First Actos Lawsuit Results in $6.5M Jury Award Over Bladder Cancer

A California man who claims that he developed bladder cancer from Actos has been awarded $6.5 million by a California jury, which found that Takeda Pharmaceuticals failed to adequately warn about the potential side effects of the popular diabetes drug.

The award came following more than two months of trial in the Superior Court of California for Los Angeles, involving a complaint brought by Jack Cooper. The case was the first of more than 3,000 Actos bladder cancer lawsuits filed throughout the country to reach a jury.

Cooper, a former Pacific Bell cable splicer, was diagnosed with bladder cancer in November 2011, after using Actos for more than two years. He has a prognonsis of only a few months to live, which resulted in an expedited trial date in California state court due to his grave medical condition.

Jury selections began in the Actos case on February 19, and after a full week of deliberations, the jury returned a verdict on Friday that found Actos caused Cooper’s bladder cancer. The jury determined that Takeda Pharmaceuticals should be held liable for the injury after determining that inadequate warnings were provided to Cooper and his physicians about the potential Actos side effects.

However, the jury rejected Cooper’s claim for punitive damages, which would have allowed the jury to increase the verdict to punish Takeda for acting with malice or willful negligence.

During trial, Takeda attempted to argue Actos was not responsible for Cooper’s bladder cancer diagnosis, indicating that he had other risk factors for cancer, such as age, gender and being a former smoker.

The drug maker has indicated that it disagrees with the jury’s verdict, and is seeking to overturn the verdict by having expert witness testimony excluded from Dr. Norm Smith, a urologist who made the causative link between Cooper’s bladder cancer and Actos. Judge Kenneth R. Freeman, who presided over the trial, is likely to rule on the company’s motion later this week.

Actos Bladder Cancer Risk

Actos (pioglitazone) is a once-daily pill that was approved by the FDA in July 1999 for treatment of type 2 diabetes. The medication increases the body’s sensitivity to insulin. However, new bladder cancer warnings were added to the medication in 2011, indicating that users may face an increased risk of bladder tumors after using the medication for more than year.

In recent years, thousands of Actos lawsuits have been filed in state and federal courts throughout the country alleging that Takeda Pharmaceuticals withheld information about the risk of cancer from Actos and failed to provide adequate warnings for users or the medical community.

According to evidence introduced during Cooper’s Actos trial, Takeda Pharmaceuticals appears to have known about the potential Actos bladder cancer risk before the medication was even introduced, but chose to ignore data, downplay the risk and mislead regulators in an attempt to avoid placing a cancer warning on the drug.

Internal emails from the company suggested that the drug maker considered adding information about the risk of bladder cancer from Actos as early as 2003, when the company surveyed doctors to evaluate whether such a warning would scare them away from prescribing the drug.

An email from Takeda executive Kyoshi Kitazawa in August 2005 urged his colleges at the pharmaceutical company to “manage the issue” to ensure that Actos had a good global image and described adding information to the warning label for bladder cancer as a “worst-case scenario.”

Actos Trials May Lead To Settlement Talks

Cooper’s trial was closely watched by Actos lawyers representing former users of the diabetes drug throughout the country who have been diagnosed with bladder cancer. Many have previously indicated that the lawsuit was a difficult one for plaintiffs, and if a prior smoker like Cooper can establish his case, this may increase the pressure on Takeda to consider settling Actos cases to avoid trials in hundreds of other cases.

Most of the Actos lawsuits filed nationwide are pending in the federal court system, where the cases have been consolidated for pretrial proceedings as part of an MDL, or Multi-District Litigation, which has been centralized before U.S. District Judge Rebecca H. Doherty in the Western District of Louisiana.

A small number of test cases, or “bellwether” lawsuits, are being prepared for early trial dates in the federal Actos MDL as well, to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be offered in cases.

According to scheduling orders issued earlier this year, the first federal Actos trial is scheduled to begin on January 27, 2014. This will be followed by a second trial date set to begin on April 14, 2014. Judge Doherty has indicated that deadlines and trial dates set by the court are to be considered “hard and fast,” indicating that they will not be extended, continued or delayed unless there is “extraordinarily good cause shown.”