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FDA safety reports link Dupixent and CTCL
FDA placed Dupixent on its safety-signal list for cutaneous T-cell lymphoma. Here is what the reports do — and don’t — show.
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The FDA’s adverse event database contained 479,014 reports naming Dupixent or dupilumab as of the openFDA data release dated July 30, 2026 (retrieved August 19, 2026) — 52,833 of them coded serious, 2,193 reporting a death, and 314 carrying the coded reaction term “cutaneous T-cell lymphoma.” Those are counts of reports submitted to the agency. They are not counts of confirmed cases, and they cannot tell you what a drug caused.
FDA adverse event reports reflect what was reported to the agency; they are not verified, and a report is not proof that a drug caused an event.
Lawsuits consolidated in MDL 3180 (D.N.J.) allege that Dupixent (dupilumab) is associated with an increased risk of cutaneous T-cell lymphoma (CTCL) and that the manufacturers failed to warn about it. No court has ruled on these allegations, no settlement exists, and the litigation is in its earliest stages. Published studies report a statistical association — which the study authors themselves note does not establish causation — and the FDA has identified a potential safety signal it is still evaluating; Dupixent’s FDA label does not currently warn about lymphoma. Whether any individual has a claim depends on their medical records and the law of their state.
What is FAERS, and what is it not?
The FDA Adverse Event Reporting System collects reports of problems that occurred after someone took a drug. Manufacturers must forward the reports they receive; clinicians and patients may submit voluntarily. The agency uses it to spot patterns worth studying.
What it cannot do is measure risk. There is no denominator: FAERS does not know how many people took the drug without incident. Nobody investigates a report before it is entered, duplicates exist, and news coverage and litigation both stimulate reporting. A report says only that an event happened after exposure, not because of it. openFDA itself warns that the data are unvalidated and cannot establish causality.
How many Dupixent adverse event reports exist?
Retrieved August 19, 2026 from the openFDA drug/event endpoint (data last updated July 30, 2026):
- 479,014 total reports naming Dupixent or dupilumab
- 52,833 coded serious; 426,149 coded non-serious
- 2,193 reports in which a death was recorded, from any cause
FDA adverse event reports reflect what was reported to the agency; they are not verified, and a report is not proof that a drug caused an event.
Are Dupixent reports increasing over time?
Yes. Reports by year of receipt, retrieved August 19, 2026:
| Year received | Reports |
|---|---|
| 2017 | 843 |
| 2018 | 5,932 |
| 2019 | 12,725 |
| 2020 | 20,184 |
| 2021 | 38,176 |
| 2022 | 55,389 |
| 2023 | 61,521 |
| 2024 | 86,343 |
| 2025 | 119,947 |
| 2026 (partial year) | 77,912 |
The 2026 figure is a partial year. The trajectory is real but not a risk curve: Dupixent went from one approved use in 2017 to nine, and the treated population grew with it.
FDA adverse event reports reflect what was reported to the agency; they are not verified, and a report is not proof that a drug caused an event.
How many reports mention lymphoma?
Lymphoma-family coded reaction terms, retrieved August 19, 2026:
| Coded reaction term | Reports |
|---|---|
| Cutaneous T-cell lymphoma | 314 |
| Lymphoma | 157 |
| T-cell lymphoma | 68 |
| Cutaneous T-cell lymphoma stage IV | 23 |
| Cutaneous lymphoma | 22 |
| Non-Hodgkin’s lymphoma | 18 |
Two readings matter. A single report can carry several reaction terms, so these rows overlap and cannot be added. And the rarity of “mycosis fungoides” as a coded term does not mean that diagnosis is absent — cutaneous lymphoma reports are commonly coded under the broader CTCL term rather than under a subtype term. Context that cuts the other way: no lymphoma or cancer term appears in the twenty-five most-reported reactions for Dupixent, a list dominated by itching, atopic dermatitis, and rash.
FDA adverse event reports reflect what was reported to the agency; they are not verified, and a report is not proof that a drug caused an event.
What has the FDA said about these reports?
In its quarterly table of potential signals of serious risks identified from FAERS for the October–December 2024 quarter, the FDA listed the product “Dupixent (dupilumab) injection” with the potential signal “Cutaneous T-cell lymphoma” and this stated action: “FDA is evaluating the need for regulatory action.”
A potential-signal listing means the agency saw something worth evaluating — not that the drug causes the condition. Dupixent does not appear in the January–March 2025 table because those tables list newly identified signals per quarter. As of August 19, 2026 no safety communication has issued and the Dupixent label carries no malignancy warning.
Why can these numbers never be turned into a risk figure?
Because the arithmetic does not exist. Dividing 314 by 479,014 would produce a meaningless number: the denominator is reports, not patients, and the diagnoses are not confirmed against pathology. Any site converting these counts into a percentage risk is inventing a statistic. The published studies that examine risk directly are better-suited evidence.
FDA adverse event reports reflect what was reported to the agency; they are not verified, and a report is not proof that a drug caused an event.
How does adverse event data fit into MDL 3180?
