Actos Bladder Cancer Leads Florida Plaintiff to Join Louisiana MDL

On December 18, 2012, a new lawsuit was filed by an Actos lawyer on behalf of Florida resident Candido Garcia. The case joins the multidistrict litigation (MDL) in the Western District of Louisiana.

The plaintiff claims that the warning label on the drug was vague, incomplete and inadequate. Garcia says that if he’d been aware of the life-threatening potential of Actos, he would not have taken it.

Plaintiff Garcia brings counts of breach of warranties, defective design, failure to warn, and negligence. He also seeks compensatory and punitive damages. According to his filing, he alleges that he experienced serious injuries as a result of taking the type 2 diabetes medication. He seeks in excess of $75,000 in damages in this case.

Manufacturer alleged to have known of Actos bladder cancer risks

Actos was approved by the FDA in 1999 to treat type 2 diabetes.

Garcia states that he took Actos for a total of approximately 8 years between September 2002 and October 2010. The plaintiff claims that Actos caused his bladder cancer.

According to his Actos bladder cancer lawsuit, Garcia claims that the manufacturer of Actos, Takeda Pharmaceuticals, knew of the dangers of Actos and its links to bladder cancer as a result of animal studies indicating a cancer risk. He says that the defendants should have performed additional testing and studies prior to putting Actos on the market. The lawsuit also states that additional bladder cancer evidence was known through clinical trials on humans performed in the early 2000s.

The defendants, Garcia states, concealed and failed to completely disclose their awareness of Actos being connected to bladder cancer and did so for over ten years. The warning label on the package remained the same during this time.

[SmartLink actoslawsuit]

Actos recalled in France, but still available in U.S.

The French regulatory agency published a report on June 7, 2011 that showed a statistically significant link between Actos and bladder cancer. The report states that the risk was higher when exposure to the drug lasted longer than a year.

The European Medicine Agency suspended the use of Actos due to these findings on June 9, 2011. On June 10, 2011, the Federal Institute for Drugs and Medical Devices in Germany suspended the use of Actos.

In the United States, on June 15, 2011, the FDA informed the public of the association between Actos and bladder cancer when used for more than a year. Because of this, the label was altered to warn people of the risk.

On June 17, 2011, a review of the drug’s status was undertaken by Health Canada. A month after that, a recall of the drug was implemented in France. It is still available in the United States.