A whistle-blower has filed a lawsuit with specific and detailed information that Takeda Pharmacueticals failed to provide accurate reports about hundreds of congestive heart failures associated with the its diabetes medication Actos. It is unclear now as to how many individuals might have taken the drug and suffered damages but the government is examining data on this issue.The allegations were made public as part of a lawsuit filed by former Takeda medical reviewer Helen Ge. Ge said the company failed to classify “non-hospitalized or non-fatal” congestive heart failure cases as serious from late 2007 to January of 2010. She also says the motivation for hiding these adverse events from regulators was driven by the company interest on increasing profits.
Takeda, like all other drug manufacturers, is required to provide an accurate representation of adverse events to regulators, and if these allegations are true, Takeda has attempted to circumvent this requirement .
Ge claims that Takeda’s culture is “riddled with systematic fraud and deceit.” She claims that in addition to the hiding congestive heart failure risks, the company also downplayed their own data suggesting a link between Actos and bladder cancer.
The suit was filed under the False Claims Act and seeks to recover damages on behalf of governments that have paid for tens of thousands of false claims through health care programs.