Jury Deliberating in First Actos Bladder Cancer Case

A California state court jury is continuing deliberations following the first Actos trial in the country, which alleges that side effects of the popular type 2 diabetes drug caused a user to develop bladder cancer.

Following closing arguments last week, the jury is evaluating evidence presented over more than two months in the Superior Court of California for Los Angeles County. The trial involved a complaint filed by Jack Cooper, who claims that he developed bladder cancer from Actos, after using the medication for several years.

More than 3,000 similar Actos lawsuits have been filed in courts throughout the United States, and the Cooper trial is being closely watched by lawyers involved in the litigation, as it is the first to reach a jury. Cooper was given an expedited trial date under California state court procedure due to his grave medical condition.

Jurors were told last week that Takeda knew about the potential link between Actos and bladder cancer as far back as 2004, but that the pharmaceutical company placed their desire for profits before consumer safety by waiting years before informing the FDA. Cooper’s lawyers highlighted for the jury the huge profits generated by Takeda Pharmaceuticals while it sat on the data.

An e-mail from 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.”

During the trial, lawyers for Takeda Pharmaceuticals pointed out that Cooper’s lifestyle as a diabetic and former smoker places him in a high-risk cancer group, and maintained that there is no proof Actos caused Cooper to develop cancer. According to testimony presented at trial, Cooper has not smoked since the mid-1970s.

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 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.

The FDA first announced that there may be a possible 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 risk the longer the drug is taken. However, the Actos bladder cancer concerns did not reach the public until the summer of 2011, after a study by French insurers revealed an increased risk of bladder cancer. In June 2011, the FDA placed new Actos bladder cancer warnings on the diabetes drug and all drugs containing pioglitazone, the active ingredient.

In addition to various lawsuits pending in California and other state courts throughout the country, most of the Actos litigation is centralized in the federal court system, where the cases have been consolidated as part of an MDL or Multidistrict Litigation in the U.S. District Court for the Western District of Louisiana.

A small number of lawsuits in the Actos MDL are being prepared for early trial dates, with the first case scheduled to begin in January 2014 and a second set for April 2014

The outcomes of these early Actos trials are designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that may be repeated throughout a number of similar cases. The process may help facilitate further Actos settlement negotiations or other resolutions for the litigation.