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Takeda Hid Cancer Risks of Its Actos Diabetes Drug, Jury Hears

Apr 16, 2013

In what is the first of more than 3,000 lawsuits against the diabetes medication Actos to reach trial, attorneys for the plaintiff revealed to jurors that Takeda Pharmaceutical Co., maker of the diabetes drug, had concealed that there were cancer risks associated with it.

As early as 2004, Takeda’s internal studies found links to bladder cancer, a lawyer for the plaintiff, Jack Cooper, told a Los Angeles state court jury yesterday, as noted in a Bloomberg report. Takeda had kept mum because the drug’s annual sales were about $1.6 billion, he added.

Bloomberg quoted Miller as saying: “Selling diabetes drugs is big business in America… But companies are not allowed to downplay the risk [of their drugs]…”

The key issue for jurors is determining whether Takeda should be held liable for failing to warn patients and doctors of Actos’s potential to cause bladder cancer. Defense lawyers are expected to pitch their closings arguments today, which means the jury may begin deliberations today as well.

Cooper had been taking Actos for more than two years when he was diagnosed with bladder cancer in November 2011. He “is gravely ill,” in the words of Judge Kenneth Freeman, who is presiding over Cooper’s Los Angeles-based lawsuit. The judge expedited the trial due to Cooper’s condition, Bloomberg reported.

Cooper’s lawsuit – which has run on for about two months, so far – revealed that, according to internal Takeda emails, company executives had worked to convince the U.S. Food and Drug Administration (FDA) that there was no need to place a heightened bladder cancer warning on the Actos label.

When the FDA did begin a campaign to get the biggest drug maker in Asia to update its Actos labels in 2005 and 2006, Takeda executives “stalled and delayed,” the plaintiff’s attorney told the jury, as reported by Bloomberg. The attorney added that U.S. law places the onus on Takeda to fully disclose any risks linked to its products.

Actos first appeared in the market back in 1999, following its approval to treat Type 2 diabetes. Then, in 2011, the FDA finally got the updated Actos safety label it had wanted, which revealed that the drug may increase the risk of bladder cancer following one year of use. The warning was based on an ongoing 10-year study by Kaiser Permanente.

Other research continued to support the association between Actos and bladder cancer. In May 2012, the British Medical Journal (BMJ) published a study showing that patients were twice as likely to get bladder cancer after taking Actos for two years. In July 2012, the Canadian Medical Association Journal published a study showing that Actos use was linked to a 22% increased risk of developing bladder cancer.

Takeda is facing more than 3,000 suits alleging that its Actos drug caused bladder cancer as well as other ailments, according to court records, as reported on by Bloomberg.

More cases are pending in Illinois state court, according to court dockets; more than 1,200 lawsuits have been consolidated before a federal judge in Louisiana for pretrial information exchanges – with the first federal case due to reach the courtroom in January 2014. 

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