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Lilly partner ordered to pay more than $2M to ex-Actos user

October 6, 2014

Takeda Pharmaceutical Co. was ordered by a jury to pay more than $2 million to a woman who claimed the company’s Actos diabetes medicine caused her bladder cancer, in the latest of thousands of lawsuits involving the drug to go to trial.

Jurors in state court in Philadelphia deliberated more than five hours today before finding that officials of Osaka, Japan- based Takeda failed to properly warn Frances Wisniewski’s doctors about Actos’s cancer risk.

Indianapolis-based Eli Lilly and Co. served as Takeda’s U.S. partner in selling and marketing the drug over seven years starting in 1999. While that partnership ended in 2006, Lilly retained rights to sell Actos in parts of Asia and Europe, as well as in Canada and Mexico.

The jury found Takeda “clearly failed to warn, and it clearly caused her damage,” Wisniewski’s attorney, Mike Miller, said. “She’s got a life of bladder cancer; it’s a fair verdict,” he added.

Wisniewski, 79, a retired accountant, is the seventh Actos patient to take her suit to trial. Her case follows a $9 billion verdict this year in Louisiana against Takeda and Lilly for hiding the diabetes medicine’s risks. The companies have asked a judge to grant them a new trial in that case.

“Takeda respectfully disagrees with the verdict and we intend to challenge this outcome,” Kenneth D. Greisman, Takeda Pharmaceuticals U.S.A. Inc.’s senior vice president and general counsel, said in an e-mailed statement.

In addition, 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."

Another drug

Takeda, Asia’s largest drugmaker, scrapped development of another diabetes drug this year when research linked it to liver damage.

More than 3,500 Actos suits have been consolidated before U.S. District Judge Rebecca Doherty in Lafayette, Louisiana, for pretrial information exchanges, according to court dockets. The company faces another 4,500 cases in state courts in Illinois, West Virginia, California and Pennsylvania, according to court records.

In Wisniewski’s case, Takeda argued that smoking rather than Actos was the most likely cause of the Norristown, Pennsylvania, resident’s cancer. She “had many risk factors” for cancer other than the medicine, Craig Thompson, one of the drugmaker’s lawyers, told jurors in his closing arguments yesterday.

Sales of Actos peaked in the year ended March 2011 at $4.5 billion for Takeda and accounted for 27 percent of the company’s revenue at the time, according to data compiled by Bloomberg.

More than $16B in sales

Actos has generated more than $16 billion in sales since its 1999 release, according to court filings. Takeda now faces generic competition from Ranbaxy Laboratories Ltd.

Former Actos users contend in court filings that Takeda researchers ignored or downplayed concerns about the drug’s cancer-causing potential before it went on sale in the U.S. and misled U.S. regulators about the medicine’s risks.

During the trial, which took more than three weeks, Miller presented evidence showing Takeda officials intentionally destroyed documents about the development, marketing and sales of Actos.

The company ditched files of 46 former and current employees, including those of top executives in Japan and U.S. sales representatives, according to court filings. “We’ll never know what was in those documents,” Miller said in his closing argument.

Document destruction

Wisniewski’s lawyer argued Takeda’s mishandling of the drug and the document destruction should open the drugmaker to a punitive-damage award. Juror’s rejected the request for such punishment damages.

In 2013, juries in California and Maryland ordered Takeda to pay a combined $8.2 million in damages over the company’s handling of the drug. But those verdicts later were thrown out by judges. The company also has won defense verdicts in two cases in state court in Las Vegas and one in state court in Illinois.

Takeda faces its next Actos trial in state court in West Virginia starting Oct. 15, according to court filings.

Lilly shares were up 8 cents Monday morning, to $65.75 each.

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