Dupixent Lawsuit | 2025 Latest Updates

Critical Safety Alert

Dupixent users with eczema face a 4.59× higher risk of developing cutaneous T-cell lymphoma (CTCL) compared to non-users, according to a 2024 study published in Dermatologic Therapy. This significantly elevated cancer risk has prompted FDA safety reviews and a surge in product liability lawsuits against manufacturers Sanofi and Regeneron, who allegedly failed to warn patients and doctors about this serious danger.

What’s the Problem?

This litigation focuses on claims that users of Dupixent (dupilumab) – a medication developed by Sanofi and Regeneron for treating eczema, asthma, nasal polyps, and other inflammatory conditions – developed cutaneous T-cell lymphoma (CTCL), a rare and aggressive skin-based cancer.

Multiple studies have documented significantly increased CTCL risk, with adjusted odds ratios ranging from 3 to over 4.5, and in some cohorts over 14 times higher for combined mature T-cell and NK-cell lymphomas. This increased risk has been observed not only in atopic dermatitis patients but also in asthma patients treated with Dupixent, highlighting the broader implications for those using the drug.

Plaintiffs allege that manufacturers failed to warn patients and healthcare providers of this serious risk, which has led to delayed cancer diagnosis and worsened outcomes. As of October 2025, litigation is rapidly escalating with individual lawsuits being filed nationwide, and legal experts predict potential consolidation into multidistrict litigation (MDL) within the next 12 months.

Latest Dupixent Updates

• October 1, 2025 – The daughter of a Tennessee woman has filed a wrongful death lawsuit after her mother died from T-cell lymphoma allegedly caused by Dupixent (dupilumab). Chandra Richardson filed the lawsuit in the U.S. District Court for the Middle District of Tennessee on behalf of herself and her deceased mother, Cynthia Marie Hyde, against defendants Regeneron Pharmaceuticals Inc. and Sanofi-Aventis U.S. LLC, alleging that Hyde died from T-cell lymphoma complications on October 28, 2024 – less than five months after receiving her first Dupixent injections in June 2024.
• September 2025 – Law firms announce investigations and begin accepting potential CTCL claimants nationwide [1].
• August 2025 – Medical experts indicate Dupixent users are nearly nine times more likely to report CTCL to the FDA than users of other eczema treatments, intensifying scrutiny of safety labeling [2].
• March 2025 – FDA’s FAERS internal review reportedly identified strong safety signals linking Dupixent with CTCL, prompting increased regulatory and legal interest [3].

“Defendants failed to warn, instruct, advise, educate, or otherwise inform Dupixent users and prescribers, including Decedent and Decedent’s treating physicians, about the risk of development and/or exacerbation of CTCL and PTCL. The U.S. label for Dupixent makes no mention of these risks.”
— From Richardson v. Regeneron court filing

Dupixent Statistics

Reported Risk Levels:

• 3- to 4.5-fold increased CTCL risk in standard analyses [4].
• Over 14-fold risk for certain lymphoma subtypes with sustained exposure (16+ weeks).
• 4.59× higher relative risk specifically for eczema patients (Dermatologic Therapy, 2024).
• 30× higher reporting rate to FDA compared to all other medications.

Lawsuit Growth:

• First wrongful death lawsuit filed October 1, 2025.
• Multiple law firms nationwide actively accepting cases as of September-October 2025.
• While precise lawsuit counts remain unpublished, attorneys report significant surge in claim inquiries and formal early-stage filings throughout Q3-Q4 2025.
• Legal experts predict potential MDL consolidation by late 2026.

Market Exposure:

• Over 1 million patients globally currently being treated with Dupixent.
• FDA-approved indications continue expanding (most recently bullous pemphigoid in June 2025).
• Original approval for atopic dermatitis in 2017, with subsequent approvals for asthma, eosinophilic disorders, chronic obstructive pulmonary disease (COPD), and other conditions.

FDA Reports and Statistics

Analysis of FAERS data spanning Q2 2016–Q4 2023 identified over 5,300 suspected adverse event reports linked to dupilumab, including new signals such as dry eye, blurred vision, and rebound eczema [5].

This raises concerns beyond the relatively mild side effects seen in clinical trials. No formal FDA warning specific to lymphoma has been issued to date, but internal safety alerts and growing case reports suggest regulatory interest is escalating.

Current FDA Regulatory Status

March 2025: FDA placed Dupixent on its quarterly FAERS “Potential Signals of Serious Risks/New Safety Information” list, specifically identifying cutaneous T-cell lymphoma as a concern.

September 15, 2025: FDA confirmed it is “evaluating the need for regulatory action” regarding the Dupixent-CTCL link, including potential warning label updates.

Current Status: As of October 2025, no formal FDA warning specific to lymphoma has been issued, and CTCL remains absent from Dupixent’s official warning label. However, internal safety alerts and growing case reports suggest regulatory interest is escalating, with potential label changes anticipated.

Dupixent Injuries & Side Effects

The range of reported Dupixent side effects includes both common outcomes from trials and emerging serious concerns related to lymphoma.

