Dr. Speaks on Actos Bladder Cancer Whistleblower Lawsuit

In a recently unsealed qui tam lawsuit, Dr. Helen Ge revealed fraud and negligence on the part of Takeda Pharmaceuticals, maker of the popular diabetes drug Actos, which has now been linked to a high incidence of bladder cancer.

Ge was hired by Takeda in September 2008 to review a  number of drugs made by the pharmaceutical company, including Actos.  In a sealed whistleblower complaint filed in June 2012, Dr. Ge stated that while the FDA only received 72 reports of bladder cancer linked to Actos, Takeda Pharmaceuticals was aware of hundreds of such claims.

Actos (pioglitazone) rapidly grew in popularity after FDA approval in 1999 because of heightened concerns about another diabetes drug, Avandia, which can cause a higher rate of heart attacks and complications.

In her Actos lawsuit, Dr. Ge also states that Takeda Pharmaceuticals also failed to report the full extent of Actos heart failure cases to the FDA.  According to Dr. Ge, "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.”

Dr. Ge’s contract with Takeda Pharmaceuticals was quickly ended when she raised concerns about false study results concerning Actos congestive heart failure.

In a recent Lawyers Weekly issue, the FDA published a safety alert about the increased likelihood of bladder cancer when Actos is used for more than one year.  Because diabetes is one of the most common diseases in the U.S. population, this has huge implications for the millions of Americans currently battling diabetes, who may need to wean themselves from Actos after taking it for a year and switch to other medications.

In her complaint filed in the U.S. District Court for the District of Massachusetts, Dr. Ge states, “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.”  In her lawsuit filed under the False Claims Act, Ge seeks a refund of monies paid to Takeda by Medicaid, Medicare, and other federal health programs, stating, “Takeda has caused thousands, if not millions, of false claims to be made on federal and state health care programs.”

Contact an Actos Lawyer

If you took Actos and subsequently developed bladder cancer, you may be entitled to collect substantial compensation in pharmaceutical product liability or dangerous drug lawsuit.  Contact an experienced personal injury lawyer for a free review of your claim during a legal consultation.

May 7, 2012 | Tags: Actos, Dangerous Drugs, Whistleblower

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