WEST PALM BEACH – The U.S. District Court for the Southern District of Florida recently granted a partial summary judgment in favor of a pharmaceutical company in case involving a patient who suffered a stroke after taking the company's prescription drug.
The July 9 ruling by U.S. District Judge Robin Rosenberg granted Novartis Pharmaceutical Corporation's motion for summary judgment as to the plaintiffs’ request for punitive damages but denied Novartis' motions for summary judgment on other matters in the case.
The case stems from a situation that arose when plaintiff Dennis McWilliams was diagnosed with PH+ chronic myeloid leukemia (CML), a rare cancer of the blood, in June 2007, the court filing said. His oncologist prescribed Gleevec, a drug produced by Novartis and approved by the FDA in 2001 for patients with PH+ CML. However, in June 2011, McWilliams was prescribed Tasigna, also a Novartis medication, because of complications. Tasigna had been given FDA approval in October 2007.
On Aug. 25, 2013, McWilliams had a stroke. Based on his medical background he was a high-risk patient as he had a history of smoking, hypertension, obesity, a significant family history of coronary artery disease and stroke, and hyperlipidemia, according to the court decision.
McWilliams and his wife filed a suit alleging that his stroke was caused by Tasigna and that Novartis did not properly warn about the risks associated with its drug, the court filing said.
The two parties were in dispute over when a link between Tasigna and a risk of stroke began to be documented and when the drug’s label should have issued a warning.
“Defendant states that there were no scientific publications that evaluated cases of stroke in patients taking Tasigna when Mr. McWilliams began taking the drug in June 2011,” the court decision states. “Plaintiffs contend that as early as 2010 and continuing through 2013, there were multiple reports of patients developing atherosclerotic-related vascular disease.”
McWilliams and his wife sought compensatory and punitive damages, and alleged strict product liability under a failure to warn theory, negligence under a failure to warn theory and loss of consortium for Lori McWilliams.
In January 2014, the FDA approved new warnings and precautions on Tasigna but did not require Novartis to send a letter to health care providers advising them of the change.
Thus Novartis claims they could not have put warnings on the labels prior to a documented link between the drug and stroke risk, as well as approval from the FDA.
However, the McWilliams argue that the company “cannot meet its burden on the impossibility preemption defense because it has not offered clear evidence that the FDA would not have approved a warning about stroke.”
The court agreed.
“ Defendant has not presented clear evidence that the FDA would not have approved a change to the label of Tasigna to add stroke if defendant had proposed one and plaintiffs’ claims are not preempted,” Rosenburg wrote in her decision.
Rosenburg also indicated “there are genuine issues of material fact as to whether the allegedly inadequate warning was a proximate cause of Mr. McWilliams’ injury,” and thus denied summary judgment on this matter for the defendant. Summary judgement was also denied regarding the loss of consortium claim.