A U.S. unit of Japan-based Takeda Pharmaceutical Co. downplayed the seriousness of hundreds of cases of congestive heart failure linked to its diabetes drug Actos to federal regulators, a Takeda employee alleges in a whistle-blower lawsuit she brought against the company.
All pharmaceutical companies are required by law to report adverse drug reactions to the U.S. Food and Drug Administration’s Adverse Event Reporting System (AERS). This information updates the drug database and keeps regulators apprised of safety concerns that could influence how the drug is marketed.
Helen Ge, a medical reviewer for the Actos manufacturer, alleges that from 2007 to 2010, Takeda Pharmaceuticals North America Inc. didn’t classify congestive heart failure cases as “serious” if they weren’t fatal or didn’t result in hospitalization.
“These events were not properly identified or reported in the FDA’s safety database,” Ms. Ge alleges in the complaint. “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,” Ms. Ge says.
Ms. Ge’s complaint also alleges Takeda whitewashed clinical data exposing a link between Actos and the risk of bladder cancer. The corporate culture in Takeda is “riddled with systematic fraud and deceit,” she alleges in the lawsuit.
Ms. Ge filed the complaint in U.S. District Court in Boston in June 2010. It became public after the U.S. Department of Justice declined to join it in February.
The lawsuit also alleges that in an effort to make Actos appear safer than GlaxoSmithKline’s diabetes drug Avandia, Takeda often “improperly instructed” medical reviewers such as Ms. Ge to “change their professional opinion regarding adverse event classifications and assessments.” Ms. Ge objected to this practice and was terminated as a result, the complaint says.
Ms. Ge is suing Takeda under the federal False Claims Act, alleging that “Takeda’s fraud has caused tens of thousands of false claims to be made on federal and state health care programs,” which has led to “hundred of millions of dollars” in damages. If her case successfully recovers damages for the federal and state governments, she would be entitled to 15 to 30 percent of the damages.
ACTOS is a trademark of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc. AVANDIA is a registered trademark of GlaxoSmithKline.