On March 4, 2009, the United States Supreme Court decided the case of Wyeth v. Levine, holding that federal FDA regulations regarding drug warning labels do not preempt state law failure to warn claims. The court determined that the drug manufacturer had the option to strengthen warnings beyond those required by the FDA and, accordingly, a failure to do so could lead to a valid state products liability claim.

The Facts
Wyeth manufactured a drug called Phenergan, an antihistamine used to treat nausea. Phenergan can be injected into the patient by two methods - either directly using a syringe or indirectly through an IV drip method, where the drug is introduced into a saline solution before entering the body. Wyeth knew and provided warnings that, if Phenergan was mistakenly injected into an artery, it was extremely corrosive and would likely cause irreversible gangrene, which would lead to amputation.

In April 2000, Diana Levine had a migraine headache and a physician's assistant administered a combination of Demerol and Phenergan via direct injection. Tragically, the Phenergan entered her artery, either because the needle penetrated her artery directly or because it escaped from her vein, entered surrounding tissue and contacted arterial blood. Levine developed gangrene. Doctors first amputated her right hand and then her entire forearm.

The Legal Claims
After settling her claims against the health clinic and physician's assistant for the negligent injection, Levine sued Wyeth for common-law negligence and strict liability. Levine alleged that, although Phenergan's labeling warned about the danger of intra-arterial injection, the labeling was defective for failing to instruct clinicians to use the IV drip method as opposed to the higher risk direct injection method.

At trial, the jury found that Wyeth was negligent and that Phenergan was a defective product as a result of inadequate warnings. It awarded damages of $7.4 million, which was reduced to account for the earlier settlement with the clinic and physician's assistant.

The Appeal
Wyeth appealed, claiming that FDA drug labeling judgments preempt state law product liability claims based on the allegation that the warning labels were inadequate and made the drug unreasonably dangerous. Wyeth made two arguments in support of its position that federal regulation of its drug should preclude state law claims.

First, Wyeth asserted that it would be impossible for it to comply with its federal law labeling duties and also be subjected to state law improper warning claims. Specifically, Wyeth stated FDA regulations require pre-market approval of the exact text of labels and, generally speaking, the FDA must approve all labeling changes. However, the Supreme Court indicated that there is an FDA regulation which allows changes to labeling before receiving FDA approval, and the Court found that such changes could have been implemented to prevent Levine's injury.

Second, Wyeth argued that requiring it to comply with a state-law duty to supply a stronger warning would obstruct the purposes and objectives of FDA labeling regulations. Wyeth contended that Congress entrusted the FDA with the authority to make labeling decisions, thereby establishing both a floor and a ceiling on drug regulation. More specifically, Wyeth argued that once the FDA approved a label, no jury could find the label inadequate.

The Supreme Court rejected this argument too. The Court reasoned that if Congress thought that state products liability lawsuits posed an obstacle to its objectives, then federal legislation would have outlawed those lawsuits. Congress' silence on preemption, coupled with its awareness of the prevalence of state lawsuits, was powerful evidence that Congress did not intend FDA oversight to be the exclusive means of assuring drug safety. Further, the Court found that state lawsuits provide incentives for manufacturers to promptly disclose safety risks and serve a compensatory function that may motivate injured parties to come forward with information to improve drug safety. Ultimately, the jury's verdict was upheld.

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