LA City Atty Says At-Home COVID-19 Test Is False Advertising

By Lauren Berg
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Law360 (April 22, 2020, 10:07 PM EDT) -- A California online medical retailer falsely advertised and sold at-home coronavirus test kits, the Los Angeles Attorney's Office said in a lawsuit filed Tuesday, as the U.S. Food and Drug Administration, Centers for Disease Control and other health authorities continue to battle false information about the deadly virus.

Santa Monica-based RootMD Inc., an online retailer selling tests and products for chronic gut diseases, was recently selling what it purported to be an "at-home" novel coronavirus test, even though the FDA has not yet approved such a test, according to the complaint filed in California state court.

"Because these 'at-home' tests have not been validated by the FDA, the reliability of these 'at-home' tests have varied wildly and tests of 'frankly dubious quality' have flooded the American market, leading to false positives and false negatives," the city attorney's office said in the suit.

Beginning in March, RootMD sold kits for $249 that purported to test for COVID-19 exposure and immunity, according to the suit. While the company told customers the test hadn't yet been approved by the FDA, RootMD did claim the FDA allowed for its use under emergency provisions, according to the complaint.

When contacted by the city attorney's office, RootMD said it had stopped selling the kits on April 8, according to the suit.

RootMD co-founder Philip Segenmark told Law360 on Wednesday evening that the company's test enabled people to know if they had been exposed to COVID-19 and if the antibodies for the virus was present in their system. But he said that the company has stopped offering the at-home kits and has refunded everyone who bought one to comply with government regulations.

"All of our blood collection and laboratory testing materials used were of the highest standard and were tested against different kits in our lab to ensure accuracy," Segenmark said. "We are a tele-health medicine service that provides our patients with the highest standard of care, and always strictly adhere to HIPAA guidelines and follows all governing regulations."

"We will continue to monitor the developments regarding the new regulations and guidelines, and will govern ourselves based on the new findings and rulings," he said.

As of Wednesday, RootMD's website featured a prominent banner about its kits saying it has paused the distribution of the product to allow the federal government to authorize such tests.

The company also reassured customers who ordered finger-stick blood collection kits in the past that the ones used to determine the presence of SARS-CoV-2 antibodies "fully met industry standards," according to the website.

RootMD's website also features the disclaimer that the tests and information offered by the company are for informational purposes and are not intended to diagnose, treat or act as a substitute for advice provided by a physician.

The suit claims violations of California's Unfair Competition Law, False Advertising Law and the Sherman Food and Drug Act, which regulates the manufacture and sale of medical devices in the Golden State.

The suit seeks an injunction barring RootMD from continuing the alleged misconduct, as well as a $2,500 civil penalty for each violation and restitution to those who bought the kits.

This isn't the only business the Los Angeles City Attorney's Office has gone after for trying to sell unapproved at-home coronavirus test kits.

Earlier this month, the office reached a deal with genetic testing company Yikon Genomics resolve claims that it was illegally advertising and selling at-home coronavirus testing kits that have not been approved by the FDA.

A representative for the city attorney's office did not immediately respond to a request for comment.

California is represented by Michael N. Feurer, Wilfredo R. Rivera, Christina V. Tusan, William R. Pletcher, Miguel J. Ruiz and Rebecca A. Morse of the Los Angeles City Attorney's Office.

Counsel information for RootMD was not immediately available.

The case is The People of the State of California v. RootMD Inc., case number 20STCV15180, in the Superior Court of California, County of Los Angeles.

--Editing by Amy Rowe.

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