The Depo-Provera lawsuit: who qualifies and what's known about meningioma risk

Depo-Provera is a long-acting injectable contraceptive containing medroxyprogesterone acetate (MPA). Pfizer has marketed it in the United States since 1992 as a quarterly shot that prevents pregnancy for three months at a time. Roughly 74 million women worldwide have used it. In December 2025, after decades of growing scientific concern and after Pfizer had already added meningioma warnings to Depo-Provera packaging in dozens of other countries, the FDA finally approved a U.S. label change adding a meningioma warning.

By that point, the litigation had already started. The first Depo-Provera lawsuit was filed in late 2024 after a March 2024 BMJ study showed that women using injectable progestogens like medroxyprogesterone acetate for more than a year had approximately 5.55 times the odds of developing intracranial meningioma compared to non-users. The Judicial Panel on Multidistrict Litigation centralized the federal cases in February 2025, creating MDL 3140 in the Northern District of Florida under Judge M. Casey Rodgers. As of May 2026, approximately 3,769 cases are pending in the MDL, with roughly 650 new cases filed each month.

The litigation is moving fast for a pharmaceutical mass tort. The first bellwether trial is scheduled for December 7, 2026. Daubert hearings on general causation are set for the spring and summer of 2026. Pfizer's federal preemption defense, the company's primary legal argument, is fully briefed and awaiting ruling. The December 2025 FDA label change substantially weakened that defense.

This is the science the lawsuits rest on, who currently qualifies under MDL 3140 criteria, where the litigation stands procedurally, and what the timeline looks like from here.

The science: from suspicion to confirmation

Concerns about progestogens and meningioma risk have existed in the medical literature since the 1990s. Meningiomas are tumors that arise from the meninges, the membranes surrounding the brain and spinal cord. Most are slow-growing and benign in the technical sense (they don't metastasize), but their location matters more than their classification: a meningioma pressing on the brain or spinal cord can cause headaches, seizures, vision loss, hearing loss, cognitive decline, and other neurological symptoms, often requiring surgical removal.

The signal connecting progestogens to meningioma sharpened over the past two decades. Cyproterone acetate, a high-dose progestogen used outside the U.S., was definitively linked to meningioma risk by 2010, leading to label changes and prescribing restrictions in Europe. The question for years was whether the lower-dose progestogens used in U.S. contraceptives carried the same risk.

The March 2024 BMJ study answered that question for medroxyprogesterone acetate. French researchers analyzed national health data covering more than 100,000 women diagnosed with intracranial meningioma between 2009 and 2018, comparing their progestogen exposure to matched controls. Women using injectable medroxyprogesterone acetate for more than one year had an odds ratio of 5.55 for meningioma (95% confidence interval 2.97 to 10.39). The signal was specific to long-term use of injectable MPA, not to short-term use or to other progestogens.

A 2025 JAMA Neurology study using U.S. data confirmed the signal. Researchers found particularly elevated risk in women over age 31 and in those with four or more years of cumulative Depo-Provera exposure. A June 2025 comparative safety study published in Expert Opinion on Drug Safety calculated that women taking Depo-Provera have 3.5 times the risk of developing intracranial meningioma compared to women taking combination oral contraceptives.

The absolute risk increase remains modest. The JAMA Neurology data suggests approximately one additional meningioma case per 1,152 patients using long-term Depo-Provera compared to controls. The relative risk increase is dramatic; the absolute baseline is low. Both framings matter, and both have appeared in the litigation.

The December 2025 FDA label change reflected the convergence of evidence. The updated label now reads: "Cases of meningiomas have been reported following repeated administration of medroxyprogesterone acetate, primarily with long-term use. Monitor patients on Depo-Provera CI for signs and symptoms of meningioma. Discontinue Depo-Provera CI if a meningioma is diagnosed."

The legal theory

The core allegation against Pfizer is failure to warn. Plaintiffs argue that Pfizer knew, or should have known, about the meningioma risk associated with long-term Depo-Provera use, and failed to adequately warn U.S. patients and prescribing physicians despite warnings the company had added to Depo-Provera labeling in other countries years earlier.

Specifically, the complaint generally alleges:

Internal knowledge of risk. Pfizer's internal records and the published scientific literature available to the company showed evidence connecting injectable medroxyprogesterone acetate to meningioma risk dating back to the 1980s and 1990s. The plaintiffs allege this knowledge existed for decades before the December 2025 U.S. label change.

Failure to update U.S. warnings while updating foreign warnings. Pfizer added meningioma warnings to Depo-Provera labeling in Canada, the European Union, Australia, and other jurisdictions years before doing so in the United States. The asymmetry is central to the plaintiffs' theory of negligence.

