The Warning Letter Is Only the Start


So you’ve had a bad day — FDA has told you to stop marketing your product. The good news, things can only get better, right? Maybe not if a class action follows hot on the heels of FDA’s order. This, in brief, is the recent tale of woe of 23andMe. See Casey v. 23andMe, Inc., No. 3:13-cv-02847 (S.D. Cal. Nov. 27, 2013).

The 23andMe example is only the most recent example of an FDA Warning Letter inspiring a class action. See, e.g., Trujillo v. Avon Prods., Inc., No. CV12-09084 (C.D. Cal. filed Oct. 23, 2012) (class action filed less than three weeks after FDA Warning Letter); Nino v. L’Oreal USA, Inc., Lancôme, Inc., and Lancôme Luxury Prods., LLC , No. 1:12-cv-23462 (S.D. Fla. Sept. 21, 2012) (class action filed two weeks after FDA Warning Letter); Huey v. General Mills, Inc., No. 09-01368 (E.D. Cal. May 15, 2009) (class action filed less than two weeks after FDA Warning Letter); Mason v. The Coca-Cola Co., No. 1:09-cv-00220 (D.N.J. Jan. 14, 2009) (class action filed about a month after FDA Warning Letter).

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Topics:  23andMe, Class Action, False Advertising, FDA, Misleading Statements, Warning Letters

Published In: Civil Procedure Updates, Communications & Media Updates, Consumer Protection Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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