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$9 Billion Punitive Actos Lawsuit Award Upheld

Actos Drug Bottles The judge in one of the early Actos bladder cancer trials has upheld a record-breaking $9 billion punitive damages award against Takeda Pharmaceuticals and Eli Lilly, who recently attempted to have the Actos lawsuit award thrown out. U.S. District Judge Rebecca Doherty ruled that the jurors who assigned the award had reviewed the evidence presented and had issued a responsible verdict and that the award will stand.

Takeda and its U.S. partner had argued that the amount of the Actos lawsuit award was excessive and that, based on the evidence that the jury had responded “with passion and prejudice,” they should be granted either a new trial or an amendment to the amount of the award. The request for a new trial is still pending.

Spokesmen for both companies say that they plan to appeal the “verdict in its entirety,” contesting both the ruling that Actos was responsible for the plaintiff’s development of bladder cancer and that the punitive damages award was fair. Despite the judge’s ruling, it is likely that the award will be reduced upon appeal due to the Supreme Court’s previous ruling concerning the proportionality of such punitive awards.

Actos lawsuit award assigned for “wanton and reckless disregard”

The punitive damages award, the largest ever granted in the history of pharmaceutical lawsuits, was based on charges that the defendants had acted with “wanton and reckless disregard” in their marketing of the drug, failing to disclose a link between Actos and bladder cancer risks. Terrance Allen, the plaintiff, contended that he developed bladder cancer as a result of taking Actos and had already received a $1.5 million compensatory damages award before the jury issued the additional punitive award.

During the trial, the defendants failed to convince either judge or jury that they were unaware of the cancer risks that their drug posed, with the judge ruling that they knew of such risks by 2002 (the FDA approved Actos in 1999) but did little to disclose information about this link. Moreover, the judge also ruled that they had destroyed documents with evidence related to their knowledge of the cancer risk and, in doing so, had acted “in bad faith.”

The jury’s $9 billion punitive award was in part a response to hearing testimony about the destruction of documents. In the course of their request for a new trial or reduction of the award, the defendants had argued that the jury should not have been instructed to take this information into consideration.

Actos verdict may set standard for subsequent trials

The size of the award granted to the plaintiff in the Allen case may set the standard for the more than 3,000 lawsuits now pending against Takeda and Eli Lilly over undisclosed Actos bladder cancer risks. Prior to the Allen case, the defendants had enjoyed victory in court or had seen judgments against them overturned.

However, the Allen lawsuit serves as a “bellwether” case for the Actos multidistrict litigation (MDL) proceeding in a Louisiana court. The MDL process is designed to provide an efficient way to handle numerous cases with the same defendant and similar allegations. If the verdict is upheld in appeal it may encourage the defendants to pursue a settlement with the remaining plaintiffs rather than face multiple trials.