Japan's Takeda Agrees To $2.4B Settlement In Diabetes Drug Actos Lawsuit Over Cancer Risk Allegations

Japan’s Takeda Pharmaceutical Co. Ltd. reached a settlement on Tuesday on thousands of lawsuits filed against the company over its diabetes drug Actos. The firm agreed to reimburse families and patients in the United States up to $2.4 billion over allegations that the drug was linked to bladder cancer.

“We are pleased that Takeda has agreed to provide $2.4 billion to compensate thousands of deserving bladder cancer victims,” plaintiff lawyer Richard Arsenault said on Tuesday, according to the New York Times. “After years of hard-fought and contentious litigation, the defendants have finally stepped up to the plate, and we applaud that effort.”

Takeda, Japan’s biggest drug company by revenue, faces product liability lawsuits in the U.S. that involve about 9,000 people.

The company said the decision is expected to resolve the “vast majority” of these cases. Takeda will put the money into a settlement fund if 95 percent of plaintiffs agree to the accord, according to which each claimant would get an average $267,000. However, the exact amount for each plaintiff will be evaluated based on cumulative dosage, extent of injuries and past history of smoking.

Takeda said it will take a $2.7-billion charge against its earnings in the fourth quarter of FY2014 in order to cover the settlements and legal costs. The company expects to record a $1.22 billion loss this fiscal year, the first since it was publicly listed in 1949, according to the Nikkei Asian Review.

The company said it hopes to resolve the lawsuits quickly to help it move forward. "The settlement will reduce financial uncertainties for the company and provides a significant degree of assurance toward resolving a high percentage of the Actos product liability claims," allowing it to focus on new developments, it reportedly said in a statement.

It, however, stood by the drug, saying, "Takeda's decision to settle does not change the company's continued commitment to Actos," the Associated Press reported, citing the statement.

According to a court document filed in one of the cases against Takeda, sales of Actos in the U.S. are cumulatively worth over $24 billion. The drug went on sale in 1999, and now faces generic competitors.

Eli Lilly & Co., which was responsible for promoting Actos alongside Takeda between 1999 and 2006, will be released from liability under the settlement. Last year, a Louisiana federal court ordered Takeda and Eli Lilly to pay a combined $9 billion in punitive damages to a New York state man who said Actos had given him bladder cancer, the Wall Street Journal reported. That amount was reduced in October to about $37 million by a federal judge who ruled the charge was excessive.

In 2011, the U.S. Food and Drug Administration report found a 40 percent increase in bladder cancer risk among those who used Actos for over one year, and ordered the warning label for the medicine to include cancer risk.