Dr. Helen Ge is asking the Supreme Court to revive the whistleblower lawsuit she filed against her former employer, Takeda Pharmaceuticals Company Ltd. Her lawsuit, which was dismissed on pleading grounds, claims that her former employer concealed the safety risks associated with a diabetes drug called Actos (pioglitazone), which is one of Takeda’s most successful drugs.
Dr. Ge worked as a medical reviewer in Takeda’s pharmacovigilance division, where her job included identifying and evaluating potential safety signals for Actos. In the course of her work, she had direct knowledge of a link between Actos and harmful side effects such as bladder cancer and congestive heart failure. When she tried to report the link between Actos and bladder cancer, Dr. Ge claimed that her superiors directed her to change her assessment of the drug’s link from “related” to “unrelated.” She further claims that Takeda failed to report each adverse heart effect linked to Actos to the Food and Drug Administration (FDA).
Through her whistleblower attorneys at Baum Hedlund Aristei & Goldman, Dr. Ge filed a qui tam lawsuit in the U.S. District Court for the District of Massachusetts, First Circuit on June 18, 2010. At the time of the filing, the circuit’s pleading standards for False Claims Act cases were “in flux,” according to her attorneys. She nonetheless believed that her allegations were sufficient to state a claim under existing law, but just to be cautious she requested leave to amend in case the district court disagreed. Her pre-judgment motion was ignored and ultimately the district court rejected Dr. Ge’s claims.
Confused as to why the court was silent on her pre-judgment request, she filed a post-judgment motion to amend, replete with expert testimony, and other witness declarations. The court denied this motion without explanation. In her appeal, Dr. Ge was told her pre-judgment efforts to amend were insufficient and her post-judgment efforts were “too little, too late.”
On April 10, 2014, Ge and her lawyers filed a certiorari petition, asking the Supreme Court to decide what leniency should be given to whistleblowers in granting leaves to amend. They claim that the circuit courts have inconsistent standards allowing whistleblowers to amend and that this case represents the perfect vehicle to address the inconsistencies. “The petition raises a really important circuit split regarding what rights a plaintiff has to seek an amendment to a complaint once the case has been dismissed,” said R. Brent Wisner, one of Ge’s attorneys. “Our system should not be about meeting specific technicalities but getting to the merits of the case.”