A New Jersey state judge won’t let Allergan Inc. escape multicounty litigation by patients alleging its Biocell breast implants were defective and caused them to develop a type of non-Hodgkin’s lymphoma, finding several claims are not preempted by federal regulation.
Judge Rachelle L. Harz on Tuesday denied in part Allergan’s motion to dismiss on preemption grounds a master long-form complaint filed in the litigation, finding that while some variants of the implant and a tissue expander are protected by preemption under the U.S. Food Drug and Cosmetic Act, other claims are based on parallel state law requirements.
In the MCL, the plaintiffs allege the breast implants were defective and caused them to develop, or be at risk of developing, breast implant-associated anaplastic large cell lymphoma, a subtype of non-Hodgkin’s lymphoma.
Judge Harz agreed with Allergan regarding failure to warn claims based on alleged failures by Allergan to conduct clinical studies after the products were approved by the FDA and claims based on allegations that Allergan failed to provide information to the FDA during the premarket approval process.
However, the judge allow strict liability and negligent failure to warn claims based on allegations that Allergan failed to tell the FDA about adverse reactions and side effects post-approval, as that is a state court duty that parallels FDA regulations.
The plaintiffs also successfully alleged a manufacturing defect, Judge Harz wrote, saying the complaint alleges Allergan used a different scrubbing process than was submitted to the FDA, and therefore would not be in compliance with the specifications the FDA approved.