By As Law Online 
Key Points
- Research suggests an association between long-term use of Depo-Provera and a higher relative risk of meningioma brain tumors, though absolute risk remains low and Pfizer maintains the drug is safe when used as directed.
- More than 2,000 lawsuits are consolidated in a federal multidistrict litigation (MDL) alleging failure to warn; no settlements have been reached, with the first bellwether trial scheduled for December 2026.
- The FDA updated the drug’s label in December 2025 to include a meningioma warning, a development that may influence ongoing legal arguments.
- Individuals who used the injection and later developed meningioma should consult qualified professionals for personalized medical and legal guidance, as outcomes vary by case specifics.
Current Litigation Landscape: The Depo Provera lawsuit involves product liability claims against Pfizer and related companies. Plaintiffs allege the manufacturer did not adequately warn users or providers about potential meningioma risks before late 2025, despite earlier studies and international label differences. The cases are centralized in the U.S. District Court for the Northern District of Florida under Judge M. Casey Rodgers (MDL No. 3140, established February 2025). Case volume continues to grow, reflecting public interest in contraceptive safety.
Why It Matters Now: The FDA’s December 2025 label update added explicit language: “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.” This change followed studies linking prolonged use to elevated risk and came amid rising filings. Affected individuals include women who received multiple injections for contraception or conditions such as endometriosis.
General Information for Readers: This article provides an overview of publicly available legal and regulatory developments. It does not constitute legal advice, and readers should seek counsel from licensed attorneys for case-specific evaluation. Timelines, eligibility considerations, and potential outcomes depend on individual facts, state laws, and court rulings.
Introduction
The Depo Provera lawsuit has drawn significant attention from women, healthcare providers, and legal observers seeking clarity on contraceptive safety and pharmaceutical accountability. At its core, the litigation alleges that long-term use of the injectable contraceptive Depo-Provera (medroxyprogesterone acetate, manufactured by Pfizer and distributed in generic forms) is associated with an increased risk of meningioma, a typically benign tumor arising in the membranes surrounding the brain and spinal cord. Plaintiffs claim the manufacturer failed to provide adequate warnings on U.S. labeling until December 2025, despite emerging scientific evidence and differing international labels.
This article explains the legal and regulatory context in plain English while referencing established principles of product liability law, FDA processes, and court procedures. It addresses the history of the drug, key legal issues, latest developments as of February 2026, potential impacts, and considerations for those monitoring the situation. All information is drawn from court records, FDA documents, peer-reviewed studies, and official announcements. This article is for informational purposes only and does not constitute legal advice.
Background & Legal Context
Depo-Provera received FDA approval in 1992 as an intramuscular injectable progestin for preventing pregnancy, administered every three months. It has also been prescribed for endometriosis-associated pain and other conditions. In 2004, the FDA imposed its strongest boxed warning for loss of bone mineral density (BMD), noting that prolonged use may not be fully reversible and is not recommended beyond two years unless alternatives are inadequate.
The current wave of litigation stems from studies published in 2024 and 2025 examining progestin exposure and meningioma. A French case-control study in the BMJ (2024) analyzed national health data and reported a 5.55-fold increased risk of intracranial meningioma requiring surgery with prolonged Depo-Provera use. A subsequent U.S. cohort study in JAMA Neurology (September 2025), drawing from over 10.4 million patient records, found a relative risk of 2.43 (95% CI 1.77–3.33) compared with non-users of hormonal contraceptives. Risk escalated with duration: approximately 3.0 for 4–6 years and 3.9 for more than 6 years of exposure. The number needed to harm was calculated at 1,152, indicating a low absolute risk despite the relative increase. Risk appeared higher for women initiating use after age 31.
These findings prompted regulatory action. Unlike earlier U.S. labels, European and Canadian versions had included meningioma cautions for years. Pfizer submitted a label-change application to the FDA in February 2024. The agency approved the update in December 2025, adding a dedicated Warnings and Precautions subsection (5.4): “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 label also references patient counseling on possible growth risk in those with a history of meningioma.
Legally, the claims rest on product liability doctrines under state tort law, often invoking the Restatement (Second) of Torts § 402A (strict liability for defective products) and failure-to-warn theories. Defendants include Pfizer Inc., Pharmacia & Upjohn entities, and generic manufacturers such as Viatris and Greenstone LLC. Plaintiffs assert that the companies knew or should have known of the risk yet prioritized U.S. market access without equivalent warnings. Federal preemption defenses—arguing that FDA labeling decisions barred earlier warnings—are actively litigated, consistent with Supreme Court precedents balancing state tort claims against federal regulatory authority.
Key Legal Issues Explained
Product liability cases involving prescription drugs typically require plaintiffs to establish three core elements:
(1) The product was defective (here, through inadequate warnings or design),
(2) The defect existed when it left the manufacturer’s control
(3) The defect proximately caused the injury. In failure-to-warn claims, courts often apply the learned intermediary doctrine, under which manufacturers fulfill their duty by warning prescribing physicians, who then counsel patients.
However, evolving evidence of direct-to-consumer advertising and label adequacy can influence jury assessments.
