Once again, the US Solicitor General has lined up in support of preemption, a concept that, essentially, states FDA approval of a drug preempts state law claims challenging the safety, efficacy, or labeling. At issue is whether patients can sue a drugmaker through state law when a product has already been approved by the FDA, a controversial notion that is now making its way to the US Supreme Court.
In a related action, the Bush administration recently told the Supremes that FDA-approved medical devices are shielded from product-liability lawsuits in state courts. That position backs Medtronic in a case that has broad implications for devices makers. Unlike medical devices, however, there is no statute providing for preemption for drugs.
Nonetheless, drugmakers and the FDA argue that premption does, indeed, exist by maintaining that the agency’s actions are the final word on safety and effectiveness. The issue has become so contentious that the Supreme Court will, in fact, review a preemption case involving the Rezulin diabetes drug in February. For this reason, the Solicitor General’s brief in a case involving a Wyeth drug was widely anticipated.
And in its latest opinion sent to the Supreme Court (here it is), the Solicitor General disagrees with a ruling by a lower court - in this instance, the Vermont Supreme Court - that supported a patient’s right to sue Wyeth over the labeling for Phenergan, an injectable drug. Diana Levine, a professional musician, went to the hospital for treatment of a headache and, after being injected, was left with injuries that led to the amputation of her right arm.
Levine successfully argued that, even though the Phenergan labeling complied with FDA requirements, the adequacy of the warning still wasn’t established. Moreover, Levine’s attorneys contended Wyeth wasn’t prevented from adding or strengthening the warning on the label, even though the FDA rejected a proposed change. Levine, by the way, was awarded more than $6 million.
The Solicitor General, however, sides with Wyeth. “If manufacturers were free to make unilateral changes to labeling the day after FDA’s approval, based on information that was previously available to FDA, the approval process would be greatly undermined and the agency’s careful balancing of risks and benefits thwarted,” the Solicitor General writes.
Nonetheless, the Solicitor General recommends that the Supremes hold off on granting Wyeth’s request to hear the case until the Medtronic and Rezulin cases are decided.
Hat tip to Drug and Device Law