Dupixent Lawsuit Updates
FDA Investigating Potential Link Between Dupixent and Lymphoma
The U.S. Food and Drug Administration (FDA) is investigating reports of cutaneous T-cell lymphoma in patients using Dupixent (dupilumab), a medication prescribed for moderate-to-severe eczema and other conditions. This probe was initiated following the receipt of adverse event reports indicating this serious potential side effect. The FDA is evaluating whether regulatory action, such as a label update or recall, is warranted. Concurrently, patients who developed lymphoma are filing legal claims against the drug's manufacturer, alleging failure to warn about this cancer risk.
FDA Approves Dupixent as First Targeted Treatment for Bullous Pemphigoid
On June 20, 2025, the FDA approved Dupixent for treating bullous pemphigoid (BP), making it the first and only targeted therapy for this condition in the United States. Bullous pemphigoid is an autoimmune disease characterized by the formation of large, fluid-filled blisters on the skin, frequently appearing near skin creases. This approval provides a new treatment option for patients affected by this disorder.
Study Finds Disproportionate Rate of Adverse Event Reports for Dupixent
An analysis in the Journal of Allergy and Clinical Immunology reveals that adverse event reports for Dupilumab (Dupixent) occurred at over 60 times the average drug reporting rate in the FDA's FAERS database. Between 2017 and Q4 2023, 181,575 unique adverse event reports were filed for the drug, including 606 reports of neoplasms (cancers). This significant disparity in reporting frequency underscores potential safety concerns and is likely to influence ongoing FDA investigations and product liability litigation.
About the Dupixent Lawsuit
Once hailed as a breakthrough for conditions like eczema, asthma, and nasal polyps, Dupixent (dupilumab) is now in the spotlight for a darker reason. Dupixent users are coming forward with assertions that the allegedly defective drug caused or worsened their cancers, particularly cutaneous T-cell lymphoma (CTCL). Many of these patients are now filing lawsuits against Sanofi Genzyme and Regeneron Pharmaceuticals in hopes of holding the medication’s producers accountable.
People who used Dupixent or dupilumab and were later diagnosed with an eligible cancer (or experienced worsening of a pre-existing cancer) are encouraged to speak with an experienced attorney to understand their legal options. If you believe you or a loved one may qualify, You can fill out the sign-up form at the top of this page for a no-cost case evaluation.
Understanding Dupixent and Its Medical Uses
Dupixent (generic name dupilumab) is a biologic injectable medication intended to treat a variety of long-term conditions, including:
- Moderate to severe eczema, also known as atopic dermatitis
- Asthma
- Nasal polyps and chronic rhinosinusitis
- Chronic obstructive pulmonary disease (COPD)
- Eosinophilic esophagitis
- Prurigo nodularis
These diseases are all associated with increased inflammation in the body. Dupixent and dupilumab work primarily by blocking proteins involved in the inflammatory process, particularly interleukin-4 (IL-4) and interleukin-13 (IL-13).
The medication was designed as a different method of treatment for these chronic conditions. Unlike many traditional treatments, Dupixent does not require daily doses; instead, the drug is typically injected just once a week, or even less frequently.
This dosing schedule may appeal to patients wishing to spend less time on disease management. However, a wave of lawsuits says this convenience could come at the price of patients’ health.
Who Qualifies For The Dupixent CTCL Lawsuit?
You may be eligible to file a Dupixent dupilumab lawsuit if you meet the following requirements:
- You used Dupixent (or generic dupilumab), and
- You were later diagnosed with Cutaneous T-Cell Lymphoma (CTCL, also known as mycosis fungoides or Sézary syndrome), or
- You experienced a resulting worsening of your pre-existing cancer
You may also qualify if you were diagnosed with another type of T-cell lymphoma or any of the following CTCL subsets:
- Lymphomatoid papulosis
- Subcutaneous panniculitis-like T-cell lymphoma
- Primary cutaneous anaplastic large cell lymphoma
- Extranodal NK/T-cell lymphoma
- Primary cutaneous gamma/delta T-cell lymphoma
Biologic Therapy Risks: Cancer and Dupixent Misdiagnosis
Dupixent was reportedly marketed as a safe and convenient treatment option, but recent litigation claims this might not have been the case. Plaintiffs say the injectable drug is associated with serious health effects, including Cutaneous T-Cell Lymphoma (CTCL), a type of cancer.
Allegedly, Dupixent may increase a patient’s risk of developing CTCL and may also worsen pre-existing cases. Backed by research, these claims reputedly aren’t without merit. Some studies correlate dupilumab use with anywhere from a 300% to 350% greater chance of developing lymphoma. The assertions don’t end there.
CTCL is a rare form of cancer in its own right, which can sometimes lead to a delay in diagnosis. Worse, the cancer misdiagnosis lawsuit states, CTCL symptoms (such as itchy and painful skin rashes or plaques) can overlap with those of atopic dermatitis, one of the main illnesses Dupixent is prescribed to treat.
Because of this symptom overlap, some plaintiffs say neither they nor their doctors were alarmed by their evolving conditions, allegedly preventing a timely CTCL diagnosis. Reportedly, the symptoms instead received an erroneous eczema misdiagnosis, allowing their cancers to go dangerously unnoticed or worsen as they continued using Dupixent.
The Legal Accusations Surrounding Dupixent
For patients suffering from eczema, asthma, and nasal polyps, the search for reliable treatment options can feel like a lifelong uphill battle. Dupixent’s 2017 FDA approval brought hope to those wishing for a different type of therapy.
According to plaintiffs, the medication was marketed by Sanofi and Regeneron to doctors and patients alike as an effective, low-risk drug. Dupixent advertisements reportedly showed happy, clear-skinned people in relaxing social settings, free from any obvious signs of debilitating health problems. The medication is approved for use by patients 6 months old and up, apparently further contributing to its safe appearance.
However, the Dupixent lymphoma lawsuits state that the biologic drug is not as safe as represented by Sanofi and Regeneron. Further, plaintiffs claim that the companies should have reasonably known about Dupixent’s cancer risks yet failed to adequately warn patients and doctors. This purported negligence allegedly contributed to the suffering of patients whose cancers developed or worsened in response to the medication.
As of September 2025, Dupixent has not been recalled and is still being actively marketed by both Big Pharma companies.
How Do I Join The Lawsuit?
No one should have to face cancer for simply attempting to manage their chronic health condition. If you or a loved one were diagnosed with cancer after using Dupixent, you deserve justice.
The best way to seek accountability from pharmaceutical giants like Sanofi and Regeneron is by exercising your legal rights. Working with a qualified Dupixent attorney can give you the greatest chance at a successful lawsuit. If you believe you meet the eligibility requirements, complete the sign-up form on this page to be connected with a lawyer in the OCA network. Your case evaluation is confidential and available at no cost to you.
While considering filing a lawsuit, you may have concerns about the cost of hiring legal counsel. At OCA, we believe your financial situation should have no bearing on your ability to pursue justice. That’s why attorneys in our network typically work on a contingency fee basis, meaning no upfront payment is required. In most cases, a plaintiff would pay a portion of any potential Dupixent settlement or compensation only if their case is successful.
Our team of professionals is here to answer any questions you have about filing a Dupixent lawsuit and is standing by to support you on your legal journey.
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