Claims Over Merck Osteoporosis Drug Fosamax Labeling Are Back on

A letter from the FDA rejecting Merck Sharpe & Dohme Corp.'s proposed label warning that its osteoporosis drug Fosamax could cause stress fractures doesn’t preempt state law claims alleging the pharmaceutical giant failed to warn users of the risk of thighbone breaks, a federal appeals court said Friday.

For federal preemption of the state claims to apply, the US Food and Drug Administration had to reject the proposed label in such a way to make it clear that no label about atypical femoral fractures would have been appropriate, the US Court of Appeals for the Third Circuit said vacating the ...