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Judge Throws Out $6.5M Verdict that Linked Actos to Bladder Cancer

Takeda logo, Actos box and skyline

Takeda Pharmaceutical Co. convinced a judge to throw out a $6.5 million jury verdict awarded to a California resident who claimed the drugmaker failed to adequately warn Actos patients of bladder cancer risks caused by the blockbuster diabetes drug.

After more than five days of deliberation, jurors issued a verdict in favor of Jack Cooper, 79, bringing the nearly two-month trial to an end. But Takeda promptly filed motions asking Judge Kenneth Freedman to reverse the ruling, stating that evidence did not prove Actos caused Cooper’s cancer.

Testimony from a doctor who convinced the jury that Cooper’s bladder cancer diagnosis was Actos-related was “inherently unreliable,” Freedman said in a 27-page ruling explaining his decision to throw out the case.

Cooper’s case, overseen by Los Angeles Superior Court Judge Kenneth Freeman, was the first to go to trial and could have an important influence on future cases.

More than 1,200 federal Actos lawsuits have been transferred to the U.S. District Court for the Western District of Louisiana for pretrial proceedings, with the first federal trial slated for January 2014. Additional cases are under review in Illinois state court and in other state courts.

Lawsuit: Takeda Withheld Information

Cooper, a former employee of Pacific Bell Telephone Co., took Actos to manage his diabetes for more than four years. He was diagnosed with bladder cancer in 2011. When Judge Freeman learned that Cooper had become gravely ill, his lawsuit was expedited, according to court filings.

Cooper’s lawyers argued that Takeda researchers identified a link between Actos and bladder cancer as far back as 2004, but withheld this information from regulators for seven years. The cancer risk prompted France and Germany to pull Actos from the market in 2011.

While there was no recall in the United States, the U.S. Food and Drug Administration (FDA) did add a warning to Actos drug labels in June 2011 to update patients and doctors about potential bladder cancer risks.

In a series of internal email exchanges introduced as evidence in the trial, Takeda executives appear to have coaxed their associates to convince the FDA not to require the additional bladder cancer warnings on Actos’ safety label.

“Actos is the most important product for Takeda, and therefore we need to manage this issue very carefully and successfully not to cause any damage for this product globally,” Kiyoshi Kitazawa, Takeda’s managing director, wrote in one email.

One of Cooper’s attorneys also told jurors that Takeda executives stalled and delayed when the FDA ordered the drugmaker to update Actos health warnings back in 2005 and 2006. He said Takeda did so to prevent a decline in Actos sales, which were earning the company more than $1.6 billion per year.

FDA Still Investigating Bladder Cancer Risk

In response to Cooper’s allegations, Takeda argued that FDA researchers have yet to confirm that Actos is linked to an increased risk for bladder cancer — a finding from several clinical studies on the drug. An FDA investigation into Actos bladder cancer risks is ongoing, and results are expected next year.

Takeda’s lawyers claimed that the FDA approved Actos as safe and effective and that the drug didn’t cause Cooper to develop bladder cancer. Instead, Takeda told jurors that Cooper was at high risk for bladder cancer whether he took Actos or not. The drugmaker explained that Cooper’s age, gender and smoking history, all risk factors for bladder cancer, caused him to develop the disease.

Despite this argument, jurors initially ruled that Takeda failed to adequately warn Cooper and his doctors about Actos’ cancer risk. This failure, they said, was a substantial factor that contributed to his diagnosis.

Holding Takeda liable for Cooper’s cancer, the jury awarded $5 million in compensation to Cooper and $1.5 million to his wife for loss of consortium. The jury denied an additional award for punitive damages.

Takeda officials disagree with the verdict and maintain that the company acted responsibly while marketing Actos. They say that Takeda promptly released Actos safety data to the FDA and other regulatory agencies and issued updated product information to patients and doctors.

"Takeda empathizes with patients like Mr. Cooper, but we believe the evidence did not support a finding that Actos caused his bladder cancer,” said Kenneth D. Greisman, senior vice president, general counsel and secretary of Takeda Pharmaceuticals U.S.A., Inc.

After throwing out the case, Judge Freeman said Cooper’s attorneys couldn’t link his cancer to Actos use and jurors shouldn’t have been able to issue a verdict against Takeda. Cooper’s lawyers plan to appeal Freeman’s post-verdict ruling.