In June 2011, the U.S. Food and Drug Administration (FDA) released a public safety announcement that said using the antidiabetic medication Actos (pioglitazone) for more than one year can increase your risk of bladder cancer.
The FDA also recommended that doctors use caution when prescribing pioglitazone, weighing the benefits of blood sugar control against the risk for cancer or other side effects. After this public statement in 2011, the pharmaceutical manufacturer behind Actos was hit with thousands of lawsuits and legal claims.
Actos (Pioglitazone) And The Risk For Bladder Cancer
Actos (pioglitazone) is a prescription medication used to treat type 2 diabetes. It’s an oral medication that helps patients regulate blood sugar levels and is especially helpful for those who need an insulin alternative to manage type 2 diabetes.
Pioglitazone is sold under the brand name Actos. It is also found in:
- ActoPlus Met
- ActoPlus Met XR
In a study with over 190,000 patients with diabetes, those who took Actos for more than one year saw a 40 percent increase in bladder cancer risk. Drug regulators in Germany and France also mandated doctors to put an end to prescribing Actos. This was because a French study had already linked Actos to an increased risk of bladder cancer.
As a result, the FDA required the drugmaker to include a statement in the warning section of the medication label that it may be associated with bladder cancer.
Other Side Effects Associated With Actos Use
Although bladder cancer is the one of the major issues associated with Actos lawsuits, it isn’t the only condition or health effect that’s seen litigation.
Although multidistrict litigation in Louisiana was closed in April 2018, patients and families sought compensation for adverse health effects associated with Actos that included:
- congestive heart failure
- liver failure
- chronic kidney disease
- bone fractures
- lactic acidosis
Who Manufactures Actos (Pioglitazone)?
Pioglitazone is manufactured by Takeda Pharmaceuticals, a Japanese company. The company advertised Actos as a type 2 diabetes alternative to Avandia (rosiglitazone), which was restricted in the U.S. in 2010 over concerns of an increased risk of heart failure. Takeda marketed Actos as a safe medication that can lower blood sugar without increasing the risk of heart attack or stroke.
However, bladder cancer and other health risks associated with Actos were soon made public. After a five-year analysis of an ongoing study of the medication, the FDA made the public announcement about the safety concerns of pioglitazone.
What To Know About Actos (Peoglitazone) Lawsuits
There was a significant settlement regarding Actos Lawsuits in 2015. At the time of the settlement, there were about 9,000 claims against Takeda that cited bladder cancer or other health concerns. The claims alleged that Takeda failed to warn the public about the cancer and health risks associated with the top-selling medication. As a result, Takeda made significant payouts.
Takeda Settlements For Actos Bladder Cancer Claims
A 2015 settlement resolved the majority of the product-liability cases filed against Takeda Pharmaceuticals. Takeda agreed to pay $2.4 billion to patients and their family members who claimed that the diabetes medication caused bladder cancer.
The litigation went on for years, beginning in 2011 when the FDA made the public health announcement to inform patients of the associated risks. Even though Takeda agreed to settle, the company still defends its medication. However, the $2.4 billion payout wasn’t the only time Takeda settled over Actos.
Actos $9 Billion Payout From Takeda
In Spring 2014, a jury in Louisiana awarded punitive damages of $9 billion and $1.5 million in compensatory damages to an individual in New York who claimed his bladder cancer was caused by taking Actos.
Takeda was found 75 percent liable, and Eli Lilly, the co-marketer of the medication, was found 25 percent liable. However, the judge later reduced the plaintiff’s award to $36.8 million.
Takeda Accused Of Evidence Tampering
A former Takeda employee sued the company for allegedly concealing information about Actos side effects from the FDA. The employee, who worked in a safety division of the company, stated that Takeda was aware of the severe risks for cancer associated with the medication, but failed to recognize it or make it public.
Although this case was eventually dismissed, it led to further pending litigation that Takeda destroyed evidence, including important files about the marketing and development of the medication.
Actos Settlements Awards
For a patient to receive an Actos settlement, they must have alleged it caused bladder cancer. They must have also alleged that they first used the medication before December 2011, or around the time the FDA required Takeda to update the drug’s warning label about associated risks for bladder cancer.
The criteria that was considered for determining the compensation awarded to each plaintiff included:
- how long the plaintiff took Actos
- the plaintiff’s dose of Actos
- the extent of treatment or injury
- if they had any other risk factors for bladder cancer, such as smoking
Actos Was Never Recalled In The U.S.
Even though other countries around the world banned Actos from drug markets, Takeda never issued a voluntary recall for the medication in the United States.
Following the study in France that linked the medication to an increased risk of bladder cancer that initially started litigation against Takeda, an additional study came out in 2012. This study stated that people who took Actos for long periods of time experienced an 83 percent higher risk of bladder cancer than patients who never used pioglitazone or other antidiabetic medications.
Nonetheless, in 2014, Takeda released the findings of their 10-year study. Although details about the study are limited, Takeda stated that the results of the study found no link between bladder cancer and the long-term use of pioglitazone.
Did Takeda Admit Liability?
After all the lawsuits, settlements, and studies, Takeda never admitted liability. According to the company, they settled to avoid more complex litigation. Besides the Louisiana case that had netted an initial $9 billion verdict, there have been eight other trials in different state courts.
Three out of the additional eight cases gave verdicts that sided with Takeda. The remaining five cases saw jury verdicts that sided with the plaintiff, but at least two judges reversed the verdict and ruled in favor of Takeda. Due to conflicting studies and claims, it’s best to consult with an attorney regarding your potential Actos lawsuit.
