However, the drug was administered improperly, causing her to lose her right arm below the elbow. She successfully argued that, even though labeling complied with FDA requirements, the adequacy of the warning still wasn’t established for a particular method of administering the drug.
And she contended Wyeth wasn’t prevented from adding or strengthening the warning on the label, even though the FDA rejected a proposed change. Levine was awarded more than $6 million and, despite appeals, the Vermont Supreme Court sided with her. But Wyeth appealed again. (Read our interview with Levine here).
Wyeth’s defense hinges on preemption - the legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. The court’s decision, therefore, is being closely watched because its ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.
However, Wyeth's attorneys, in the new brief, argue that Levine's case is not really about failure to warn and, therefore, preemption is really not in play...
"Whatever might be said about preemption in those situations, they are most definitely not this case. Respondent never argued that Wyeth concealed information from FDA, and never contended that Wyeth should have changed its labeling to reflect information that came to light after its labeling was approved. Respondent tried this case on the theory that FDA had the pertinent information but reached the wrong conclusion, and that the jury should set FDA right. In this situation, state tort law is undoubtedly preempted."
This past summer, Levine's attorneys made this argument: The issue is whether a drugmaker "may be held liable under stats law for inadequately warning that one method of administering an anti-nausea drug causes unacceptable risks of amputation. When neither Wyeth nor FDA performed any risk-benefit analysis of different ways of administering Phenergan, preemption simply provides a windfall for the drug maker. It decreases manufacturers’ incentives to improve safety and to inform FDA of risks, impedes FDA’s ability to protect consumers, and denies compensation to victims of dangerous drugs for catastrophic but avoidable injuries."
Hat tip to Drug and Device Law