Academic journal article American Journal of Law & Medicine

How the FDA Can Overturn Wyeth V. Levine

Academic journal article American Journal of Law & Medicine

How the FDA Can Overturn Wyeth V. Levine

Article excerpt


In Wyeth v. Levine, the Supreme Court held that an FDA-approved drug label did not preempt state tort law. Although the Supreme Court did not defer to the FDA's position, language in the opinion, and Breyer's concurring opinion, suggest that the FDA may be able to abrogate Wyeth v. Levine using the administrative law doctrine originally announced in Chevron v. Natural Resources Defense Council. That is, the FDA may claim deference to its position in a future case involving the same legal questions. This Note explains how Wyeth impacts the Chevron doctrine and identifies how the FDA assertion that drug labels preempt state law may win in a future case.


Typically, an agency cannot overturn a Supreme Court decision, yet an administrative law doctrine may permit the Food and Drug Administration (FDA) to abrogate a recent Court decision construing a federal statute without Congressional action. The Supreme Court recently decided Wyeth v. Levine, holding that an FDA-approved drug label does not preempt state tort failureto-warn claims.1 The 6-3 decision split on whether a state jury's verdict in favor of plaintiff Diane Levine, which requires pharmaceutical-company Wyeth to strengthen its warning on the drug Phenergan, conflicted with Congressional intent and the FDA regulatory scheme. 2 The majority concluded that the jury's verdict did not conflict with the FDA regulatory scheme or Congressional intent, and thus federal law did not preempt state failure-to-warn claims.

Justice Breyer wrote a separate (and short) concurring opinion in the case for one reason: "to emphasize the Court's statement that we have no occasion in this case to consider the preemptive effect of a specific agency regulation bearing the force of law."3 Breyer's point may permit the FDA to preempt state tort laws, despite the court's decision in Wyeth. If the FDA specifically determines that state tort law acts as a "help or a hindrance to achieving" its mission, then "it is possible that such determinations would have pre-emptive effect."4

Breyer suggests that the Supreme Court would defer to the FDA if the agency establishes its position through the formal rule making process which carries the force of law. Thus, the FDA has the authority to overturn Wyeth v. Levine without Congressional action.5 After this introduction, Part II summarizes the facts and reasoning of the court in Wyeth, including a summary of federal preemption laws. Part III discusses the court's deference to agency interpretations, especially in preemption cases. Part IV argues that Breyer's concurring opinion, as well as language in the majority opinion itself, highlights a way the agency can overturn the Court by using formal procedures and that, in fact, the FDA has already begun that process.


A. A Tragic Accident

In April 2000, patient and plaintiff Diane Levine suffered from nausea stemming from a migraine headache.6 A nurse administered Phenergan, an anti-nausea medication, through an intramuscular injunction, but her nausea returned later that same day.7 A different nurse administered a second injection directly into Levine's arm, in the interior crook of the elbow known as the antecubital fossa, using a technique known as "IV push" which provides faster relief.8 According to its label, Phenergan should only be injected into a vein, never into an artery because of the risks of gangrene. 9 An IV-push into the antecubital fossa region is very dangerous because the drug may enter an artery either because the nurse accidentally injects the drug into an artery by mistake or because of perivascular extravasion - a process where the drug can transfer between an artery and vein due to their thin walls in the area.10 Nurses generally know about the danger of perivascular extravasion, although the nurse who administered the drug later admitted that she was unaware that an IV-push in the antecubital fossa could result in intra-arterial, rather than intra-venous, injection. …

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