Riegel, Individually and as Administrator of Estate of Riegel v. Medtronic, Inc.

We consider whether the pre-emption clause enacted inthe Medical Device Amendments of 1976, 21 U. S. C. §360k, bars common-law claims challenging the safety and effectiveness of a medical device given premarket approvalby the Food and Drug Administration (FDA).

I

A
The Federal Food, Drug, and Cosmetic Act (FDCA), 52Stat. 1040, as amended, 21 U. S. C. §301 et seq., has longrequired FDA approval for the introduction of new drugs into the market. Until the statutory enactment at issue here, however, the introduction of new medical devices was left largely for the States to supervise as they saw fit.See Medtronic, Inc. v. Lohr, 518 U. S. 470, 475–476 (1996).

The regulatory landscape changed in the 1960's and 1970's, as complex devices proliferated and some failed. Most notably, the Dalkon Shield intrauterine device, introduced in 1970, was linked to serious infections and several deaths, not to mention a large number of pregnancies. Thousands of tort claims followed. R. Bacigal, The Limits of Litigation: The Dalkon Shield Controversy 3 (1990). In the view of many, the Dalkon Shield failure and its aftermath demonstrated the inability of the common-law tort system to manage the risks associated with dan-gerous devices. See, e.g., S. Foote, Managing the MedicalArms Race 151–152 (1992). Several States adopted regu-latory measures, including California, which in 1970 enacted a law requiring premarket approval of medical devices. 1970 Cal. Stats. ch. 1573, §§26670–26693; see also Leflar & Adler, The Preemption Pentad: Federal Preemption of Products Liability Claims After Medtronic,64 Tenn. L. Rev. 691, 703, n. 66 (1997) (identifying 13state statutes governing medical devices as of 1976).
Congress stepped in with passage of the Medical DeviceAmendments of 1976 (MDA), 21 U. S. C. §360c et seq.,1 which swept back some state obligations and imposed a regime of detailed federal oversight. The MDA includes an express pre-emption provision that states:

"Except as provided in subsection (b) of this section, no State or political subdivision of a State may estab-lish or continue in effect with respect to a device in-tended for human use any requirement -

"(1) which is different from, or in addition to, any requirement applicable under this chapter to the de-vice, and

"(2) which relates to the safety or effectiveness of the device or to any other matter included in a re-quirement applicable to the device under this chap-ter." §360k(a).

The exception contained in subsection (b) permits the FDA to exempt some state and local requirements from
- - - - - - 1Unqualified §360 et seq. numbers hereinafter refer to sections of 21
U. S. C.
pre-emption.

The new regulatory regime established various levels ofoversight for medical devices, depending on the risks they present. Class I, which includes such devices as elastic bandages and examination gloves, is subject to the lowestlevel of oversight: "general controls," such as labelingrequirements. §360c(a)(1)(A); FDA, Device Advice: Device Classes, http://www.fda.gov/cdrh/devadvice/3132.html (allInternet materials as visited Feb. 14, 2008, and available in Clerk of Court's case file). Class II, which includes such devices as powered wheelchairs and surgical drapes, ibid., is subject in addition to "special controls" such as perform-ance standards and postmarket surveillance measures, §360c(a)(1)(B).

The devices receiving the most federal oversight arethose in Class III, which include replacement heart valves, implanted cerebella stimulators, and pacemaker pulsegenerators, FDA, Device Advice: Device Classes, supra. In general, a device is assigned to Class III if it cannot beestablished that a less stringent classification would pro-vide reasonable assurance of safety and effectiveness, and the device is "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health," or "presents a potential unreasonable riskof illness or injury." §360c(a)(1)(C)(ii).

