Patients who developed bladder cancer after taking the diabetes medication Actos may be in a position to file an Actos lawsuit.

According to an Actos lawsuit investigation, studies have concluded that the type-2 diabetes drug is linked to the development of bladder cancer. Already, thousands of Actos lawsuits have been filed by consumers against the drug’s manufacturer, Takeda Pharmaceuticals.

Overview: Filing an Actos Lawsuit

Takeda Pharmaceuticals has faced thousands of lawsuits from consumers over allegations that the drug caused them to develop bladder cancer. The Actos lawsuits accuse Takeda of knowing that the drug causes increased risks to bladder cancer, but failing to inform physicians, patients, and federal agencies regarding that risks.

In 2010, the Food and Drug Administration (FDA) first asked Takeda Pharmaceuticals to add warnings of possible bladder cancer risks to their product’s label. This label change was based on provisional results at the five-year mark of a 10-year Actos study.

The study found that the diabetes drug increased risks for bladder cancer when the medication was taken at a high dosage and when it was taken for long time periods. A separate study discovered that when dosage levels were similarly increased for those taking the medicine long term, there was also increased risks for developing bladder cancer.

The FDA warned of the increased risk of bladder cancer linked to Actos in an announcement in 2016, although the first warnings made public by the FDA in June 2011 told consumers to avoid taking Actos for more than one year because of an increased bladder cancer risk.

Due to the results of these studies, the 2016 FDA announcement stated that Actos “may be associated with an increased risk in urinary bladder cancer, and we have updated the drug levels to include information about these additional studies.”

An Actos settlement also resolved thousands of lawsuits for $2.4 billion in 2015. At the time of the settlement, there had been nearly 9,000 lawsuits pending against Takeda. The lawsuits alleged that Takeda knew of bladder cancer side effects, but decided to hide these risks from the public.

Although the company agreed to the billion dollar settlement, they continued to assert that they were not responsible for bladder cancer in Actos patients. However, lawsuits filed against the company allege that Takeda knew of these side effects from animal studies and human clinical trials conducted in the early 2000s.

Additionally, in a separate trial in 2014, Takeda Pharmaceuticals was ordered by a jury to pay $9 billion in punitive damages. The jury found that Takeda did hide the risks between Actos and bladder cancer. A judge later decreased the amount to $36.8 million.

According to a separate class action lawsuit filed against the company in May 2018, Takeda kept bladder cancer risks hidden because they “knew that, if the medical community were aware that Actos could cause bladder cancer, it would not have been the blockbuster drug they needed Actos to be.”