This is Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm.
A California state court jury has reached a verdict for the plaintiff in the first Actos trial in the country.  The verdict comes after almost two months of trial, and jury deliberations that lasted more than a week.  The jury ruled Takeda failed to warn plaintiff, Jack Cooper, of the risks of bladder cancer.  Cooper and his wife were awarded 6.5 million dollars in damages
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.
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.
Some Background on Actos:
Actos (pioglitazone) was approved by the FDA in 1999 to treat Type 2 diabetes. In 2005, a study found a link between use of Actos and increased risk of bladder cancer. In 2010, the FDA announced that it would be investigating evidence of the connection between bladder cancer and Actos to evaluate the potential risk. Early in 2011, the American Diabetes Association published another study that also found a link between bladder cancer and Actos.
In June 2011, the FDA issued a public safety announcement warning that use of Actos for longer than 12 months may increase the risk of developing bladder cancer and ordered that warning to be added to the Actos label. The warning came after the agency reviewed the five-year results of an ongoing 10-year epidemiological study of Actos side effects.
The same month, sales of Actos were suspended in France and Germany because of the risk of Actos bladder cancer. However, there has been no such Actos recall in the United States.
Following the FDA warning, many patients took the step of filing an Actos bladder cancer lawsuit. Such lawsuits allege that Takeda knew or should have known of the risk of Actos bladder cancer, but failed to warn the public and the medical community. In December 2011, an Actos MDL was established in the Western District of Louisiana to consolidate Actos lawsuits at the federal level. Altogether, there are currently more than 1,000 Actos cases pending in state and federal courts, and that number is expected to grow.
Studies have shown that those who use Actos for over one year have as much as a 40 percent increase in the risk for bladder cancer. The risk seems to be increased in the male population and further increased with Actos use over two years.
The Michael Brady Lynch Firm has been at the forefront of litigation involving the association between bladder cancer and Actos and is aggressively pursuing claims against the manufacturer of Actos. If you or someone you know has taken Actos and have bladder cancer, please contact me directly for a free, no-obligation evaluation of your claim.