The second Fosamax femur fracture trial is underway and involve allegations that Merck’s Fosamax (alendronate) caused femur fractures in some people. The trial began in New Jersey federal court and opening statements are being heard.
The lawsuit is one of 3,300 that alleges that the bone loss drug makes patients more susceptible to bone breaks, particularly atypical femur fractures. Merck faces another 1,230 lawsuit brought over allegations that Fosamax caused similar fractures in jaws, said Bloomberg News.
According to opening statements made by the plaintiff’s attorney, Merck & Co. was aware that Fosamax might cause brittle bones and lead to increased fracture risks years before Fosamax was released to the public. In fact, as far back as 1990—five years before approval was won for the osteoporosis drug—consultants were warning Merck that Fosamax could lead to so-called “spontaneous bone fractures” because the drug inhibits the natural bone repair of micro-fractures, according to the plaintiff’s attorney, said Bloomberg News. Jurors were told that they would have the opportunity to see evidence from Merck that the drug maker expressed concern about femur fractures, but neglected to warn of these dangers.
The plaintiff in this case is a 58-year-old woman who had been taking Fosamax for about seven years when she suffered a femur fracture while bending over to pick something up off the ground. The first lawsuit recently ended in a mistrial unrelated to the injury allegations.
Fosamax was approved by the U.S Food and Drug Administration (FDA) in 1995 for the treatment of bone loss due to osteoporosis and osteopenia. Some bisphosphonates, like Fosamax, are approved to treat bone-weakening diseases such as osteoporosis and Paget’s disease and bisphosphonate drug therapy is also used to prevent fractures from bone metastases.
In 2010, the FDA updated the safety information on Fosamax to warn about the risk of atypical femur fractures associated with the drug. The agency also published a review in The New England Journal of Medicine on May 31, 2012, that suggested there is little benefit from taking bisphosphonates for longer than five years. The findings were based on trials involving 2,342 post-menopausal women.
Fosamax and other bisphosphonates have proven to be moderately successful in reducing bone loss in menopausal women; however, serious side effects have also been associated with these drugs involving bone decay or weakening. Hundreds of women who say they have taken Fosamax for long periods or at high doses claim to have suffered from a weakening of the femur bone, which has led to atypical fractures. While Fosamax was being taken to prevent bone loss, the drug was, in fact, increasing fracture risks to one of the body’s strongest bones. An atypical femur fracture may occur during normal everyday activities and with little or no trauma.
“We are pleased that the day has finally arrived: Merck has been called before a jury to face these claims, and the jury will see the extent of what Merck knew about the potential damaging side effects related to Fosamax,“ said Matthew J. McCauley, Senior Litigation Counsel at national law firm, Parker Waichman LLP. “Unfortunately, many didn’t have this opportunity before their femur broke while they were taking Fosamax.” Parker Waichman has filed approximately 200 cases on behalf of individuals who allege suffering injuries as a result of taking Fosamax.