Although the MDA established a rigorous regime ofpremarket approval for new Class III devices, it grand-fathered many that were already on the market. Devices sold before the MDA's effective date may remain on themarket until the FDA promulgates, after notice and com-ment, a regulation requiring premarket approval.§§360c(f)(1), 360e(b)(1). A related provision seeks to limitthe competitive advantage grandfathered devices receive.A new device need not undergo premarket approval if the FDA finds it is "substantially equivalent" to another device exempt from premarket approval. §360c(f)(1)(A). The agency's review of devices for substantial equivalence is known as the §510(k) process, named after the section of the MDA describing the review. Most new Class III de-vices enter the market through §510(k). In 2005, for example, the FDA authorized the marketing of 3,148 devices under §510(k) and granted premarket approval to just 32 devices. P. Hutt, R. Merrill, & L. Grossman, Food and Drug Law 992 (3d ed. 2007).

Premarket approval is a "rigorous" process. Lohr, 518
U. S., at 477. A manufacturer must submit what is typi-cally a multivolume application. FDA, Device Advice - Premarket Approval (PMA) 18, http://www.fda.gov/cdrh/ devadvice/pma/printer.html. It includes, among other things, full reports of all studies and investigations of the device's safety and effectiveness that have been publishedor should reasonably be known to the applicant; a "fullstatement" of the device's "components, ingredients, and properties and of the principle or principles of operation"; "a full description of the methods used in, and the facilitiesand controls used for, the manufacture, processing, and,when relevant, packing and installation of, such device"; samples or device components required by the FDA; and a specimen of the proposed labeling. §360e(c)(1). Before deciding whether to approve the application, the agency may refer it to a panel of outside experts, 21 CFR§814.44(a) (2007), and may request additional data fromthe manufacturer, §360e(c)(1)(G).

The FDA spends an average of 1,200 hours reviewing each application, Lohr, supra, at 477, and grants premar-ket approval only if it finds there is a "reasonable assur-ance" of the device's "safety and effectiveness," §360e(d). The agency must "weig[h] any probable benefit to healthfrom the use of the device against any probable risk of injury or illness from such use." §360c(a)(2)(C). It may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alterna-tives. It approved, for example, under its Humanitarian Device Exemption procedures, a ventricular assist device for children with failing hearts, even though the survivalrate of children using the device was less than 50 percent. FDA, Center for Devices and Radiological Health, Sum-mary of Safety and Probable Benefit 20 (2004), online athttp://www.fda.gov/cdrh/pdf3/H030003b.pdf.

The premarket approval process includes review of thedevice's proposed labeling. The FDA evaluates safety and effectiveness under the conditions of use set forth on the label, §360c(a)(2)(B), and must determine that the pro-posed labeling is neither false nor misleading, §360e(d)(1)(A).

After completing its review, the FDA may grant or denypremarket approval. §360e(d). It may also condition approval on adherence to performance standards, 21 CFR §861.1(b)(3), restrictions upon sale or distribution, or compliance with other requirements, §814.82. The agencyis also free to impose device-specific restrictions by regula-tion. §360j(e)(1).
If the FDA is unable to approve a new device in its proposed form, it may send an "approvable letter" indicat-ing that the device could be approved if the applicant submitted specified information or agreed to certain condi-tions or restrictions. 21 CFR §814.44(e). Alternatively,the agency may send a "not approvable" letter, listing thegrounds that justify denial and, where practical, measures that the applicant could undertake to make the device approvable. §814.44(f).

Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufactur-ing processes, labeling, or any other attribute, that wouldaffect safety or effectiveness. §360e(d)(6)(A)(i). If the applicant wishes to make such a change, it must submit,
and the FDA must approve, an application for supplemen-tal premarket approval, to be evaluated under largely the same criteria as an initial application. §360e(d)(6); 21 CFR §814.39(c).

After premarket approval, the devices are subject toreporting requirements. §360i. These include the obliga-tion to inform the FDA of new clinical investigations orscientific studies concerning the device which the appli-cant knows of or reasonably should know of, 21 CFR §814.84(b)(2), and to report incidents in which the device may have caused or contributed to death or serious injury,or malfunctioned in a manner that would likely cause or contribute to death or serious injury if it recurred, §803.50(a). The FDA has the power to withdraw premar-ket approval based on newly reported data or existing information and must withdraw approval if it determinesthat a device is unsafe or ineffective under the condi- tions in its labeling. §360e(e)(1); see also §360h(e) (recall authority).

