A Philadelphia jury heard opening arguments on Wednesday in a case against Takeda Pharmaceutical Co., the latest in a string of suits against the drugmaker, alleging that a retired high-school teacher developed bladder cancer after taking the diabetes drug Actos.
Miller Firm LLC attorney Michael Miller told the jury that warnings issued beginning in June 2011 about the risks associated with Actos had come too late for his client, John Kristufek, who was diagnosed with bladder cancer in December 2008.
“Actos causes bladder cancer, and the company now warns doctors that Actos could cause bladder cancer,” Miller said. “We’re here today because Takeda never warned his doctors.”
John Kristufek, a resident of 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.
The case is the second Actos-related suit to go to trial in the Philadelphia County Court of Common Pleas and at least the eighth nationwide.
In another case litigated by the Miller Firm, a Philadelphia County jury slapped Takeda with a $2 million verdict in October after finding that the company had negligently failed to warn physicians about the risks associated with Actos. The drugmaker has since filed post-trial motions challenging the award and seeking judgment in its favor.
Kristufek’s complaint alleges that Takeda’s efforts to obscure the drug’s association with bladder cancer had left the plaintiff’s prescribing physician unaware of the risks until shortly after he was forced to have his bladder removed entirely in July 2011.
During opening arguments, Miller said that Kristufek’s doctor immediately took the plaintiff, as well as all of his other patients, off Actos after learning about the association.
In addition to seeking compensation for his medical expenses, Kristufek is seeking punitive damages aimed at punishing the company for what Miller described as an effort to put profits over the health of patients.
“We think they showed a reckless indifference to the health of the people in the state of Pennsylvania,” he said.
Sheila Boston, an attorney with Kaye Scholer LLP representing Takeda, told the jury that at least one recent major study had shown no statistically significant link between Actos and bladder cancer and that prior research suggesting an association between the two were not sufficient to prove causation.
“There is a difference between association and causation,” she said. “The two are not the same.”
She added that Kristufek possessed a number of other risk factors for bladder cancer, including obesity and a history of smoking. She stressed that the drug had been an effective means for treating diabetes in millions of patients since it was introduced to the market in 1999.
“Who is the bad guy in this case? I submit to you that it is Type 2 diabetes, the silent killer,” she said, pointing to the litany of health complications, including bladder cancer, that it can cause.
The Miller Firm last notched a win in November after a West Virginia jury found that Takeda intentionally destroyed documents that detailed what the company knew about the bladder cancer risks associated with Actos. The jury in that case, however, rejected negligent-failure-to-warn claims leveled by the plaintiff..
The biggest blow to Takeda, however, was a $9 billion punitive damage award handed down by a Louisiana federal jury in a bellwether trial over allegations that the the company, along with Eli Lilly, hid the cancer risks associated with Actos in order to keep sales high. The case was the first to be tried as part of multidistrict litigation over the drug.
While a federal judge shrank the punitive damages to $36.8 million in October, the company has announced plans to appeal the award.
The arguments were presented for Kristufek by Michael Miller of the Miller Firm LLC.
The arguments were presented for Takeda by Sheila Boston of Kaye Scholer LLP.
The case is John Kristufek v. Takeda Pharmaceuticals America Inc., case number 120702275, in the Philadelphia County Court of Common Pleas.