A Florida man who suffered a stroke while taking Tasigna to treat his chronic myeloid leukemia (CML) will be able to pursue his lawsuit against Novartis AG, after a federal judge found that his failure-to-warn claims are not preempted.
Novartis brought Tasigna to market in 2007. It was intended to replace another leukemia medication called Gleevec, which at the time was the company’s best-selling drug and set to lose patent protection in 2015. Today, Tasigna ranks among the top-ten selling cancer drugs worldwide, bringing Novartis more than $1.7 billion in sales in 2016.
The same year Gleevec lost patent protection, Novartis agreed to pay $390 million to settle federal allegations that it had paid illegal kickbacks to specialty pharmacies to push sales of certain drugs, including Tasigna. The U.S. Department of Justice had also accused the company of engaging in an aggressive marketing campaign that utilized false claims and omitted risk information to promote Tasigna over other leukemia treatments.
Several studies published in recent years have suggested that Tasigna patients are more likely to develop arteriosclerosis or other life-threatening vascular conditions compared to those who take Gleevac. In 2013, the drug’s Canadian label was updated with new warnings to reflect the growing number of arteriosclerosis cases reported among patients treated with Tasigna.
Plaintiff Dennis McWilliams began taking Tasigna in 2001. He alleges that the stroke he suffered in 2013 was the direct result of his treatment.
Among other things, the Tasigna lawsuit filed by McWilliams and his wife claims that Novartis failed to warn doctors and patients about the risks associated with the medication.
Novartis filed a motion for summary judgment that it could not have added a stroke warning to Tasigna’s box label without prior approval from the U.S. Food & Drug Administration (FDA). The company also assert that the agency would have rejected such a warning had it proposed one.
However, U.S. District Judge Robert L. Rosenberg of the Southern District of Florida, rebuffed the company’s assertion in an Order dated July 9th, finding that there is not clear evidence that the FDA would have rejected a proposed stroke warning.
“Defendant notes that, in October 2013, the FDA requested that the manufacturer of a leukemia chemotherapy drug, Inclusig, suspend marketing because of cardiovascular and arterial adverse events. Defendant notes that the FDA revised the boxed warning for Inclusig and found that ‘similar rates of serious vascular events have not been observed in several other drugs of this class. ‘Defendant argues that “[i]f FDA had wanted to add a boxed warning for Tasigna, it could have done so at the same time that it updated the Iclusig label,” Judge Rosenberg wrote. “This is not clear evidence that the FDA would not have approved a change to the label of Tasigna to add stroke if Defendant had proposed one. It does not follow that, because the FDA did change the label of one drug, the FDA would not have approved a change to the label of Tasigna.”