Causation is central and relies on expert testimony applying methodologies such as those in Daubert v. Merrell Dow Pharmaceuticals (1993). Plaintiffs reference epidemiological data (relative risks from BMJ and JAMA Neurology studies) alongside biological plausibility (progestin receptor expression in many meningiomas) and temporal association (diagnosis after repeated injections). General causation (does the drug capable of causing meningioma?) and specific causation (did it cause this plaintiff’s tumor?) are distinct thresholds.
Design-defect claims may allege that a lower-dose subcutaneous alternative (Depo-SubQ Provera 104) was safer yet not sufficiently promoted. Statutes of limitations vary by state but frequently incorporate the discovery rule—accrual begins when a plaintiff knew or reasonably should have known of the injury and its potential link to the drug. Equitable doctrines such as fraudulent concealment may toll deadlines where material information was allegedly withheld.
Latest Developments or Case Status
On February 7, 2025, the Judicial Panel on Multidistrict Litigation centralized cases into MDL No. 3140 in the Northern District of Florida, citing common factual questions: whether Depo-Provera causes meningioma, defendants’ knowledge of the risk, adequacy of warnings, and promotion of safer alternatives. Presiding Judge M. Casey Rodgers oversees pretrial proceedings, including discovery, expert challenges, and bellwether selection.
As of February 2026, more than 2,100 cases are pending in the MDL, with additional filings in state courts (e.g., significant dockets in California, New York, Pennsylvania, Delaware, and Illinois). The first bellwether trial is scheduled for December 2026. Pretrial orders address proof-of-use requirements (medical records, pharmacy billing, or subpoenas confirming at least two injections) and injury questionnaires submitted via centralized systems.
In August 2025, Pfizer moved for summary judgment on preemption grounds, arguing the FDA’s prior rejection of warning language barred failure-to-warn claims. Oral arguments occurred in September 2025; supplemental briefing followed the FDA’s December 2025 label approval, which plaintiffs contend undermines the defense. No global settlement has been announced. Monthly case management conferences continue, with the next scheduled into March 2026. Parallel class-action efforts for medical monitoring have been filed but remain separate from the personal-injury MDL.
Who Is Affected & Potential Impact
Primary plaintiffs are women of reproductive age or older who received multiple Depo-Provera injections (typically two or more) and were subsequently diagnosed with intracranial or spinal meningioma. Diagnosis may follow symptoms such as headaches, seizures, vision changes, or incidental MRI findings. Tumors can be benign (WHO Grade I) or require surgical resection, radiation, or ongoing monitoring.
Broader impacts extend to healthcare systems (increased neurosurgical demand), insurers (coverage for long-term sequelae), and public health policy (contraceptive counseling). Families may experience emotional and financial strain from lost wages, caregiving, or permanent neurological deficits. Defendants face potential liability for compensatory damages (medical expenses, pain and suffering) and, in rare cases, punitive awards if willful misconduct is proven.
The following table summarizes key risk and litigation metrics drawn from cited studies and court data:
| Category | Metric/Details | Source/Reference |
|---|---|---|
| Relative Risk (Overall) | 2.43 (95% CI 1.77–3.33) | JAMA Neurology (2025) |
| Relative Risk (>4 years use) | 3.0–3.9 | JAMA Neurology (2025) / BMJ (2024) |
| Number Needed to Harm | 1,152 | JAMA Neurology (2025) |
| MDL Case Count (Feb 2026) | >2,100 pending | MDL records / litigation updates |
| First Lawsuit Filed | October 2024 | Court filings |
| FDA Label Update | December 2025 (meningioma warning added) | FDA-approved prescribing information |
| Bellwether Trial | December 2026 | MDL scheduling orders |
What This Means Going Forward
The Depo Provera lawsuit underscores ongoing scrutiny of hormonal contraceptives and pharmaceutical warning obligations. A ruling on preemption could shape failure-to-warn claims nationwide. Successful bellwether outcomes may influence settlement negotiations, while adverse rulings could prompt appeals or alternative state-court strategies.
Industry-wide, the case highlights the importance of post-market surveillance and international label harmonization. Regulators may revisit risk-benefit profiles for progestin-only injectables. For the public, it reinforces the need for informed discussions with healthcare providers about contraceptive options, duration limits, and symptom monitoring. Readers should track official FDA communications, MDL docket updates via PACER, and peer-reviewed publications for evolving data.
Frequently Asked Questions
What is the primary allegation in the Depo Provera lawsuit?
Claims center on alleged failure to warn about meningioma risk associated with long-term use prior to the December 2025 label update.
Who qualifies to participate in related litigation?
Individuals with documented use of Depo-Provera or generic equivalents followed by a meningioma diagnosis may have claims, subject to medical-record verification and applicable statutes of limitations. Eligibility determinations are fact-specific.
How does the FDA label change affect existing cases?
The addition of explicit meningioma language may influence preemption arguments and future prescribing practices but does not automatically resolve pending claims.
Are there other known risks associated with Depo-Provera?
Yes; the boxed warning addresses BMD loss. Additional warnings cover thromboembolic events, breast cancer signals in some studies, irregular bleeding, weight gain, and delayed fertility return.
What is the current status of settlement discussions?
No global settlement has been reached. Projections in legal analyses remain speculative and vary by injury severity.
How can affected individuals stay informed?
Monitor FDA announcements, the Northern District of Florida MDL website, and peer-reviewed journals. Consultation with licensed medical and legal professionals is recommended.
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