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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