• Common adverse effects – Injection site reactions, conjunctivitis, nasopharyngitis, and dry skin were frequently observed in trials.
• Lymphoma risks (CTCL and other T-cell cancers) – Multiple studies show significantly elevated lymphoma risk in Dupixent users versus controls.
• Ocular and dermatologic issues – FAERS surveillance data points to dry eye, blurred vision, and rebound dermatitis as additional areas of concern.

Do You Qualify for a Dupixent Lawsuit?

You may be eligible to file a Dupixent lawsuit if:

• You received Dupixent (dupilumab) between 2017 and 2025.
• You were later diagnosed with CTCL or another T-cell lymphoma.
• Your lymphoma symptoms were not present before starting Dupixent, or they worsened during treatment.
• You have medical diagnosis documentation (biopsy, dermatology report, pathology results).
• You have records of Dupixent use (prescription, pharmacy or clinical dosing info).

Evidence Required for a Dupixent Lawsuit

• Medical records – Dermatology notes, pathology reports, lymphoma staging, treatment history, and Dupixent prescribing records.
• Product evidence – Prescription history, dosage logs, and duration of treatment.
• Symptom timeline – Dates of Dupixent initiation, onset of CTCL signs, biopsy or diagnostic confirmation.
• Expert opinions – Medical expert analysis linking lymphoma to Dupixent exposure, if available.

Damages You Can Recover

Medical Expenses: Costs for diagnosis (biopsies, imaging, lab work), cancer treatment (chemotherapy, radiation, immunotherapy, skin-directed therapy), hospitalizations, and ongoing monitoring and future medical needs.

Lost Income and Earning Capacity: Wages lost during treatment and recovery, reduced ability to work, and diminished future earning potential.

Pain and Suffering: Physical pain from cancer and treatment, emotional distress, loss of enjoyment of life, and psychological trauma from cancer diagnosis.

If your loved one died from T-cell lymphoma after Dupixent treatment, eligible family members may recover funeral and burial expenses, medical bills prior to death, loss of financial support and companionship, and compensation for mental anguish.

Punitive Damages

Courts may award punitive damages in cases where failure to warn or deceptive practices are proven, serving to punish manufacturers and deter similar conduct.

Settlement Estimates: While litigation is in early stages, legal experts analyzing similar pharmaceutical litigation suggest potential compensation could range from $100,000 to $500,000+ depending on injury severity, treatment complexity, and strength of evidence. Wrongful death cases may command higher values.

Current Status: No Recall, But Increased Scrutiny

Recall Status: No recall has been issued as of October 2025.

Current FDA Stance: Dupixent remains on the market with continued approvals for new indications (most recently bullous pemphigoid in June 2025).

However: Increased regulatory scrutiny, FDA safety signal identification, and mounting litigation suggest potential future regulatory actions. The FDA’s placement of Dupixent on its “Potential Signals” list in March 2025 and ongoing evaluation of warning label changes signal that regulatory intervention may be forthcoming.

What This Means for Patients: Staying informed and preserving evidence is essential for affected patients, regardless of whether a formal recall occurs. Lawsuits can proceed independently of FDA recall decisions.

Statute of Limitations for Dupixent Lawsuits

Product liability statutes of limitations vary by state but generally allow 2 to 4 years from diagnosis or injury discovery. In some jurisdictions, the clock may begin when a patient learns of a possible drug-related harm. Because lymphoma diagnosis may be delayed, consulting an attorney early is critical to avoid missed deadlines.

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FAQs

1. Can Dupixent cause lymphoma?

Studies indicate a significantly increased risk of CTCL and other T-cell malignancies among users.

2. Does Dupixent suppress the immune system?

Dupixent does not broadly suppress the immune system like traditional immunosuppressants. Instead, it is a monoclonal antibody that specifically targets and blocks two proteins in the immune system – interleukin-4 (IL-4) and interleukin-13 (IL-13) – which are involved in inflammatory responses.

3. What should I do if diagnosed?

Seek medical care, gather your records, and contact a legal team to evaluate your case promptly.

4. Is there a class action Dupixent lymphoma lawsuit?

No class action exists yet; current cases are individual filings or may consolidate into MDL in future.

5. Why didn’t the label warn me?

Lawsuits allege manufacturers withheld or delayed warning about lymphoma risks despite emerging evidence.

6. How long do I have to file?

Most states allow 2–4 years from date of diagnosis or awareness—consult legal counsel immediately to preserve rights.

6. What evidence is essential?

Medical diagnosis, prescription history, and timeline connecting Dupixent use to CTCL onset are key.

7. Who can be liable?

Dupixent manufacturers Sanofi and Regeneron may be defendants based on failure-to-warn claims.

References:

1. https://www.presspublications.com/premium/newsusa/stories/lawyers-pursue-skin-cancer-cases-after-medication-use,67304
2. https://pubmed.ncbi.nlm.nih.gov/38945437/
3. https://pmc.ncbi.nlm.nih.gov/articles/PMC11903887/
4. https://pubmed.ncbi.nlm.nih.gov/38588818/
5. https://pubmed.ncbi.nlm.nih.gov/40074775/