CTCL Diagnosis Leads to Lawsuit Over Dupixent Cancer Risks

Dupixent lawsuit notes that more than 200 cases of CTCL were reported among users of the popular drug from 2017 to 2024.

According to a Florida man’s product liability lawsuit, two years of Dupixent use to treat atopic dermatitis led to the development of a rare form of blood cancer, a risk the manufacturers allegedly knew about, but failed to disclose to users or the medical community.

Giovanni Fraioli filed the complaint (PDF) in the U.S. District Court for the Southern District of Florida on January 30, alleging defendants Regeneron Pharmaceuticals Inc., Sanofi-Aventis U.S. LLC and Genzyme Corporation withheld information about the risk that Dupixent side effects may cause or exacerbate the development of a rare cancer, known as cutaneous T-cell lymphoma (CTCL) .

Dupixent (dupilumab) was approved by the U.S. Food and Drug Administration in 2017 for the treatment of atopic dermatitis, a form of eczema. The U.S. Food and Drug Administration (FDA) later expanded the label to include the use of Dupixent to treat asthma, chronic obstructive pulmonary disease (COPD) and other inflammatory diseases affecting the respiratory tract and skin.

More than one million patients have received the injections since Dupixent’s approval. However, despite the manufacturers marketing the drug as safe and effective, concerns quickly arose about a potential link between Dupixent and lymphoma side effects, including both the development of CTCL and peripheral T-cell lymphoma (PTCL).

As a result, a growing number of former users like Fraioli are now pursuing Dupixent CTCL lawsuits, each raising similar claims that plaintiffs could have avoided the cancer diagnosis if the drug makers had not chosen to place their desire for profits over patients’ safety.

Fraioli’s lawsuit indicates he was prescribed Dupixent in December 2019 for the treatment of his atopic dermatitis. Although he was diagnosed with Mycosis Fungoides, a form of CTCL, he continued using the drug until October 2021, unaware of a potential connection, he states.

Since the diagnosis, Fraioli has endured extensive and prolonged cancer treatments including chemotherapy and phototherapy, the latter of which has continued twice every week for more than three years.

The lawsuit alleges the manufacturers failed to clearly warn of an increased risk of CTCL, information that would have likely led his physician to choose a different treatment and prevented Fraioli from taking the drug.

According to the complaint, the manufacturers began to receive postmarketing reports of Dupixent users developing CTCL within a year of its approval, in March 2018. Before the year was out, manufacturers received a total of 15 reports of spontaneous CTCL being diagnosed in Dupixent patients. By the end of 2024, Dupixent use was linked to more than 200 reports of CTCL, which medical experts consider a rare form of cancer.

“Consumers and physicians alike have been misled about the safety and efficacy of Dupixent, and as a result consumers, including Plaintiff, have developed CTCL.”

– Giovanni Fraioli v. Regeneron Pharmaceuticals Inc. et al

Fraioli presents claims of failure to warn, negligence, fraudulent misrepresentation and negligent misrepresentation. He seeks punitive as well as compensatory damages.

Dupixent Cancer Lawsuits

Individuals like Fraioli, who used Dupixent and were later diagnosed with CTCL, PTCL or other types of T-cell lymphoma, may be eligible to pursue legal claims for compensation for their injuries and related losses.

Dupixent lawyers provide no-cost consultations to review medical records, discuss possible claims and determine whether individuals may be eligible for a Dupixent lawsuit settlement. 

These claims are handled on a contingency basis, meaning there are no upfront legal costs and attorney fees are only paid if a settlement or verdict is obtained.