According to Takeda Pharmaceuticals, the manufacturer of the popular type 2 diabetes drug, enough plaintiffs have accepted the settlement program to settle their Actos bladder cancer lawsuits.
A global Actos settlement was announced by Takeda back in April, but the company wanted a 96% participation by the injured patients in order to move ahead. With the threshold for plaintiff settlement participation achieved recently, the $2.4 billion settlement is moving towards resolution.
More Than 10,000 Actos Lawsuits Filed Across United States
There are currently more than 10,000 Actos personal injury bladder cancer and defective product liability lawsuits filed in the United States, filed in both federal and state courts. Diabetic patients claimed that the drug manufacturer withheld critical information about the Actos bladder cancer side effects, from patients, federal regulators and the medical community.
Actos Causes Bladder Cancer
Actos (pioglitazone) was an extremely popular type 2 diabetes drug, which achieved blockbuster sales in the United States. In 2010, experts began to question the safety profile of the drug, particularly the increased risk of bladder cancer.
In June 2011, the FDA made Takeda Pharmaceuticals to update the Actos warning label to include the increased bladder cancer risk, and that patients were exposed to an increased risk the longer the diabetic medication is used.
How Does Actos Cause Bladder Cancer?
The exact mechanism how Actos and its breakdown products cause bladder cancer is in dispute. But according to some experts, the active by- product of Actos is crystalline and that is passed in the urine, causing chronic irritation to the lining of the bladder. Studies have shown that chronic irritation increases the risk of bladder cancer.
Takeda Knew of The Increased Risk of Bladder Cancer
According to lawsuit allegations, the plaintiffs claim that Takeda knew about the risk of Actos bladder cancer, but actively hid the shocking information to continue the explosive sales of their drug.
The Japanese manufacturer lost five of the first eight bellwether trials, but two verdicts later were overturned on appeal. The Actos settlement offer came after several juries returned multi-million dollar damage awards, including one case that resulted in a $9 billion verdict with punitive damages designed to punish the drug maker.
The federal judge overseeing over the litigation reduced the verdict to $37 million.
Actos Settlement Details
According to the Master Settlement Agreement, the amount of money each claimant may be awarded will be calculated using a “Points Matrix.” Each claim will be awarded points, and the more points awarded, the more money a claimant could receive.
Some of the settlement criteria include:
- Extent of injury and treatment, severe injuries will get a bigger settlement
- Age, younger patients diagnosed with bladder cancer will get more than older patients
- Length of time a person took Actos
- Cumulative dosage of Actos
- Risk factors for bladder cancer, including smoking
Takeda did not admit liability, saying it had settled to “reduce the uncertainties of complex litigation.” It said that the claims in the lawsuit were without merit and that the benefits of Actos outweighed any risks. Takeda continues to sell Actos.
Sales of Actos in the United States have exceeded $24 billion since it went on sale in 1999, with more than 100 million prescriptions written. The drug now faces generic competition.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.