The plaintiff is a 79-year-old retired accountant. She is the seventh Actos patient to bring her case to trial.
The U.S. Food & Drug Administration approved the use of Actos in 1999 to treat Type 2 diabetes. In 2011, the FDA warned that the use of Actos for more than one year may be linked to bladder cancer. In fact, long-term studies had shown that Actos use for more than one year increased a patient’s chances of getting cancer by as much as 40 percent.
Last spring, a federal jury awarded $1.5 million to an Actos plaintiff with bladder cancer, and slapped the manufacturer, Japan-based Takeda Pharmaceuticals, and co-marketer Eli Lilly, with $9 billion in punitive damages. The defendants have requested a new trial in that case.
In the Pennsylvania trial, the woman’s lawyer alleged that Takeda executives knew as early as 2004 that studies had shown Actos use was linked to cancer but didn’t start warning its users until seven years later, in 2011. The alleged motive was billions of dollars in earnings from the drug.
Sales of the drug reached a high of $4.5 billion in the year ended March 2011, and accounted for fully 27 percent of Takeda’s revenue at the time, according to Bloomberg news.
Takeda is the largest drug manufacturer in Asia.
The plaintiff’s attorney alleged that Takeda officials ignored or downplayed concerns about cancer links to Actos even before it went on sale in the U.S., and that they intentionally misled U.S. regulators about possible risks. In closing arguments, her attorney said, “Takeda chose to protect profits rather than patients.”
Takeda tried to argue that the plaintiff had other risk factors that caused her cancer other than Actos, including the fact that she smoked.
After the verdict was announced, Takeda’s general counsel issued a statement saying “Takeda respectfully disagrees with the verdict and we intend to challenge this outcome.”
During the trial, the woman’s team also alleged that Takeda executives purposefully destroyed documents related to Actos, including documents about its development, marketing and sales. “We’ll never know what was in those documents,” the plaintiff’s lawyer told the jury.