Depo-Provera and Meningioma Claims: What the Record Shows

Depo-Provera is an injectable contraceptive containing medroxyprogesterone acetate, given by intramuscular injection every three months. In December 2025 the FDA approved a labeling supplement adding meningioma, a tumor in the membranes around the brain and spinal cord, to the product’s warnings and patient information. Federal lawsuits alleging that long-term use caused meningiomas were consolidated in February 2025 into MDL No. 3140 in the Northern District of Florida, where thousands of actions are pending and a settlement of a majority of the claims is being administered. No court has determined that the drug caused any individual’s meningioma; the central causation questions were briefed and set for a hearing, not decided.

What the FDA label now says

The current FDA-approved prescribing information for Depo-Provera CI and depo-subQ provera 104, revised December 2025, lists “Warnings and Precautions, Meningioma (5.4) 12/2025” among recent major changes. Section 5.4 states that meningioma cases “have been reported following repeated administration of medroxyprogesterone acetate, primarily with long term use,” and directs clinicians to monitor patients and to discontinue the drug if a meningioma is diagnosed. The patient information warns of “possible increased risk for growth of a meningioma (a usually benign brain tumor), primarily when the product is used for a long time.”

The FDA’s supplement approval letter, signed December 12, 2025, records the sequence: an application dated and received February 5, 2024, an FDA action letter of November 1, 2024, and a Pfizer amendment of June 12, 2025 treated as a complete response. It covers NDA 020246/S-074 (Depo-Provera CI) and NDA 021583/S-045 (Depo-SubQ Provera 104).

The July 2024 labeling had no meningioma section: Section 5.4 then addressed ectopic pregnancy. The meningioma warning appears first in the December 2025 revision.

What is established, and what is still only alleged

Established: Depo-Provera CI was first approved in the United States in 1959 and is dosed at 150 mg every three months (FDA labeling). The December 2025 meningioma labeling change is a regulatory action, not a judicial finding. The JPML centralized related federal actions into MDL No. 3140 on February 7, 2025, and the proceeding had grown to 6,403 pending and 6,510 total actions as of the Panel’s September 1, 2026 report. A settlement of a majority of the claims was announced in June 2026, a master agreement was signed in July, and a settlement administrator was appointed in August (Case Management Orders No. 12 and No. 13).

Alleged, and not decided: that repeated long-term use caused meningiomas, that the defendants knew of the risk and failed to warn adequately, and that they failed to promote a lower-dose subcutaneous alternative. The JPML transfer order frames the common questions that way, quoting the contention that Depo-SubQ Provera 104 “is safer due to its lower dose of medroxyprogesterone acetate.” The court’s MDL page records the defendants’ position that “the medication is safe and effective.”

Where the claims stand procedurally

The case is MDL No. 3140, In re: Depo-Provera (Depot Medroxyprogesterone Acetate) Products Liability Litigation, master docket 3:25-md-3140 in the U.S. District Court for the Northern District of Florida, Pensacola Division, before Judge M. Casey Rodgers and Magistrate Judge Hope T. Cannon. The Panel created it on February 7, 2025 from 27 actions in eight districts, limited to plaintiffs alleging intracranial meningiomas (JPML transfer order).

Case Management Order No. 12 records that general causation discovery was completed, that general causation summary judgment and Rule 702 motions were fully briefed as of June 5, 2026, and that a hearing on those motions was scheduled for September 18, 2026.

That order also records that leadership counsel announced a settlement of a majority of claims in the MDL and in New York state court on June 15, 2026, that a Master Settlement Agreement was signed July 21, 2026, and that the parties estimated roughly 80 percent of MDL plaintiffs would be eligible under it. The court vacated the pilot-case schedule and canceled a December 2026 trial because those plaintiffs are settlement-eligible. Case Management Order No. 13, entered August 5, 2026, appointed BrownGreer PLC as settlement administrator to determine eligibility. The court noted that no fairness determination applies because the MDL is not a class action (Case Management Order No. 12), and that there is no admission of fault or liability (Case Management Order No. 14).

