Former Lilly partner ordered to pay $2.3M to Actos user

Takeda Pharmaceutical Co. was ordered by a jury Thursday to pay more than $2.3 million in damages to a former teacher who blamed the company’s Actos diabetes drug for causing his bladder cancer.

Jurors in state court in Philadelphia deliberated more than eight hours over two days before finding that Osaka, Japan-based Takeda failed to properly warn John Kristufek’s doctors about Actos’s cancer risks. The panel concluded Kristufek deserved more than $300,000 for his medical expenses and $2 million for pain and suffering tied to the cancer diagnosis, his lawyers said.

The jury also said Takeda showed “reckless indifference” to Kristufek’s health by hiding Actos’ risks, a finding that opens up the drugmaker to a potential punitive award. The panel will consider Friday whether to award those damages.

Kristufek is the fifth Actos patient to convince a jury that Takeda’s former top-selling drug causes bladder cancer. Last year, a federal jury in Louisiana ordered Takeda and Eli Lilly and Co., which at one time sold Actos in the U.S., to pay $9 billion to a shopkeeper who blamed his cancer on the drug. That award was cut to $36.8 million.

Lilly was Takeda’s U.S. partner in selling and marketing the drug over seven years starting in 1999. That partnership ended in 2006, with Lilly retaining rights to sell Actos in parts of Asia and Europe as well as in Canada and Mexico.

Lilly said earlier this year that  it "will be indemnified by Takeda for its losses and expenses with respect to the U.S. litigation and other related expenses in accordance with the terms of its indemnification agreement."

“Given the number of trial losses Takeda has suffered over Actos, the company should seriously consider negotiating some sort of global settlement,” said Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia. “They still face thousands of lawsuits over this drug.”

Takeda appeal

More than 3,500 Actos suits have been consolidated before a federal judge in Louisiana for pretrial information exchanges. The company faces 4,500 more in state courts in places including Illinois, West Virginia and Pennsylvania, according to court records. The company faces its next trial in March in Wisconsin.

Takeda officials said Thursday they were disappointed with the jury award to Kristufek and will consider appealing.

“We believe the evidence showed that Mr. Kristufek’s condition was not caused by Actos,” Ken Greisman, a U.S.-based spokesman for Takeda, said in an e-mailed statement.

Actos has generated more than $16 billion in sales since its 1999 release, according to court filings. Sales peaked in the year ended in March 2011 at $4.5 billion, 27 percent of Takeda’s revenue at the time, according to data compiled by Bloomberg. Takeda now faces generic competition from Ranbaxy Laboratories Ltd. over the diabetes drug.

Kristufek and other former Actos users argue Takeda executives ignored or downplayed concerns about the drug’s cancer-causing potential before it went on sale in the U.S. in 1999 and misled U.S. regulators about the medicine’s risks.

Other trials

Takeda has argued in court filings the company properly vetted the drug and included all required warnings on its safety label. It has battled former users’ claims in trials across the country starting in 2013.

Juries in California and Maryland in 2013 ordered Takeda to pay a combined $8.2 million in damages over the handling of the drug. Those verdicts later were thrown out by judges and are on appeal. The company also won defense verdicts in two cases in state court in Nevada.

Last year, a Philadelphia jury awarded more than $2 million in damages to a retired accountant who blamed her bladder cancer on Actos. That case also is on appeal.