This is Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm.

Things are heating up in Actos litigation, with defendant Takeda hit with another verdict rising from the use of the drug the development of bladder cancer.

On February 12th, Takeda Pharmaceuticals Inc. was hit with a $2.3 million verdict after a Philadelphia jury concluded that the diabetes drug Actos had been a significant cause of a retired Pennsylvania teacher’s bladder cancer and that the man’s doctor had been inadequately warned about the risks.

The jury returned a verdict after a little more than a day of deliberation, awarding John Kristufek $318,000 in past medical expenses plus $2 million in noneconomic damages in the second successful bid by plaintiffs in the Philadelphia County Court of Common Pleas to hold the Japanese drugmaker liable for injuries related to Actos.

The jury also opened the door for punitive damages against the company by finding that Takeda had acted with reckless disregard for patients in its development and marketing of the drug. A potential punitive damage award will be put to the jury following a hearing on Friday.
In a statement to Law360, Takeda general counsel and senior vice president Kenneth D. Greisman defended the drug.

“Takeda is disappointed in today’s verdict and we will be considering our options, including post-trial motions and an appeal. While we have empathy for the plaintiff and his family, we believe the evidence showed that Mr. Kristufek’s condition was not caused by Actos,” he said. “We remain confident that Actos is an important option for the treatment of type 2 diabetes and we will continue to defend the company vigorously against these cases.”

Kristufek, a resident of Butler County in western Pennsylvania, filed suit in July 2012 alleging that he was diagnosed with bladder cancer in 2008 after using the drug for about three years.

The verdict comes after nearly a month of testimony in the case.

Kristufek alleged that Takeda’s efforts to obscure the drug’s association with bladder cancer had left his prescribing physician unaware of the risks until shortly after he was forced to have his bladder removed entirely in July 2011.

According to testimony in the case, the drug’s label was updated in the weeks after Kristufek’s bladder removal to indicate that use of pioglitazone-based medications, such as Actos, for more than a year was associated with an increased cancer risk.

The warning remains on the drug’s label today, according to testimony in the case.

The damages awarded to Kristufek come on the heels of a $2 million verdict awarded to a Philadelphia-area woman who similarly claimed that Actos had caused her to develop bladder cancer.

A Philadelphia County judge recently denied a set of post-trial motions filed by Takeda asking that the verdict be stricken, clearing the way for the company to pursue an appeal to the state’s Superior Court.

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.

About the Firm: The Michael Brady Lynch Firm is a trial firm with a focus on pharmaceutical mass tort cases involving SSRI and Anti-Seizure Medication Birth Defects including Lexapro, Zoloft, Effexor, Prozac, Celexa, Paxil, Depakote and Topamax, Xarelto bleeding injuries, Mirena IUD, Actos Bladder Cancer, Testosterone heart attack and stroke injuries and medical device cases including DePuy Hip and Trans-Vaginal Mesh cases. Contact us today if you or someone you know has experienced side effects involving these products.