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Lilly partner accused of putting Actos profit ahead of safety

October 3, 2014

Takeda Pharmaceutical Co. was accused by a lawyer for a woman who blames Actos for her cancer of sacrificing safety for profit by failing to warn patients and doctors about the diabetes medicine’s risks.

Executives at Osaka, Japan-based Takeda knew by 2004 that studies found links between Actos and cancer, and didn’t issue a warning until seven years later to protect billions of dollars in sales of the drug, Michael Miller told a state-court jury in Philadelphia on Thursday.

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.

“Takeda chose to protect profits rather than patients,” Miller said in closing arguments in the trial of Frances Wisniewski’s lawsuit against Takeda. The company’s main goal was “to protect the product,” Miller added.

Wisniewski, a retired accountant who has bladder cancer, 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 cancer risks. The companies have asked a judge to grant them a new trial in that case.

In that case, Lilly was ordered to pay $3 billion of the $9 billion award. The company said 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."

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.

Takeda’s stance

In Wisniewski’s case, Takeda contends smoking rather than Actos is the most likely cause of the Norristown, Pennsylvania, resident’s bladder cancer. The 79-year-old Wisniewski “had many risk factors” for cancer other than the medicine, Craig Thompson, one of the drugmaker’s lawyers, told jurors in his closing arguments.

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.

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.

Wisniewski and other 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.

Documents gone

Miller also told jurors in the Philadelphia Court of Common Pleas that 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 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 won defense verdicts in two cases in state court in Las Vegas.

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

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