Negligent design and marketing. Plaintiffs allege that Pfizer marketed Depo-Provera as safe for long-term use without adequately studying or disclosing the long-term risks.

The defendants are Pfizer (which manufactures Depo-Provera under its current corporate structure), along with Prasco, Greenstone, and Viatris (which manufacture or distribute authorized generic versions of medroxyprogesterone acetate).

Pfizer's primary legal defense is federal preemption. The argument: under FDA regulations, Pfizer cannot unilaterally change the warning label on Depo-Provera; any label change requires FDA approval. Pfizer claims it sought a meningioma warning in 2024 and the FDA initially declined to approve the change, which Pfizer argues preempts state-law failure-to-warn claims for the period before the December 2025 label update. Plaintiffs counter that the relevant analysis turns on the "clear evidence" standard from Wyeth v. Levine, that Pfizer's submission was insufficient and untimely given the existing scientific evidence, and that the December 2025 label change itself demonstrates that an earlier warning was both possible and warranted.

Pretrial Order 30, issued January 27, 2026, made an important procedural ruling: the preemption decision and the Daubert decisions will apply to every case in the MDL. This makes the preemption ruling binary; either the defense applies to all cases or it applies to none. The ruling is expected in mid-to-late 2026.

Who qualifies

Qualification criteria for joining MDL 3140 have stabilized as the litigation has developed. Most plaintiff firms screening cases now require:

Documented Depo-Provera or authorized generic use. Pharmacy records, prescription records, medical records showing the injections, or other documentation establishing actual use of Depo-Provera, Depo-SubQ Provera 104, or generic medroxyprogesterone acetate. Most firms require at least two injections.

Diagnosis of intracranial meningioma. Imaging reports (MRI or CT showing the tumor), surgical pathology reports if the meningioma was resected, and physician notes confirming the diagnosis. Spinal meningioma cases are being evaluated but are smaller in number.

Temporal relationship between use and diagnosis. The meningioma must have been diagnosed after Depo-Provera use began. Most firms require at least 24 months of use before diagnosis as a baseline threshold, though some cases with shorter exposure are being filed where the science supports the connection.

No prior brain tumor history. A pre-existing meningioma or other brain tumor before first Depo-Provera injection generally disqualifies the case.

Statute of limitations compliance. Statutes vary by state, ranging from one to six years from diagnosis or from discovery of the connection. Some states use the discovery rule, which starts the clock when the plaintiff knew or should have known of the connection between Depo-Provera and her meningioma. Others use a strict accrual rule from the date of diagnosis. State-specific analysis is critical; a case that would be timely in one state may be barred in another.

The MDL is currently focused on meningioma claims specifically. Other potential injury theories (pseudotumor cerebri, idiopathic intracranial hypertension, secondary effects of long-term progestin exposure) are being explored by some firms but are not part of the coordinated MDL proceedings at this time. Plaintiffs with non-meningioma injuries may have viable claims, but the litigation infrastructure is built around meningioma.

Where the litigation stands

The procedural posture as of mid-2026 is active discovery moving toward bellwether trial.

Cases pending. Approximately 3,769 cases in MDL 3140 as of May 2026, plus several hundred additional cases in coordinated state court proceedings in California, New York, and Delaware. Judge Rodgers holds joint case management conferences with state court judges to coordinate the proceedings. Total active claims across federal and state forums approach 4,200.

Expert discovery. General causation expert depositions have been underway through the spring of 2026. Plaintiffs' experts have addressed the BMJ and JAMA Neurology data, the biological mechanism connecting progestogens to meningioma formation, and the epidemiological strength of the association. Pfizer's experts have challenged causation methodology and argued the scientific literature is more equivocal than plaintiffs claim.

Daubert hearings. The Daubert hearings (named for the 1993 Supreme Court case Daubert v. Merrell Dow that established federal expert evidence standards) are scheduled for the summer of 2026. Judge Rodgers will determine whether plaintiffs' general causation experts can testify at trial that long-term Depo-Provera use can cause meningioma. A ruling excluding plaintiffs' experts would devastate the litigation; a ruling admitting them would clear the path to bellwether trial.

Bellwether selection. Five bellwether cases have been selected from the broader pool. Trial sequence: Toney v. Pfizer first (December 7, 2026), followed by Blonski, Schmidt, Wilson, and Arceo through 2027. Bellwether outcomes don't legally bind the other 3,700 cases, but they typically drive settlement negotiations.

