Actos Bladder Cancer Trial Outcome in Jury's Hands

The California state court jury that heard the first Actos trial in the U.S., is continuing deliberations. The plaintiff, Jack Cooper, alleged that the type 2 diabetes drug caused his bladder cancer after using the medication for several years.
The first Actos trial in the U.S., took place over two months in the Superior Court of California for Los Angeles County.

Scope of Actos Litigation

To date over 3,000 Actos lawsuits have been filed throughout the United States. Cooper was given an expedited trial date under California state court procedure due to his serious medical condition.

Cooper alleged that Takeda knew about the potential link between Actos and bladder cancer as early as 2004, but that the pharmaceutical company waited years before informing the FDA.

"Smoking Gun" Emails

Takeda executive Kiyoshi Kitazawa in August 2005 urged his colleagues at the company to “manage the issue,” to ensure Actos had a good global image and described a label for bladder cancer as a “worst-case scenario.”

“Actos is the most important product for Takeda and therefore we need to manage this issue very carefully and successfully not to cause any damage for this product globally,” Takeda executive Kiyoshi Kitazawa said in an e-mail.

According to Mike Miller, Cooper's attorney, "Even after FDA officials asked the drugmaker in 2005 and 2006 to update warnings about Actos’s health risks, Takeda executives stalled and delayed because the company was making $1.6 billion a year on the drug. Under U.S. law, it was Takeda’s responsibility to fully disclose its products’ risks."

The case is Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court (Los Angeles).

What is Actos?

Actos (pioglitazone) was approved by the FDA in July 1999. It is a once-daily pill for treatment of type 2 diabetes that increases the body’s sensitivity to insulin. Bladder cancer warnings were added to Actos in 2011, which indicate that use of the medication for more than one year may increase the risk of developing tumors.

FDA Investigates and Issues Actos Warning

The FDA announced that there may be a connection between bladder cancer and Actos in September 2010, after preliminary data from an on-going 10 year study suggested that there may be an increased bladder cancer risk the longer the drug is taken. The FDA placed new Actos bladder cancer warnings on the diabetes drug and all drugs containing the active ingredient pioglitazone.

Federal Actos MDL Underway

The Actos lawsuit litigation is also centralized in the federal court system. Here the Actos cases are consolidated as part of an MDL or Multidistrict Litigation in the U.S. District Court for the Western District of Louisiana. Bellwether trials in the Actos MDL are being scheduled, with the first case scheduled to begin in January 2014 and a second set for April 2014.
The successful outcome of these bellwether Actos trials helps facilitate Actos settlement negotiations for the litigation.