Legal woes for 23andMe are deepening, with two more customers suing the California maker of health-related genetic tests for making bogus marketing claims. The lawsuits represent continued fallout over the FDA's assertion that the company marketed its products for years without proper regulatory approval.
The Boston Business Journal reported that the latest suit, filed in U.S. District Court in Boston, seeks class-action status for the complaint. It also follows a California lawsuit filed earlier in December by another customer alleging that 23andMe made false marketing and health assertions.
According to the story, Tara Stefani of Hingham, MA, and Tanya Vullaneuva of Oakland, CA, claim in their lawsuit that 23andMe sold its tests without proper marketing authorization or approval. They also assert that the company used misleading advertising to make claims about what its tests could accomplish regarding both genetic history and gauging future health risks.
This is an issue that has brewed for years, but the FDA brought it to a head with a scathing Nov. 22 warning letter slamming the company, after years of interaction with regulators, for its delays in submitting to the approval process for its Personal Genome Service saliva-based tests and related products. The FDA also wanted 23andMe to take the tests off the market until they could be formally reviewed and approved as official medical devices under the law. Executives at the company resisted at first but then agreed to regulators' demands in early December.
Customers who purchased 23andMe's Personal Genome Service tests on or after Nov. 22 can now only gain access to ancestry-related genetic information and raw genetic data, minus interpretation. Unhappy customers who don't like the change can get a full refund, though customers who signed on before the Nov. 22 warning letter can still get access to their full health-related results.
The FDA insists that it backs a market that lets consumers easily gain information about their genomes and genomic tests, despite its aggressive action against 23andMe. Rather, it wants to make sure that direct-to-consumer tests such as the ones offered by the company that convey health information are safe.
CEO and co-founder Anne Wojcicki, married to Google ($GOOG) co-founder Sergey Brin, has said that 23andMe wants to work cooperatively with the FDA to reach a positive outcome, though she stands by her company's data, standards and the high accuracy rate of its tests.
- read the full BBJ story