Depo-Provera Litigation After the Settlement: What Attorneys Need From OB/GYN and Epidemiology Experts

By Tracy L. Liberatore Esq, PA-Emeritus

A settlement does not end a mass tort. It sorts it. In the Depo-Provera meningioma litigation, the parties estimate that roughly 80 percent of federal plaintiffs will be eligible for the confidential program Pfizer and plaintiffs’ leadership signed in July 2026.2 The other claims, and every case that opts out, now move onto a track where the court requires a case-specific causation report, a ruled-out list of alternative causes, and a precise account of every injection. As of the October 1, 2026 JPML statistics report, 6,412 actions are pending in MDL No. 3140, with 6,524 total actions filed since centralization.1

Our first Depo-Provera post covered the injury itself and the neurosurgery and neuroradiology experts it requires. This post looks at the questions that will decide the claims left outside the settlement: how long the patient used the drug, when the tumor was diagnosed relative to the last injection, what the label said and when, and what the epidemiology can and cannot prove for one woman. Those are questions for obstetrician-gynecologists and epidemiologists.

The Litigation Landscape

In re: Depo-Provera (Depot Medroxyprogesterone Acetate) Products Liability Litigation, MDL No. 3140, No. 3:25-md-3140, is pending in the Northern District of Florida, Pensacola Division, before U.S. District Judge M. Casey Rodgers, with Magistrate Judge Hope T. Cannon.1,3 Plaintiffs allege that Pfizer Inc., Pharmacia LLC, and Pharmacia & Upjohn Co. LLC failed to adequately warn that prolonged use of the injectable contraceptive is associated with intracranial meningioma. Pfizer denies the allegations, and the court’s August 10, 2026 order notes that there is no admission of fault or liability in connection with the settlement.3

The settlement and who it leaves out

Leadership counsel announced a settlement of a majority of the MDL claims, and claims in New York state court, on June 15, 2026. A Master Settlement Agreement was signed on July 21, 2026. The terms are private and confidential, and because the MDL is not a class action the agreement is not subject to a court fairness review. The court vacated the original Pilot case schedule and canceled the December 7, 2026 trial because the original Pilot plaintiffs were eligible to participate.2 Eligible claimants must register by November 30, 2026, and the parties have told the court they expect payments to begin rolling out in the first quarter of 2027.2,3 BrownGreer PLC is the settlement administrator, and an administrative docket allows eligible claimants who signed with counsel by June 11, 2026 to file without a filing fee, with those complaints due by November 30.7

Case Management Order No. 14 sorts everyone else into defined groups. Non-Settling Plaintiffs are eligible but do not participate. Ineligible Plaintiffs are excluded for other reasons. Future Filed Plaintiffs filed after the order. Two groups are singled out for separate proceedings on cross-cutting defenses: Limitations Plaintiffs, excluded because of the date they sued, and Latency Plaintiffs, excluded because of “the timing of the individual’s meningioma diagnosis relative to their last use” of the drug.3 Latency is an epidemiology question. Limitations, as the next section shows, is partly one too.

The statute of limitations track

After the original Pilot plaintiffs became settlement eligible, the court granted Pfizer’s motion to substitute three new Pilot cases: Yeager v. Pfizer, Davis v. Pfizer, and Ponder v. Pfizer, each filed between March 27 and June 15, 2026. Pfizer has said it will argue that the French national case-control study published in the BMJ on March 27, 2024 put plaintiffs on notice, so that in states with a two-year limitations period any case filed after March 27, 2026 is time-barred. According to the court’s order, that argument reaches the three Pilot cases and more than 200 others. The court allowed expedited, limitations-focused discovery to build a summary judgment record.4 Consistent with that theory, CMO 14 requires any Future Filed Plaintiff who alleges a meningioma before March 27, 2024 to file a certification explaining why the claim is not time-barred, and every Future Filed Plaintiff must swear to when and how she first learned her tumor might be related to the drug.3

