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First Trial to Begin in Actos Bladder Cancer Lawsuit

Feb 20, 2013

One man’s claim that the type 2 diabetes drug Actos caused him to develop bladder cancer will be heard by a jury soon.

According to a Bloomberg report this week, jury selection in the trial of Jack Cooper vs. Takeda Pharmaceuticals, the makers of Actos, began earlier this week. Cooper is the first of more than 3,000 people in the U.S. to have his claim that the top-selling diabetes treatment caused him to develop life-threatening bladder cancer reach a jury trial. California Superior Court in Los Angeles will serve as the setting for this trial and it should garner national attention as Actos has been prescribed to many Americans who’ve been diagnosed with type 2 diabetes.

Like others, Cooper claims that taking Actos caused him to develop this life-threatening condition. He says in his lawsuit that he had taken Actos for two years to regulate blood sugar levels before he was diagnosed with bladder cancer in November 2011. His lawsuit not only claims that taking Actos caused him to develop bladder cancer but also that Takeda Pharmaceuticals, the Japanese maker of the drug, hid evidence of this specific risk and also bristled at requests from the Food and Drug Administration to add a warning to the drug’s safety label to indicate this risk.

Earlier this week it was reported that Takeda had conducted a secret survey among a dozen doctors to determine what impact a warning of a risk of bladder cancer might have on sales of Actos and whether doctors would be apprehensive to prescribe it to their patients. Based on the results of that survey, Takeda spent nearly the entire next decade ignoring claims that its top-selling diabetes treatment could be responsible for causing bladder cancer.

After learning about a decade ago that another diabetes drug increased the risk of cancerous tumors to grow in the bladders of lab animals, the FDA questioned Takeda on its drug’s risk of causing the same complications. Takeda ignored these requests and never indicated on its safety label for Actos that the drug could cause bladder cancer.

Instead, the company rode a wave of success behind Actos, generating more than $4.5 billion in sales in 2011, good enough for more than one-fourth of Takeda’s overall revenue.

It was not until that year that Takeda had finally taken action to include warnings about the risk of bladder cancer but not until being ordered to do so by the FDA. It was then that the agency determined in a safety warning that taking Actos at high doses or for more than a year significantly increased a person’s risk of developing this life-threatening side effect. During this time, Actos was removed from several European markets.

In addition to Cooper’s case, there are more than 3,000 lawsuits filed nationwide against Takeda and Eli Lilly & Co., which helped market the drug in the U.S. Many of those lawsuits have been consolidated as part of a federal Multidistrict Litigation filed in U.S. District Court. Jerrold S. Parker, a founding partner of the national law firm of Parker Waichman LLP, has been named to serve on the Plaintiffs’ Steering Committee in that litigation.

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