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Takeda May Have Known of Actos Cancer Risk in 2005

Actos Bladder Cancer LawsuitThe first Actos bladder cancer lawsuit to go to trial is now underway in the Superior Court of California for Los Angeles County. The key piece of evidence is a collection of emails dating back to 2005 that indicate defendent, Takeda Pharmaceuticals knew of the increased risk of bladder cancer associated with Actos, and was planning ways to avoid stating the risk on their warning label.

The lawsuit was filed by Jack Cooper, who alleges long-term use of the drug caused his bladder cancer. The trial date was expedited due to Mr. Cooper’s ill health. It is the first of 3,000 lawsuits filed against Takeda to reach court, all of which allege the company put sales of the diabetes drug ahead of concerns about consumer safety. As the first major piece of Actos litigation news for months, the trial is the subject of much speculation and media interest, as it may give an indication of how juries will respond to evidence given in future trials.

Actos formerly top-selling diabetes drug

Actos, the brand-name for pioglitazone, is an oral diabetes drug that helps regulate blood sugar levels. It first hit the market in 1999, and became the top-selling type 2 diabetes drug in the United States. Takeda is facing thousands of allegations relating to cancer and congestive heart failure, neither of which was listed as a side effect on the labeling.

Following reports of an Actos cancer risk, the FDA launched a review of the medication in September 2010. Actos was removed from some European markets in 2011, the same year the FDA added a warning to the labeling in the U.S. stating that use of the medication for more than a year may increase the risk of developing bladder cancer.

Takeda sought ‘good global image’

In 2003, Takeda reportedly surveyed doctors to evaluate whether adding cancer warnings to the label would put them off prescribing the drug. According to Cooper’s Actos bladder cancer lawsuit, the manufacturer determined that such warnings would damage sales, and did not add the information to the label.

The most damaging piece of evidence is a selection of in-house emails from August 2005, which were discussed at trial by a clinical pharmacologist giving expert testimony for the plaintiff. The email thread was led by a Takeda executive, who raised concerns about what regulators might do if they determined there was an Actos cancer risk. The executive advised colleagues to ‘manage the issue’ to ensure the drug maintained a ‘good global image’. He also described a warning label as a ‘worst-case scenario.’

Attorneys for the defendants suggested that Cooper’s smoking habit contributed to his cancer, and maintain that the views expressed by the Takeda executive in the emails were not representative of company policy.

‘Product came first’ according to expert witness

The clinical pharmacologist who gave evidence, Howard Greenberg, also discussed multiple emails from different levels of Takeda management. He told jurors the emails indicated that “the product came first.”

The Actos bladder cancer lawsuit being heard in Los Angeles is expected to open the floodgates for the thousands of pending claims waiting to be heard. A number of federal court cases have been consolidated into multidistrict litigation. The MDL is being overseen by U.S. District Judge Rebecca Doherty, who has scheduled the first bellwether trial to be held in November, before the MDL goes ahead in 2014.

Takeda Worried About Actos Bladder Cancer Link, Bloomberg (Feb.15, 2013)