A Pennsylvania woman has filed a lawsuit against the drug maker Merck Sharp & Dohme Corp., alleging that a generic version of the popular osteoporosis drug Fosamax caused her thigh bone to break for no apparent reason while walking down a sidewalk.
The Fosamax femur fracture lawsuit was filed by Theresa Metz this week in the U.S. District Court of New Jersey. Metz alleges that she had been taking a generic Fosamax version manufactured by Merck Sharp & Dohme Corp for about a year when her femur spontaneously fractured.
As a result of the thigh bone fracture from Fosamax, Metz was hospitalized and had two titanium rods inserted in her femur. However, during surgery she suffered respiratory failure, was placed in an intensive care unit (ICU) and had to have a blood transfusion to save her life. She underwent extensive physical therapy and home health care and continues to suffer from pain and scarring and requires a cane to walk.
The product liability lawsuit charges Merck with designing a defective product and failing to warn of the health risks. The complaint seeks both compensatory and punitive damages.
Fosamax (alendronate sodium) is a member of a class of drugs known as bisphosphonates, which have been increasingly associated with low-impact or no-impact femur fractures, which typically occur with falls from standing height or less.
A growing number of lawsuits over Fosamax femur fractures have been filed by users of the popular osteoporosis drug. The complaints allege that the drug makers knew or should have known about the risk, yet failed to adequately warn consumers or the medical community.
In October 2010, the FDA added warnings about the risk of femur fracture with Fosamax and other bisphosphonate medications. The new warnings now recommend that doctors discuss the potential problems with patients and instruct them to seek immediate medical attention if they experience new groin pain or thigh pain, which can occur weeks or months before a complete fracture of the femur on Fosamax occurs.
Last month, a study was published in the Journal of the American Medical Association (JAMA), which indicated that long-term use of Fosamax or similar medications significantly increases the risk of atypical thigh bone fractures, known as subtrochanteric and diaphyseal femur fractures. Researchers found that the femur fractures happened to about 1 out of every 1,000 women who had been taking a medication like Fosamax for six years, and more than doubled to 2.2 thigh fractures for every 1,000 women by the seventh year.
More than 1,000 people have already filed a Fosamax lawsuit against Merck in state and federal courts throughout the United States, but most of those claims have involved allegations that side effects of Fosamax cause jaw bone damage, known as osteonecrosis of the jaw (ONJ). However, many Fosamax lawyers expect that as more consumers learn that these spontaneous, low-impact femur fractures may have been caused by the long-term use of the medication, the number of Fosamax fracture lawsuits is likely to increase substantially.