Will Novartis Be Found Guilty Of Denying Zometa Risks?
Make a commentBy Ed Silverman // October 21st, 2009 // 6:52 am
A jury will continue deliberating today a lawsuit brought by a woman who alleges Novartis was negligent when it failed to disclose health risks associated with its Zometa bone-strengthening drug. Peggy Stevens has lymphoma and developed serious dental and jaw-related problems after taking Zometa for several years.
UPDATE: She won - and was awarded $3.2 million (see here).
Her attorneys say the company knew patients taking the drug were vulnerable to a degenerative jaw disorder called osteonecrosis, particularly those patients who undergo invasive dental procedures, like root canals or tooth extractions, The Missoulian reports. She was given the drug for three years before she had a tooth pulled in 2007 and developed the disease, which can cause pain, loosening of teeth, exposed bone and infection.
On a national level, Novartis faces lawsuits from about 550 plaintiffs whose cases have been consolidated in a Tennessee federal court and a New Jersey state court. The first of those cases is slated for trial in March 2010. Although Stevens’ case was never part of the mass tort, a verdict in her favor could bear significantly on the other cases.
Joe Hollingsworth, an attorney representing Novartis, said evidence at trial showed the drug maker “flatly and specifically warned that dental surgery should be avoided,” and that it began printing the warnings on labels in 2003. It also warned the medical community in a self-published paper.
An expert witness hired by Stevens’ legal team testified the labels were vague and misleading and the publication tainted, but Hollingsworth said FDA guidelines require warnings to be “adequate and reasonable under the circumstances.” The FDA never expressed any problem with the company’s “phamacovigilance,” he said. “The evidence shows that our warning was adequate, make no mistake. There is no way that a different label would have altered Ms. Stevens’ use of Zometa.”
Terry Trieweiler, an attorney representing Stevens, said Novartis downplayed the risks, and obscured and delayed the release of information to the public and the medical community. “Instead of disclosing concerns about this relationship (between dental work and the jaw disorder) in a timely fashion, Novartis focused on obscuring the causal relationship, delaying disclosure and controlling the public relations fallout that would occur from the disclosure,” Trieweiler wrote in a legal motion.
He said Tuesday that Novartis attorneys contradicted themselves at trial by arguing that the company adequately warned of health risks, and then denying the seriousness of those risks. “That scattered approach is called covering your bases,” Trieweiler said. “Your job is to decide based on the simple evidence you have heard at trial that it is time for them to accept responsibility.”
Leave a Comment
Subscribe
Comments feed for this post only.
Tags
Novartis, Zometa