Actos News

Judge Denies Motion to Overturn $9 Billion Actos Jury Award
August 28, 2014

A federal judge has denied a motion by Takeda Pharmaceuticals and Eli Lilly and Company to overturn the verdict of a jury that recently ordered the two drug makers to pay $1.5 million in compensatory damages and $9 billion in punitive damages to the plaintiff after finding that Takeda hid evidence linking its diabetes drug, Actos, to an increased risk of bladder cancer. The plaintiff in the case, Terrance Allen, blamed Actos for his bladder cancer.

In language that was often harsh, Judge Rebecca Doherty, U.S. District Judge for the Western District of Louisiana, who presided over the Allen trial, chided the defendants for rehashing arguments they had already brought before the court, while providing no new evidence or legal justification. The defendants’ arguments, she said, were “heavily weighted toward straw-men argument,” and based on a confused intermingling of separate legal issues that the judge found “quite problematic.” Several times she expressed her view that the defendants’ motion ignored evidence presented by the plaintiff’s and either misstated or misinterpreted relevant case law.

Citing previous rulings from the Fifth Circuit Court of Appeals, Judge Doherty stated, “Courts should be wary of upsetting jury verdicts, and should do so only when there is not a legally-sufficient evidentiary basis for the jury’s verdict” (emphasis in the original). She then proceeded to review, over the next twenty-five pages of her ruling, the “plethora of evidence” presented at trial that supported the plaintiff’s claim that Takeda intentionally concealed evidence that tied Actos to bladder cancer - hiding it, in particular, from the U.S. Food and Drug Administration. Additional evidence revealed Takeda’s financial motive. Former FDA head, Dr. David Kessler, she noted, had testified that Takeda was obligated to strengthen the Actos label regarding bladder cancer as early as July 2002, nearly four years before Mr. Allen began taking Actos.

In her legal analysis, Judge Doherty focused on what she called the defendant’s “overall false framing of certain issues raised during the trial.” Among those issues were:

• Takeda’s suggestion that Actos’ value to diabetics as a whole was in question at trial – it was not, said the judge.
  
  
• The argument from both Takeda and Lilly that federal law precluded them from sharing information about the drug’s health risks. Case law, the judge concluded, does not support this contention.
  
  
• The defendants’ argument that the FDA would have precluded them from changing the Actos label to warn of the bladder cancer association, a position, said the judge, that “blatantly and distressingly ignores” the evidence of Takeda’s concerted efforts to resist FDA attempts to add bladder cancer warnings to the Actos label.

Judge Doherty further ruled that the jury “was not unreasonable” in relying upon the expert testimony of plaintiffs’ expert Dr. Scott Delacroix, a urologic oncologist, in finding that Actos caused Mr. Allen’s bladder cancer.

Regarding the defendants’ assertion that there was insufficient evidence that they had “acted with wanton and reckless disregard of the effects of its actions” and were therefore not subject to punitive damages, Judge Doherty reviewed the considerable body of evidence presented by the plaintiffs  that Takeda and Lilly acted in a concerted manner to conceal and withhold evidence of the danger of bladder cancer posed by Actos. She wrote that the evidence was “sufficiently substantial in nature” to meet the standards for punitive damages required under New York law.

Finally, Judge Doherty took up the question of whether the jury’s awareness that Takeda had destroyed key evidence had unfairly biased them against the drug makers and prompted the severe punitive damages, ruling that Takeda’s destruction of files was “merely one piece of evidence the jury could or could not have relied upon in making its determination as to the punitive damage claim made against Takeda.”