The controversy over 23andMe, which lets you get a genetics test through the mail, has expanded to a class action that demands refunds for the $99 test.

Double Helix
photo: The Cancer Genome Atlas

California-based 23andMe, already in the midst of a regulatory firestorm with the FDA, is being targeted by a class action lawsuit that claims its ads are misleading, and that the results of its $99 genetic test are “not supported by any scientific evidence.”

In a complaint filed last week, San Diego resident Lisa Casey claims she paid for 23andMe’s services, and received results by email, after learning of the home-based saliva test via TV and online ads. Now, days after the FDA issued a stinging letter that ordered the company to stop its marketing, Casey seeks to represent the “ten or hundreds of thousands” of others across America who paid for the product.

According to the complaint, which seeks at least $5 million under various California state laws, 23andMe makes false and misleading claims about the tests’ ability to provide relevant genetic information about breast cancer, diabetes, lactose intolerance and various other conditions.

23andMe, which is currently in discussions with the FDA, is still in the process of pulling down its commercials, which depict people standing next to pictures of their genetic profiles and saying things like “This part makes my eyes blue” and “I might have an increased risk of heart disease.”

The company, which is run by Anne Wojcicki, wife of Google founder Sergey Brin, has been at the center of controversy since last week when the FDA issued a letter saying that 23andMe had been marketing medical devices without permission, and that its practices could lead to health risks like unnecessary mastectomies.

Some medical experts have defended the company, telling the New York Times “Is the only pathway for me to get access to the contents of my cells via some guy in a white coat?”

23andMe declined to comment on the lawsuit. You can read the complaint for yourself below:

Casey v 23andMe

The complaint was spotted by Law360 (sub req’d).

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  1. This is an interesting case. It does not seem as though the marketing has been lying, more that they do not have the FDA approval to use such statements in their marketing. I wonder if a class-action suit could actually win as there is not proof that their claims are false, more that they do not have FDA approval to make such claims

  2. Looking Glass Medicine Monday, December 2, 2013

    Did the FDA hold off on filing their complaint because of the connection to Google?

  3. Somebody smells money.

  4. offbeatmammal Monday, December 2, 2013

    This is so sad. 23andMe provide some insight into an otherwise closed book. they make no claims that are outrageous to the right thinking mind… this is just ambulance chasing following on from the FDA picking on an easy target rather than actually helping.

    In a healthcare system which is motivated by medicating for dollars and propping up insurance companies any knowledge in the hands of the patient seems to be deemed dangerous… understanding why my eyes are the color they are, or getting corroboration for an already known genetic condition is a great data point, but it’s just that… a data point that I’d discuss with my doctor before doing anything about (or hell, maybe I’d just make that little extra effort to eat right and get a bit more exercise rather than seeking someone to blame)

  5. The plaintiff appears to be married to one of the partners in the law firm representing her. Scum.

    1. That doesn’t surprise me. They should be ashamed of themselves.

  6. Damn!

    This is such bull crap!

  7. I have some similar concerns about the company but not sure I get much in joining suit. I haven’t used the kit, I’ll just return it.

    1. Matthew, Why do you have concerns? I have had all their test done and not only here but with FTDNA. They are right on target here. They were doing test FTDNA started doing much later and my cousins match in both groups. I do this for genealogy purposes and it has help me a great deal. The health thing doesn’t bother me at all. They have been correct in the health thing with me too. If you don’t want the health thing don’t do it. I think it is very mean to come over here and want to sue these very talented people.

  8. Frances Allred Monday, December 2, 2013

    I don’t think they will win a class action suit. If the woman doesn’t like the testing here just shut up and go somewhere else. They do a good job here. They do a lot of work for 99.00. I am well pleased and believe that most of the people feel as I do.

  9. nolongernakedrunning Monday, December 2, 2013

    This is disgusting. I’m a 23&Me user and when/if I get notice I’ll be one who “Opts out” of this frivolous suit. I hope that everyone opts out and they see that no-one was ‘injured’ by spitting in a tube and reading about some interesting genetic results and have multiple disclaimers behind them.

  10. This is just some opportunistic idiot who doesn’t have enough brain cells to interpret the information provided so they are jumping on what they picture as the easy money bandwagon…can anyone say McDonald’s coffee is HOT?!

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