National law firm, Parker Waichman LLP, just filed a lawsuit on behalf of the estate of a Kentucky man who developed bladder cancer and subsequently died, allegedly due to the use of 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 15th in the U.S. District Court for the Western District of Louisiana (Case No. 6:12-cv-01710) where it is pending in the multidistrict litigation as part of In Re: Actos (Pioglitazone) Products Liability Litigation (MDL No. 6:11-md-2299).
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. The lawsuit also alleges that Actos use caused him severe mental and physical pain and suffering leading up to his death, as well as economic loss due to medical expenses and living expenses needed as a result of a new lifestyle. The defendants knew or should have known that Actos is associated with bladder cancer, but failed to adequately warn the public, the complaint also alleges, adding that the now-deceased patient would not have taken Actos had he been fully aware of its risks.
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.
The U.S. Food and Drug Administration (FDA) publicly acknowledged the potential link between Actos and bladder cancer in a Safety Communication it issued in September 2010. After reviewing the interim results of an ongoing 10-year study conducted by Kaiser Permanente, the agency noted a statistically significant increased risk of bladder cancer after two years of Actos exposure.
The FDA released an updated Safety Communication last June, this time stating that the risk was significant after taking the medication for more than one year; apparently, the risk increased with time and dosage. According to the Safety Communication, patients taking Actos for more than one year were 40% likelier to develop bladder cancer compared to patients who never took Actos. The agency addressed this risk by updating the Warnings and Precautions section of Actos’ label.
Concerns over the Actos and bladder cancer link have gone beyond the U.S. Just days before the FDA’s announcement last June, use of the drug was halted in France and Germany after data from the French Medicines Agency revealed an increased risk in male patients after one year of exposure, the lawsuit stated. In April, Canada’s healthcare regulatory agency updated Actos warning label to include the risk of bladder cancer. Most recently, a study in the British Medical Journal found that patients exposed to Actos for at least two years were twice as likely to develop bladder cancer.
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.