Genetic Testing Company Slapped With $5 Million Lawsuit After Being Banned by FDA

Last week, the U.S. Food and Drug Administration (FDA) ordered genetic testing company 23andMe to cease sales of its test kits, and now, they find themselves on the receiving end of a lawsuit for $5 million.

The class action lawsuit, filed by California resident Lisa Casey, asserts that the genetic testing kits are “meaningless”, unsupported by any scientific evidence, and falsely advertised to consumers for their own financial gains. The lawsuit is seeking at least $5 million under various California state laws, and predicts that “tens or hundreds of thousands” of U.S. consumers are entitled to damages in the class action lawsuit.

In addition, the complaint alleges that 23andMe gathers the genetic information from the consumers, which it uses to its benefit by giving them to scientists to help in the research process. 23andMe even admitted that eventually, they plan to create databases from millions of consumers to use for medical research.

23andMe, based out of the Silicon Valley and supported by Google, lists their “spit-kits” online for $99. These kits collect the consumer’s saliva, and are subsequently sent out for DNA testing. The purpose is to give the consumer an analysis of their genetic makeup, so that they better determine their susceptibility to certain health risks, including 240 conditions and diseases.

The FDA’s demand to 23andMe to discontinue the sale of these kits occurred on November 27, 2013. Their reason was that the company was not obeying U.S. law in that the tests were never cleared by the government to make medical claims. The FDA has been warning the company since 2010 that the test kit is considered a medical product, and that they were placing the product under the potential for federal review.

23andMe said that they stopped their television, radio, and online advertisements last week. However, the test kit is still on the website.

Before this lawsuit, 23andMe received negative feedback due to the fact that they currently hold the patent rights which allow for sperm and egg recipients to see how their genes will pan out inside of their potential donor. Critics have termed this method of baby labor the “designer baby” market, since you can essentially pick the optimal match.

When asked about the criticism, 23andMe stated that the company no longer plans on using this patented technology in any of their fertility clinics. 23andMe has been selling the test kit since 2007.

For more information, contact a Gacovino Lake attorney at 1-800-246-HURT (4878).

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