Opinion ID: 145831
Heading Depth: 1
Heading Rank: 2

Heading: The MDA's preemption clause states:

Text: [N]o 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. 21 U.S.C. § 360k(a). Absent other indication, the Court states, reference to a State's `requirements' includes its common-law duties. Ante, at 1008. Regarding the MDA, however, other indication is not [a]bsent. Contextual examination of the Act convinces me that § 360k(a)'s inclusion of the term requirement should not prompt a sweeping preemption of mine-run claims for relief under state tort law. [3]
Congress enacted the MDA to provide for the safety and effectiveness of medical devices intended for human use. 90 Stat. 539 (preamble). [4] A series of high-profile medical device failures that caused extensive injuries and loss of life propelled adoption of the MDA. [5] Conspicuous among these failures was the Dalkon Shield intrauterine device, used by approximately 2.2 million women in the United States between 1970 and 1974. See In re Northern Dist. of Cal., Dalkon Shield IUD Prods. Liability Litigation, 693 F.2d 847, 848 (C.A.9 1982); ante, at 1002-1003. Aggressively promoted as a safe and effective form of birth control, the Dalkon Shield had been linked to 16 deaths and 25 miscarriages by the middle of 1975. H.R.Rep. No. 94-853, p. 8 (1976). By early 1976, more than 500 lawsuits seeking compensatory and punitive damages totaling more than $400 million had been filed. Ibid. [6] Given the publicity attending the Dalkon Shield litigation and Congress' awareness of the suits at the time the MDA was under consideration, I find informative the absence of any sign of a legislative design to preempt state common-law tort actions. [7] The Court recognizes that § 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations. Ante, at 1011. That remedy, although important, does not help consumers injured by devices that receive FDA approval but nevertheless prove unsafe. The MDA's failure to create any federal compensatory remedy for such consumers further suggests that Congress did not intend broadly to preempt state common-law suits grounded on allegations independent of FDA requirements. It is difficult to believe that Congress would, without comment, remove all means of judicial recourse for large numbers of consumers injured by defective medical devices. Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 251, 104 S.Ct. 615, 78 L.Ed.2d 443 (1984). The former chief counsel to the FDA explained: FDA's view is that FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection. FDA regulation of a device cannot anticipate and protect against all safety risks to individual consumers. Even the most thorough regulation of a product such as a critical medical device may fail to identify potential problems presented by the product. Regulation cannot protect against all possible injuries that might result from use of a device over time. Preemption of all such claims would result in the loss of a significant layer of consumer protection .... Porter, The Lohr Decision: FDA Perspective and Position, 52 Food & Drug L.J. 7, 11 (1997). Cf. Brief for United States as Amicus Curiae on Pet. for Cert. in Smiths Industries Medical Systems, Inc. v. Kernats, O.T. 1997, No. 96-1405, pp. 17-18; Dept. of Health and Human Services, Public Health Service, Advisory Opinion, Docket No. 83A-0140/AP, Letter from J. Hile, Associate Comm'r for Regulatory Affairs, to National Women's Health Network (Mar. 8, 1984). [8] The Court's construction of § 360k(a) has the perverse effect of granting broad immunity to an entire industry that, in the judgment of Congress, needed more stringent regulation, Lohr, 518 U.S., at 487, 116 S.Ct. 2240 (plurality opinion), not exemption from liability in tort litigation. The MDA does grant the FDA authority to order certain remedial action if, inter alia, it concludes that a device presents an unreasonable risk of substantial harm to the public health and that notice of the defect would not by itself be sufficient to eliminate the unreasonable risk. 21 U.S.C. § 360h(b)(1)(A). Thus the FDA may order the manufacturer to repair the device, replace it, refund the purchase price, cease distribution, or recall the device. § 360h(b)(2), (e). The prospect of ameliorative action by the FDA, however, lends no support to the conclusion that Congress intended largely to preempt state common-law suits. Quite the opposite: Section 360h(d) states that [c]ompliance with an order issued under this section shall not relieve any person from liability under Federal or State law. That provision anticipates [court-awarded] damages for economic loss from which the value of any FDA-ordered remedy would be subtracted. Ibid. [9]
Congress enacted the MDA after decades of regulating drugs and food and color additives under the Federal Food, Drug, and Cosmetic Act (FDCA), 52 Stat. 1040, as amended, 21 U.S.C. § 301 et seq. The FDCA contains no preemption clause, and thus the Court's interpretation of § 360k(a) has no bearing on tort suits involving drugs and additives. But § 360k(a)'s confinement to medical devices hardly renders irrelevant to the proper construction of the MDA's preemption provision the long history of federal and state controls over drugs and additives in the interest of public health and welfare. Congress' experience regulating drugs and additives informed, and in part provided the model for, its regulation of medical devices. I therefore turn to an examination of that experience. Starting in 1938, the FDCA required that new drugs undergo preclearance by the FDA before they could be marketed. See § 505, 52 Stat. 1052. Nothing in the FDCA's text or legislative history suggested that FDA preclearance would immunize drug manufacturers from common-law tort suits. [10] By the time Congress enacted the MDA in 1976, state common-law claims for drug labeling and design defects had continued unabated despite nearly four decades of FDA regulation. [11] Congress' inclusion of a preemption clause in the MDA was not motivated by concern that similar state tort actions could be mounted regarding medical devices. [12] Rather, Congress included § 360k(a) and (b) to empower the FDA to exercise control over state premarket approval systems installed at a time when there was no preclearance at the federal level. See supra, at 1014, and n. 3; infra, at 1018, and n. 14. Between 1938 and 1976, Congress enacted a series of premarket approval requirements, first for drugs, then for additives. Premarket control, as already noted, commenced with drugs in 1938. In 1958, Congress required premarket approval for food additives. Food Additives Amendment, § 3, 72 Stat. 1785, as amended, 21 U.S.C. § 348. In 1960, it required premarket approval for color additives. Color Additive Amendments, § 103(b), 74 Stat. 399, as amended, 21 U.S.C. § 379e. In 1962, it expanded the premarket approval process for new drugs to include review for effectiveness. Drug Amendments, § 101, 76 Stat. 781, as amended, 21 U.S.C. § 321 et seq. And in 1968, it required premarket approval for new animal drugs. Animal Drug Amendments, § 101(b), 82 Stat. 343, as amended, 21 U.S.C. § 360b. None of these Acts contained a preemption clause. The measures just listed, like the MDA, were all enacted with common-law personal injury litigation over defective products a prominent part of the legal landscape. [13] At the time of each enactment, no state regulations required premarket approval of the drugs or additives in question, so no preemption clause was needed as a check against potentially conflicting state regulatory regimes. See Brief for Sen. Edward M. Kennedy et al. as Amici Curiae 10. A different situation existed as to medical devices when Congress developed and passed the MDA. As the House Report observed: In the absence of effective Federal regulation of medical devices, some States have established their own programs. The most comprehensive State regulation of which the Committee is aware is that of California, which in 1970 adopted the Sherman Food, Drug, and Cosmetic Law. This law requires premarket approval of all new medical devices, requires compliance of device manufacturers with good manufacturing practices and authorizes inspection of establishments which manufacture devices. Implementation of the Sherman Law has resulted in the requirement that intrauterine devices are subject to premarket clearance in California. H.R.Rep. No. 94-853, p. 45 (emphasis added). [14] In sum, state premarket regulation of medical devices, not any design to suppress tort suits, accounts for Congress' inclusion of a preemption clause in the MDA; no such clause figures in earlier federal laws regulating drugs and additives, for States had not installed comparable control regimes in those areas.
Congress' experience regulating drugs also casts doubt on Medtronic's policy arguments for reading § 360k(a) to preempt state tort claims. Section 360k(a) must preempt state common-law suits, Medtronic contends, because Congress would not have wanted state juries to second-guess the FDA's finding that a medical device is safe and effective when used as directed. Brief for Respondent 42-49. The Court is similarly minded. Ante, at 1008-1009. But the process for approving new drugs is at least as rigorous as the premarket approval process for medical devices. [15] Courts that have considered the question have overwhelmingly held that FDA approval of a new drug application does not preempt state tort suits. [16] Decades of drug regulation thus indicate, contrary to Medtronic's argument, that Congress did not regard FDA regulation and state tort claims as mutually exclusive.