Pharmaceutical Lawsuits
Dupixent and CTCL Lawsuits: What MDL 3180 Shows
A factual review of the Dupixent CTCL litigation: the June 2026 order creating MDL 3180, the pending count, and what the FDA label does and does not say.
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Dupixent is the brand name of dupilumab, a prescription biologic that the FDA first approved in 2017. The federal lawsuits collected as MDL No. 3180, In re: Dupixent (Dupilumab) Products Liability Litigation, allege that the drug caused users to develop cutaneous T-cell lymphoma (CTCL), or accelerated a CTCL that was already present. The Judicial Panel on Multidistrict Litigation created the proceeding by a transfer order filed June 4, 2026, and assigned it to Judge Zahid N. Quraishi in the District of New Jersey. The Panel’s statistics report dated October 1, 2026 lists 38 actions pending, against 39 total actions reported. The current FDA prescribing information does not list CTCL or lymphoma among its warnings, and no court has issued a causation finding in the documents reviewed for this article.
What is established versus what is alleged
Established by the documents reviewed for this article: the identity of MDL No. 3180, its transferee district and judge; the transfer order of June 4, 2026 and the Panel’s account of the claims before it; the three corporate defendants; the pending count of October 1, 2026; and the contents of the FDA-approved prescribing information described below.
Alleged, and not decided: that Dupixent causes CTCL or accelerates an existing CTCL; that the defendants knew or should have known of a link between the drug and the condition; and that the warnings supplied with the drug were inadequate. The Panel recorded those matters as the plaintiffs’ allegations.
The order describes the plaintiffs this way: “Most plaintiffs used the prescription biologic medication Dupixent, which is commonly prescribed to treat atopic dermatitis, and were later diagnosed with Cutaneous T-Cell Lymphoma (CTCL).” It adds that other plaintiffs are the spouses or survivors of Dupixent users who were diagnosed with CTCL, and that each plaintiff alleges that Dupixent “caused them, their spouse, or the decedent to develop CTCL (or that Dupixent accelerated a preexisting CTCL).”
The Panel framed the common questions of fact as whether “the scientific literature shows a causal link between Dupixent use and CTCL development,” when the defendants should have learned of such a link, and whether they gave adequate warnings about the drug’s risks. Those are the questions the Panel expects the litigation to address. It did not answer them.
What the FDA label says
The prescribing information reviewed for this article is the version effective April 22, 2026, as published by the National Library of Medicine’s DailyMed service. It records the product’s initial U.S. approval as 2017. Its indications include atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic obstructive pulmonary disease, chronic spontaneous urticaria, bullous pemphigoid and allergic fungal rhinosinusitis.
The label carries no boxed warning. Its warnings and precautions section runs from 5.1 to 5.10 and covers hypersensitivity; conjunctivitis, keratitis and blepharitis; eosinophilic conditions; acute symptoms of asthma or chronic obstructive pulmonary disease and acute deteriorating disease; risk associated with abrupt reduction of corticosteroid dosage; patients with comorbid asthma; psoriasis; arthralgia and psoriatic arthritis; parasitic (helminth) infections; and vaccinations. CTCL, lymphoma and malignancy do not appear in that section, and a full-text search of the label finds no occurrence of “lymphoma,” “malignancy,” “cancer” or “tumor.”
The nonclinical toxicology section states: “Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of dupilumab.” The postmarketing experience section lists angioedema, psoriatic arthritis, facial skin reactions, new-onset psoriasis, vasculitis and several ocular disorders, among other reactions. It does not list lymphoma or CTCL.
A label is a regulatory document. What it requires a manufacturer to tell prescribers and patients is not a finding that the drug does or does not cause a particular condition. The absence of a CTCL warning means the approved labeling does not warn about CTCL. It is not a judicial or scientific determination one way or the other, and this article draws none.
Where the claims stand procedurally
The transfer order was signed by Judge Matthew F. Kennelly, Acting Chair of the Panel, on June 4, 2026. It transferred the actions listed on Schedule A to the District of New Jersey for coordinated or consolidated pretrial proceedings under 28 U.S.C. § 1407. That procedure centralizes discovery and pretrial motions. It does not merge the individual claims into one lawsuit, and it does not decide whether any claim has merit.
The Panel’s Schedule A lists 14 actions from 12 districts. In its discussion the Panel wrote that “fifteen actions and seven potential tag-along actions” were pending across those districts at the time of the decision. The order names Regeneron Pharmaceuticals, Inc., Sanofi-Aventis U.S. LLC and Genzyme Corporation as the defendants.
