Score one for the plaintiffs in Takeda Pharmaceuticals' Actos litigation. A California jury weighed in against the drugmaker, deciding that Takeda didn't do enough to warn patient Jack Cooper about a heightened risk of bladder cancer. The company was ordered to pay $6.5 million in the case--and more than 3,000 lawsuits are still outstanding.
It was the first bladder-cancer trial for Takeda, in a bellwether suit heard in State Judge Kenneth Freeman's court. A number of similar suits have been consolidated in that court, as Bloomberg reports, with another set under review in Illinois. Some 1,200 federal lawsuits are gathered in a Louisiana court.
The trial went on for two months, as jurors heard allegations that Takeda ignored, hid and downplayed the diabetes pill's links to bladder cancer. Cooper and other plaintiffs contend that Takeda kept back reports about Actos risks and even misled the FDA about its potential dangers. One expert witness highlighted a 2005 email exchange, in which executives discussed new data on Actos patients' risks of bladder cancer. The "worst-case scenario," they said, would be label warnings highlighting the drug's links to cancer. So, employees needed to work with regulators for a "positive outcome," the emails noted.
Takeda maintains that there's no proof Actos causes bladder cancer and says it handled the drug and its safety questions responsibly. The company has asked Judge Freeman to toss out the verdict, and may appeal if that motion is denied. "Takeda empathizes with patients like Mr. Cooper, but we believe the evidence did not support a finding that Actos caused his bladder cancer," SVP and general counsel Kenneth Greisman said in a statement. "We also believe we demonstrated that Takeda acted responsibly. … We promptly disclosed Actos safety data to the [FDA] and other regulatory authorities and provided updated product information to health care professionals and patients."
The lawsuits follow years of questions about Actos and its potential to increase the risk of bladder cancer. The FDA flagged the risk in an analysis of an Actos trial, which suggested that Actos patients faced increased risk of bladder cancer and heart problems. Soon after the FDA's announcement, regulators in Germany and France forced Takeda to pull Actos off the market.
FDA has since required new warning language on the drug's label. Meanwhile, a study published last year in the journal BMJ tied Actos to bladder cancer, with the risk of developing the disease rising with long-term use. The results of FDA's ongoing review are due next year.
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