Medical reviewer Helen Ge has filed a whistleblower lawsuit on behalf of the government in U.S. District Court, District of Massachusetts (Boston), against Takeda Pharmaceutical Co. alleging the drug manufacturer failed to accurately report hundreds of congestive heart failure cases that were associated with the diabetes drug Actos.
All drug makers are required to update the Food and Drug Administration’s Adverse Event Reporting System, however, the lawsuit claims that Takeda did not classify “non-hospitalized or non-fatal” congestive heart failure events as serious in the database from 2007 to 2010.
In the lawsuit, Ge says, “These events were not properly identified or reported in the FDA’s safety database. 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,” Bloomberg reported.
Takeda’s Tokyo-based spokesman Hisashi Tokinoya said in an emailed response that “Takeda complies with all laws and regulations regarding the reporting of adverse events,” Bloomberg said.
Ge filed the lawsuits under the False Claims Act and seeks to recover damages on behalf of the government, which has declined to join the lawsuit.