Federal preemption of medical device tort claims; not what Congress (or the doctor) ordered.

The right of injured persons to sue for damages under state law is one of the most traditional features of the U.S. legal system. So, too, is the importance of "Our Federalism"--the ability of states to govern themselves free from unwarranted federal interference.

But these principles are increasingly being undermined by the doctrine of federal preemption. Based on the supremacy clause of the U.S. Constitution--art. VI, [sections]2--this doctrine holds that federal law, including congressional enactments, shall prevail over any conflicting state law.

In recent years, the preemption doctrine has been used with devastating effect by corporate defendants to limit plaintiffs' right to recovery in cases involving pesticides, smoking, environmental protection, automobile safety, and many other topics. Preemption law threatens to become, as a weapon against state economic and social regulation, the modern-day equivalent of Lochner v. New rork.(1) This infamous decision symbolized the Supreme Court's efforts to use the "substantive due process" protected by the Fourteenth Amendment to shield businesses from state law.

Nowhere is this alarming trend more evident than in the area of products known as "medical devices"-- technically, everything from tongue depressors to breast implants--where two recent decisions by the U.S. Courts of Appeals for the First and Fifth Circuits have set a dangerous precedent for consumer interests nationwide.

In King v. Collagen Corp.,(2) the First Circuit held that a plaintiff could not pursue her state law products liability claims against the maker of a collagen implant. Called "Zyderm," the implant consists of processed cow tissue that is injected under the skin to smooth out wrinkles.

The plaintiff alleged that Zyderm had caused her to suffer a painful autoimmune response requiring hospitalization and that Zyderm was unsafe, negligently designed and manufactured, and mislabeled. But the court held that her claims were preempted by the Medical Device Amendments of 1976 (MDA)(3) even if her factual allegations were true, even if Zyderm's maker had failed to disclose its dangers to her, and even if the manufacturer had fraudulently obtained U.S. Food and Drug Administration (FDA) approval for its device.

In Stamps v. Collagen Corp.,(4) the Fifth Circuit reached the same result in a similar case.

The precedential implications of these cases are foreboding. They threaten not only collagen implant patients but also victims of many other dangerous medical devices. Already, courts have relied on the King and Stamps decisions to preempt claims by those injured by defective heart valves,(5) as well as state claims by victims of pacemakers that were never made subject to any but the most lenient FDA regulation.(6)

Moreover, the reasoning of King and Stamps can hardly be confined to the medical device context. The cases lend important support to the theory that a defendant is immunized from liability whenever an administrative agency approves a particular design--even if the agency has no intention of thereby conferring a blanket exemption from statelaw liability.

This technology-based approach is at odds with the emphasis of contemporary regulatory policy on market-oriented incentives that continually stimulate manufacturers to innovate and develop safer products. The approach is also blind to the contemporary recognition that government regulators frequently lack the information, expertise, and other resources of the firms they are charged with overseeing, so that regulatory policy must take into account not only the problem of "market failure," but also the likelihood of "government failure"--that is, ineffective or even counterproductive regulation.(7)

More fundamentally, King and Stamps are irreconcilable with the basic assumptions of federalism on which the preemption doctrine is based.

Medical Device Amendments

The irony of the far-reaching decisions in King and Stamps is that Congress's intent in regulating medical devices has always been to protect consumers, not to deprive them of their legal remedies under state law. The MDA were not enacted on a blank slate; they were simply additions to the Food, Drug, and Cosmetic Act of 1934, a federal statute that has never been accorded broad preemptive effect.

Under the MDA, the Food and Drug Administration is charged with regulating medical devices by classifying them into one of three categories.

* Class I devices, like cotton swabs, generally pose little or no threat to public safety. Consequently, they are subject only to general controls on manufacturing processes.

* Class II items are more complex and pose greater risks to consumers. This category includes, for example, tampons and oxygen masks used in anesthesiology. Class II devices may be subject to FDA recommendations, guidelines, postmarketing surveillance, development of patient registries, and even promulgation of specific performance standards should the FDA deem the products a sufficient health hazard to require strict product specifications or warnings.

