A Cook County man has filed a class action suit against 23andMe, a personal genetic testing company that the U.S. Food and Drug Administration (FDA) ordered late last year to stop offering some of its services.
Gary Newland filed the suit Jan 15 in Chicago’s federal court, claiming he and others who bought 23andMe’s Personal Genome Service (PGS) were misled by the company's advertising on the benefits and accuracy of the analysis.
Daniel Edelman of Edelman, Combs, Latturner & Goodwin in Chicago submitted the suit on behalf of Newland and a proposed class. Newland's suit is just one of several that have been brought against the company following the FDA order.
23andMe, a California-based company with ties to Google, is part of a new wave of companies that use the advances in genetic sequence technology to offer low-cost analysis of individuals genomes. What sets 23andMe and its peers apart from previous personal genetic analysis is their attempt to deliver predictive health-related analysis.
In the case of 23andMe, the analyst cost about $100 per individual. After someone bought the service, 23andMe mailed them a saliva depository. The customer would put their saliva into the depository and mail it back to 23andMe, which then claimed to test the person’s DNA for more than 240 conditions and traits.
In 2010, the federal Government Accountability Office (GAO) sent identical genetic material to four different consumer genetic testing companies, including 23andMe. The analysis the GAO got back from the companies included different predictions for the likelihood of prostate cancer in the genetic sample.
Eventually, the FDA issued a warning letter to 23andMe, claiming the Personal Genome Service the company offered violated the federal Food, Drug and Cosmetic Act.
“To date, 23andMe has failed to provide adequate information to support a determination that the PGS is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it,” the FDA’s November letter states.
The letter specifically addresses 23andMe’s marketing material that suggests its analysis would allow customers to have more information about how they might respond to certain medication. The FDA went as far as suggesting 23andMe’s analysis could be deadly.
“Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment," the FDA letter states.
"For example," it adds, "false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect."
Newland's suit against 23andMe includes counts for breach of express warranty, breach of implied warranty, violation of the Illinois Consumer Fraud and Deceptive Business Practices Act, consumer fraud, common law fraud and unjust enrichment.
He is seeking compensatory and punitive damages, as well as costs for himself and the rest of the class that could exceed $5 million.
23andMe is still offering genetic testing, but only gives customers results relating to ancestry and trait-related results (i.e. hair and eye color). The company is currently working to get FDA approval to again release health-related genetic analysis.