A class action lawsuit has been filed in Quebec on behalf of anyone in the province who developed bladder cancer after using Actos, a popular type-2 diabetes drug that has been tied to an increased risk after long-term use.
The complaint was filed last month in the Superior Court of Montreal by the lead plaintiff, Jimmy Whyte, who was diagnosed with bladder cancer in April after having taken Actos since November 2008.
Actos (pioglitazone) is a prescription medication that has been prescribed to millions of type 2 diabetics. The drug increases the body’s sensitivity to insulin, but recent studies have suggested that side effects may increase the risk of bladder cancer.
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The class action alleges that the drug makers Takeda Pharmaceuticals and Eli Lilly knew or should have known about the link between side effects of Actos and bladder cancer, but failed to adequately warn about the risk.
This is at least the second class action lawsuit over Actos filed in Canada, after a similar complaint was filed in Ontario in December.
Actos Bladder Cancer Concerns
In recent years, the popularity of Actos has increased, resulting in an estimated $4.3 billion in sales last year as it became one of the ten best selling drugs in the United States.
However, over the past 18 months concerns have emerged about the risk of bladder cancer from Actos, after interim data released in September 2010 indicated that long-term use of the diabetes drug was linked to an increased rate of tumors.
In June 2011, the FDA issued a drug safety communication to indicate that new information would be added to the warning label for Actos, which indicates that use of the medication for more than one year may increase the risk of developing bladder cancer.
So far this year, several studies have been released confirming the risk of bladder cancer side effects from Actos. A study published this month in the Canadian Medical Association Journal found that users of Actos may face a 22% increased risk of bladder cancer after using Actos.
Although regulators in France removed Actos from the market due to the risk in June 2011 after identifying an increased incidence of bladder cancer among users of the diabetes drug, there is no indication that the FDA is planning to issue an Actos recall in the United States.
Actos Suits in the United States
Allegations raised in the Quebec class action mirror claims raised in many Actos lawsuits filed in the United States by individuals who have been diagnosed with bladder cancer after using the medication, suggesting that the drug makers failed to properly research the medication or provide adequate warnings to users and the medical community.
All complaints filed in U.S. District Courts nationwide have been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, which has been centralized before Judge Rebecca Doherty in the Western District of Louisiana. There are currently more than 780 lawsuits filed by individuals who indicate that they developed bladder cancer from Actos, and the number of complaints is continuing to increase.
Although MDL proceedings in the U.S. are often confused with an Actos class action suit, each of the consolidated claims remains an individual lawsuit. The cases are coordinated during pretrial proceedings to reduce duplicative discovery, conflicting rulings from different judges and to serve the convenience of the witnesses, parties and the courts. However, if an Actos settlement or other resolution is not reached during pretrial litigation, each of the claims may be remanded back to U.S. District Courts throughout the country for an individual trial date.
According to an order issued earlier this month, the first Actos trial date in the federal MDL is not scheduled to begin until November 2014, with a second trial in January 2015.
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