* Class III devices, most dangerous of all, require premarket approval (PMA), which enables the FDA to determine whether a proposed product provides "reasonable assurance of its safety and effectiveness."(8) The collagen implants at issue in King and Stamps were Class III devices. These devices are subject to the more stringent PMA process because they "present...a potential unreasonable risk of illness or injury."(9)

The PMA process requires a manufacturer to submit a detailed application to the FDA, including information pertaining to product specifications, intended use, manufacturing methods, and proposed labeling.(10) The agency refers each application to a panel of qualified experts that prepares a report and recommendation. The FDA must either accept or reject the application within six months.(11)

Understanding of Congress

In constructing this regulatory framework, Congress clearly legislated against a background understanding that state tort remedies would remain available to injured consumers. Thus, a proposed provision for a federal cause of action in the original Food, Drug, and Cosmetic Act of 1934 was deleted as being duplicative of existing state law.(12)

The MDA's purpose was to protect consumers from "increasingly complex devices which pose serious risk if inadequately tested or improperly designed."(13) Post-1976 amendments restated that the goal was to "modify the underlying law in ways that will result in greater protection of the public health."(14)

At no time did Congress state that its aim was to insulate manufacturers from state-law liability. In fact, there is no suggestion at all in the legislative history to support the extreme view adopted in King and Stamps, or to suggest that any state could possibly have imagined that passage of the MDA would have had the impact of a wrecking ball on consumer rights.

The elaborate safeguards erected for Class III devices show Congress's understanding of the dangers involved. But the practical reality is that the FDA must rely heavily on manufacturers' representations of safety and efficacy.

Indeed, because of the sheer number of devices and the agency's limited resources, the vast majority of devices have not undergone the PMA approval process or any detailed FDA review. Devices marketed before May 28, 1976, were "grandfathered." Today, most new devices reach the market via a premarket notification procedure in which the manufacturer need only assert that the new device is "substantially equivalent" to one marketed before May 28, 1976, that is, a device that may have been grandfathered when the amendments were passed.(15)

The FDA has not adopted formal guidelines for demonstrating substantial equivalence, and manufacturers are not required to prove devices' safety or even efficacy. For this reason, the agency has declared that its acceptance of a claim of "substantial equivalence" does "not in any way denote official approval of the device."(16)

The absence of any evidence of a congressional intent to abolish state-law tort remedies is critical, for preemption can be triggered only by clear signs of congressional intent to displace state law. In one of the Supreme Court's most recent preemption decisions, Cipollone v. Liggett Group, Inc.,(17) the Court strongly reaffirmed the principle that federal statutes must be construed "in light of the presumption against the preemption of state police power regulations."

Significantly, the Court rejected Justice Antonin Scalia's dissenting argument that this presumption applies only to the question of whether Congress intended to displace state law at all and that it "dissolves once there is conclusive evidence of intent to preempt in the express words of the statute itself."(18)

The presumption, in other words, is that Congress acts with a scalpel, removing state law with precision and great care--not that Congress cuts with a meat cleaver. And the presumption is especially strong when Congress has failed to provide a separate federal remedy for a person injured by tortious conduct, since "it is difficult to believe that Congress would, without comment, remove all means of judicial recourse for those injured by illegal conduct."(19)

The presumption against preemption is not simply a doctrinal curiosity; it has a constitutional foundation. The Tenth Amendment provides that "the powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people."

The Supreme Court has shown great solicitude for state sovereignty under this provision. It has ruled, for example, that Congress may not "commandeer the legislative processes of the States by directly compelling them to enact and enforce a federal regulatory program"(20) and that Congress did not intend the Age Discrimination in Employment Act of 1967 to apply to state judges.(21) But the Court has emphasized that the primary protections for the states lie in the structure of government as a whole and especially in the political branches.(22)

The Court has therefore demanded a crystal-clear statement of congressional intent before stripping the states of the right to govern themselves and to protect their citizens against unsafe products. Only a plain statement can put the states on notice of the impending preemption of state law and enable the political safeguards of federalism to function. King and Stamps fly in the face of this principle.

Express Preemption

The thin reed on which King and Stamps rest is language in the MDA prohibiting any state from "establish[ing] or continu[ing] 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."(23)

Even if this language were interpreted to refer to state tort law as well as to state statutes and administrative regulations, it should not be accorded broad preemptive effect. After all, the provision is qualified by the very next section of the MDA, which exempts state law from preemption "if the requirement is more stringent than a requirement under [the act]."(24)

And the sections of the MDA relating to recall of devices posing a substantial risk of harm to the public provide that "compliance with...this section shall not relieve any person from liability under Federal or State law."(25) This language would make no sense if the preemptive effects of the MDA were as sweeping as the King and Stamps decisions supposed.

Accordingly, it would be difficult to suppose that, when the MDA was enacted, the states were on clear notice that the law would bar suits based on generally applicable, society-wide norms (like the duty not to deceive or the duty not to defraud) rather than those targeted at a particular activity or industry (like a particular safety requirement).

