Gomez v. St. Jude Medical Daig Division Inc.

How courts have described this case

Verbatim parenthetical descriptions written by other courts when citing this decision. Ranked by citation-network relevance.

• holding that design defect, failure-to-warn, and breach of express warranty claims under LPLA were preempted by § 360k(a)
• holding a breach of express warranty claim preempted when the warranty was part of a medical device’s “Instructions for Use” that was reviewed and approved by the FDA
• noting that claims based on “marketing that complied with the FDA-approved requirements” could not be maintained because success on such claims “requires a showing that the FDA requirements themselves are deficient”
• noting that plaintiff must “eliminate alternative causes with ‘reasonable certainty’ ”
• affirming summary judgment of LPLA failure to warn claim against collagen plug manufacturer based on preemption
• finding LPLA 5 Case: 20-30793 Document: 00516058015 Page: 6 Date Filed: 10/18/2021 No. 20-30793 defective-design and failure-to-warn claims for an allegedly defective PMA- approved medical device preempted by § 360k

Source: CourtListener parenthetical corpus (CC0).