Danell Gomez had a surgical catheterization in 1999. A device known as an "Angio-Seal" was used to close the hole in Gomez's artery. The Angio-Seal is regulated by the FDA under the Federal Medical Device Amendments. The Angio-Seal uses a plug of collagen to seal the hole, and uses an anchor to prevent the collagen from entering the artery.

Gomez alleges that the anchor failed to prevent the collagen from entering Gomez's artery and it formed a blockage in her femoral artery in her leg. Gomez underwent nine surgeries as a result of the blockage to her artery. She sued the manufacturer under Louisiana product liability law on several counts, but the defendant's motion 370 PART TWO Private Law and the Legal Environment of Business for summary judgment on the ground of federal preemption was granted.

Gomez appealed; the Fifth Circuit Court of Appeals affirmed most of the preemption claims, but reversed and remanded the summary judgment for Gomez's claim of manufacturing defect. Gomez claimed that the Angio-Seal had been manufactured improperly and that the defect had caused the anchor to fail. Why would this claim not be preempted by the Federal Medical Device Amendments?