Fosamax Maker Loses Bellwether Trial

New York, NYMerck, maker of Fosamax, lost only its second bellwether Fosamax side effects lawsuit earlier this month. The drugmaker faces thousands of lawsuits in state and federal court alleging a link between Fosamax and osteonecrosis of the jaw. There are another 800 lawsuits alleging a link between Fosamax and femur fractures.

According to Reuters (2/5/13), an eight-person federal jury awarded the plaintiff, Rhoda Scheinberg, $285,000 in her Fosamax lawsuit, which alleged Fosamax was a defective product and that the drug caused her to develop jaw bone disease after dental surgery. Although the jury rejected the argument that Fosamax is defective, it did find that Merck did not adequately warn about the risks associated with the medication.

Merck has reportedly said it disagrees with the verdict.

Of seven bellwether cases to go to trial, Merck has won five. The first loss was to plaintiff Shirley Boles (Boles v. Merck & Co., Inc., 06-cv-09455), who was awarded $8 million in her lawsuit alleging she developed osteonecrosis of the jawbone after using Fosamax. A judge later reduced the award to $1.5 million, finding the original award unreasonably high. Boles then opted to file another lawsuit. In September 2012, Law360 (9/18/12) reported that Merck reached a deal in the lawsuit, but noted that the deal was not considered a settlement.

Osteonecrosis of the jaw is a serious condition in which the jawbone fails to heal properly after minor trauma - such as tooth extraction - causing the tissue in the bone to die. Patients who develop osteonecrosis of the jaw may require long-term antibiotic therapy and surgery to remove the dead tissue. Symptoms of osteonecrosis of the jaw include pain or swelling in the jaw, numbness or infection.

Fosamax has also been linked to non-traumatic femur fractures. In January 2011, the US Food and Drug Administration (FDA) issued a warning that bisphosphonates (a class of drug that includes Fosamax) have been linked to atypical femur fractures. The FDA recommended that patients taking bisphosphonates, especially those taking the drugs for more than five years, periodically evaluate whether continued therapy is needed. The agency did note, however, that it was not clear the bisphosphonates caused the thigh fractures, but that they may be linked. The drugs’ warning labels were updated to reflect this potential link.

Bisphosphonates are typically prescribed to strengthen a patient’s bone density, especially in women with osteoporosis. Some critics are concerned that the drugs are being used more frequently on patients who do not have osteoporosis as a preventive measure, putting them at unnecessary risk of side effects.