Chicago, ILDue diligence by the US Food and Drug Administration (FDA) in June 2011 and the regulator’s warning that use of Actos for more than one year can raise the risk for Actos bladder cancer would certainly not have helped a New York plaintiff who was prescribed Actos (pioglitazone) for Type 2 diabetes in 2003.
Seven years later, in 2010, the plaintiff was diagnosed with bladder cancer. Amongst other injuries the man is said to have suffered, court records indicate the plaintiff was forced to undergo multiple surgical procedures, and lost one of his kidneys.
He filed his Actos bladder cancer lawsuit June 12, 2014 in the Circuit Court of Cook County, Illinois (Case No. 2014-L-006265).
This plaintiff together with his Actos lawsuit is not alone. There are more than 3,000 such cases in the pipeline consolidated in multidistrict litigation MDL 2299 in the US District Court for the Western District of Louisiana.
Various studies on Actos, manufactured by Takeda Pharmaceuticals Inc., the Japanese drugmaker, have suggested a statistical link between pioglitazone (Actos) and the emergence of Actos bladder cancer - not to mention various other Actos side effects - when Actos is used continuously for a period of one year or longer.
For the Actos patient this is a problem, given that Type 2 diabetes is an issue that requires constant monitoring and treatment. Unlike a temporary issue requiring use of medication for a month or two, akin to a painkiller, until the pain goes away, Type 2 diabetes tends to be a chronic condition once it emerges, requiring constant treatment.
Thus, a medication that must be stopped inside of a year to avoid the risk for bladder cancer or, for that matter, Actos heart failure, makes little sense if it is prescribed to combat a chronic condition. The numbers don’t add up and the stars don’t align.
But then, the stars do not often align for a drug regulator that appears to suffer from chronic “oopsy” after drugs that are apparently well-tested and vetted before they are brought to market become the subject of caution and concern years later.
In the case of Actos and bladder cancer, various plaintiffs have alleged that Takeda withheld important pieces of information that would have otherwise proven beneficial to consumers with regard to the risk for bladder cancer, Actos macular edema, kidney issues and other Actos side effects. Recent lawsuits have also uncovered a failure to preserve documentation with regard to Actos on the part of Takeda, an issue that has incurred judicial wrath.
Following the approval of Actos by the FDA in 1999, the next watershed year for Actos appears to be 2011. That’s when the American Diabetes Association (ADA) published a study linking pioglitazone (Actos) and bladder cancer. That study, together with the results of a French study, found its way into an FDA official safety communication in June 2011, noting the statistically significant increase in risk for Actos bladder cancer when pioglitazone is used for longer than one year.
France pulled Actos off the market. Germany did, too.
The FDA just sends out letters and asks us to be careful.
For many bladder cancer patients, the preferred response is to flip the bird at the FDA and flip through the phone book for the nearest Actos bladder cancer attorney…
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