A Texas man has filed a lawsuit claiming that he suffered from serious injuries including cardiac arrest after taking the gout drug Uloric.
The complaint says he started using Uloric in 2010 and experienced a cardiac arrest requiring medical treatment in 2018. The man blames Uloric for the cardiac arrest, saying he and his doctors weren’t aware of Uloric’s cardiovascular risks.
The lawsuit seeks to hold the drug’s manufacturer, Takeda Pharmaceuticals, strictly liable for damages, saying the drug was “a defective and unreasonably dangerous product,” and “Defendants failed to properly and adequately warn and instruct Plaintiff and Plaintiff’s treating physician as to the risks of the Defendants’ Uloric product. To the contrary, Defendants withheld information from Plaintiff and Plaintiff’s physician regarding the true risks related to prescribing the Uloric product.”
The lawsuit accuses Takeda of negligence, saying “Defendants failed to exercise ordinary care in the manufacture, sale, labeling, and marketing [of] Uloric in that Defendants know or should have known that Uloric created a high risk of unreasonable harm to Plaintiffs and other users.”
The lawsuit accuses Takeda of breaking promises they made to get the drug FDA approved. Takeda promised to comply with adverse event reporting obligations as part of their new drug application process.
The lawsuit says that instead of complying with the adverse event reporting obligations, Takeda “initiated a system to intentionally conceal a substantial number of adverse event reports and thus had no intention of complying with its certifications and promises.”
“In order to dominate the gout drug markets and to increase the sales of Uloric, Defendants misrepresented and/or concealed material facts regarding adverse events attributable to Uloric,” the lawsuit continues.
The lawsuit says that the adverse event reports which should have been sent to the FDA would have shown that there were increased risks from Uloric.
The FDA mandated that Takeda study the drug’s cardiovascular safety as a precondition for FDA approval of Uloric. The data from this trial was published in March 2018, concluding that cardiovascular and all-cause mortality were higher with Uloric than with allopurinol.
The FDA then added a black box warning to Uloric’s label in February 2019, warning of the medication’s cardiovascular risks.
The lawsuit seeks to require compensation for pain and suffering, medical costs, past wage loss and future loss of earning capacity.
The FDA has recommended that patients who suffer from the following side effects while taking Uloric seek emergency care immediately:
• Pain in the chest
• Irregular or rapid heartbeat
• Sudden and severe headache
• Shortness of breath
• One-sided weakness or numbness
• Difficulty with speech