23andMe Faces Class Action Lawsuit for False Advertising

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A California woman has filed a class action lawsuit against the DNA testing company 23andMe Inc., alleging that the advertisements for its Saliva Collection Kit/Personal Genome Service are false and misleading because the type of analysis it offers is invalid.

Plaintiff Lisa Casey alleges in the 23andMe class action lawsuit, filed Nov. 27, that the genetic testing company uses the information it collects to build a database and gather statistical information that it then sells to other organizations and the scientific community “even though the test results are meaningless.”

Casey purchased a DNA test kit from 23andMe on Sept. 19, 2013 after hearing and reading several ads for the company. She received her results via email on Nov. 19, 2013.

According to the class action lawsuit, 23andMe has not been approved by the U.S. Food and Drug Administration to market its product, and the increased marketing campaigns including TV ads violate the Federal Food, Drug and Cosmetic Act.

The Personal Genome Service kit is a DNA genetic test that consumers buy directly from 23andMe for $99. The customer receives a packet that contains a saliva depository that the person spits into and mails back. The DNA is contained in the saliva. According to 23andMe, the saliva is then tested for 240+ conditions and trait, which it details in a report the company sends back to the customer. The genetic testing company tests for health risks such as coronary heart disease, rheumatoid arthritis, gluten sensitivity as well as drugs a person may have an adverse reaction to.

“Learn hundreds of things about your health,” the website states. “Using you DNA information, 23andMe helps you know more about your health so you can take an active role in managing it. With reports on over 240+ health conditions and traits, here are a few of the things you’ll learn about you.”

They then list topics such as carrier status, health risks, drug response, health tools, inherited traits, and scientific advances.

23andMe also claims that parents can have their children’s DNA tested to find out if they’re at “risk for inherited conditions.”

In addition, the company says they will send “personalized recommendations” about preventative care.

According to the class action lawsuit, the FDA has been trying to work with the company since July 2009 to get them “to provide proof of the validity of such marketing claims.” The federal agency wants the company to “comply with regulatory requirements regarding safety and effectiveness and to obtain marketing authorization for the [personal genome service kit].”

The FDA sent a warning letter on Nov. 22, 2013 to 23andMe citing concerns it has about the test’s accuracy saying that there are concerns “about public danger in false positives and false negatives for such serious health conditions purportedly tested” by the kit, the suit claims.

The agency said that “’23andMe has failed to provide adequate information” that support that the kit really does any of the things it is marketed to do.

They added that it has met with the company 14 times in person and communicated several times via email and other forms of written communication, but “‘even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the [personal genome service kit] for its intended uses.”

Casey’s class action lawsuit claims that 23andMe’s genetic test has been “falsely, unfairly, and misleadingly advertised . . . to the detriment of class members.”

The DNA testing company also does not have clinical data to support the efficacy of its DNA test.

“If the data is unknown or cannot be produced by researchers, the marketing claims are hollow and misleading, created without backing and with the aim of drawing customers to purchase the product,” Casey claims.

She is charging 23andMe with false and misleading advertising as well as violating other business codes, breach of warranty, unjust enrichment and negligent misrepresentation.

She is asking for actual, statutory and punitive damages.

The plaintiff is represented by Mark Ankcorn of Ankcorn Law Firm, PC.

The 23andMe False Advertising Class Action Lawsuit is Lisa Casey v. 23andMe, Inc., Case No. 13-cv-2847-H-JMA, in the U.S. District Court for the Southern District of California.

UPDATE: A federal judge dismissed the 23andMe class action lawsuit on June 25, 2014, ruling that consumers must arbitrate their claims as agreed to under the Terms of Service.

UPDATE 2: September 2017, the 23andMe DNA testing kit class action settlement is now open. Click here to file a claim.