552 U.S. 312 (2008), 06-179, Riegel v. Medtronic, Inc.

• Citation: 552 U.S. 312, 128 S.Ct. 999
• Opinion Judge: SCALIA, J., C. J., and KENNEDY, SOUTER, THOMAS, BREYER, and AUTO, JJ., STEVENS, J., STEVENS, J., GINSBURG, J.
• Party Name: Donna S. RIEGEL, individually and as administrator of the Estate of Charles R. Riegel, Petitioner, v. MEDTRONIC, INC.
• Attorney: Allison M. Aleve argued the cause tor petitioner. With her on the briefs were Brian Wolfman, Scott L. Nelson, and Wayne P. Smith. Theodore B. Olson argued the cause for respondent. With him on the brief were Matthew D. McGill, Amir C. Tayrani, Kenneth S. Geller, David M. Gossett, and Andrew E. Ta...
• Judge Panel: SCALIA, J., delivered the opinion of the Court, in which ROBERTS, C. J., and KENNEDY, SOUTER, THOMAS, BREYER, and AUTO, JJ., joined, and in which STEVENS, J., joined except for Parts III-A and III-B. STEVENS, J., filed an opinion concurring in part and concurring in the judgment, post, p. 330. GI...
• Case Date: February 20, 2008
• Court: U.S. Supreme Court

Page 312

552 U.S. 312 (2008)

128 S.Ct. 999

Donna S. RIEGEL, individually and as administrator of the Estate of Charles R. Riegel, Petitioner,

v.

MEDTRONIC, INC.

No. 06-179.

United States Supreme Court

February 20, 2008

Argued December 4, 2007.

[128 S.Ct. 1000] ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT

Syllabus

The Medical Device Amendments of 1976 (MDA) created a scheme of federal [128 S.Ct. 1001] safety oversight for medical devices while sweeping back state oversight schemes. The statute provides that a State shall not "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 [federal law] 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" relevant federal law. 21 U.S.C. §360k(a). The MDA calls for federal oversight of medical devices that varies with the type of device at issue. The most extensive oversight is reserved for Class III devices that undergo the premarket approval process. These devices may enter the market only if the FDA reviews their design, labeling, and manufacturing specifications and determines that those specifications provide a reasonable assurance of safety and effectiveness. Manufacturers may not make changes to such devices that would affect safety or effectiveness unless they first seek and obtain permission from the FDA.

Charles Riegel and his wife, petitioner Donna Riegel, brought suit against respondent Medtronic after a Medtronic catheter ruptured in Charles Riegel's coronary artery during heart surgery. The catheter is a Class III device that received FDA premarket approval. The Riegels alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law. The District Court held that the MDA pre-empted the Riegels' claims of strict liability; breach of implied warranty; and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter, and their claim of negligent manufacturing insofar as the claim was not premised on the theory that Medtronic had violated federal law. The Second Circuit affirmed.

Held:

The MDA's pre-emption clause bars common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA. Pp. 321-330.

Page 313

(a) The Federal Government has established "requirement[s] applicable . . . to" Medtronic's catheter within §360k(a)(1)'s meaning. In Medtronic, Inc. v. Lohr, 518 U.S. 470, 495, 500–501, 116 S.Ct. 2240, 135 L.Ed.2d 700, the Court interpreted the MDA's pre-emption provision in a manner "substantially informed" by an FDA regulation, 21 CFR §808.1(d), which says that state requirements are pre-empted only when the FDA "has established specific counterpart regulations or there are other specific requirements applicable to a particular device" under federal law. Premarket approval imposes "specific requirements applicable to a particular device." The FDA requires that a device that has received premarket approval be marketed without significant deviations from the specifications in the device's approval application, for the reason that the FDA has determined that those specifications provide a reasonable assurance of safety and effectiveness. Pp. 321-323.

(b) Petitioner's common-law claims are pre-empted because they are based upon New York "requirement[s]" with respect to Medtronic's catheter that are "different from, or in addition to" the federal ones, and that relate to safety and effectiveness, §360k(a). Pp. 323-330.

