Actos Settlement To Go Forward After Participation Threshold Reached

Takeda Pharmaceuticals indicates that a sufficient number of plaintiffs nationwide have agreed to settle their Actos bladder cancer lawsuits, so a previously announced $2.4 billion settlement program will move forward.

There are currently more than 8,000 product liability lawsuits pending throughout the United States, which were brought by individuals diagnosed with bladder cancer, alleging the drug maker withheld information about the potential side effects of Actos.

In a press release issued this week, Takeda Pharmaceuticals announced that 96% of all eligible claimaints have opted in to an Actos settlement program first announced on April 28. The statement comes after weeks of speculation about whether the deal would reach the required 95% participation threshold required to prevent the drug maker from backing out of the agreement.

Actos (pioglitazone) was one of the most widely used type 2 diabetes drugs in the United States, until concerns emerged in 2010 about the potential link between Actos and bladder cancer.

In June 2011, the FDA required Takeda Pharmaceuticals to update the Actos warning label to add information about the bladder cancer risk, informing consumers that they may face an increased risk the longer the drug is used.

In lawsuits filed in state and federal courts throughout the United States, plaintiffs allege that Takeda knew about the risk of bladder cancer from Actos, but actively withheld the information in an attempt to minimize the impact on sales of their blockbuster treatment.

The Actos settlement offer came after several juries returned multi-million dollar damage awards in individual cases that have gone to trial, including one case that resulted in a $9 billion award with punitive damages designed to punish the drug maker. Although the federal judge presiding over the litigation subsequently reduced the verdict to $37 million, she indicated that the case was an example of why the Supreme Court needs to update rules on what is considered excessive punitive damages in order to more effectively deter the type of bad behavior exhibited by Takeda surrounding Actos.

The $2.37 billion agreement is expected to provide an average payment of about $296,000 per case for individuals diagnosed with bladder cancer. However, the individual awards may be reduced based on the user’s age, exposure to other cancer-causing toxins and smoking history. The amount is set to rise to $2.4 billion if 97% of all eligible claimants participate.