The medical reviewer and former Takeda Pharmaceuticals Company Ltd. employee who blew the whistle on her former employer has asked the Supreme Court to revive her qui tam lawsuit. Dr. Helen Ge, a former safety consultant at Takeda, had her whistleblower lawsuit against Takeda dismissed on pleading grounds. She claims that Takeda hid the safety risks associated with Actos (pioglitazone), a diabetes drug that generated sales in the billions.
Dr. Ge and her attorneys at Baum Hedlund Aristei & Goldman filed a lawsuit against Takeda in 2010. The lawsuit claims that through her work as a medical reviewer, Dr. Ge learned about harmful side effects associated with Actos, including a link to bladder cancer and congestive heart failure. She took her findings to her superiors who challenged her assessment of drug’s link to these harmful side effects as “related” to the drug as opposed to “unrelated.”
Her lawsuit was filed in U.S. District Court for the District of Massachusetts, First Circuit where the pleading standards for False Claims cases were “in flux” at the time, according to her lawyers. Before her claims were heard, Dr. Ge filed a pre-judgment request to amend her allegations, just to make sure they were sufficient under existing law. Her motion was ignored and the district court rejected her claims. The court was silent as to why her pre-judgment motion was ignored.
Undeterred, she filed a post-judgment motion to amend, adding expert testimony and declarations from other witnesses. This motion was also denied without explanation.
On April 10, 2014, Dr. Ge and her attorneys filed a certiorari petition, asking the Supreme Court to decide whether whistleblowers should be granted leaves to amend, saying that the Takeda case represents the perfect vehicle to address inconsistencies in circuit court pleading standards. “Our system should not be about meeting specific technicalities but getting to the merits of the case.”
Takeda issued a response to the petition, which sought to rebut Dr. Ge’s argument that the same leave to amend standards should apply to each circuit court. On June 27, 2014, Dr. Ge and her attorneys filed another brief in support of her previous request to have the Supreme Court weigh in on the leave to amend standard. “Certiorari should be granted because, absent some direction from this court, the ability of litigants to amend pleadings and have the merits of their claims addressed, one way or the other, will frequently depend on the happenstance of geography, not the uniform application of the law,” the brief said.
The Supreme Court still has not decided whether to hear Dr. Ge’s case.
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