Preparations Progressing for First Actos Bladder Cancer MDL Lawsuit in 2014

Lafayette, LAWe’re about 10 days away from the next status conference pertaining to Actos bladder cancer multidistrict litigation (In re: Actos Product Liability Litigation, MDL No. 22990). According to PRWeb Newswire (6/20/13), July 25 is the date for the next scheduled status conference that will eventually pave the way for some 1,500 Actos lawsuits to go to trial in the US District Court, Western District of Louisiana.

To that end, the first trial in the federal Actos litigation is scheduled to get underway January 27 of next year.

The 1,500 MDL plaintiffs having filed an Actos bladder cancer lawsuit, together with what are described as hundreds of lawsuits filed in the states of California and Illinois, allege that Actos manufacturer Takeda Pharmaceuticals knew or should have known that Actos pioglitazone had the potential to cause Actos bladder cancer. Thousands of Type 2 diabetes patients were switched to Actos from Avandia due to the belief that Actos was a safer alternative - only to find out too late that Actos appeared to have a detrimental impact on the bladder.

Long an also-ran to the more successful Avandia, manufactured by GlaxoSmithKline, the fortunes of Actos changed almost overnight when Avandia, in 2008, was identified as posing serious cardiovascular risks. While Actos also poses certain risks to the cardiovascular system, it was felt that Actos posed a lesser risk than Avandia, and doctors switched their patients to pioglitazone in droves.

Beyond increasing the fortunes of Takeda and putting Actos on a larger stage, the adoption of Actos as an alternative to the popular Avandia placed Actos side effects under a more intense spotlight, a focus exacerbated by the larger number of Actos patients across the country.

As for Actos side effects, beyond the known risk for Actos heart failure, there was little if any mention of the potential for Actos and bladder cancer until cases began to snowball. Just over two years ago, on June 15, 2011, the US Food and Drug Administration (FDA) released a statement that cautioned Type 2 diabetes patients not to use Actos beyond one year, lest they face a greater risk for developing Actos bladder cancer.

Germany and France pulled Actos from the market altogether. The FDA, however, has chosen to continue making Actos available, albeit with beefed-up warnings.

That stance has not placated the thousands of Actos patients whose only recourse has been to file an Actos lawsuit following a diagnosis for bladder cancer. A majority of plaintiffs assert there was little to no warning about the potential for Actos and bladder cancer at the time they started taking Actos.

There are other adverse reactions associated with Actos - namely Actos macular edema and Actos CHF (congestive heart failure).

However, it’s Actos and bladder cancer that appears to be grabbing the headlines and the attention of the courts. Takeda, for its part, seems to be taking the lawsuits in stride, as the pharmaceutical company appears to have no intention of removing Actos from the market. Nor, it seems, does the FDA - which continues within its mandate that a drug is not considered unsafe for human consumption as long as the benefits of the drug outweigh the risks for the constituency to which the drug was designed and directed.

As lawsuits mount, will Takeda take a lead position and remove Actos from the market? Or will the FDA follow the lead of their regulatory counterparts in France and Germany, in banning Actos? Time will tell. In the meantime, all sides appear to be digging in their heels, and Actos plaintiffs having filed an Actos bladder cancer lawsuit await their first day in court, early next year.