Breaking News (which is No Big Surprise)
Updated 6 December: 23andMe continues to sell kits, but will provide only minimal genomic information and has suspended advertising. The Washington Post reports that “In a statement Thursday night, the firm went a step further, announcing that it would only provide ancestry information and raw health data. A spokesperson for the company said that “interpreted results” would not be included.” 23andMe had earlier this week suspended advertising (Cnet/Reuters). Customers who had purchased kits prior to the FDA letter on 22 November will receive full reports. 23andMe statement on website. Matthew Herper in Forbes today on how both parties were in a ‘kind of detente’ until the bolder claims (and undoubtedly the adverts with those claims) started. And for weekend consideration, the CoreGenomics (UK) blog looks at the genomic truth-or-consequences.
The Class Action Lawsuit: Gigaom reports that a California plaintiff, Lisa Casey, filed on 27 November against 23andMe in the US District Court, Southern California citing false and misleading advertising of the Personal Genome Service (PGS) without “‘analytical or clinical validation” and that 23andMe “advertises and markets PGS as a reliable health aid”. Included in the class action complaint is (of course) every online and advertising claim regarding diseases and conditions that 23andMe’s genetic testing can assist a consumer, that (of course) FDA has not approved the marketing of the kits and that 23andMe markets the information to others even though “the test results are meaningless”. The lawsuit seeks damages extending well beyond the cost of the kit (of course), a jury trial and importantly to certify the class action and the attorney’s representation of same. Most interesting is the seemingly modest representation of Ms. Casey, Mark Ankcorn of his eponymous law firm (see his blog entry here). However, in tracing back his email domain, this Editor discovered that Mr. Ankcorn, a trial lawyer with a major-league track record of wins, recently joined the high-powered CaseyGerry firm of San Diego, which specializes in high-profile personal injury/death class action lawsuits including litigation against the NFL on TBI and CTE plus the 2011 Reno Air Races crash.
Our readers should not be surprised as our article last week was blunt on the red carpet 23andMe was figuratively rolling out for the lawyers: Get what your product does (your implied warrant of service) rock solid (23andMe is not at this point) and backed up by studies. Structure your claims as if a trial lawyer will come after you, because they come with the territory.
Well, they are here, and the mystery remains why 23andMe has chosen a path that for most early-stage companies would be corporate annihilation. 23andMe hit with class action over “misleading” genetic ads Filing (PDF) Hat tip to David E. Albert, MD of AliveCor via Twitter (@DrDave01)
Related articles of interest: Dan Munro in Forbes, writing at the same time as this Editor on the kerfuffle, analyzes far more than here on the ‘test results are meaningless’ point. My comment is below his article (expand comments). See also Mr. Munro’s comment on Illumina (which 23andMe uses for its testing–and just gained premarket clearance for their MiSeqDx test) also confirming that 23andMe lost its Chief Legal Officer in July without a replacement, which would tend to cramp dealings with FDA. See also Bernard Munos’ ‘fumbling gene’ takedown, from a scientific POV, of same. KPBS (San Diego) coverage.
Previously in TTA: FDA tells 23andMe genomic test to stop marketing