Indeed, the FDA has recognized that its regulations implementing the statute do not preempt "State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices ...or to unfair trade practices in which the requirements are not limited to devices."(26)

The Supreme Court has always drawn a significant distinction between the preemption of specially targeted laws and preemption of generally applicable, background norms of disclosure, nondeception, and fair dealing. For example,

* In the Cipollone case, a plurality of the Supreme Court held that state laws permitting plaintiffs to recover for express warranty, frand, and conspiracy to misrepresent or conceal material facts were not preempted by the federal cigarette statutes because those state laws did not constitute requirements "based on smoking and health." Liability for fraud is, according to the plurality, predicated "on a more general obligation--the duty not to deceive."(27)

* In New York Telephone Co. v. New York State Department of Labor, a plurality explained that congressional preemption of state power to "enforce... general laws is more difficult to infer than an intent to preempt laws directed specifically at concerted activity."(28)

* In United Steelworkers of America v. Rawson, the Court distinguished, for purposes of labor law preemption, between duties imposed on a labor union by a collective bargaining agreement and generally applicable obligations, such as "the duty of reasonable care owed to every person in society."(29)

* And, in Gade v. National Solid Wastes Management Association--a decision announced six days before the decision in Cipollone--the Court held that the federal Occupational Safety and Health Act of 1970 preempts only state law that "constitutes, in a direct, clear and substantial way, regulation of worker health and safety." The Court stressed that the act does not preempt "state laws of general applicability (such as laws regarding traffic safety or fire safety)," despite their demonstrable effect on occupational safety."(30)

King and Stamps may prove to be aberrant decisions. Or they may turn out to be the tip of a preemption iceberg in the lower courts. One can only hope that other, better-reasoned decisions will supplant them, or that the Supreme Court will intervene to protect the important principles of federalism--and consumer rights--that are now at risk.

Notes

(1)198 U.S. 45 (1905) (invalidating, as a violation of federal substantive due process, a New York statute limiting bakers to a 60-hour work week). See Paul Wolfson, Preemption and Federalism: The Missing Link, 16 HASTINGS CONST. L. Q. 69 (1988).

(2)983 F. 2d 1130 (1st Cir.), cert. denied, 114 S. Ct. 84 (1993).

(3)21 U.S.C. [sections]360c-3601 (1988 & Supp. III (1991).

(4)984 F. 2d 1416 (5th Cir.), cert. denied, 114 S. Ct. 86 (1993).

(5)Michael v. Shiley, Inc., Civ. No. 93-1729, 1994 U.S. Dist. LEXIS 1973 (E.D. Pa. Feb. 25, 1994); Kemp v. Pfizer, Inc., 835 F. Supp. 1015 (E.D. Mich. 1993).

(6)Mendes v. Medtronic, Inc., No. 93-1911, 1994 U.S. App. LEXIS 4153 (1st Cir. Mar. 9,1994); Griffin v. Medtronic, Inc., 840 F. Supp. 396 (D. Md. 1994).

(7)See, e.g., ECONOMIC REPORT OF THE PRESIDENT 169-203 (1993).

(8)21 U.S.C. [sections]360c(a)(C).

(9)21 U.S.C. [sections]360c(a)(1)(C)(ii)(II).

(10)21 U.S.C. [sections]360e(c).

(11)21 U.S.C. [sections]360e(d).

(12)Hearings Before a Subcomm. of the Comm. on Commerce of the United States Senate on S. 1944, 73d Cong., 2d Sess. 400, 403 (1933).

(13)S. REP. NO. 33, 94th Cong., 2d Sess. 5 (1975).

(14)H.R. REP. NO. 808, 101st Cong., 2d Sess. 13 (1990).

(15)21 U.S.C. [sections]360e(b)(B).

(16)21 C.F.R. [sections]807.97 (1993).

(17)112 S. Ct. 2608, 2618 (1992).

(18)Id. at 2632 (Scalia, J., concurring in part and dissenting in part).

(19)Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 251 (1984).

(20)New York v. United States, 112 S. Ct. 2408, 2420 (1992) (citation omitted).

(21)Gregory v. Ashcroft, 111 S. Ct. 2395, 2399-2403 (1991).

(22)See Garcia v. San Antonio Metro. Transit Auth., 469 U.S. 528, 551 (1985).

(23)21 U.S.C. [sections]360k(a).

(24)21 U.S.C. [sections]360k(b).

(25)21 U.S.C. [sections]360(h)(d).

(26)21 C.F.R. [sections]808.1(d)(1) (emphasis added).

(27)112 S. Ct. 2608, 2624.

(28)440 U.S. 519, 533 (1979).

(29)495 U.S. 362, 371 (1990).

(30)112 S. Ct. 2374, 2387 (1992) (internal quotations omitted).