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Plaintiff Claims Actos Led to His Bladder Cancer

According to his complaint, on around December 17, 2002, Indiana resident Gerald Johnson started taking Actos for the long-term maintenance of his type II diabetes. He took it for six years and stopped on February 28, 2008. Johnson claims that as a result of using the drug for an extended period of time, he was diagnosed with bladder cancer on December 15, 2010.

Had he been properly warned of the risks by the manufacturer of Actos, Takeda Pharmaceuticals, Johnson says he wouldn’t have taken the drug. He was not aware of a potential link between Actos and bladder cancer until late 2011, after the FDA warned about the risk.

Huge sales and hidden side effects

Johnson, filing an Actos lawsuit on June 21, 2012 in the Circuit Court of Cook County, Illinois, seeks to hold Takeda liable for his injuries. The suit calls Actos “unreasonably dangerous.” In his complaint, Johnson notes that in the past year Actos had global sales of $4.8 billion accounting for approximately 27 percent of Takeda’s revenue. In addition, back in 2008, while allegedly having knowledge of the association between long-term Actos use and bladder cancer, Takeda made Actos the tenth bestselling medication in the U.S.

Actos suspended by France and Germany

On September 17, 2010, just a few months before Johnson was diagnosed with bladder cancer, a safety announcement was released by the FDA stating that it was conducting a review of the data from an ongoing, ten year epidemiological study evaluating the association between Actos and cancer.

From June to July, 2011, risks and side effects resulting from Actos were highlighted. On June 9, the French Medicines Agency decided to suspend the use of pioglitazone-containing medications like Actos. On June 10, Germany joined France in suspending the use of Actos. On June 15, the U.S. FDA issued another safety announcement warning physicians that the use of Actos for more than a year was associated with a 40 percent increased risk of bladder cancer. On July 12, 2011, Takeda issued an Actos recall in France.

Launched in North America in 1999, Actos was approved by the FDA to treat type II diabetes.

In his complaint, Johnson states that as a result of the allegedly defective nature of Actos, people who ingested it for a continuous period of time were at an increased risk of developing bladder cancer. The defendants allegedly concealed their knowledge of the risk from the medical community, failing to adequately inform consumers about the potential links with bladder cancer. A 2005 study (PROactive) was noted by Johnson’s lawyer. The study discovered a significantly higher percentage of bladder cancer cases in patients receiving Actos versus comparators. These results were not published by the defendants.

Johnson is suing for strict liability and negligence.


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