Bisphosphonate Lawsuit Results in $10 Million Award

Central Islip, NYAlthough much focus on bisphosphonate side effects has been on Fosamax, bisphosphonate lawsuits have been filed regarding other medications, including Zometa. One such bisphosphonate osteonecrosis lawsuit recently resulted in an award for the plaintiff, according to reports.

The bisphosphonate in question is Zometa, a cancer medication used to treat hypercalcemia of malignancy. It is also used to delay bone complications due to multiple myeloma. According to Bloomberg, Barbara Davids filed a lawsuit against Novartis, maker of Zometa, alleging she developed osteonecrosis of the jaw (jawbone death) from her use of Zometa, which she was given for breast cancer.

As part of the lawsuit, Davids' attorneys reportedly showed a 2003 Novartis internal email discussing a link between Zometa and jawbone problems. The jury sided with Davids and awarded her $450,000 in compensatory damages and $10 million in punitive damages.

A spokesperson for Novartis said the company will examine its options.

Other lawsuits regarding Zometa have also gone to trial. So far, eight Zometa lawsuits concerning claims of jawbone death have gone to trial. Plaintiffs have reportedly won four of those cases. Plaintiffs in Fosamax lawsuits have not been so fortunate. As of April 2012, six Fosamax lawsuits had gone to trial, with Merck winning all but one. Lawsuits concerning Fosamax have also focused on osteonecrosis of the jaw.

Bisphosphonates, a class of drug that includes Zometa and Fosamax, have been linked to osteonecrosis of the jaw and atypical subtrochanteric femur fractures. In 2010, the US Food and Drug Administration (FDA) issued a Drug Safety Communication (03/10/10) concerning the possible link between bisphosphonates and atypical femur fractures. At the time, the FDA noted that its research did not show a clear link between bisphosphonates and atypical femur fractures, but the agency said it would continue to review reports concerning bisphosphonates and update patients as new information became available.

In addition to concerns about jawbone death and atypical femur fractures, the FDA is investigating a potential link between the use of bisphosphonates at the development of esophageal cancer.

Despite potential links to osteonecrosis of the jaw and atypical femur fractures, the benefits of bisphosphonate medications outweigh the risks, the FDA says.

The Davids lawsuit is Davids v. Novartis, 2:06-cv-431, U.S. District Court, Eastern District of New York (Bloomberg notes that the award could not be confirmed in court).