Although much of the focus on bisphosphonate side effects has been on Fosamax (alendronate), bisphosphonate lawsuits have been filed regarding other medications, including Zometa. One such lawsuit recently resulted in a $10.4 million verdict for the Plaintiff. Zometa is a cancer medication used to treat hypercalcemia of malignancy. It is also used to delay bone complications due to multiple myeloma. Barbara Davids filed a lawsuit against Novartis, maker of Zometa, alleging she developed osteonecrosis of the jaw from her use of the medication. She was given Zometa for breast cancer.
During Ms. Davids’ trial, a 2003 Novartis internal email discussing a link between Zometa and jawbone problems was introduced into evidence. The jury ruled for Ms. Davids’ and awarded her $450,000 in compensatory damages and $10 million in punitive damages. Another woman, who had been a Plaintiff in this case, settled her claims prior to the trial.
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 won four of those cases. 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 U.S. Food and Drug Administration issued a Drug Safety Communication 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 and the development of esophageal cancer. Interestingly, despite potential links to osteonecrosis of the jaw and atypical femur fractures, the FDA has said the benefits of bisphosphonate medications outweigh the risks.
The case is Davids v. Novartis, 2:06-cv-431, U.S. District Court, Eastern District of New York