Riley v. Cordis Corp.

How courts have described this case

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

• noting that the terms of a Class III medical device’s PMA “severely limit[ ]” a device manufacturer’s ability to alter its labels, including in situations where the manufacturer “becomes aware of a new off-label use of the device”
• granting leave to file an amended complaint with the necessary detail to state a claim that is not preempted by the FDCA
• Buckman imposed implied preemption on state claims that “would not exist if the FDCA did not exist”
• failure to warn claim could escape express preemption if plaintiff alleged that manufacturer affirmatively promoted off-label use in a manner that violated federal law
• “a private litigant cannot bring a state-law claim against a defendant . . . when the state claim would not exist if the FDCA did not exist.”
• the second requirement for a non-preempted “parallel” state law claim is that the defect alleged would give rise to a recovery under state law, even in the absence of the FDCA

Source: CourtListener parenthetical corpus (CC0).