Plaintiffs in the MDL 3180 proceeding allege that the accumulating reports, alongside the published literature, put the manufacturers on notice of a lymphoma question the label never addressed. The Panel framed the shared issues the same way: whether the science shows a causal link, when the defendants should have learned of it, and whether the warnings were adequate. No court has ruled on any of it.
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Call (888) 348-2735 or use the form on this page. Marin & Murphy Law Firm is currently accepting Dupixent CTCL cases.
Court costs and litigation expenses are advanced by counsel and repaid from the recovery. You are not responsible for court costs or litigation expenses if there is no recovery, unless a court directs otherwise. The attorney’s fee is a percentage of the gross recovery, calculated before expenses are deducted.
What should you do with this data if you took Dupixent?
Not much on its own — which is the point of publishing it plainly. A claim is evaluated on your records, not national counts: proof of Dupixent use, a pathology report establishing the diagnosis, and the timeline between them.
This page is about a lawsuit — it is not medical advice, and filing a claim does not require you to stop taking Dupixent. Decisions about your medication belong with you and your doctor.
Free Confidential Evaluation — No Fee Unless There Is a Recovery
Call (888) 348-2735 or use the form on this page.
Court costs and litigation expenses are advanced by counsel and repaid from the recovery. You are not responsible for court costs or litigation expenses if there is no recovery, unless a court directs otherwise. The attorney’s fee is a percentage of the gross recovery, calculated before expenses are deducted.
What else do people ask about Dupixent adverse event reports?
How many Dupixent adverse event reports are in the FDA’s database?
479,014, on the openFDA data release dated July 30, 2026, retrieved August 19, 2026 — 52,833 coded serious and 2,193 reporting a death. FDA adverse event reports reflect what was reported to the agency; they are not verified, and a report is not proof that a drug caused an event.
How many of those reports involve cutaneous T-cell lymphoma?
314 carry the coded term “cutaneous T-cell lymphoma,” with 157 more coded “lymphoma” and 68 “T-cell lymphoma.” FDA adverse event reports reflect what was reported to the agency; they are not verified, and a report is not proof that a drug caused an event.
Does 314 reports mean 314 people got CTCL from Dupixent?
No. A report is a submission, not a confirmed case: reports can be duplicated and one report may carry several reaction terms. FDA adverse event reports reflect what was reported to the agency; they are not verified, and a report is not proof that a drug caused an event.
What is FAERS?
The FDA Adverse Event Reporting System: the agency’s database of reports of problems experienced after taking a drug. The FDA uses it to find patterns worth investigating, not to determine what caused any individual event.
Why are Dupixent reports rising every year?
Reporting volume tracks how many people take a drug and how much attention it receives; rising counts are not evidence of rising risk. FDA adverse event reports reflect what was reported to the agency; they are not verified, and a report is not proof that a drug caused an event.
Has the FDA acted on the lymphoma reports?
It listed Dupixent in its October–December 2024 quarterly table of potential signals, with the signal “Cutaneous T-cell lymphoma” and the action “FDA is evaluating the need for regulatory action.” No label change has followed.
Can I look these numbers up myself?
Yes. Every figure comes from the public openFDA drug/event endpoint, and the query URLs are listed in Sources below.
How do these reports fit into the lawsuits?
Plaintiffs allege that these reports, with the published studies, put the manufacturers on notice of a lymphoma question the label never addressed. That data is one input to the argument, not proof of it.
Sources
- openFDA drug/event endpoint, all figures retrieved August 19, 2026 (data last updated July 30, 2026): combined brand-or-generic total — total query; seriousness breakdown — count=serious; death-coded reports — seriousnessdeath query; yearly series — receiptdate template (year substituted per row); top 25 reactions — reaction count query.
- Lymphoma-family and neoplasm reaction term counts, retrieved August 19, 2026 — lymphoma query and neoplasm query.
- FDA, Potential Signals of Serious Risks Identified from FAERS, October–December 2024 — fda.gov; January–March 2025 table (Dupixent not listed) — fda.gov
- Current Dupixent label (no lymphoma or malignancy warning; label data last updated August 14, 2026) — api.fda.gov
Matthew T. Marin — RI, CT, MA, SC, U.S.D.C. D.R.I. · Stefanie A. Murphy — RI, CT, MA, U.S.D.C. D.R.I./D.Conn./D.Mass.
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Attorney Advertising. This page is for general information and is not legal advice; reading it does not create an attorney-client relationship, and no attorney-client relationship is formed until a written engagement agreement is signed. Marin & Murphy Law Firm attorneys are licensed in Rhode Island, Connecticut, Massachusetts, and South Carolina; the firm’s mass-tort practice is directed from its Charleston, South Carolina office. Responsible attorney: Matthew T. Marin, 997 Morrison Drive, Suite 200, Charleston, SC 29403. Cases may be handled together with co-counsel; whether a claim is accepted is determined after review. No representation is made that the quality of legal services is greater than that of other lawyers. Prior results do not guarantee a similar outcome; every case depends on its own facts.