Bloomberg News

Takeda Denies Actos Bladder-Cancer Link at First Trial

April 16, 2013

Takeda Pharmaceutical Co. (4502), Asia’s biggest drugmaker, denied its Actos drug caused a California man’s bladder cancer in the first of more than 3,000 lawsuits over the diabetes medication to go to trial.

Plaintiff Jack Cooper developed bladder cancer, the fifth- most common form of cancer, as a result of factors other taking Actos, Sara Gourley, a Takeda lawyer, told a state court jury in Los Angeles today. Cooper, 79, is diabetic and a former smoker, she said.

“The evidence is not only clear, it is overwhelming, that Mr. Cooper is in the highest-risk groups, and that his bladder cancer had nothing to do with Actos,” Gourley said.

Jurors ended deliberations today over whether Takeda, based in Osaka, Japan, should be held liable for failing to properly warn patients and their doctors that Actos could cause bladder cancer. The panel will continue considering the case tomorrow.

Michael Miller, a lawyer for Cooper, told jurors yesterday that Takeda hid the cancer risks of Actos to protect billions of dollars in sales. While Takeda’s internal studies uncovered links to bladder cancer as early as 2004, the company didn’t alert U.S. regulators until seven years later, he said.

“Selling diabetes drugs is big business in America,” Miller said in his closing arguments. “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.”

Actos Sales

In January, Takeda won U.S. regulatory approval for Nesina, a diabetes drug to replace Actos, which lost patent protection last year. Actos sales peaked in the year ended March 2011 at $4.5 billion, or 27 percent of the Takeda’s revenue at the time, according to data compiled by Bloomberg.

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

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.

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.

Executive E-Mails

During the almost two-month trial, Miller produced internal Takeda e-mails in which executives urged 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’s health risks, Takeda executives “stalled and delayed” because the company “was making $1.6 billion a year” on the drug, Miller said.

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

‘It’s Fair’

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

In their defense, Takeda officials have said the FDA found Actos to be safe and effective and they contend there’s no proof the drug causes bladder cancer.

Gourley said today that although some studies found a possible “association” of Actos and bladder cancer, none have uncovered a causal connection. FDA researchers have “not concluded that Actos increases the risk of bladder cancer,” she said.

While Cooper’s lawyers told jurors their client had stopped smoking in the mid-1970s, that wouldn’t take the former telephone-company employee out of the high-risk category for getting bladder cancer, Gourley said.

“By 1974, he had smoked at least 21 years,” she said. “It doesn’t matter when he stopped. The damage was done.”

The Takeda attorney also argued that the company fully disclosed Actos’s health risks on warning labels, including information about cancer tumors that appeared in rats being studied during the drug’s development.

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; 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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