A woman has filed an Actos and bladder cancer risk lawsuit after her husband died of the disease.

According to Martha G., her husband took Actos (pioglitazone), a prescription medicine used to control blood sugar in patients with diabetes.

She alleges the drug’s maker, Takeda Pharmaceuticals, knew that patients taking Actos for more than 12 months were at risk of bladder cancer, but failed to warn consumers and the medical community.

Nelson G. allegedly began taking Actos in 2008. He purportedly was unaware of any link between Actos and bladder cancer risk.

Nelson was diagnosed with bladder cancer in October 2014 and allegedly stopped taking Actos in April 2016. He died on April 19, 2017. The lawsuit alleges that Actos and bladder cancer caused his death.

Evidence of Actos and Bladder Cancer Risk

According to Martha’s complaint, “Prior to Actos being approved by the FDA, a two-year carcinogenicity study was conducted on male and female rats. Drug-induced tumors were observed in male rats receiving doses of Actos that produced blood drug levels equivalent to those resulting from a clinical dose.”

Actos was FDA-approved in July of 1999.

In 2005, the results of a three-year clinical study called PROactive (PROspective Pioglitazone Clinical Trial in MacroVascular Events) were published.

The study was designed to evaluate heart-related events and outcomes, but researchers noticed a significant increase in bladder cancer cases among the patients.

Neither the study nor the final paper mentioned the Actos and bladder cancer risk seen among the patients.

Takeda is accused of withholding the knowledge found in the PROactive study regarding the increased risk of bladder cancer in patients taking Actos in order to prevent the chances of Actos being delayed or rejected by the FDA.

Martha alleges such actions were made “willfully, wantonly and with malice” by Takeda.

The FDA issued a safety announcement in June 2011 that stated, “use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.”

The FDA noted that the Actos and bladder cancer risk was dependent upon the dose and duration of the drug. Compared to patients who had never taken Actos, patients who were on Actos for more than 12 months had a 40 percent increased risk of bladder cancer.

In the summer of 2011, Actos was recalled in Germany and France, but not in the United States.

Martha’s complaint alleges that Takeda met a marketing goal by making Actos the 10^thbest-selling medication in the U.S. in 2008 – the year her husband began taking Actos – while knowingly placing American patients at an increased risk of bladder cancer.

Martha says she and her husband believed Actos was a safe drug that did not cause any dangerous side effects.

Takeda has faced other Actos lawsuits and agreed to a $2.4 billion settlement in 2015 that settled more than 8,000 lawsuits regarding Actos and bladder cancer and other serious health consequences.

The Actos and Bladder Cancer Risk Lawsuit is Martha G., et al. v. Takeda Pharmaceuticals America Inc., et al., Case No. 1:18-cv-25148-PCH, in the U.S. District Court for the Southern District of Florida.