Depo-Provera (medroxyprogesterone acetate / MPA) is a contraceptive injection administered every three months. Over 2,000 lawsuits consolidated in MDL 3140 in the Northern District of Florida allege that Pfizer failed to warn about a significantly elevated risk of meningioma — a tumor in the tissue surrounding the brain and spinal cord. Women who received the shot for more than one year face up to a 5.6-fold increased risk, and the risk escalates with duration of use.
Litigation Timeline
Upjohn Seeks First FDA Approval — Rejected Over Cancer Concerns
Upjohn Company submits a new drug application for Depo-Provera as a contraceptive. The FDA identifies cancer concerns after beagle dogs develop tumors and rejects the application.
FDA Approves U.S. Meningioma Warning After Decade of International Warnings
The FDA approves Pfizer's supplemental label change adding meningioma to Depo-Provera's Warnings and Precautions — a full decade after Canada's 2015 warning. Rule 702 hearings on general causation are set for May 2026.
FDA Rejects Depo-Provera a Second Time
After a seven-year beagle study reveals malignant breast tumors in two of 36 test animals, the FDA again rejects Depo-Provera for contraceptive use in the United States.
FDA Public Board of Inquiry — Third Rejection
A rare FDA Public Board of Inquiry convenes to evaluate Depo-Provera safety. The board recommends against approval, making it the third federal rejection.
FDA Finally Approves Depo-Provera After 25 Years
Despite three prior rejections and opposition from women's health advocates, the FDA approves Depo-Provera as a contraceptive. Upjohn argues that international experience with over 30 million users supports safety.
Pfizer Acquires Pharmacia & Upjohn
Pfizer completes its acquisition of Pharmacia Corporation (which had merged with Upjohn in 1995), inheriting Depo-Provera and all associated regulatory responsibilities and liabilities.
FDA Adds Black Box Warning for Bone Density Loss
The FDA requires its most serious warning — a black box — regarding significant bone mineral density loss with long-term use, recommending a 2-year usage limit.
Canada Adds Meningioma Warning to Depo-Provera Label
Health Canada adds meningioma as an adverse reaction to the Canadian Depo-Provera label, noting reports of meningiomas following long-term progestin administration. American women receive no equivalent warning.
French BMJ Study Reports 5.6x Meningioma Risk
Roland et al. publish a landmark population-based study in The BMJ showing that women who received Depo-Provera long-term face a 5.6-fold increased risk of meningioma. The study triggers a wave of U.S. lawsuits.
MDL 3140 Established in Northern District of Florida
The Judicial Panel on Multidistrict Litigation consolidates all federal Depo-Provera meningioma lawsuits into MDL 3140 under Judge M. Casey Rodgers in the Northern District of Florida.
Notable Verdicts & Settlements
MDL 3140 Bellwether Trial (Pending)
VerdictRule 702 hearings on general causation are scheduled for late May 2026. Bellwether trial selection and scheduling will follow. No verdict has been reached yet.
Comparable: Mirena IUD Pseudotumor Cerebri Litigation
Verdict$12.2 million individual verdict in Mirena IUD litigation involving pseudotumor cerebri (elevated intracranial pressure). Bayer faced failure-to-warn claims similar to the Depo-Provera meningioma theory. The neurological injury parallel makes this a key benchmark.
Comparable: Elmiron Vision Loss MDL — $54.5M Bellwether
Verdict$54.5 million bellwether verdict in Elmiron (pentosan polysulfate) vision loss litigation. Like Depo-Provera, the case involved failure to warn about a long-latency injury from long-term pharmaceutical use. Establishes benchmark for delayed-warning pharmaceutical claims.
Comparable: Depakote Birth Defect — $15M Verdict
Verdict$15 million verdict against Abbott Laboratories for failure to warn about Depakote birth defect risks. The pharmaceutical failure-to-warn theory and pregnancy/reproductive health context parallel the Depo-Provera litigation.
Comparable: Actos Bladder Cancer — $9B Verdict (Later Reduced)
Verdict$9 billion verdict (later reduced to $36.8 million) against Takeda Pharmaceuticals for hiding bladder cancer risks of the diabetes drug Actos. Demonstrates potential for massive jury awards when pharmaceutical companies are found to have concealed known cancer risks.
Comparable: Mesothelioma Brain Tumor Verdicts — Average Values
VerdictAverage mesothelioma/brain tumor verdicts range from $1.5–5 million. Brain tumor litigation consistently produces high per-plaintiff values due to the severity, permanence, and life-threatening nature of intracranial tumors. Depo-Provera meningioma cases are expected to fall within this range.
Comparable: NuvaRing Contraceptive Settlement — $100M Total
Verdict$100 million global settlement by Merck resolving approximately 3,800 NuvaRing hormonal contraceptive injury claims. As a hormonal birth control failure-to-warn case with a similar plaintiff profile, NuvaRing provides a baseline comparator for per-plaintiff values in the Depo-Provera litigation.
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