Merck & Co. has another chance for a reprieve in its long-running fight against Fosamax liability lawsuits. After an appeals court revived hundreds of patient claims last year, the U.S. Supreme Court has decided to hear Merck’s bid to put them to rest again.
Merck argues that the FDA rebuffed its 2008 bid to update the osteoporosis drug's label to warn of a link to severe bone fractures, but decided to order a warning in October 2010, when Merck did so. Now, Merck shouldn’t be held liable for that lack of a warning, because the FDA’s labeling power shields it, the company says.
And the high court will now review that argument, in an important development for the drug industry.The question of FDA pre-emption has made its way through multiple courts in recent years, and Merck’s Supreme Court appeal could settle it. That, in turn, could affect product liability cases across pharma.
The history in Merck’s case is similar to a few other legal battles. Back in 2014, a federal judge dismissed a set of Fosamax fracture claims, saying the FDA’s decisions pre-empt state-court claims from patients. An appeals court in New Jersey revived those lawsuits—about 500 of them—and ordered them to be tried before a jury, because the facts weren’t a question for a judge to decide.
In reviewing Merck’s request for a hearing, the high court asked the U.S. Solicitor General to weigh in, and in its amicus brief backing Merck, the office says exactly the opposite: that FDA pre-emption is a legal question for a judge, not a jury. The FDA’s decision to reject Merck’s proposed label change supported pre-emption because it “prevented [Merck] from modifying the relevant labeling before late 2010.” Thus, he added, the court of appeals made a mistake in rejecting Merck’s defense. A war of words followed between the respondents in the case—the patients making the failure-to-warn claims—and Merck, culminating in the Supreme Court’s Thursday decision to take up the case.
When the company petitioned the court to weigh in on the Fosamax case last December, it argued in part that resolving the pre-emption puzzle would be vital to public health. Legal experts see it as vital to liability cases across the pharma industry.
Merck’s attorneys noted in its petition that even when drug companies collaborate with the FDA and propose a label warning, “they remain on the hook based on a lay jury's psychoanalysis of why the agency had blocked compliance with state law." Such an approach is “untenable” and “of great importance,” they said, “as proliferating tort suits stifle innovation, raise drug costs, undercut the FDA's role and ultimately hurt public health."
Fosamax was once one of the company's top sellers, but it's faced generic competition since 2008; last year it brought in less than $250 million, down from more than $3 billion at its peak.