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DNA testing company 23andMe is being slapped with a $5 million class action suit by customers who felt they were misled by the company's advertising.
The suit came shortly after the Food and Drug Administration (FDA) ordered 23andMe to stop marketing its personalized DNA diagnostic home kit, stating that the Silicon Valley startup had failed to provide adequate evidence for the kit's advertised uses, reports The Associated Press. The FDA was particularly concerned with claims that 23andMe's genetic kits could diagnose diseases -- and so are the company's customers.
Can 23andMe customers expect compensation for allegedly being misled?
23andMe Alleged to Have Sinister Purpose
23andMe was started by Anne Wojcicki in 2006. Customers could purchase a home DNA test kit -- promising to provide insight into genetic disease risks and ancestry information -- for only $99, reports Business Insider.
The problem with the kits is that the FDA had warned 23andMe -- as well as a handful of other genetic testing companies -- that without proper approval, their kit was an unapproved medical device and could not be marketed to "diagnose disease."
After the FDA publically blocked the sale of the 23andMe kits in late November, San Diego resident Lisa Casey filed her class action suit against the company in California federal court. Among its allegations, the suit claims that 23andMe is slowly compiling a DNA database from customers' paid tests, which it "then markets to other sources and the scientific community in general."
But while selling DNA information sounds a bit "Gattaca"-esque, it isn't the main legal thrust of the suit.
False, Misleading Advertising?
The genetic testing company is primarily on the hook for allegedly false and misleading advertising. This advertising led consumers to believe that 23andMe's tests were able to make predictions or risk assessments about their health -- claims which are currently disputed by the FDA.
Despite any legal hedging 23andMe might have used in disclaimers to disavow the medical value of its home DNA test, future courts will be sure to factor in the overall impression of customers based on the company's advertising.
And with advertising bits like "[l]earn hundreds of things about your health," the impression that the kit is a medical diagnostic tool may be somewhat difficult to dispel.