Women who took Makena during pregnancy may be entitled to financial compensation through the ongoing Makena lawsuit targeting AMAG Pharmaceuticals and Covis Pharma. This drug was sold as a way to prevent preterm birth. Clinical trials later showed it simply did not work.
Thousands of women received injections of hydroxyprogesterone caproate, the active ingredient in Makena, based on promises the drug never delivered. That gap between what was marketed and what the science showed is at the heart of every lawsuit being filed.
This article covers who qualifies, what injuries are alleged, how much compensation may be available, and where the litigation stands heading into 2026. If you or someone you know took this drug during pregnancy, the information below applies directly to you.
One number worth noting up front: the FDA’s own advisory committee voted 9 to 7 in 2019 that Makena’s benefit had not been confirmed. By 2023, the drug was off the market.
What Is the Makena Drug Lawsuit About
The Makena lawsuit is a legal action against the companies that made and sold a drug that clinical evidence could not support as effective for preventing preterm birth.
Makena is the brand name for hydroxyprogesterone caproate. It was approved by the FDA in 2011 under an accelerated approval pathway. That pathway is designed for drugs that show early promise. It is not a guarantee the drug actually works.
The problem is that post-approval trials, specifically the PROLONG trial, found no statistically significant reduction in preterm birth rates compared to placebo. Women were paying hundreds to thousands of dollars per injection cycle for a drug that performed like a sugar pill.
Lawsuits allege that AMAG Pharmaceuticals, and later Covis Pharma (which acquired Makena’s rights), knew or should have known the drug lacked proven efficacy. They continued marketing it aggressively anyway.
| Core Allegation | Detail |
|---|---|
| Drug Name | Makena (hydroxyprogesterone caproate / 17-OHPC) |
| Original Manufacturer | AMAG Pharmaceuticals |
| Subsequent Owner | Covis Pharma |
| FDA Approval Year | 2011 (accelerated approval) |
| Key Study | PROLONG trial, published 2019 |
| PROLONG Finding | No significant benefit over placebo |
| FDA Market Withdrawal | October 2023 |
The core legal argument is simple: you cannot charge patients for a drug that does not do what you claim it does.
AMAG Pharmaceuticals Lawsuit: Who Is Being Sued
AMAG Pharmaceuticals is the primary defendant in most Makena lawsuits filed before the company sold its rights to Covis Pharma.
AMAG held the drug from its 2011 FDA approval through roughly 2020. During that period, the company ran aggressive marketing campaigns, particularly targeting high-risk pregnancies. Ob-gyns across the country were encouraged to prescribe Makena as a first-line intervention.
When the PROLONG trial results came back negative in 2019, AMAG did not pull the drug. It disputed the findings and pushed back against FDA advisory recommendations.
Covis Pharma acquired Makena’s assets and is also named in many lawsuits covering the period after 2020. Plaintiffs argue that Covis continued selling a drug with known efficacy problems.
| Defendant | Role | Period of Liability |
|---|---|---|
| AMAG Pharmaceuticals | Original manufacturer and marketer | 2011 to approx. 2020 |
| Covis Pharma | Acquired drug rights, continued sales | 2020 to 2023 |
| Compounding pharmacies | Produced generic 17-OHPC versions | Ongoing parallel claims |
Compounding pharmacies that produced cheaper generic versions of 17-OHPC face separate but related claims. Some plaintiffs allege these compounded versions created additional safety concerns not present with the branded version.
Makena FDA Withdrawal: What the Regulatory History Shows
The FDA’s withdrawal of Makena in October 2023 is one of the strongest pieces of evidence plaintiffs use in their lawsuits.
The withdrawal process started years before the actual removal. In 2019, the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee reviewed the PROLONG trial data. The committee voted 9 to 7 that the study did not verify clinical benefit for Makena.
That was enough for the FDA to begin withdrawal proceedings under the accelerated approval pathway. The manufacturer disputed the findings and requested a hearing. That process dragged on for years while the drug remained on pharmacy shelves.
By October 2023, the FDA formally withdrew Makena’s approval. The agency stated the evidence did not confirm the drug reduced the risk of preterm birth before 35 weeks of gestation.
| FDA Timeline | Event |
|---|---|
| 2011 | Makena receives accelerated FDA approval |
| 2019 | PROLONG trial results show no significant benefit |
| 2019 | FDA advisory committee votes 9 to 7 against confirmed benefit |
| 2020 to 2022 | FDA begins withdrawal proceedings; manufacturer appeals |
| October 2023 | FDA officially withdraws Makena from the market |
That 12-year gap between approval and withdrawal is not lost on plaintiffs’ attorneys. It is a timeline that suggests women were exposed to a drug of unproven benefit for over a decade.
Key Takeaway: The FDA’s own withdrawal of Makena in 2023, based on failed clinical trials going back to 2019, gives plaintiffs a strong factual foundation for their legal claims against AMAG Pharmaceuticals and Covis Pharma.
Makena Recall Lawsuit: Was There an Official Recall
Makena was not subject to a traditional FDA recall. The distinction matters legally, and it confuses a lot of people.
A recall typically happens when a product has a manufacturing defect or contamination issue. Makena’s withdrawal was based on lack of proven efficacy, not a safety defect in the traditional sense. The FDA used its accelerated approval withdrawal authority, which is a separate regulatory mechanism.
That said, many lawsuits use “recall” language loosely because the practical effect was the same: the drug was removed from the market.
What plaintiffs actually argue in court is product liability based on failure to warn and misrepresentation, not contamination-based claims. That is an important distinction when courts evaluate which legal theories apply.
| Term | Meaning in Makena Context |
|---|---|
| FDA Recall | Did NOT happen for Makena |
| Market Withdrawal | DID happen in October 2023 |
| Legal Basis | Lack of efficacy, failure to warn, misrepresentation |
| Consumer Impact | Patients paid for a drug later shown not to work |
Some plaintiffs also argue unjust enrichment. They say the manufacturers collected billions in revenue from a drug that never demonstrated it could do what it was sold to do.
Makena Ineffective Drug Lawsuit: The Science Behind the Claims
The science showing Makena did not work is the backbone of every lawsuit filed. It is worth understanding exactly what the studies found.
The PROLONG trial, which stands for Progestin’s Role in Optimizing Neonatal Gestation, was a large international study involving over 1,700 women. It was designed to confirm the benefit that the earlier MEIS trial had suggested. Instead, it found no statistically significant difference in preterm birth rates between the Makena group and the placebo group.
The MEIS trial, which originally supported Makena’s approval in 2011, enrolled a different patient population and used different endpoints. Scientists have debated whether the two trials are directly comparable. Plaintiffs argue that regardless of the scientific debate, the manufacturer had an obligation to inform physicians and patients when the confirmatory data came back negative.
Think of it like this: if a car manufacturer knew a safety feature did not work as advertised but kept selling that feature as a premium option, the legal exposure would be obvious.
| Study | Year | Finding |
|---|---|---|
| MEIS Trial | 2003 | Suggested 17-OHPC reduced preterm birth risk |
| PROLONG Trial | 2019 | Found no significant benefit over placebo |
| FDA Advisory Vote | 2019 | 9 to 7 against confirmed clinical benefit |
Plaintiffs argue the PROLONG results should have triggered immediate action: updated labeling, physician warnings, and marketing changes. None of those happened quickly enough.
Hydroxyprogesterone Caproate Lawsuit: Understanding the Drug
Hydroxyprogesterone caproate, often shortened to 17-OHPC or 17P, is a synthetic progestin hormone. Makena is simply the brand name for this compound.
The theory behind using 17-OHPC to prevent preterm birth was based on the idea that progesterone plays a role in maintaining pregnancy. That is not a controversial idea. What became controversial was whether an injected synthetic version of this hormone could meaningfully reduce preterm birth risk.
Makena was administered as a weekly injection, typically from around week 16 to week 36 of pregnancy. Each injection cost significantly more than compounded generic versions available from specialty pharmacies. AMAG actively discouraged use of the cheaper compounded version, partly through lobbying efforts that led the FDA to restrict compounded 17-OHPC availability.
| Drug Detail | Information |
|---|---|
| Generic Name | Hydroxyprogesterone caproate |
| Brand Name | Makena |
| Common Abbreviations | 17-OHPC, 17P |
| Drug Class | Synthetic progestin |
| Administration | Weekly injection, weeks 16 to 36 |
| Compounded Version | Available from specialty pharmacies at lower cost |
Lawsuits connected to the compounding pharmacy angle argue that AMAG’s interference with compounded 17-OHPC access forced patients into a more expensive branded option that performed no better.
Key Takeaway: The hydroxyprogesterone caproate lawsuit is rooted in scientific trial data showing the drug did not outperform placebo, combined with allegations that manufacturers withheld or minimized that information while continuing to profit from sales.
