A federal jury in Boston has found Takeda Pharmaceutical liable for causing approximately $885 million in damages by orchestrating an anticompetitive scheme to delay a cheaper generic version of its constipation drug Amitiza (lubiprostone). The verdict, returned Monday in the U.S. District Court for the District of Massachusetts following a five-week trial, sided with a class of plaintiffs that included pharmacies, insurers, health funds, and major retailers such as CVS and Walgreens, who argued they were forced to overpay for the drug for years as a direct result of the arrangement.
According to Reuters, the jury's award breaks down to roughly $475 million for direct purchasers and $347 million for individual retailers. Under federal antitrust law, $821.7 million of that total is subject to automatic trebling upon entry of final judgment, which would push the payout to approximately $2.47 billion. Takeda said in a statement released shortly after the verdict that the damages figure is not final and remains subject to further court proceedings, and that the company intends to "vigorously pursue post-trial motions and an appeal."
How a 2014 Settlement Became the Heart of the Case
The case traces its origins to 2012, when Par Pharmaceutical filed for FDA approval to market a generic version of Amitiza. Sucampo Pharmaceuticals — which developed Amitiza and partnered with Takeda to market it in the U.S. following FDA approval in 2006 — and Takeda responded with a patent infringement lawsuit. Par pushed back, arguing the patents were invalid. The litigation resolved in a 2014 settlement under which Par agreed not to launch a competing generic until January 2021. In exchange, Par was permitted to sell an authorized generic version of Amitiza supplied by Sucampo under a profit-sharing agreement. Plaintiffs' lawyers described the arrangement to jurors as a $210 million payoff that locked out cheaper alternatives for six additional years.
Sucampo was later acquired by Mallinckrodt in a $1.2 billion deal in 2018. By the time Par's authorized generic entered the market in January 2021, Amitiza had been generating peak annual revenues of close to $500 million. In Takeda's fiscal year 2020 — the period when the first generic competition arrived — Amitiza sales fell nearly 25 percent year-over-year to roughly $191 million. Takeda no longer markets the drug; its license was terminated in 2024.
A Landmark in Pay-for-Delay Litigation
Monday's verdict is the first time a federal jury has found a pharmaceutical company liable in class-action litigation over a pay-for-delay agreement since the U.S. Supreme Court's 2013 ruling in FTC v. Actavis established that such settlements can violate antitrust law. Three earlier trials brought by private plaintiffs under similar theories all ended in defense verdicts. "We were incredibly fortunate to have a committed jury that really showed up every day, took their job seriously," said Kristen Johnson, a lawyer for the direct purchaser class. "They understood that paying off a competitor has real consequences on competition."
Seattle-based law firm Hagens Berman, which represented the direct purchaser class, said in a statement that the delay caused "hundreds of millions of dollars in overcharges" for its clients. The Federal Trade Commission has previously estimated that pay-for-delay arrangements cost consumers and taxpayers roughly $3.5 billion in higher drug prices annually, and has pursued several such cases in recent years, including a landmark $1.5 billion settlement with Teva in 2015.
Takeda Disputes the Verdict and Signals a Long Appeal
Takeda denied wrongdoing throughout the trial. Joshua Barlow, one of the company's defense attorneys, told jurors in his closing argument that the 2014 settlement with Par was both lawful and pro-competitive — that without it, a generic version of Amitiza would not have reached the market until the company's final patents expired, which he said is not scheduled until October 2027. Takeda also maintained that the deal actually allowed Par to introduce a generic more than six years ahead of that patent cliff. In its post-verdict statement, the company said it "remains firm in our conviction that the plaintiffs' case lacks merit" and cited what it called "evidentiary and legal errors made during the trial." The verdict cannot be enforced until the court formally enters judgment, and Takeda's appeal is expected to proceed through the First Circuit.
