We are no longer accepting Actos cases.
Dr. Helen Ge is a medical doctor and former safety consultant to Takeda. In 2010, Baum Hedlund, Aristei & Goldman filed Dr. Ge’s qui tam action (a lawsuit brought by a private party on behalf of the government) under the federal False Claims Act. The lawsuit alleges that Takeda intentionally made false statements to, and withheld facts from, the Food and Drug Administration in an effort to maximize profits from its diabetes drug, Actos. This opening brief lays out the basis of Dr. Ge’s lawsuit.
The essence of Dr. Ge’s argument is stated simply in the preliminary statement: “Takeda was able to mislead one hand of the government (the FDA) while getting paid handsomely for its deception by the other (federally-funded healthcare organizations).” Dr Ge’s lawsuit was dismissed by a lower court and has been appealed to the United States Court of Appeals for the First District. The Federal government and a prominent law firm have both filed amicus briefs in the suit, arguing, as does the plaintiff in this opening brief, that the lower court misinterpreted the language, intent, and legal requirements of the False Claims Act.
Dr. Ge alleges that while she worked for Takeda she “was directed to misreport adverse events, including incidences of congestive heart failure, renal failure, pancreatic cancer, cardiomyopathy, suicidal ideation and most notably, bladder cancer.” She contends that, in essence, Takeda made false claims to the federal government by failing to properly report the bladder cancer risk associated with Actos, thereby allowing Takeda to receive monetary payment that it would not have received had it been forthcoming regarding Actos’ bladder cancer risk. The government is therefore entitled to recover Medicare and Medicaid expenditures that were based upon Takeda’s misrepresentation of its drug’s safety.
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