Dupixent Injection Lawsuits Consolidated in MDL Over CTCL Diagnoses

While the Multidistrict Litigation (MDL) currently only includes Dupixent CTCL lawsuits, the U.S. JPML will consider other forms of T-cell lymphoma caused by the injections when future claims are filed.

A panel of federal judges has determined that all Dupixent injection lawsuits brought over the risk of cutaneous T-cell lymphoma (CTCL) will be centralized before one U.S. District Judge in New Jersey for coordinated discovery and pretrial proceedings, as part of a new federal multidistrict litigation (MDL).

Dupixent (dupilumab) is a blockbuster medication sold by Regeneron Pharmaceuticals and Sanofi-Aventis U.S., which was originally approved for the treatment of atopic dermatitis, commonly known as eczema. However, its approved uses have expanded substantially in recent years, and Dupixent is now prescribed for a number of inflammatory conditions affecting the skin and respiratory system, including asthma, chronic obstructive pulmonary disease, or COPD, and other conditions involving overactive immune responses.

The medication works by targeting certain immune system pathways involved in inflammation. While promoted as an important treatment option for patients with chronic inflammatory diseases, a series of Dupixent lawsuits are now being filed, alleging that the manufacturers failed to adequately investigate and disclose evidence that the drug may cause, accelerate or mask symptoms of rare T-cell lymphomas.

Cutaneous T-cell lymphoma (CTCL) is a rare form of non-Hodgkin’s lymphoma that primarily affects the skin. Symptoms may resemble eczema or other inflammatory skin conditions, which plaintiffs allege can make the cancer difficult to diagnose in those being treated with Dupixent for atopic dermatitis. Some complaints claim individuals continued receiving Dupixent while their CTCL progressed, because doctors and patients were not adequately warned to monitor for signs that the drug may be worsening or revealing an underlying malignancy.

Since the release of the study, more than a dozen lawsuits over Dupixent T-cell lymphoma side effects have been filed in various U.S. District Courts nationwide. Each claim alleges that the manufacturers failed to provide adequate warning about the cancer risks and also failed to instruct healthcare providers to take appropriate medical monitoring steps while their patients are using Dupixent.

Dupixent Injection Lawsuit MDL

In February, plaintiffs asked the U.S. Judicial Panel on Multidistrict Litigation (JPML) to establish a federal Dupixent injection lawsuit MDL in the Northern District of Georgia, so that one judge could oversee discovery and pretrial proceedings. The defendants agreed, indicating both sides believe consolidation would prevent contradictory rulings, duplication of discovery efforts, and serve the convenience of common parties, witnesses and the courts.

However, Regeneron and Sanofi disagreed with plaintiffs over where the cases should be transferred, suggesting that it would be more convenient if the claims were consolidated in the Southern District of New York.

Following oral arguments held late last month, the JPML issued an order (PDF) on June 4, indicating that the Dupixent injection litigation would benefit from consolidation into an MDL, determining that the lawsuits should be centralized before U.S. District Judge Zahid N. Quraishi in the District of New Jersey. The panel noted that Sanofi’s principal place of business is in the district’s boundaries, and that Regeneron has corporate offices in New Jersey as well, and its headquarters are nearby in Tarrytown, New York.

“Relevant witnesses and evidence are thus likely to be in or near the District of New Jersey, which is also easily accessible for the parties and witnesses in this nationwide litigation.”

– Judicial Panel on Multidistrict Litigation

The panel also addressed a dispute over how broadly the MDL should be defined. Defendants asked the JPML to limit the centralized litigation to lawsuits involving CTCL, excluding claims involving other lymphomas or malignancies. Plaintiffs agreed that the MDL should not include claims involving B-cell lymphoma, Hodgkin’s lymphoma or diseases that are not T-cell lymphomas.

However, they opposed limiting the MDL only to CTCL, arguing that scientific literature also links Dupixent to other T-cell lymphomas, including peripheral T-cell lymphoma (PTCL) and anaplastic large cell lymphoma.

For now, the JPML declined to decide whether future non-CTCL T-cell lymphoma claims should be included in the MDL. The panel noted that all lawsuits currently before it involve CTCL or a CTCL subtype, even though some complaints cite literature involving other T-cell lymphoma diagnoses.

If future Dupixent lawsuits are filed over peripheral T-cell lymphoma, anaplastic large cell lymphoma or other non-cutaneous T-cell lymphomas, the JPML indicated those cases can be considered through the conditional transfer process.

As part of the coordinated management of the Dupixent MDL, Judge Quraishi will handle the discovery process, pretrial motions, and is expected to direct the parties to prepare several cases representative of the litigation as a whole to serve as bellwether trials. These early test trials would give the parties a chance to see how juries interpret the evidence and testimony that would be key in claims throughout Dupixent injection lawsuits.

The results of these trials are not binding on other cases, but the outcomes could help the parties form the basis of a Dupixent injection lawsuit settlement agreement.

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