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Fate of Thousands of Actos Lawsuits at Stake as Cancer Trial Set to Begin

With the outcome of thousands of lawsuits potentially at stake, the first bellwether Actos cancer trial is scheduled to begin soon in U.S. District Court for the Western District of Louisiana. This trial is expected to set the tone for future Actos litigation, as plaintiffs, defendants and their attorneys get an early taste of how juries might respond to testimony and evidence. Over 3,000 plaintiffs with complaints currently pending in federal court against Actos manufacturer Takeda will be watching this first bellwether trial with interest to see how their cases might eventually resolve.

Actos is a type 2 diabetes drug that, according to product liability lawsuit complaints, significantly raises the risk of bladder cancer in patients who use the drug for more than 12 months. Plaintiffs who developed cancer after using Actos allege that Takeda never adequately warned them of the risk.

Bellwether case selected out of thousands

The first Actos bellwether trial was selected by representatives for both plaintiffs and defendants out of more than 3,000 Actos bladder cancer lawsuits currently filed in federal court, and thousands more expected to join them. The trial is scheduled to begin on January 27, 2014. The plaintiffs in this complaint, Terrance Allen and his spouse, allege Allen’s use of Actos to treat type 2 diabetes from 2004 to 2011 led to a bladder cancer diagnosis in 2011.

The plaintiffs plan to show in their trial that Actos was a direct cause of his bladder cancer, and that Takeda failed to warn consumers about the potential risk associated with their drug.

Actos was approved by the FDA to treat type 2 diabetes in 1999. The drug has been used for long-term management of diabetes, as it was in Allen’s case. However, studies have now shown long-term use of Actos can significantly increase a person’s risk for bladder cancer.

History of Actos side effects

In 2011, the FDA reported results from the first half of a 10-year study that showed patients who took higher doses of Actos for one year or longer increased their risk for bladder cancer by as much as 40%. The agency published those results in a safety communication on its website and alerted the medical community and consumers that the warning would also be added to the product’s label. However, many individuals who took the drug and developed bladder cancer prior to the 2011 warning have filed lawsuits against Takeda, claiming the company failed to provide proper warnings about their product.

In December, 2011, eleven cases involving Actos side effects were transferred to the U.S. District Court in Louisiana and coordinated into multidistrict litigation. Also referred to as MDL, multidistrict litigation is assigned when there is a growing number of complaints involving common questions of fact. The coordination is designed to make early trial proceedings more efficient and convenient for plaintiffs, defendants and witnesses.

Growing MDL numbers

Since the MDL was established, the case number has grown to more than 3,000 in coordinated proceedings. In addition, there are hundreds more Actos lawsuits pending in state courts across the country. Three of those cases have already been decided. Two ended in favor of the plaintiffs, including jury awards of $1.7 million and $6.5 million, although one verdict was thrown out by the judge because of a technicality of law, and the other is on appeal. The third was decided in favor of the defendant.

Despite these early rulings, this first bellwether trial will be the one to truly set the stage for future Actos litigation. The judge overseeing these trials, Judge Rebecca Doherty, will preside over all pretrial proceedings, including motions and discovery proceedings. Bellwether trials are also often the catalysts to begin settlement negotiations between plaintiffs and defendants.

As the court, plaintiffs and defendants continue to prepare for this first Actos lawsuit trial on January 27, thousands of eyes will be on the Western District of Louisiana to determine how Actos litigation might proceed in the future.


  1. United States District Court, Western District of Louisiana, Welcome to the Web Site for MDL No. 2299, http://www.lawd.uscourts.gov/welcome-web-site-mdl-no-2299

  2. FDA, FDA Drug Safety Communication: Update to Ongoing Safety Review of Actos (pioglitazone) and Increased Risk of Bladder Cancer, http://www.fda.gov/drugs/drugsafety/ucm259150.htm