2011 a Watershed Year for Actos and Bladder Cancer

Washington, DCWith the first Actos lawsuit in the federal Actos litigation expected to go to trial in the New Year, Actos watchers are still looking in their rear-view mirrors to the bellwether case involving plaintiff Jack Cooper (Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court Los Angeles), which was tossed earlier this year by a judge following a jury award of more than $6 million.

While the case may have been lost and the health of plaintiff Cooper presumably continues to deteriorate, health advocates critical of Actos manufacturer Takeda Pharmaceuticals and concerned over emerging cases of Actos bladder cancer continue to ruminate over testimony heard at the trial.

According to court filings summarized in a Bloomberg News (2/28/13) report, Takeda is alleged to have known about the risk for Actos and bladder cancer but downplayed the risk in order to secure approval by the US Food and Drug Administration (FDA) to bring Actos to the US market.

It is a well-known fact that Takeda’s Actos was the beneficiary of troubles affecting GlaxoSmithKline’s rival diabetes drug Avandia, when studies suggested that Avandia carried a high risk for heart attack and cardiovascular events. While Actos carried similar risks, those risks for Actos heart failure were thought to be lower than that of Avandia, which caused Actos to appear as a safer alternative in the eyes of physicians. Doctors switched their type 2 diabetes patients to Actos in droves, and sales of pioglitazone (Actos) soared.

Even at that time, about five years ago, Actos and bladder cancer wasn’t anywhere near the radar of public consciousness. However, attorneys for plaintiff Cooper alleged during trial that Takeda officials were, indeed, cognizant of the risk and yet set the wheels in motion to turn Actos into a blockbuster.

According to Cooper’s Actos bladder cancer lawsuit, Takeda is alleged to have hired some 600 sales representatives to support an intensive marketing and promotion campaign for Actos, once approved by the FDA. According to court records, Takeda sales reps reported in with plaintiff Cooper’s doctor every two weeks for eight years starting in 1999, the year Actos was approved by the FDA.

It wasn’t until 12 years after those visits began, according to testimony heard at trial, that a Takeda representative first articulated the risk for that most grievous of Actos side effects - Actos bladder cancer - to Cooper’s doctor in August 2011. The physician, according to Cooper’s Actos lawyer, responded by halting the issuance of all new prescriptions for Actos, and banned Takeda associates from his office.

According to closing arguments in the trial as recounted by Bloomberg (4/16/13), internal studies undertaken by Takeda revealed links to bladder cancer as early as 2004 - but that Takeda failed to alert the FDA of their findings until 2011. That was well after sales of Actos spiked following a massive shift to Actos from Avandia for patients battling type 2 diabetes.

That was also when, according to the report, Takeda admitted to plaintiff Cooper’s physician that Actos carried a slight risk for Actos bladder cancer. It was also the year that the FDA mandated revised warnings on the Actos labeling with regard to the potential for bladder cancer.

Health regulators in France and Germany requested in 2011 - a watershed year for Actos - that Takeda remove Actos from the market in those countries. Meanwhile, the Actos multidistrict litigation in the US is In re: Actos Product Liability Litigation, MDL No. 2299. Various status updates have been ongoing throughout the summer, with an eye to proceeding with the first MDL trial in January 2014.