General causation and preemption are still open

The general causation Rule 702 hearing went forward in Pensacola on September 18, 2026, in the new Pilot cases. The court heard live testimony from Pfizer’s expert Dr. Emily Levitan and plaintiffs’ expert Dr. Nicholas Butowski, then argument on Pfizer’s motion to exclude plaintiffs’ general causation experts (ECF No. 630) and plaintiffs’ motions to exclude Pfizer’s experts (ECF Nos. 619, 621, 624, 626, and 628). The minutes record “order to follow.”5 As of this writing we found no ruling posted on the court’s MDL 3140 orders page. Pfizer’s motion for summary judgment on federal preemption also remains pending; the court postponed ruling on it after the settlement was announced.24 The court has said it will decide preemption and general causation for ineligible and opt-out cases, and that those rulings will not affect participating plaintiffs.2

On September 24, 2026, the court canceled the October and November case management conferences, citing the settlement registration process and the Pilot case summary judgment schedule. Written status reports are due November 20 and December 14, and the next conference remains on calendar for December 18, 2026.6

State courts

At the July 27, 2026 conference, counsel reported 129 cases in New York, 410 in Delaware, and 118 in California, where preemption has been briefed and bellwether cases selected. Earlier-stage dockets include Minnesota (72 cases, 6,899 plaintiffs), Connecticut (13 cases, 76 plaintiffs), and Illinois (12 cases). Delaware Superior Court Judge Kathleen Vavala heard Rule 702 argument on June 25, 2026, and had the motions under review at that time.2

The Questions That Decide the Remaining Claims

The settlement removed the easy cases. What is left are claims where the facts are contested at the edges: short exposure, long gaps after the last injection, diagnoses that predate the 2024 science, or alternative explanations for the tumor. Pfizer’s own expert framed the battleground. According to plaintiffs’ motion to exclude her opinions, Dr. Levitan, a professor of epidemiology, agreed at deposition that for some women who have taken Depo-Provera for a long period of time, the drug can cause the growth of meningioma. Plaintiffs then challenged four of her limiting opinions: that there is no reliable evidence of increased risk two years after stopping the drug, that use of less than one year cannot cause meningioma, that the drug promotes growth of existing tumors rather than initiating them, and that the association was not apparent before 2024.12 Each of those four points maps directly onto a group of claims outside the settlement.

  • Duration and dose. How many injections, over what period, with what gaps? Pharmacy and clinic records for a quarterly injection are often scattered across Planned Parenthood clinics, health departments, OB/GYN offices, and urgent care settings.
  • Latency. How long after the last injection was the tumor diagnosed, and does the published evidence support an elevated risk in that window?
  • Initiation versus growth. If the drug promotes growth of a tumor that was already present, how does that affect specific causation for a tumor found years after use stopped?
  • Notice and label history. What did the label say during the plaintiff’s use, what did her prescriber know, and when did the science become available to a reasonable patient?
  • Alternative causes. Prior cranial radiation, neurofibromatosis type 2, other progestogen exposure, age, and obesity all appear in the literature and in the case-specific record.

The Science Behind the Claims

General causation may not be where most remaining cases are won or lost, because, according to plaintiffs’ motion, even Pfizer’s epidemiology expert accepts that prolonged use can cause meningioma growth in some women. The fight is over the shape of the dose-response curve and how long risk persists. The literature is now large enough that each side can cite peer-reviewed support, which is exactly why careful epidemiological reading matters.

Duration of use

  • French national case-control study (BMJ, 2024). Among 18,061 women who had surgery for meningioma and 90,305 matched controls, injectable medroxyprogesterone acetate was associated with an odds ratio of 5.55 (95% CI, 2.27 to 13.56), and the excess risk was driven by prolonged use of one year or more. Only 9 exposed cases drove that estimate, which explains the wide interval.14
  • U.S. TriNetX cohort (JAMA Neurology, 2025). After propensity matching, 88,667 users had a relative risk of 2.43 (95% CI, 1.77 to 3.33). The authors reported the risk was confined to patients with more than four years of exposure or who started after age 31, and calculated a number needed to harm of 1,152.15
  • Swedish register study (Neuro-Oncology, 2026). Medroxyprogesterone-containing contraceptives carried an odds ratio of 5.49 (95% CI, 4.51 to 6.67), corresponding to about 2 additional meningioma cases per 10,000 exposed women per year.16
  • U.S. comparative safety study (Expert Opinion on Drug Safety, 2025). Compared with users of a levonorgestrel combined pill, women using medroxyprogesterone acetate for more than one year had an adjusted incidence rate ratio of 3.55 (95% CI, 1.85 to 6.85).21

