Bloomberg News

Takeda’s Actos Diabetes Drug Tied to Cancer, Jury Is Told

April 16, 2013

Takeda Pharmaceutical Co. (4502), Asia’s biggest drugmaker, hid the cancer risks of its Actos drug to protect billions in sales, a jury was told in the first of more than 3,000 lawsuits over the diabetes medication to go to trial.

While Takeda’s internal Actos studies uncovered links to bladder cancer as early as 2004, the company didn’t alert U.S. regulators until seven years later, Michael Miller, a lawyer for plaintiff Jack Cooper, told a state court jury in Los Angeles yesterday. The company kept quiet to protect more than $1.6 billion in annual Actos sales, he added.

“Selling diabetes drugs is big business in America,” Miller said in closing arguments in the trial of Cooper’s suit against Takeda. “There’s a lot of money to be made. But companies are not allowed to downplay the risk. Patient safety is the No. 1 thing.”

Jurors may begin deliberating as early as today over whether Takeda should be held liable for failing to properly warn patients and their doctors that Actos could cause bladder cancer. The company’s defense lawyers are slated to give their closings arguments prior to the jury’s deliberations.

In January, Takeda won U.S. regulatory approval for Nesina, a new diabetes drug to replace Actos, which lost patent protection last year. 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.

3,000 Suits

Takeda is facing more than 3,000 suits alleging Actos caused bladder cancer or other ailments among patients, according to court records. Cooper’s suit is among those that have been gathered before Judge Kenneth Freeman in Los Angeles. There are other cases in state court in Illinois, according to court dockets.

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 2014, according to court filings.

Cooper, a former Pacific Bell Telephone Co. cable splicer who took Actos for more than two years, was diagnosed with bladder cancer in November 2011 and “is gravely ill,” according to Freeman, who put the case on an expedited basis because of Cooper’s condition.

Bladder Cancer

During the almost two-month trial, Miller produced internal Takeda e-mails in which executives urged their colleagues to persuade the U.S. Food and Drug Administration not to demand increased warnings about bladder cancer on Actos’s label.

“Actos is the most important product for Takeda and therefore we need to manage this issue very carefully and successfully not to cause any damage for this product globally,” Takeda executive Kiyoshi Kitazawa said in an e-mail.

Even after FDA officials asked the drugmaker in 2005 and 2006 to update warnings about Actos’ health risks, Takeda executives “stalled and delayed,” Miller said. That’s because the company “was making $1.6 billion a year” on the drug, he added.

Under U.S. law, its Takeda’s responsibility to fully disclose their products’ risks, Miller told jurors.

‘Company’s Responsibility’

“It’s the company’s responsibility and it’s fair,” he said. “The FDA is not making $1.6 billion a year on this drug. The FDA doesn’t have 800 sales representatives out on the street” talking about the medication with doctors, Miller added.

In their defense, Takeda officials have noted the FDA found Actos to be safe and effective and say there’s no proof that it causes bladder cancer.

In opening statements, the company’s lawyers told jurors that its likely Cooper developed bladder cancer as a result of factors other taking Actos.

The disease is the fourth most-common cancer among men after prostate, lung and colon cancer, according to the Bladder Cancer Advocacy Network.

The case is Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court (Los Angeles).

To contact the reporters on this story: Valerie Reitman in Los Angeles; Phil Milford in Wilmington, Delaware, at pmilford@bloomberg.net; 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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