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In FDA preemption cases, a loss on devices, a close call on drugs.

This year, the Supreme Court is taking up the issue of FDA preemption of state common law tort claims in three separate cases. The Court recently decided the first two: Riegel v. Medtronic, Inc. (128 S. Ct. 999 (2008)) and Warner-Lambert Co. v. Kent (128 S. Ct. 1168(2008) (mem.)).


In Riegel, the Court ruled 8-1 that state tort claims against the manufacturers of certain medical devices are preempted by federal law, while in Kent, an evenly divided court affirmed a Second Circuit ruling that the plaintiffs' products liability claims against a drug manufacturer could proceed under a unique Michigan law.

Charles Riegel was injured when a balloon catheter manufactured by Medtronic ruptured during a coronary angioplasty. He and his family sued Medtronic under various products liability theories, and the company succeeded in having the claims thrown out of court on federal preemption grounds.

The Supreme Court affirmed, holding that the express preemption provision of the Medical Device Amendments (MDA) preempts state tort claims involving devices, such as the Medtronic catheter, that the FDA has approved through its "rigorous" premarket approval (PMA) process. It found that such claims impose state "requirements" that are "different from or in addition to" federal requirements applicable to the same device.

Justice Ruth Bader Ginsburg dissented on the ground that Congress intended the MDA provision to preempt only state statutes and regulations, not state tort claims.

The Riegel decision should not apply to the large number of medical devices that have not undergone the PMA process. Nor does it support preemption of "parallel" state claims, those that provide a damages remedy based on a violation of FDA regulations. Nevertheless, the ruling will deprive many plaintiffs injured by medical devices of any remedy for their injuries. AAJ will seek to overturn this decision in Congress. (For additional analysis of Riegel, see Supreme Court Review on page 62.)

Kent involved tort claims against Warner-Lambert, the manufacturer of the diabetes drug Rezulin. Under a unique Michigan statute, most products liability claims against drug manufacturers are preempted if the drug was manufactured and labeled in accordance with FDA requirements, unless a plaintiff can show that the manufacturer withheld or misrepresented information that would have caused the FDA to deny drug approval.

The plaintiffs in Kent alleged that they could show this, but WarnerLambert moved to have this "fraud" exception and the plaintiffs' claims preempted based on an earlier Supreme Court decision, Buckman Co. v. Plaintiffs' Legal Committee, which had held that cases alleging fraud on the FDA were preempted by federal law. (531 U.S. 341 (2001).)

The Second Circuit rejected this argument because the plaintiffs' proof of fraud was not a required element of their claims but only evidence to rebut an affirmative defense.

The Supreme Court granted certiorari to resolve a conflict between this decision and an earlier ruling by the Sixth Circuit. (Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004).) Chief Justice John Roberts, who owns Warner-Lambert stock, recused himself. The Court divided 4-4, letting the Second Circuit decision stand without opinion and leaving the circuit conflict intact.

This fall, the Supreme Court will tackle the issue of FDA preemption more squarely in Wyeth v. Levine. (No. 06-1249). Until then, the doctrine of federal preemption continues to threaten to leave many victims injured by FDA-approved products without a remedy.
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Title Annotation:CCL report: Center for Constitutional Litigation
Date:May 1, 2008
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