(PRWEB) June 19, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs, has filed a lawsuit alleging Actos caused bladder cancer and wrongful death of a Louisiana man. The suit 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 currently pending in the multidistrict litigation as part of In Re: Actos (Pioglitazone) Products Liability Litigation (MDL No. 6:11-md-2299). Takeda Pharmaceuticals America, Inc., Takeda Pharmaceuticals USA, Inc., Takeda Pharmaceuticals North America, Inc., Takeda Pharmaceutical Company Limited and Eli Lilly and Co. have been named as Defendants. [http://www.lawd.uscourts.gov/MDL2299/ Jerrold S. Parker, founding partner of Parker Waichman LLP, has been appointed to the Plaintiffs' Steering Committee in the Actos Litigation. [lawd.uscourts.gov/MDL2299/html/news.html]
According to the complaint, the Plaintiff-Decedent took Actos in the manner it was prescribed from approximately 2002 to 2009. The suit alleges that the drug caused the man to develop bladder cancer, resulting in his death in April 2009. The lawsuit alleges severe mental and physical pain and suffering prior to the Plaintiff-Decedent’s death, economic loss due to medical expenses and living related expenses due to a new lifestyle.
The lawsuit also alleges that the manufacturers knew or should have known that Actos was linked to bladder cancer, specifically after one year of use. Because of the Defendants’ actions or lack thereof, the Plaintiff-Decedent and other consumers were needlessly exposed to bladder cancer, the lawsuit claims. The complaint alleges that the Plaintiff would not have taken Actos if the Defendants had properly disclosed the risks.
The U.S. Food and Drug Administration (FDA) approved Actos in 1999 for treatment of type 2 diabetes. The complaint states that the drug was launched by Takeda and Eli Lilly, but Takeda announced the end of their collaboration in April 2006. According to the lawsuit, Actos is among Takeda’s best-selling drugs, with global revenues of over $4.8 billion last year. The suit also states that researchers found a higher rate of bladder cancer among Actos users in the PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) study, which investigated cardiovascular events. According to the lawsuit, the PROactive study was published in 2005 but the association between Actos and bladder cancer was not included.
In September 2010, the FDA stated in a Safety Announcement that it was reviewing data from an ongoing ten-year epidemiological Kaiser Permanente study investigating the relationship between Actos and bladder cancer. At the planned five-year interim, data indicated that Actos was associated with an increased risk of bladder cancer after two years of use. Last June, the agency released another Safety Announcement finding that the increased risk became significant after only one year of Actos exposure. Compared to those who had never been exposed to the diabetes drug, use of Actos for more than a year was associated with a 40 percent increased risk of bladder cancer, the agency said. The FDA also noted that the risk increased with both dosage and duration. In light of the relevant data, the agency ordered a label change. [http://www.fda.gov/Drugs/DrugSafety/ucm226214.htm; http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm
Days before the FDA released its second Safety Announcement in June 2011, the use of Actos was suspended in France and Germany. According to the complaint, the decision was based on a retrospective cohort study using the French National Health Insurance Plan; researchers found an increased risk of bladder cancer among men taking Actos for more than a year.
Another recent study, published in the British Medical Journal, also linked Actos to bladder cancer. Researchers found that users exposed to the drug for more than two years had double the risk of developing bladder cancer. [bmj.com/content/344/bmj.e3500?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+bmj%2Frheumatology+%28Latest+Rheumatology+articles+from+the+BMJ%29]
Parker Waichman LLP continues to offer free legal consultations to victims of Actos. If you or a loved one were diagnosed with bladder cancer after taking Actos, please contact their office by visiting the firm's Actos injury page at http://www.yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding Actos side effect lawsuits and Parker Waichman LLP, please visit http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney