Actos Lawsuits | Actos Bladder Cancer Study

Mississippi Plaintiff Files Actos Side Effects Lawsuit in Illinois

Staff Writer | July 31st, 2012

On July 20, 2012, Leandrew Williams, a resident of Mississippi, filed an Actos bladder cancer lawsuit in the Circuit Court of Cook County, Illinois. Like other lawsuits involving Actos, Williams’ complaint alleges that manufacturer Takeda Pharmaceuticals was aware of the risks, but chose to conceal their knowledge from patients and the medical community.

Actos lawsuits argue Takeda had prior knowledge of side effects

In 1999, the Food and Drug Administration (FDA) approved Actos as a treatment for type II diabetes. However, as cited in many Actos lawsuits, Takeda had knowledge of a two-year carcinogenicity study conducted before FDA approval. The study revealed that male rats receiving clinical doses of Actos developed drug-based tumors.

Furthermore, in 2005, results were published from the three-year PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) study. The study reviewed the total mortality and macrovascular morbidity in patients using Actos, but during the three-year period, researchers had become aware that there was a “statistically significant” demonstrated higher percentage of bladder cancer cases in patients using Actos versus competitors.

However, neither during the study nor in the final published results did Takeda publish information regarding the increased risk of Actos bladder cancer.

Takeda denies risk of Actos bladder cancer

This alleged concealment of information has led many Actos lawsuits to charge Takeda with failure to warn. In fact, though the FDA has issued several safety announcements to warn the public of bladder cancer risks, Takeda still maintains its position. Robert Spanheimer, Vice President of Medical and Scientific Affairs for Takeda, claimed to Reuters that the Kaiser Permanente study has not shown a risk to patients of cancer from Actos.

A 2007 study also confirmed the risk of Actos heart failure, another serious allegation in Actos litigation. Actos already carries a black-box warning that the drug may cause or worsen heart problems like congestive heart failure.

Plaintiff diagnosed with Actos cancer during first year of treatment

According to his lawsuit, Leandrew Williams began taking Actos in 2011 for long-term maintenance of his type II diabetes. In 2011, the plaintiff was diagnosed with bladder cancer; he did not discontinue his Actos treatment until 2012, when he became aware that the drug was linked to increased risk of bladder cancer.

Williams’ lawsuit states that he and, “his physicians were unaware, and could not have reasonably known or have learned through reasonable diligence, that [Williams] had been exposed to the risks identified in [his complaint], and that those risks were the direct and proximate result of [Takeda's] conduct.”

Williams charges Takeda with strict liability and negligence. He claims to have suffered, and states that he will continue to suffer injury of a personal and pecuniary nature, including pain and suffering, medical expenses, lost income, and disability. The plaintiff seeks to recover damages associated with his injuries.