The US Third Circuit Court of Appeals in Philadelphia, Pennsylvania, has ruled that 5,000 lawsuits brought by patients taking Merck & Co.’s osteoporosis drug Fosamax (alendronate) must be reopened, three years after the dust on the dispute was believed to have settled. The plaintiffs had claimed that the drug was responsible for their femur fractures.

The decision overturns a 2014 case in which a district court in New Jersey  dismissed the claims brought by patients allegedly injured before Sept. 24, 2010 on grounds the suits were preempted by “clear evidence” that the US Food and Drug Administration (FDA) would not have approved a warning label on the package. The appeals court said it was “not evident” that Merck was entitled to a preemption and that any decision on the matter was one for a jury rather than a judge to make. 

Additionally, Circuit Judge Julio Fuentes said the FDA was “undisputedly” aware of the possible link between Fosamax and so-called atypical fractures well before a 2010 study pointed to them but Merck had not identified the dangers in a 2011 label change. Fuentes said he had found evidence that could lead a jury to conclude that the FDA would possibly have approved a warning and that some doctors would not have prescribed Fosamax if they had been aware of the fracture risk.

Merck & Co won two bellwether suits over femur fractures suffered by Fosamax patients and in 2013 reached a separate settlement of $27 million with some 1,200 Fosamax users who suffered necrosis of the jawbone.