If you purchased, used, or paid out of pocket for Makena, you could be eligible for part of a $7.5 million class action settlement. Let’s break down what this is about — and how you can claim your share.
Why is there a lawsuit?
A class action lawsuit accused AMAG Pharmaceuticals, Inc. of misleading consumers and healthcare providers about the effectiveness of Makena, a hormone injection meant to help reduce the risk of preterm birth.
Makena was approved by the FDA in 2011, but after years of study, the FDA withdrew its approval in April 2023, finding no proven benefit.
AMAG denies wrongdoing, but agreed to a $7.5 million settlement to resolve the lawsuit and avoid the expense and uncertainty of further litigation.
Who qualifies?
You may be part of the settlement if you:
Took, were prescribed, purchased, paid for, or incurred out-of-pocket costs for Makena in the U.S.
Between March 8, 2019, and July 11, 2025.
Note: This includes Makena in any form (vial or auto-injector) but does not include generic or compounded versions of hydroxyprogesterone caproate.
How much can people get?
Payments will come from the $7.5 million Settlement Fund, after deducting court-approved costs and fees. Here’s what class members can expect:
| Proof Submitted | Payment per Treatment | Details |
|---|---|---|
| Proof of Treatment and Proof of Out-of-Pocket Payment | $22 per treatment | Or $4 per treatment if you used a government healthcare program (e.g., Medicaid). |
| Proof of Treatment only | $1 per treatment (max $40)** | If you can’t provide receipts or records. |
| No proof | $1 per treatment (max $40)** | Based on your sworn statement. |
All payments are subject to pro rata adjustment, meaning the exact amount could go up or down depending on how many valid claims are filed.
What Are Your Options?
| Action | Deadline / Date | What It Means |
|---|---|---|
| Claim Form Deadline | November 10, 2025 | Submit to receive a payment. |
| Exclusion (Opt-Out) Deadline | November 10, 2025 | Opt out if you want to keep your right to sue AMAG separately. |
| Objection Deadline | November 10, 2025 | Tell the Court if you disagree with the settlement. |
| Final Approval Hearing | January 12, 2026 at 10:30 AM EST | Court reviews the settlement at 50 Walnut St., Newark, NJ. |
How to File a Claim
You can file online or by mail — it only takes a few minutes.
- File Online here.
- Mail: Download and send your completed claim form to the administrator listed on the website.
You don’t need proof to file, but submitting documentation like pharmacy receipts or medical records may increase your payment.
