/

Takeda failed to adequately warn of Actos cancer risks, U.S. jury finds

Bloomberg

A Maryland jury has ruled that Takeda Pharmaceutical Co. failed to properly warn a former U.S. Army translator and his doctor about the risks of the firm’s Actos diabetes drug and ordered it to pay more than $1.7 million (¥168 million) in damages, but a judge immediately threw out the verdict, court documents show.

Jurors in state court in Baltimore deliberated more than six hours over two days before finding Asia’s largest drugmaker liable for the death of Diep An from cancer, said one of the family’s lawyers, Michael Miller.

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 Thursday in an interview.

This is the second time a U.S. jury has found that Takeda hid Actos’ links to bladder cancer. The company, which faces more than 3,000 suits over the drug, is preparing for further trials in state courts in Las Vegas and Chicago and in a Louisiana federal court over 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 the drugmaker, said.

Sales of Actos peaked at $4.5 billion (about ¥443 billion) in the year ended March 2011, accounting for 27 percent of Takeda’s revenue at the time, data compiled by Bloomberg News show. Generic versions of the drug are now available.

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 United States in 1999, and that the firm misled American regulators about the risks.

Officials at the U.S. Food and Drug Administration found in a 2011 review of a Takeda-sponsored study that some Actos users faced an increased risk of developing bladder cancer or heart problems. The company pulled the drug in France that year at the request of regulators and the German government removed Actos from its reimbursed list of medicines at the same time, Takeda said.

Takeda officials said in a statement that the study reviewed by FDA officials is ongoing and final results are expected next year. Other information generated by the study showed that over time, a patient’s risks of developing bladder cancer from Actos decreased, they said.

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 (¥641 million) in damages to a diabetic defendant who blamed Actos for his bladder cancer. The judge in that case later threw out the verdict and the family appealed.

Even though two juries in the U.S. have now found that Takeda failed to properly warn patients and doctors about the drug’s links to bladder cancer, Greisman, the company spokesman, said it is pleased with the outcomes of each trial.

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

In the Baltimore suit, 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.

His family’s lawyers had sought as much as $4 million in damages.