Merck & Company, the maker of Fosamax (alendronate), is facing a second of thousands of cases brought by plaintiffs who allege they suffered Fosamax injuries. The first lawsuit recently ended in a mistrial unrelated to the injury allegations.
The plaintiff in this case is alleging that taking Fosamax for seven years led to a weakening of her femur and a femur break. The three-week jury trial just began and involves allegations that were brought by the 58-year-old female plaintiff, Bloomberg News said. This is the second Fosamax thighbone fracture case filed against Merck that has made it to the jury. In the first case, being heard in state court in Atlantic City, New Jersey, the trial was called off when the plaintiff suffered a “sudden illness” unrelated to her use of Fosamax, according to a statement Merck made on its website last month, wrote Bloomberg News
Litigation strategies and damage awards are expected to be revealed, noted Bloomberg News, likely making this case a bellwether. Jury selection began today; opening statements are scheduled for tomorrow.
Merck said in a pre-trial statement that it rejected claims that it neglected to appropriately study Fosamax prior to its release. The plaintiff, in her April 17, 2009 complaint, said that felt a “pinch” in her right leg when she bent to pick up something in her driveway. “She then attempted to take a step, but fell and sustained a fracture on her right femur,” the complaint continued. She underwent surgery and was implanted with a rod and screws, said Bloomberg News.
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. Cancer patients will undergo bisphosphonate drug therapy to prevent fractures from bone metastases.
Bisphosphonates have proven to be moderately successful in reducing bone loss in menopausal women; however, serious side effects have been associated with drugs—such as Fosamax—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—which manifests as a subtrochanteric or diaphyseal fracture—may occur during normal everyday activities and with little or no trauma.
More than 3,300 lawsuits have been brought against Merck and allege that the drug maker ignored signs that extended use of bisphosphonates, such as Fosamax, could lead to femur weakening in some patients, said Bloomberg News. According to Merck, it also faces another 1,230 cases over allegations that Fosamax caused jaw fractures.
A recent study revealed that risks for developing osteonecrosis of the jaw (ONJ) following dental extractions significantly increased in those patients who are taking Fosamax and other bisphosphonates. In 2005, the FDA mandated warnings about ONJ be included on the labels of bisphosphonate drugs, such as Fosamax. It is believed that osteonecrosis may develop when bisphosphonates prevent the body from repairing microscopic jawbone damage; for instance, repair needed following routine dental procedures.
The Archives of Internal Medicine published a study comparing patients with atypical versus “classic” femur fractures. The researchers discovered that 82 percent of patients in the atypical fracture group had taken bisphosphonates. The FDA also published research in The New England Journal of Medicine concerning the risks and benefits of bisphosphonate therapy and found that of the over 2,300 postmenopausal women studied, there was little reason to use Fosamax, or drugs like it, for more than five years.