Novartis, Maker of Zometa, Sued for Withholding Information about Risk

Zometa (zoldedronic acid) is a treatment used to prevent or reduce bone complications, such as fractures, associated with multiple myeloma and bone metastases from solid tumors. Although Zometa is used to strengthen bones, it is a member of a class of medications known as bisphosphonates, which have been associated with an increased risk of osteonecrosis of the jaw (ONJ). This debilitating, painful condition causes decay or death of the jawbone, often requiring surgery to remove portions of the jaw.

After being diagnosed with metastatic breast cancer in October 2003, Barbara Davids was prescribed Zometa, receiving 16 infusions over the following year and a half. During the treatment, Barbara began suffering pain and swelling in her jaw. Soon after, her teeth began to fall out along with decayed bone pieces. An oral maxillofacial surgeon diagnosed bisphosphonate-related osteonecrosis of the jaw (BRONJ), a permanent, disfiguring, debilitating condition where the jawbone actually decays. This can lead to total loss of the jawbone.

Davids discontinued the drug in January 2005, but her problems persisted. In 2008, she underwent surgery to relieve her jaw pain, but the left side of her face became permanently numb, and remains numb to this day. To make matters worse, she is unable to receive dental implants since bisphosphonates have a long half-life, and the procedure could potentially trigger another episode of BRONJ. Davids suffers from tooth loss and disfigurement. She must avoid certain foods and is only able to chew on one side. Davids is at permanent risk of a future recurrence of the disease.

Davids sued Novartis, the manufacturer of Zometa, alleging that the drug had caused her BRONJ and that the company was aware of the risk but failed to timely and adequately warn about the danger and initiate proper studies.

The plaintiff ordered evidence that physicians had notified Novartis as early as 2002 that patients receiving Aredia, the first generation of Zometa, were developing severe BRONJ. Even in spite of this, Davids alleged Novartis failed to conduct further testing or warn of the risk until September 2003, when it added a simple mention of osteonecrosis to the label’s adverse events section. The label also stated, however, that the condition had other risk factors and that it was not possible to determine whether the condition was related to Zometa. The company did not include BRONJ in the drug’s precautions section until August 2004 and finally sent a “Dear Doctor” letter in September of that year. The plaintiff contended that the letter contained false statements about the cause of BRONJ, directing physicians’ attention away from Zometa.

One damaging piece of evidence that has been presented in a number of trials is a 2003 internal Novartis email from a marketing executive warning of a “quite damaging” report that linked Zometa to jawbone complications, such as osteonecrosis. A later email from the same employee detailed plans on how to prevent the damage caused by the report. The email said, “In summary: we’ll try to avoid that the paper is ever published; we will be ready to react in case it gets published.”

Based on this evidence, it seems clear that Novartis tried to conceal important information about potential Zometa side effects. Due to this deliberate omission, the plaintiff and other patients were unable to make an informed decision about taking Zometa, and they suffered serious health consequences as a direct result.

Davids also sought punitive damages, alleging that Novartis knowingly withheld and actively tried to suppress information about Zometa’s connection to BRONJ.

The plaintiff did not claim medical expenses or lost earnings.

Novartis denied that it downplayed the risks of Zometa and argued that its warnings were adequate based on the information available at the time. It also argued that a different warning would not have prevented David’s injury.

On November 2nd, after only a few hours of deliberation, a Central Islip, New York jury found that Novartis had failed to adequately warn of the BRONJ risk and that an adequate warning would have made a difference. Only $450,000 of the verdict was for compensatory damages; $350,000 for past damages, $100,000 for future damages. The remaining $10 million was awarded for punitive damages, which are designed to punish Novartis for its behavior in failing to warn about the risk of jaw decay from Zometa.

The trial court denied certain defense motions. Still pending are Novartis’s motions to reduce or eliminate the punitive damages.

This case is the fourth of only eight Zometa-jawbone trials that have reached a jury. Of the eight cases, four have resulted in victories for the plaintiffs. It is one of several hundred lawsuits filed over Zometa and Aredia, a similar chemotherapy drug. Federal complaints over both drugs have been consolidated together as part of a multidistrict litigation (MDL) in U.S. District Court for the District of Nashville for pretrial proceedings. Hopefully, more injured victims will be able to successfully hold Novartis accountable in court.

Pharmaceutical companies that deliberately conceal risks are endangering people and must be held accountable. Feel free to comment on this blog post. You can contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

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