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From Health Law Daily, April 29, 2015

Takeda agrees to pay $2.4B to settle claims that Actos® causes cancer

By Bryant Storm, J.D.

Takeda Pharmaceutical Company Limited and its subsidiary, Takeda Pharmaceuticals U.S.A., Inc. have agreed to settle the vast majority of products liability lawsuits asserting that the manufacturer’s diabetes drug Actos® causes bladder cancer. Under the agreement, Takeda will pay families and patients up to $2.4 billion, depending on how many current litigants and claimants elect to participate in the settlement. The agreement is estimated to resolve the majority of about 9000 bladder cancer claims that are currently pending against the pharmaceutical manufacturer.

Settlement. According to a Takeda press release, under the agreement, “the settlement will become effective if 95 percent of current litigants and claimants opt into the settlement.” Once the 95 percent threshold is achieved, Takeda will put $2.37 billion into a fund that will be used to pay current litigants and claimants. Takeda’s contribution to the fund will rise to $2.4 billion if 97 percent of current litigants and claimants decide to participate. The amount received by individual claimants will depend upon their particular circumstances. The settlement will also release Eli Lilly & Co., which promoted Actos alongside Takeda between 1999 and 2006.

Actos. According to Takeda’s indication for the drug, “Actos (pioglitazone) is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.” Takeda's decision to settle does not change the company's continued commitment to Actos, which is approved for use in 95 countries including the U.S., Japan, several countries in Europe, Australia, Brazil, Canada and Russia. The company did not admit liability as part of the settlement and indicated that it agreed to the settlement in order to reduce financial uncertainties associated with litigation.

Liability. Actos has placed Takeda in the spotlight before. For example, a 2011 FDA report indicated that among those who used Actos for over one year, the risk of bladder cancer increased by 40 percent. Additionally, according to coverage in the New York Times, in 2014, “a jury in Louisiana ordered Takeda and Eli Lilly to pay a combined $9 billion in punitive damages after deciding that Takeda had hidden the cancer risks.”

Companies: Takeda Pharmaceutical Company Limited; Takeda Pharmaceuticals U.S.A., Inc.; Eli Lilly & Co.

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