Products Liability Law Reporter

A federal district court held that a plaintiff’s failure to identify a specific defect in the manufacturing process for the Medtronic SynchroMed II Infusion System justified dismissal of the plaintiff’s products liability lawsuit against Medtronic, Inc.

Debra Sims, who was implanted with a Medtronic SynchroMed II Infusion System, developed a granuloma mass in her spine. She sued Medtronic, Inc., alleging strict liability manufacturing defect, negligent manufacturing, and breach of implied warranty. The lawsuit also sought punitive damages. The defendant moved to dismiss, arguing that the plaintiff’s claims were expressly preempted.

The district court granted the motion. The court noted that statutory or common law causes of action imposing different standards or additional duties for a product receiving premarket approval are expressly preempted under the Medical Device Amendments of 1976. But where there is a violation of FDA regulations and a specific defect that led to a specific injury, the court found, damages may be recovered.

The court rejected the plaintiff’s argument that catheter recalls involving the defendant’s infusion system showed that her SynchroMed II was defectively manufactured. Identifying a recall differs from naming a specific manufacturing defect that led to a particular injury, the court said, reasoning that the possibility of adverse side effects that would drive a recall effort does not necessarily mean that any defect led to a plaintiff’s injury.

Consequently, the court dismissed all of the plaintiff’s claims without prejudice.

Citation: Sims v. Medtronic, Inc., 2021 WL 2291014 (N.D. Tex. June 4, 2021).