May 21, 2015, Trial News
Takeda agrees to landmark Actos settlement
Alyssa E. Lambert
In one of the largest pharmaceutical products liability settlements in U.S. history, Takeda Pharmaceutical Co. has agreed to pay more than $2.3 billion to settle cases brought by plaintiffs who allege they developed bladder cancer after taking the diabetes drug Actos.
Takeda Pharmaceutical Co. has agreed to pay more than $2.3 billion to settle about 9,000 cases brought by plaintiffs who allege they developed bladder cancer after taking the diabetes drug Actos. It is one of the largest pharmaceutical products liability settlements in U.S. history.
Actos was one of Takeda’s best-selling products, generating $16 billion in sales in the United States since it went on the market in 1999. It was marketed as an alternative to Rezulin and Avandia, which were recalled after being linked to liver and heart damage. Takeda and Eli Lilly & Co. jointly promoted the drug from 1999 until 2006. In 2011, Takeda changed the drug’s label in response to an FDA alert warning patients and physicians that taking Actos for more than a year might be associated with an increased risk of bladder cancer.
The settlement covers the 4,300 cases in a federal MDL consolidated in the Western District of Louisiana and another 4,500 cases pending in state courts across the country, including California, Illinois, Pennsylvania, and West Virginia. (In re Actos (Pioglitazone) Prods. Liab. Litig., MDL No. 2299 (W.D. La. Apr. 28, 2015).)
Takeda announced that 95 percent of the claimants must agree to the settlement, but legal experts said the company is unlikely to pull out if participation does not reach 95 percent. At 95 percent participation, the global settlement is $2.37 billion. That increases to $2.4 billion at 97 percent participation.
New York City attorney Paul Pennock, co-lead counsel on the plaintiffs’ MDL steering committee, said the settlement is “fair and reasonable” for most claimants. “It’s always very rewarding to work on something for years . . . and have it become successful,” Pennock said. “Most companies, even ones as large as Takeda, feel something very significant when they have to pay $2.4 billion. There is no question that Takeda recognizes that something went egregiously wrong, but of course, it continues to deny liability.”
The first federal bellwether resulted in a $9 billion punitive damages award that was slashed to $36.8 million in October, as Trial News previously reported. In that case, Terrence Allen began taking Actos in 2006 and developed bladder cancer in 2011. The jury found the defendants liable for failure to warn and negligent marketing. The next bellwether was scheduled for May 2016. (Allen v. Takeda Pharm. Co., Ltd., No 6:12-cv-00064 (W.D. La. Apr. 7, 2014).)
News reports indicate the average case settlement will be about $296,000, and Houston attorney Mark Lanier, who represents the Allen family, said it’s the largest per-case average settlement in any U.S. drug litigation. “The settlement was put together on a matrix,” Lanier said, so plaintiffs with the strongest cases recover more for their injuries. “One of the biggest landmark settlements ever was Vioxx—$4.75 billion—and it covered 50,000 plaintiffs,” he noted. In comparison, the Actos settlement includes fewer than 10,000 plaintiffs.
Lanier said that global settlement made sense. “We would be fortunate to try five or 10 cases a year. The one that we won. . . .What are the odds that we do that again?” he said. “You have to be realistic about this. . . . Many of these plaintiffs are well into their eighties. We figured out how to get them money now, rather than in 10 years.”
Pennock cautions attorneys with Actos cases to read the detailed settlement agreement thoroughly and then act quickly. “Lawyers have to ascertain what they have to do for their clients ASAP, because the [settlement] timeline is very tight. It can’t be left to the last minute,” he said. The agreement is available at www.actosofficialsettlement.com.