Depo-Provera meningioma lawsuit MDL 3140: the 3,700+ pending cases, the 2024 BMJ study linking medroxyprogesterone to brain tumors, the December 2025 FDA label update, and the Pfizer preemption defense

If you used the contraceptive injection Depo-Provera for an extended period and were subsequently diagnosed with an intracranial meningioma (a tumor in the membrane surrounding the brain), this is the active litigation that may apply to your case. The MDL is In Re: Depo-Provera (Depot Medroxyprogesterone Acetate) Products Liability Litigation, MDL 3140, consolidated in the U.S. District Court for the Northern District of Florida, Pensacola Division, before Judge M. Casey Rodgers. As of May 2026, the MDL has more than 3,700 pending cases, having grown rapidly from approximately 435 cases in July 2025.

The litigation alleges that Pfizer (the manufacturer) and related entities failed to warn that Depo-Provera increases the risk of meningioma. The active ingredient, medroxyprogesterone acetate, is a synthetic progestin; the plaintiffs allege that the hormone's effect on meningioma growth was known or knowable, and that the manufacturers failed to warn US consumers even after warnings appeared on Canadian and European labels.

The litigation is relatively new (the first lawsuit was filed in October 2024) but has grown rapidly following the publication of substantial epidemiological evidence and the FDA's December 2025 label update. The next phase will determine whether Pfizer's federal preemption defense succeeds and how the bellwether process develops.

The drug and the mechanism

Depo-Provera is a contraceptive injection administered every three months. The active ingredient, medroxyprogesterone acetate, is a synthetic version of the hormone progesterone. The drug has been widely used; approximately 24.5% of sexually active women in the United States have used Depo-Provera at some point.

The alleged mechanism: meningioma growth is linked to the hormone progesterone. Many meningiomas have progesterone receptors, and exposure to progestogens (including synthetic progestins like medroxyprogesterone acetate) can stimulate meningioma growth. The plaintiffs allege that prolonged exposure to the high-dose synthetic progestin in Depo-Provera substantially increases the risk of developing intracranial meningiomas.

Meningiomas are tumors that grow in the meninges (the membranes surrounding the brain and spinal cord). While many meningiomas are benign (non-cancerous), they can cause serious harm: they can grow large, press on the brain, cause vision loss, headaches, seizures, and neurological deficits, and require craniotomy (brain surgery) for removal. Even benign meningiomas can be life-altering or fatal depending on their location and size.

The science that triggered the litigation

The litigation traces to a March 2024 study published in the BMJ (British Medical Journal): Roland N, et al., "Use of progestogens and the risk of intracranial meningioma: national case-control study," BMJ 2024;384:e078078. The French researchers examined 18,061 women who were diagnosed with and underwent surgery to remove intracranial meningioma.

The study found that women who used medroxyprogesterone acetate (the Depo-Provera active ingredient) for longer than one year had a risk of meningioma approximately 5.5 times higher than women who did not use the medication. Other types of birth control did not show the same risk, which supports the specificity of the association to the progestin.

A subsequent study strengthened the evidence. In September 2025, a Cleveland Clinic study analyzing more than 10 million women found that long-term users of the contraceptive had a 2.45-fold increased risk of meningioma. The two studies, using different populations and methodologies, both found substantial increased risk, providing replication that strengthens the causal inference.

The biological mechanism (progesterone-receptor-positive meningiomas stimulated by synthetic progestin exposure) is well-established in the neuro-oncology literature. The combination of the epidemiological evidence and the biological plausibility forms the scientific foundation of the litigation.

The FDA label update

A central fact in the litigation: the warning timeline differed between the United States and other countries.

Canadian and European Depo-Provera labels included meningioma warnings before the US label did. As of April 2024 (after the BMJ study), Pfizer had not yet updated the US label to warn about meningioma.

In December 2025, the FDA required Pfizer to update the Depo-Provera warning label to notify users of the increased risk of meningiomas. The label update came after the substantial epidemiological evidence had accumulated.

The plaintiffs argue that the delay in updating the US label (relative to the Canadian and European labels, and relative to the date the scientific evidence became available) demonstrates that Pfizer knew or should have known about the risk and failed to warn US consumers timely.

The MDL structure

MDL 3140 was created in 2025. The Judicial Panel on Multidistrict Litigation heard oral arguments on the consolidation motion in Miami, Florida on January 30, 2025, with the decision following in February 2025. The MDL was assigned to Judge M. Casey Rodgers in the Northern District of Florida (Pensacola Division), an experienced MDL judge.

There was a venue dispute during the consolidation process. Pfizer and the other defendants pushed for consolidation in the Southern District of New York (arguing proximity to key witnesses and evidence); the plaintiffs advocated for the Northern District of California (citing the volume of cases filed there). The JPML ultimately selected the Northern District of Florida.

The defendants:

Pfizer Inc. (the primary defendant, current manufacturer).

Pharmacia & Upjohn Company LLC (related entity in the manufacturing history).

Generic manufacturers including A-S Medication Solutions, Greenstone LLC, Prasco Laboratories, Preferred Pharmaceuticals Inc., and Viatris.

Christopher Seeger of Seeger Weiss was appointed lead counsel in the litigation by Judge Rodgers.

The Pfizer preemption defense

Pfizer's primary defense is federal preemption. The argument: when a manufacturer cannot simultaneously comply with both federal labeling requirements and the stronger warnings that state tort law would require, the state law claims are preempted under the Supremacy Clause.

Pfizer's specific preemption arguments:

The FDA initially rejected a stronger meningioma warning. Pfizer argues that even after the FDA approved a limited meningioma warning in late 2025, the agency would not allow language about an "increased risk" or include summaries of the studies that plaintiffs rely upon. Pfizer argues this means it could not have unilaterally added the warnings that state law would require.

