Takeda Didn’t Warn of Actos Cancer Risk, Lawyer Says

Takeda Pharmaceutical Co. (4502), Asia’s biggest drugmaker, failed to warn doctors of the cancer risk associated with its Actos diabetes treatment, a lawyer said as the first of more than 3,000 lawsuits over the drug goes to trial.

Takeda sales representatives never warned a doctor for California resident Jack Cooper in more than 195 visits, Cooper’s lawyer Michael J. Miller said today in opening statements in state court in Los Angeles. The doctor prescribed the drug to Cooper in 2006.

The Osaka-based company is facing thousands of lawsuits alleging Actos caused bladder cancer or other ailments among patients, according to court records.

“Jack Cooper will be dead in the next seven months from bladder cancer,” Miller told jurors. “There is no cure.”

Cooper’s suit is among the cases that have been gathered before Judge Kenneth Freeman in California. The drugmaker is also facing cases in state court in Illinois and more than 1,200 lawsuits consolidated before a federal judge in Louisiana. The first federal trial is scheduled for November 2014, according to court filings.

Takeda officials have defended the company’s handling of Actos by noting the U.S. Food and Drug Administration found it safe and effective. There is no proof that it causes bladder cancer, the company has said. Lawyers for the company are set to present their opening statements in the trial later today.

Diabetes Market

Takeda pushed to enter the U.S. diabetes market starting in 1996, Miller said. By 1999, when the drug received approval from the FDA, the company had hired 600 sales representatives to market the medicine, he said. The company also sought to retain doctors as key opinion leaders to tout the drug to their colleagues.

“The evidence will show that Takeda has not been fair or balanced in the marketing of Actos,” Miller told jurors at the trial, according to an online feed from Courtroom View Network. “A reasonable pharmaceutical company would have warned doctors.”

Takeda’s sales representatives visited Cooper’s family doctor every two weeks, treating him to dinners and free lunches from 1999 to September 2006, Miller said. The representatives first mentioned the drug’s increased risk of cancer in August 2011. The doctor stopped writing new prescriptions that month and banned sales representatives from his office, Miller said.

Cooper, a former cable splicer for Pacific Bell, took Actos for more than two years before being diagnosed with bladder cancer in November 2011. The grandfather and veteran, who has been married for 56 years, was in “good shape” before he started on the medication, Miller said.

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

To contact the reporters on this story: Sophia Pearson in Philadelphia at spearson3@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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