HarrisMartin recently profiled EGS’s new federal lawsuit against Novartis in its Drugs & Medical Devices publication.
The family of a California man who died from an atherosclerosis-related condition allegedly caused by the leukemia drug Tasigna has sued Novartis AG, claiming the manufacturer failed to warn doctors and patients in the United States about dangerous side effects linked to the drug.
In a March 22 complaint filed in U.S. District Court for the Eastern District of California, the surviving family of Dainis Lauris contend that since at least 2011, Novartis has been aware of numerous reports indicating that Tasigna caused severe, accelerated and irreversible atherosclerosis in patients taking the drug. However, Novartis never disclosed the information to doctors or U.S. health officials, even after Canada’s health agency issued a warning to doctors in 2013 about the risks associated with the drug, the complaint says.
Lauris was prescribed Tasigna in 2012 after taking a similar drug marketed by Novartis for the treatment of chronic myeloid leukemia. According to the lawsuit, Lauris did not suffer from any atherosclerosis-related conditions at the time his physician switched him to Tasigna, but that he began to show symptoms of peripheral arterial disease almost immediately upon taking the drug. The suit says that Lauris mistakenly believed that the symptoms were the result of muscle cramping unrelated to his CML or treatment for the disease.
In September 2013, an angiogram revealed that Lauris was suffering from 100 percent blockage in his right femoral artery, and 90 percent blockage in the arteries behind both knees. Around the same time, Lauris’s oncologist read a medical journal article discussing the link between Tasigna and accelerated atherosclerosisrelated conditions. Lauris was taken off of Tasigna and prescribed a CML drug manufactured by Bristol Myers Squibb. But despite his change in treatment, Lauris died as a result of complications from his atherosclerosis in March 2014.
According to the complaint, the arterial blockage in Lauris’s legs — as well as the narrowing of cerebral and coronary arteries discovered at autopsy — were caused by Tasigna and, more specifically, Novartis’s concealment of known side effects associated with the drug.
Novartis reportedly issued an advisory to Canadian health care professionals and the Canadian public in April 2013, warning of atherosclerosis risks associated with Tasigna and that patients taking the drug should be closely monitored for signs of arterial disease. The manufacturer also updated its product information sheets and warnings for Tasigna to include reference to the risk of potentially fatal atherosclerosis-related conditions.
Those warnings, however, never trickled down to U.S. health official or patients such as Lauris, the lawsuit says.
“Novartis did not send advisories to the United States public or to United States doctors. Nor did Novartis properly warn of the atherosclerosis-related risks on the United States Tasigna label,” the complaint alleges. “Novartis’s failure to warn United States doctors and patients of the serious risks of developing atherosclerosis-related conditions associated with Tasigna was intentional, and part of an aggressive marketing strategy to sell Tasigna over competing TKI drugs.”
The Laurises’ lawsuit includes caused of action for strict products liability, negligence, wrongful death and survival.
The Laurises are represented by James D. Weakley of Weakley & Arendt in Fresno, Calif., and Richard M. Elias, Greg G. Gutzler and Tamara M. Spicer of Elias Gutzler Spicer in St. Louis. Lauris, et al. v. Novartis AG, et al., No. 16-393 (E.D. Calif.).