B

Except as otherwise indicated, the facts set forth in thissection appear in the opinion of the Court of Appeals. The device at issue is an Evergreen Balloon Catheter marketed by defendant-respondent Medtronic, Inc. It is a Class III device that received premarket approval from the FDA in1994; changes to its label received supplemental approvals in 1995 and 1996. Charles Riegel underwent coronary angioplasty in 1996,shortly after suffering a myocardial infarction. App. to Pet. for Cert. 56a. His right coronary artery was diffusely diseased and heavily calcified. Riegel's doctor inserted theEvergreen Balloon Catheter into his patient's coronary artery in an attempt to dilate the artery, although the device's labeling stated that use was contraindicated forpatients with diffuse or calcified stenoses. The label also
warned that the catheter should not be inflated beyond itsrated burst pressure of eight atmospheres. Riegel's doctor inflated the catheter five times, to a pressure of 10 atmos-pheres; on its fifth inflation, the catheter ruptured. Com-plaint 3. Riegel developed a heart block, was placed on life support, and underwent emergency coronary bypass surgery.

Riegel and his wife Donna brought this lawsuit in April1999, in the United States District Court for the Northern District of New York. Their complaint alleged that Med-tronic's catheter was designed, labeled, and manufactured in a manner that violated New York common law, and that these defects caused Riegel to suffer severe and per-manent injuries. The complaint raised a number of com-mon-law claims. The District Court held that the MDA pre-empted Riegel's claims of strict liability; breach of implied warranty; and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter. App. to Pet. for Cert. 68a; Complaint 3–4. It also held that the MDA pre-empted a negligent manufac-turing claim insofar as it was not premised on the theorythat Medtronic violated federal law. App. to Pet. for Cert. 71a. Finally, the court concluded that the MDA pre-empted Donna Riegel's claim for loss of consortium to theextent it was derivative of the pre-empted claims. Id., at 68a; see also id., at 75a.2

The United States Court of Appeals for the SecondCircuit affirmed these dismissals. 451 F. 3d 104 (2006). The court concluded that Medtronic was "clearly subject to
the federal, device-specific requirement of adhering to thestandards contained in its individual, federally approved" premarket approval application. Id., at 118. The Riegels'claims were pre-empted because they "would, if successful,impose state requirements that differed from, or added to" the device-specific federal requirements. Id., at 121. We granted certiorari.3 551 U. S. ___ (2007).

II

Since the MDA expressly pre-empts only state require-ments "different from, or in addition to, any requirementapplicable . . . to the device" under federal law, §360k(a)(1), we must determine whether the Federal Government has established requirements applicable to Medtronic's catheter. If so, we must then determine whether the Riegels' common-law claims are based uponNew York requirements with respect to the device that are"different from, or in addition to" the federal ones, and that relate to safety and effectiveness. §360k(a). We turn to the first question. In Lohr, a majority of thisCourt interpreted the MDA's pre-emption provision in a manner "substantially informed" by the FDA regulationset forth at 21 CFR §808.1(d). 518 U. S., at 495; see also id., at 500–501. That regulation says that state require-ments are pre-empted "only when the Food and DrugAdministration has established specific counterpart regu-lations or there are other specific requirements applicable to a particular device . . . ." 21 CFR §808.1(d). Informed by the regulation, we concluded that federal manufactur-ing and labeling requirements applicable across the board to almost all medical devices did not pre-empt the common-law claims of negligence and strict liability at issue in Lohr. The federal requirements, we said, were not re-quirements specific to the device in question - they re-flected "entirely generic concerns about device regulationgenerally." 518 U. S., at 501. While we disclaimed a conclusion that general federal requirements could never pre-empt, or general state duties never be pre-empted, weheld that no pre-emption occurred in the case at hand based on a careful comparison between the state and federal duties at issue. Id., at 500–501.

Even though substantial-equivalence review under §510(k) is device specific, Lohr also rejected the manufac-turer's contention that §510(k) approval imposed device-specific "requirements." We regarded the fact that prod-ucts entering the market through §510(k) may be mar-keted only so long as they remain substantial equivalentsof the relevant pre-1976 devices as a qualification for anexemption rather than a requirement. Id., at 493–494; see also id., at 513 (O'Connor, J., concurring in part and dis-senting in part).

