In Wyeth v. Levine, the Supreme Court addressed whether FDA approval of a drug and drug labeling should serve as a complete defense for drug companies from state products liability claims. In a 6-3 decision in favor of Diana Levine (Levine), the Vermont musician who lost part of her right arm following the intravenous administration of Wyeth’s antinausea drug, Phenergan, the court rejected the notion of federal regulations pre-empting state actions.
In this matter, Levine was administered a dose of Wyeth’s Phenergan via "IV-push," wherein the drug is injected directly into the patient’s vein. The corrosive drug was mistakenly injected into an artery rather than a vein, and as a result, Levine developed irreversible gangrene, which necessitated a partial amputation of the limb. Levine filed suit against Wyeth for failure to adequately warn against the dangers of administering Phenergan via the IV-push method. The drug labeling disclosed the risk of gangrene requiring amputation when the drug is inadvertently administered into an artery rather than a vein; however, Levine contended that the labeling failed to instruct clinicians to use the IV-drip administration rather than the IV-push method. She went on to claim that the drug is not reasonably safe for IV administration because the foreseeable risk of gangrene necessitating amputation is too great when weighed against the benefits of the drug. A Vermont jury found in favor of the plaintiff, and on appeal, the decision was upheld by the Vermont Supreme Court.
Wyeth argued that it could not comply with the state duty to modify the Phenergan labeling without violating federal regulations. Wyeth claimed that FDA regulations prohibit pharmaceutical companies from unilaterally changing drug product labeling, as such changes necessitate the filing of a supplemental drug application, which then must be approved by the FDA. Moreover, where drug labeling is part of the new drug application approved by the FDA, Wyeth contended that the warnings issued were approved by the FDA. The court rejected this argument as a "cramped" interpretation and "fundamental misunderstanding" of the FDA’s regulations, and specifically cited the agency’s "Changes Being Effected" doctrine, which permits manufacturers to enhance drug safety warnings at the time a supplemental application is filed, rather than waiting for FDA approval. The court also rejected the notion that responsibility for the adequacy of labeling warnings rests upon the FDA; rather, it reaffirmed that this obligation lies with the manufacturer at all times, noting that, prior to 2007, the FDA did not have the authority to mandate labeling revisions. The court recognized that the FDA could have rejected labeling revisions made under the "Changes Being Effected" doctrine, but stated that in the absence of evidence that the FDA would have done so, the court refused to accept that it was impossible for Wyeth to comply with both federal regulations and the state duty to warn. The court also rejected Wyeth’s argument that state failure-to-warn claims pose an obstacle to the FDA’s regulation of drug labeling by substituting the judgment of juries for that of the expert agency. Rather, the court stated that the FDA has traditionally viewed state law to be a complementary method of drug regulation, offering an additional layer of consumer protection, and reinforcing the idea that responsibility for drugs lies with the manufacturer, and not the FDA.
This decision stands in stark opposition to the decision in last year’s Riegel v. Medtronic, Inc., which held that federal medical device regulations preempt state law claims unless there also has been a violation of federal device regulations. This dichotomy indicates that the preemption fight is far from over, with each case likely turning on the particular state claims and facts at issue.