Texas Woman Files Actos Bladder Cancer Lawsuit

On October 26, 2012, Justine Zapalac of Texas chose to file an Actos lawsuit in the Circuit Court of Cook County, Illinois. She claims that when she took the medication to treat her type II diabetes, she was not aware of the possible links connecting Actos to bladder cancer. She seeks to hold the manufacturer of Actos, Takeda, responsible for the injuries she sustained as a result of taking the drug.

Studies find link between Actos and bladder cancer

Actos has long been the subject of investigations regarding the risks. In September of 2010, a safety announcement was issued by the Food and Drug Administration (FDA) as the agency examined data from a continuing 10-year epidemiological study to consider the connection of Actos to bladder cancer. In April of 2011, a paper published by the American Diabetes Association asserted that they discovered that the disease and the drug were associated.

Actos recalled in France

Actos has also been under scrutiny in Europe. On June 9, 2011, the European Medicines Agency announced that the French Medicines Agency had decided to suspend the use of Actos and medications of a similar nature pending the completion of a review.

The French National Health Insurance Plan discovered a substantial rise in the incidences of bladder cancer in males who had been exposed to Actos for over a year in duration.

Germany suspended the use of Actos on June 10, 2011, recommending that doctors refrain from prescribing the drug for new patients. In the U.S., on June 15, 2011, the FDA released an updated safety announcement stating that a 40% greater risk of bladder cancer could occur when using Actos for more than a year.

The manufacturer recalled the medication in France on July 12, 2011, but it is still available in the U.S.

Plaintiff blames Actos for her bladder cancer

Plaintiff Zapalac was prescribed Actos by her doctor to provide maintenance for her type II diabetes. She was eventually diagnosed with bladder cancer and her lawsuit claims that this is a side effect resulting from Actos. She requires ongoing care and treatment due to her disease and has suffered significant physical pain and suffering. She brings counts of strict liability and negligence against Takeda.

According to her complaint, Zapalac states that had she been aware of the risks of side effects resulting from Actos when taken over the long-term, she would not have chosen to take it. She also claims that she was unaware of any potential link between the drug and the disease until the FDA issued its safety announcement in June of 2011.

Studies connecting Actos to bladder cancer are referenced in the case

Various warnings and studies are referenced in Zapalac’s complaint. Actos was approved by the FDA to treat patients with type II diabetes in 1999, but before the approval, a carcinogenicity study that went on for two years discovered that rats receiving Actos grew tumors.

Another study—the 2005 PRO-active study—examined the cardiovascular effects of the medication and noted that the risk of bladder cancer was higher in those taking Actos in comparison to other, similar medications.

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