July 2008

Does Riegel v. Medtronic Signal Expansion of Federal Preemption of State Law Product Liability Claims?

By Henry R. Chalmers, Litigation News Associate Editor

Is federal preemption of state common-law product liability claims growing? Several months ago, the U.S. Supreme Court ruled, in Riegel v. Medtronic, Inc., that an express preemption clause in a federal statute governing medical devices preempts product liability actions challenging a device that received federal pre-market approval. Next term, the Supreme Court will decide, in Wyeth v. Levine, whether preemption is implied where the federal statute governing pharmaceutical labeling does not explicitly preempt state law product liability claims. The product liability bar is anxiously awaiting the answer.

“I haven’t seen such a slowdown in litigation in this arena in years,” says James C. Barton Jr., Birmingham, AL, cochair of the Pharmaceuticals Subcommittee of the Section of Litigation’s Products Liability Committee. “It seems that many members of the plaintiffs’ bar are in a wait-and-see mode right now. Attorneys may still be developing pharmaceutical products liability cases, but many are not filing them until they see how the Court rules in Levine.”

In its recent foray this year into the preemption arena, the Court in Riegel came down squarely on the side of preemption. The ruling, however, will have a fairly narrow application. The plaintiffs in Riegel sued Medtronic, asserting state common-law tort claims when a catheter Medtronic designed and manufactured allegedly ruptured during heart surgery. The Supreme Court affirmed the trial court’s ruling that the Medical Device Amendments of 1976 (MDA) preempted the plaintiffs’ state law claims.

The MDA requires Food and Drug Administration (FDA) approval before novel medical devices may be sold. The MDA also includes a preemption provision stating that no state may impose requirements on medical devices that differ from or are in addition to the requirements found in the MDA, or relate to the safety or effectiveness of any such device.

In Medtronic, the Court found that state common-law tort claims constituted state-imposed “requirements” for purposes of the MDA and that the federal government had already established “requirements” for Medtronic’s catheter because the device had been subject to an extensive FDA pre-market approval process. Thus, the MDA’s explicit preemption provision barred the plaintiff’s state common-law claims.

“The Riegel decision confirmed the prevailing view that already existed in the circuit courts,” says Neville H. Boschert, Jackson, MS, cochair of the Medical Device Subcommittee of the Section’s Products Liability Committee. “It’s also not as broad as some people might think,” Boschert adds, “because it deals only with class III medical devices that have undergone the pre-market approval process” in contrast to the vast majority of devices, which are cleared for marketing based solely on their substantial equivalence to existing products with FDA clearance.

The Court’s next opportunity to weigh in on preemption is unlikely to have such a modest impact. The Levine case involves the more complicated question of whether a statute that is silent on its face can nonetheless implicitly preempt state common-law claims. “Unlike Riegel, which has a fairly narrow application, if the Court were to rule broadly in Levine, a finding of implied preemption could be a significant sea change and could pull the rug out from under most pharmaceutical litigation,” Barton says.

In Levine, the plaintiff was given an injection of Phenergan into one of her veins—known as an “IV push”—to treat her migraine-induced nausea. The FDA-approved label for Phenergan warned that contact with arteries could cause gangrene and advised against administration by IV drip. The label did not address use of the IV push method. The plaintiff ultimately developed gangrene and had to have her arm amputated.

A jury found that Wyeth, the drug’s manufacturer, failed to warn of the risks associated with the IV push method and awarded the plaintiff $6.7 million in damages. The Vermont Supreme Court affirmed, ruling that Wyeth could have used the FDA-approved label and could have provided additional warnings against IV push administration, and that doing so would not have obstructed any goals of the federal Food, Drug, and Cosmetic Act (FDCA).

Wyeth and the solicitor general argue that the plaintiff’s claims are impliedly preempted by the FDCA because they challenge labeling that FDA approved, even though the FDCA lacked an explicit preemption clause. In recommending that the Supreme Court grant certiorari, the solicitor general compared the approval process for pharmaceuticals to the pre-market approval process for medical devices at issue in Riegel and argued that preemption was appropriate because both processes involve detailed consideration of safety issues by the federal government.

“If the Court does find implied preemption in Levine, it would have a major impact on litigation and some would think a major impact on the ability of plaintiffs to recover” in pharmaceutical labeling cases, says Lori B. Leskin, New York City, cochair of the Pharmaceuticals Subcommittee of the Section’s Products Liability Committee.

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