Opinion ID: 598969
Heading Depth: 3
Heading Rank: 4

Heading: Product Misbranding, Misrepresentation & Failure to Warn

Text: 33 Appellant contends that Zyderm was misbranded or mislabeled. Misbranding generally occurs when labeling is false or misleading in any particular. 21 U.S.C. § 352(a). Under the MDA, the FDA must reject proposed labeling when the labeling is false or misleading in any particular. Id. § 360e(d)(2)(D). As there is no indication in the record that the Zyderm administered to Ms. King was anything but what the FDA-approved labeling said it would be, notwithstanding appellant's bald statements, we find this claim preempted. 34 Appellant's fifth and sixth claims of misrepresentation and failure to warn are preempted for similar reasons. A finding that Collagen misrepresented Zyderm to appellant would impose a requirement on Collagen to change its packaging or labeling in order to correct the misrepresentation. The failure to warn claims similarly challenge the adequacy of Zyderm's FDA-regulated packaging and labeling. The MDA forecloses these claims because Collagen cannot be forced to change Zyderm's packaging and labeling by virtue of these state law damage claims.