Timing and latency

  • Danish nationwide nested case-control study (JAMA Network Open, July 2026). Across 3 million women, injectable medroxyprogesterone carried an odds ratio of 4.55 (95% CI, 2.19 to 9.45), and exposure within the past year was associated with the highest risk.17
  • Active comparator study (Current Oncology, 2025). Exposure at any time was not significantly associated with meningioma (OR 1.75, 95% CI 0.81 to 4.95), but exposure within one year of diagnosis was (OR 3.38 against an active comparator; 6.90 against a non-active comparator).20
  • Regression after stopping. Two 2026 case series report soft-tissue tumor regression after the drug was discontinued, beginning as early as 14 months after cessation in one series. The BMJ Neurology Open series also found that hyperostotic bone did not regress, and two patients still needed optic nerve decompression.22,23

Defense experts will read the timing data as showing that risk fades after use stops. Plaintiff experts will point out that regression after withdrawal supports a hormone-driven mechanism, that a slow-growing tumor may be diagnosed long after it was stimulated, and that no study has defined a safe interval. According to the parties’ joint report before the September hearing, Dr. Levitan identified the 2026 Danish study and the 2026 meta-analysis by Reynolds and colleagues as additional support for her opinions.13 The same studies will be cited by both sides. An expert who can explain why is worth more than one who can only quote the headline number.

Two meta-analyses, two confidence levels

A 2026 meta-analysis from the University of Alabama at Birmingham pooled nine case-control studies and one cohort study and reported an overall odds ratio of 2.78 (95% CI, 2.20 to 3.52), rising to 3.49 (95% CI, 2.35 to 5.18) for use of two years or more, and rated the evidence moderate quality under GRADE.18 A French meta-analysis published the same year pooled six studies and reported an odds ratio of 2.68 (95% CI, 1.72 to 4.19), but with very high heterogeneity (I2 92.7 percent) and a GRADE rating of low.19 The point estimates are almost identical. The certainty ratings are not. Under amended Rule 702, the court asks whether an expert’s opinion reflects a reliable application of method to the data, and that kind of gap is where cross-examination lives.

Label History: What Prescribers Were Told

Label history matters for failure to warn, for the learned intermediary doctrine, for preemption, and now for limitations. The key dates are in the record:

  • Since 2004, Depo-Provera has carried a boxed warning for loss of bone mineral density, and the label states the drug is not recommended as a long-term birth control method, meaning longer than 2 years, unless other options are considered inadequate.9 That existing limitation is significant: many plaintiffs used the drug for far longer, which raises standard of care and counseling questions that only an OB/GYN can answer.
  • On September 5, 2024, the European Medicines Agency’s safety committee recommended adding meningioma to the contraindications and warnings for all injectable medroxyprogesterone products, including a statement that shrinkage had been observed after the depot form was stopped.11
  • Pfizer says it submitted a supplemental application to FDA on February 5, 2024 seeking a meningioma warning, and that FDA issued a complete response letter declining it. That rejection is the core of Pfizer’s preemption motion.8 FDA’s later approval letter refers to a November 1, 2024 action letter and Pfizer’s June 12, 2025 amendment.9
  • In a letter dated December 12, 2025, FDA approved the label change. Section 5.4 now states that meningiomas have been reported following repeated administration, primarily with long-term use, and directs prescribers to monitor for symptoms and to discontinue the drug if a meningioma is diagnosed.9,10

Plaintiffs contend the risk was knowable well before 2024. Pfizer contends FDA’s own 2024 decision shows the evidence did not support a warning until later. Experts on both sides will be asked what a reasonable prescriber knew, when, and what she would have done differently.

