The FDA is looking into a possible link between the type 2 diabetes drug Actos and bladder cancer. Diabetes is a serious health condition. Often dangerous conditions require treatment with potent pharmaceuticals that pose some risks of their own. But is bladder cancer an acceptable risk? Our lawyers do not think it is. This is why suits are being filed all around the country.
This drug has been pulled from some European markets. If the FDA is concerned enough to review the findings of a long-term study on this drug and bladder cancer can a U.S. recall be far behind?
Do you want more information about your situation to find out whether you may have a potential claim? Lawsuits have already been filed, and a plaintiff has already won $6.5 million (since overturned on appeal). Another has won, as we discuss in our update below, a stunning $9 billion.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.Why Are Lawyers Filing 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
In August 2011, lawsuits starting flying. Quickly, a federal MDL was set up in December 2011 to coordinate the cases under one judge in Louisiana.
What does this mean to you? It means that all of the cases are going to be in Louisiana for discovery before getting sent back to the court in your home state. These lawsuits read a little different, but all allege 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.
We do not think there are a lot of cases out there, thankfully, at least not relatively speaking. Probably someone in the neighborhood of 750 filed lawsuits is our guess when all is said and done. But the viable cases that are out there are going to be - in our opinion - are going to be very high dollar cases with settlements and verdicts in the millions.Latest Actos Update
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. The next bellwether trial on tap is John Chiody v. Takeda Pharmaceuticals America,
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.
Diabetes is a far-reaching condition. For some, the benefits of taking Actos may - let's be clear about this - outweigh the risks for some patients. It may reduce the risk for secondary stroke or have other benefits that make it worthwhile in individual patients. This is a question for a doctor, not a lawyer. Medication should not be stopped without speaking to a health care provider. Paying close attention to any side effects is a good idea with any medication.
But paying close attention to any FDA findings - and talking to your doctor about them, is also advisable.