(Updates with company comment in sixth paragraph.)
Dec. 16 (Bloomberg) -- Takeda Pharmaceutical Co. officials properly warned a Nevada man’s doctors about the cancer risk of the company’s Actos diabetes drug, a jury found in the third of more than 6,000 lawsuits over the product to go to trial.
Jurors in state court in Las Vegas deliberated for about five hours today before finding Osaka, Japan-based Takeda not liable for Allen Alsabagh’s bladder cancer. Alsabagh, a former baker, said he got the disease in 2011 after taking Actos for four years for diabetes. Alsabagh’s doctors say he may live only another six months, according to trial testimony.
The case marks the first time Takeda has persuaded a U.S. jury to reject claims involving what had been one of the its most profitable products. Actos has generated more than $16 billion in sales since its 1999 release. The company now faces generic competition from Ranbaxy Laboratories Ltd.
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.
Takeda officials said they were pleased jurors found the company handled Actos properly and threw out Alsabagh’s claims for as much as $11 million in damages. The panel found the company properly warned Alsabagh’s doctors about the drug’s bladder-cancer risks.
“We’re going to vigorously defend these cases,” Ken Greisman, general counsel for Takeda’s U.S. unit, said in a telephone interview after the verdict was announced. “We’re going to fight for this product and for the patients who need this medication.”
Michael Miller, Alsabagh’s lawyer, said in an interview that he was disappointed jurors rejected the former baker’s claims and vowed to appeal.
Former Actos users contend in court filings Takeda researchers 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.
FDA officials found in a 2011 review of a company-sponsored study that some Actos users faced an increased risk of developing bladder cancer or heart problems. The company pulled the drug off the market in France that year at the request of regulators. In Germany, the government removed Actos from its reimbursed list of drugs at the same time, the company said.
Takeda officials said in an e-mailed statement earlier this year the study FDA officials reviewed is continuing and results are scheduled to be available next year. They said other information generated by the study showed that over time, patients’ risks of developing bladder cancer from the medicine decreased.
More than 1,200 suits have been consolidated before a federal judge in Louisiana for pretrial information exchanges. The first federal case is set for trial in January, according to court filings. Takeda officials now say more than 6,000 plaintiffs have sued in both the consolidated federal case and state courts. As many as 17 cases are scheduled for trial next year, the company said.
In the first Actos case to go to trial, jurors in state court in Los Angeles ordered Takeda in April to pay $6.5 million in damages to a diabetic who blamed the drug for his bladder cancer. The judge in the case later threw out the verdict and the ruling is on appeal.
The second trial in Baltimore, Maryland resulted in a $1.7 million verdict for the family of a former U.S. Army translator who died of bladder cancer after taking Actos. A judge immediately threw out that award and the ruling is on appeal.
Miller argued in the Nevada case that Takeda dragged its feet in warning Actos users like Alsabagh about the drug’s cancer risks even though it had research stretching back a decade raising questions about links to the disease. Alsabagh’s doctors weren’t told about the medicine’s dangers when they prescribed it for the 66-year-old man, Miller added.
“There was nothing he could do to save his own life except not take Actos,” Miller said in closing arguments.
Alsabagh’s lawyer added Takeda had gotten away with “the perfect crime” by selling Actos in the U.S. while knowing some studies showed it caused cancer. Takeda’s lawyers objected to Miller’s suggestion the company engaged in criminal behavior and Judge Susan Johnson ordered jurors to disregard it.
Takeda’s attorneys argued in their closing statement that evidence in the case shows Alsabagh had bladder-cancer symptoms long before he took Actos and the native of Lebanon put off proper medical treatment. The drugmaker contends men in their 60s are at high risk for developing bladder cancer independent of Actos use.
“This is a great city and state,” D’Lesli Davis, one of Takeda’s attorneys, told jurors in her closing argument. “Here, we can make our own choices without judgment. But when we place blame where it doesn’t belong, that is wrong.”
The case is Alsabagh v. Takeda Pharmaceuticals America Inc., A-12-665708-C, Clark County District Court, Nevada (Las Vegas).
--With assistance from Sophia Pearson in federal court in Philadelphia. Editors: Peter Blumberg, Mary Romano