Why OB/GYN and Epidemiology Experts Are Now Critical

CMO 14 sets out exactly what a Litigating Plaintiff must serve, within 90 days of becoming a Non-Settling, Ineligible, or Future Filed plaintiff: a Rule 26(a)(2) expert report stating that the plaintiff’s meningioma was caused by her use of the drug, an opinion ruling out alternative causes, “an as-precise-as-possible identification of all” product use and the timing of the injury, a sworn causation statement with all supporting literature, and the medical records relied on, plus a separate damages report. Form or template reports will be stricken, and uncured deficiencies lead to a show cause order and dismissal with prejudice.3 That is a specific causation report on a deadline, for every remaining case.

Obstetrics and Gynecology

The OB/GYN is the expert who can reconstruct exposure and judge the prescribing decisions. Plaintiff and defense counsel need an OB/GYN to:

  • Build the injection-by-injection exposure timeline from fragmented clinic, pharmacy, and insurance records, and identify gaps, late doses, and switches to or from other progestogens
  • Explain why a patient was on the drug, including contraception, endometriosis, abnormal bleeding, or other indications, and whether alternatives were considered under the label’s two-year limitation
  • Address what prescribers were told before and after the December 2025 label change, what counseling the standard of care required, and whether a different warning would have changed the prescribing decision
  • Evaluate competing hormonal exposures, including other progestogen contraceptives, menopausal hormone therapy, and fertility treatment, which the literature treats very differently from injectable medroxyprogesterone
  • Give the court and jury a clinician’s view of why women stay on a quarterly injection for years, which bears on both damages and notice

Epidemiology and Biostatistics

Every remaining case will turn on whether population data can be applied to one woman. Attorneys need an epidemiologist to:

  • Explain relative risk, odds ratios, confidence intervals, and number needed to harm in plain terms, including why a doubling of risk matters in jurisdictions that use it as a benchmark for specific causation
  • Analyze dose-response by duration of use and place the plaintiff on that curve
  • Address latency and the time since last use, the exact ground on which Latency Plaintiffs were excluded
  • Critique study design: surgical-case definitions, exposure misclassification, residual confounding, heterogeneity, and active versus non-active comparators
  • Address when the association became knowable, which bears on Pfizer’s March 27, 2024 limitations theory and on the plaintiffs’ failure-to-warn timeline

Other specialties these reports require

  • Reproductive endocrinology to explain progesterone receptor biology and the initiation versus growth debate
  • Neurosurgery and neuro-oncology to address tumor behavior, surgical history, and recurrence
  • Neuroradiology to date tumor growth from serial imaging and identify the skull base pattern
  • Neuropathology to address histology, grade, and receptor status
  • Clinical pharmacology to address exposure, dose, and mechanism
  • Life care planning and forensic economics for the separate damages report CMO 14 requires

What Attorneys Should Look For

  • An OB/GYN with real prescribing experience with injectable contraception, active board certification, and the ability to explain counseling standards across the years at issue
  • Formal epidemiological training, not just familiarity with the studies. Rule 702 challenges in this MDL have focused on how experts used the literature, so methodology must be explainable and consistent
  • Comfort with both sides of the data. The best experts can explain the Danish and TriNetX findings that the defense relies on, and still show why their opinion holds
  • Records discipline. CMO 14 demands precise exposure histories and forbids template reports. Your expert must be willing to work from the actual chart
  • Clean credentials and disclosure. Every prior opinion, publication, and license history will be examined

