Litigation Update: Allergan Motion to Dismiss Denied in Breast Implant Cases

On May 5, Judge Rachelle L. Harz of the New Jersey Superior Court denied in part Allergan’s motion to dismiss the master long-form complaint filed by the plaintiffs in the multi-county litigation (MCL) consolidated in June, 2020 to provide centralized case management for the Biocell Textured Breast Implant cases filed against Allergan, Inc. and Allergan USA, Inc.  Judge Harz has been appointed to oversee the coordinated discovery and pretrial proceedings in an effort to streamline the judicial process, reduce duplicative discovery, and avoid conflicts in trial schedules.

In their motion, the defendants argued that the complaint should be dismissed on preemption grounds since the products at issue were protected by preemption under the U.S. Food Drug Cosmetic Act (FDCA) and the complaint sought to impose more stringent regulations than those required by the U.S. Food and Drug Administration’s (FDA) premarket authorization system.  Allergan also contended that the long-form complaint failed to allege a cause of action under the parallel New Jersey state law as needed to survive a preemption challenge.

The complaint at issue alleges that the Biocell Textured breast implants were defective and caused the plaintiffs to be at risk of or to actually develop breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.

Judge Harz did agree with the defendant manufacturers on a number of points. Allergan sought to dismiss claims that they failed to conduct clinical studies after the FDA had already approved the product and had failed to provide the FDA with data during the product’s premarket approval process. Plaintiffs’ claims that Allergan failed to update the label were also dismissed, with Judge Harz noting that any such relabeling was voluntary.

The litigation will proceed on strict liability, breach of express warranty and consumer fraud as well as design defect claims for products sold before the premarket approval process.

Read our latest blog posts on Allergan’s litigation.