President Trump has signed legislation that provides liability protection to manufacturers of certain face masks used to address COVID-19. Manufacturers and distributors of a wider range of products, and others involved in the COVID-19 effort, may qualify for similar protection.
A provision of the Families First Coronavirus Response Act, H.R. 6201, provides that respirators certified by the National Institute for Occupational Safety and Health (NIOSH) and used in response to the outbreak are subject to liability protection under the Public Readiness and Emergency Preparedness (PREP) Act of 2005.
The PREP Act offers immunity from tort claims resulting from the administration to or the use by an individual of a “covered countermeasure.” Covered countermeasures include:
- A qualified pandemic or epidemic product, which is a drug, biological product or device approved or cleared by FDA to diagnose, mitigate, prevent, treat or cure a pandemic such as COVID-19, or a product or technology used to enhance the use or effect of such a drug, device or biological product;
- A security countermeasure, which is a drug, biological product or device that is used for these purposes and that the Secretary of the Department of Health and Human Services (HHS) finds to be a necessary countermeasure to protect public health; or
- A drug, biological product or device that is authorized for emergency use under certain provisions of the Federal Food, Drug, and Cosmetic Act.
H.R. 6201 creates a fourth category of a covered countermeasure: a NIOSH-approved personal respiratory protective device that is subject to an emergency use authorization issued by the HHS Secretary for use in response to the COVID-19 outbreak. The law covers any respirator approved by NIOSH under 42 C.F.R. part 84. These are non-powered, air-purifying, particulate-filter respirators, such as the common N95, which are single-use disposable devices that block 95% of particles. These respirators are certified by NIOSH to protect workers from various contaminants, but not all are FDA-cleared as medical devices for use in a healthcare setting. The new law will ensure that the PREP Act liability protection applies when respirators are used in response to COVID-19 until the provision sunsets on October 1, 2024.
Other industries that are contributing to the COVID-19 response effort can benefit from the PREP Act’s liability protection. To do so, a product must qualify as a “covered countermeasure” and be included within a PREP Act declaration issued by the HHS Secretary. Other declarations, such as a Public Health Emergency Declaration or Emergency Use Authorization, may permit a product’s use for otherwise unauthorized purposes during an emergency, but do not, alone, trigger the PREP Act’s liability protection.
HHS Secretary Alex Azar issued a PREP Act declaration on March 10, 2020, addressing medical countermeasures against COVID-19. Under the declaration, covered countermeasures include “any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product.”
The declaration observes that the PREP Act’s liability protection depends on the facts and circumstances of each case. For example, the Directive notes that “liability claims alleging negligence by a manufacturer in creating a vaccine, or negligence by a health care provider in prescribing the wrong dose, absent willful misconduct” fall within the Act’s protection. “Likewise, the Act precludes a liability claim relating to the management and operation of a countermeasure distribution program or site, such as a slip-and-fall injury or vehicle collision by a recipient receiving a countermeasure at a retail store serving as an administration or dispensing location that alleges, for example, lax security or chaotic crowd control.” Lawsuits alleging injuries that are not directly related to countermeasure activities are not covered.
Persons injured as a result of covered countermeasures do not have a tort remedy but may be entitled to recover from a federal fund called the Countermeasures Injury Compensation Program.
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