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Lawsuit Claims Takeda Failed To Warn About Uloric’s Dangers


A lawsuit filed in August accuses Takeda Pharmaceuticals of failing to adequately warn about the cardiovascular risks linked to Uloric.

The lawsuit was filed on behalf of a woman who died after suffering a heart attack which led to additional health problems, including brain swelling, strokes and respiratory failure.

The complaint notes that Takeda, upon filing for FDA approval of Uloric, agreed to “comply with all adverse event reporting requirements.”

“Contrary to the adverse event reporting promises and certifications that [Takeda] had given to FDA, [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,” the complaint states.

The FDA mandated that Takeda conduct a clinical trial into Uloric’s safety upon approving the drug. That trial found a link between an elevated risk of cardiovascular death and Uloric use. The FDA then announced that a black box warning about this risk would be added to Uloric’s label.

Takeda hid and failed to submit full and complete adverse event reports to the FDA “in order to dominate the gout drug markets and to increase the sales of Uloric,” according to the complaint. The complaint states these reports would have shown that Uloric carried with it increased risks.

The complaint notes that the reason the FDA mandated a clinical safety trial upon Uloric’s approval was out of concern over “the increased risk of cardiac thromboembolic events.”

The complaint seeks to recover damages based on several counts, including:

Strict liability: The complaint argues that Takeda knew or should have known Uloric was dangerous yet failed to warn the public about it, that Uloric was defective, that a “feasible and suitable alternative design” which would have reduced the cardiovascular risk existed for the drug at the time the drug left Takeda’s control and that the woman was harmed because of the defect and failure to warn.

Negligence: The complaint argues that Takeda “failed to exercise ordinary care in the manufacture, sale, labeling, and marketing [of] Uloric in that [Takeda knew] or should have known that Uloric created a high risk of unreasonable harm.” The complaint argues Takeda was negligent when they failed to test their product adequately, failed to warn consumers about their product’s risks, intentionally concealed data from the FDA and continued “to manufacture and sell Uloric with the knowledge that Uloric was unreasonably safe and dangerous.”

Wrongful death: The complaint argues that the woman’s death was “a direct and proximate result of [the] carelessness and negligence of [Takeda].”

The complaint seeks to recover numerous forms of damages, including:

  • Pain and suffering
  • Inconvenience
  • Loss of enjoyment of life
  • Medical bills
  • Loss of wages and earning capacity

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