Merck's Fosamax (alendronate)

In 2005, FDA requested all oral bisphosphonate manufacturers to include a precaution about the risk of osteonecrosis of the jaw (ONJ) and musculoskeletal pain. In October 2010, FDA required labeling of bisphosphonates to state the uncertainty of the optimal duration of use for osteoporosis and required a REMS medication guide that described the risk for atypical fractures of the thigh.

In 2014, Merck and Plaintiffs' Steering Committee finalized a $27.3m master settlement agreement for 1,200 plaintiffs claiming Fosamax caused ONJ. Approximately 15 cases are pending in federal and state courts.

In cases alleging femur factures, Merck won a jury verdict in April 2013 in the only MDL bellwether trial to date. In June 2013, the court ruled in another case that plaintiff's failure to warn claim was preempted by federal law. Approximately 1,190 cases have been dismissed. In March, The Third Circuit reversed the preemption ruling and remanded cases back to the MDL and reversed summary judgment in a case that found Merck's 2011 label updates were adequate. More than 3,000 cases are pending in the MDL and state courts.

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