Last Spring, a federal jury found that the makers of the diabetes drug Actos knew about and concealed the drug’s cancer risks. The plaintiff in that case was a New York man who claims his bladder cancer was caused by Actos.
The jury awarded the plaintiff $1.5 million in compensatory damages and, additionally, a $9 billion punitive damages award was ordered against the manufacturers. This amounted to $6 billion against Japan-based Takeda Pharmaceuticals and $3 billion against Eli Lilly, which co-marketed the drug.
After the trial, charges have been made that Takeda’s company and its lawyers concealed evidence. In late June, the judge formally admonished Takeda for destroying evidence in the case. A later decision will consider attorney misconduct regarding Takeda’s defense team.
Actos is the brand name of the prescription drug pioglitazone, which was approved by the FDA to treat Type 2 diabetes in 1999. In July 2011, the FDA issued a warning that Actos “may be associated with an increased risk of bladder cancer” after use for more than one year. This came after long-term studies showed not just a cancer link, but a high cancer link – patients who used Actos for more than one year had up to a 40% increased chance of developing cancer.
Takeda’s History of Concealment
Evidence at trial showed that Takeda experts knew that Actos had a link to bladder cancer seven years before the company issued any warnings about it.
During the trial, plaintiffs’ lawyers also claimed that Takeda had failed to preserve evidence, and destroyed essential documents. In a June 20 ruling on this issue, U.S. District Judge Rebecca Doherty wrote: “There is no dispute in this case as to the intentional nature of the defendants’ document destruction.”
She went on to address the impact of those actions on the plaintiffs in the original case, and in the ongoing multi-district litigation (MDL):
“The absence of those files can be reasonably assumed to have prejudiced Mr. and Mrs. Allen from presenting a full and complete picture of Takeda’s actions and will prejudice the [plaintiffs steering committee] within this MDL, as those documents are forever lost and the electronically generated or stored information was deleted and cannot be fully reconstituted.”
Judge Doherty ordered Takeda to attempt to reconstruct the deleted files.
On the same day of the ruling, Takeda issued a statement denying intentional destruction of files: “Takeda denies that any documents were destroyed with the intent of prohibiting their use in litigation.”
According to Bloomberg, Actos sales peaked at $4.5 billion in the year ended March 2011; the drug accounted for 27% of Takeda’s revenue at the time.