In 2015, Takeda Pharmaceutical Company reached an Actos bladder cancer settlement in the face of thousands of queued lawsuits.

At the time of the Actos bladder cancer settlement for $2.4 billion, there were up to 9,000 cases filed and waiting to present evidence against the Japanese drug manufacturer, maker and distributor of Actos, known generically as pioglitazone, a medication used to treat type-2 or adult-onset diabetes.

History of Pioglitazone Before the Actos Bladder Cancer Settlement

Pioglitazone, sold under the brand name Actos, was approved for commercial distribution by the U.S. Food and Drug Administration (FDA) in 1999. At the time of the drug’s debut, the drug oversight agency made the stipulation that Takeda undertake and fund post-market clinical trials five and ten years in length.

Takeda achieved a great deal of economic success with the diabetes drug Actos. The medication that purportedly reduces the body’s resistance to insulin brought in nearly one-third of the pharmaceutical company’s gross revenue as measured in 2010—11 years after its approval.

It was just a year after this, however, that data from the five year post-approval study prompted the FDA to warn the American public and professional medical community. Study results indicated that Actos posed some risks to bladder health and may contribute to the development of cancer. High dosage and long use seemed related to possible development of cancerous bladder conditions.

The FDA safety alert was released in 2011 and Takeda was asked to create a new label for the product. While data was being collected from the ten-year post-market clinical trial, legal claims based on the initial FDA warning and patient experience were slowly accumulating.

The Actos bladder cancer settlement was then offered by Takeda in 2015, followed by the public release of data from the ten-year trial in 2016. At that point, there was more evidence that Actos increased the chance of a type-2 diabetic patient getting bladder cancer proportionate to length of ingestion and dose.

Actos Lawsuit Allegations

According to lawsuits filed before and even after the 2015 Actos bladder cancer settlement, Takeda knew of increased bladder risks posed by the type-2 diabetes drug. This knowledge was gained through pre-market animal studies that were allegedly omitted when drug commercial approval was sought through the FDA.

When this omission came to light during a 2014 trial, both Takeda and the Eli Lilly Company were forced to pay punitive damages of $36.8 million dollars. This was negotiated down after an initial figure of $9 billion was assessed.

If you or a loved one took Actos and later developed bladder cancer or another bladder injury, you may have a legal claim.