Source: http://caselaw.findlaw.com/us-supreme-court/552/312.html
Timestamp: 2015-07-03 22:27:22
Document Index: 649114958

Matched Legal Cases: ['§360', '§360', '§808', '§360', '§808', '§360', '§360', '§301', '§26670', '§360', '§360', '§360', '§360', '§360', '§360', '§360', '§510', '§510', '§510', '§360', '§814', '§360', '§360', '§360', '§360', '§360', '§360', '§861', '§814', '§360', '§814', '§814', '§360', '§360', '§814', '§360', '§814', '§803', '§360', '§360']

RIEGEL, INDIVIDUALLY AND AS ADMINISTRATOR OF ESTATE OF RIEGEL v. MEDTRONIC, INC. | FindLaw
RIEGEL, INDIVIDUALLY AND AS ADMINISTRATOR OF ESTATE OF RIEGEL v. MEDTRONIC, INC.
RIEGEL, INDIVIDUALLY AND AS ADMINISTRATOR OF ESTATE OF RIEGEL v. MEDTRONIC, INC., (2008)
Argued: December 4, 2007 Decided: February 20, 2008
The Medical Device Amendments of 1976 (MDA) created a scheme of federal 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. 8-17.
(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, 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. 8-10. (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. 10-17.
(i) Common-law negligence and strict-liability claims impose "requirement[s]" under the ordinary meaning of that term, see, e.g., Lohr, supra, at 503-505, 512, Cipollone v. Liggett Group, Inc., 505 U. S. 504, 521-523, 548-549. There is nothing in the MDA that contradicts this normal meaning. Pp. 10-12. (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. 14-17. (c) The Court declines to address in the first instance petitioner's argument that this lawsuit raises "parallel" claims that are not pre-empted by §360k under Lohr, supra, at 495, 513. P. 17. 451 F. 3d 104, affirmed. Scalia, J., delivered the opinion of the Court, in which Roberts, C. J., and Kennedy, Souter, Thomas, Breyer, and Alito, 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. Ginsburg, J., filed a dissenting opinion. DONNA S. RIEGEL, individually and as administra-tor of the ESTATE OF CHARLES R. RIEGEL,PETITIONER v. MEDTRONIC, INC.
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).
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, 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 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, §§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.,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 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., 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 or for a use which is of substantial importance in preventing impairment of human health," or "presents a potential unreasonable risk of illness or injury." §360c(a)(1)(C)(ii).
Although the MDA established a rigorous regime of premarket approval for new Class III devices, it grandfathered many that were already on the market. Devices sold before the MDA's effective date may remain on the market until the FDA promulgates, after notice and comment, a regulation requiring premarket approval. §§360c(f)(1), 360e(b)(1). A related provision seeks to limit the 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 devices 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 typically 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 published or should reasonably be known to the applicant; a "full statement" 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 facilities and 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 from the manufacturer, §360e(c)(1)(G).
The FDA spends an average of 1,200 hours reviewing each application, Lohr, supra, at 477, and grants premarket approval only if it finds there is a "reasonable assurance" of the device's "safety and effectiveness," §360e(d). The agency must "weig[h] any probable benefit to health from 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 alternatives. It approved, for example, under its Humanitarian Device Exemption procedures, a ventricular assist device for children with failing hearts, even though the survival rate of children using the device was less than 50 percent. FDA, Center for Devices and Radiological Health, Summary of Safety and Probable Benefit 20 (2004), online at http://www.fda.gov/cdrh/pdf3/H030003b.pdf.
The premarket approval process includes review of the device'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 proposed labeling is neither false nor misleading, §360e(d)(1)(A).
After completing its review, the FDA may grant or deny premarket 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 agency is also free to impose device-specific restrictions by regulation. §360j(e)(1).
If the FDA is unable to approve a new device in its proposed form, it may send an "approvable letter" indicating that the device could be approved if the applicant submitted specified information or agreed to certain conditions or restrictions. 21 CFR §814.44(e). Alternatively, the agency may send a "not approvable" letter, listing the grounds 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, manufacturing processes, labeling, or any other attribute, that would affect 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 supplemental 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 to reporting requirements. §360i. These include the obligation to inform the FDA of new clinical investigations or scientific studies concerning the device which the applicant 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 premarket approval based on newly reported data or existing information and must withdraw approval if it determines that a device is unsafe or ineffective under the conditions in its labeling. §360e(e)(1); see also §360h(e) (recall authority).
Except as otherwise indicated, the facts set forth in this section 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 in 1994; 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 the Evergreen 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 for patients with diffuse or calcified stenoses. The label also warned that the catheter should not be inflated beyond its rated burst pressure of eight atmospheres. Riegel's doctor inflated the catheter five times, to a pressure of 10 atmospheres; on its fifth inflation, the catheter ruptured. Complaint 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 April 1999, in the United States District Court for the Northern District of New York. Their complaint alleged that Medtronic'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 permanent injuries. The complaint raised a number of common-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 manufacturing claim insofar as it was not premised on the theory that 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 the extent 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 Second Circuit 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 the standards 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).