Takeda Pharmaceuticals, maker of the type-2 diabetes drug Actos, is facing yet another Actos lawsuit as plaintiff Carlos Cadiz Parrilla files an Actos lawsuit against Takeda.

Parrilla took the drug for nearly five years before he was diagnosed with bladder cancer in August 2013. He alleges that the active ingredient in Actos, pioglitazone, was the direct cause of his bladder cancer. The allegations include fraud, negligence and failure to properly warn about the true risks associated with taking Actos.

According to the Actos lawsuit, there were pre-clinical trials involving both humans and animals that showed a possible link between Actos and bladder cancer, but Takeda failed to inform the Food and Drug Administration (FDA) and the medical community.

The plaintiffs argue that Takeda did not carry out enough tests and trials of Actos prior to the approval of the FDA, but have continued to experience strong sales of the drug for about 10 years now.

According to a three-year liver study, there was a higher percentage of bladder cancer cases in patients taking Actos versus those who did not take Actos.

Actos Studies and Recalls

In September 2010, after the liver study, the FDA released a safety announcement that they were reviewing further data regarding the Actos side effects but so far have concluded that there is evidence to believe that the risk of bladder cancer increases with the use of Actos. The significant increased risk is believed to happen after 24 months of regular use.

In 2011, the American Diabetes Association published a report titled “Assessing the Association of Pioglitazone Use and Bladder Cancer Through Drug Adverse Event Reporting.” This report looked at all adverse event reports submitted to the FDA between 2004 and 2009. Their findings were consistent with pre-clinical studies that found that there is an association between pioglitazone and bladder cancer.

In addition, in June 2011, the European Medicine Agency suspended the use of Actos after more reports began to surface in French government committees.

Takeda Pharmaceuticals issued a product recall in Europe just one month later.

The Future of Actos Class Action Lawsuits

Following these studies and recalls, more and more people are filing Actos lawsuits upon realizing that they may have developed bladder cancer as a direct result of prolonged Actos use.

There is an Actos multidistrict litigation (MDL) or mass tort currently underway for the Actos lawsuits that have been filed. A MDL is a group lawsuit similar to a class action lawsuit, but the lawsuits retain their individual plaintiffs and are ultimately tried separately. However, Actos lawsuits within the Actos MDL are able to take advantage of the same resources and discovery processes, making it easier for both the plaintiffs and the defendant.

The Actos MDL is In re: Actos (Pioglitazone) Products Liability Litigation, Case No. 6:11-md-02299, in the U.S. District Court for the Western District of Louisiana.