(i) Common-law negligence and strict-liability claims impose "requirement[s]" [128 S.Ct. 1002] under the ordinary meaning of that term, see, e.g., Lohr, supra, at 503–505, 512, 116 S.Ct. 2240, Cipollone v. Liggett Group, Inc., 505 U.S. 504, 521–523, 548-549, 112 S.Ct. 2608, 120 L.Ed.2d 407. There is nothing in the MDA that contradicts this normal meaning. Pp. 323-325.

(ii) The Court rejects petitioner's contention that the duties underlying her state-law tort claims are not pre-empted because general common-law duties are not requirements maintained "with respect to devices." Petitioner's suit depends upon New York's "continu[ing] in effect" general tort duties "with respect to" Medtronic's catheter. Title 21 CFR §808.1(d)(1)—which states that MDA pre-emption does not extend to "[s]tate or local requirements of general applicability [whose] purpose . . . relates either to other products in addition to devices . . . or to unfair trade practices in which the requirements are not limited to devices"—does not alter the Court's interpretation. Pp. 327-330.

(c) The Court declines to address in the first instance petitioner's argument that this lawsuit raises "parallel" claims that are not preempted by §360k under Lohr, supra, at 495, 513, 116 S.Ct. 2240. P. 1011.

451 F.3d 104, affirmed.

Page 314

Allison M. Aleve argued the cause tor petitioner. With her on the briefs were Brian Wolfman, Scott L. Nelson, and Wayne P. Smith.

Theodore B. Olson argued the cause for respondent. With him on the brief were Matthew D. McGill, Amir C. Tayrani, Kenneth S. Geller, David M. Gossett, and Andrew E. Tauber.

Deputy Solicitor General Kneedler argued the cause for the United States as amicus curiae urging affirmance. With him on the brief were Solicitor General Clement, Assistant Attorney General Keisler, Daryl Joseffer, Douglas N. Letter, Sharon Swingle, and Daniel Meron^[*]

SCALIA, J., delivered the opinion of the Court, in which ROBERTS, C. J., and KENNEDY, SOUTER, THOMAS, BREYER, and AUTO, JJ., joined, and in which STEVENS, J., joined except for Parts III-A and III-B. STEVENS, J., filed an opinion concurring in part and concurring in the judgment, post, p. 330. GINSBURG, J., filed a dissenting opinion, post, p. 333.

Page 315

OPINION

Scalia, Justice

We consider whether the pre-emption clause enacted in the 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 approval by the Food and Drug Administration (FDA).

I

A

The Federal Food, Drug, and Cosmetic Act (FDCA), 52 Stat. 1040, as amended, 21 U.S.C. §301 et seq., has long required 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, [128 S.Ct. 1003] 518 U.S. 470, 475-476, 116 S.Ct. 2240, 135 L.Ed.2d 700 (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 dangerous devices. See, e.g., S. Foote, Managing the Medical Arms Race 151-152 (1992). Several States adopted regulatory measures, including California, which in 1970 enacted a law requiring premarket approval of medical devices. 1970 Cal. Stats. ch. 1573,

Page 316

§§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 13 state statutes governing medical devices as of 1976).

Congress stepped in with passage of the Medical Device Amendments of 1976 (MDA), 21 U.S.C. §360c et seq.,¹which 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 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." §360k(a).

The exception contained in subsection (b) permits the FDA to exempt some state and local requirements from pre-emption.

The new regulatory regime established various levels of oversight 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 lowest level of oversight: "general controls," such as labeling requirements. §360c(a)(1)(A); FDA, Device Advice: Device Classes, http://www.fda.gov/cdrh/devadvice/3132.html (all Internet 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.,

Page 317

is subject in addition to "special controls" such as performance standards and postmarket surveillance measures, §360c(a)(1)(B).

The devices receiving the most federal oversight are those in Class III, which include replacement heart valves, implanted cerebella stimulators, and pacemaker pulse generators, FDA, Device Advice: Device Classes, supra. In general, a device is assigned to Class III if it cannot be established that a less stringent classification would provide reasonable assurance of safety and effectiveness, and the device is "purported or represented to be for a use in supporting or sustaining human life...