Law360 is providing free access to its coronavirus coverage to make sure all members of the legal community have accurate information in this time of uncertainty and change. Use the form below to sign up for any of our weekly newsletters. Signing up for any of our section newsletters will opt you in to the weekly Coronavirus briefing.
Sign up for our Consumer Protection newsletter
You must correct or enter the following before you can sign up:
Thank You!
Law360 (June 5, 2020, 10:10 PM EDT) -- A Chinese manufacturing company produced and exported nearly half a million misbranded and defective masks to the United States as the country scrambled to equip its medical workers with personal protective equipment amid the coronavirus pandemic, the U.S. Department of Justice said Friday.
In a complaint filed in Brooklyn federal court, prosecutors said that between April 6 and 21, King Year Packaging and Printing Co. Ltd. manufactured nearly 500,000 defective masks that they claimed to be N95 respirators and then exported them to be sold in the U.S.
The company stamped the National Institute for Occupational Safety and Health and U.S. Food and Drug Administration logos on the packaging for its masks, even though the products were not approved or authorized by either of the agencies, prosecutors said. The masks were also labeled "N95," prosecutors said, even though they fell well below the minimum 95% filtration standard.
Federal authorities seized the shipments of masks in April at John F. Kennedy Airport in New York, according to the complaint.
NIOSH-approved N95 masks must filter out at least 95% of small particles, such as droplets that can contain viruses, but when the Centers for Disease Control & Prevention tested King Year's masks, all of the masks tested with a filter efficiency rate of below 90%, according to prosecutors.
Prosecutors said King Year's misbranded and defective masks could have deceived U.S. consumers, including health care workers and first responders, into believing they were buying authentic N95 respirators, which would put them at risk.
To cover up the poor quality of its masks, King Year provided false documents attesting to their authenticity and filled out a fraudulent registration statement with the FDA.
Federal prosecutors charged King Year with violating the U.S. Food Drug and Cosmetic Act for exporting substandard masks to the U.S. and falsely saying they met the N95 respirator standard. The company was also charged with making a false statement.
Each charge carries a maximum fine of $500,000 or the greater of twice the gross gain or twice the gross loss from the offense, prosecutors said.
"These charges demonstrate the continued commitment of the DOJ and our partners to aggressively pursue those who sell misbranded and defective personal protective equipment, whether they are located here or abroad," Craig Carpenito, U.S. Attorney for the District of New Jersey, said in a statement Friday. "We will aggressively investigate and charge manufacturers that put our medical professionals and first responders at risk in fighting this crisis."
Contact information for King Year was not immediately available.
The government is represented by Jonathan Fayer of the Economic Crimes Unit for the U.S. Attorney's Office for the District of New Jersey.
Counsel information for King Year was not immediately available.
The suit is U.S. v. King Year Printing and Packaging Co. Ltd., case number 20-mj-00416, in the U.S. District Court for the Eastern District of New York.
--Editing by Jay Jackson Jr.
For a reprint of this article, please contact reprints@law360.com.
