A whistleblower complaint has been made public filed by a former Takeda medical reviewer alleging that Takeda Pharmaceuticals Co. failed to give accurate reports to regulators about hundreds of congestive heart failure cases associated with its diabetes medication, Actos. When the reviewer brought this to the company’s attention, she claims she was fired. The whistleblower complaint claims, “Takeda’s motivation to fraudulently report and under-report the serious adverse events was driven by an economic desire to falsely enhance Actos’s safety profile and to increase sales.”
The case brought under the False Claims Act was filed under seal in June 2010 and has now become public after the U.S. Justice Department declined to intervene. Although whistleblowers have the right to pursue their case even after the government doesn’t intervene, it is not very common for it to occur. The whistleblower’s lawyer believes that additional evidence might persuade the Justice Department to change its mind.
The whistleblower also claims that Takeda downplayed data suggesting a link between Actos and bladder cancer. Actos is currently the subject of hundreds of lawsuits on behalf of individuals who claim their ingestion of Actos is linked to their diagnosis of bladder cancer.