Federal Preemption of State Product Liability Law Cuts Both Ways

One current hot topic in product liability law is the scope of federal preemption of state laws. The doctrine of preemption holds that a valid federal law may expressly or impliedly preempt state or local law. Congress may regulate all aspects of interstate commerce, including products produced by the pharmaceutical industry. In short, if Congress has not legislated on the matter, a state or local government may regulate aspects of interstate commerce. If Congress has legislated on the matter, then federal law is said to “preempt” or take precedence over, the state law. Recent cases involving federal preemption focused on whether FDA approval schemes can preempt state products liability actions.

Riegel v. Medtronic, Inc.
Recently, the Supreme Court held in Riegel v. Medtronic, Inc. that the express preemption provision in the Medical Device Amendments of 1976 allows U.S Food and Drug Administration (FDA) premarket approval to preempt state tort law in product liability claims involving Class III medical devices. The Medical Device Amendments prohibit a state from imposing requirements relating to the “safety or effectiveness” of a device that differ from requirements established by the FDA.

While undergoing an angioplasty procedure in 1996, Charles Riegel died because a catheter manufactured by Medtronic, Inc. ruptured during the procedure. The FDA approved label indicated that the device was contraindicated for patients, like Mr. Riegel, who suffered from calcified stenoses. The plaintiff claimed that Medtronic failed to warn about the risks of using the catheter on patients with calcified stenoses. However, because the device was used in a manner that was not in compliance with the FDA approved design, the Supreme Court, by an 8-1 vote, found that federal law preempted state law in this case. This narrow decision addresses Class III medical devices only.

Warner Lambert v. Kent
Another recent case went against the manufacturer. The Supreme Court let a lower court decision stand with a 4 to 4 vote (Chief Justice Roberts recused himself). The lower court decision held that federal law preempted a Michigan state law that generally grants immunity to drug manufacturers in product liability and negligence actions for FDA approved drugs. Because of the deadlock, the Supreme Court offered no guidance as to their positions and simply reported the result. Thus the state action was allowed to proceed.

Wyeth v. Levine
With no real guidance from Warner Lambert, and only narrow guidance from Medtronic, product liability attorneys are closely watching a case on the fall Supreme Court docket—Wyeth v. Levine. This case should address the scope of federal preemption of products approved by the FDA (except those covered in Medtronic).

The issue in Wyeth v. Levine centers on a state failure-to-warn action. In this case, the plaintiff argues that the FDA-approved label does not set a standard but is merely a minimum requirement and that the label, nevertheless, should have been stronger and more specific.

Unlike Medtronic, the Food, Drug, and Cosmetic Act does not contain an express preemption provision. Thus the Supreme Court cannot base its decision on such a provision and must decide whether the FDA regulatory scheme itself preempts state law.

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