Brief Fact Summary. A woman lost her hand and forearm to gangrene when she was injected with Phenergan, an anti-nausea drug made by Wyeth. She won a jury verdict in Vermont under a theory Wyeth had failed to include an adequate warning on the drug’s label.
Synopsis of Rule of Law. Congress did not expressly intend for the FDCA to preempt all state common law tort claims, and with respect to prescription drugs, state tort law claims offer an additional important layer of consumer protection which complements, and does not obstruct, FDA regulation.
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.
Issue. If a drug meets the labeling requirements of the FDA, does that give rise to federal preemption of state law regarding inadequate labeling?