Key Dates Attorneys Should Know

DateEventWhy it matters
February 5, 2024Pfizer submits supplemental application seeking a meningioma warningBasis of Pfizer’s preemption argument8,9
March 27, 2024French national case-control study published in the BMJPfizer’s proposed limitations trigger4,14
September 5, 2024EMA safety committee recommends meningioma warning and contraindication in the EUForeign regulatory action11
November 1, 2024FDA action letter on Pfizer’s applicationPfizer says FDA declined the warning8,9
February 2025JPML centralizes cases in the Northern District of FloridaMDL No. 3140 created1
August 22, 2025Pfizer moves for summary judgment on preemption (ECF No. 413)Still pending8,24
December 12, 2025FDA approves meningioma warning, Section 5.4Label now advises monitoring and discontinuation9,10
June 15, 2026Settlement announced; Pilot schedule vacated, December 7 trial canceledAbout 80 percent of MDL plaintiffs estimated eligible2
July 21, 2026Master Settlement Agreement signedTerms confidential2
July 29, 2026Order substituting Yeager, Davis, and Ponder as Pilot cases (ECF No. 703)Expedited statute of limitations track4
August 10, 2026CMO 14, ongoing litigation order90-day case-specific expert report requirement3
September 15, 2026CMO 18 creates no-fee administrative docketComplaints due by November 307
September 18, 2026General causation Rule 702 hearing heldOrder to follow; no ruling posted as of this writing5
October 1, 2026JPML statistics report6,412 pending, 6,524 total actions1
November 20, 2026Written status reports dueNo conference in October or November6
November 30, 2026Settlement registration deadlineIneligible claimants identified to the court after this3,7
December 18, 2026Next case management conferenceSubject to change6
First quarter 2027Settlement payments expected to beginPer the parties’ representation to the court2

For any client outside the settlement, the clock starts the day she becomes a Litigating Plaintiff. Ninety days is not long to collect a decade of injection records, rule out alternative causes, and produce a report that survives a Rule 702 challenge. The experts need to be retained before that clock starts, not after.

How Med Legal Pro Helps

Med Legal Pro connects plaintiff and defense attorneys with credentialed experts matched to the exact questions in their case. For Depo-Provera claims, that includes a board-certified obstetrician-gynecologist and reproductive endocrinologist with four decades of clinical practice, former faculty appointments at two major academic medical centers, an MPH with a major in biostatistics, and a law degree (see his profile, expert reference OBGYN-JW). That combination covers prescribing standards, exposure reconstruction, hormone biology, and the epidemiology in a single expert who understands what a court needs from a report. We also work with neurosurgery, neuroradiology, pathology, and life care planning experts for the rest of the CMO 14 report package.

We can review records before you commit to a case, build the exposure and diagnosis timeline, and deliver reports written with our C.L.E.A.R. Method™ for clarity and courtroom durability. Browse our expert witness directory, read our first Depo-Provera post on meningioma and the neurosurgical experts it requires, or contact us at experts@medlegalpro.com or (844) 633-5345.

Are you an OB/GYN, epidemiologist, neuro-oncologist, or neuroradiologist who wants to do expert work in pharmaceutical litigation? We are adding experts in these specialties now. Med Legal Pro: The Expert for Experts.

This article summarizes allegations, court orders, and published research for attorneys. It is not legal advice. All claims against the defendants are allegations, and the defendants deny liability.

