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Actos Lawsuit News: Qui Tam Lawsuit Against Takeda Dismissed

In the latest Actos lawsuit news, a federal appeals court recently dismissed claims made by a relator in a qui tam case against Takeda Pharmaceuticals. On December 6, 2013, the 1st Circuit U.S. Court of Appeals rejected the theories of Dr. Helen Ge, who had alleged that all claims submitted for the drugs Actos and Prevacid were rendered false because of alleged misconduct on the part of the defendants. The Court found that the relator did not properly present her theories to the trial court and that sufficient specific information was not presented.

A qui tam case is one that involves a whistleblower and a relator is the plaintiff. The relator does not need to have been personally adversely affected by the alleged misconduct of the defendants. Qui tam lawsuits enable whistleblowers and government bodies to work together to stop all types of fraud, including Medicare and Medicaid fraud. The relator is also eligible for monetary compensation.

Relator alleged reporting discrepancies

Dr. Helen Ge is a medical doctor and former medical reviewer who had worked for Takeda Pharmaceuticals. She worked in the company’s pharmacovigilance department. Her job responsibilities included evaluating adverse event reports and identifying safety signals for drugs such as Actos. According to her complaint, she attempted to truthfully report about the Actos cancer risk, but was instructed by supervisors to falsely alter her assessment. As the relator was reviewing adverse event reports, she found 100 reports of bladder cancer made to the company, yet only 72 were passed on to the FDA. These reporting discrepancies formed the basis of one of Ge’s qui tam lawsuits, along with other allegations. The relator had filed two complaints, which involved different drugs.

The relator also claimed that because Takeda failed to adequately disclose the bladder cancer risks of Actos and other drugs, false claims were submitted by physicians and patients. These alleged false claims were of interest to government officials investigating potential Medicare and Medicaid fraud.

Court finds insufficient supporting evidence

Takeda Pharmaceuticals moved for dismissal for failure to plead fraud with particularity. The defendants also claimed failure to state a claim. The Court found for the defendants, dismissing the claim because “although relator has alleged facts that would demonstrate a ‘fraud-on-the-FDA’ with respect to intentional under-reporting of adverse events, she has failed to allege the specific details of any claims that were allegedly rendered ‘false’ as a result.”

The Court noted that the relator tried to rectify this problem with a reference to the total aggregate expenditure data for Actos by the government, which was available in her attorney’s declaration. However, the Court determined that while they could consider this Actos data, the information did not meet Rule 9(b)’s particularity requirement.

Since Ge’s qui tam lawsuit lacked specifics, the Court had to assume that the relator was alleging that all claims for Actos and Prevacid were rendered false because of misconduct by Takeda. Ultimately, the Court decided that Ge’s assertions did not prove that the FDA would have withdrawn approval for the drugs had they received the information that had been withheld.

In related Actos lawsuit news, other plaintiffs who have been personally harmed by the side effects of the drug are still awaiting their day in court. The plaintiffs claim that they were inadequately warned that Actos had the potential to cause life-threatening bladder cancer.

  1. Yahoo Health, Actos Side Effects,

  2. Bloomberg News Service, Takeda Failed to Properly Warn About Actos, Jury Rules,