Actos Lawsuits – Side Effects, FDA Warnings and Bladder Cancer
In 1999, the FDA approved the medication Actos (pioglitazone) for the treatment of type 2 diabetes. The drug works by helping the body to become more sensitive to the hormone insulin, lowering blood sugar levels.
However, within a few years of the medication’s launch, patients began coming forward complaining of serious side effects and filing Actos lawsuits. Most claims are related to Actos bladder cancer and heart failure. Plaintiffs maintain that Takeda Pharmaceuticals, the drug manufacturer, waited until 2011 to warn consumers about the risk of bladder cancer, after several studies and an FDA safety communication indicated a connection between the diabetes drug and the disease.
To date, over 3,000 Actos lawsuits have been filed in federal and state courts, and the number continues to rise. Patients who have taken Actos for one year or longer who are diagnosed with bladder cancer or heart complications are encouraged to talk to a lawyer about whether they qualify to file a claim of their own.
2011 FDA warning sparks more Actos lawsuits
Though studies linking Actos and bladder cancer were published as early as 2005, the bulk of the pending litigation was not filed until 2011 after the FDA released a safety announcement regarding the link between Actos and bladder cancer.
Back in September 2010, the FDA released an announcement stating that they were undertaking a review of the medication. Several studies later, the agency revealed a close connection between pioglitazone and the life-threatening disease. The findings were the result of the agency’s review of the interim results of a 10-year epidemiological study. In June 2011, they announced their conclusions— that patients taking high doses or consuming the drug for 12 months or more may have a higher likelihood of developing Actos-related bladder cancer.
Shortly thereafter, Takeda Pharmaceuticals updated the Actos label to reflect the FDA warning. Thousands of type 2 diabetes patients had been unwittingly exposed to the risk prior to the Takeda Actos label update, however. With the increased awareness spawned by the FDA warning, many victims decided to talk to a lawyer about recovering damages. In 2011, numerous Actos lawsuits were filed in courtrooms across the country.
Consolidation of Actos lawsuits
As the number of people who filed anActos bladder cancer lawsuit continued to rise, the U.S. Judicial Panel on Multidistrict Litigation (JPML) realized that the management of these cases could become difficult. To make it easier on all parties involved, the panel consolidated all federal cases into one court in the Western District of Louisiana.
The resulting Actos multidistrict litigation (MDL) allows all discovery and witness testimony to be centralized in one court, rather than in several around the country. This reduces the risk of inconsistent rulings, and is more cost efficient for both the plaintiffs and defendants.
State courts have the option to centralize Actos lawsuits filed in that state under a single court. Such litigation is often called a mass tort. Claims filed in California, for example, were consolidated in Los Angeles state court in January 2012. Similar to an MDL, a mass tort or centralized action coordinates all pre-trial proceedings to save resources and ensure consistency in pretrial rulings across cases that share common issues of fact and law.
In each of these types of litigation, the plaintiffs retain the individual status of their cases. Barring any pre-trial settlements, each case returns to its original filing location for trial. In a class action lawsuit — which is another option for plaintiffs claiming injuries from Actos—one plaintiff typically represents a group of people that have similar complaints. The attorneys in an Actos class action lawsuit would represent the interests of the entire class. Unlike an MDL or mass tort, however, the plaintiffs waive their rights to individual Actos lawsuits, and any settlement or jury award is equally divided.
Why do patients file Actos lawsuits?
Patients who develop bladder cancer or other serious side effects from Actos file claims to hold Takeda Pharmaceuticals liable for failing to provide adequate warnings about the serious health risks. The lawsuits often claim that the company failed to conduct sufficient safety studies on the drug before releasing it on the market. According to most lawsuits against Takeda, had additional pre-market testing been done, the company could have detected the risks much sooner, and prevented many patients from suffering bladder cancer and other problems.
Plaintiffs also contend that Takeda Pharmaceuticals should have warned about the risk of bladder cancer so that patients could have made more informed decisions before ingesting the drug. The company was reportedly aware of a potential connection between Actos and bladder cancer even before they released the medication, because of an early animal study that resulted in tumors.
Claimants hope that successful litigation will result in an Actos settlement or jury award that compensates them for medical expenses, lost wages, continued disability, pain, and suffering. In many other drug-related injury lawsuits, the attorneys on both sides may negotiate a settlement before trial. If the parties are unsuccessful at negotiation, the case will go to court.
Actos litigation news
The first of 2700 Actos lawsuits filed in the federal court system went to trial in 2014, and concluded with a headline-grabbing $9 billion jury verdict against Takeda and its U.S.-based partner Eli Lilly. Plaintiff Terrence Allen was awarded $1.5 million in compensatory damages. Allen’s lawyers argued that Takeda knew that Actos could cause cancer but hid this information from the medical community and the public to preserve profits from sales of the blockbuster drug. Evidence introduced at trial suggested that Takeda executives knowingly destroyed internal documents concerning the development of Actos, which may have shown that the company was aware that Actos was linked with an increased risk of developing cancer, particularly in patients who used the drug for more than 12 months. Takeda plans to appeal the verdict.
The first Actos lawsuit to reach trial in the U.S. was filed by plaintiff Jack Cooper in Los Angeles, California. Cooper claimed that Takeda willfully misled U.S. medical regulators about the risks. In documents submitted as evidence at the trial, it was revealed that Takeda executives had exchanged internal emails outlining a strategy in which information about the drug’s association with increased cancer risks would be downplayed to preserve sales numbers.
The plaintiff further claimed that the bladder cancer he was diagnosed with in 2011, after taking Actos for over four years, was directly caused by the medication.
In April, 2013, the California state court jury issued a verdict in favor of the plaintiff, and awarded Cooper $6.5 million in damages. The verdict was later vacated by Judge Kenneth Freeman, who ruled that the plaintiff failed to provide convincing evidence that Actos could be the direct and only cause of his cancer. Cooper’s attorneys intend to appeal the judge’s decision.
Talk to a lawyer about your Actos related injury
In addition to the 2011 FDA warning, several studies have linked Actos with bladder cancer.
- In 2005, the PROactive three-year study, which looked at cardiovascular outcomes, found a statistically higher percentage of bladder cancer cases in patients taking Actos versus comparable medications.
- In early 2011, the American Diabetes Association (ADA) published a study that found an association between Actos and bladder cancer.
- That same year, a retrospective cohort study in France demonstrated a significant increase in the risk of bladder cancer in men exposed to Actos for more than one year. In July 2011, Takeda Pharmaceuticals implemented an Actos recall in France.
At this time Actos is still available in the United States. Those who have been harmed by the Type 2 diabetes medication are urged to talk to a lawyer about their options for filing an Actos lawsuit. Don’t delay—all states have time limits for filing a claim.