Actos Litigation in Federal Court Now Includes More Than 1,500 Cases

More than 1,500 Actos bladder cancer lawsuits have been filed against Takeda Pharmaceuticals in the federal court system, with the first cases expected to go to trial early next year.  

Actos (pioglitazone) is a type 2 diabetes drug that has been used by millions of Americans since it was introduced by Takeda in 1999. However, in recent years, concerns have emerged about an increased risk of bladder cancer from Actos following long-term use of the medication.

Most of the complaints have been filed since the FDA required Takeda to update the Actos warning label in August 2011, providing information for the first time that indicated users may face an increased risk of developing bladder tumors following use of the medication.

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In December 2011, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered the consolidated pretrial management for all complaints filed against Takeda in U.S. District Courts throughout the country, centralizing the Actos litigation before U.S. District Judge Rebecca H. Doherty in the Western District of Louisiana, as part of an MDL or Multidistrict Litigation. At that time, there were about 100 cases pending throughout the federal court system.

According to information presented at a recent status conference before Judge Doherty, there are now more than 1,500 cases involved in the Actos MDL, including at least 800 plaintiffs that were filed through a bundling option allowed by the Court, where an unlimited number of cases can be included on one complaint.

Trial Dates in Federal Actos MDL

The centralized management of the Actos cases during pretrial proceedings is designed to reduce duplicative discovery in hundreds of cases, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

As part of the MDL, a small group of cases are being prepared for early trial dates, known as “bellwether” cases. The first Actos trial in the MDL is scheduled to begin on January 27, 2014, involving a case originally selected by the plaintiffs. That case will be followed by a second trial scheduled to begin on April 14, 2014, involving a defendant pick.

The original pool of bellwether cases have been narrowed to 4 plaintiff selections and 4 defense selections. Discovery is ongoing for this pool of cases with the final designation of trial plaintiffs expected to be made in July.

The preparations and outcomes of these early trial dates are designed to help the parties gauge the relative strengths and weaknesses of their cases, which may promote Actos settlement negotiations in a large number of other cases pending in the MDL.

Actos State Court Litigation

In addition to the federal court litigation involving Actos, there are also a large number of cases pending in state courts throughout the country.

Earlier this year, the first trial in the country was held in California state court involving a man who developed bladder cancer in November 2011, following two years of Actos use. That case was given an expedited trial date under California procedural rules, due to his grave health condition.

Following more than two months of trial, a Los Angeles jury awarded $6.5 million in damages in the Actos case, finding that Takeda Pharmaceuticals failed to adequately warn about the potential side effects of their blockbuster diabetes drug. However, earlier this month, the judge who presided over the trial overturned the damage award after excluding key expert witness testimony offered at trial to establish that side effects of Actos were the cause of this specific plaintiff’s bladder cancer diagnosis.

Prior to the first trial dates in the federal Actos MDL, other state court actions are likely to go to trial, including a claim pending in Maryland state court that is expected to begin in August.


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