Actos, a popular Type 2 diabetes medication, has recently come under scrutiny. A brand name version of the generic drug pioglitazone, Actos is currently the subject of a number of safety concerns. Used in conjunction with diet and exercise, the drug is designed to help control patients' blood sugar levels.
The U.S. Food and Drug Administration (FDA) approved Actos in 1999. Manufactured by Takeda Pharmaceuticals, the medication has been a financial success with domestic sales of over $3.5 billion in 2010 alone. However, the expiration of Takeda's patent on Actos and recent negative publicity about the drug's safety have led to a decline in sales.
Serious Side Effects
Actos has been linked to two serious side effects: heart failure and bladder cancer.
In 2007, the FDA determined that the thiazolidinedione (TZD) class of diabetes medications, which includes Actos, may cause heart failure in some patients. Thus, the FDA required that Takeda place a black box warning, the FDA's strongest warning, on Actos labeling to alert consumers of the increased risk for heart failure.
Bladder cancer is another serious complication associated with Actos, subjecting Takeda to numerous Actos lawsuits. In 2011, the FDA announced that long term use of Actos (regular use for more than one year) may be associated with an increased risk of bladder cancer. The FDA approved the risk information on Actos labeling after carefully reviewing a ten-year long medical study on Actos. The study revealed that patients with greater exposure to Actos, due to either prolonged use or a higher dosage, faced an increased risk of bladder cancer. Consequently, the FDA advised health care professionals to avoid prescribing Actos to patients with bladder cancer or a history of bladder cancer.
Many Actos users have filed product liability lawsuits against Takeda to recover compensation for their injuries such as medical expenses, lost wages, and pain and suffering. Under product liability law, manufacturers and sellers have a duty to ensure that the products they place in the market are free from any unreasonable defects or dangers.
For a product liability to be successful, the plaintiff must prove that the product was defective and this defect caused his or her injuries. There are three types of defects in product liability: design defects, manufacturing defects, and warning defects.
A common defect claim in the Actos lawsuits is defective warning. Warning defects occur when manufacturers fail to provide adequate instructions or warnings for their products. For example, many plaintiffs argue that Takeda breached its duty to warn consumers about Actos' increased risk of bladder cancer. Plaintiffs allege that Takeda knew about this risk several years before the FDA's 2011 mandate to include the black box warning but continued to sell the drug for the sake of profits.
Actos Lawsuit Results
Many of the Actos-related lawsuits filed against Takeda in federal courts have been consolidated into a multidistrict litigation (MDL) in Louisiana. An MDL is a federal court procedure used to consolidate civil cases involving similar issues and a common defendant into a single court for pre-trial proceedings.
In April 2014, the first case from the Actos MDL that went to trial resulted in a multibillion dollar verdict against Takeda. For Actos lawsuits, this case was a bellwether trial. Bellwether trials are representative cases selected by judges and parties that feature all of the issues that will arise in each plaintiffs' case. Bellwether trials are used to resolve massive product liability cases. By providing an idea of what kind of results can be expected, the parties are encouraged to reach settlements in other cases. This bellwether trial suggests that juries may rule in favor of plaintiffs in future cases.
In the bellwether case, the verdict against Takeda included $1.5 million in compensatory damages as well as $6 billion in punitive damages. Punitive damages serve two main purposes: the first is to punish the conduct of parties that knowingly and purposefully acted wrongfully, and the second is to deter others from engaging in similar conduct. As a note, the punitive damages are likely to be reduced because the U.S. Supreme Court has previously held that excessive punitive damages (anything in excess of ten times the compensatory damages) are unconstitutional.
There have been other substantial awards arising from Actos litigation in state courts, but those verdicts were thrown out. So far, there has been no indication of any substantial Actos settlements.
Learn More About Your Actos Claim
If you think you've been injured by Actos and are considering legal action, you can have an experienced product liability attorney review your claim. You should act as soon as possible because all states have statues of limitations, or time limits, for these types of claims.
Contact a qualified product liability attorney to make sure your rights are protected.