January 27, 2009
On Monday, November 3, the Supreme Court heard oral argument in Wyeth v. Levine. The Supreme Court here considers state tort claims based on inadequate prescription drug labeling. The case concerns Diana Levine, a Vermont musician, who went into a clinic for headache-related nausea and ended up having her arm amputated. The amputation was a consequence of complications arising from the administration of the antihistamine drug Phenergen by the "IV push" method. The FDA-approved labeling for Phenergen did not prohibit "IV push" delivery, but did warn against it, precisely because of the possibility of such complications. So Levine brought a negligence claim against the drug's manufacturer Wyeth in state court, arguing that the drug's labeling was inadequate for not prohibiting "IV push" delivery. Wyeth argued that such a claim was preempted by federal law, but the jurors, having considered the FDA's approval of the drug's label, ruled in Levine's favor to the tune of more than six million dollars. The Vermont Supreme Court upheld the ruling, and now the United States Supreme Court considers whether prescription drug labeling judgments approved by the FDA preempt state tort claims that these labels were insufficient to make the drugs reasonably safe for use. Appellate litigator Erin Glenn Busby discusses the case.
Oral Argument - November 3, 2008: