The U.S. Supreme Court: no federal preemption of failure to warn tort actions against pharmaceutical manufacturers.

• Author: Paul, Niall

This article originally appeared in the June 2009 Toxic and Hazardous Substances Litigation Committee Newsletter.

On March 4, 2009, the U.S. Supreme Court handed down its much-anticipated opinion in Wyeth v. Levine. (1) The Court held 6-to-3 that "failure-to-warm" state tort actions against drug manufacturers are not preempted by federal law. (2) Justice Stevens delivered the opinion of the Court, with Justices Kennedy, Souter, Ginsburg, Breyer, and Thomas concurring. Justices Alito, Roberts, and Scalia dissented.

Wyeth had appealed its case to the U.S. Supreme Court after a Vermont state jury had found that Wyeth, the manufacturer of the drug Phenergan, had failed to provide in its label an adequate warning regarding the risk of injecting Phenergan via the IV-push method and, as a result, Diana Levine suffered the amputation of her arm.

Levine had visited her local clinic for treatment of a migraine headache. She received intramuscular injections of Demerol for her headache and Phenergan for her nausea. She returned later that day and received a second injection of both drugs. However, during the second visit, the physician assistant administered the drugs by the IV-push method. Either because the needle penetrated an artery directly or because the drug escaped from the vein into surrounding tissue, Phenergan came into contact with Levine's arterial blood. As a result, Levine developed gangrene. Doctors first amputated her right hand and then her entire forearm because of the infection.

Levine settled her claims against the health facility and clinician and then brought a lawsuit against Wyeth, relying on Vermont common law negligence and strict-liability theories.

Although Phenergan's label warned of the danger of gangrene and amputation following inadvertent intra-arterial injection, Levine alleged that the labeling was defective because it failed to instruct clinicians to use the IV-drip method of intravenous administration instead of the higher risk W-push method. The warnings on Phenergan's label had been deemed sufficient by the federal Food and Drug Administration (FDA) when it approved Wyeth's new drug application in 1955 and when it later approved changes in the drug's labeling.

In its appeal to the U.S. Supreme Court, Wyeth made two separate preemption arguments: first, that it would have been impossible for Wyeth to comply with the state law duty to modify Phenergan's labeling without violating federal law, and second, that recognition of Levine's state tort action created an unacceptable obstacle to the accomplishment and execution of the full purposes and objectives of Congress because it substituted a lay jury's decision about drug labeling for the expert judgment of the FDA. Regarding the second argument, the majority opinion narrowed the question to whether federal law preempted Levine's claim that Phenergan's label did not contain an adequate warning about using the IV-push method of administration. (3)

1. Congressional Intent

   The majority opinion started its analysis by stating that it is guided by two cornerstones of preemption jurisprudence. First, "the purpose of Congress is the ultimate touchstone in every preemption case." (4) Second, in all preemption cases, and particularly in those in which Congress has "legislated ... in a field which the States have traditionally occupied ... we start with the assumption that the historical police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress." (5)

   Additionally, the majority pronounced that the presumption against preemption is out of respect for the States as independent sovereigns in the federal system and leads the Court to assume that Congress does not cavalierly preempt state-law causes of action. (6)

   In the majority's preemption analysis, the Court first examined Congress' intent in enacting the Food Drug and Cosmetics Act (FDCA), which was enacted during the 1930s in response to Congress' concern about unsafe drugs and fraudulent marketing. In 1962, Congress amended the FDCA. The 1962 amendments added a saving clause, indicating that a provision of state law would only be invalidated upon a direct and positive conflict with the FDCA. (7) Conversely, when Congress enacted an express preemption provision for medical devices in 1976, (8) Congress declined to enact such a provision for prescription drugs. (9)

2. Impossibility Preemption

   Wyeth argued that Levine's state law claims were preempted because it was impossible for Wyeth to comply with both the state-law duties underlying those claims and its federal labeling duties, as a manufacturer may only change a drug label after the FDA approves a supplemental application. Wyeth insisted that it was impossible for it to discharge its state law obligation to provide a stronger warning about IV-push administration...