Ellume Faces Lawsuit for Not Refunding Costs of Recalled COVID-19 Tests

At a time when the federal government is making free at-home COVID-19 rapid tests available on a massive scale, the accuracy of those products has come into question. In recent months, there’s been a series of Class 1 recalls of rapid, at-home COVID-19 tests due to their risk of generating false positive results. One of the companies involved in the recalls is Ellume, the firm that secured the first Emergency Use Authorization for an at-home COVID-19 test. And now the legal action against Ellume has moved to a second front in the form of a class action lawsuit by test users for failing to provide refunds for the recalled tests.

The Ellume Recalls

On December 15, 2020, the Ellume COVID-19 Home Test became the first fully at-home SARS-CoV-2 testing kit to receive EUA for over-the-counter sale. In studies, the 20-minute antigen test registered an overall sensitivity of 96 percent and specificity of 100 percent. In February, the Australian test maker cut a $231.8 million deal with the Departments of Defense and Health and Human Services to establish a US production facility and crank out 8.5 million of the tests for distribution across the country. But on October 5, 2021, Ellume recalled 200,000 of the test kits shipped to US retailers from April through August due to concerns that they were reporting a higher than expected rate of false positive results. FDA characterized the recall as Class 1, the most serious kind. The recalled lots also included 227,000 kits that had already been used. A month later, Ellume expanded the recall to include over 2 million test kits.

The Class Action Lawsuit

Now Ellume has a new and unexpected headache to deal with in relation to the recall. On March 22, consumers filed a class action lawsuit against the company in a Maryland federal district court for refusing to provide refunds for the recalled tests in violation of federal and state consumer laws. Allowing the company to retain the “ill-gotten” profits it derived from the sale of “inaccurate, unsafe, ineffective, and worthless” products “would unjustly enrich the company at the” consumers’ expense, the complaint argues. The class is represented by two individual plaintiffs. The first, Karen Kerschen, was on vacation in Ireland in October and shelled out $65 for an Ellume test kit hoping to get the negative result she needed to return to the US. Instead, she tested positive. So, she and the rest of her tour group had to quarantine in the hotel and miss a scheduled excursion and related meal for which she paid $380. According to the lawsuit, Ellume told Kerschen to ignore the test result and leave the hotel to get another test. The test, plus taxi to the center, cost her another $152. When she got back to the US, she asked Ellume to refund the cost of the recalled test and other incidental expenses; she’s still waiting for the refund. The other plaintiff, Wallace Lovejoy, claims that a false positive result from the Ellume test forced him to cancel a planned July 2021 vacation with his wife. He asked Ellume for a refund on not only the costs of the test kit but also the additional expenses he incurred in getting retested and rebooking the vacation. In Oct. 2021, he got an email from Ellume informing him of the recall and offering a “free replacement test.” No longer needing the test kit, he and his wife contacted Ellume for a full refund of the original kits, which they were told they would receive. They later received a check from Ellume for less than the full cost of the test kits and related fees, with no explanation of the amount they were refunded. The plaintiffs are seeking damages for the costs of the Ellume tests as well as attorneys’ fees and costs, statutory and punitive damages, and declaratory and injunctive relief for themselves and other members of the class, according to the complaint.