Actos Whistleblower Suit Unsealed

In late February 2012, U.S. District Court Judge F. Dennis Saylor unsealed a qui tam whistleblower lawsuit, alleging that a doctor contracting with Takeda Pharmaceuticals, the manufacturer of Actos, was met with resistance from her superiors at Takeda when she attempted to report Actos bladder cancer findings. Dr. Helen Ge claimed that Takeda hired her under contract in September of 2008 and charged her with the task of reviewing various drugs in the Takeda portfolio for adverse reactions, including Actos.

In her whistleblower complaint, which was filed under seal in June of 2010, Dr. Ge asserts that at a time when an excess of 100 cases of Actos bladder cancer had been reported to the company, the U.S. Food & Drug Administration (“FDA”) only received 72 of those reports. Dr. Ge’s complaint also alleges that Takeda failed to report all cases of Actos heart failure to the FDA and instructed its medical reviewers not to report hundreds of non-hospitalized or non-fatal congestive heart failure cases as serious adverse events. Dr. Ge claims that her contract with Takeda was abruptly terminated when she approached the firm with accusations that the pharmaceutical company was underreporting adverse reactions to Actos. Dr. Ge’s complaint was recently summarized in Lawyers Weekly USA (March 19, 2012).

Last year, the FDA issued a safety bulletin on the findings that taking Actos for more than 12 months is associated with an increased risk for bladder cancer. Actos is a Type 2 diabetes medication that became a popular treatment for Type 2 diabetes patients when GlaxoSmithKline’s Avandia was found to be linked to a greater risk of heart attacks and other adverse cardiac events. Takeda may have been motivated to fraudulently report and under report serious adverse events so that Actos would not suffer the same fate as Avandia. According to Dr. Ge’s lawsuit, Takeda’s alleged conduct was driven by an economic desire to falsely enhance Actos’ safety profile and to increase sales.
Dr. Ge’s lawsuit is filed in the U.S. District Court for the District of Massachusetts, and is filed under the False Claims Act. It seeks to recover funds paid to Takeda by Medicaid, Medicare, and other federally funded healthcare programs.

In addition to the whistleblower lawsuit, men and women all over the United States are filing claims against Takeda for Actos related injuries such as bladder cancer. If you or a loved one has been diagnosed with bladder cancer after taking Actos, you should contact one of Pope McGlamry’s Actos side effects lawyers (Atlanta: 877-285-7656 / Columbus: 877-265-7656) today to discuss your claim.