DNA tester 23andMe Inc. has been hit with a class action in which the company is accused of falsely advertising its saliva collection kit and personal genome service product as accurately providing health reports on more than 240 genetic medical conditions.
According to the Complaint:
“This proposed class action alleges that 23andMe, Inc. (“Defendant”) falsely and misleadingly advertises their Saliva Collection Kit/Personal Genome Service (“PGS”) as providing “health reports on 240+ conditions and traits”, “drug response”, “carrier status”, among other things, when there is no analytical or clinical validation for the PGS. In addition, Defendant uses the information it collects from the DNA tests consumers pay to take to generate databases and statistical information that it then markets to other sources and the scientific community in general, even though the test results are meaningless.
3 Despite Defendant’s failure to receive marketing authorization or approval from the Food and Drug Administration (“FDA”), Defendant has slowly increased its list of indications for the PGS, and initiated new marketing campaigns, including television advertisements in violation of the Federal Food, Drug and Cosmetic Act (“FDC Act”). Defendant 23andMe, Inc., a Delaware Corporation, was and is a corporation founded in 2006, headquartered in Mountain View, California, existing under the laws of the State of Delaware and doing business in the State of California and elsewhere throughout the United States of America.”
FACTUAL ALLEGATIONS from the 23and Me Class Action:
- ” PGS is a direct-to-consumer DNA genetic test. After a consumer purchases the PGS for $99.00 plus applicable taxes, Defendant mails to the customer a packet including a saliva depository. The customer spits into the depository, thereby providing his or her DNA sample, and mails the packet back to Defendant. Defendant allegedly runs a DNA test for 240+ conditions and traits, and mails a report to the customer regarding the risks or family history characteristics such as coronary heart disease or rheumatoid arthritis. Additionally, the customer can log-in to Defendant’s website for more features.
- Defendant Advertises and Markets PGS as a Reliable Health Aid 10 To benefit Defendant’s sales of PGS, Defendant advertises and markets PGS in multiple media forms, including internet, print, and television.
- A small sample of such advertising and marketing under the “Health” tab of Defendant’s website shows representations regarding the value of the PGS to a customer’s health:
- “Learn hundreds of things about your health. Using your DNA information, 23andMe helps you know more about your health so you can take an active role in managing it. With reports on over 240+ health conditions and traits, here are a few of the things you’ll learn about you.”
- “Plan for the future. Find out if your children are at risk for inherited conditions, so you can plan for the health of your family.”
- “Living well starts with knowing your DNA.”
- “Health tools – Document your family health history, track inherited conditions, and share the knowledge.”
- “Drug response – Arm your doctor with information on how you might respond to certain medications.”
- “Below are a few examples [diabetes, arthritis, coronary heart disease, breast cancer, plavix, lactose intolerance] where we can help you learn more. And when you know more, you can make better lifestyle choices, look out for common conditions and take steps toward mitigating serious diseases.”(https://www.23andme.com/health/ Accessed 11/26/13)
- Defendant markets and advertises specific examples of diseases and conditions for which the PGS can aid the consumer. Further, Defendant claims, “Get personalized recommendations. Based on your DNA, we’ll provide specific health recommendations for you.” Defendant offers information on a consumer’s risk regarding such serious diseases as diabetes, coronary heart disease, and breast cancer. (https://www.23andme.com/health/ Accessed 11/26/13)
- Defendant describes the PGS service further: “23andMe is a DNA analysis service providing information and tools for individuals to learn about and explore their DNA, We use the Illumina HumanOmniExpress-24 format chip…Our chip consists of a fully custom panel of probes for detective single nucleotide polymorphisms (SNPs) selected by our researchers. The selection was made to maximize the number of actionable health and ancestry features available to customers as well as offer flexibility for future research.”
- Defendant Has Provided No Support for Such Advertisements and Marketing to FDA.
- Defendant has reaped the profit involved in marketing seemingly useful and reliable PGS health services while simultaneously failing to provide proof of the validity of such marketing claims to FDA in violation of the FDC Act
- Beginning in July 2009, FDA worked diligently with Defendant to try to help Defendant comply with regulatory requirements regarding safety and effectiveness and to obtain marketing authorization for the PGS device.
- FDA sent Defendant a “Warning Letter” on November 22, 2013, citing concerns over whether or not these tests work. The FDA cited concern about the public danger involved in false positives and false negatives for such serious health conditions purportedly tested by PGS.
- The FDA Warning Letter further indicated, among other things, that, ‘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; no other submission for the PGS device that you are marketing has been provided under section 510(k) of the [FDC] Act, 21 U.S.C. § 360(k).
- After more than 14 face-to-face meetings, hundreds of email messages, and dozens of written communications between Defendant and FDA concerning the public health consequences of inaccurate results from the PGS device, FDA has concluded, “…even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses…”
- After FDA cited specific examples of potential dangers to consumers, its letter states, “The risk of serious injury or death is known to be high when patients are either non-complaint or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported.”
- Defendant has marketed and sold PGS to consumers for years without any analytical or clinical data to support the device’s efficacy. Despite lacking data to support their claims, Defendant made material representations to customers.
- Without clinical data, Defendant continues to make health and efficacy claims about the PGS. Without such claims, consumers would lack incentive to purchase the product. Thus, Defendant has benefitted, and continues to benefit, from its misleading and unfair advertising and marketing.
- If the data is unknown or cannot be produced by researchers, the marketing claims are hollow and misleading, created without backing and with the aim of drawing customers to purchase the product.
- In a January 9, 2013 letter, Defendant stated to FDA that it was “completing the additional analytical and clinical validations for the tests that have been submitted” and “planning extensive labeling studies that will take several months to complete.” Thus, a full 5 years after the commencement of marketing the PGS to consumers, Defendant cannot support its marketing claims with scientific validation. In the absence of validation, 5 years of marketing claims were unfair, deceptive, and misleading to the consumers who trusted Defendant with potentially life-altering health matters.
- Defendant also publishes “research” based on the test results it complies from individual consumers paying to have the PGS test administered, falsely claiming the results provide meaningful statistical data and useful scientific results.
- Plaintiff alleges that, in committing the wrongful acts alleged herein, Defendant, in concert with its subsidiaries, affiliates, and/or other related entities and their respective employees, planned, participated in and furthered a common scheme to induce members of the public to purchase the PGS by means of misleading, deceptive and unfair representations, and that Defendant participated in the making of such representations in that it disseminated those misrepresentations and/or caused them to be disseminated.”