Shortly after the U.S. Supreme Court agreed in June to hear Merck & Co.’s appeal in the years-long Fosamax liability litigation, acting Solicitor General Jefferey Wall asked for permission to present oral arguments. It would be a plus for Merck, because Wall has been a major voice on the hotly debated issue of pre-emption, which revolves around the question of whether FDA decisions protect pharma companies from state legal challenges.
On Monday, SCOTUS agreed to let the feds participate in the oral arguments.
The pre-emption question dates back to the original Fosamax case, which was filed by patients who suffered femoral fractures while taking the osteoporosis drug. Merck added language to the product’s label about the risk in 2011, but more than 500 patients claimed that their injuries occurred before then, and Merck should have warned them sooner.
Merck said it tried to update the label earlier, but failed because the FDA rejected its proposed wording. Because it was the FDA's call, pre-emption should apply, Merck said—and Wall concurred. Now, the Supreme Court will offer 10 minutes for the U.S. to make its case.
"The government has a significant interest in the proper resolution of the case, which concerns the manner in which the scope and effect of an FDA labeling decision is determined in private tort litigation," Wall wrote (PDF).
Fact is, SCOTUS’ ability to resolve the pre-emption question could have a ripple effect on the entire pharma industry. The issue generated heated debate a few years back, when a liability case raised questions about whether generics makers can be held responsible for patients’ injuries, given that they must use label language the FDA approved for branded versions of the drugs.
In a close 5-4 decision, the justices ruled that generics makers could not be held liable in those cases.
Initially, it looked as if Merck would prevail in its pre-emption argument, too. It won two bellwether lawsuits filed over alleged Fosamax injuries. Then, in 2014, a federal judge tossed out 5,000 lawsuits from patients who claimed their fractures were caused by Fosamax. But then, a federal appeals court revived the case by throwing out that dismissal.
Lawyers representing the patients in this case have argued that Merck’s pre-emption argument is faulty because it’s largely based on an internal memo recounting a phone conversation one of its employees had with the FDA.
"Respondents are aware of no other pre-emption case in which the manufacturer relied on hearsay accounts of informal FDA communications," the lawyers said in a recent brief.
Both Merck and the Solicitor General contend that if the FDA believed there was scientific reason to support a labeling change, the agency would have added the warning, because federal laws require it to do so.
As SCOTUS gets set to hear the case, more than a half-dozen individuals and organizations have filed briefs urging the justices to uphold the lower court ruling that would allow those thousands of Fosamax suits to go forward. Consumer watchdog Public Citizen, for example, filed a brief earlier this month suggesting that Merck’s pre-emption argument is invalid because federal statutes do not support the idea that "the FDA’s rejection of a particular proposed warning constitutes a determination ‘that no new labeling language is warranted.’"
Besides, Public Citizen argued (PDF), SCOTUS should preserve patients' rights to pursue drug liability claims in state courts, and by siding with Merck, the judges might make it much harder for those suits to be filed.
"Allowing patients to pursue tort claims against pharmaceutical manufacturers for injuries caused by inadequate warnings is important as both an incentive for manufacturers to be vigilant about product safety and a means to provide remedies to patients," Public Citizen wrote. "For this reason, the case has important implications that go well beyond the interests of the parties."
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