Products Liability Law Reporter

A federal district court held that the Medical Device Amendments (MDAs) to the Federal Food, Drug, and Cosmetic Act do not preempt a plaintiff’s manufacturing defect and negligent manufacturing claims against the manufacturer of an implantable drug infusion system.

John Brumfield, 70, suffered from chronic lower back pain. He underwent a series of treatments before doctors implanted Medtronic’s SynchroMed II Infusion System. The device, which was implanted in Brumfield’s abdomen, is a programmable drug infusion system that delivers medication—in his case, hydromorphone. Several years later, Brumfield began to experience a recurrence of his back pain. His physician recommended replacement of the device’s pump, and Brumfield later underwent surgery. The physician’s surgical report noted that Brumfield’s pump was in a state of “motor stall.”

Brumfield sued Medtronic, Inc., and affiliated entities, alleging strict liability manufacturing defect and negligent manufacturing. The plaintiff also claimed that he was entitled to punitive damages. According to the lawsuit, the infusion device’s motor stalled as a direct result of the defendants’ defective manufacturing and violations of federal law. The plaintiff asserted that the defendants had not conformed to federal requirements when manufacturing the infusion device and cited FDA inspections and warnings to bolster his claims. The defense moved to dismiss, arguing, in part, that the plaintiff’s claims were expressly preempted by the MDAs and that the complaint did not contain a plausible claim entitling him to relief.

Denying in part, the district court noted that Class III medical devices like the SynchroMed II device must undergo extensive oversight and a rigorous premarket approval (PMA) process. The FDA may approve a device maker’s application and issue a PMA approval order based on a comprehensive description of the device’s components, ingredients, and properties, in addition to descriptions of its manufacturing methods, facilities, and processes. Once approved, a manufacturer may not make changes to a device unless FDA permission is obtained, the court said, adding that a device maker also must adhere to the FDA’s Current Good Manufacturing Practices (CGMP).

The court also found that under §360k(a)(1) of the Federal Food, Drug, and Cosmetic Act, all state requirements different from or in addition to any requirement of the act are invalid. Citing case law, the court added that a two-step analysis must be used for determining whether a plaintiff’s claims are preempted. The first step determines whether the device at issue is subject to federal statutory requirements, and the second step considers whether the claims attempt to impose state safety and effectiveness requirements that are different from or in addition to federal requirements, the court said.

Applying these principles here, the court noted that each of the plaintiff’s claims is premised on his assertion that the defendants’ manufacturing practices deviated from the specifications set out in the PMA process and the CGMP regulations and that these deviations caused his device’s motor to stall, leading to his withdrawal symptoms and other injuries. Because the plaintiff’s claims are based on the PMA and CGMP requirements, the court found, his claims are not preempted. The court reasoned that liability based on a deviation from FDA-approved specifications or CGMP regulations does not impose requirements different from or in addition to federal law because those requirements apply to Class III device manufacturers.

Finally, the court also found that the plaintiff had alleged his claims with sufficient specificity to state a plausible claim. The complaint included specific allegations as to the infusion device and included its model and serial numbers as well as the alleged malfunction and its cause. This provided the defendants with adequate notice of the nature and scope of the plaintiff’s claims, the court said, noting that to hold otherwise would impose an impossible pleading standard on the plaintiff.

Consequently, the court held that dismissal of the manufacturing defect and negligent manufacturing claims was not warranted.

Citation: Brumfield v. Medtronic, Inc., 2021 WL 933869 (S.D. W. Va. Mar. 11, 2021).

Plaintiff counsel: AAJ members Robert V. Berthold Jr. and Robert V. Berthold III, both of Charleston, W. Va.; and AAJ member Ellen A. Presby, Dallas.