Drug Makers Agree Dupixent Cancer Lawsuits Should Be Centralized in MDL

Regeneron and Sanofi-Aventis are seeking to have a Dupixent cancer lawsuit MDL established in the U.S. District Court for the Southern District of New York, where both companies are headquartered.

The makers of the eczema drug Dupixent indicate that they agree a growing number of product liability lawsuits being filed nationwide over the failure to disclose lymphoma risks associated with their blockbuster treatment should be consolidated before one federal judge for coordinated pretrial proceedings.

Manufactured by Regeneron and Sanofi-Aventis, Dupixent (dupilumab) is a widely used treatment that has been approved for atopic dermatitis, eczema, asthma, chronic obstructive pulmonary disease (COPD) and other inflammatory conditions, primarily those that affect respiration and the skin.

Over the past few months, the drug makers have faced a steadily growing number of Dupixent cancer lawsuits brought throughout the federal court system, each involving similar allegations that users and the medical community were not adequately warned about the risk of cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL).

The litigation emerged after the publication of recent studies, linking Dupixent side effects to the two rare forms of T-cell lymphoma, which attacks the body’s white blood cells and weakens the immune system. The findings have raised concerns that the medication may cause or accelerate the development of cancer, and make the body more vulnerable to other forms of cancer, particularly other lymphomas and skin cancer.

Plaintiffs allege that Regeneron and Sanofi-Aventis knew or should have known about these risks, yet placed a desire for profits before the safety of users, by failing to disclose the potential risk of T-cell lymphoma, leaving patients and their doctors without the critical information needed to make informed treatment decisions.

Last month, plaintiffs filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML), requesting to consolidate all federal Dupixent cancer lawsuits before one judge in the Northern District of Georgia for coordinated pretrial proceedings.

Plaintiffs indicated that consolidation would prevent contradictory rulings between different judges, lessen duplication of discovery efforts and serve the convenience of common parties, witnesses and the courts.

On March 24, the defendants responded in support of the motion (PDF), agreeing with plaintiffs that creation of a Dupixent cancer lawsuit MDL is the most efficient way to approach the relatively new litigation. However, they want the cases consolidated in the Southern District of New York, where Regeneron and Sanofi-Aventis are headquartered.

According to the filing, the manufacturers intend to argue that atopic dermatitis itself is “both associated with a higher risk of developing T-cell lymphoma and can appear nearly indistinguishable from it.” They indicate consolidation would be the best way to confirm the science in court and address the litigation at once.

The next step is for the JPML to determine whether to schedule oral arguments on the motion, which typically occurs during one of its upcoming hearing sessions. If set, both sides will present arguments on whether the cases should be consolidated, after which the panel will issue a decision on whether to establish an MDL and its venue.

Dupixent MDL Consolidation

When plaintiffs first brought the motion to transfer, there were 15 Dupixent cancer lawsuits across the country. According to the defendants, as of March 24 that number was up to 18 cases, filed in a dozen different federal courts nationwide.

If the JPML decides Dupixent cancer lawsuit consolidation is warranted, the cases will be placed under the purview of one U.S. District Judge for discovery processes, pretrial motions, and will likely have several representative claims prepared for early test trials. These “bellwether” trials would allow the parties to see how juries respond to evidence and testimony that would likely be relevant in nearly every case.

While the outcomes of bellwether trials are not binding, they can help the parties negotiate a settlement agreement once it becomes clear how juries are likely to decide. However, if no Dupixent cancer settlement has been reached by the end of the bellwether trials, the judge may begin remanding the cases back to their original district courts for individual trial dates.

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