Years after suing drug giant Merck & Co. for serious injuries allegedly caused by osteoporosis drug Fosamax, more than 500 plaintiffs will have to wait to hear the U.S. Solicitor General's take on their case, and the outcome could reverberate across the pharmaceutical industry.
That's because Merck's bid at the U.S. Supreme Court seeks to reestablish a federal preemption defense it argues has been chipped away in courts over the years. The drug giant says the current case is the "ideal vehicle in which to lay down a legal marker for when a failure-to-warn claim is properly preempted in the branded drug context, and thus revive the preemption defense."
The Supreme Court has asked (PDF) the U.S. government to weigh in on a case over whether Merck should be liable for hundreds of thigh fractures and whether the company's efforts to get warning language added to the drug's label should absolve it of responsibility. In asking for a Supreme Court review of a lower court's decision, Merck also said pharma cases are especially important to get right because of their impact on public health.
In its filing (PDF), Merck says it brought the "specific risk to the FDA's attention and proposed adding a warning about it to its label," but that the FDA rejected the proposal.
Merck petitioned the Supreme Court to review its case after a lower court concluded a jury could find the drugmaker liable because the FDA might have accepted its label change if the company had proposed slightly different language, according to the drugmaker. The company questions whether a state-law failure-to-warn claim is preempted by federal law if the FDA rejected a label change proposal.
Meanwhile, the plaintiff's attorney fired back that the question Merck presents is "hypothetical, because petitioner never proposed such a warning."
"Instead, petitioner proposed a warning only about a different risk," he wrote, for minor stress fractures.
"Because petitioner never proposed a warning about 'the risk at issue,' and the FDA never rejected such a warning, the question as to which petitioner seeks review is not in fact presented in this case," the plaintiff's attorney wrote.
The plaintiffs are more than 500 patients who took Fosamax and suffered femoral fractures before the risk was added to the drug's label in 2011. They claim Merck should have included the risk in Fosamax's label earlier than it did. Fosamax won its initial approval way back in 1995.
With those points and others considered, the Supreme Court has asked for the Solicitor General's opinion before potentially striking up a review; now, the sides can lobby that office with their arguments.
But Merck added another wrinkle by arguing that pharma cases are especially important for the courts to get right and that the Supreme Court has recently taken up similar cases.
Asking for a review, Merck's attorneys wrote that "even if manufacturers engage in good faith with the agency, propose a relevant warning, and follow the FDA's instructions, they remain on the hook based on a lay jury's psychoanalysis of why the agency had blocked compliance with state law."
"That untenable approach is of great importance, as proliferating tort suits stifle innovation, raise drug costs, undercut the FDA's role and ultimately hurt public health," the drugmaker's lawyers argued.
As Reuters notes, the Supreme Court's request for the Solicitor General's opinion is already a win for pharma, as the court outright denied a previous petition from Johnson & Johnson.