Narrowing down preemption
The oral arguments at the U.S. Supreme Court in Wyeth v. Levine last week suggest that the first decision in favor of FDA preemption of state tort laws in a prescription drug case is a very real possibility. But such a decision might be narrow, and not insulate drug manufacturers as much as they might hope.
Product liability suits against FDA-approved products are one of the largest generators of mass torts. The U.S. Supreme Court has taken an interest in whether FDA authority preempts state tort laws in such cases, having ruled in favor of preemption in a device case in February and then splitting 4-4 in a case that allowed Michigan state courts and juries to determine whether a company defrauded FDA.
Wyeth v. Levine is focused on Phenergan promethazine, which was approved to treat nausea associated with migraine. The label included administration via deep intramuscular injection or IV. IV administration works faster than IM, but also increases the risk of arterial exposure, which can cause gangrene.
James Beck, of counsel at Dechert LLP, wrote in the Supreme Court's official preview of the case that Wyeth v. Levine is important because it could "establish the foundational principle that implied preemption does apply to prescription drug litigation - and will probably determine the fate of several other broadly applicable legal propositions asserted by one side or the other. With these propositions established, all subsequent litigation would concern only the scope, not the existence, of preemption."
During oral arguments last week, the justices forced the two parties to delineate some boundaries on when preemption would or would not be appropriate. These confines could enable the court to rule very narrowly in favor of preemption, but the justices will have to decide if there are enough facts to determine whether this case falls within such boundaries.
The focus of the justices' questions makes it likely that the decision will hinge on their definition of "new information" and whether Wyeth failed in its duty to protect patients by disclosing such information, according to many stakeholders contacted by BioCentury.
The facts in Wyeth