Premarket approval, in contrast, imposes "require-ments" under the MDA as we interpreted it in Lohr. Unlike general labeling duties, premarket approval isspecific to individual devices. And it is in no sense anexemption from federal safety review - it is federal safety review. Thus, the attributes that Lohr found lacking in §510(k) review are present here. While §510(k) is "‘fo-cused on equivalence, not safety,'" id., at 493 (opinion of the Court), premarket approval is focused on safety, not equivalence. While devices that enter the market through§510(k) have "never been formally reviewed under theMDA for safety or efficacy," ibid., the FDA may grantpremarket approval only after it determines that a device offers a reasonable assurance of safety and effectiveness,§360e(d). And while the FDA does not "‘require'" that a device allowed to enter the market as a substantial
equivalent "take any particular form for any particularreason," ibid., at 493, the FDA requires a device that has received premarket approval to be made with almost nodeviations from the specifications in its approval applica-tion, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness.

III

We turn, then, to the second question: whether theRiegels' common-law claims rely upon "any requirement"of New York law applicable to the catheter that is "differ-ent from, or in addition to" federal requirements and that"relates to the safety or effectiveness of the device or toany other matter included in a requirement applicable tothe device." §360k(a). Safety and effectiveness are the very subjects of the Riegels' common-law claims, so thecritical issue is whether New York's tort duties constitute "requirements" under the MDA.

A

In Lohr, five Justices concluded that common-law causes of action for negligence and strict liability do im-pose "requirement[s]" and would be pre-empted by federal requirements specific to a medical device. See 518 U. S., at 512 (opinion of O'Connor, J., joined by Rehnquist, C. J., and SCALIA and THOMAS, JJ.); id., at 503–505 (opinion ofBREYER, J.). We adhere to that view. In interpreting two other statutes we have likewise held that a provision pre-empting state "requirements" pre-empted common-lawduties. Bates v. Dow Agrosciences LLC, 544 U. S. 431 (2005), found common-law actions to be pre-empted by aprovision of the Federal Insecticide, Fungicide, and Roden-ticide Act that said certain States "‘shall not impose or continue in effect any requirements for labeling or packag-ing in addition to or different from those required under
this subchapter.'" Id., at 443 (discussing 7 U. S. C. §136v(b); emphasis added). Cipollone v. Liggett Group, Inc., 505 U. S. 504 (1992), held common-law actions pre-empted by a provision of the Public Health CigaretteSmoking Act of 1969, 15 U. S. C. §1334(b), which said that"[n]o requirement or prohibition based on smoking and health shall be imposed under State law with respect tothe advertising or promotion of any cigarettes" whose packages were labeled in accordance with federal law. See 505 U. S., at 523 (plurality opinion); id., at 548–549 (SCALIA, J., concurring in judgment in part and dissentingin part).

Congress is entitled to know what meaning this Courtwill assign to terms regularly used in its enactments. Absent other indication, reference to a State's "require-ments" includes its common-law duties. As the plurality opinion said in Cipollone, common-law liability is "prem-ised on the existence of a legal duty," and a tort judgment therefore establishes that the defendant has violated a state-law obligation. Id., at 522. And while the common-law remedy is limited to damages, a liability award " ‘canbe, indeed is designed to be, a potent method of governing conduct and controlling policy.'" Id., at 521.

In the present case, there is nothing to contradict thisnormal meaning. To the contrary, in the context of this legislation excluding common-law duties from the scope of pre-emption would make little sense. State tort law that requires a manufacturer's catheters to be safer, but hence less effective, than the model the FDA has approved dis-rupts the federal scheme no less than state regulatory law to the same effect. Indeed, one would think that tort law, applied by juries under a negligence or strict-liability standard, is less deserving of preservation. A state stat-ute, or a regulation adopted by a state agency, could at least be expected to apply cost-benefit analysis similar to that applied by the experts at the FDA: How many more
lives will be saved by a device which, along with itsgreater effectiveness, brings a greater risk of harm? A jury, on the other hand, sees only the cost of a more dan-gerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court. As JUSTICE BREYER explained in Lohr, it is implau-sible that the MDA was meant to "grant greater power (toset state standards ‘different from, or in addition to' fed-eral standards) to a single state jury than to state officials acting through state administrative or legislative lawmak-ing processes." 518 U. S., at 504. That perverse distinc-tion is not required or even suggested by the broad lan-guage Congress chose in the MDA,4 and we will not turn somersaults to create it.

