Actos News

New Details Emerge in $6.5 Million Verdict against Actos Maker
Takeda Pharmaceuticals
Monday, April 29, 2013

Details continue to emerge in the $6.5 million verdict returned last Friday against Japanese drug company Takeda Pharmaceuticals for failing to warn a California man of the bladder cancer risk associated with its diabetes drug, Actos.

The jury found Takeda liable on the grounds of strict product liability and negligence, but denied the plaintiff’s claim for punitive damages, finding that the company did not act with malice. The jury awarded $5 million to plaintiff Jack Cooper, whose doctors have given him only months to live, and $1.5 million to his wife. Cooper’s suit was the first of more than 3,000 similar Actos bladder cancer lawsuits to go to trial.

During the trial, plaintiff’s counsel Michael Miller argued that Takeda had known of research linking Actos to bladder cancer since at least 2004, but  to protect their profits ($4.5 billion in 2011 from Actos sales), the company consistently thwarted the numerous Food and Drug Administration’s attempts to revise the drug’s product label to notify doctors and patients of the risk. Studies also suggested that the risk was increased the longer one took the diabetes drug, making the timing of a label change even more significant. Cooper began taking Actos (pioglitazone) in late 2006. It wasn’t until 2011 that a bladder cancer warning was finally added to the label. 

Takeda argued that other factors were responsible for Cooper’s cancer, including his history of smoking, but Cooper had quit smoking at least 12 years before he began taking the drug, which reduced his risk to that of a non-smoker, according to recent research. One plaintiff’s expert, urologist Dr. Norm Smith, testified that Actos was the primary cause of Cooper’s cancer.

In its closing arguments, defense counsel portrayed Takeda as a company “that has worked hard and tirelessly to understand everything it could about this medicine,” but jurors were apparently not convinced. Internal Takeda emails presented to the jury cast the drug maker in a different light – as a company that had carried out a well-orchestrated plan to reveal as little as possible of what it knew about the drug’s association with bladder cancer.

Takeda has moved to strike Dr. Smith’s testimony and asked the judge to overturn the jury’s ruling and issue a directed verdict. The judge is expected to deliver his ruling on Wednesday. Takeda has announced its plans to “vigorously defend the company against future lawsuits,” and went so far as to add information from the current Actos drug label to its press release – too little too late, at least in the view of this jury, for Jack Cooper.

“Mike and Nancy Miller’s team [Cooper’s attorneys] did a phenomenal job of assembling inculpatory documents that were pivotal to this jury’s findings, and Mike Miller explained them in a way the jurors found persuasive and compelling,” said Michael Baum, consumer advocate and senior managing partner of Baum, Hedlund, Aristei & Goldman. Baum Hedlund is currently representing dozens of clients who developed bladder cancer after taking Actos. Along with Baum Hedlund Actos attorney Cynthia Garber, Mr., Baum is currently preparing these cases for trial in both state and federal court.