Takeda Settles Actos Claims For $2.4 Billion

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Japanese pharmaceutical company Takeda Pharmaceuticals has agreed to pay $2.4 billion to settle lawsuits against the company claiming the diabetes drug Actos led to a higher risk of bladder cancer.

Friday, May 8, 2015 - Takeda Pharmaceuticals have reached a multi-billion dollar settlement in multidistrict litigation regarding the company‘s Actos medication. The settlement, which was announced Tuesday, can be worth up to $2.4 billion with enrollment percentages for plaintiffs deciding the final amount to be paid by the Japanese pharmaceutical company. Takeda did not accept liability for the claims made against them as a condition of the settlement.

At least 95 percent of plaintiffs must accept the settlement to receive a $2.37 billion settlement, and that number reaches the maximum amount of $2.4 billion if 97 percent or more plaintiffs accept the deal. The settlement is one of the largest product liability suits found against a pharmaceutical company, and could end up being the largest settlement ever for a drug that is still on the market.

The lawsuits against Takeda claim that their drug Actos, prescribed as a diabetes medication, created a higher risk for bladder cancer. A warning label applied to the medication by the FDA in 2011 stated that taking Actos for more than two years led to the risk of bladder cancer jumping 40 percent for patients. Plaintiffs claim that Takeda was aware of the drug‘s connections to bladder cancer as early as 2002, but didn‘t warn consumers of the potential dangers associated with Actos.

Takeda has reported in the wake of the announcement that the company will have to take out $2.7 billion against their earning to cover the settlements and end multidistrict litigation related to the Actos claims. Takeda has sold more than $24 billion worth of Actos since 1999. $4.5 billion of that total took place during a 12-month period in 2010 and 2011.

A jury awarded $9 billion to plaintiffs during a bellwether trial that took place earlier in litigation last year, however that award was later reduced to $36.8 billion by the presiding judge. The results of all the bellwether trials however were scattered, as the jury ruled in favor of Takeda in three out of eight hearings.

Estimates for the settlement following the bellwether trial varied widely throughout the life of the MDL, though came more into focus recently. Takeda reportedly offered $2.2 billion to resolve the lawsuits about a month ago, which turned out to be $200 million less than the final sum agreed upon this week.

The settlement will cover more than 4,000 lawsuits filed in the Western District of Louisiana where this Actos MDL was centralized, as well as pay out a similar amount of cases filed in Illinois. There are still lawsuits pending against Takeda in multiple state courts around the country that combine with the Louisiana MDL to make up roughly 9,000 pending Actos lawsuits. Settlement amounts will be determined based on the particulars of individual cases, with factors such as dosage and smoking history being considered in those judgments.

The settlement includes all relevant claimants that experienced problems prior to April 28, 2015, even if potential class members have not yet filed claims against Takeda. Actos will remain available on the market as a diabetes medicine.