Takeda Pharmaceutical Co., 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 went to trial.
Takeda sales representatives never warned ex-Actos user Jack Cooper’s doctor the diabetes medicine could cause bladder cancer in any of more than 195 office visits to discuss the company’s products, Michael Miller, Cooper’s lawyer, said today in opening statements in state court in Los Angeles. Cooper took the drug for more than four years before being diagnosed with the disease in 2011, according to court filings.
“Jack Cooper will be dead in the next seven months from bladder cancer,” Miller said. “A reasonable pharmaceutical company would have warned doctors” about Actos’s links to the fatal disease.
The trial comes a month after Osaka, Japan-based 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.
In her opening statement, a lawyer for Takeda said that 78-year-old Cooper didn’t get bladder cancer from Actos. The former telephone company employee was more likely to develop the disease because of his gender and his years as a smoker, the company contends.
Cooper “already was at high risk” for developing bladder cancer “for reasons that had nothing to do with Actos,” said Sara Gourley, one of the drugmaker’s attorneys.
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.
FDA officials found in 2011 that an analysis of a company-sponsored study showed some Actos users faced an increased risk of developing bladder cancer or heart problems. The company pulled the drug off the market in Germany and France that year at the request of those countries’ regulators.
Takeda executives said in a Feb. 11 statement the Actos study FDA officials 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, officials added.
Cooper’s lawyers contend in court filings Takeda researchers ignored or downplayed concerns about the drug’s cancer-causing potential before it went on the U.S. market in 1999 and misled U.S. regulators about the medicine’s risks.
Once U.S. regulators approved Actos for sale, Takeda hired 600 sales representatives to market the diabetes medicine, Miller said. The company also sought to retain doctors as so-called “key opinion leaders” to tout the drug to their colleagues, he added.
Takeda’s sales representatives visited Cooper’s family doctor every two weeks over an eight-year period starting in 1999, treating him to dinners and free lunches as part of the company’s Actos marketing effort, Miller said.
The drugmaker’s sales reps first mentioned Actos’s increased cancer risk to Cooper’s doctor in August 2011, Miller said. The physician stopped writing new prescriptions that month and banned the company’s salespeople from his office, the lawyer said.
‘Fair or Balanced’
“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.
Cooper, a retired cable splicer for Pacific Bell, was diagnosed with bladder cancer in 2011, Miller said. The grandfather had been in “good shape” before he started on the medication, regularly walking five miles at a clip, repairing his own roof and going deep-sea fishing with his grandchildren, the lawyer added.
Gourley countered in her opening statement that since Cooper had a history of smoking, he was in the higher risk category for bladder cancer, which is the fourth-most common cancer among men after prostate, lung and colon cancer, according to the Bladder Cancer Advocacy Network.
Despite conflicting evidence in the case about when Cooper kicked his cigarette habit, “the damage from smoking was already done” before he took Actos, Gourley said.
Gourley also told jurors Takeda already has disclosed to the FDA that Actos users faced a small risk of developing bladder cancer. The company strengthened its warnings about the cancer link in 2011 at regulators’ behest.
Still, the company’s continuing research on the drug shows that only “10 in 10,000 people” may be at risk for developing cancer from the diabetes medicine, she said.
“Now we have eight years of data available and it doesn’t show any significant risk of bladder cancer from Actos,” Gourley added. “You cannot conclude that Actos causes bladder cancer today.”
The case is Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court (Los Angeles).