A new trial claiming Merck & Co. had hid risks that its osteoporosis drug Fosamax could cause femur fractures is scheduled to start next week. This trial, the second of more than 3,300 lawsuits alleging Fosamax (alendronate) had caused broken legs, will begin on April 9 in federal court in Trenton, New Jersey, Bloomberg News reports.
The first trial ended in a mistrial last month, after the plaintiff suffered a health problem unrelated to Fosamax use, according to a statement on Merck’s website.
In addition to the femur-fracture suits, another 1,230 cases allege jaw-related injuries, including osteonecrosis, bone death resulting from loss of blood supply to the bone.
Fosamax was approved by the U.S. Food and Drug Administration (FDA) in 1995 for use in treating postmenopausal osteoporosis and is also prescribed for some cancer patients whose bones are weakened by cancer treatments.
FDA concerns about injury risks associated with extended use of bisphosphonates
A 2012 article in the New England Journal of Medicine addressed FDA concerns about injury risks associated with extended use of bisphosphonates, the class of drugs to which Fosamax belongs, The New York Times reported. The article concluded that further research is needed on the risks and benefits of extended bisphosphonate use.
The plaintiff in the first trial alleged that Fosamax was to blame for her femur fracture and that Merck researchers ignored signs that extended use of the drug caused femur deterioration in some users, Bloomberg News wrote.
Merck officials contend that Fosamax did not cause the 67-year-old plaintiff’s fracture; the company says she was in the category of women at risk for “fragility fractures.” Further, the company maintains that it properly warned doctors and patients about the drug’s risks.
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