A woman in North Carolina has filed a new Uloric lawsuit that accuses Takeda Pharmaceuticals of concealing the heart risks associated with its gout drug.
According to a complaint filed in the U.S. District Court, Northern District of Illinois, on November 22nd, Shelley Owens started taking Uloric for gout in 2012. She began experiencing heart problems about four years later, including unstable angina, chest pain, and multiple vessel coronary artery disease, which resulted in the need for heart surgery. (Case No. 1:19-cv-07716)
The U.S. Food & Drug Administration (FDA) approved Uloric in 2009, five years after Takeda initially submitted an application to the agency. The delay reflected the FDA’s concern regarding possible Uloric heart risks. Once the agency cleared Uloric for sale, Takeda was required to conduct a post market study to better assess its cardiovascular side effects.
Takeda has since completed that trial, and the results were published in the March 2018 issue of the New England Journal of Medicine. The study suggested the risk of all-cause mortality and cardiovascular death were higher with Uloric compared to an older gout drug called allopurinol. The FDA subsequently ordered Takeda to add a new Black Box Warning – the strongest possible safety notice –reflective of these findings to the Uloric label and restricted the use of the drug to patients who can’t tolerate or haven’t responded well to allopurinol.
Owens alleges her heart problems were the direct result of her gout treatment, and further asserts that Takeda could have notified doctors and patients of Uloric heart risks long before the FDA mandated the Black Box Warning.
“Defendants ignored reports from patients and health care providers throughout the United States of Uloric’s failure to perform as intended, which led to the severe and debilitating injuries suffered by Plaintiff, and numerous other patients,” the Uloric lawsuit states. “Rather than doing adequate testing to determine the cause of these injuries or rule out Uloric’s design as the cause of the injuries, Defendants continued to market Uloric as a safer and more effective prescriptive drug as compared to other available alternative treatment for hyperuricemia and gout.”
Because Takeda failed to update the Uloric label in a timely manner, Owens and other patients, along with their doctors, remained oblivious to its alleged defects or significant dangers. The Uloric lawsuit seeks monetary compensation for or Owen’s severe physical pain, mental suffering, inconvenience, and loss of the enjoyment of life, as well as her injury-related medical bills and past and present lost wages.