MDL Track
MDL 3180
Dupixent (dupilumab) cutaneous T-cell lymphoma
Pharmaceutical · claims alleging dupilumab (Dupixent) causes or accelerates cutaneous T-cell lymphoma (CTCL) and other lymphoproliferative disorders, centralized in MDL 3180
Defendant
Sanofi-Aventis U.S. LLC
MDL / Track
MDL 3180
D.N.J.
Judge
Judge Zahid N. Quraishi
Plaintiffs
35 pending
Bellwether / Trial
No verdicts yet
Settlement Status
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Case overview
Federal Dupixent lymphoma lawsuits are consolidated in MDL No. 3180 before Judge Zahid N. Quraishi in the District of New Jersey, centralized June 4, 2026. Plaintiffs allege Sanofi and Regeneron failed to warn that cutaneous T-cell lymphoma (CTCL) can mimic eczema and that Dupixent may mask cancer symptoms, delaying diagnosis. Twenty-six cases were pending as of July 1, 2026; no court has ruled on the merits and no settlement exists.
Causation Theory
Plaintiffs' causation theory centers on two mechanisms: CTCL's early presentation mimics atopic dermatitis, leading to misdiagnosis and inappropriate Dupixent treatment; and dupilumab may temporarily improve visible skin symptoms of undiagnosed CTCL, masking disease progression. Published case series describe initial improvement followed by lymphoma progression. The FDA identified CTCL as a potential safety signal in its October–December 2024 quarterly review and stated it is evaluating the need for regulatory action. However, a January 2026 large-scale retrospective cohort study in Frontiers in Medicine found no increased lymphoma risk with dupilumab and observed significantly reduced risk of non-Hodgkin lymphoma and Sézary disease compared to other systemic treatments.
Case Management Orders
Litigation status
MDL No. 3180 centralized June 4, 2026 in D.N.J. before Judge Zahid N. Quraishi. The litigation remains in early pretrial posture with coordinated discovery and leadership appointments pending; no bellwether schedule has been set.
MDL Track
MDL 3180
Dupixent (dupilumab) cutaneous T-cell lymphoma
State Court Activity
No significant state court activity reported
Geographic exposure
Dupixent approved March 2017 with nine indications. No lymphoma or malignancy warning on FDA label as of August 2026. FDA evaluating potential safety events for CTCL; published studies report statistical association but authors note causation unestablished. Comprehensive review identified 124 patients with lymphoproliferative disorders post-dupilumab, median 5 months to biopsy, 39.05% advanced stage. No national prescription volume or total exposed population data available in sources.
MDL 3180 centralized federal Dupixent CTCL cases before Judge Zahid N. Quraishi on June 4, 2026. JPML transferred 15 cases from 12 federal districts at formation. Approximately 28 cases on file as of mid-August 2026. No merits rulings, no settlement.
Case filings heavily concentrated here, per source describing 'heavily concentrated in Georgia' as driver for MDL consolidation. One of originating jurisdictions among 12 federal districts at MDL 3180 formation.
First Dupixent wrongful death lawsuit filed in Middle District of Tennessee (Oct. 2025), predating MDL formation. One-year statute of limitations: Tenn. Code Ann. § 28-3-104. Early litigation incubator for CTCL/PTCL claims.
Originating jurisdiction among cases JPML transferred into MDL 3180 at formation. Per source, Alabama filings included in initial 15-case transfer.
Regeneron Pharmaceuticals facility in Rensselaer, NY — active FDA inspection history with documented issues (last FDA action March 22, 2024). U.S. ingredient manufacturing site for dupilumab.
Two facilities with Dupixent supply chain: Genzyme Ireland Limited (Waterford, last FDA action Jan. 17, 2025) and Regeneron Ireland DAC (Limerick, last FDA action March 14, 2023). Both have documented FDA inspection issues.
Sanofi-aventis Deutschland GmbH (Frankfurt am Main) — Dupixent manufacturing facility with documented FDA inspection issues (last action Jan. 16, 2025).
