A doctor under contract with Takeda Pharmaceuticals claims in a whistleblower lawsuit that she met with resistance from her superiors at Takeda when she attempted to report Actos bladder cancer findings. Dr. Helen Ge, in a qui tam lawsuit recently unsealed, said that Takeda hired her under contract in September 2008, charging her with the task of reviewing various drugs in the Takeda portfolio—including Actos and bladder cancer—for various adverse reactions.
In her whistleblower complaint, which was filed under seal on June 18, 2010, Dr. Ge asserts that at a time when in excess of 100 cases of Actos bladder cancer had been reported to the company, the FDA only received 72 of those reports. Actos became the golden child in Takeda’s drug portfolio and hit the jackpot after GlaxoSmithKline’s Avandia was linked to a greater risk for heart attack and other cardiac events. Doctors switched their Type 2 diabetes patients to Actos in droves, believing that Actos carried less risk for heart failure and other adverse reactions to their patients. Takeda took full advantage of that belief.
Dr. Ge also alleges in her Actos lawsuit that Takeda failed to report all cases of Actos heart failure to the FDA. It was further alleged that “Takeda instructed its medical reviewers not to report hundreds of non-hospitalized or non-fatal congestive heart failure cases as ‘serious adverse events’ and thus avoided its responsibility of accurately analyzing and reporting these hundreds of serious adverse events to the FDA.” When Dr. Ge approached Takeda with the accusation that the pharmaceutical company was underreporting cases of Actos heart failure and congestive heart failure events to the FDA, her contract with the firm was abruptly terminated.
The FDA issued a safety bulletin last year relating to the concern that taking Actos for more than 12 months is associated with an increased risk for bladder cancer. Type 2 diabetes is one of the maladies affecting some of the largest pockets of the US population and the treatment to manage diabetes is an ongoing process. Mitigating the risk for Actos bladder cancer, therefore, would require coming off Actos after a year and switching to other medications. Dr. Ge alleges in her complaint:
Takeda’s motivation to fraudulently report and underreport the serious adverse events was driven by an economic desire to falsely enhance Actos’ safety profile and to increase sales.
The Actos lawsuit, filed in the U.S. District Court for the District of Massachusetts, under the False Claims Act, seeks to recover funds paid to Takeda by Medicaid, Medicare and other federally funded health care programs. It is alleged in the lawsuit:
Takeda has caused thousands, if not millions, of false claims to be made on federal and state health care programs.
The case asserts causes of action under false claims statutes of no fewer than 24 states. The qui tam whistleblower lawsuit for Actos bladder cancer and other Actos side effects was unsealed by US District Court Judge F. Dennis Saylor.
Source: Lawyers and Settlements
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.