Zometa Jaw Decay Trial Ends in Defense Verdict

A New Jersey jury returned a defense verdict this week in a trial over claims that the bone-strengthening drug Zometa caused a woman’s jaw bone to decay.  

Several hundred product liability lawsuits have been filed against Novartis that allege the drug maker failed to adequately warn about the side effects of Zometa, as well as the similar drug Aredia.

Zometa (zoledronic acid) is a treatment used to reduce bone complications associated with multiple myeloma and bone metastases from solid tumors. Although it is used to strengthen bones, Zometa is a member of a class of medications known as bisphosphonates, which have been associated with an increased risk of the jaw bone weakening and deteriorating.

The complaints allege that the medication increases the risk of osteonecrosis of the jaw (ONJ), a debilitating condition where the jaw bone decays and dies, resulting in exposed portions of bone inside the mouth and often requiring surgery to remove parts of the jawbone.

Following a 13-day trial in New Jersey state court, a jury ruled that Novartis provided adequate warnings in a case brought by Beverly Meng. This was at least the second Zometa lawsuit to go to trial in New Jersey state court and the ninth case nationwide.

While Novartis has successfully defended the safety of their drug in several cases, many of the lawsuits have resulted in substantial damage awards after juries determined that evidence suggested that the drug maker’s employees intentionally covered up evidence of the Zometa side effects.

Last year, a New York state court jury awarded $10.5 million in Zometa damages, including $450,000 in compensatory damages and $10 million in punitive damages, which were designed to punish Novartis for failing to warn about the risk of jaw decay from Zometa.

In 2010, a North Carolina federal court jury awarded $13 million for a Zometa jaw injury, which was subsequently upheld by U.S. District Judge James Beaty, who found that there was sufficient evidence for the jury to find that Novartis should be subject to punitive damages for intentionally misleading consumers and trying to conceal evidence of ONJ from Zometa.

In the federal court system, all lawsuits over Zometa and Aredia have been consolidated in the U.S. District Court for the District of Nashville for pretrial proceedings, as part of an MDL or multidistrict litigation.

The cases are similar to hundreds of Fosamax jaw necrosis lawsuits that are pending against Merck & Co. over their oral bisphosphonate medication. Although Fosamax is used to treat osteoporosis and reduce the risk of bone fractures, long term use of the medication has also been linked to an increased risk of jaw osteonecrosis.