Claims related to Depo-Provera prescriptions before July 2024 are preempted because the scientific evidence supporting the FDA warning was not available then. Pfizer argues that it could not have warned about a risk that had not yet been established by the available science.

The preemption defense is substantial and will be a central battleground in the litigation. The leading Supreme Court precedent on pharmaceutical failure-to-warn preemption is Wyeth v. Levine, 555 U.S. 555 (2009) (holding that brand-name drug failure-to-warn claims are generally not preempted because the manufacturer can use the FDA's "changes being effected" regulation to strengthen warnings) and PLIVA v. Mensing, 564 U.S. 604 (2011) (holding that generic drug failure-to-warn claims are preempted because generic manufacturers cannot unilaterally change their labels). The application of these precedents to the Depo-Provera facts (brand-name vs. generic, the timing of the scientific evidence, the FDA's specific labeling decisions) will substantially shape the litigation.

What qualifying cases look like

For an individual case within MDL 3140:

Diagnosis. Intracranial meningioma confirmed by imaging (MRI or CT scan). The diagnosis must be radiologically confirmed; clinical suspicion alone is not sufficient. Spinal meningiomas may also qualify in some case theories.

Depo-Provera use. Use of Depo-Provera, typically for more than one year (the BMJ study's threshold for the 5.5x increased risk). Some intake criteria specify at least 2 injections after 1992. The plaintiff should be able to document the Depo-Provera use through medical records, pharmacy records, or prescribing records.

Causation timing. The meningioma diagnosis must postdate the Depo-Provera use, with a latency period consistent with the biological mechanism. The strongest cases involve prolonged use (multiple years) followed by meningioma diagnosis.

Documentation. Medical records confirming the meningioma diagnosis (the MRI/CT imaging reports), records of Depo-Provera use (prescription and administration records), and records of the treatment (craniotomy, radiation therapy, ongoing monitoring).

The prior bone density litigation

Depo-Provera was the subject of earlier litigation over bone mineral density loss (osteoporosis). The drug carries a boxed warning about bone density loss, and Pfizer faced lawsuits in both the US and Canada over the failure to adequately warn about the osteoporosis risk. Those lawsuits were settled, with Pfizer reportedly paying more than $2 million in settlements.

The prior bone density litigation is relevant to the current meningioma litigation in two ways: it demonstrates that Depo-Provera has a history of warning-adequacy disputes, and it establishes that Pfizer has previously settled claims arising from inadequate warnings about the drug's risks.

Settlement framework expectations

There is no global settlement as of May 2026. The litigation is at an earlier stage than some other mass torts; the MDL was only created in 2025, the case count is still growing rapidly, and the preemption defense has not yet been resolved.

The settlement framework will depend substantially on:

The resolution of the preemption defense. If Pfizer's preemption argument succeeds (in whole or in part), the litigation could be substantially narrowed or limited to post-July-2024 prescriptions. If the preemption defense fails, the full range of cases proceeds.

The bellwether trial outcomes (once the bellwether process develops).

The strength of the scientific evidence as tested through the Daubert process.

For cases that survive the preemption defense and proceed, settlement values will depend on injury severity (the size and location of the meningioma, the treatment required, the permanence of any neurological deficits), the duration of Depo-Provera use, and the strength of the causation evidence.

How Depo-Provera cases compare to other mass torts

The framework shares features with several Halstonberg-covered mass torts:

Hair relaxer uterine cancer (MDL 3060) similarly involves a hormone-related cancer mechanism (endocrine disruption), a failure-to-warn theory, and a substantial affected population.

Ozempic/GLP-1 gastroparesis (MDL 3094) similarly involves a pharmaceutical product with a developing scientific record and active bellwether-stage proceedings.

Risperdal gynecomastia involves a pharmaceutical product with substantial endocrine effects and a failure-to-warn framework.

Elmiron pigmentary maculopathy involves a pharmaceutical product with delayed onset of injury and a US-vs-international warning timeline disparity, similar to the Depo-Provera label timing issue.

The Depo-Provera litigation is distinctive in the strength of the preemption defense (which turns on the specific FDA labeling decisions) and the relatively recent emergence of the scientific evidence (the 2024 BMJ study). The preemption resolution will substantially shape the litigation's trajectory.

Practical guidance

For someone who used Depo-Provera and was diagnosed with a meningioma:

The MDL is actively accepting new cases. The case count is growing rapidly; filing now positions the case within the developing framework.

Obtain the imaging documentation. The MRI or CT scan confirming the meningioma is the foundation of the diagnosis element. The radiology reports document the tumor's size and location.

Gather your Depo-Provera use records. Pharmacy records, administration records, and prescribing records document the use history. The duration of use is critical; the strongest cases involve prolonged use.

Document the treatment history. Craniotomy records, radiation therapy records, and ongoing monitoring records document the severity of the injury and inform the damages calculation.

Be aware of the preemption defense and the July 2024 timing issue. Pfizer argues that prescriptions before July 2024 are preempted because the scientific evidence was not available then. The resolution of this defense will substantially affect which cases proceed. Counsel familiar with the MDL framework can assess how the preemption issue applies to your specific timeline.

For wrongful death cases (where the affected person has died), the case is brought by the estate or surviving family members. Several wrongful death cases are part of the MDL.

Be cautious about advertised "claims companies" that are not actual law firms. The Depo-Provera litigation has substantial advertising activity; counsel actively practicing in MDL 3140 is the correct contact.

The litigation is at an earlier stage than some other mass torts, which means the framework is still developing. The preemption resolution, the bellwether process, and the Daubert proceedings over the next 12-24 months will determine the litigation's trajectory. Cases filed and worked up during this period are positioned within the developing framework.