The cases had been dismissed based on Merck's labeling pre-empting liability. However, Plaintiffs’ attorneys state that the previous ruling had erroneously concluded that a "convoluted and watered-down" label change proposed to the FDA by Merck was sufficient to win federal pre-emption for the company from state claims for failure to warn.
Fosamax (Alendronate) belongs to a class of drugs called bisphosphonates, which are prescribed to increase bone density in patients (mainly menopausal women) with osteoporosis. Fosamax side effects include Fosamax osteonecrosis, also known as Fosamax dead jaw, and recently Fosamax femur fractures. Osteonecrosis of the jaw (ONJ) is a disease in which bone tissue in the jaw does not heal after minor traumas such as tooth extraction or oral surgery.
In 2008, researchers at Cornell University Medical School released a major study revealing that Fosamax patients are more than 125 times as likely to suffer non-traumatic femur fractures than patients who have not taken Fosamax.
In 2013, Merck reached a separate settlement of $27 million with approximately 1,200 Fosamax users who suffered necrosis of the jawbone.