For the second time, Takeda Pharmaceuticals is trying to fend off claims that it didn't warn Actos patients about the diabetes drug's links to bladder cancer. Earlier this year, it lost the first case to go to trial, but it persuaded a judge to toss the $6.5 million jury verdict.
At issue in both cases is whether a) Takeda knew about Actos' potential to increase the risk of bladder cancer long before it warned patients and doctors about it, and b) whether Actos actually caused bladder cancer in the patients who've sued. Takeda faces more than 3,000 similar lawsuits around the country, many of them consolidated in Louisiana federal court. Early court decisions could help determine how and whether the rest of the cases are settled--and how much, if anything, Takeda will eventually pay the plaintiffs.
As this second trial opened Tuesday in Baltimore, attorney Stuart Simms blamed Actos for the death of Diep An, a Vietnamese immigrant whose family chose to sue. An began taking Actos in 2007 and was diagnosed with bladder cancer in September 2011. Just three months earlier, the FDA had raised a red flag on Actos' potential to increase the risk of bladder cancer, and authorities in France asked Takeda to suspend sales. Germany restricted reimbursement but left it on the market.
"The bladder cancer that caused Diep An's death can be linked directly to his use of Actos," Simms claimed in opening arguments. Takeda "knew the risks" of Actos, the lawyer said, and failed to warn An or his doctors about them because they were more worried about sales than patient safety.
Takeda maintains that there's no proof Actos causes bladder cancer and says it handled the drug and its safety questions responsibly. Before it went off patent in 2012, Actos was Takeda's top-selling drug, with peak sales of $4.3 billion. Last year it brought in $1.5 billion.
Actos and its links to bladder cancer have been argued for years; regulators have been eyeing the data almost since the drug was approved in 2000. The FDA's 2011 safety alert--and required changes to the drug's label--were based on an analysis from an Actos safety study that's still ongoing.
A more recent study, however, touched off a new round of debate, and the FDA says its review of the new data will wrap up next year. In June, India suspended sales of Actos and its generics, citing similar moves by regulators in other countries, but has since allowed the drugs back on the market.
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Editor's note: This story has been updated to clarify Actos' status in Germany.