A recently filed product liability lawsuit alleges Takeda Pharmaceuticals knew about the heart failure risks from use of Uloric for gout treatment, yet withheld information from patients and the medical community.
Glen Cepak filed the complaint (PDF) late last month in the U.S. District Court for the Northern District of Illinois, indicating the drug maker placed hundreds of thousands of lives at risk by selling Uloric without adequate label warnings.
According to the lawsuit, Cepak had Uloric prescribed for treatment of gout 2016, indicating exposure to the medication caused him to suffer a heart attack in February 2017, and develop congestive heart failure.
Uloric (febuxostat) was introduced by Takeda Pharmaceuticals in 2009, as a prescription medication intended to lower the blood uric levels among adults diagnosed with gout.
Amid aggressive marketing, the drug rapidly became a blockbuster treatment over the past 10 years. However, growing evidence has emerged in recent years which established a link between Uloric and cardiovascular problems, leading the FDA to require new heart warnings last year.
In February 2019, the FDA announced the drug must carry the strongest label warning the agency can require a drug maker to place on their product, adding a Uloric “black box” warning about the risk of cardiovascular side effects, which was not adequately reflected by the drug maker in the past.
“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,” Cepak’s 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 prescription drug as compared to other available alternative treatment for hyperuricemia and gout.”
Cepak’s lawsuit presents claims of strict liability and negligence, and seeks damages for severe physical pain, suffering, loss of enjoyment of life, medical costs, wage loss and loss of future earning capacity.
Although some critics have called for a Uloric recall to be issued, the FDA decided to allow the drug to remain on the market, with severe limitations on its approved uses.
Cepak’s case is one of a growing number of Uloric lawsuits being pursued by individuals throughout the U.S., each raising similar allegations that strokes and other heart problems may have been avoided if Takeda had provided earlier warnings about the risks associated with the gout treatment.