$7.5M Makena Settlement Aims to Resolve Lawsuit Over Preterm Birth Medication Advertising

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AMAG Pharmaceuticals has agreed to pay a $7.5 million settlement that, if approved by the court, will resolve a consolidated class action lawsuit that alleged the drug manufacturer misled consumers about the efficacy of its preterm birth medication, Makena.

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If preliminarily approved by the court, the proposed Makena class action settlement will cover all consumers who took, were prescribed, purchased, paid for or otherwise incurred out-of-pocket costs in connection with treatment with Makena in the United States between March 8, 2019 and the date the deal receives initial court approval.

Court documents estimate there are between 65,000 and 81,000 class members.

The proposed agreement with AMAG covers Makena products (hydroxyprogesterone caproate injection) regardless of dose, formulation or whether the drug was supplied via auto-injector or in single- or multi-dose vials. The covered products include, but are not limited to, those sold under the National Drug Codes 64011-243-01, 64011-247-02 and 64011-301-03, the settlement agreement says.

The Makena settlement does not cover any generic or compounded version of hydroxyprogesterone caproate, the document notes.

If the deal is initially approved, class members who submit a timely, valid claim form may be eligible to receive a pro-rated share of the $7,500,000 settlement fund.

Class members can file a Makena settlement claim form by mail or online through the court-authorized settlement website once it is established.

ClassAction.org will update this page if and when the official Makena settlement website is launched.

According to the settlement agreement, class members who submit a timely, valid claim form with proof of treatment and proof of out-of-pocket payment for a covered product may receive the full amount of out-of-pocket expenses incurred for each treatment during the qualifying period. Each dose of Makena constitutes a “treatment,” the document specifies.

Class members who file a claim without proof of treatment or proof of out-of-pocket payment, but for whom the number of treatments and amount of incurred costs can be reasonably substantiated through settlement attorneys’ records, will also be entitled to receive the full amount spent out of pocket for each treatment during the qualifying period.

Related Reading: Two Women File Class Action After Study Exposes Ineffectiveness of Preterm Birth Drug Makena

Furthermore, consumers who submit a claim with proof of treatment but without proof of out-of-pocket costs, and for whom the amount of incurred expenses cannot be reliably verified through attorneys’ records, may receive $22 for each treatment during the qualifying period, the agreement says. However, if a class member in this category participated in any government healthcare program at the time of treatment, the consumer will be eligible to receive only $4 for each treatment.

Consumers who file a claim without proof of treatment and without proof of out-of-pocket costs, and for whom the number of treatments and amount of incurred expenses cannot be substantiated through records, may receive $1 for each treatment during the relevant period, capped at a $40 total payment, the settlement agreement shares.

All Makena settlement payouts are subject to adjustment on a pro rata basis as needed to exhaust what remains of the settlement fund after the payment of administrative costs, attorneys’ fees and service awards.

The plaintiffs filed an unopposed motion and supporting brief detailing the terms of the deal with AMAG on May 8, 2025. The parties now await preliminary approval from United States District Judge Julien Xavier Neals.

The settlement website will be established, and notices will be issued by mail and email to eligible class members, within 30 days following the date of initial approval, the agreement explains.

According to the Makena class action lawsuit, the prescription drug, a progestin hormone treatment, was approved by the United States Food and Drug Administration (FDA) in 2011 to reduce the risk of preterm birth in certain pregnancies. However, the FDA withdrew Makena’s approval in April 2023 following the completion of a study in 2019 that failed to confirm the drug delivered the advertised benefits, court documents describe.

In light of Makena’s loss of FDA approval, the consolidated class action suit alleged that AMAG had unlawfully misrepresented the drug, causing consumers to pay a premium price for medication that was “no more effective than a placebo.”

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