Products Liability Law Reporter

A federal district court held that dismissal of a patient’s state law products liability and consumer protection claims against the maker of breast implants was warranted under the preemption provision of the Medical Device Amendments (MDA) to the federal Food, Drug, and Cosmetic Act.

Pamela Shelp underwent breast augmentation surgery and was implanted with either Allergen Natrelle silicone-filled gel implants or Mentor breast implants. She developed complications from the implants within several months of the surgery—including headaches, memory loss, and shortness of breath—and subsequently had the implants removed. It was then discovered that the right implant had ruptured.

Shelp and her husband sued Mentor Worldwide, LLC, and Allergan, Inc., among others, alleging negligent design, failure to warn, and violation of Washington’s consumer protection law. The case was removed to federal court, and Mentor moved to dismiss on the basis that the MDA expressly preempts the plaintiffs’ claims.

Granting the motion, the court found that the MDA preempt a state law cause of action where federal law imposes requirements applicable to the device at issue, such as premarket approval, and where a claim seeks to impose state requirements different from or in addition to relevant FDA requirements. Citing case law, the court found that state common law claims, including negligent design and failure to warn, are preempted in cases involving medical devices receiving premarket approval.

Applying these principles here, the court found that the FDA had granted premarket approval for the Mentor breast implants long before Shelp’s breast augmentation surgery. Additionally, although the plaintiffs’ complaint alleges state law products liability claims, nothing in the complaint alleges the Mentor implant violated any FDA requirement. Thus, the court concluded, the plaintiffs’ claim impermissibly seeks to impose safety requirements on the Mentor implants that are both different from and in addition to FDA premarket approval requirements. Consequently, the court concluded that all of the plaintiffs’ claims are preempted by the MDA.

Citation: Shelp v. Allergan, Inc., 2018 WL 6694287 (W.D. Wash. Dec. 20, 2018).