Sanofi Winthrop Industrie (Le Trait) — Dupixent manufacturing facility with documented FDA inspection issues (last action April 25, 2023).
Key defendants
Sanofi-Aventis U.S. LLC
Role: Manufacturer
Named in all filed complaints; MDL motion filed Feb. 13, 2026 seeks consolidation of at least 15 federal cases. No answer or dismissal motion yet noted.
Regeneron Pharmaceuticals Inc.
Role: Manufacturer
Co-defendant with Sanofi; joint development and marketing of Dupixent. No separate defense posture reported; both defendants aligned in early litigation stage.
| Defendant | Role | Intelligence Note |
|---|---|---|
| Sanofi-Aventis U.S. LLC | Manufacturer | Named in all filed complaints; MDL motion filed Feb. 13, 2026 seeks consolidation of at least 15 federal cases. No answer or dismissal motion yet noted. |
| Regeneron Pharmaceuticals Inc. | Manufacturer | Co-defendant with Sanofi; joint development and marketing of Dupixent. No separate defense posture reported; both defendants aligned in early litigation stage. |
Timeline
FDA Identifies CTCL Safety Signal
FDA quarterly FAERS review identifies cutaneous T-cell lymphoma as potential safety signal for Dupixent, states agency is evaluating need for regulatory action. Signal remains under review with no mandated label change to date.
First Federal Complaint Filed
Richardson v. Regeneron Pharmaceuticals, Inc., et al., No. 3:25-cv-01125, filed in M.D. Tenn., first wrongful death action alleging Dupixent caused fatal T-cell lymphoma.
MDL Centralization Motion Filed
Plaintiffs file motion before Judicial Panel on Multidistrict Litigation to consolidate federal Dupixent CTCL cases, proposing N.D. Georgia venue; defendants support consolidation but seek S.D.N.Y.
JPML Hears Oral Argument on Venue
Judicial Panel on Multidistrict Litigation hears oral arguments in Milwaukee on MDL formation; parties dispute venue with plaintiffs favoring Georgia and defendants seeking New York.
MDL No. 3180 Created in D.N.J.
JPML issues transfer order centralizing federal Dupixent cases as In re: Dupixent (Dupilumab) Products Liability Litigation, MDL No. 3180, in U.S. District Court for the District of New Jersey, rejecting both parties' venue preferences. Order transfers 15 pending actions with 7 potential tag-alongs identified.
Judge Quraishi Assigned to MDL
Judge Zahid N. Quraishi (D.N.J.) appointed presiding judge over MDL-3180. Docket No. 3:26-md-03180.
MDL Grows to 28 Pending Cases
JPML pending-docket report shows MDL No. 3180 has expanded to 28 actions, nearly doubling from original 15 transferred cases. Litigation remains in early pretrial and coordinated discovery stage; no bellwether trials scheduled.
Statute of limitations
No MDL established as of March 2026. Individual cases filed in federal courts including M.D. Tenn. (Richardson, response deadline Jan. 7, 2026 per Magistrate Judge Alistair Newbern). Primary accrual theories: (1) date of CTCL diagnosis; (2) date of discovery of Dupixent-CTCL link. FDA placed Dupixent on potential serious risks list March 2025; label still lacks CTCL warning per November 2025 reports. Discovery rule critical in most jurisdictions given latency period (August 2024 JAAD study showed 4.1x increased risk, median diagnosis >1 year post-initiation). Federal preemption defenses likely; no federal recall. Screen for: minimum 1 month Dupixent use; CTCL, mycosis fungoides, or Sézary syndrome diagnosis; no prior lymphoma/leukemia.
