The number of legal claims included in the Fosamax multidistrict litigation (MDL) continues to increase, with more than 2,000 complaints filed on behalf of individuals who claim to have been injured by Merck’s controversial osteoporosis drug. The vast majority of the suits allege complications such as osteonecrosis of the jaw (ONJ), atypical femur fractures, and other injuries. The Fosamax MDL is currently centralized before Judge Carol Higbee in the Superior Court of New Jersey for Atlantic County.
Fosamax Femur Fracture Update 3/13/13: A new study has identified a causal link between Fosamax and nonhealing femur fractures. The research, which was published in last month’s edition of the Journal of Bone & Joint Surgery, found that nonhealing femur fractures are not just associated with Fosamax and other diabetes drugs, but directly caused by them.
What’s the problem?
September 24, 2012 – As of last week, there were a total of at least 2,067 Fosamax lawsuits filed in New Jersey state court. While the earliest complaints were filed as far back as 2006, the number of cases included in the MDL has increased exponentially since 2010, and nearly half of all complaints pending in New Jersey have been filed over the past year alone. All of the lawsuits involve similar allegations that drugmaker Merck & Co. knew – or should have known – about Fosamax’s ability to cause serious side effects, but that it was negligent in failing to warn both the public as well as the medical communities about these risks.
While the vast majority of the early Fosamax lawsuits were filed on behalf of individuals who allegedly developed a rare form of jaw damage known as osteonecrosis of the jaw (ONJ), most of the newer complaints involve spontaneous femur fracture injuries, which often occur with little or no trauma at all.
First approved by the U.S. Food & Drug Administration (FDA) in 1995, Fosamax (generic: alendronate sodium) belongs to a controversial class of medications known as bisphosphonates, which are designed to strengthen bones and reduce the risk of osteoporosis-induced bone fractures. However, research has shown long-term bisphosphonate use to be linked to an increased risk for low-trauma bone fractures, where the femur may completely fracture while taking a step or falling from standing height or less.
In October 2010, the FDA sent letters to Merck and other bisphosphonate manufacturers requiring them to add updated warnings about the risk of bone fractures to labels of their medications. The new warnings would include information about how users should contact their doctors if they experience groin pain, which is a major indicator of an impending femur fracture.
In June, Judge Higbee sent lawyers involved in the Fosamax MDL a communication indicating that the next trial date scheduled in the litigation will involve a femur fracture rather than an ONJ case, even though the jaw injury complaints are older.