Whistleblower Lawsuit Alleges Drug Company Knew Actos Was Linked to Heart Failure

A whistleblower lawsuit filed by a former medical reviewer for Takeda Pharmaceutical Co, claims the company gave false reports to regulators concerning the safety of diabetes drug Actos.

The lawsuit alleges Takeda gave inaccurate information to the U.S. Food and Drug Administration's Adverse Event Reporting System about the number of congestive heart failure cases associated with Actos. According to the whistleblower, the culture at Takeda is fraught with fraud and deceit. Takeda also allegedly hid information about a link between Actos and bladder cancer.

According to papers filed in federal court, the pharmaceutical giant told medical reviewers to change their professional opinion when recording adverse event classifications. The lawsuit also claims that Takeda falsified the reports to make Actos appear safer than GSK's diabetes drug, Avandia, and to increase sales.

A Takeda spokesperson states that the company "complies with all laws and regulations regarding the reporting of adverse events," but would not comment on several current Avandia lawsuits as they are still pending.

In 2007, the FDA ordered Takeda and their competitor, GalaxoSmithKline (GSK), to place the strongest warning labels on their drugs about the risk of congestive heart failure.

In 2010, GalaxoSmithKline paid $250 million as part of a settlement relating to the manufacture and distribution of their drugs. Cases involving healthcare fraud and cover-ups about the ill effects of widely-distributed medications like Avandia and Actos are common in the United States. In fact, about 90 percent of such lawsuits are actually initiated thanks to insiders (whistleblowers) on behalf of the government.

Those that have knowledge of deceitful practices at drug companies have the right to speak out about potential fraud and improper marketing practices. Bringing evidence of inaccurate testing information or falsified numbers is an important step in protecting patients across the nation from potentially dangerous drugs. Those with evidence of such practices should talk to an attorney about their rights under qui tam (whistleblower) actions.

And for those who have suffered as a result of taking a dangerous drug like as Avandia or Actos, speak to an experienced pharmaceutical litigation attorney about your legal options.

Related resource: Bloomberg.com, "Takeda Hid Actos Adverse Effects From Regulators, Suit Says," 3/7/12.