Dive Brief:
- Consumers have launched a class action lawsuit against Ellume over the company's refusal to refund buyers of COVID-19 tests that were later recalled because of the risk of false positives.
- The two named plaintiffs used Ellume's rapid antigen tests in relation to their travel to and from Europe. Both plaintiffs bought kits that delivered positive results, disrupting their travel plans, only for other tests to find they were negative.
- Ellume acknowledged the false positive risk when it pulled millions of kits from the market in a Class I recall in October and November. One plaintiff received a $215 check from Ellume but the lawsuit argues neither individual has been fully refunded.
Dive Insight:
In October, FDA issued a notice about Ellume's recall of its rapid antigen test, the first over-the-counter, fully at home COVID-19 kit to come to market in the U.S. The initial recall covered around 400,000 tests that were found to have a higher than acceptable false positive rate because of a manufacturing issue.
Ellume added more than 2 million tests to the recall the following month.
One of the plaintiffs paid $65 for an Ellume test kit that she used in October to meet the requirements for returning to the U.S. from Ireland. The positive result forced the plaintiff and the rest of her tour group to quarantine in the hotel, causing her to miss a scheduled excursion and related meal for which she paid $380.
According to the lawsuit, Ellume told the plaintiff to ignore the test result and leave the hotel to get another test. The test, plus taxi to the center, cost the plaintiff €139 ($152).
When she returned to the U.S., the plaintiff asked Ellume to refund the cost of the recalled test. As of the filing of the lawsuit, Ellume was yet to refund the cost of the COVID-19 test kit or "any of the incidental costs related thereto."
The second plaintiff paid $538 for two packs of four Ellume COVID-19 test kits for use by him and his wife to meet the requirements for traveling to the U.K. The plaintiff's wife received a positive result. After the test, the plaintiff's wife paid $215 for two PCR tests at walk-in clinics and at a clinic she visited as a participant in a COVID-19 vaccine trial. The two paid-for tests were negative. The trial clinic did not report her result "but strongly implied that if she had been positive they would have notified her."
Despite the negative PCR results, the plaintiff canceled the trip because his wife would have needed to quarantine for the duration of their time in the U.K. The plaintiff was unable to cancel the flights or a prepaid planned excursion. When the plaintiff rebooked the flights several months later, he paid around $1,000 because of a fare increase.
Ellume offered a "free replacement test" but the plaintiff requested a refund. In November, the plaintiff received a check from Ellume for $215 but no explanation of how Ellume calculated the amount.
The lawsuit argues that "allowing Ellume to retain ill-gotten gains it derived from its sale of defective COVID-19 Home Tests" deprives the plaintiffs and "unjustly" enriches the company.
The plaintiffs are seeking "damages for the monies paid to purchase the Ellume COVID Tests, statutory and punitive damages, attorneys' fees and costs, declaratory, and injunctive relief."
