Mark Gomez suffered a heart attack roughly two years after he began taking Uloric, Takeda Pharmaceutical’s controversial gout drug.
According to a Uloric lawsuit recently filed on his behalf in the U.S. District Court, Northern District of Illinois, adequate safety warnings could have prevented the Vermont resident’s suffering. (Case No. 1:19-cv-04347)
The U.S. Food & Drug Administration approved Uloric (febuxostat) in 2009, following nearly five years of interaction with Takeda. The Uloric lawsuit asserts the delay reflected agency concern over the medication’s cardiovascular risks.
When the FDA finally agreed to approve Uloric, Takeda was ordered to conduct a post-market study focusing on cardiovascular side effects. The trial, which was published in the New England Journal of Medicine in March 2018, ultimately concluded that the risk of all-cause mortality and cardiovascular death were higher with febuxostat compared to an older gout drug called allopurinol.
Because of these findings, the FDA ordered Takeda to add a Black Box Warning – the strongest possible safety notice – to the Uloric label in February 2019.
But according to Gomez’s Uloric lawsuit, these risks should have been apparent to Takeda years earlier.
“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.
Yet Takeda never acted to update the Uloric label on its own and continued to market the medication as a superior alternative to allopurinol. Thus, Gomez and his doctor remained oblivious to Uloric’s alleged defects or significant dangers.
“As a direct and proximate result of one or more of the above-stated negligent acts by Defendants, Plaintiff suffered grievous bodily injuries and consequent economic and other losses, including pain and suffering, loss of a normal life, medical expenses, lost income and disability,” the Uloric lawsuit concludes.