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Class Action Suit Filed Against 23andMe

NEW YORK (GenomeWeb News) – 23andMe has been hit with a class action lawsuit just a few days after the US Food and Drug Administration told the firm that it must stop marketing its spit test and genome service to consumers because it has failed to address FDA's questions about the clinical and analytical validity of the product.

The suit was filed Nov. 27 in the US District Court for the Southern District of California by plaintiff Lisa Casey on behalf of consumers who purchased the 23andMe Saliva Kit and Personal Genome Service (PGS). The suit alleges that 23andMe "falsely and misleadingly" advertises its services as providing health reports on 240-plus conditions and traits as well as other information on drug response and carrier status, "when there is no analytical or clinical validation for the PGS for its advertised uses."

The suit was filed just a few days after the FDA sent a letter to 23andMe telling the firm it must cease marketing the Saliva Collection Kit and Personal Genome Service to consumers immediately, and it may not start marketing it again until it has received the agency's authorization. The FDA considers 23andMe's offering a medical device because it is "intended for use in the diagnosis of diseases or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body."

Though 23andMe previously filed for 510(k) clearance for several of the intended uses for its genome service, the FDA said the company has failed to respond to questions from the agency regarding the validity of those uses.

Although the company told the FDA early this year that it is completing additional analytical and clinical validations and is planning "extensive labeling studies" that would take months to complete, FDA Office of In vitro Diagnostics and Radiological Health Director Alberto Gutierrez said in the letter to 23andMe that his office still has not received the information it is seeking.

"Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS," Gutierrez wrote.

Guiterrez's comments were noted in the lawsuit, which further stated that 23andMe "has reaped the profit involved in marketing seemingly useful and reliable PGS health services while simultaneously failing to provide proof of the validity of such marketing claims to FDA in violation of the [Federal Food, Drug and Cosmetic Act]."

The plaintiff alleges that "[i]n the absence of validation, 5 years of marketing claims were unfair, deceptive, and misleading to the consumers who trusted the Defendant with potentially life-altering health matters."

However, in 23andMe's terms of service, which customers must agree to in order to purchase its tests, the company informs that the reported results are for research and informational use only, and not meant as medical advice. "While we measure many hundreds of thousands of data points from your DNA, only a small percentage of them are known to be related to human traits or health conditions," the company states in the TOS.

Furthermore, the company cautions that customers might learn results they don't anticipate and they shouldn't change health behaviors based solely on 23andMe's test results. "You should not assume that any information we may be able to provide to you, whether now or as genetic research advances, will be welcome or positive," 23andMe informs customers.

The plaintiff, who purchased her 23andMe product on Sept. 19, 2013, noted in the suit that there are potentially "tens of thousands, if not millions, of consumers nationwide" who could be eligible for participation in the class action. The suit claims that members of the class action are entitled to damages in the amount of the purchase price of the PGS, which is currently offered by 23andMe as a cost of $99.

A spokesperson for 23andMe said that the firm is unable to comment on legal matters.