Class Action Lawsuit Over Actos Bladder Cancer Risk Filed in MDL

Takeda Pharmaceuticals faces a new class action lawsuit over the side effects of Actos, which has been filed in the federal multidistrict litigation (MDL) alleging that that the drug maker withheld information about the risk of bladder cancer. 

On September 16, U.S. District Judge Rebecca Doherty issued an order (PDF) that indicates the class action over Actos recently brought by the Painters & Allied Trades District Council 82 Health Care Fund and other plaintiffs will remain a separate single case, instead of being consolidated with more than 3,500 Actos bladder cancer lawsuits filed by former users of the drug.

The class action complaint (PDF) was filed by the health care fund and a number of other plaintiffs directly into the MDL in July, alleging that Takeda Pharmaceuticals misrepresented the risks of Actos bladder cancer.

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The plaintiffs maintain that the misleading data led the fund to have to reimburse members for prescriptions for a diabetes drug that was too dangerous for them to take.

Actos Injury Lawsuits Over Bladder Cancer Risk

The allegations raised are similar those brought on behalf of thousands of former users of the medication diagnosed with bladder cancer, claiming that Takeda failed to provide adequate warnings for them or their physicians about the risk of bladder cancer from Actos.

Judge Doherty is presiding over all injury cases filed in U.S. District Courts throughout the country, since they all involve similar questions of law and fact. The litigation is centralized in the U.S. District Court for the Western District of Louisiana to reduce duplicative discovery, avoid conflicting rulings and to serve the convenience of the parties, witnesses and the courts.

Earlier this year, a federal jury awarded $9 billion in damages in the first Actos trial held in the MDL to help gauge how juries across the country may respond to certain evidence and testimony that is likely to be similar to what will be presented in other cases. The verdict included a record setting punitive damage award designed to punish the drug makers for withholding information about the Actos bladder cancer risk.

The case was the first in what is expected to be a series of bellwether trials before Judge Doherty in the MDL. While the outcome of these early trial dates are not binding on other claims, they may lead to Actos settlements that resolve large number of cases.

A status conference before Judge Doherty is scheduled for September 25, at which time parties are expected to discuss recent developments in the litigation, continuing discovery proceedings and an update on where the other bellwether cases stand.

Link Between Actos and Bladder Cancer

Actos (pioglitazone) is a once-daily pill that was approved by the FDA in July 1999 for treatment of type 2 diabetes. The medication increases the body’s sensitivity to insulin.

The litigation has been continuing to mount since 2010, when concerns about the link between Actos and bladder cancer first emerged.

The FDA announced that it was investigating the potential risk in September 2010, after preliminary data from an on-going 10 year study suggested that there may be an increased chance of developing bladder cancer among Actos users.

New bladder cancer warnings were added to Actos in 2011, indicating that users may face an increased risk after using the drug for more than one year. However, evidence that has emerged in recent years suggests that Takeda considered adding warnings as early as 2003, when the drug maker surveyed some doctors to evaluate whether such a warning may scare them away from prescribing the drug.

As the first Actos trials begin to reach juries, now lawsuits continue to be filed in state and federal courts nationwide. According to the latest update (PDF) provided by the U.S. Judicial Panel on Multidistrict Litigation (JPML), there are currently more than 3,700 cases pending before Judge Doherty, with hundreds of other cases pending in various state courts.


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