Sept. 26 (Bloomberg) -- Takeda Pharmaceutical Co. duped patients and doctors about the risks of its Actos diabetes drug and should be held liable for the cancer death of a former U.S. Army translator, a lawyer argued in the second case over the medicine to go to trial.
Officials of Osaka, Japan-based Takeda, Asia’s largest drugmaker, failed to provide any warning until 2011 that researchers had linked Actos to bladder cancer, Michael Miller, a lawyer for the family of Diep An, told a jury yesterday in state court in Baltimore. The lack of a warning allowed the company to protect billions in sales of the drug, Miller said.
“Failure to warn is what we are here about,” Miller told the four-woman, two-man jury in closing arguments of the trial of the family’s lawsuit. Deliberations began late yesterday.
The case is the second of more than 3,000 suits over Actos to come to trial. A California jury ordered Takeda to pay $6.5 million in damages to a diabetic man who blamed the drug for his bladder cancer. The judge in the case later threw out the verdict and the family appealed.
Takeda contends An’s bladder cancer wasn’t caused by Actos and the company properly warned consumers and physicians about the drug’s risks. Scientists haven’t conclusively linked Actos to bladder cancer, Craig Thompson, one of the company’s lawyers, said in his closing argument.
Studies finding a connection between Actos and bladder cancer are based on “tenuous science,” he said.
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. The drug is now available as a generic.
Former Actos users contend in court filings that Takeda researchers ignored or downplayed concerns about the drug’s cancer-causing potential before it went on sale in the U.S. in 1999, and misled U.S. regulators about the medicine’s risks.
U.S. Food and Drug Administration officials found in a 2011 review of a company-sponsored study that some Actos users faced an increased risk of developing bladder cancer or heart problems. The company pulled the drug off the market in France that year at the request of regulators. In Germany, the government removed Actos from its reimbursed list of drugs at the same time, the company said.
Takeda officials said in an e-mailed statement that the study FDA officials reviewed is continuing and final results are slated to be available next year. They said other information generated by the study showed that over time, patients’ risks of developing bladder cancer from the medicine decreased.
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.
Thompson reminded jurors that An was a former smoker who consumed half a pack of cigarettes a day for 30 years before stopping in 1996 and researchers have found smoking increases the risk of bladder cancer.
Takeda’s lawyer added the U.S. Food and Drug Administration repeatedly approved Actos for use in the U.S. and the drug is still on the market. “There’s been no hiding of truth in this courtroom and no hiding of truth from the FDA,” Thompson added.
An’s lawyers contend the former U.S. Army translator took Actos to treat diabetes starting in 2007 and was diagnosed with “high-grade bladder cancer” in September 2011, according to court filings. He died in January 2012.
Miller contends An’s wife and children deserve $4 million in compensatory damages over the death of the family’s patriarch. Judge Brooke Murdock ruled the family can’t seek punitive damages in the case.
“FDA approval is not a defense,” Miller said. “It doesn’t relieve them of their responsibility” to properly warn about the medicine’s risks, Miller said.
The case is An v. Nieberlein, 24-C12003565, Circuit Court for the City of Baltimore, State of Maryland.
--Editors: Andrew Dunn, Glenn Holdcraft