Takeda Pharmaceutical Co. Ltd announced last week it has agreed to settle the “vast majority” of Actos lawsuits, budgeting a whopping $2.4 billion to resolve more than 90% of cases filed over an alleged link to bladder cancer. The company has agreed to set aside $2.37 billion if 95% of plaintiffs currently seeking compensation agree to opt in to the agreement, with the fund rising to $2.4 billion if more than 97% of plaintiffs take part. The agreement between Takeda and plaintiffs’ lawyers is aimed at reducing the “uncertainties of complex litigation,” according to a spokesperson, who added that Actos remains on the market in Japan, the U.S., and in other countries.
Actos, used to treat type 2 diabetes, is the subject of thousands of lawsuits across the country, and was subject to an FDA warning in June, 2011 over a potential link to increased rates of bladder cancer in patients given the drug. Takeda was accused of failing to properly warn doctors and patients about the risks despite knowing about possible side effects. More than 3,000 lawsuits have now been filed, with many alleging that Takeda was capable of producing a safer alternative to Actos but chose not to. During one of the first cases to come to trial last year, the company was found to have destroyed crucial evidence relating to the development of Actos despite a litigation hold, in a move described as “troubling” by the judge. As we reported at the time, documents from more than 40 staff members who worked on clinical trials and research were later destroyed by Takeda – actions described by plaintiffs’ attorneys as “without persuasive, credible, and informed explanation.”
Takeda was later hit with a $9 billion verdict by a jury in Louisiana in the first bellwether trial at a state court, although that was shrunk by a judge to a $36.8 million award. The company has said it intends to appeal the decision further.
In the end, the upcoming $2.4 billion settlement may not hurt the company too much. Actos has already brought in more than $16 billion worth of revenue. The latest settlement fund is being combined with the cost of related Actos cases in a $2.7 billion charge taken against Takeda’s fourth quarter earnings for 2014. It’s big money, sure, but for a company the size of Takeda, it’s manageable. As always, the biggest losers may end up being patients who, forewarned or not, were given a drug that carried far more side effects than anybody knew.