23andme Faces Two New Lawsuits

The FDA recently informed genetic-testing firm 23andme that its products must undergo regulatory approval. Following that news, the company agreed to halt sales of its health-related genetic tests. As is often the case following such FDA action, new lawsuits from consumers have been filed, alleging that the company participated in wrongdoing. In this case, the litigation is being brought by Tara Stefani of Hingham, MA and Tanya Vullanueva of Oakland, CA, who allege that company's marketing caused them duress. "23andMe made [...] promises without providing any scientific or clinical validation that its Saliva Kits are accurate, reliable or fit for their advertised uses," according to the lawsuit. In addition, the litigation alleges that 23andme illegally collected personal information from its users, which it then sold to the researchers "for unknown uses."The lawsuit follows separate litigation that was filed in early December, which also alleges the company made misleading claims regarding its products. The first suit was filed five days after the warning letter was issued to 23andme. That suit also alleged that the company illegally solicited customer data to the scientific community:

In its warning letter, FDA alleged that false positives from 23andme tests could lead patients to undergo life-threatening procedures such as preventive mastectomy. On the other hands, a false negative could lead to patients having a false sense of their risk for various diseases. Speaking on the former issue, cardiologist and geneticist Eric Topol, MD commented: "First of all, I don't know any woman who would go have a double-mastectomy based on a 23andMe genotype. Secondly, the 23andMe for BRCA gene, that's only one common mutation. There are so many more. You have to get the sequence to know anything."