The $6.5 million jury verdict in Takeda Pharmaceuticals' first Actos trial didn't last long. Judge Kenneth Freeman tossed out the jury's judgment, saying that plaintiffs' lawyers didn't prove that Jack Cooper's bladder cancer was linked to his use of Actos.
Acting on a motion filed by the Japanese drugmaker, Freeman said testimony from a key witness, a doctor who concluded that Actos triggered Cooper's disease, was "inherently unreliable," Bloomberg reports. That in itself justified throwing out the case, the judge said.
Takeda has said there's no proof that Actos causes bladder cancer and maintains that it handled the drug and its safety questions responsibly. Commenting on the ruling, SVP and general counsel Kenneth Greisman said, "We have empathy for Mr. Cooper and his family, but agree with the court's finding. ... [T]he plaintiffs failed to offer any reliable evidence that Mr. Cooper's disease was caused by Actos."
It was the first bladder-cancer trial for Takeda, in a bellwether state-court suit. A number of similar suits have been consolidated in Freeman's court, and another set are under review in Illinois. Some 1,200 federal lawsuits are gathered in a Louisiana court. In all, the company faces more than 3,300 bladder cancer claims.
The lawsuits follow years of questions about Actos and its potential cancer risks. First, a re-analysis of trial data suggested that Actos patients faced an increased risk of bladder cancer and heart problems. Soon after, the FDA announced it would review that data and other evidence on the drug's safety, and then, regulators in Germany and France forced Takeda to pull Actos off the market. FDA has since required new warning language on the drug's label, and the results of FDA's ongoing review are due next year.
Meanwhile, Actos has fallen off patent, and Takeda's sales are suffering on generic competition for the drug. As Bloomberg notes, the company recently won approval for a follow-up diabetes drug, Nesina, in hopes of replacing lost Actos sales. The company also has been snapping up smaller drugmakers to help fill the gap.
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