Who Qualifies for the Makena Lawsuit
You may qualify for the Makena lawsuit if you received Makena or compounded 17-OHPC injections during pregnancy and suffered financial or physical harm as a result.
Eligibility is not a single checkbox. Attorneys evaluating Makena claims look at several factors to determine whether a case has merit and what type of damages might apply.
Factors that strengthen your eligibility:
- You received Makena injections between 2011 and 2023
- You were prescribed Makena specifically to prevent preterm birth
- Your baby was still born premature despite completing the injection course
- You experienced side effects from the injections
- You paid out-of-pocket costs or insurance covered significant costs
- You were not clearly informed the drug’s efficacy was in dispute
| Eligibility Factor | Strengthens Claim |
|---|---|
| Received Makena injections | Yes |
| Preterm birth occurred despite treatment | Yes |
| Side effects experienced | Yes |
| Financial costs incurred | Yes |
| Informed of PROLONG results before treatment | Weakens claim |
| Received compounded 17-OHPC only | Separate claim track |
Patients who received the compounded generic version rather than branded Makena may have claims against different defendants, typically the compounding pharmacy or prescribing physician, depending on the circumstances.
Makena Side Effects Lawsuit: What Injuries Are Being Claimed
Side effects from Makena injections form a separate but related category of legal claims.
The FDA-approved labeling for Makena listed known side effects including injection site reactions, hives, itching, nausea, and diarrhea. More serious reported effects included blood clots, depression, and elevated blood pressure. Plaintiffs argue the labeling did not adequately communicate the risks, particularly given that the drug’s benefit was unproven.
Some plaintiffs allege fetal or neonatal harms. Research examining neonatal outcomes in PROLONG trial participants raised questions about whether 17-OHPC exposure was associated with increased rates of miscarriage and stillbirth in certain subgroups, though this remains an area of active scientific debate.
| Reported Side Effect | Category |
|---|---|
| Injection site pain, swelling, bruising | Common |
| Hives, itching, rash | Allergic reaction |
| Nausea, diarrhea | Gastrointestinal |
| Blood clots | Serious cardiovascular |
| Depression | Psychiatric |
| Elevated blood pressure | Cardiovascular |
| Fetal/neonatal concerns | Emerging, disputed |
The failure-to-warn claim rests on the argument that even if these side effects were known, physicians and patients were not given a complete picture of the risk-benefit balance when evidence of efficacy started falling apart after 2019.
Makena Wrongful Birth Claim: A Specific Legal Theory
A wrongful birth claim in the Makena context argues that a woman would not have taken the drug had she been properly informed it was likely ineffective, and that she experienced harm as a result of that uninformed decision.
This is a distinct legal theory from standard product liability. It does not require that the drug directly caused a birth defect or injury. It requires that the patient’s informed consent was compromised.
Think of it this way: a doctor who withholds information you need to make a decision about your own body has done something legally actionable, even if the outcome might have been the same either way. The wrong is the deception, not just the result.
Wrongful birth claims in the Makena context generally allege:
- Physicians were misled about efficacy by marketing materials
- Patients were not told the PROLONG trial contradicted the drug’s approved use
- Consent for the injection course was obtained without full disclosure of known efficacy questions
| Wrongful Birth Claim Element | What Plaintiff Must Show |
|---|---|
| Duty to disclose | Manufacturer or doctor owed patient full information |
| Breach of duty | Key information about efficacy failure was withheld |
| Causation | Patient would have made a different choice with full information |
| Damages | Financial costs, emotional distress, physical side effects |
These claims are state-specific. Some states recognize wrongful birth more broadly than others, which affects whether this theory survives in court.
Key Takeaway: The wrongful birth claim angle gives Makena plaintiffs a legal path even when the drug did not directly cause a detectable physical injury, focusing instead on the right to make informed medical decisions.
Makena Class Action: Is This a Class Action or Mass Tort
The Makena litigation is generally structured as a mass tort, not a traditional class action, though both terms appear in coverage of this litigation.
The distinction matters for potential claimants.
In a class action, one lawsuit covers thousands of plaintiffs who all receive roughly equal shares of a settlement. Individual differences between plaintiffs receive little weight. In a mass tort, each plaintiff files an individual claim. Cases are often coordinated under multidistrict litigation (MDL) for efficiency, but damages are assessed individually based on each person’s specific harm.
