US Supreme Court justices on Monday grilled lawyers on both sides of a case hinging on whether Merck should be held liable for failing to update a label that the company had attempted to update but had its attempt denied.
Justices on Monday sparred over whether the label update for the osteoporosis drug Fosamax was rejected by the US Food and Drug Administration (FDA) because of the type of fracture that was initially proposed by Merck.
Shay Dvoretzky explained on behalf of Merck about how the issue is that FDA, “fully informed of the risk of atypical femoral fractures, ignored that risk and its own statutory and regulatory responsibilities because it didn't like the way Merck phrased its proposed warning. That cannot be right. If a manufacturer, as Merck did here, informs the FDA of a possible risk and unsuccessfully asks to revise its label in light of that risk, then failure to warn claims based on that risk are preempted as a matter of law.”
Justice Elena Kagan pressed Dvoretzky on whether FDA looked at Merck’s proposed label changes and said: “They’re not talking about major fractures; they’re only talking about stress fractures; and there’s no reason to think that stress fractures are a real risk and no reason to put that in the label.”
But Dvoretzky fired back noting that FDA’s complete response letter has to be understood within the context of its statutory obligations, noting the agency has a duty to have a back and forth with a manufacturer if there is something the agency believes should be included in a label.
On the other side of the case, however, David Frederick argued that brand name drug makers are responsible at all times for keeping their labels up to date.
“If the FDA rejects an inadequate warning, or is uncertain about whether and how to mandate a proper warning, those federal decisions do not make it impossible for Merck to comply with state law duties to market safe drugs,” he said.
And Frederick explained how Merck did not provide FDA with a complete picture of the information it knew. He cited a Merck consultant’s amicus brief explaining how he does not believe that Merck gave "medically accurate education" to FDA about these types of fractures.
“He's the one who had coined the term ‘Fosamax fracture’ because, in all of his years of osteology, he had not encountered these kinds of fractures until he had patients coming to him who were on this drug,” Frederick said.
And in arguing that Merck could have unilaterally updated its label, he noted how the FDA’s complete response letter “as a matter of law could not have made it impossible for Merck to update its labels.”
Dvoretzky countered in his rebuttal that, “If the FDA does not know yet whether a warning is justified or not, that means no, the manufacturer in that situation can't change the label. That's true whether we're talking about the CBE [Changes Being Effected] process or the PAS [Prior Approval Supplement] process.”