October 3, 2014 — Bloomberg reports that a jury in Philadelphia has awarded $2 million to a woman who developed bladder cancer after taking Actos (pioglitazone), a diabetes drug manufactured by Takeda Pharmaceuticals.
The jury deliberated for five hours, with eight out of nine jurors agreeing that Takeda should be held liable for failing to adequately warn Frances Wisniewski and her doctors about evidence linking Actos and cancer.
These claims were disputed by an FDA official tapped as Takeda’s expert witness, according to Law360. Dr. David Feigel, Jr., said the label on Actos contained all relevant information about the risk of bladder cancer.
Attorneys for Wisneiwski argued that the information was buried in a section describing carcinogenic and mutagenic data, rather than highlighted in the warning section on the label.
In June 2011, the U.S. Food and Drug Administration (FDA) published a Safety Communication warning about studies linking Actos to a 40% increased risk of bladder cancer compared to patients who never used the drug.
At that time, sales of Actos had peaked at $4.5 billion per year and the blockbuster drug made up nearly 30% of Takeda’s revenue. Attorneys argued that Takeda intentionally downplayed evidence of cancer, putting corporate profits above public safety. Takeda also destroyed documents on 46 employees, including top executives who were involved in Actos’s development and marketing.
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