Pharmaceutical giant Merck & Co. is headed back to court this week defending the safety profile of its popular bone loss drug Fosamax.
According to a report at Law360.com, the company will be back in court this week in New Jersey as jurors are selected in a trial which claims taking the company’s popular and heavily-marketed bone loss drug Fosamax causes a rare fracture of the femur.
The lawsuit filed in a court in Atlantic City, N.J., is one of more than 2,000 cases against the company that claim taking Fosamax as recommended resulted in an atypical fracture of the femur. The claims maintain that while taking Fosamax to prevent bone loss – a condition common for women in menopause – the drug is actually weakening the strong femur bone from the inside out and resulting in severe and painful fractures.
These claims also contend that Merck failed to warn of this risk and that the company is aware of the risks associated with the drug but that it continues to market the best-selling product as safe and effective. The company uses celebrity endorsements, including award-winning actress Sally Field, to pitch the benefits of it while glossing over the risks associated with it.
Fosamax is one of many bisphosphonate drugs available to women in or post-menopause that are aimed to prevent bone loss and osteoporosis. In 2010, the Food and Drug Administration issued a warning that is likely to benefit those who’ve filed claims against Merck for thigh fractures caused by Fosamax. The agency warned that taking bisphosphonate drugs could lead to an atypical fracture of the femur bone. The FDA noted that patients taking Fosamax and other bisphosphonate drugs for longer periods of time were most at risk of suffering femur fractures.
At the time of the warning, the FDA also mandated that makers of bisphosphonate drugs, including Merck and its entry in that class Fosamax, place a warning on the safety labels indicating the risk of fractures.
Law360.com reports that Merck had some success defending the Fosamax safety profile against claims that the drug was responsible for a breakdown and fractures of the jaw bone but more evidence and claims that it causes femur fractures appear stronger, especially weighing the FDA warnings.
In one study commissioned by the American Society of Bone and Mineral Research, of the more than 300 cases of atypical femur fractures examined for the research, 94 percent of the victims had been taking a bisphosphonate drug, including Fosamax.