Supreme Court Orders New Look at Fosamax Claims Against Merck

(Bloomberg) -- The U.S. Supreme Court told a lower court to consider throwing out hundreds of patient claims that Merck & Co. was too slow to warn about the risk of thigh-bone fractures from its Fosamax osteoporosis drug.

The justices, ruling unanimously Monday though dividing on their reasoning, gave Merck another chance to argue that it should be shielded from suit. A federal appeals court had let those claims move forward as part of broader lawsuits.

The case turns on the impact of the Food and Drug Administration’s 2009 rejection of a warning Merck proposed for its product inserts. Merck says the rejection made it impossible for the company to tell patients about the risk of atypical femoral fractures, especially serious breaks in which bones can snap in two.

The patients say the FDA rejected Merck’s proposed warning, which referred to "stress fractures," because the agency concluded the language was inadequate. The patients say that left room for the company to issue a stronger warning.

The Supreme Court ruled in 2009 that brand-name pharmaceutical companies can be sued under state law for failing to warn of product dangers in the absence of "clear evidence" that the FDA would have rejected a proposed warning.

In Monday’s case, Justice Stephen Breyer said a judge should decide whether that "clear evidence" standard was met. The appeals court had said a jury should decide that question.

"Judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination," Breyer wrote.

Breyer said evidence linking Fosamax to atypical fractures dated back to the 1990s, but no warning appeared until the FDA ordered one in 2011 based on the agency’s own analysis.

Justice Samuel Alito said in a separate opinion that Breyer had described the case in a "misleading" way that could undercut Merck’s arguments. Alito said Merck and the FDA were in extensive communication after the 2009 rejection.

"A reader of the court’s opinion will inevitably be left with the impression that, once the FDA rejected Merck’s proposed warning in 2009, neither the FDA nor Merck took any other actions related to atypical femoral fractures until 2011,” Alito wrote in an opinion joined by Chief Justice John Roberts and Justice Brett Kavanaugh. "But that is simply not true."

Merck had the support of the Trump administration, which said the FDA concluded in 2009 that the data was insufficient to justify a change. The administration says the FDA didn’t decide that Merck should warn about atypical femoral fractures until the following year.

The Supreme Court ruled in 2011 that generic-drug companies can’t be sued because federal law requires them to have the same warnings as brand-name companies.

The case is Merck Sharp & Dohme v. Albrecht, 17-290.

To contact the reporter on this story: Greg Stohr in Washington at gstohr@bloomberg.net

To contact the editors responsible for this story: Joe Sobczyk at jsobczyk@bloomberg.net, Laurie Asséo

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