B

The dissent would narrow the pre-emptive scope of theterm "requirement" on the grounds that it is "difficult to believe that Congress would, without comment, remove all means of judicial recourse" for consumers injured by FDA-approved devices. Post, at 5 (opinion of GINSBURG, J.)(internal quotation marks omitted). But, as we have explained, this is exactly what a pre-emption clause for medical devices does by its terms. The operation of a lawenacted by Congress need not be seconded by a committee
report on pain of judicial nullification. See, e.g., Connecti-cut Nat. Bank v. Germain, 503 U. S. 249, 253–254 (1992). It is not our job to speculate upon congressional motives.If we were to do so, however, the only indication avail-able - the text of the statute - suggests that the solicitude for those injured by FDA-approved devices, which the dissent finds controlling, was overcome in Congress's estimation by solicitude for those who would suffer with-out new medical devices if juries were allowed to apply thetort law of 50 States to all innovations.5
In the case before us, the FDA has supported the posi-tion taken by our opinion with regard to the meaning of the statute. We have found it unnecessary to rely uponthat agency view because we think the statute itself speaks clearly to the point at issue. If, however, we had found the statute ambiguous and had accorded the agency's current position deference, the dissent is correct, see post, at 6, n. 8, that - inasmuch as mere Skidmore deference would seemingly be at issue - the degree ofdeference might be reduced by the fact that the agency'searlier position was different. See Skidmore v. Swift & Co., 323 U. S. 134 (1944); United States v. Mead Corp., 533
U. S. 218 (2001); Good Samaritan Hospital v. Shalala, 508
U. S. 402, 417 (1993). But of course the agency's earlier position (which the dissent describes at some length, post,at 5–6, and finds preferable) is even more compromised, indeed deprived of all claim to deference, by the fact that itis no longer the agency's position.

The dissent also describes at great length the experienceunder the FDCA with respect to drugs and food and coloradditives. Post, at 7–11. Two points render the conclusion
the dissent seeks to draw from that experience - that the pre-emption clause permits tort suits - unreliable. (1) It has not been established (as the dissent assumes) that no tort lawsuits are pre-empted by drug or additive approvalunder the FDCA. (2) If, as the dissent believes, the pre-emption clause permits tort lawsuits for medical devices just as they are (by hypothesis) permitted for drugs and additives; and if, as the dissent believes, Congress wantedthe two regimes to be alike; Congress could have appliedthe pre-emption clause to the entire FDCA. It did not do so, but instead wrote a pre-emption clause that applies only to medical devices.

C

The Riegels contend that the duties underlying negli-gence, strict-liability, and implied-warranty claims are not pre-empted even if they impose "‘requirements,'" because general common-law duties are not requirements main-tained "‘with respect to devices.'" Brief for Petitioner 34–
36. Again, a majority of this Court suggested otherwise in Lohr. See 518 U. S., at 504–505 (opinion of BREYER, J.); id., at 514 (opinion of O'Connor, J., joined by Rehnquist,
C. J., and SCALIA and THOMAS, JJ.).6 And with good reason. The language of the statute does not bear the Riegels' reading. The MDA provides that no State "mayestablish or continue in effect with respect to a device . . . any requirement" relating to safety or effectiveness that is different from, or in addition to, federal requirements. §360k(a) (emphasis added). The Riegels' suit depends
upon New York's "continu[ing] in effect" general tort duties "with respect to" Medtronic's catheter. Nothing inthe statutory text suggests that the pre-empted state requirement must apply only to the relevant device, or only to medical devices and not to all products and all actions in general.

