is so ordered.
Notes
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. 1 (1983).
S. Rep. No. 94-33, p. 5 (1975).
The FDA has not yet initiated nor suggested the initiation of a PMA process for pacemakers or most other grandfathered devices. But see 60 Fed. Reg. 41984, 41986 (1995) (pursuant to Safe Medical Devices Act of 1990, 104 Stat. 4511, calling for submission of information by February 1997 which may lead the FDA to reclassify or initiate PMA process at some time in the future for implantable pacemaker pulse generators and lead adapters).
In 1990, Congress enacted amendments to the MDA which were designed to reduce the FDA’s reliance on the § 510(k) process while continuing to ensure that particularly risky devices received full PMA review. See Safe Medical Devices Act of 1990.
Subsection (b) of the statute authorizes the FDA to grant exemptions to state requirements that would otherwise be pre-empted by subsection (a).
“(b) Exempt 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, еxempt 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
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.,
See, e. g., English v. Mentor Corp.,
The FDA’s authority to require manufacturers to recall, replace, or refund defective devices is of little use to injured plaintiffs, since there is no indication that the right is available to private parties, the remedy would not extend to recovery for compensatory damages, and the authority is rarely invoked, if at all. See Adler, The 1976 Medical Device Amendments: A Step in the Right Direction Needs Another Step in the Right Direction, 43 Food Drug Cosm. L. J. 511, 526-527 (1988).
There were actually two pre-emptive statutes at issue: The first, enacted in 1965, provided that “[n]o statement relating to smoking and health ... shall be required” on any cigarette package or in any cigarette advertising. See Cipollone v. Liggett Group, Inc.,
Unlike
The text of the statute is quoted supra, at 482, and n. 5.
All 22 exemptions at
Special statutory exemptions, for example, permit the FDA (with various oversight provisions) to allow investigative, experimental devices to be used in commerce without either PMA review or “substantial equivalence.” See
Furthermore, if Congress had intended the MDA to work this dramatic change in the availability of state-law remedies, one would expect some reference to that change in the extensive contemporary reviews of the legislation. We have been able to find no such reference. See, e. g., Lesparre, Industry Spokesman Comments on Medical Device Amendments of 1976, 50 Hospitals 99, 103 (Sept. 16, 1976); A. Levine, Device Failure and the Plaintiff’s Lawyer, in Proceedings of the Second Annual AAMI/FDA Conference on Medical Device Regulation 54 (1975); Medical Device Amendments of 1975, Hearings before the Subcommittee on Health and the Environment of the House Committee on Interstate and Foreign Commerce, Ser. No. 94-39, 94th Cong., 1st Sess., 271 (1975) (statement of Anita Johnson, Public Citizen’s Health Research Group) (arguing that the pre-emption provision should not be included, but making no mention of commоn law, and specifically discussing only a positive California enactment regarding the safety of intrauterine contraceptive devices); Medical Devices and Equipment Liability Avoidance (Frost & Sullivan pub. June 1977) (comprehensive 2-volume, 600-page review of published medical device product liability eases from 1910 to 1976, suggesting nowhere that MDA had mooted or even altered the longstanding ability of plaintiffs to seek and receive damages awards under state law).
As the FDA Commissioner put it in 1982: “[T]he 510(k) provision of the law is a procompetition mechanism that permits firms to make and quickly market me-too versions of pre-1976 devices. The Congress apparently believed that a firm whose device happened to be on the market before enactment of the amendments and was never subject to preclearance by FDA should not enjoy a lengthy monopoly at the expense of other firms and ultimately the consumer.” FDA Oversight: Medical Devices, Hearing before the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, 97th Cong., 2d Sess., 9 (1982). See also Kahan, Premarket Approval Versus Premarket Notification: Different Routes to the Same Market, 39 Food Drug Cosm. L. J. 510, 514-515 (1984); D. Kessler, S. Pape, & D. Sundwall, The Federal Regulation of Medical Devices, 317 New England J. Med. 357, 359 (1987).
See n. 5, supra;
We also note that the agency permits manufacturers of devices that have received PMA to make certain labeling, quality control, and manufacturing changes which would “enhanc[e] the safety of the device or the safety in the use of the device” without рrior FDA approval. See
Some GMP’s include the duty to institute a “quality assurance program,” §820.5, to have an “adequate organizational structure,” §820.20, to ensure that personnel in contact with a device are “clean, healthy, and suitably attired” where such matters are relevant to the device’s safety,
FDA’s narrow understanding of the scope of
“(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
“(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 аddition to devices (e. g., requirements such as general electrical codes, and the Uniform Commercial Code (warranty of fitnéss)), 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.”
A plurality of this Court concluded in Cipo llone that a similar analysis was required under the Public Health Cigarette Smoking Act of 1969. That Act pre-empted requirements and prohibitions based on smoking and health “imposed under State law with respect to the advertising or promotion” of cigarettes in packages that were labeled in conformity with that Act.
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.
Concurrence Opinion
concurring in part and concurring in the judgment.
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?
I
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:
“[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).
Moreover, in Cipollone v. Liggett Group, Inc.,
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 wbuld 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
t-H HH
The answer to the second question turns on Congress’ intent. See, e. g., Barnett Bank of Marion Cty., N. A. v. Nelson,
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-ineh 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.,
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
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,
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 thе 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.
Concurrence Opinion
with whom The Chief Justice, Justice Scalia, and Justice Thomas join, concurring in part and dissenting in part.
The cases require us to determine whether the Lohrs’ state common-law claims survive pre-emption under
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.,
“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
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 “requiremеnt” 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 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
I also agree that the Lohrs’ claims are not pre-empted by
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
To summarize, I conclude that