Sources

  1. Judicial Panel on Multidistrict Litigation, Pending MDL Dockets by Actions Pending (October 1, 2026), MDL No. 3140. jpml.uscourts.gov
  2. Case Management Order No. 12, MDL No. 3140, ECF No. 701 (N.D. Fla. July 27, 2026). flnd.uscourts.gov
  3. Case Management Order No. 14 (Case Management Order for Ongoing Litigation), MDL No. 3140, ECF No. 738 (N.D. Fla. Aug. 10, 2026). flnd.uscourts.gov
  4. Order Granting Motion to Substitute Pilot Cases and to Address Threshold Statute of Limitations Defenses, MDL No. 3140, ECF No. 703 (N.D. Fla. July 29, 2026). copy of order
  5. Civil Minutes, General Causation/Daubert Hearing, MDL No. 3140, ECF No. 765 (N.D. Fla. Sept. 18, 2026); see also Order, ECF No. 749 (Sept. 6, 2026). copy of minutes
  6. Order canceling October and November 2026 conferences, MDL No. 3140, ECF No. 770 (N.D. Fla. Sept. 24, 2026). copy of order
  7. Case Management Order No. 18 (Establishment of Administrative Docket), MDL No. 3140, ECF No. 761 (N.D. Fla. Sept. 15, 2026). copy of order
  8. Pfizer’s Memorandum in Support of Motion for Summary Judgment Based on Federal Preemption, MDL No. 3140, ECF No. 414 (N.D. Fla. Aug. 22, 2025). courtlistener.com
  9. Pfizer, Depo-Provera CI Prescribing Information, revised 12/2025, Boxed Warning, Section 1 (Limitations of Use), and Section 5.4; FDA supplement approval letter, NDA 020246/S-074. DailyMed
  10. Case Management Order No. 9, MDL No. 3140 (N.D. Fla. Dec. 21, 2025) (noting FDA label approval letter dated December 12, 2025). flnd.uscourts.gov
  11. European Medicines Agency, PRAC recommendations on signals adopted at the 2 to 5 September 2024 meeting, Medroxyprogesterone acetate: meningioma (EPITT No. 20030). ema.europa.eu
  12. Plaintiffs’ Motion to Exclude Defense Expert Dr. Emily B. Levitan, MDL No. 3140, ECF No. 626 (N.D. Fla. Apr. 22, 2026). copy of motion
  13. Joint Report on Rule 702 Evidence Presentations, MDL No. 3140 (N.D. Fla. Sept. 2026). copy of report
  14. Roland N, et al. Use of progestogens and the risk of intracranial meningioma: national case-control study. BMJ. 2024;384:e078078. doi:10.1136/bmj-2023-078078
  15. Xiao T, et al. Depot Medroxyprogesterone Acetate and Risk of Meningioma in the US. JAMA Neurol. 2025;82(11):1094-1102. doi:10.1001/jamaneurol.2025.3011
  16. Tettamanti G, et al. Hormonal contraceptives and the risk of meningioma: A Swedish register-based case-control study. Neuro Oncol. 2026;28(2):552-561. doi:10.1093/neuonc/noaf228
  17. Hasselblad Lundstrøm N, et al. Contraceptive Progestogens and Incident Meningioma. JAMA Netw Open. 2026;9(7):e2622603. doi:10.1001/jamanetworkopen.2026.22603
  18. Reynolds LM, Arend RC, Griffin RL. A Systematic Review and Meta-Analysis of the Association Between Depot Medroxyprogesterone Acetate and Cerebral Meningioma. Cancers. 2026;18(8):1252. doi:10.3390/cancers18081252
  19. Hudelist B, et al. Progestogen use and the risk of intracranial meningioma: a systematic review and meta-analysis. EClinicalMedicine. 2026;92:103791. doi:10.1016/j.eclinm.2026.103791
  20. Griffin R, Arend R. A Matched Case-Control Study Examining the Association Between Exposure to Depot Medroxyprogesterone Acetate and Cerebral Meningioma Using an Active Comparator. Curr Oncol. 2025;32(7):401. doi:10.3390/curroncol32070401
  21. Frey C, et al. Use of medroxyprogesterone acetate and risk of meningiomas: a comparative safety study. Expert Opin Drug Saf. 2025. doi:10.1080/14740338.2025.2526787
  22. Gordillo A, et al. Meningioma regression following discontinuation of depot medroxyprogesterone acetate. Neurosurg Focus. 2026;61(3):E3. doi:10.3171/2026.6.FOCUS26225
  23. De John B, et al. Meningioma regression following depot medroxyprogesterone acetate withdrawal: a case series. BMJ Neurol Open. 2026;8(2):e001676. doi:10.1136/bmjno-2026-001676
  24. Pretrial Order No. 30A, MDL No. 3140, ECF No. 661 (N.D. Fla. June 23, 2026). flnd.uscourts.gov
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About Tracy L. Liberatore Esq, PA-Emeritus

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