misrepresentation of FDA clearance as FDA approval needs non-anecdotal evidence of consumer deception to be actionable

Repro-Med Sys., Inc. v. EMED Technol. Corp., 2019 WL 1427978, No. 13-cv-01957-TLN-CKD (E.D. Cal. Mar. 29, 2019)The parties have been fighting over their competing medical devices for a while. Here, RMS alleged among other things that EMED was intentionally misrepresenting FDA “clearance” as “approval.” There are other cases indicating that this difference can be literal falsity, since clearance and approval are two separate things, but the court here, relying on California law, required evidence that the statements were “misleading to a reasonable consumer,” and further stated that “[a]necdotal evidence alone is insufficient to prove that the public is likely to be misled.”  Seamlessly transitioning to the Lanham Act standard, the court required “extrinsic evidence, such as consumer survey evidence, that the challenged statements tend to mislead consumers.”  By not analyzing the literal/implicit divide and…

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