This page is about the Actos bladder cancer lawsuits that settled many years ago.
Actos is a medication used to treat type 2 diabetes, manufactured by Takeda Pharmaceuticals. It was first approved by the FDA in 1999 and quickly became a popular medication for treating diabetes. However, concerns over the medication’s potential link to bladder cancer began to emerge in the mid-2000s.
In 2010, the FDA issued a safety announcement warning that patients taking Actos for more than a year may be at an increased risk of bladder cancer. The warning was based on data from a Takeda-funded study that found an increased risk of bladder cancer in patients taking the medication for more than 12 months. The FDA required Takeda to add a warning to the medication’s label about the potential increased risk of bladder cancer.
What Actos Treats
Actos (Pioglitazone) is prescribed to treat type 2 diabetes. Pioglitazone is in a class of medications called thiazolidinediones and works by increasing the body’s sensitivity to insulin. It is taken orally, typically once a day. This medication is approved as an adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes (non-insulin-dependent diabetes mellitus). It is also used in combination with a sulfonylurea, metformin, or insulin when diet and exercise are not able to get the patient’s glycemic under control.
ACTOS Bladder Cancer Lawsuit
This since settled litigation involved the possible link between the type 2 diabetes drug Actos and bladder cancer. These cases settled for an average of nearly $300,000 per claim. The drug is still on the market but with a black box warning that apprises of the risk. This warning is why lawyers are no longer filing Actos bladder cancer lawsuits.
- The Zantac bladder cancer lawsuit in 2023 is very similar to Actos (although the results may be very different)
Why Lawyers Filed Actos Lawsuits?
In September 2010, the FDA posted a notice that they were “reviewing data from an ongoing, ten-year epidemiological study designed to evaluate whether pioglitazone is associated with an increased risk of bladder cancer. Findings from studies in animals and humans suggest this is a potential safety risk that needs further study.”
The manufacturer, Takeda, warns in its drug information insert:
In clinical studies, more people who took pioglitazone developed bladder cancer than people who did not take pioglitazone. Talk to your doctor about the risk of taking this medication.
In what may be a harbinger of things to come in the United States, both Germany and France have suspended any new prescription of this medication after a three-year French study found a 22% greater chance of cancer in Actos users compared to other diabetics. This is significant as there is already a higher risk of bladder cancer among diabetics.
Thus far, the Japanese Health Ministry has no plans to halt sales of the drug, but in a move mirroring the FDA, the European Medicines Agency, based in London, said it was reviewing information and studies regarding the link between this medication and cancer.
For now, the FDA recommends that healthcare providers continue to prescribe it according to the drug label recommendations. But obviously, there is some reason for concern. Besides the cancer risk, the drug has a long list of reported side effects, including:
- vision problems
- increased bone fractures in women
- muscle pain
- congestive heart failure
The Actos Lawsuits
In August 2011, lawsuits starting flying following the FDA’s warning by patients who claimed that the medication caused them to develop bladder cancer. In December 2011, a multidistrict litigation (MDL) was established in the U.S. District Court for the Western District of Louisiana to consolidate the numerous lawsuits filed against Takeda. The MDL was overseen by Judge Rebecca Doherty.
What does this mean? It meant that all federal Actos lawsuits would be in Louisiana for discovery before getting sent back to the court in your home state. These lawsuits read a little different, but all alleged the same core fact: Takeda concealed that it knew that this diabetes drug increased the risk of bladder cancer and that it kept that concern to itself and did not warn patients and their doctors about the risk.
Latest Actos Updates
Certainly, the biggest Actos update was the verdict in Allen v. Takeda Pharmaceuticals North America. The jury awarded a stunning $9 billion compensatory and punitive verdict award on April 8, 2014.
That verdict got some attention. The length of the trial and the amount of the award has thrown the litigation off kilter. This verdict set the stage for a global class action settlement. The Actos MDL was disbanded after six years in 2018. There were still some outstanding cases that were remanded to local federal courts for trial.
- $2.4 billion settlement: More than 97 percent of plaintiffs have accepted a $2.4 billion settlement in 2015. This comes out to an average settlement of about $296,000 per victim.
- How to manage Actos side effects in 2023