Delaware
2 years from date of injury or diagnosis
Rule: Product liability and personal injury claims must be filed within two years of the date of injury or diagnosis per Morris James LLP guidance
Discovery: Accrual may begin when symptoms first appeared, when diagnosis was made, or when connection to Dupixent was discovered
Exceptions may apply; early consultation advised given multiple potential accrual triggers
Tennessee
1 year from accrual (typical wrongful death)
Rule: Wrongful death claim filed October 2025 in M.D. Tenn. (Richardson v. Regeneron/Sanofi) with response deadline January 7, 2026 per Magistrate Judge Alistair Newbern order
Discovery: Accrual tied to death date or discovery of causation; case management conference held December 8, 2025
Federal court handling early bellwether; no MDL yet established
Illinois
2 years from accrual (typical personal injury)
Rule: Cancer lawsuit filed December 2025 per Sokolove Law update; standard Illinois product liability SOL applies
Discovery: Discovery rule likely available given CTCL latency period (studies show median diagnosis >1 year post-initiation)
Filed as individual action; no consolidation yet
California
2 years from discovery of injury
Rule: Discovery rule standard; accrual when plaintiff knew or should have known of injury and its cause
Discovery: Critical given August 2024 JAAD study publication and March 2025 FDA serious risks list placement as potential notice triggers
No state revival statute applicable; federal preemption defenses expected
New York
3 years from accrual
Rule: CPLR 214(2) product liability; 3 years from date of injury or discovery
Discovery: Discovery rule applies; continuous treatment doctrine may toll if misdiagnosis ongoing
Large plaintiff pool expected given Dupixent prescribing volume; screen for eczema patients with delayed CTCL diagnosis
Texas
2 years from accrual
Rule: Tex. Civ. Prac. & Rem. Code § 16.003; product liability claims subject to 2-year SOL
Discovery: Discovery rule applies; fraudulent concealment possible given lack of CTCL warning on label
No pending revival legislation; federal court filings likely given manufacturer diversity
Florida
4 years from accrual (2 years wrongful death)
Rule: Fla. Stat. § 95.11(3)(a) product liability; 4 years for personal injury, 2 years for wrongful death
Discovery: Discovery rule applies; statute begins when injury discovered or should have been discovered with due diligence
Longer SOL window but early filing strategic given potential MDL formation
| State | SOL | Rule | Discovery Rule | Notes |
|---|---|---|---|---|
| Delaware | 2 years from date of injury or diagnosis | Product liability and personal injury claims must be filed within two years of the date of injury or diagnosis per Morris James LLP guidance | Accrual may begin when symptoms first appeared, when diagnosis was made, or when connection to Dupixent was discovered | Exceptions may apply; early consultation advised given multiple potential accrual triggers |
| Tennessee | 1 year from accrual (typical wrongful death) | Wrongful death claim filed October 2025 in M.D. Tenn. (Richardson v. Regeneron/Sanofi) with response deadline January 7, 2026 per Magistrate Judge Alistair Newbern order | Accrual tied to death date or discovery of causation; case management conference held December 8, 2025 | Federal court handling early bellwether; no MDL yet established |
| Illinois | 2 years from accrual (typical personal injury) | Cancer lawsuit filed December 2025 per Sokolove Law update; standard Illinois product liability SOL applies | Discovery rule likely available given CTCL latency period (studies show median diagnosis >1 year post-initiation) | Filed as individual action; no consolidation yet |
| California | 2 years from discovery of injury | Discovery rule standard; accrual when plaintiff knew or should have known of injury and its cause | Critical given August 2024 JAAD study publication and March 2025 FDA serious risks list placement as potential notice triggers | No state revival statute applicable; federal preemption defenses expected |
| New York | 3 years from accrual | CPLR 214(2) product liability; 3 years from date of injury or discovery | Discovery rule applies; continuous treatment doctrine may toll if misdiagnosis ongoing | Large plaintiff pool expected given Dupixent prescribing volume; screen for eczema patients with delayed CTCL diagnosis |
| Texas | 2 years from accrual | Tex. Civ. Prac. & Rem. Code § 16.003; product liability claims subject to 2-year SOL | Discovery rule applies; fraudulent concealment possible given lack of CTCL warning on label | No pending revival legislation; federal court filings likely given manufacturer diversity |
| Florida | 4 years from accrual (2 years wrongful death) | Fla. Stat. § 95.11(3)(a) product liability; 4 years for personal injury, 2 years for wrongful death | Discovery rule applies; statute begins when injury discovered or should have been discovered with due diligence | Longer SOL window but early filing strategic given potential MDL formation |
Live intelligence
AI litigation brief
Dupixent CTCL remains emerging with 45 current signals in the accepted feed.
