23andME Faces $5M Lawsuit in Wake of FDA Warning Letter

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Direct-to-consumer genetic testing service provider 23andME is now facing an imminent legal battle stemming from its genetic testing kits and services.

On November 22, 2013, the FDA issued a warning letter to 23andME, which required the company to “immediately discontinue marketing” its Saliva Collection Kit and Personal Genome Service. The letter, which was addressed to 23andME CEO Anne Wojcicki, cited the company’s failure to address the FDA’s concerns regarding the public health consequences of false positives and false negatives resulting from the Personal Genome Service.  Less than one week later, on November 27, 2013, 23andME was served with a class action lawsuit in San Diego District Court.  According to media outlets, the complaint seeks $5 million in damages and alleges that 23andME has misled consumers with respect to its Personal Genome Service advertising.

Prior to receiving the recent FDA warning letter, the company had been engaged in an aggressive consumer ad campaign touting its personalized tests as providing insight into a user’s genetic ancestry and susceptibility to various diseases.  The 23andME website now prominently displays a disclaimer on its homepage, and is no longer offering personalized data interpretation services along with its genetic tests.

According to a recent press release, 23andME CEO Anne Wojcicki remains committed to the company’s long-term objectives, and intends to cooperate with the FDA to resolve its ongoing issues.

Nick Belair
Nick Belair is an Associate at our Orange County office. Mr. Belair received his J.D. from Boston University, where he was the Executive Editor of the Boston University Journal of Science and Technology Law. Mr. Belair received his B.S. and M.S. degrees from the University of Southern California, where he majored in Biomedical Engineering. Prior to attending law school, Mr. Belair worked as an R&D Engineer at EV3 Neurovascular. While at EV3, he helped design and develop catheter-based devices for the treatment of neurovascular disease. Mr. Belair worked as a summer associate at the firm in 2012 and joined the firm as an associate in 2013.
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