Establishing Liability In An Actos Lawsuit
Over the thousands of cases brought forth against Takeda, there have been several different allegations.
Examples of allegations include:
- failure to warn
- negligent misrepresentation
- fraudulent concealment
Plaintiffs in these cases have sought a variety of damages with the assistance of experienced and qualified attorneys. To collect damages, your attorney will need to show that the pharmaceutical manufacturer was liable for your injuries because the company failed to warn you of the potentially dangerous side effects, including bladder cancer and congestive heart failure.
During a dangerous drug lawsuit, you’ll need to prove:
- the medication came with a risk of serious medical complications at the time of manufacturing, distribution, or sale
- the medical complications were knowable in ways accepted by the scientific community
- the risk of harm was a significant danger when the medication was used as directed
- the manufacturer did not warn consumers about the potential health risks
- the plaintiff suffered serious harm (like developing bladder cancer)
- the lack of appropriate warnings was a significant factor in causing harm
Types Of Actos (Pioglitazone) Lawsuits
Although there is little active litigation regarding Actos after the major product-liability settlement in 2015, you may still have the option of filing a lawsuit. If you experienced severe side effects or were injured as a result of taking Actos, consult with an attorney to find out if it’s worth it to pursue legal action.
Actos (Pioglitazone) Product Liability Lawsuits
There have been thousands of product liability lawsuits filed against the manufacturers of Actos. A product liability suit seeks to recover compensation and damages for injuries caused by taking Actos, including lost wages, medical expenses, and overall pain and suffering.
Due to product liability law, Takeda and Eli Lilly (the makers and marketers of Actos) have a duty to consumers to ensure their medications are safe and free of unreasonable dangers or defects. For Actos cases, the manufacturers failed to warn consumers about the potential risks of cancer.
You must have taken Actos before 2011, or when the FDA required Takeda to update the warning label, to pursue a product liability case.
Actos (Pioglitazone) Wrongful Death Claims
A wrongful death claim is one type of personal injury claim that suggests your family member or loved one died as a result of bladder cancer that may have been caused by taking the antidiabetic medication. There are also countless Actos wrongful death claims pending in the U.S.
Wrongful death claims make the case that the person may not have died if they were aware that taking Actos could be harmful. Negligent parties, including Takeda and Eli Lilly, could be liable for putting an unsafe medication on the market.
Actos (Pioglitazone) Class Action Lawsuits
Dangerous drug class action lawsuits are designed for a group of people who have been harmed by a medication to receive compensation for the money they spent on Actos. In a class action lawsuit, there is a lead plaintiff who plays an active role in the case.
Takeda and Eli Lilly were named in a class action lawsuit that claimed Actos can cause bladder cancer. The lawsuit alleges that patients paid for a dangerous diabetes drug, and should be compensated for the money they spent on the medication.
Takeda Pharmaceutical and Eli Lilly also face a revived class action lawsuit that claims they hid a link between Actos and bladder cancer. The plaintiff is arguing that they never would have paid for the drug if the company made the health and safety risks public.
Actos RICO Class Action Lawsuits
The Racketeer Influenced and Corrupt Organization Act (RICO) is a federal statute that provides extended criminal penalties designed to combat organized crime. However, RICO has also recently been cited in class action lawsuits against Tekeda.
For Actos cases, RICO allows patients and insurance companies to pursue litigation that claims the drug manufacturers and marketers deceived regulators about the risks that the medication could cause bladder cancer. The alleged deception occurred over 10 years ago.
This RICO class action lawsuit, which takes place in several district courts in California, alleges that the two companies committed mail and wire fraud to intentionally mislead consumers, insurers, and doctors about the safety of Actos.
Consolidating Actos Claims For Multidistrict Litigation
Due to the high volume of claims associated with Actos use and health concerns, many of the thousands of cases brought forward were consolidated into multidistrict litigation (MDL) in federal court for the Western District of Louisiana.
MDL is a federal court procedure that combines civil lawsuits involving the same defendant and similar issues into a single case or court.
The $9 billion settlement case in April 2014 in Louisiana was the first federal multidistrict litigation case to go to trial, which is also known as a bellwether trial. A bellwether trial is used as a test case to help determine future settlements within multidistrict litigation.
Actos (Pioglitazone) Lawsuit Attorneys Serving The U.S.
Even though there is little active litigation involving Actos, you may still be entitled to a case. If you’ve taken Actos and developed bladder cancer or other severe side effects, consult with an attorney to help you determine if taking legal action is possible and in your best interest.
At Florin|Roebig, our top-rated dangerous drug and Actos lawsuit attorneys include:
- Wil H. Florin, B.C.S.
- Tommy D. Roebig, B.C.S.
- Michael L. Walker, B.C.S.
- Shaun M. Cummings
- Luca G. Esposito
- Chad K. Florin, M.B.A., LL.M.
- Nicholas S. Costantino
- Jordan A. Kolinski
- Matthew L. McMullen
- Michael A. Ossi, O.C.
- Lawrence J. Najem, O.C.
- Andrew M. Leone, O.C.
- Nollys R. Solarte, O.C.
- Brian R. Dettman, O.C.
Contact Florin|Roebig For Help Filing An Actos Lawsuit
Once you reach out to our offices, you’ll receive a free case evaluation. This case evaluation can help you decide if you wish to pursue further legal action. Tekeda has been involved in litigation surrounding Actos for nearly a decade, and you may have a case depending on the details of your claim.
To find out if you qualify for an Actos lawsuit, contact Florin|Roebig today.