The national law firm, Parker Waichman LLP, just filed a lawsuit on behalf of a man who developed bladder cancer after taking Type 2 diabetes drug, Actos. The lawsuit names Takeda Pharmaceuticals America, Inc., Takeda Pharmaceuticals USA, Inc., Takeda Pharmaceuticals North America, Inc., Takeda Pharmaceutical Company Limited, and Eli Lilly and Co. as defendants.
The lawsuit was filed on June 14th in the U.S. District Court for the Western District of Louisiana (Case No. 6:12-cv-1696) and is one of the many cases pending in the multidistrict litigation as part of In Re: Actos (Pioglitazone) Products Liability Litigation (MDL No. 6:11-md-2299). Jerrold S. Parker, co-founder of Parker Waichman, has been appointed to the Plaintiffs’ Steering Committee.
The complaint alleges that the plaintiff developed bladder cancer in July 2009 after he had taken Actos from 2007 to 2011 and that Actos caused the bladder cancer and other subsequent adverse events due to his long-term, prescribed use of the drug. The lawsuit also claims severe mental and physical pain and suffering, past and future permanent injuries and emotional distress, and economic loss due to medical expenses and living-related expenses due to a new lifestyle caused by his illness.
According to the lawsuit, the plaintiff would never had suffered these effects if the drug makers had not concealed Actos’ risks. Specifically, the complaint discusses the significant increased risk of bladder cancer linked to one year’s exposure; this association was addressed by the U.S. Food & Drug Administration (FDA) last June in a Safety Announcement. Based on data from an ongoing 10-year study by Kaiser Permanente, the agency stated that the risk of bladder cancer increased 40% after just one year of Actos versus those who never took the drug.
That information was an update of a prior Safety Announcement issued in October 2010, which stated that the risk reached significance after two years. The FDA ordered a label change to address this risk and Health Canada, Canada’s healthcare regulatory agency, made similar adjustments to the Actos label this April.
Days before the FDA made its announcement last June, France and Germany suspended use of the drug; data indicated an increased risk of bladder cancer in male patients after one year of exposure. And, most recently, the British Medical Journal published a study that revealed a two-fold increased risk of bladder cancer in patients exposed to the drug for more than two years.
Meanwhile, Parker Waichman LLP, filed another lawsuit on behalf of the estate of a Kentucky man who developed bladder cancer and subsequently died, allegedly due to the use of Actos. The man took Actos, as prescribed, between 2010 and 2011, says the complaint, which alleges that taking the drug caused him to develop bladder cancer, from which he died last November.
Actos was approved in 1999 to treat patients with type 2 diabetes. According to the lawsuit, it is one of Takeda’s top-sellers and accounts for approximately 27% of the company’s revenue; in 2008, Actos was the tenth best-selling drug in the United States.
We also just wrote that a newly published study is raising concerns that patients who take Actos or Avandia may face an increased risk of developing diabetic macular edema, an eye disorder that can result in vision loss. The study found that type 2 diabetics who use thiazolidinediones, a group of drugs that includes Actos and Avandia, had a two-to-three times greater higher risk of macular edema. The risk was higher if patients used insulin in combination with the drugs.
Some legal experts believe that Takeda Pharmaceuticals, the maker of Actos, could eventually be named in as many as 10,000 Actos side effect lawsuits.