Walters v. Boston Scientific Corp.

Charity Walters, as personal representative of the estate of Naomi Joy Lee, sued Boston Scientific Corp. after Lee's implanted defibrillator allegedly failed to operate as intended, leading to her death on September 27, 2022.The defibrillator, an EMBLEM MRI S-ICD® Class III device, allegedly failed to send a signal to the monitoring clinic, preventing timely medical intervention.Walters asserted claims of strict products liability, negligence, breach of warranty, and wrongful death.Boston Scientific removed the case from Alabama state court to federal court and moved to dismiss on federal preemption grounds.

The court granted Boston Scientific's motion to dismiss, ruling that all of Walters's claims were preempted by federal law.

Whether the plaintiff's state-law claims against Boston Scientific were preempted by the express preemption provision of the Medical Device Amendments to the federal Food, Drug, and Cosmetic Act.The court found that the plaintiff failed to plead specific violations of any binding federal requirements in the design, manufacturing, or labeling of the device.

The ruling reinforces the high bar for plaintiffs in medical device product liability cases involving FDA-approved Class III devices, requiring specific allegations of federal regulatory violations to survive preemption challenges. The decision highlights the narrow gap remaining for private litigants under the Medical Device Amendments.