Big Pharma scored a victory on Wednesday when a federal judge in Trenton, New Jersey, granted Merck & Co. summary judgment in long-running litigation by users of the company’s osteoporosis drug Fosamax.

Plaintiffs’ claims that Merck failed to warn that use of Fosamax is linked to fractures of the femur are preempted by federal law when the Food and Drug Administration rejected Merck’s proposed warnings about the drug, Chief U.S. District Judge Freda Wolfson of the District of New Jersey said when she granted summary judgment to Merck. Because the FDA’s rejection was based on insufficient evidence of a link between Fosamax and femoral fractures, the agency would not have approved a differently worded warning about such a risk, Wolfson said. 

Judge Freda Wolfson.