Two product liability cases on the Supreme Court’s docket have set the stage for the Court to rule on the issue of preemption of state efforts to regulate pharmaceutical and medical device products. It long has been FDA’s position that FDA approval of labeling under the Federal Food, Drug, and Cosmetic Act preempts conflicting or contrary state law. FDA, in court filings, has made it clear that decisions by state and federal courts, imposing liability on manufacturers under state tort law theories, conflict with FDA’s statutory authority, regulations, and public health mission. Warner-Lambert v. Kent arises in the context of a conflict among circuit court decisions with regard to the application of federal preemption of state law exceptions for fraud-on-the-FDA involving an approved pharmaceutical product. Riegel v. Medtronic revisits the question of whether a specific provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. § 360k(a), preempts state law claims for injuries caused by medical devices that received premarket approval (“PMA”) from FDA. This article first discusses the two Supreme Court cases and then comments on the potential implications of the Court’s decisions.

Warner-Lambert v. Kent (467 F.3d 85 (2d Cir. 2006), U.S. No. 06-1498)

Respondents in Warner-Lambert v. Kent are Michigan citizens who brought suits claiming injuries resulting from taking Rezulin, a prescription drug used to treat Type-2 diabetes. Asserting various common law claims, including defective design and fraud, the respondents alleged Warner-Lambert “knowingly concealed material facts about the safety and efficacy of Rezulin from the FDA, which would have prevented its approval and/or resulted in its earlier removal.” For jurisdictional reasons, the cases were removed to the Judicial Panel on Multidistrict Litigation in the Southern District of New York.

Warner-Lambert argued liability was foreclosed under a Michigan law that shields FDA-approved drugs from liability based on defective design. Warner-Lambert also argued that a requirement in the Michigan statute requiring the plaintiffs to establish a state law finding there was fraud-on-the-FDA which, if known by the FDA, would have prevented approval of the drug was impliedly preempted. Warner-Lambert relied on the Supreme Court’s holding in Buckman Co. v. Plaintiffs’ Comm., 531 U.S. 341 (2001) and the Sixth Circuit’s application of the Buckman decision in Garcia v. Wyeth Ayerst Labs., 385 F.3d 961 (6th Cir. 2004) that fraud-on-the-FDA claims were impliedly preempted by federal law. The district court agreed, and the case was dismissed.

Reinstating the suit on appeal, the Second Circuit held that when deciding questions of federal law, it was not bound by the Sixth Circuit’s decision involving the laws of Michigan. Relying on a presumption against preemption, and contrary to the Sixth Circuit’s holding in Garcia, the Second Circuit held federal law did not preempt state common law liability through a fraud exception. The Second Circuit distinguished Warner-Lambert from Buckman by narrowly reading Buckman and finding the appellants were not asserting a standalone cause of action for fraud-on-the- FDA, as did the appellants in Buckman, but rather, were asserting claims under traditional state tort law. Other district courts and state courts have adopted a similarly narrow approach to Buckman. However, as noted in Warner-Lambert’s Petition, the Second Court’s decision is contrary to holdings rendered by the Third, Sixth, and Ninth Circuits’ more functional application of Buckman.

Warner-Lambert asserts two potentially far-reaching effects of the issues raised in the case: (1) resolving the circuits’ split will impact many cases and the Michigan statute; and (2) a reasoned interpretation of Buckman, consistent with the Sixth Circuit’s, is essential to avert the dire consequences to the FDA regulatory process that Buckman predicted would result from allowing state law fraud-onthe- FDA claims.

Riegel v. Medtronic (451 F.3d 104 (2d Cir. 2006), U.S. No. 06-179)

The plaintiffs in Riegel brought state law damage claims against Medtronic, for injuries that resulted when the company’s coronary angio-plasty catheter burst during a procedure. The plaintiffs alleged design and manufacturing defects implicated an express warranty and inadequate warnings claims, among others. The focus of the inadequate warning claim centered on apparently conflicting information on the product labeling. The labeling stated not to inflate the balloon catheter above eight atmospheres of pressure, but also contained test results for balloon inflations of up to 13 atmospheres. The plaintiffs, therefore, argued inflation above eight atmospheres was acceptable. The district court granted Medtronic’s motion for summary judgment on the inadequate warning claims. The Second Circuit found preemption on the basis that PMA imposes device-specific requirements, and state law design defect and inadequate warning claims are specific enough to devices to warrant federal preemption.

The question presented to the Supreme Court by Riegel is whether the express preemption provisions of the Medical Device Amendments (“MDA”) to the Food, Drug and Cosmetic Act preempt state-law claims seeking damages for injuries caused by medical devices that received premarket approval. The Supreme Court previously addressed this issue in its 1996 medical device preemption review of Medtronic Inc. v. Lohr. 518 U.S. 470 (1996). At issue in Lohr was whether the presence of a state law damage remedy for violations of FDA requirements under the 510(k), Premarket Notification (PMN), approval process imposed additional requirements upon medical device manufacturers. In Lohr, the Supreme Court held certain state law requirements that parallel FDA requirements, such as a state law damages remedy for violations of FDA requirements for products approved under a 510(k), do not impose additional burdens on device manufacturers, but “merely provide another reason for manufacturers to comply with…federal law.” Accordingly, the state requirements did not fall within the intended scope of the federal statute and regulations, and thus, were not preempted. Although the court found no preemption in the Lohr case, it left open the issue of whether there could ever be preemption.

Potential Implications of the Supreme Court Decisions

FDA is considered the expert federal public health agency charged by Congress with ensuring that medical products are safe and effective, and that their labeling adequately informs professionals and patients of the risks and benefits of the product and is truthful and not misleading. Courts have traditionally deferred to FDA’s interpreting and administering the Food, Drug, and Cosmetic Act.

Inconsistent court decisions regarding the application of federal preemption analysis in state actions for product liability against drug and device manufacturers creates confusion and uncertainty for both FDA and manufacturers. With these two cases, and possibly a third before the Court, the Court has an opportunity to resolve the divisions among the lower courts and to provide much needed guidance in an increasingly inconsistent area of law. The Court also has an opportunity to clarify the law of preemption and to remove the obstacle of state failure-to-warn claims that frustrate the full achievement of FDA’s objectives and purposes. Failure to do so will create even greater confusion than currently exists with courts’ divergent analyses of the application of federal preemption to the regulation of medical products evaluated and approved by FDA.