Years after agreeing to pay nearly $2.4 billion to resolve more than 8,000 Actos lawsuits, the manufacturers of the controversial diabetes drug face a new product liability lawsuit brought on behalf of a man diagnosed with bladder cancer, as well as a loss of consortium claim brought by his wife.
The complaint (PDF) was filed last week on behalf of Jay Rosenblum and Robin Rehders in the U.S. District Court for the Middle District of Florida, naming Takeda Pharmaceuticals and Eli Lilly and Company as defendants.
Rosenblum began taking Actos in 2008, and continued to use the drug until April 2016, when he first discovered that there may be a link between Actos and bladder cancer he was diagnosed with in October 2014. He has since died, and the lawsuit claims that he never would have used Actos if the drug makers had adequately disclosed the risks.
Actos (pioglitazone) was one of the most widely used type 2 diabetes drugs in the United States at one time, but sales of fallen sharply since information has emerged about the potential link between Actos and bladder cancer. While the first concerns emerged in 2020, like Rosenblum, many individuals continued to take the medication without learning about the true nature of the risk until after thousands of lawsuits were settled, and the FDA required updated bladder cancer warnings in December 2016.
Takeda and Eli Lilly previously agreed to pay a massive Actos settlement in 2015, resolving claims that had been filed by that date. However, the companies contiued to face potential liability in other claims involving individuals later diagnosed with bladder cancer, or who still had additional time under the statute of limitations to pursue their claim.
The lawsuit filed on behalf of Rosenblum and Rehders indicate that as a result of the drug makers’ failure to disclose the true and significant risks associated with long-term Actos use, they remained unaware, and could not have discovered or learned about the link earlier.
“As a result of the defective nature of Actos, persons who were prescribed and ingested Actos for more than twelve months, including Plaintiff, were at increased risk for developing bladder cancer, have suffered and may continue to suffer from bladder cancer,” the lawsuit states. “Defendants concealed their knowledge that Actos can cause bladder cancer from Plaintiff, other consumers, and the medical community.”
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. However, it was not until December 2016 that the warning was strengthened to fully describe the risk, which plaintiffs allege should have been added earlier.
While the FDA has not required an Actos recall, sales of the drug have fallen substantially since information has become available to consumers and doctors about the potential bladder cancer risk.