The Supreme Court said Monday that a judge must decide whether a dispute between drugmaker Merck and patients who alleged they were injured by its bone-strengthening drug Fosamax can go forward.
All nine justices agreed that the case should go back to a lower court for further proceedings. The case is at an early stage, and the justices said the question of whether it can move forward should be decided by a judge, not a jury.
Users of Fosamax, which is prescribed to treat osteoporosis in women who have gone through menopause, had sued arguing that Merck had failed to provide adequate warnings of a specific risk of bone fracture on the drug's label. A trial court initially threw out claims against the New Jersey-based company but an appeals court revived them.
The Supreme Court did not answer whether the case should move forward. Instead, it explained that if a judge finds clear evidence Merck told federal regulators about the reasons for a warning and that warning was rejected by regulators, the case should be dismissed. Only three justices — Justice Samuel Alito, Chief Justice John Roberts and Justice Brett Kavanaugh — suggested that was the case.
David Frederick, a lawyer for the patients, said in a statement that the court's ruling "protects access to justice for injured patients." Merck said in its own statement that it was pleased with the decision and "will continue to present evidence that it acted appropriately at all times" in warning about the potential risk of the fractures.
Fosamax was first approved in 1995, but after the drug went on the market, evidence began to emerge that it increases the risk of an unusual type of thigh-bone fracture. In 2008, the FDA said it was concerned about reports of those fractures in Fosamax users and users of similar drugs. In response, Merck proposed changing Fosamax's label.
The FDA agreed Merck should alert users by changing the "adverse reaction" section of Fosamax's label. But the FDA rejected Merck's proposed changes to the label's more serious "warnings" section. At the same time, the FDA began studying the issue, and in 2010 the FDA decided to require Merck to add a warning about the fractures to Fosamax's label.
Hundreds of people ultimately sued Merck, alleging they'd sustained Fosamax-related thigh-bone fractures and arguing that Merck had failed to provide adequate warnings on the drug's label.
The Trump administration had sided with Merck, arguing that the company couldn't have added a warning before 2010 because the FDA determined the available evidence didn't support a change before then.
The case is Merck Sharp & Dohme Corp. v. Albrecht, 17-290.