Actos Lawsuit Plaintiff: If Only He Had Known the Risks

Lafayette, LAAs the inevitable fallout continues from the once-meteoric rise in the fortunes of Takeda Pharmaceuticals following a massive switch to Actos from GlaxoSmithKline’s Avandia a few years ago, lawsuits alleging Actos bladder cancer continue to take hold.

One of the latest was filed February 5, 2013, in US District Court for the Western District of Louisiana, Lafayette Division (Case No. 6:13-cv-0267). The Actos lawsuit alleges the plaintiff began taking Actos in August 2009. By March 2011, according to the lawsuit, the plaintiff had been diagnosed with Actos bladder cancer allegedly due to his use of pioglitazone hydrochloride (Actos).

The US Food and Drug Administration (FDA) is not prepared to pull Actos off the market, given that in the FDA’s view the benefits to the overall patient population for management of diabetes outweighs any risks associated with Actos side effects. And yet, the FDA has taken a cue from a 10-year study undertaken by Kaiser Permanente and suggests that Actos not be used continuously for longer than one year, given an increased risk associated with use of Actos beyond 12 months.

As diabetes for most is a permanent and ongoing condition, it leaves one to speculate what a diabetes patient is to do beyond that one-year cutoff?

The concern over Actos side effects appears warranted. According to PRWeb Newswire (2/4/13), a study published in the British Medical Journal in May 2012 suggested that patients on Actos for two years were twice as likely to emerge with Actos bladder cancer. To that end, the Canadian Medical Association Journal came out with a study this past summer that found Actos associated with a 22 percent increased risk for Actos bladder cancer.

It should be noted that Germany and France, two countries that are known for their progressive stance on health care, both suspended sales of Actos in July 2011.

Actos became the primary beneficiary of problems surrounding Avandia in 2008, when researchers at the Cleveland Clinic found an overwhelming risk for heart attack and cardiovascular issues in Type 2 diabetes patients taking Avandia to manage their condition. Actos, an Avandia competitor with sales that dwarfed the performance of Avandia at the time, became the benefactor of Avandia’s fall from grace when doctors switched their diabetic patients to Actos in droves. While Actos was also identified as having certain cardiovascular risks, it was widely believed that risks of Actos heart failure were lower than those posed by Avandia. That, in the eyes of both doctor and patient, made Actos appear a far safer bet.

Actos bladder cancer was never part of the dialogue at the time.

It is now.

The plaintiff in the aforementioned Actos lawsuit alleges that defendant Takeda Pharmaceuticals knew Actos could cause bladder cancer but failed to warn the Plaintiff or the public. The suit alleges the manufacturer made misrepresentations and omissions in an attempt to conceal the risks associated with Actos. The lawsuit alleges there to be several safer alternatives for treating Type 2 diabetes, and further states, the Plaintiff would not have taken Actos if he were fully informed of the risks. The Plaintiff is suing for severe mental and physical pain and suffering, permanent injuries, emotional distress, and economic loss associated with his Actos bladder cancer.

There are 25 million Americans living with diabetes in the US.