Mike Miller and his firm, have three wins in front of a jury in four trials against Takeda Pharmaceuticals, the makers of Actos.
A Philadelphia jury was sent to deliberate Wednesday afternoon after being urged to find that Takeda Pharmaceuticals Inc. had willfully worked to obscure evidence linking the blockbuster diabetes drug Actos to an increased risk of bladder cancer.
Miller Firm LLC attorney Michael Miller asked the jury during closing arguments to return a verdict in favor of plaintiff John Kristufek, who claims that Actos was a significant cause of his bladder cancer and that he’d received inadequate warnings about the drug’s risks, and to find that the company disregarded the health and safety of patients in their development and marketing of the medication.
“At every turn there was a reckless disregard for the health and safety and the rights of the plaintiff,” Miller said. “It was profit over patient every time.”
While Miller is seeking both compensatory and non-economic damages on behalf of Kristufek, a finding that the company had operated with reckless disregard would open the door for an award of punitive damages in the case.
John Kristufek, a retired math teacher from Butler County in western Pennsylvania, filed suit in July 2012 alleging that he was diagnosed with bladder cancer in 2008 after using the drug for about three years.
Kristufek alleged that Takeda’s efforts to obscure the drug’s association with bladder cancer had left his prescribing physician unaware of the risks until shortly after he was forced to have his bladder removed entirely in July 2011.
According to testimony in the case, the drug’s label was updated in the weeks after Kristufek’s bladder removal to indicate that use of pioglitazone-based medications, such as Actos, for more than a year may be associated with an increased cancer risk. The warning remains on the drug’s label today.
During the course of testimony that lasted nearly a month, the jury was presented with evidence that Takeda had urged a putative partner in the drug’s development in the early 1990s, the Upjohn Co., to say that it had backed away from the project due to concerns over the drug’s efficacy and not because of data showing potential health risks.
Miller also showed the jury evidence that sales representatives for the company were instructed not to bring up the drug’s potential association with bladder cancer to physicians unless specifically asked.
He said that it was up to the jury to hold the company accountable for its conduct.
“Only an American jury can stop them,” Miller said.
Orlando Richmond, an attorney with Butler Snow LLP representing Takeda, told the jury during closing arguments that Miller had attempted to sling mud at the company in order to distract the jury from its responsibility to determine whether there was a clear link between Actos and Kristufek’s bladder cancer.
“You’ve been bombarded with some things that are not at all designed to help you answer the question of whether Actos caused Mr. Kristufek’s bladder cancer,” he said. “They say, ‘Let’s bank on the jury hating a big company and maybe they’ll give us a break on our burden of proof.’”
Instead he pointed to other significant risk factors, including obesity and a long history of smoking, that he said could also be to blame for Kristufek’s cancer.
He said that Kristufek’s more than 20 years of smoking, a habit he gave up in 1990, was a more likely culprit and that cancer took a longer time to develop than the three years the plaintiffs spent taking Actos to treat his diabetes.
“Here’s what we know about cancer: it takes a long time,” he said. “To get to a point where a tumor is discernable takes years and years and years.”
Kristufek’s is the second Actos-related case to go to trial in Philadelphia. In October, a jury returned a more than $2 million verdict in favor of a plaintiff who leveled similar claims against the company.
A judge in that case denied post-trial motions last Friday aimed at striking down the damage award, clearing the way for the company to launch an appeal with the state’s Superior Court.
The case was presented for Kristufek by Michael Miller of the Miller Firm LLC.
The was presented for Takeda by Orlando Richmond of Butler Snow LLP.
The case is John Kristufek v. Takeda Pharmaceuticals America Inc., case number 120702275, in the Philadelphia County Court of Common Pleas.