September 16, 2015 — After floating another $100 million, Takeda Pharmaceuticals has gained enough participants to ink a $2.3 billion deal and settle thousands of lawsuits involving Actos.
The settlement is the largest-ever for a drug remaining on the market and will compensate over 10,000 individuals or families injured by Actos, according to a statement by attorneys for Takeda.
Takeda faces approximately 4,800 lawsuits in a centralized federal litigation in Louisiana, according to an update (PDF) yesterday by the Judicial Panel on Multidistrict Litigation (JPML). Another 4,500 cases are pending in mass-torts in California, Pennsylvania, Illinois, and West Virginia.
In early August, only 75% of claimants agreed to the settlement, leading some to question whether it would survive. Today, Takeda said it has 96% of claimants signed up, which is enough to move forward with the deal. If 97% opt-in, the settlement will grow to $2.4 billion.
The deal would provide more than $296,000 per case for plaintiffs with bladder cancer, but the amount may be reduced depending on risk-factors like smoking history and toxin exposure.
Takeda continues to stand by the risk-benefit profile of Actos, citing a 10-year study that showed no statistically significant increased risk of bladder cancer — but higher rates of pancreatic cancer and prostate cancer. The 5-year results of that study found a 41% increased risk of bladder cancer in patients who took high doses for at least a year, prompting a Safety Warning from the FDA in 2011.
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