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All eyes are on the U.S. Supreme Court, which accepted six cases dealing with pre-emption, a legal defense that prevents consumers from bringing lawsuits for harm caused by defective products. It’s big business versus individual rights.

Pre-emption arises out of the Supremacy Clause and is a legislative intention to bar common law claims seeking, among other remedies, damages for personal injuries caused by dangerous products. In effect, pre-emption grants total immunity to a manufacturer from even the threat of tort litigation in state or federal courts. This collides with two long-standing constitutional policies protecting individual rights, the Seventh Amendment right to trial by jury and the doctrine of federalism. In past Supreme Court decisions, this constitutional tension created a presumption against pre-emption. This court accepted six cases dealing with varying forms of pre-emption.

On Feb. 20, 2008, the Supreme Court published its opinion in the medical device case, Riegel v. Medtronic, Inc., ruling that pre-emption barred the plaintiff’s claim for a device that went through the full FDA premarket approval process. On March 3, 2008, an equally divided court affirmed the 2nd U.S. Circuit Court of Appeals decision in Warner-Lambert Co., Inc. v. Kent, allowing an injured person to prove fraud, challenging a Michigan state statute limiting citizens’ rights to sue drug manufacturers where the Food and Drug Administration has approved a drug as safe and effective, unless the FDA has been defrauded. These two cases provide some insight and perspective into the present Supreme Court’s view on federalism as it affects corporate America.

Riegel and the Medical Device Amendments

The Riegel opinion, delivered by Justice Antonin Scalia, followed the court’s rationale in its previous decision, Medtronic v. Lohr, 518 U.S. 470 (1996).

In Lohr, the court found that the pre-emption clause in the Medical Device Amendments (MDA) of 1976, 21 U.S.C. Section 360k, bars common law claims challenging the safety and effectiveness of a medical device given premarket approval by the FDA. A majority of the court found that language in the FDA regulation, 21 CFR Section 808.1(d)a, “substantially informed” the public on the safety of devices that the FDA approved through the premarketing process. That regulation 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. . . . ” 21 CFR Section 808.1(d). Federal manufacturing and labeling requirements, applicable to almost all medical devices, could not pre-empt the common law claims or negligence and strict liability at issue in Lohr because the requirements were not specific to the device in question. Further, products entering the market through the Section 510(k) “substantial equivalence” process, a much less rigorous process than premarket approval, are marketed as an exemption rather than a requirement. Thus, the 510k device in Lohr was not entitled to immunity from state court litigation.

In considering the effect of the MDA, legislative history is important. In 1976, Congress passed the MDA after some states adopted regulations requiring premarket approval of medical devices. The act contained an express pre-emption provision:

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, Section 360k(a).

Clearly concerned about competing state regulations, Congress preferred a uniform system for premarket approval, rather than varying requirements in different states. Thus, in this narrow area (only 32 devices have received FDA premarket approval), the FDA has the only word on device safety. It is doubtful that Congress intended 360k(a) language to give manufacturers sweeping immunity from liability caused by defective devices.

Fast forward to 2005, when the court, in Bates v. Dow Agrosciences, LLC, 544 U.S. 431, did not interpret common law judgments as a requirement different than federal agency’s regulations. However, Scalia, in Riegel, held that state court judgments are, in effect, state requirements. Riegel‘s rationale suggests public policy favors immunizing device manufacturers whose products save lives, rather than compensating patients who are injured by devices. The court found that the FDA is a better fact finder on safety than a 12-person jury, putting less emphasis on other public policy consideration such as:

reimbursing Medicare for medical expenses paid on account of defective devices;

increasing litigation against health care providers, rather than the device makers whose products cause injury; and

burdening states and health care insurers who now pay medical bills associated with injuries and the costs of replacing damaged devices without recovering these expenses from a more responsible party.

Language in the Bates opinion suggests that legislative history is not necessary, given the broad language used in the express pre-emption clause. Still, the Supreme Court’s interpretation of this history, while troubling for the victims of defective medical devices, may not be dispositive for other products, such as drugs.

Warner-Lambert Co. Inc. v. Kent - Support for Consumers

The Warner-Lambert Co. Inc. v. Kent case involved a Michigan state law granting immunity in prescription drug litigation, enacting a bar against suing drug manufacturers wherever the FDA had approved a compound as safe and effective. Plaintiffs could proceed under Michigan law only where the company committed fraud against the FDA during the approval process. The issue in Kent involves one of the most important of a state’s traditional police powers, an area without a history of significant federal presence, and where Congress has not declared intent to pre-empt state tort law. The company sought to invalidate the fraud exception to pre-emption, and the District Court found the litigation was pre-empted under Buckman v. Plaintiff’s Legal Com., 531 U.S. 341 (2001), in which state law fraud on the FDA claims were pre-empted by federal law. The 2nd Circuit reversed the decision, and it went to the Supreme Court. On March 3, 2008, a week after the oral argument, the court, in a tied decision, affirmed the 2nd Circuit in a per curiam decision proving the fraud exception to the FDA total defense, under the Michigan statute, was not pre-empted.

An Uncertain Future

What should the practitioner take away from these two decisions? In Riegel, the court continued pre-emption for a narrow set of medical devices, which received full premarket approval, under a specific express pre-emption section of the MDA. In Kent, an equally divided court affirmed that under Michigan law, a cause of action exists for fraud on the FDA – a result that narrows Buckman. Some more clarity may evolve in October 2008, when the Supreme Court will address the Supreme Court of Vermont decision, Levine v. Wyeth, in which common law cases for unsafe drugs were not pre-empted. The court will determine whether prescription drug labeling imposed on manufacturers by the FDA, pursuant to its safety and efficacy authority, pre-empts state law product liability claims. Careful review of the court’s pre-emption precedents and the argument transcripts from Riegel and Kent give little clue on how the court will rule. So, hang on to your hats.

SOL WEISS is a shareholder in Anapol Schwartz Weiss Cohan Feldman & Smalley, most recently serving as plaintiffs’ co-liaison counsel in the New Jersey Vioxx litigation. Mr. Weiss has also served as liaison counsel in prior state court mass tort litigations, as well as on MDL steering committees involving unsafe drugs and medical devices. He can be e-mailed at [email protected].

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