The global scope of the coronavirus pandemic has resulted in a severe shortage of respirators, or what people commonly call face masks. In the U.S., the National Institute for Occupational Safety and Health (NIOSH) manages performance standards for respirators. Manufacturers seeking NIOSH approval for their products must go through a detailed and extensive application process. If approved, the respirator will bear NIOSH-approved markings, which include the manufacturer’s approval number, model and lot number, and the official NIOSH logo.
As noted by the Centers for Disease Control (CDC), NIOSH-approved N95 or better masks are the mainstay of preventing airborne diseases from being transmitted and is the minimum required mask for Health Law workers when treating cases of suspected coronavirus (COVID-19). A rush by the general public to purchase masks, combined with dramatically increased global demand, has resulted in a shortage of masks for first responders and medical professionals.
Unfortunately, unscrupulous individuals are taking advantage of this opportunity and are selling masks that have fake NIOSH markings. Fake masks often have the look and feel of approved ones, including the use of approval numbers from approved manufacturers. Counterfeits can be very convincing. Examples can be found here.
The scale of this problem is massive, and it is global. For example, Chinese authorities seized 31 million counterfeit masks in February 2020, and made 1,560 arrests.
Needless to say, these masks have not gone through NIOSH testing. Not surprisingly, tests by NIOSH revealed that many fake masks failed to meet minimum NIOSH protection standards.
In addition to the health consequences associated with use of fake masks, businesses are legally vulnerable if they buy or sell fake masks. For example, the Occupational Safety and Health Administration (OSHA) mandates that any masks used in workplaces where masks are required Personal Protective Equipment (PPE) must be NIOSH-approved. Failure to comply with this OSHA standard could result in a finding of noncompliance by the Employer. This finding could lead to civil monetary penalties and the need for corrective action.
Likewise, on March 2, 2020, the Food and Drug Administration (FDA) issued an emergency authorization to the CDC allowing the use of certain NIOSH-approved masks for medical uses even though the masks do not meet separate FDA requirements. The significance of this authorization is that these newly authorized masks are eligible for liability protection under the Public Readiness and Emergency Preparedness Act. The Act provides limited liability against claims of loss resulting from the distribution, administration or use of countermeasures to diseases that constitute a public health emergency, a determination made for COVID-19 on February 4, 2020. As such, NIOSH-approved masks authorized for emergency use by FDA are considered medical “countermeasures” and enjoy the Act’s liability protection. Businesses who purchase or sell fake masks will not have the liability protection afforded by the Act thus making them subject to future claims for injury.
Despite the quality of fakes, businesses should not expect claims of inadvertent purchases or sales of fake masks to protect them against liability or enforcement actions. The burden is on employers to use approved PPE, a burden which includes ensuring the PPE is legitimate and effective. In addition, sellers may be liable to purchasers as a result of express or implied warranties associated with their transaction. Sellers may be adjudged as knowing or that they should have known the quality of the products they sell. Businesses may find it difficult to defend claims brought by ill employees or buyers if it is shown the business issued or sold a fake mask. Moreover, businesses may find it difficult to recover any losses if the unscrupulous vendor or manufacturer is overseas or only exists virtually.
Businesses should purchase masks only from known vendors, and from manufacturers identified by the CDC. Businesses should be on guard if they find products with unusually low prices, seemingly unlimited availability in light of current shortages, or from obscure websites. Businesses can find information regarding NIOSH-approved masks here.
A list of NIOSH-approved masks that can be used as medical devices can be found here.
Businesses who become aware that they purchased or sold fake masks should seek advice from counsel. Our firm is available to help you assess your rights and liabilities, including what options may exist to recover from vendors or manufacturers of masks bearing false markings. In addition, our firm is available to advise on regulatory requirements and emergency authorizations during this trying time.
Please visit our specialized Coronavirus Legal Services page: