Gelber v. Stryker Corp.

How courts have described this case

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

• holding that manufacturing defect claims alleging that a device was not manufactured in accordance with FDA requirements are not preempted
• concluding that “a defective manufacturing claim based upon a violation of [21 C.F.R. § 808(1)(d)] is not preempted”
• finding plaintiffs allegation that defendant’s device was “adulterated” under the CGMPs sufficient to survive preemption
• finding plaintiffs manufacturing defect claims not preempted where she provided supporting evidence in the form of an FDA warning letter and a subsequent voluntary recall
• finding plaintiffs’ implied warranty claim not preempted as it was based on their manufacturing claim, for selling an adulterated device makes the product unfit for its ordinary purpose
• “Imposing liability on defendants for “fail[ing] to implement effective corrective or preventive actions” or “fail[ing] to timely identify the causes of the device failure” would impose additional state law requirements on defendants.”

Source: CourtListener parenthetical corpus (CC0).