Actos Verdict: $6.5 Million

First Actos Trial

A Los Angeles jury on April 26, 2013 found Takeda liable for injuries that included bladder cancer suffered by a former Pacific Bell telephone cable splicer, Jack Cooper. The jury returned a verdict of $6.5 million (Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court, Los Angeles).

Jury deliberations lasted eight days following testimony before Judge Kenneth Freeman in Los Angeles Superior Court. The jury found defendants’ failed to provide adequate warnings about Actos’  dangers, and that Takeda’s Actos was a substantial factor in Mr. Cooper’s injuries.  The jury also awarded $1.5 million for loss of consortium.  Cooper was diagnosed with bladder cancer in November 2011 after taking Actos for diabetes for more than two years.

Evidence in the nearly two-month trial revealed in-house emails in which Takeda executives urged colleagues to persuade the U.S. FDA not to demand increased bladder cancer warnings on Actos’ label.

In one email, Takeda executive Kiyoshi Kitzaawa wrote: “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.”

Actos’ sales peaked in 2011 at 4.5 billion, which was then about 27% of Takeda’s revenue, according to data gathered by Bloomberg news. Takeda today faces more than 3,000 suits alleging Actos causes bladder cancer or other ailments. Other cases wait in state court in Illinois. More than 1,200 suits have been consolidated before a federal judge in Louisiana. According to court filings, the first federal case is set for trial in January.

See 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 50 (0.22%) of 22,512 people reporting Actos side effects,  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. It found that one-fifth of patients reporting bladder cancer were taking Actos.

Dose-Related Dangers

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.  Taking Actos for longer than one year was associated with a forty percent higher risk of bladder cancer compared with never taking Actos.

A French Medicines Agency study 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.