Opening arguments today signaled the start of the second trial charging Merck’s Fosamax with causing femur fractures.
In New Jersey federal court the focus was on the case of 58-year-old Bernadette Glynn, who says that the osteoporosis drug is part of the reason why she broke her leg in 2009. Glynn claims that Merck’s Fosamax weakened her femur, which ultimately caused her leg to break when she fell in her driveway.
The jury trial is expected to last about three weeks.
The initial trial against Merck over Fosamax ended in a mistrial; the plaintiff became severely ill during proceedings – though her sudden illness was unrelated to Fosamax.
Merck, the second-largest drug maker in the U.S., is facing more than 3,300 lawsuits that claim Fosamax caused femurs to deteriorate, as well as some 1,230 allegations that Fosamax caused jaw fractures.
Fosamax was approved by the U.S. Food and Drug Administration (FDA) in 1995 to treat and prevent postmenopausal osteoporosis and to treat other bone loss, including weakened bones following some cancer treatments. In 2010, the U.S. Food and Drug Administration (FDA) updated the safety information on Fosamax to warn about the risk of atypical femur fractures. The agency has also published a review in The New England Journal of Medicine suggesting that there is little benefit from taking bisphosphonates for longer than five years. The findings were based on trials involving 2,342 postmenopausal women.
Additionally, a research report in the Journal of Bone and Mineral Research, also made available in 2010, noted that Fosamax and rival bone-loss drugs may pose high risks of thighbone fractures. About 94% of 310 patients who had suffered uncommon types of thighbone fractures were reportedly taking a bisphosphonate-based drug. The majority was taking the medicine for more than five years.
According to NJ.com, Fosamax along with other osteoporosis drugs have become widely over-prescribed, and diagnoses of the ailment have taken off since the assessment method was changed. The method for evaluating osteoporosis was once based on clinical criteria, such as prior bone fracture; now, however, the key indicator stems from the results of testing bone-mass density, reported NJ.com.
The World Health Organization is probing the “arbitrary” ways of diagnosis, Glynn’s lawyers said in the complaint.