For many years, Makena was promoted with the kind of subdued assurance that pharmaceutical companies frequently display when they would prefer that patients not inquire too much. It had a clinical history, was FDA-approved, and had a price tag that implied seriousness. In some high-risk pregnancies, the medication hydroxyprogesterone caproate, marketed under the Makena brand, was prescribed to lower the risk of preterm birth. That promise meant a lot to women who had already given birth prematurely.
At least in one courtroom, it is now established law that the promise was broken.
In order to settle a consolidated class action lawsuit alleging that AMAG Pharmaceuticals misled customers about the efficacy of Makena, the company agreed to pay $7.5 million. The settlement, which was approved by the court in January 2026, covers people who used, bought, or paid for Makena treatments in the US between March 8, 2019, and July 11, 2025. Between 65,000 and 81,000 people are thought to be in the class, the majority of whom are women going through one of the more stressful phases of pregnancy.
AMAG disputes any misconduct. That’s the norm. The way the underlying science came apart so clearly is not quite standard.
Makena was granted “accelerated approval” by the FDA, which permits medications to enter the market sooner as long as a confirmatory study is subsequently finished to demonstrate their efficacy. That confirmatory study, called PROLONG, was funded by AMAG. The results, which were made public in March 2019, were straightforward: Makena did not prevent preterm birth any more effectively than a placebo. Due to regulatory bureaucracy, the FDA’s eventual decision to withdraw the medication took years to complete. It wasn’t until April 2023 that Makena was completely removed from the market.
The uncomfortable part is what transpired in between. Plaintiffs claim that even after those PROLONG results were made public, AMAG persisted in aggressively marketing Makena. Plaintiffs claim that the company’s 2020 acquisition by Covis Group increased sales while the FDA withdrawal was still pending. In one version of the story, the timeline is interpreted as opportunistic, taking advantage of administrative delays to maintain revenue from a medication that its own research indicated was ineffective.
Depending on the documentation that class members can produce, the settlement itself offers a variety of payouts. Every Makena dose may be fully reimbursed to those who provide documentation of their treatment and out-of-pocket expenses. $22 per treatment may be given to those who have proof of treatment but no payment records. Members of the class who are unable to provide documentation may be awarded $1 for each treatment, up to a total of $40. By the end of May 2026, the distribution was anticipated.
Here, it’s difficult to ignore the math. After deducting legal fees and administrative expenses, seven and a half million dollars spread over a potential 81,000 class members equates to settlements that are, at most, modest for individual patients. Depending on who is counting, the money may represent recognition, responsibility, or just the expense of legal proceedings.
A parallel story is presented in a different lawsuit that Kessler Topaz filed in Massachusetts on behalf of third-party payors such as health and welfare funds. In April 2025, the court dismissed that case due to a number of procedural and substantive issues. The First Circuit is currently considering an appeal.
Beyond the court dates and settlement percentages, there is something more straightforward. These were actual patients who were prescribed a medication they had every reason to think would help, many of whom were already burdened by a prior preterm birth. The clinical record has already made its own judgment regarding whether or not AMAG is legally liable for that belief, a matter on which the courts have disagreed.
Makena was ineffective. That won’t be altered by the settlement. However, it closes a chapter that ought to have ended with those PROLONG results, at least in part.
