Takeda Pharmaceutical has been exposed.
Whistleblower and former medical reviewer, Helen Ge, claimed that Takeda Pharmaceutical neglected to report hundreds of congestive heart failure cases associated with type 2 diabetes drug, Actos, and will be suing the company.
According to the suit, Takeda’s U.S. unit didn’t red-flag heart failure cases that weren’t fatal and didn’t require hospitalization when reporting them to the FDA, in order to one up the competition and appear as a safer alternative.
Ge’s whistleblower lawsuit was filed in June 2010 in U.S. District Court, District of Massachusetts. It was sealed until recently, when the U.S. Justice Department declined to join the lawsuit, Bloomberg reported. Despite the federal government’s refusal to join her suit, Ge is going ahead with her claim. But Ge’s lawyer says he believes that additional evidence will persuade prosecutors to join up.
The whistleblower lawsuit is seeking three times the amount of actual damages that the federal government, and any states that were involved, incurred. It also seeks civil penalties for each false claim that Takeda made. Because the lawsuit was filed under the federal False Claims Act, GE would be entitled to as much as 30 percent of what the government recovers.