Depo-Provera Litigation Update: FDA Warning and MDL Growth – January 2026

The Depo-Provera MDL has surpassed 2,100 cases as of January 2026, following a pivotal development: on December 12, 2025, the FDA added a meningioma warning to the contraceptive injection's label. This regulatory shift significantly weakens Pfizer's preemption defense—their primary legal strategy—as the litigation accelerates toward a December 2026 bellwether trial. A 2024 BMJ study had previously established that women using the injectable contraceptive for over one year face a 5.5-fold increased risk of developing intracranial meningiomas.

The litigation stems from allegations that Pfizer failed to warn women about the brain tumor risk associated with medroxyprogesterone acetate (MPA), the active ingredient in Depo-Provera. With an estimated millions of American women having used the contraceptive since its 1992 FDA approval, the potential plaintiff pool remains substantial as awareness of the link between the drug and meningiomas continues to grow.

Case Background & Timeline

The Depo-Provera litigation gained momentum in early 2025 following publication of major studies linking the contraceptive to brain tumors. The litigation has moved quickly through the federal court system.

Medical & Scientific Evidence

Two major studies form the scientific foundation for the litigation, both demonstrating a significant link between injectable medroxyprogesterone acetate and intracranial meningiomas.

BMJ Study (March 2024)

The British Medical Journal published a French national case-control study analyzing data from 2009-2018. Researchers found that women using injectable progestogens like Depo-Provera had approximately 5.55× higher odds of developing intracranial meningiomas. The risk increased with duration of use, particularly after one year of continuous use.

JAMA Neurology Study (November 2025)

A Cleveland Clinic/Case Western Reserve University study analyzed U.S. healthcare data and confirmed the elevated risk, finding approximately 2.43× increased risk among Depo-Provera users. The study identified two key risk factors:

• Women who began use after age 31
• Women who used the drug for more than four years

What This Means for Pending Cases

The December 2025 FDA label change fundamentally alters the litigation landscape. Pfizer's preemption defense—arguing that the FDA rejected earlier label warning requests—is significantly weakened now that the agency has approved a meningioma warning.

Key Legal Developments

Preemption Motion Pending: Pfizer filed for summary judgment on preemption grounds, arguing the FDA previously blocked their proposed label warning. Following the December 2025 label update, Judge Rodgers ordered supplemental briefing to address how the new warning affects the preemption analysis.

Five Pilot Cases Selected: The court has directed preparation of five bellwether cases to resolve key issues including general causation and preemption. Results from these trials will shape the broader litigation path.

Case Qualification & Medical Records

Who Qualifies

Potential plaintiffs must meet these criteria:

• Product: Used Depo-Provera, Depo-SubQ Provera 104, or generic medroxyprogesterone acetate injections
• Duration: Typically used for at least one year (longer use strengthens claims)
• Diagnosis: Confirmed intracranial meningioma diagnosis
• Timing: Used the product before the December 2025 label warning

Medical Records Needed

Building strong Depo-Provera cases requires comprehensive medical documentation:

1. Injection/Prescription Records – Dates, dosages, and provider information documenting Depo-Provera use
2. Diagnostic Imaging – MRI or CT scans confirming meningioma diagnosis
3. Pathology Reports – Biopsy or surgical pathology confirming tumor type
4. Neurology/Neurosurgery Records – Treatment history, surgical reports, follow-up care
5. Pharmacy Records – Corroborating prescription fill history

Firms screening Depo-Provera cases need rapid access to both reproductive health and neurology records. AI-powered retrieval services like LlamaLab can obtain records from OB/GYN practices, pharmacies, and neurosurgery centers in 24-48 hours—critical for efficiently building cases in a rapidly growing MDL.

What's Next

Statute of Limitations Considerations

Statute of limitations varies by state, with most jurisdictions applying a 2-3 year window from discovery of injury. Important considerations include:

• Discovery rule: SOL typically begins when the plaintiff knew or should have known of the connection between Depo-Provera and their meningioma
• FDA warning impact: The December 2025 label update may trigger new discovery dates for some plaintiffs
• Study publication dates: The BMJ (March 2024) and JAMA Neurology (November 2025) studies may also serve as discovery triggers under some state laws

The Bottom Line

The Depo-Provera litigation has reached a critical inflection point. With over 2,100 cases filed, a new FDA warning on the label, and bellwether trials scheduled for December 2026, the litigation trajectory favors plaintiffs. The FDA's acknowledgment of the meningioma risk—coming after Pfizer argued for years that such a warning was unnecessary—significantly undermines the manufacturer's primary defense strategy.

Law firms handling these cases should focus on comprehensive medical record retrieval to document both drug use history and meningioma diagnosis. With Daubert hearings approaching in May 2026, building evidence packages now ensures readiness for key litigation milestones.

Sources: MDL Update, FLND Court MDL 3140, Drugwatch, The Legal Link, TSEG, The Guardian. Case counts current as of January 2026.

This article provides general information about Depo-Provera litigation developments and should not be construed as legal or medical advice. Consult with qualified professionals for advice specific to your situation.