Key dates

• February 5, 2024: Pfizer’s labeling application reaches the FDA (FDA approval letter).
• July 2024: Depo-Provera CI labeling revised, with no meningioma section (FDA 7/2024 labeling).
• November 1, 2024: FDA action letter on the supplement (FDA approval letter).
• February 7, 2025: the JPML creates MDL No. 3140 from 27 actions (JPML transfer order).
• June 12, 2025: Pfizer’s amendment received as a complete response (FDA approval letter).
• December 12, 2025: FDA approves the meningioma labeling change (FDA approval letter).
• June 5, 2026: general causation and Rule 702 briefing complete (Case Management Order No. 12).
• June 15, 2026: settlement of a majority of claims announced (Case Management Order No. 12).
• July 21, 2026: Master Settlement Agreement signed (Case Management Order No. 12).
• August 5, 2026: BrownGreer PLC appointed settlement administrator (Case Management Order No. 13).
• September 1, 2026: the JPML reports 6,403 pending and 6,510 total actions in MDL No. 3140.
• September 18, 2026: general causation and Rule 702 hearing scheduled (Case Management Order No. 12).
• December 18, 2026: next case management conference listed by the court (court MDL page).

What this does not establish

Nothing in the record reviewed here shows a court finding that Depo-Provera caused any individual’s meningioma: the general causation and Rule 702 motions were briefed and set for a hearing, and no ruling appears in the orders reviewed. An FDA labeling change is a regulatory decision, not a finding of causation or liability, and the court’s MDL page still records the defendants’ position that the medication is safe and effective.

The settlement is neither a judgment nor an admission. The court has said it is not conducting a fairness determination because the MDL is not a class action, that eligibility is governed by the Master Settlement Agreement’s terms, and that there is no admission of fault or liability. The publicly posted orders reviewed here state no total settlement amount, and claims outside the agreement’s eligibility terms remain in litigation.

Frequently asked questions

Is there a Depo-Provera class action settlement?

No class action settlement appears in the court orders reviewed: MDL No. 3140 is a consolidated pretrial proceeding, not a class action, and no fairness determination applies. A settlement program announced June 15, 2026 is governed by a Master Settlement Agreement signed July 21, 2026.

What does the December 2025 label change mean for these cases?

It is an FDA regulatory action adding meningioma information to the labeling for Depo-Provera CI and Depo-SubQ Provera 104. It does not decide whether the drug caused any particular person’s tumor; the July 2024 labeling had no meningioma section.

How does an MDL differ from a class action?

An MDL consolidates federal cases for coordinated pretrial proceedings, but each plaintiff keeps an individual claim and generally must prove causation and damages separately. A class action resolves a defined group’s claims as one case, usually with a court-approved settlement and a fairness hearing. Background guides on how mass tort litigation works and on MDLs and class actions explain more, along with the pharmaceutical lawsuits hub and the Oxbryta withdrawal litigation.

Sources

1. U.S. Judicial Panel on Multidistrict Litigation - “In re: Depo-Provera (Depot Medroxyprogesterone Acetate) Products Liability Litigation, MDL No. 3140, Transfer Order” (link, accessed 2026-10-13)
2. U.S. District Court for the Northern District of Florida - “Depo-Provera (Depot Medroxyprogesterone Acetate) Products Liability Litigation, MDL No. 3140” (link, accessed 2026-10-13)
3. U.S. District Court for the Northern District of Florida - “Case Management Order No. 12” (link, accessed 2026-10-13)
4. U.S. District Court for the Northern District of Florida - “Case Management Order No. 13 (Appointment of Settlement Administrator)” (link, accessed 2026-10-13)
5. U.S. District Court for the Northern District of Florida - “Case Management Order No. 14 (Case Management Order for Ongoing Litigation)” (link, accessed 2026-10-13)
6. U.S. Food and Drug Administration - “Supplement Approval, NDA 020246/S-074 and NDA 021583/S-045 (Depo-Provera CI; Depo-SubQ Provera 104)” (link, accessed 2026-10-13)
7. U.S. Food and Drug Administration - “Depo-Provera CI and depo-subQ provera 104 prescribing information, revised 12/2025” (link, accessed 2026-10-13)
8. U.S. Food and Drug Administration - “Depo-Provera CI prescribing information, revised 7/2024” (link, accessed 2026-10-13)
9. U.S. Judicial Panel on Multidistrict Litigation - “MDL Statistics Report: Distribution of Pending MDL Dockets by Actions Pending, September 1, 2026” (link, accessed 2026-10-13)

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