Mass tort structure means your payout is based on your specific experience: how long you took the drug, what you paid, what injuries you claim, and what evidence you can provide.
| Structure Type | How It Works | Makena Fit |
|---|---|---|
| Class Action | One lawsuit, equal shares, collective resolution | Possible for consumer/refund claims |
| Mass Tort / MDL | Individual claims, coordinated discovery, individual damages | Primary structure for injury claims |
| Individual Lawsuit | Single plaintiff, standalone case | Option for high-damages claims |
Some consumer protection and unjust enrichment claims are better suited to class action structure. Injury-specific claims almost always proceed under mass tort or individual lawsuit structures.
As of early 2026, attorneys are still evaluating the best legal vehicle for different categories of Makena claims.
Makena Settlement Amount: How Much Could You Receive
No global Makena settlement has been announced as of early 2026. Individual settlements and negotiations are ongoing, and no official public payout figure has been confirmed.
That said, legal analysts and attorneys working these cases have discussed what damages categories look like.
Damages that may be available:
- Out-of-pocket costs for Makena injections not covered by insurance
- Insurance co-pays and related pregnancy costs
- Compensation for physical side effects, including documented medical treatment
- Emotional distress damages
- Punitive damages in cases where egregious conduct is proven
- Wrongful birth damages where applicable under state law
| Damage Category | Potential Range (Estimated) |
|---|---|
| Out-of-pocket cost reimbursement | Amount paid, typically $500 to $20,000+ per patient |
| Side effect compensation | Varies widely by severity and documentation |
| Emotional distress | Typically $5,000 to $50,000 in similar mass torts |
| Punitive damages | Unpredictable; depends on jury and case strength |
These figures are not guarantees. Mass tort outcomes vary widely. Comparable pharmaceutical cases have settled for tens of thousands per plaintiff on the lower end and several hundred thousand for serious injury claims.
Makena Compensation: What Factors Affect Your Payout
Your Makena compensation amount depends on several personal and legal factors specific to your case.
Attorneys use a point system or tiered model in most mass tort cases. Plaintiffs with stronger documentation, more severe injuries, and longer drug exposure typically receive larger payouts.
Key factors that affect compensation:
- Total number of injections received
- Duration of Makena use during pregnancy
- Whether preterm birth occurred despite treatment
- Severity of any documented side effects
- Total out-of-pocket financial costs
- Strength of medical records supporting your claim
- State of residence and applicable legal standards
| Factor | Effect on Compensation |
|---|---|
| Long injection course | Higher |
| Severe side effects with medical documentation | Higher |
| Preterm birth outcome despite treatment | Higher |
| Strong pharmacy and prescription records | Higher |
| Minimal financial costs incurred | Lower |
| No documented side effects | Lower |
| Compounded version (not branded Makena) | Different claim track |
Having complete medical records is the single most important thing you can do right now to protect and strengthen a potential claim. Get copies of your prenatal records, pharmacy receipts, and any documentation of complications.
Key Takeaway: Makena compensation is not one-size-fits-all. Your payout depends heavily on how long you took the drug, what you paid, what injuries you documented, and how strong your medical records are.
How to File a Makena Claim in 2026
Filing a Makena claim starts with finding an attorney who specializes in pharmaceutical mass torts.
The process is typically free to begin. Most attorneys handling Makena cases work on a contingency fee basis, meaning they collect a percentage of your settlement only if you win. You owe nothing upfront.
Steps to file a Makena claim:
- Gather your medical records, including prenatal records showing Makena prescriptions
- Collect pharmacy receipts and any documentation of costs
- Document any side effects with your medical provider
- Contact a mass tort attorney specializing in pharmaceutical litigation
- Complete an intake form and provide your records for evaluation
- The attorney determines if your case qualifies and files the claim
| Step | What to Do |
|---|---|
| Step 1 | Gather medical records from your OB-GYN |
| Step 2 | Collect pharmacy records and receipts |
| Step 3 | Document any side effects in writing |
| Step 4 | Contact a pharmaceutical mass tort attorney |
| Step 5 | Complete case intake evaluation |
| Step 6 | Attorney files your claim |
Do not wait to gather your records. Medical records from pregnancies more than seven years ago can be harder to obtain, and some facilities purge records after statutory retention periods expire.
Makena Lawsuit Deadline: What Are the Filing Deadlines
The Makena lawsuit deadline varies by state because each state has its own statute of limitations for personal injury and product liability claims.