The Riegels' argument to the contrary rests on the textof an FDA regulation which states that the MDA's pre-emption clause does not extend to certain duties, including"[s]tate or local requirements of general applicabilitywhere the purpose of the requirement relates either toother products in addition to devices (e.g., requirementssuch as general electrical codes, and the Uniform Com-mercial Code (warranty of fitness)), or to unfair tradepractices in which the requirements are not limited to devices." 21 CFR §808.1(d)(1). Even assuming that thisregulation could play a role in defining the MDA's pre-emptive scope, it does not provide unambiguous support for the Riegels' position. The agency's reading of its ownrule is entitled to substantial deference, see Auer v. Rob-bins, 519 U. S. 452, 461 (1997), and the FDA's view put forward in this case is that the regulation does not refer togeneral tort duties of care, such as those underlying the claims in this case that a device was designed, labeled, or manufactured in an unsafe or ineffective manner. Brief for United States as Amicus Curiae 27–28. That is so, according to the FDA, because the regulation excludes from pre-emption requirements that relate only inciden-tally to medical devices, but not other requirements.General tort duties of care, unlike fire codes or restrictions on trade practices, "directly regulate" the device itself, including its design. Id., at 28. We find the agency'sexplanation less than compelling, since the same could be said of general requirements imposed by electricalcodes, the Uniform Commercial Code, or unfair-trade-practice law, which the regulation specifically excludes
from pre-emption.

Other portions of 21 CFR §808.1, however, support theagency's view that §808.1(d)(1) has no application to thiscase (though still failing to explain why electrical codes, the Uniform Commercial Code or unfair-trade-practicerequirements are different). Section 808.1(b) states that the MDA sets forth a "general rule" pre-empting stateduties "having the force and effect of law (whether estab-lished by statute, ordinance, regulation, or court decision). . . ." (Emphasis added.) This sentence is far more com-prehensible under the FDA's view that §808.1(d)(1) has noapplication here than under the Riegels' view. We are aware of no duties established by court decision other thancommon-law duties, and we are aware of no common-law duties that relate solely to medical devices.

The Riegels' reading is also in tension with the regula-tion's statement that adulteration and misbranding claimsare pre-empted when they "ha[ve] the effect of establish-ing a substantive requirement for a specific device, e.g., aspecific labeling requirement" that is "different from, or in addition to" a federal requirement. §808.1(d)(6)(ii). Surelythis means that the MDA would pre-empt a jury determi-nation that the FDA-approved labeling for a pacemaker violated a state common-law requirement for additional warnings. The Riegels' reading of §808.1(d)(1), however,would allow a claim for tortious mislabeling to escape pre-emption so long as such a claim could also be brought against objects other than medical devices.

All in all, we think that §808.1(d)(1) can add nothing toour analysis but confusion. Neither accepting nor reject-ing the proposition that this regulation can properly be consulted to determine the statute's meaning; and neitheraccepting nor rejecting the FDA's distinction betweengeneral requirements that directly regulate and those thatregulate only incidentally; the regulation fails to alter ourinterpretation of the text insofar as the outcome of this
case is concerned.

IV

State requirements are pre-empted under the MDA only to the extent that they are "different from, or in addition to" the requirements imposed by federal law. §360k(a)(1).Thus, §360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case "parallel,"rather than add to, federal requirements. Lohr, 518 U. S., at 495; see also id., at 513 (O'Connor, J., concurring inpart and dissenting in part). The District Court in this case recognized that parallel claims would not be pre-empted, see App. to Pet. for Cert. 70a–71a, but it inter-preted the claims here to assert that Medtronic's deviceviolated state tort law notwithstanding compliancewith the relevant federal requirements, see id., at 68a. Although the Riegels now argue that their law- suit raises parallel claims, they made no such conten-tion in their briefs before the Second Circuit, nor did theyraise this argument in their petition for certiorari. We decline to address that argument in the first instance here.

* * *

http://www.supremecourtus.gov/opinions/07pdf/06-179.pdf

For the foregoing reasons, the judgment of the Court ofAppeals is
Affirmed.

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