Actos Maker Accused of Hiding Heart Side Effects in Whistleblower LawsuitMar 8, 2012 | Parker Waichman LLP
A whistleblower lawsuit recently unsealed in Massachusetts federal court will likely raise more concerns about the safety of Actos. The whistleblower, a former medical reviewer for Takeda Pharmaceuticals, the maker of Actos, alleges that the company did not properly classify cases of congestive heart failure associated with the type 2 diabetes drug when they were reported to the U.S. Food & Drug Administration (FDA) Adverse Event Reporting System.
Congestive heart failure is a well-known Actos side effect. Since 2007, the Actos label has included a serious safety warning, a "Black Box," detailing this risk.
According to allegations made by Helen Ge, Takeda allegedly failed to classify “non-hospitalized or non- fatal” congestive heart failure cases as serious from late 2007 to January 2010. Ge claims Takeda was trying to make Actos appear safer than Advandia.
Avandia received a Black Box warning in 2007 because of its association with heart attacks, and sales of the drug were severely restricted in 2010. Actos was thought to be safer for the heart than Avanida. But last year, a study involving medical data from 28,938 people who took either Avandia or Actos found that that about 4 percent of each group died from heart failure or a heart attack.
“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,” Ge said.
Pharmaceutical companies are required to report drug side effects to the FDA. But according to Ge, Takeda directed its medical reviewers to "change their professional opinion regarding the classification of Actos adverse events” on multiple occasions between 2007 and 2010. Ge also claims that when she protested, her contract with Takeda was terminated.
Ge's lawsuit was brought under the federal False Claims Act, which allows private citizens to bring suit in instances of fraud against the federal government.
“Takeda’s fraud has caused tens of thousands of false claims to be made on federal and state health care programs,” causing “hundreds of millions of dollars” in damages, Ge alleges.
The Justice Department has declined to join Ge's Actos whistleblower lawsuit, but she has decide to pursue it on her own. If she prevails and recovers damages on behalf of the government, Ge will be entitled to as much as 30 percent of the recovery.