The Washington Post reports today that questions from Supreme Court justices during oral argument in Wyeth v. Levine, No. 06-1249 (U.S.), suggest a narrow ruling on a broad question of federal preemption.
The case presents the sweeping issue of whether the Food and Drug Administration's "prescription drug labeling judgments" preempt state law claims for injuries that result from inadequate warnings of medical risks.
The plaintiff, Diana Levine, lost her right arm after receiving an "IV-push" injection of Phenergan, an anti-nausea medication. The inadvertently arterial administration of the drug resulted in gangrene and led to amputation of the guitarist's arm. Ms. Levine alleged that Wyeth should've given a stronger warning about the danger of using the IV-push method. A Vermont jury awarded her $6.7 million in damages; the Supreme Court of Vermont declined to overturn the verdict.
The Post story notes that "the justices seemed more likely on Monday to be headed toward a narrow ruling that might be confined to the facts of Levine's case." It elaborates:
"How could the FDA have concluded that IV push was safe and effective," Alito asked, given that Phenergan is not a lifesaving drug and gangrene can result from improper administration?
Justice Ruth Bader Ginsburg chimed in, "How could the benefit outweigh the substantial risk?"
The questions imply doubt that FDA approval of a label precludes inquiry into the quality of the agency's review — and the integrity of drug-makers' disclosures.
Kurt R. Karst, who attended the argument, has more in this post on FDA Law Blog. He observes:
[G]iven the tenor of the Court’s questions, which dealt specifically with what FDA knew and what the submissions were, we believe that: (1) an outcome either way is likely to be narrowly focused; and (2) that a narrow outcome could result in additional litigation as to whether preemption is available in any specific set of facts (i.e., a sweeping proclamation of preemption involving all drug labeling is unlikely).
