A man has filed an Actos bladder cancer class action lawsuit that alleges Takeda Pharmaceuticals and Eli Lilly & Company committed consumer fraud.

Plaintiff Frank F. alleges in his complaint that he and other patients allegedly paid for Actos prescriptions that they would have otherwise avoided if not for the alleged fraud.

Takeda and Eli Lilly are accused of knowing that Actos caused bladder cancer, but made efforts to keep the findings from the public. Eli Lilly is no longer involved with Takeda in the Actos marketing campaign.

Frank says he was prescribed Actos from the year 2000 through 2010. During the time he “was purchasing and ingesting Actos, he did not know that Actos’ drug label and advertising were deceptive or that they lacked material information about the drug’s risk of causing bladder cancer,” says the complaint.

Actos is a prescription medication intended to lower the blood sugar of patients with type-2 diabetes. These patients often have a pancreas that produces insulin, but their bodies are unable to absorb it.

Actos and its main competitor Avandia  are in a class of drugs known thiaxolidenedione (TZD) that reduce insulin resistance by activating a receptor inside the cells to hinder insulin resistance. The receptor is known as a peroxisome proliferator-activated receptor (PPAR).

Actos Bladder Cancer Link

According to the Actos bladder cancer lawsuit, in 1996, Takeda researchers conducted a study that showed abnormal bladder cell and tumor formation in male and female rats and in male mice. They also discovered a kidney tumor in a female mouse. The abnormalities allegedly were precursors to bladder cancer.

Takeda allegedly turned to Dr. Sam Cohen of the University of Nebraska Medical Center to help explain why the Actos bladder cancer data didn’t apply to humans. He created the “Cohen hypothesis” that pointed at urine crystal production allegedly seen exclusively in male rats as an attempt to explain why rats were developing Actos bladder cancer, but humans would not face the same risk. The Cohen hypothesis would later be debunked, the complaint says.

“The Cohen hypothesis, however, was a sham theory, designed to hide the observed bladder cancer risks,” says the Actos bladder cancer lawsuit.

The FDA approved Actos in 1999, in part because of the Cohen hypothesis, even though one FDA reviewer had issues with Cohen’s explanation. According to the Actos bladder cancer lawsuit, Dr. Cohen allegedly colluded with Takeda and Eli Lilly “to deceive the FDA about a material risk of Actos.”

In the summer of 2002, the FDA began taking a closer look at PPAR drugs and possibilities of increased cancer risks. Still, Takeda continued to deflect the Actos bladder cancer link until 2009 and 2010.

In 2011, the FDA ordered a warning that Actos could increase the risk of bladder cancer be placed on the medication’s label.

In 2015, a $2.4 billion Actos bladder cancer settlement was reached with Takeda in an MDL to settle nearly 9,000 claims by patients and family members.

The Actos Bladder Cancer Lawsuit is Case No. 2:18-cv-01142, in the U.S. District Court for the Eastern District of California, Sacramento Division.