The Plaintiff In A New Actos Lawsuit Claims The Manufacturer Failed To Warn Of Bladder Cancer Risks

A new lawsuit against the manufacturer of the diabetes drug Actos, Takeda Pharmaceuticals America, Inc., was filed on August 1, 2012, in the Circuit Court of Cook County, Illinois. The plaintiff, Rodkey Dale Roberts, alleges that Takeda did not adequately warn patients and medical practitioners about the chances of Actos bladder cancer as a result of taking the drug.

Actos (pioglitazone) is recalled in France and Germany

On June 14, 2011, the FDA issued a safety announcement stating that “use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer,” and ordered this increased risk of Actos side effects to be added to the warning label for all pioglitazone-containing medicines. This information was based on the FDA’s review of data from a planned five-year interim analysis of an ongoing, ten-year epidemiological study. An increased risk was noted among those patients with the longest exposure to, and the highest cumulative doses of, pioglitazone.

The FDA announcement also referenced a recent epidemiological study in France that similarly suggests a correlation between an increased risk of bladder cancer and pioglitazone. As a result of this study, the use of pioglitazone had been suspended in France while awaiting the outcome of an ongoing review by the European Medicines Agency. Following the suspension of sales, Takeda Limited issued a recall of the drug in France.

After reviewing the French study, Germany followed suit, suspending treatment of new patients with the drug.

Multiple counts of liability and negligence are alleged in the lawsuit

Plaintiff Roberts’s Actos lawsuit charges multiple counts of liability and negligence, alleging that the defendants concealed their knowledge that Actos can cause bladder cancer from consumers and the prescribing medical community for more than twelve months.

Actos is indicated to improve glucose (blood sugar) control in adults with Type II diabetes, in conjunction with diet and exercise. Roberts was prescribed Actos by his physician in 2003, as part of a long-term maintenance plan for his Type II diabetes.

The lawsuit alleges that Roberts’s diagnosis of bladder cancer in June of 2008, and subsequent recurrences in June of 2010 and August of 2011, were “a direct result of ingestion of Actos.” Roberts stopped taking the drug in July 2011, and is suing for compensation for pain and suffering, medical expenses, lost income, and disability.

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