Drug giant Novartis settles Zometa “bone death” case, Meng v. Novartis, one of two cases in New Jersey concerning the bone loss drug to make it to trial. The settlement was reached at the last minute before the case was to go before a state appeals court. The three-judge panel that was to hear the case as to whether to reverse or affirm a no-cause verdict for Novartis instead announced, “the issues in the dispute have been amicably resolved.” Details of the settlement are not being disclosed. Neither is any information regarding the possible outcomes of the 119 remaining Zometa/Aredia cases in New Jersey.
The issue in the Zometa cases centers on whether Novartis provided adequate warning to the plaintiffs that use of the bisphosphonate drug could cause osteonecrosis, or “bone death”, of the jaw. The drug is commonly prescribed as a treatment for osteoporosis or to control bone metastases from breast cancer. Plaintiffs claim pain and disfigurement due to tooth loss and loss of the jawbone, which may require surgical removal.
Meng’s original suit, filed in 2007, described her use of the drug as lasting for approximately three and one-half years. Meng had metastatic breast cancer in her spine. She stopped using Zometa in November 2006 when her dentist noticed exposed bone. She was diagnosed with osteonecrosis in February 2007.
Her suit didn’t go to trial until the spring of 2013 claiming failure to provide an adequate warning. Her other claims, strict liability, design defect, breach of express warranty and consumer fraud, were dismissed after Novartis filed a motion for summary judgment. The surviving claim – failure to provide adequate warning – advanced.
In reviewing Novartis’ warnings, it was discovered that the first mention of osteonecrosis was in September 2003. The package insert stated that osteonecrosis had “other well-documented multiple risk factors” such that determining if Zometa was to blame was impossible. The warning was revised in February 2004 when information that most cases of osteonecrosis were cancer patients with other risk factors. The other factors included chemotherapy, corticosteroids, infection and anemia. The warning went on to say that these cases were “attendant to a dental procedure” and therefore, “it is prudent to avoid dental surgery.”
Another update appeared in August 2004. This update stated that the majority of cases were connected to tooth extraction with signs of local infection. It advised patients to have dental examinations before starting Zometa therapy and to not have invasive dental procedures during therapy. This was the version of the warning at the time Meng’s dentist discovered her osteonecrosis.
The trial judge held that sufficient evidence existed to allow the case to proceed. Meng’s expert witness said the warning was “misleading” in that it blamed other risk factors. Meng’s doctor went on record to say that if he had been better informed of the risks he would have treated Meng differently by adjusting the duration and dosing of the drug. His opinion was that a black box warning instead of an adverse event warning in the caution portion of the label was necessary. The jury didn’t buy it and voted 7-1 in favor of Novartis.
As the details of the settlement are not being released, one can only hope that Meng received a fair deal. In my opinion, enough is known about Zometa and its impacts on cancer patients, that a black box warning is necessary. From personal experience, I can say that the only warning my mother received was to report to her oncologist any jaw pain as it might indicate a serious problem.
I’m tired of drug companies hiding behind technicalities. I understand the process of human clinical trials; if a subject so much as stubs their toe, potential foot pain must be reported on the package insert (I’m exaggerating, but not by much). It would be fine, in the toe example, if Novartis said, “Hey! Not our bad!”
However, with mounting evidence that Zometa can negatively impact cancer patients, I think this attempt to dodge responsibility is reprehensible. It’s not like Novartis can’t afford to take responsibility, after all. I have the hospital bills for the Zometa treatments my mother had and I can honestly say, “Wow! That’s a pricey drug!”
Obviously, Novartis must at some level realize it needs better warnings. Why else would it have agreed to a settlement when Meng lost her first suit? I only hope this is a sign that the 119 other patients get a fair settlement too, and that Novartis exercises the duty it has to provide adequate warnings in the future.