Bloomberg News

Takeda Failed to Properly Warn About Actos Risks, Jury Rules (1)

September 26, 2013

A Maryland jury ruled that Takeda Pharmaceutical Co. (4502) didn’t properly warn an ex-U.S. Army translator and his doctor about the risks of its Actos diabetes drug and ordered the company to pay more than $1.7 million in damages. A judge immediately threw out the verdict.

Jurors in state court in Baltimore deliberated more than six hours over two days before finding Asia’s largest drugmaker liable for the cancer death of Diep An, Michael Miller, one of An’s lawyers, said in an interview. Since jurors also found that An contributed to his death by smoking for 30 years, Judge Brooke Murdock set the verdict aside based on Maryland law.

“We consider the verdict to be a vindication of our claims that Takeda failed to properly disclose the risks of this drug,” Stuart Simms, another lawyer representing the An family, said today in an interview.

It’s the second time a U.S. jury has found that Osaka, Japan-based Takeda hid Actos’s links to bladder cancer. The drugmaker, which faces more than 3,000 suits over the drug, is preparing for trials in state courts in Las Vegas and Chicago and a federal court in Louisiana during the next four months.

“We believe we acted responsibly and we are pleased with the judgment in favor of Takeda,” Ken Greisman, a U.S.-based spokesman for Takeda, said in an interview.

Actos Sales

Sales of Actos peaked in the year ended March 2011 at $4.5 billion, accounting for 27 percent of Takeda’s revenue at the time, according to data compiled by Bloomberg. The drug is now available as a generic.

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.

U.S. Food and Drug Administration 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 that the study FDA officials reviewed is continuing and final results are expected next year. Other information generated by the study showed that over time, patients’ risks of developing bladder cancer from the medicine decreased, they said.

Federal Trial

More than 1,200 suits have been consolidated before a federal judge in Louisiana for pretrial information exchanges. The first of those cases goes to trial in January.

In April, A California jury ordered Takeda to pay $6.5 million in damages to a diabetic man who blamed the drug for his bladder cancer. The judge in the case later threw out the verdict and the family appealed.

Even though two juries have found Takeda failed to properly warn patients and doctors about the drug’s links to bladder cancer, Greisman said the drugmaker is pleased with the outcomes of the two cases.

“In both cases, Takeda has been victorious in the ultimate outcomes,” he said.

Bladder Cancer

In the Baltimore case, An’s lawyers argued 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. Miller and Simms sought as much as $4 million in damages for his family.

Takeda’s lawyers presented evidence showing that An was a former smoker who consumed half a pack of cigarettes a day for 30 years before stopping in 1996. Researchers have found smoking increases the risk of bladder cancer, the lawyers said.

The company also argued it provided adequate warnings about the drug’s risks and noted the U.S. Food and Drug Administration had approved it and never demanded it be taken off the market.

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

To contact the reporter on this story: Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net


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