Drug maker Merck & Co. is asking a federal judge to dismiss the nearly 500 lawsuits remaining in mass tort litigation in Trenton, N.J., alleging the company’s osteoporosis drug Fosamax caused femur fractures. The action comes after Merck won two bellwether suits making the same claims – a June 2013 judgment and a June 2014 ruling, both of which claimed the drug’s labeling failed to warn of the dangers of developing a fractured femur.
In the 2013 case, the plaintiff alleged she used Fosamax before the company revised the drug’s label in January 2011 to highlight potential side effects. That lawsuit was dismissed after finding that New Jersey’s failure-to-warn laws were preempted by federal law. The second lawsuit was dismissed after the same judge ruled that the revised warning label was adequate.
Following the 2013 case, the judge granted Merck’s motion to dismiss about 650 lawsuits involving fractured femurs occurring before Sept. 14, 2010, based on preemptive grounds. The assumption was that plaintiffs who claimed later injuries would base their claims on the contention that the warning labels which were revised in January 2011, were inadequate.
In October 2010, the Food and Drug Administration (FDA) ordered makers of drugs containing biophosphonates, such as Fosamax, to add warnings for femur fractures to its precautions section of its safety labels. Merck added this warning to the labels of Fosamax in January 2011.
Merck has been named in nearly 4,500 lawsuits claiming Fosamax caused patients to suffer femur fractures. About 2,800 of them went to Superior Court of New Jersey, and another 525 were sent to state court in California.
Merck is also named in about 1,150 lawsuits alleging Fosamax caused patients to develop necrosis of the jawbone, or ONJ, a serious bone death in the jaw. Most of those lawsuits have settled.
Source: NJ Law Journal