In what promises to be one of the most important preemption cases to come out of the Supreme Court this year, Wyeth v. Levine was awarded yesterday by a 6-3 majority to Diana Levine, a Vermont musician whose arm was amputated due to gangrene caused by the Wyeth drug Phenergan.
In 2000, a physician’s assistant administered Phenergan to Levine as a migraine/nausea treatment using a technique called the intravenous (IV) push method, which had been approved by the FDA for Phenergan administration since 1995. What Levine did not know at the time, but which the FDA had been aware of and weighing in their labeling considerations for several years, is that administering Phenergan by the IV push method carries a significant risk of gangrene if the injection unintentionally hits an artery rather than a vein—which is exactly what happened to Diana Levine.
Two weeks after receiving Phenergan, Levine had developed gangrene in her arm so severe that the arm had to be amputated at the elbow. She initially filed suit against Wyeth in Vermont state court, arguing that Phenergan’s warning label did not adequately address or prevent the risks associated with IV use of Phenergan. The state’s jury agreed with Levine, awarding her $7.4 million in damages. The Vermont Supreme Court upheld the decision, finding no conflict of interest between federal and state governments and stating that the “FDA and the state share the purpose of encouraging pharmaceutical companies to alter their drug labels when they are inadequate to protect consumers.”
In its US Supreme Court appeal, Wyeth argued that only the FDA can properly decide how to label drugs, and that Congress intends for the FDA to have the final say on drug labeling—preempting (i.e. prohibiting) consumer claims against drug manufacturers even when FDA labels fail to adequately protect consumers. Levine, in turn, argued that Congress intended for the FDA’s powers to be checked by state governments, which generally have stricter consumer protection laws.
Ultimately, the question the Supreme Court had to decide was whether or not Wyeth should be liable for Levine’s gangrene and subsequent arm amputation because the company knew of the risks of gangrene from the IV push method, and nevertheless marketed the drug to be used this way. Along the road to this final decision, however, were the many questions surrounding the FDA’s role in the approval and labeling of Phenergan. The FDA has known about the drug’s gangrene risks since the mid-nineties, and despite the over 50 amputations that have resulted from the IV push method of administration, has continued to approve the drug for IV push use, including only a mild warning on the label to advise doctors of the risk.
The victory for Levine (and a solid one at that, thanks to Justice Clarence Thomas’ unanticipated support for the majority) sets a powerful precedent for consumers seeking accountability from pharmaceutical companies who have neglected to inform the public of their products’ risks to lives and livelihoods—particularly when publicizing these risks might interfere with company profits.