U.S. District Judge F. Dennis Saylor issued an order on February 24, 2012, to unseal a whistleblower case (Case 1:10-cv-11043-FDS) by a former medical reviewer in Takeda’s pharmacovigilance division involving the failure to report bladder cancer and Congestive Heart Failure (CHF) adverse events for the diabetes drug Actos (the only drug in the same class and competing with GlaxoSmithKline’s Avandia).
The whistleblower also called a relator, is Dr. Helen Ge, a medical doctor and former safety consultant to Takeda Pharmaceuticals. She was hired by Takeda to work in the company’s pharmacovigilance department to review adverse events and to identify and evaluate potential safety signals for Actos (amongst other drugs).
Dr. Helen Ge’s Whistleblower Case Is Currently on Appeal
Dr. Ge had direct knowledge of the Actos bladder cancer risk and, according to the complaint, encountered resistance from her superiors when she tried to report bladder cancer as related to Actos. Dr. Ge claims her supervisors directed her to change her “related” assessment to unrelated. According to her recollection of reviewing Takeda’s adverse event database for Actos, there were more than 100 bladder cancers reported to the company, but only 72 reported to the FDA, which she states is “a serious discrepancy.” Dr. Ge also states in her complaint that carcinogenesis from Actos was discovered during the initial Actos animal studies.”
She alleges that Takeda failed to properly report all of the Actos related Congestive Heart Failure adverse events to the FDA. Specifically, according to the complaint, “Takeda instructed its medical reviewers not to report hundreds of non-hospitalized or non-fatal Congestive Heart Failure cases as ‘serious’ adverse events and thus avoided its responsibility of accurately analyzing and reporting these hundreds of serious adverse events to the FDA.” Dr. Ge estimates that Takeda failed to report several hundred Congestive Heart Failure events as serious between late 2007 and 2010.
When Dr. Ge complained to her superiors that her medical assessments were being downgraded from “serious” to “non-serious” and that, as a result of this, the Congestive Heart Failure events were being under-reported to the FDA, her contract with Takeda was terminated.
Dr. Ge also claims that Takeda not only took advantage of Avandia’s downfall (due to cardiovascular risks) by pushing Actos as a safe alternative to Avandia but possibly even orchestrated its downfall in order to seize the remaining market.
Baum Hedlund Aristei & Goldman filed the original qui tam lawsuit on June 18, 2010. An amended complaint was filed on September 29, 2011. In late 2011, Baum Hedlund was joined by Michael Sullivan, former U.S. Attorney for the District of Massachusetts, in representing the whistleblower.
Dr. Ge has filed this qui tam action on behalf of the United States and 23 states, including California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Minnesota, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Rhode Island, Tennessee, Texas, Wisconsin, The Commonwealths of Massachusetts and Virginia, and The District of Columbia.