In 2011, three years after John Kristufek began taking the type 2 diabetes drug Actos,, he developed bladder cancer. Coincidentally that same year, studies linked Actos to an increased risk of type 2 diabetes. Since then, evidence began to surface that Actos maker Takeda Pharmaceuticals knew its blockbuster diabetes drug could cause bladder cancer but failed to warn doctors or patients.
Now, after several procedures to have recurring tumors removed and, subsequently his entire bladder removed, Kristufek is getting his day in court. Kristufek’s filed his lawsuit alleging the Actos bladder cancer link in July 2012 in the Philadelphia Court of Common Pleas, and testimony is currently underway.
Takeda is fighting the evidence mounting against it in Kristufek’s case, claiming the man was a heavy smoker, a risk factor for bladder cancer, and that he had been diagnosed with bladder cancer years earlier though he had since been pronounced cancer free.
The warnings Takeda eventually placed on packages of Actos after the FDA’s insistence states that preclinical and clinical trial data and results from an observational study suggested an increased risk of bladder cancer in users of Actos, and that the risk increases with duration of use. The label also warns that the drug should not be used in patients with active bladder cancer and that caution should be used in patients with prior history of bladder cancer.
The federal multidistrict litigation alleging Actos causes bladder cancer turned heads when a Louisiana federal jury awarded a single plaintiff $9 billion in damages. U.S. District Judge Rebecca Doherty was rather vocal in her opinions regarding Takeda’s evidence spoliation, though punitive damages against Takeda were later slashed to $27.7 million.