Thursday, September 05, 2013

Takeda Put Actos Sales Ahead of Safety, Lawyer Tells Jury

Takeda Pharmaceutical Co. (4502)Asia’s biggest drugmaker, put sales ahead of safety by failing to warn consumers about its Actos diabetes medicine’s cancer risks, a lawyer argued in the second case over the drug to go to trial.

Officials of Osaka, Japan-based Takeda knew by 2005 at the latest that studies had shown links between Actos and cancer, and didn’t issue a warning until six years later, Stuart Simms, a lawyer for the family of Diep An, told a jury yesterday in state court in Baltimore. An’s family blames Actos for the Vietnamese immigrant’s bladder-cancer death last year.

Takeda executives “knew the value of the drug and they knew the risks” Actos posed and they opted not to adequately warn An or his doctors, Simms told jurors in opening arguments of the trial of the family’s suit against Takeda. The delay in issuing the warning allowed the company to push ahead with efforts to “sell, sell, sell” Actos, he said.

The case is the second of more than 3,000 suits over Actos to come to trial. A California jury ordered Takeda 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. That ruling is on appeal.

Takeda contends An’s bladder cancer wasn’t caused by Actos and the company properly warned consumers about the drug’s risks. The drug was approved by the U.S. Food & Drug Administration and hasn’t been taken off the market, Craig Thompson, one of the company’s lawyers, said in his opening argument.

$4.5 Billion

Thompson urged jurors to “continue to ask yourself what the rest of the story is” when they hear evidence about the company’s handling of Actos.

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.

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. 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 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.

Army Translator

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.

An’s lawyers contend the former U.S. Army translator took Actos to treat diabetes starting in 2007 and was diagnosed with “high-grade bladder cancer” in September 2011, according to court filings. He died in January 2012.

“The bladder cancer that caused Diep An’s death can be linked directly to his use of Actos,” Simms told jurors yesterday.

Thompson said yesterday that An was a former smoker who consumed half a pack of cigarettes a day for 30 years before stopping in 1996. Takeda officials contend smoking may have been the cause of his cancer, the lawyer said.

Takeda closed at 4,620 yen in Tokyo, unchanged from yesterday and up 19.8 percent since the start of the year.

The case is An v. Nieberlein, 24-C12003565, Circuit Court for the City of Baltimore, State of Maryland.

To contact the reporters on this story: Jef Feeley in Wilmington, Delaware at; Peter Geier in Baltimore

To contact the editor responsible for this story: Michael Hytha


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