Whistleblower (Qui Tam) Lawsuit: Actos Heart Problems Kept from FDA

According to a recent whistleblower lawsuit, Takeda Pharmaceuticals hid evidence about the association of their drug, Actos, with congestive heart failure and the death of some Actos patients.

In a suit filed by former Takeda medical reviewer Helen Ge, it is alleged that hundreds of Actos heart failure cases were not reported between the years of 2007 and 2010.  Ge made these allegations in 2010, and the complaint was recently unsealed.

Federal laws require pharmaceutical companies to report adverse events linked to their drugs.  Actos lawyers have suggested that Takeda hid the number of Actos heart attacks in an attempt to gain an advantage over a competitive drug, Avandia.

May 2007 saw the release of the first of a number of scientific studies that linked Avandia, a diabetes drug, to a heightened risk of heart attacks.  Increasing evidence in support of this link caused Avandia sales to drop sharply, while Actos sales increased.  In 2010, the FDA issued severe restrictions for the use of Avandia.  Several other countries banned Avandia altogether.

During this period, Actos was commonly compared to Avandia and the Takeda drug was made to seem safer by comparison.  In Ge’s qui tam lawsuit, she claims that Takeda hid reports on hundreds of cases where Actos users suffered non-fatal heart failure.

Actos (pioglitazone) was approved for the treatment of Type 2 Diabetes by the FDA in 1999.  At its most popular, Actos generated roughly $4 billion per year in sales.

According to Ge, Takeda medical reviewers were encouraged to change their professional opinions regarding adverse event reports received by the pharmaceutical company.  When Ge protested this “encouragement”, she was fired.  In a similar suit, Ge is also suing Takeda for hiding side effects of a gout medication called Uloric.

Ge filed her claim under the qui tam provision of the False Claims Act, which entitles individuals who report fraud against the government to receive some of the money recovered in a subsequent suit.

Contact an Actos Lawyer

It is now well-documented that there is a link between Actos and congestive heart failure.  If you suffered heart problems after taking Actos for diabetes, you may be able to recover compensation in a dangerous drug lawsuit.  For more information, contact a personal injury lawyer to schedule a free consultation and discussion of your options.

March 22, 2012 | Tags: Actos, Dangerous Drugs

View All Legal News