Foulston Law Office Blog

Monday, June 3, 2013

Takeda Put Actos Sales Ahead of User Safety, Witness Says

By Jef Feeley - Mar 5, 2013 11:01 PM CT

Takeda Pharmaceutical Co. (4502), Asia’s biggest drug maker, put sales of its Actos diabetes drug ahead of concerns about consumer safety, a witness testified in the first trial over claims the medicine caused cancer.

In 2005 e-mails discussing whether regulators in the U.S. and Europe might seek warning labels about Actos’s potential links to bladder cancer, Takeda officials emphasized protecting the product rather than its users, Howard Greenberg, a clinical pharmacologist, said in state court in Los Angeles yesterday.

“There are multiple e-mails from different levels of Takeda management that indicate the product came first,” Greenberg told jurors in the first day of testimony about Jack Cooper’s claims over Actos.

Testimony in the trial comes about a month after Osaka, Japan-based Takeda won U.S. regulatory approval for Nesina, a replacement for Actos, which lost patent protection last year. Actos sales peaked in the year ended March 2011 at $4.5 billion for Takeda, accounting for 27 percent of the company’s revenue at the time, according to data compiled by Bloomberg.

The U.S. Food and Drug Administration approved Actos for the U.S. market in 1999 and the drug later became the world’s best-selling diabetes treatment.

European Regulators

Health regulators in Germany and France ordered Actos pulled off the market in 2011 after an analysis of a company-sponsored study showed some Actos users faced an increased risk of developing bladder cancer or heart problems.

Takeda executives said in a Feb. 11 statement the Actos study regulators reviewed is continuing and final results should be available next year. Other information generated by the study showed that over time, patients’ risks of developing bladder cancer from the medicine decreased, Takeda said.

Cooper, a retired cable splicer for Pacific Bell, was diagnosed with bladder cancer in 2011, according to court filings. He took Actos for more than four years. His lawyer told jurors in opening statements that Cooper had been in “good shape” before he started on the medication, regularly walking five miles, repairing his own roof and going deep-sea fishing with his grandchildren.

Takeda’s lawyer countered in her opening statement that Cooper’s history as a smoker and his gender put him at higher risk for developing bladder cancer. The disease is the fourth-most common cancer among men after prostate, lung and colon cancer, according to the Bladder Cancer Advocacy Network.

Internal Documents

Greenberg, testifying as an expert for Cooper, said he reviewed internal Takeda documents to prepare for his testimony, according to an online feed from Courtroom View Network. Greenberg said he formerly worked as a drug researcher for companies such Bristol-Myers Squibb Co. (BMY) and Johnson & Johnson (JNJ)’s Janssen Pharmaceuticals unit.

Among the files Greenberg reviewed was an August 2005 e-mail from Takeda executive Kiyoshi Kitazawa on regulators’concerns about Actos’ cancer links, the pharmacologist said.

In the e-mail, Kitazawa highlighted Actos’s value for colleagues who had analyzed what regulators might do in the wake of research showing that users may be at higher risk of getting bladder cancer. Takeda officials were worried that regulators would demand that the company add warnings about the illness to Actos’s label, according to the e-mail.

“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,” Kitazawa said.


Takeda officials said that the “worst-case scenario”would be for regulators to mandate the inclusion of a bladder cancer warning on Actos’s label, according to the e-mail. Kitazawa urged colleagues to seek a “positive outcome” on the warning issue from “regulatory authorities,” the e-mail shows.

Under cross examination by Takeda lawyer Bruce Parker, Greenberg acknowledged that employee e-mails may not indicate the drugmaker’s corporate policies on issues such as patient safety. “I’d agree with that,” the pharmacologist said.

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


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