MemoryGel silicone breast implants are Class III medical devices, approved by the FDA through the premarket approval (PMA) process in 2006. Premarket approval was a federal requirement imposed on the device. Plaintiff sued in product liability (negligence based on failure to warn and manufacturing defect, negligence per se, strict liability in design and manufacturing defect, breach of express and implied warranty) and asserted claims of “Breast Implant Illness” related to the implants’ safety and effectiveness. Webb v. Mentor, 5:19 CV 1604 (N.D.N.Y. April 7, 2020). Defendants moved to dismiss the complaint, asserting that plaintiff’s claims were preempted by the Federal Food, Drug and Cosmetic Act 21 U.S.C. § 301 et sq., pursuant to the Medical Device Amendments (MDA) of 1976, 21 U.S.C. § 360c and, alternatively, that plaintiff failed to state any claims upon which relief, under FRCP 12(b)(6).

To succeed in asserting a claim that fits through the narrow gap between express and implied preemption, plaintiff must identify a parallel federal law upon which she has based her state law claims. Plaintiff alleged that defendants did not comply with the FDA‘s Quality System Regulations and Current Good Manufacturing Practices (CGMPs). However plaintif failed to identify specific regulations or explain how defendants violated the CGMPs. Plaintiff’s general allegations could not withstand preemption because they failed to establish the necessary link between defendants’ federal violations and her alleged causes of action. Plaintiff’s failure to warn and design defect claims were preempted because they sought to impose safety related requirements on the device, or labeling requirements beyond those imposed by the FDA. Plaintiff’s express and implied warranty claims were preempted; plaintiff did not identify specific representations of the manufacture which exceeded the scope of FDA approved labeling statements nor did she show defendants’ alleged federal violations caused the implants to have deviated from their purpose, that they failed, or that they were unfit for patients. As a matter of law, the MDA preempted plaintiff’s claims.