Makena $7.5M Product Liability Class Action Settlement

Consumers who took, were prescribed, purchased or paid out-of-pocket for Makena (hydroxyprogesterone caproate injection) in the United States between March 8, 2019, and July 11, 2025, may qualify to claim a cash payment from a class action settlement.

Amag Pharmaceuticals Inc. agreed to pay $7.5 million to settle a class action lawsuit alleging it made misrepresentations and omissions in its marketing and public statements about Makena, a drug the Food and Drug Administration previously approved to reduce the risk of preterm birth in certain pregnancies. The FDA withdrew approval for Makena in April 2023 after a post-marketing study failed to confirm its effectiveness.

Who can file a claim?

The settlement class includes all natural persons who:

Took, were prescribed, purchased, paid for or otherwise incurred out-of-pocket costs for Makena in the United States between March 8, 2019, and July 11, 2025
Received Makena (hydroxyprogesterone caproate injection) in any dose or formulation, including single-dose or multidose vials or auto-injector, specifically those sold under National Drug Codes 64011-243-01, 64011-247-02 or 64011-301-03
Did not receive a generic or compounded version of hydroxyprogesterone caproate

Makena Care Connection records identified Individuals who are likely class members. They should have received a settlement notice. However, those who did not receive a notice may still be eligible if they meet the criteria.

There are several categories of class members based on the documentation they can provide:

Those with proof of both treatment and out-of-pocket payment
Those with proof of treatment but not out-of-pocket payment
Those with neither proof but whose information class counsel’s records can substantiate
Those with neither proof nor substantiating records

How much is the Makena payout?

The settlement administrator will distribute the fund as follows:

Full reimbursement (with proof of treatment and payment): Class members who submit a valid claim with proof of both treatment and out-of-pocket payment for Makena will receive the full amount of their out-of-pocket costs for each treatment during the class period. This payment is subject to pro rata adjustment if total claims exceed available funds.
Full reimbursement (substantiated by records): Class members who do not have proof but class counsel’s records can reliably substantiate their number of treatments and out-of-pocket costs will also receive the full amount of their out-of-pocket costs per treatment. This payment is subject to pro rata adjustment if total claims exceed available funds.
$22 per treatment (with proof of treatment only): Class members who provide proof of treatment but not out-of-pocket costs and whose costs counsel's records cannot substantiate will receive $22 per treatment. Those who participated in a government health care program at the time of treatment will receive $4 per treatment.
$1 per treatment (no proof, no records): Class members who do not provide proof and do not have substantiating records will receive $1 per treatment up to a maximum of $40.

If the total amount of valid claims exceeds the net settlement fund (after deducting attorneys’ fees, service awards and administration costs), the settlement administrator will reduce each claimant’s payment proportionally. Conversely, if total claims are less than the available funds, the settlement administrator may increase payments.

How to claim a settlement payout

Class members can file the online claim form or download, print, complete and mail the PDF claim form to the settlement administrator. They can also request a claim form by calling 1-833-722-4162 or emailing info@MakenaSettlement.com. The claim deadline is Nov. 10, 2025.

Settlement administrator’s mailing address: Makena Claim Administrator, 1650 Arch St., Suite 2210, Philadelphia, PA 19103

What proof or documentation required to submit a claim?

All class members must provide the number of doses they purchase or took; the location (i.e., pharmacy) and approximate date range over which they purchased or took Makena; the amount, if any, they paid out of pocket, i.e., net of any insurance coverage/reimbursement, copay assistance or any other financial assistance; and whether they participated in any government health care program on the date of purchase or administration.

The required proof depends on the category:

To receive full reimbursement (with proof of treatment and payment), class members must provide proof of treatment, such as medical records, insurance records or pharmacy receipts, and proof of out-of-pocket payment, such as medical bills, itemized pharmacy receipts or insurance statements.
To receive $22 per treatment (with proof of treatment only), class members must provide proof of treatment, such as medical records, insurance records or pharmacy receipts.
For full reimbursement (substantiated by records) and $1 per treatment (no proof, no records), class members do not need to submit any proof.

Payout options

PayPal
Venmo
Zelle
Virtual prepaid card
Paper check

$7.5 million settlement fund breakdown

The $7,500,000 settlement fund includes:

Settlement administration costs: $190,000
Attorneys’ fees and expenses: Up to $2,500,000
Service awards to class representatives: Up to $5,000 each
Payments to eligible class members: Remainder of the fund

Important dates

Deadline to file a claim: Nov. 10, 2025
Exclusion (opt-out) deadline: Nov. 10, 2025
Final approval hearing: Jan. 12, 2026

When is the Makena settlement payout date?

The settlement administrator will issue payments after it resolves any appeals and the court grants final approval of the settlement.

Why is there a class action settlement?

The class action lawsuit alleged Amag Pharmaceuticals Inc. made misrepresentations and/or omissions in marketing materials and public statements about Makena, specifically regarding its effectiveness in reducing the risk of preterm birth. The FDA withdrew approval for Makena in April 2023 after a post-marketing study failed to confirm its efficacy.

Amag denied all allegations but agreed to settle to avoid the expense and uncertainty of continued litigation.