Aredia, Zometa Jaw Damage Lawsuit Results in $13M Verdict

The estate of a North Carolina woman has been awarded nearly $13 million through a lawsuit over jaw damage from Aredia and Zometa, two chemotherapy drugs.

The Aredia and Zometa lawsuit was brought against drug maker Novartis by Rita Fussman, who died of breast cancer last year. Her family alleged that Fussman suffered additional discomfort before her death due to the side effects of Zometa and Aredia, which they say caused her jaw bone to decay; a condition known as osteonecrosis of the jaw (ONJ).

The case is the third osteonecrosis of the jaw lawsuit over Zometa to go to trial. The first ended in a $3.2 million verdict in October 2009, and the second Zometa trial resulted in a defense verdict last month.

The lawsuits are considered a bellwether cases that could be an indicator of how juries will respond in the future to other Zometa lawsuits, and may be used by the parties to reach a potential Zometa settlement agreement.

Aredia (pamidronate disodium) and Zometa (zoledronic acid) are treatments used to reduce bone complications associated with multiple myeloma and bone metastases from solid tumors. Although they are used to strengthen bones, the drugs are part of a class of medications known as bisphosphonates, which have been associated with an increased risk of osteonecrosis of the jaw. The debilitating and painful condition causes decay or death of the jaw bone, often resulting in the need for surgery to remove portions of the jaw.

There are about 600 Aredia and Zometa suits, which have all been consolidated and centralized in U.S. District Court in Nashville as part of a multidistrict litigation, or MDL, for pretrial proceedings. Another 150 lawsuits are currently pending in state courts in New Jersey.

One of the more damaging pieces of evidence presented during the trial was an internal email from a marketing executive that seemed to suggest the company suppressed a report outlining a number of cases where Zometa was linked to ONJ. Novartis began warning doctors of the potential for jaw damage in 2005, but the lawsuit alleged that Novartis knew about the link much earlier, potentially as early as the 1980s. Fussman began taking Zometa in 2001.

The jury in the North Carolina federal court awarded the family $287,000 in compensatory damages and $12.6 million in punitive damages. However, a punitive damages cap in North Carolina will reduce that amount to three times the compensatory award, meaning that Novartis will pay approximately $1.1 million.

The Zometa lawsuits are similar to more than 900 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.