In this case, Diana Levine received Wyeth’s antinausea drug Phenergan during treatment for a migraine headache. The hospital administered the drug using the “IV push” method, involving injection of the drug into a vein, which the FDA-approved label did not mention as a valid method of administration. After the drug made contact with her arteries and led to gangrene, doctors were forced to amputate her right arm.
In her state-law tort claim against Wyeth, Levine alleged injury as a result of Wyeth’s failure to provide adequate warning of the drug’s dangers. In awarding her $6.7 million, a Vermont jury concluded that Wyeth had failed to warn of the risks associated with the “IV push” method of administering Phenergan.
The Vermont Supreme Court ruled that the state-law failure-to-warn claim was not preempted by the FDA’s approval of the Phenergan label, reasoning that Wyeth could have provided the FDA-approved label and an additional warning against IV push administration.
The Supreme Court agreed. On March 4, 2009, the Court ruled 6 to 3 that FDA approval of a prescription drug label does not preempt state-law failure-to-warn claims. It found that Wyeth could have unilaterally provided a stronger warning while also seeking FDA approval of the new warning. The manufacturer bears primary labeling responsibility, despite the requirement that labels be approved by the FDA. The Court rejected language in the preamble of the drug labeling rule saying that state failure-to-warn actions threaten the FDA's role, calling the statement inherently suspect because it was announced without notice and comment, conflicts with congressional intent, and reverses long-standing FDA policy.