Sanders v. Advanced Neuromodulation Systems, Inc.

Summary

The Supreme Court of Mississippi considered whether federal law preempted William Sanders's state-law claims against the manufacturer of a totally implantable spinal-cord stimulator. The court held that the device was a class III medical device because it was introduced after May 28, 1976, the FDA denied reclassification to class II, and the FDA approved the device through the premarket-approval process. Applying the Medical Device Amendments and Riegel v. Medtronic, Inc., the court affirmed summary judgment for the manufacturer.

Holdings

1. The GenesisXP was a class III medical device because it was introduced after May 28, 1976, was not covered by the class II regulation for a stimulator with an implanted receiver and external transmitter, and had been treated by the FDA as a class III device.
2. The MDA preempted Sanders's state-law claims against ANS because the claims challenged the safety and effectiveness of a class III device that had received FDA premarket approval and would impose requirements different from or in addition to federal requirements.
3. Summary judgment for ANS was proper because there was no genuine issue of material fact regarding the device's class III designation and the undisputed facts established federal preemption.

Questions Presented

1. Whether the trial court erred by granting summary judgment to ANS.
2. Whether the GenesisXP totally implantable spinal-cord stimulator was a class III medical device subject to federal preemption under the Medical Device Amendments.
3. Whether Sanders's negligent-manufacture, defective-product distribution, and strict-liability claims challenging the safety or effectiveness of the FDA-approved device were preempted.

Disposition

affirmed