Preemption ruling. Pfizer's preemption motion was fully briefed by February 2026. Judge Rodgers's ruling is expected in mid-to-late 2026, before the December bellwether. A defense ruling on preemption would gate every case in the MDL on whether plaintiffs can proceed under state law at all. A plaintiff ruling on preemption clears the path to trial.

Plaintiff leadership has been reappointed through March 2027 under Pretrial Order 31, suggesting Judge Rodgers expects the litigation to continue through at least one full bellwether cycle before settlement discussions intensify.

What cases are worth

No global settlement has been reached, and individual case values cannot be reliably predicted before bellwether outcomes. Plaintiff attorneys generally project individual settlement values in the $100,000 to $500,000 range for cases that qualify, with substantial variation based on injury severity, treatment history, duration of use, and strength of causation evidence in the specific case.

The factors most affecting case value:

Severity of meningioma. A meningioma requiring craniotomy with significant neurological complications generally carries higher value than one managed with observation. Cases with multiple meningiomas, requiring multiple surgeries, or resulting in permanent neurological deficits sit at the higher end of projected ranges.

Duration of Depo-Provera use. Longer use strengthens both the medical causation argument and the negligence theory (longer use means more opportunities for Pfizer to update warnings). Cases with 5+ years of use generally carry more value than cases with 2-3 years.

Treatment costs and lost income. Documented medical expenses, ongoing treatment requirements, and quantifiable economic losses (lost wages, future medical care, disability) add directly to compensatory damages.

Causation strength. Cases where the temporal pattern, exposure level, and clinical presentation match the strongest scientific evidence are valued higher than cases where the connection is more attenuated.

The first bellwether outcomes in late 2026 and early 2027 will be the first meaningful data points on case values. Until then, the projected ranges are educated estimates from attorneys experienced in pharmaceutical mass tort settlements.

What to do if you may qualify

The procedural path to filing a Depo-Provera claim is structured.

Gather documentation. Pharmacy records showing Depo-Provera injections (CVS, Walgreens, and most pharmacies retain prescription histories going back 5 to 10 years; older records may require contacting the prescribing OB-GYN). Medical records establishing the meningioma diagnosis: imaging reports, surgical pathology, neurology and neurosurgery records, treatment notes. Timeline documentation showing the relationship between use and diagnosis.

Confirm statute of limitations. Statutes vary by state and by whether your jurisdiction uses the discovery rule or strict accrual. The cleanest baseline: most states allow at least two years from diagnosis or from discovery of the connection between Depo-Provera and the meningioma. Some states are shorter; California uses one year from discovery for product liability claims, though specific exceptions apply. Statute of limitations analysis is the first thing a qualified attorney will run.

Consult a pharmaceutical injury attorney. Most attorneys handling Depo-Provera cases work on a contingency fee basis, taking a percentage of any recovery rather than charging upfront fees. Standard contingency fees in pharmaceutical mass tort cases are typically 33% to 40% of recovery, plus reimbursement of case expenses. Ask specifically whether the attorney is filing cases in MDL 3140, what their experience with pharmaceutical mass tort is, and whether their contingency includes the appeals process.

Decide on filing venue. Cases can be filed directly in MDL 3140 in the Northern District of Florida under Judge Rodgers's direct filing order (Pretrial Order 10), or filed in your home state and transferred to the MDL by the JPML for coordinated pretrial proceedings. Some plaintiffs may have grounds for state court filing in California, New York, Delaware, or other jurisdictions with coordinated proceedings; this can matter for choice of law on substantive issues.

File before bellwether outcomes. Cases filed before the first bellwether outcomes typically have access to whatever global settlement framework emerges from those trials. Cases filed after a settlement framework is established may face more limited eligibility or shorter response windows. The current filing pace of roughly 650 cases per month suggests the practical filing window will continue through 2026 and into 2027.

The case for waiting to file is minimal. Statutes of limitations don't pause for litigation developments. Settlement frameworks, when they emerge, generally favor cases already filed and in process. Documentation is easier to gather sooner rather than later. If you believe you may qualify, the procedural path is structured to be navigable, and the time to start is now rather than after bellwether outcomes are known.

The Depo-Provera litigation represents one of the more scientifically supported pharmaceutical mass torts to emerge in recent years. The BMJ data is robust, the JAMA Neurology confirmation strengthens it, and the December 2025 FDA label change validates the underlying safety concern. Whether the individual cases will succeed at trial depends on Daubert rulings, preemption rulings, and the bellwether outcomes still to come. The procedural path to filing is open, the eligibility criteria are defined, and the litigation has moved faster than most pharmaceutical mass torts of comparable scope. For women who used Depo-Provera long-term and were later diagnosed with intracranial meningioma, the legal framework to pursue compensation now exists.