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Depo-Provera Meningioma Lawsuit: What the MDL and FDA Label Say

Federal lawsuits allege that Depo-Provera and generic injections were linked to meningioma and that warnings were inadequate. Here is what the MDL, FDA label, study evidence and dated settlement report establish—and what they do not.
From TheFinanceBase Team3 min to read
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Federal lawsuits allege that Depo-Provera and generic depot medroxyprogesterone acetate injections were linked to meningioma and that patients were not adequately warned. The cases were centralized in federal court in 2025, but centralization is not a ruling that the drug caused any individual tumor or that defendants are liable. The headline’s “400 women” figure is not verified as a current case count in the sources reviewed.

What the Depo-Provera brain tumor lawsuits allege

The lawsuits concern meningioma, a tumor that develops in the membranes surrounding the brain and spinal cord. Plaintiffs allege an association between meningioma and use of Depo-Provera or generic depot medroxyprogesterone acetate injections, and claim that manufacturers failed to provide adequate warnings about the risk. These are allegations, not established findings of causation or liability.

The court’s official MDL page says defendants maintain that the medication is safe and effective. That statement describes the defendants’ position; it is not a court finding.

Why the “400 women” headline needs qualification

The reviewed sources do not verify “400 women” as a current count. Lawsuit totals can change, and a number may refer to cases in a particular court, plaintiffs, or claims rather than everyone who may have a legal claim. The official court information establishes that federal claims were centralized, but it does not substantiate the headline’s figure as a current total.

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What MDL No. 3140 means

On February 7, 2025, federal Depo-Provera meningioma cases were centralized for pretrial proceedings in the U.S. District Court for the Northern District of Florida as MDL No. 3140. Multidistrict litigation, or MDL, coordinates related federal cases—often for shared discovery and other pretrial work. It does not itself decide whether the medicine caused a particular person’s meningioma, establish that a warning was inadequate, or award compensation. Individual claims may still require separate resolution.

What medical evidence says—and does not say

A U.S. retrospective cohort study using TriNetX data compared depot medroxyprogesterone acetate users with controls after propensity-score matching. Xiao et al., in JAMA Neurology (2025), reported a relative risk of 2.43 (95% CI 1.77–3.33) for a meningioma diagnosis. The authors said the observed increase was concentrated among people with more than four years of exposure or who began use after age 31. They also reported a number needed to harm of 1,152.

Those are population-level estimates from an observational study, not a prediction of an individual’s risk. A relative risk compares groups; it is not the same as a person’s absolute chance of developing a tumor. The study’s association does not by itself prove that the medication caused a tumor in any participant or lawsuit plaintiff.

What the FDA label now says

The FDA-approved U.S. prescribing information revised in December 2025 lists meningioma under Warnings and Precautions. It instructs clinicians to monitor for signs and symptoms and states: “Discontinue Depo-Provera CI if meningioma is diagnosed.” The FDA approval letter says the supplement added meningioma-risk information to labeling for both Depo-Provera CI and Depo-SubQ Provera 104.

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Depo-Provera CI is the intramuscular formulation; its U.S. label recommends 150 mg every 13 weeks. Depo-SubQ Provera 104 is a separate subcutaneous formulation. Label changes are important safety information, but they do not determine whether a specific patient’s tumor was caused by use or resolve the lawsuits.

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Settlement reporting and what remains unknown

DepoWatch, a secondary litigation tracker, reported that Pfizer and plaintiffs’ leadership counsel reached a settlement in principle in June 2026. Its report dated July 19, 2026 said the terms were not public. The official court information reviewed does not independently confirm final terms, a completed settlement, or eligibility rules. A settlement in principle should not be treated as a final agreement or proof that any particular person qualifies.

No reliable payout amount, payment schedule, or eligibility criteria are established by these sources. Anyone assessing a possible claim would need advice based on their own medical and legal circumstances; an MDL listing or a reported settlement does not guarantee compensation.

What someone considering a claim should verify

  • Whether there is a diagnosed meningioma and relevant medical documentation.
  • Which injectable formulation was used, and when and for how long it was used, if those details are available.
  • Whether a lawyer can assess the person’s facts, applicable deadlines, and any verified settlement terms or eligibility rules.

These checks are not a published eligibility test. The sources reviewed do not establish a universal checklist or a filing deadline for every potential claimant.

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