On April 26, 2013, a Los Angeles jury found Takeda liable for injuries including bladder cancer sustained by Jack Cooper, a former Pacific Bell telephone cable splicer, and returned a verdict of $6.5 million (Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court, Los Angeles).  The jury deliberated eight days after the conclusion of testimony before the Hon. Kenneth Freeman, Judge of the Los Angeles Superior Court.  The jury found the defendants’ failure to provide adequate warnings about the dangers of Actos, Takeda’s diabetes drug was a substantial factor in Mr. Cooper’s injuries.  The jury also awarded $1.5 million for loss of consortium to his wife.  Cooper was diagnosed with bladder cancer in November 2011 after taking Actos for more than two years.

During the almost two-month trial, evidence showed internal Takeda e-mails in which executives urged colleagues to persuade the U.S. Food and Drug Administration not to demand increased warnings about bladder cancer on Actos’s 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,” Takeda executive Kiyoshi Kitazawa said in an e-mail.

Takeda marketed the drug in the US with peak sales in 2011 at 4.5 billion, or about 27% of Takeda’s revenue according to data compiled by Bloomberg news.  Takeda is facing more than 3,000 suits alleging Actos caused bladder cancer or other ailments, according to court records.  Other cases are in state court in Illinois and more than 1,200 suits have been consolidated before a federal judge in Louisiana for pretrial information exchanges.  The first federal case is set for trial in January, according to court filings.

Click here to read the full Bloomberg article: Takeda Denies Actos Bladder-Cancer Link at First Trial

In August 2011, a report by eHealthMe based on FDA reports and the user community stated that of 22,512 people reporting side effects, 50 (0.22%) had bladder cancer.  A May 2011 study of a half million diabetes drug Adverse Event reports to the FDA between 2004 and 2009 suggested a “disproportionate risk” of bladder cancer in Actos patients, finding that of patients reporting bladder cancer, one-fifth of these were taking Actos.

Actos Has Been Linked To Increased Risk of Developing Bladder Cancer

In September 2010, the FDA ordered a safety review of Actos.  The FDA is continuously reviewing the results of an ongoing ten-year study of the long-term risk of bladder cancer in approximately 193,000 diabetic patients taking Actos.  A significantly increased risk of bladder cancer has been seen among patients from this group who take the highest doses of Actos (more than 28,000 mg) and who take Actos for longer than one year.  Compared to patients never having taken Actos, taking Actos for longer than one year was associated with a forty percent higher risk of bladder cancer.

A European study by the French Medicines Agency found a 22 percent higher risk of bladder cancer in approximately 155,000 patients taking Actos from 2006 to 2009, compared to 1.3 million patients not taking the drug.  The risk was highest in patients taking a cumulative Actos dose of 28,000 mg or more during the study period. Authorities responded to the evidence of bladder cancer risk by recalling Actos in France and Germany.

If you or a loved one has been diagnosed with bladder cancer and took the diabetes drug Actos, you may have a claim for your injuriesThomas J. Brandi and the Brandi Law Firm are leaders in nationwide pharmaceutical litigation for decades and is now representing clients who have suffered bladder cancer related to Actos use and filed suits on their behalf. For a free consultation call us at 1-800-481-1615 or email us.