The Panel chose the District of New Jersey because Sanofi’s principal place of business is there and Regeneron, which is headquartered in Tarrytown, New York, has corporate offices in the district. It also addressed the scope of the proceeding. The defendants asked the Panel to limit the MDL to cases alleging CTCL, while the plaintiffs who moved for centralization argued that the scientific literature also links Dupixent to other T-cell lymphomas. The Panel said it need not rule on that question at that stage, because none of the plaintiffs then before it alleged a T-cell lymphoma other than CTCL or one of its subtypes. It said future expansion could be handled through the conditional transfer process.
The Panel’s statistics report for October 1, 2026, the most recent posted at the time of this article, lists 38 actions pending in MDL No. 3180, against 39 total actions reported. That is a count of open dockets, not a measure of the strength of any claim.
The RECAP docket page for the proceeding records June 4, 2026 as the date of the last known filing, and the page itself was last updated July 4, 2026. The documents reviewed for this article contain no case management order, no trial date, no verdict, no class certification and no announced or approved settlement. A docket can change after a page is captured, so the court record is the authority on current status.
Key dates
- 2017: the FDA grants initial U.S. approval for Dupixent (dupilumab), according to the prescribing information.
- February 13, 2026: plaintiffs file the motion to transfer that begins the MDL proceeding, listing 15 actions from 12 districts (JPML docket, Document 1).
- February 17, 2026: the Panel assigns MDL No. 3180 and accepts the motion for filing (JPML docket, Document 2).
- April 22, 2026: the effective date of the prescribing information reviewed for this article (DailyMed).
- May 28, 2026: the Panel holds a hearing session in Milwaukee, Wisconsin, at which the matter is designated for oral argument (JPML docket, Document 40).
- June 4, 2026: the Panel files the transfer order creating MDL No. 3180 before Judge Zahid N. Quraishi in the District of New Jersey (Document 47).
- October 1, 2026: the Panel’s statistics report lists 38 actions pending, against 39 total actions reported, in MDL No. 3180.
What this does not establish
Nothing in the documents reviewed for this article shows a court finding that Dupixent caused or accelerated any person’s CTCL, that the defendants knew of such a risk before it was alleged, or that the label warnings were legally inadequate. Those remain allegations. The transfer order decides where the cases will be heard together; it does not decide the merits.
The absence of a CTCL warning in the label is not a finding that the drug is safe, and the plaintiffs’ allegations are not a finding that it is dangerous. The record reviewed here contains no verdict, no settlement, no admission of liability and no determination of what any individual claim may be worth. For the FDA-approved information about the drug’s risks, this article relies on the labeling described above.
Frequently asked questions
Is there a Dupixent settlement?
No settlement appears in the documents reviewed for this article. MDL No. 3180 was created on June 4, 2026, the Panel’s October 1, 2026 report still lists 38 actions pending, and the docket reviewed here records no trial date or fairness hearing.
Does the Dupixent label warn about CTCL?
No. The prescribing information effective April 22, 2026 does not list CTCL, lymphoma or malignancy in its warnings and precautions, and it states that animal studies were not conducted to evaluate the drug’s carcinogenic potential. The label is a regulatory document, not a finding on causation.
Is MDL 3180 a class action?
No. MDL No. 3180 is a consolidation of individual federal actions for coordinated or consolidated pretrial proceedings under 28 U.S.C. § 1407. The difference is explained in MDLs compared with class actions.
Who are the defendants in the Dupixent litigation?
The transfer order names Regeneron Pharmaceuticals, Inc., Sanofi-Aventis U.S. LLC and Genzyme Corporation.
How many cases are in MDL 3180?
The Panel’s statistics report dated October 1, 2026 lists 38 actions pending, against 39 total actions reported. The transfer order’s Schedule A lists 14 actions.
Background on how these proceedings work appears in the pharmaceutical lawsuits hub and in how mass tort litigation works, alongside the GLP-1 litigation, the Tepezza hearing loss litigation and the Depo-Provera meningioma litigation.
Sources
- U.S. Judicial Panel on Multidistrict Litigation: “In re: Dupixent (Dupilumab) Products Liability Litigation, MDL No. 3180, Transfer Order (June 4, 2026)” (link, accessed 2026-10-19)
- U.S. Judicial Panel on Multidistrict Litigation: “MDL Statistics Report: Distribution of Pending MDL Dockets by Actions Pending, Report Date 10/1/2026” (link, accessed 2026-10-19)
- National Library of Medicine, DailyMed: “DUPIXENT (dupilumab) injection, solution, prescribing information (label effective April 22, 2026)” (link, accessed 2026-10-19)
- Free Law Project, RECAP archive: “In re: Dupixent (Dupilumab) Products Liability Litigation, MDL No. 3180, docket entries via the RECAP archive” (link, accessed 2026-10-19)
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