The emergence of different COVID-19 variants and the corresponding surge in COVID-19 cases brings with it an increased demand for COVID-19 tests, particularly those that offer immediate results and can be done from the comfort of home. Unfortunately, like many other products on the market, at-home COVID tests are not immune to false claims or false results.
Earlier this month, the U.S. Food and Drug Administration (“FDA”) announced a Class I recall of at-home COVID-19 rapid antigen tests manufactured by E25Bio Inc. According to the FDA, E25Bio marketed and distributed its SARS-CoV-2 Antigen Test Kits (“E25Bio Tests”) to customers throughout the United States without authorization, clearance, or approval from the FDA and with insufficient data demonstrating that the E25Bio Tests performed accurately. Rapid antigen tests are designed to detect proteins called antigens from the SARS-CoV-2 virus in patient samples. And according to the FDA, the E25Bio Tests contained inaccurate claims and instructions, including a statement misrepresenting the test as FDA-authorized.
A Class I recall is the most serious type of recall, reserved for situations where the use of a product or device may cause serious injury or death. In this case, the FDA warned that the E25Bio Tests carried a risk of both false-negative and false-positive test results as well as a risk of injury if users followed labeling instructions directing self-collection of testing samples from deep inside the nose and the throat. The recall affects over 70,000 tests sold in the United States between September 2020 and November 2021.
Just two weeks after the FDA announcement, E25Bio was hit with, Urena v. E25BIO Inc., 1:22-cv-01379 (S.D.N.Y) (filed Feb. 18, 2022), a consumer class action lawsuit claiming that the recalled tests are “worthless and inaccurate,” illegally distributed, and not FDA-approved. More specifically, the complaint alleges that E25Bio falsely labeled its Tests and made a number of false claims, touting the “novel technology” with “better accuracy than ‘gold standard’ PCR [tests].” According to the complaint, the risks of false test results are dire, as a “false negative” can lead to further spread of COVID-19, and a “false positive” may lead to a delay in the correct diagnosis and the appropriate treatment for a person’s actual illness. Accordingly, the plaintiff, a New York resident, asserts warranty, fraud, consumer protection, and unjust enrichment claims on behalf of a nationwide class and New York subclass of purchasers. He seeks reimbursement of the cost of buying the E25Bio Tests, as well as statutory and punitive damages, and attorney fees and costs.
The ongoing pandemic means continued demand for quick and convenient tools to prevent and diagnose COVID-19. This is not the first time the FDA has recalled an at-home COVID-19 test, and it is not likely to be the last (other recalls include Ellume COVID-19 Home Test, Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test, LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva), and Flowflex COVID Rapid Tests). As recalls continue, so too may class action lawsuits.