Takeda Pharmaceutical Loses First Actos Trial

A California jury has found that Takeda Pharmaceutical should pay $6.5 million to a California man for failing to warn doctors and consumers that Actos (pioglitazone), a diabetes drug, could cause bladder cancer.

This case is the first of more than 3,000 Actos lawsuits against Takeda to go to trial, the South China Morning Post (SCMP) reports. Jack Cooper, now 79, took Actos for more than four years before being diagnosed with bladder cancer in 2011. His case was heard first because he is now gravely ill.

Takeda officials have filed motions seeking to have the verdict and the entire case thrown out, SCMP says. Judge Kenneth Freeman will review those requests this week.

Takeda faces more than 3,000 suits alleging that Actos caused bladder cancer or other illnesses, according to court records. Cooper’s suit was among those in a multidistrict litigation (MDL) before Freeman in Los Angeles. There are cases in state court in Illinois, and more than 1,200 suits have been consolidated before a federal judge in Louisiana for pretrial information exchanges.

Lawyers for former Actos users have alleged that Takeda researchers ignored or downplayed concerns about the drug’s cancer-causing potential and misled U.S. regulators about the risks, the SCMP writes. Cooper’s lawyers told the jury that Takeda’s own research indicated as early as 2004 that there were links between Actos and bladder cancer, but company officials did not tell regulators about the findings for seven years. The lawyers also produced internal Takeda e-mails in which company executives urged colleagues to persuade the U.S. Food and Drug Administration  (FDA) not to require increased warnings about bladder cancer on the Actos label.

Takeda lawyers argued that Cooper was among those patients more likely to develop bladder cancer because he was elderly, male and a former smoker who had Type 2 diabetes. Jurors, however, found that Takeda’s failure to adequately warn Cooper’s doctors about the cancer risk was “a substantial factor” in his level of harm, according to court filings, the SCMP says.



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