Overview
MDL No. 3180 centralized June 4, 2026 in D.N.J. before Judge Zahid N. Quraishi. The litigation remains in early pretrial posture with coordinated discovery and leadership appointments pending; no bellwether schedule has been set.
Key developments
Trajectory
Press and regulatory signals are moving in tandem for Dupixent CTCL. The next escalation check is whether these agency actions prompt new PACER filings or MDL scheduling orders.
Editorial intelligence
MDL 3180 should stay on the lead docket watch because it is the primary consolidation vehicle for Dupixent CTCL.
Generated Sep 30, 2026, 10:00 AM UTC
45 events detected
Google News (10)
NJ MDL: Eczema Drug Users Claim Manufacturers Knew of Cancer Risk, Failed to Update Warning - Law.com
Cutaneous T-cell lymphoma in adult atopic dermatitis patients treated with dupilumab or tralokinumab - Springer Nature Link
Dupixent and Cutaneous T-Cell Lymphoma: What Patients Should Know About the Growing Litigation - JD Supra
Sanofi tests Dupixent SC with Alteogen tech, expands beyond oncology - CHOSUNBIZ - Chosunbiz
Manufacturers of Dupixent Facing Lawsuits Over Drug Outcomes - GLK Law
Sanofi Eczema Drug Suits Consolidated, Sent To NJ Fed Court - Law360
Regeneron Opens Lower After Cancer Trial Setback - TechStock²
Regeneron Pharmaceuticals stock (US75811P1003): Biotech leader in eye and oncology treatments - ad-hoc-news.de
Regeneron Pharmaceuticals stock (US75811P1003): Biotech leader in eye and oncology treatments - AD HOC NEWS
Regeneron beats quarterly estimates on strong Dupixent demand - ETPharma.com
BMJ case reports • Crane J • PMID 42805618 • Journal Article.
Clinical and experimental dermatology • Pujol RM • PMID 41972340 • Journal Article.
The American Journal of dermatopathology • Pradhan D • PMID 42685682 • Journal Article.
Intractable & rare diseases research • Ishii T • PMID 42643725 • Journal Article.
Journal of the European Academy of Dermatology and Venereology : JEADV • Weatherhead SC • PMID 42639955 • Letter.
No recent court filing signals. Monitoring is active — this section updates automatically.
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LexGenius Ranking
90Score
Court, news, and regulatory activity are elevated
Monitoring
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Last: Sep 30, 2026, 10:00 AM UTC
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Source Monitoring
PACER
PACER
Google News
FAERS
PubMed
Event feed
45
events detected
AI Brief
Dupixent CTCL remains emerging with 45 current signals in the accepted feed.
Overview
MDL No. 3180 centralized June 4, 2026 in D.N.J. before Judge Zahid N. Quraishi. The litigation remains in early pretrial posture with coordinated discovery and leadership appointments pending; no bellwether schedule has been set.
Key developments
Law.com news on Aug 14: NJ MDL: Eczema Drug Users Claim Manufacturers Knew of Cancer Risk, Failed to Update Warning - Law.com. ‖ FAERS FDA alert on Jun 29: FAERS Filing 26936320: Lymphoma. ‖ PubMed research on Sep 28: Cutaneous T-cell lymphoma emerging during long-term dupilumab therapy in a patient with longstanding atopic diathesis: diagnostic challenges and mechanistic considerations..
Generated Sep 30, 2026, 10:00 AM UTC
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