Remember Wyeth v. Levine, U.S. Supreme Court decision that held federal approval of labels drug warning labels does not preclude lawsuits under state law claiming inadequate warnings? Well, the government, through the FDA, has now added a final chapter to that story.
Facts of Wyeth v. Levine
Wyeth v. Levine was a landmark U.S. Supreme Court case that involved a Vermont musician named Diana Levine who had her right hand amputated after being injected with Phenergan, an anti-nausea medication made by Wyeth, a pharmaceutical company that was later acquired by Pfizer.
Levine had gone to a clinic to receive treatment for a migraine headache, and a nurse had injected Phenergan into her arm using a method known as “IV-push.” However, the needle accidentally punctured Levine’s artery, causing the medication to be delivered directly into her bloodstream. As a result, Levine developed gangrene and had to have her right hand amputated.
The label originally warned that the IV push method could lead to inadvertent injection into arteries, but the label did not expressly forbid that procedure. Now, after the conclusion of the Wyeth case, the FDA has allowed the Court’s decision to lead the way, and has amended the label to include a black box warning: “due to the risks of intravenous injection, the preferred route of administration is a deep muscular injection and that subcutaneous injection is contraindicated.”
The case focused on the issue of federal preemption, which is the idea that federal law can preempt state law in certain circumstances. Wyeth argued that the FDA’s approval of the Phenergan label preempted state law failure-to-warn claims like Levine’s. However, the Supreme Court ultimately ruled in favor of Levine, finding that Wyeth could be held liable under state law for failing to provide adequate warnings, even if the FDA had approved the drug’s label. The Court held that the FDA’s approval of a drug’s label does not necessarily shield the manufacturer from liability for failure to warn claims under state law. The court found that, in this case, Wyeth could have included a stronger warning on the Phenergan label, and that failure to do so was a proximate cause of Levine’s injury.
Look, Wyeth had a duty to provide patients and healthcare providers with clear and specific warnings about the risks of using the IV-push method to administer Phenergan, given the severity of the potential side effects. Wyeth was aware of these risks. So how do you argue that it should not have taken steps to provide clearer warnings on the drug’s label and through other means of communication with healthcare providers. Shouldn’t a jury be able to decide?
Preemption is just unfair. Point blank Can anyone doubt that if Wyeth was truly concerned with patient safety, it would provide full warnings as soon as possible? Unfortunately, it seems as though the almighty dollar is the reason for holding back on warnings, with the fear that fewer patients will take drugs when the risks are appropriately disclosed. It is a game of “hide the ball.” The results: ask Diana Levine’s.
Impact of Wyeth v. Levine in 2023
One high-profile case that was dismissed based on the Wyeth v. Levine precedent was Pliva v. Mensing. In this case, the Supreme Court ruled that generic drug manufacturers could not be held liable under state law for failing to include adequate warnings on their labels, as they are required by law to use the same labels as the brand-name drugs they are copying. The ruling was based on the principle of federal preemption, which the Court had upheld in Wyeth v. Levine with respect to branded drugs. As a result, many lawsuits against generic drug manufacturers, like Zantac, antidepressant use during pregnancy, and Fosamax.