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The first of several thousand Actos lawsuits filed on behalf of former users who developed bladder cancer after using the popular diabetes drug is set for trial to begin this week in California state court.
Jury selections began today in the Superior Court of California for Los Angeles County, involving a lawsuit brought by Jack Cooper, who was given an expedited trial date due to his grave health.
Takeda Pharmaceuticals faces more than 3,000 Actos cancer lawsuits pending throughout the United States, which all involve similar allegations that the drug maker failed to adequately warn consumers or the medical community about the potential increased risk of bladder cancer associated with long-term use of the medication.
Actos (pioglitazone) was approved by the FDA for treatment of type 2 diabetes in July 1999. It is a once-daily pill that increases the body’s sensitivity to insulin. However, new warnings were added to the medication in 2011 that indicate use of the medication for more than one year may increase the risk of developing bladder cancer.
According to allegations raised by Cooper and other plaintiffs, Takeda Pharmaceuticals knew about the link between bladder cancer and Actos before the medication was introduced, but the drug maker ignored data, downplayed the risk and misled regulators in an attempt to avoid placing a cancer warning on the drug.
Actos Bladder Cancer Trial Will Be Closely Watched
The Actos trial involves a complaint filed by Jack Cooper, who was diagnosed with bladder cancer in November 2011, after using the diabetes drug for more than two years.
The case will be closely watched by product liability lawyers involved in the Actos litigation, as it will serve as a gauge for how juries may respond to evidence and testimony that will likely be repeated throughout a large number of cases.
While Takeda Pharmaceuticals faces Actos lawsuits in various state courts, such as California and Illinois, all federal complaints filed in U.S. District Courts throughout the country have been consolidated for pretrial proceedings as part of an Actos MDL, or multidistrict litigation, which is centralized before U.S. District Judge Rebecca Doherty in the Western District of Louisiana.
A small group of Actos cancer lawsuits in the federal MDL are also being prepared for early trial dates, known as “bellwether” cases. However, the first trial in federal court is not scheduled to begin until November 3, 2014, with a second trial set to begin on January 12, 2015.
In complex pharmaceutical litigation, where a large number of lawsuits have been filed by individuals who allege that they suffered similar injuries from the same medication, early trial dates are often influential in promoting settlement discussions, and the outcome may eventually lead to widespread Actos settlements.
Takeda Failed To Warn About Link Between Actos and Cancer
Takeda Pharmaceuticals has maintained that it acted responsibly and that studies do not establish a link between Actos and bladder cancer. The manufacturer is expected to argue at trial that Actos was not responsible for Cooper’s diagnosis of bladder cancer.
According to a report by Bloomberg News, documents publicly released as part of the Cooper trial suggest that Takeda Pharmaceuticals was concerned about the connection between Actos and cancer years before warnings were added to the medication.
Takeda reportedly considered adding warnings to the label as early as 2003, when the drug maker surveyed doctors to evaluate whether such a warning would scare them away from prescribing the drug. After determining that warning about the possible risk of bladder cancer from Actos would damage sales, the drug maker did not add the information to the label, according to allegations that will be raised by Cooper at trial.
The records also show that in 2002, the competing drug maker Novo Nordisk abandoned attempts at marketing a drug that worked in a similar fashion to Actos after animal testing led to cancerous tumors on the bladders of rats. The FDA questioned Takeda about the potential link between Actos and bladder cancer, resulting in the survey of doctors.
According to the lawsuit filed by Cooper, Takeda dodged the FDA on the question for years and instructed its sales representatives to avoid mentioning bladder cancer when discussing the drug’s safety unless directly asked about it by doctors.
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. Around that same time, Takeda was forced to recall Actos in France and Germany at the request of foreign regulators.