A whistle-blower lawsuit filed by Dr. Helen Ge against her former employer, Takeda Pharmaceuticals, has been dismissed.
In her 2010 suit, Ge claimed that Takeda officials had failed to report the side effects of their popular diabetes drug Actos to the U.S. Food and Drug Administration (FDA). Ge also said that Takeda “intentionally misrepresented and altered the descriptions of adverse events in reports” submitted to the FDA, labeling the side effects as “non-serious.”
The suit was dismissed earlier this month by U.S. District Judge F. Dennis Saylor of the District of Massachusetts, who said that Ge should have brought her complaints to the FDA and allowed the agency to determine the next action, rather than file a suit under the federal False Claims Act.
Ge worked as a drug safety consultant at Takeda from 2008-2010 and was involved in the study of potential adverse effects that patients could experience from Takeda’s products, including Actos. Prior to her employment with Takeda, she was a clinical research fellow at the University of Pittsburgh School of Medicine and an associate medical director at the Harvard Clinical Research Institute.
Between 2007 and 2010, Ge claims, Takeda failed to accurately report incidences of congestive heart failure linked to Actos, which is used to treat patients with type 2 diabetes.
“These events were not properly identified or reported in the FDA’s safety database,” Ge claimed in the suit. “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 also states that Takeda “improperly instructed” its medical reviewers to “change their professional opinion regarding adverse event classifications and assessments.” When she protested, “her contract was summarily terminated.”
In addition, she claims, Takeda discounted data that suggested a link between Actos and bladder cancer. According to Ge, more than 100 patients who were taking Actos reported cases of bladder cancer. Also, during animal testing prior to the drug’s release in 1999, Ge reports that test animals developed cancer.
In 2007, the FDA added a black-box warning to Actos to make patients aware of the risk of congestive heart failure. And in 2011, the FDA issued a safety warning that use of Actos for longer than a year may be associated with an increased risk of bladder cancer.
Ge filed her lawsuit under federal and state whistle-blower statutes that protect employees who report potentially dangerous issues. Ge sued under the False Claims Act, which allows a citizen to file suit on behalf of the government, specifically against a company that commits fraud against a government agency.
As part of her suit, Ge stated that the misrepresentation of side effects had led to increased strain on the Medicare system, in which patients taking Actos experienced heart problems and bladder cancer. The federal government, as well as two dozen states, declined to join the lawsuit.
In his decision to dismiss the case, Saylor stated that Ge should have brought her complaints to the FDA. He also cited the lack of specificity in “the details of any claims for payment made to any of the states.”