23andMe Hit with Second Class Action Lawsuit Over Home DNA Testing Kits

Genetic testing company 23andMe Inc. has been hit with a second class action lawsuit for failing to obtain authorization from the Food and Drug Administration to market and sell its home DNA Testing Kits.

In the latest 23andMe class action lawsuit, New Mexico resident Vernon Stanton claims to have purchased DNA testing kits from 23andme that were supposed to suss out what genetic conditions he and his wife may be at risk for and other information promised by the company. However, as a result of not being able to obtain the results and concerns from the FDA, Veronon decided to sue 23andMe for false advertising, negligent misrepresentation, unjust enrichment, breach of warranty, and more.

Stanton alleges in the class action lawsuit that he purchased two 23andMe DNA Testing Kits in September 2013 because the company promised that the home-testing kits would help consumers “[l]earn hundreds of things about [their] health” and “[f]ind out if [their] children are at risk for inherited conditions.” Staton says he submitted the saliva samples pursuant to the company’s procedures prior to receiving an email from 23andMe stating that it would not be delivering results while it was working with the FDA regarding regulatory issues.

On Nov. 22, the FDA ordered 23andMe to halt sales of its genetic home-testing kits because it was “marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act).”

The FDA has been trying to work with the company since July 2009 to get them to provide proof of the validity of their marketing claims, including the ability to detect diseases such as cancer. In its November letter, the FDA said that despite extensive correspondence with 23andMe, regulators “still do not have any assurance that the firm has analytically or clinically validated the [personal genome service] for its intended uses.”

A similar class action lawsuit (Lisa Casey v. 23andMe Inc.) was filed soon after the FDA warning letter was issued.

Stanton is represented by class action attorneys Jonas P. Mann, Michael McShane and Dana M. Isaac of Audet & Partners LLP and Shane Rowley, Nancy A. Kulesa and Matthew Rand of Levi & Korsinsky LLP.

The 23andMe Class Action Lawsuit is Vernon Stanton v. 23andMe Inc., Case No. 14-cv-00294, in the U.S. District Court, Northern 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.