By Bio-IT World Staff
UPDATED 12/4/13: Paragraph four of this article has been updated to clarify how 23andMe has changed its marketing practices since receiving the FDA letter. The original text of the article is still in place.
December 3, 2013 | If observers couldn't help but notice the stern wording of the FDA letter to 23andMe posted Nov 22, it's nothing compared to the class action that has now been filed against the company. The document contends that 23andMe "has benefitted, and continues to benefit, from its misleading and unfair advertising and marketing... [Its] marketing claims are hollow and misleading, created without backing and with the aim of drawing customers to purchase the product."
The suit has been filed by the Ankcorn Law Firm on behalf of plaintiff Lisa Casey, a 23andMe customer in San Diego, and is directed to the United States District Court for the Southern District of California. The choice to file directly in federal court is significant, as it indicates a claim of at least $5 million, an amount the document itself confirms.
The lawsuit quotes freely from the FDA letter that has halted 23andMe's marketing efforts and sparked widespread debate over the fairness of the company's health claims. Particularly favored by the law firm were passages citing a lack of "assurance that the firm has analytically or clinically validated the PGS [Personal Genome Service] for its intended uses."
Among the genetics community, a major question seems to be whether 23andMe's tests can be said to be "diagnostic," and whether unvalidated health claims made by the company could lead to inappropriate interventions on the part of its customers. This class action may ultimately sidestep that question, as it neither identifies any specific health claims made in Ms. Casey's 23andMe report, nor alleges that she has suffered any health-related consequences. Rather, the injury cited to the plaintiff is the $99 fee she paid for her test after being "misled into purchasing the Products by Defendant's deceptive conduct." The action extrapolates this fee to the tens of thousands of other customers who have bought 23andMe kits to arrive at the minimum $5 million figure. The lawsuit will also seek to end 23andMe's marketing, an action the FDA has already ordered and with which the company appears to be rapidly complying. UPDATED: 23andMe has already pulled its online, radio, and television advertisements in order to comply with the FDA's directive to "immediately discontinue marketing the PGS." (Source: Reuters.) However, the kit is still being sold on 23andMe's website, and it is not clear whether this distinction between "marketing" the PGS and actually selling it will pass muster with the agency.
It remains to be seen whether the class action attracts further plaintiffs, including any willing to claim that their health has actually been endangered by their PGS results, but it will be another headache for 23andMe CEO Anne Wojcicki as she rushes to respond to the FDA order and clear a path for her company's survival in a suddenly live regulatory environment.