Most states allow two to four years from the date of injury or the date you discovered the injury to file a claim. The “discovery rule” is important here. For Makena, many attorneys argue the clock started running in October 2023 when the FDA formally withdrew the drug, because that is when patients had clear public notice that the drug may have been ineffective.
| State Category | Typical Statute of Limitations |
|---|---|
| Short limitation states | 2 years from discovery |
| Standard limitation states | 3 years from discovery |
| Longer limitation states | 4 years from discovery |
| Discovery rule application | Clock may start from FDA withdrawal (Oct 2023) |
If the discovery rule applies and the clock started in October 2023, many plaintiffs may have until late 2025 or 2026 to file, depending on their state. Some states may set earlier deadlines.
Do not assume you have time. Statutes of limitations are hard cutoffs. Missing the deadline typically ends your right to file forever, regardless of how strong your case might be.
Makena Litigation Update 2026: Where Things Stand Now
The Makena litigation entered a more active phase in 2025 and continues to develop through 2026.
Attorneys across the country have been evaluating and filing individual and coordinated cases since the FDA’s October 2023 withdrawal. The volume of filings prompted discussions about MDL consolidation, which would bring related cases into one federal court for coordinated pre-trial proceedings.
MDL consolidation, if it proceeds, would accelerate the discovery process and potentially lead to global settlement negotiations. It is a standard tool in large pharmaceutical litigation.
As of early 2026, no global settlement has been announced. Cases are still in early to middle pre-trial phases. Bellwether trials, which are early test cases that help both sides gauge jury reactions, have not yet been publicly scheduled.
| 2026 Litigation Milestone | Status |
|---|---|
| FDA drug withdrawal confirmed | Complete (October 2023) |
| Individual lawsuits filed | Active and ongoing |
| MDL consolidation | Under discussion or early process |
| Bellwether trials | Not yet scheduled as of early 2026 |
| Global settlement | Not yet announced |
| Filing deadline pressure | Increasing through 2025 to 2026 |
For plaintiffs, this is actually a reasonable window to join the litigation. Cases filed now are positioned to benefit from early coordination and any eventual global resolution.
Frequently Asked Questions
What is the Makena lawsuit about?
The Makena lawsuit is a legal action against AMAG Pharmaceuticals and Covis Pharma over a preterm birth drug that clinical trials showed was no more effective than a placebo.
Women were given weekly injections of hydroxyprogesterone caproate during pregnancy and paid significant costs for a drug that the FDA eventually withdrew from the market in October 2023.
Lawsuits allege failure to warn, misrepresentation, and unjust enrichment.
Who qualifies for the Makena lawsuit?
Women who received Makena or compounded 17-OHPC injections during pregnancy between 2011 and 2023 may qualify for the lawsuit.
Eligibility is strongest for those who paid out-of-pocket costs, experienced side effects, or delivered preterm despite completing the injection course.
An attorney specializing in pharmaceutical mass torts can evaluate your specific situation.
How much money can I get from the Makena settlement?
No confirmed settlement amount exists as of 2026, since no global settlement has been announced.
Estimated damages in similar pharmaceutical mass torts range from several thousand dollars for cost reimbursement to tens of thousands for documented injury claims.
Your specific payout depends on injection duration, financial costs, side effects, and the strength of your medical records.
What is the deadline to file a Makena lawsuit claim?
The deadline to file a Makena lawsuit depends on your state’s statute of limitations, typically two to four years from the date of discovery.
Many attorneys argue the discovery clock started in October 2023 when the FDA formally withdrew Makena, which means deadlines may fall in 2025 or 2026 for many states.
Contact an attorney immediately, as missing the deadline permanently bars your right to file.
Was Makena recalled or just withdrawn from the market?
Makena was not recalled in the traditional sense. The FDA issued a market withdrawal in October 2023 based on lack of confirmed efficacy, not a manufacturing defect or contamination issue.
A recall typically involves a safety defect; a withdrawal under accelerated approval rules occurs when post-market studies fail to confirm the drug’s benefit.
The practical effect was the same: the drug was removed from the market.
What This All Means for You
The Makena lawsuit represents one of the more significant pharmaceutical accountability cases of the past decade. A drug marketed to protect vulnerable pregnancies turned out to have no proven benefit. Women paid for it. Some may have suffered for it.
If you took Makena during pregnancy, your window to act is real and it is closing. Gathering your records now costs you nothing. Waiting could cost you everything.
Find an attorney who handles pharmaceutical mass torts. Most offer free case evaluations. The statute of limitations is not a suggestion. It is a hard cutoff that no court will overlook.
