Wyeth v. Levine

Facts

Plaintiff Levine was treated for a migraine in an emergency room with an injection of the drug Phernergan manufactured by Defendant Wyeth, which can be injected intramuscularly or intravenously (IV-push), or put into an IV-drip. The drug is corrosive and causes irreversible gangrene if it enters a patient’s artery. While administering the IV into Plaintiff’s vein, the drug somehow entered into an artery (either because it penetrated an artery or escaped the vein and mixed with arterial blood). Consequently, Plaintiff’s forearm had to be amputated. After settling medical malpractice claims, Plaintiff brought common law negligence and strict liability claims for failure to provide an adequate warning of the risks of the drug. The FDA approved Defendants label in its new drug application, as well as in a subsequent revision of the labeling. The trial court jury found in favor of Plaintiff and awarded damages and disregarded Defendant’s preemption arguments. The Vermont Supreme Court affirmed because federal labeling requirements create a “floor, not a ceiling” for state regulation and Defendant could have provided an additional warning for IV-push administration.