In times of national public health crises such as the COVID-19 pandemic, manufacturers and distributors of products are often called to the frontlines of battle to create, supply, and administer the tools necessary to combat the spread of infectious disease. To be sure, expansion of manufacturing and distribution of such products, known as countermeasures, raises questions regarding potential liabilities for those in the chain of supply. In order to alleviate such concerns and expand immunity for manufacturers and suppliers of important products and medical devices used to combat COVID-19, the federal government has taken two significant steps: (1) Passage of the Families First Coronavirus Response Act which, in relevant part, amends prior legislation to expand immunity for manufacturers of masks; and (2) Issuance of an administrative declaration that provides relatively broad immunity to manufacturers and distributors of other products used as countermeasures.
Masks for Respiratory Protection
Concerns about respiratory protective device shortages have been well-publicized by medical professionals, the media, and government officials in light of the anticipated surge in patients treated by hospital physicians resulting from COVID-19. The Public Health Service Act previously provided immunity to manufacturers of FDA-approved masks only. Whereas FDA-approved face masks are only a small subset of available respiratory protective devices, masks approved by the National Institute for Occupational Safety and Health (“NIOSH”) make up the vast majority of face masks on the market. As such, Congress recently enacted the Families First Coronavirus Response Act, HR 6201; a provision in this legislation expands the immunity previously afforded to manufacturers of FDA-approved masks to manufacturers of NIOSH-approved respiratory protection devices during the period of January 27, 2020 to October 21, 2024 as well. Such legislation is aimed at incentivizing mask producers to increase the supply of available respiratory protection for medical professionals in close contact with the virus by granting manufacturers immunity to lawsuits that could result despite the need for these devices in the midst of a pandemic.
Additional Countermeasures for COVID-19 Response
The Public Readiness and Emergency Preparedness Act (“PREP Act”), codified at 42 U.S.C. 247d-6d, empowers the Department of Health and Human Services (“HHS”) to issue a declaration that immunizes covered entities and individuals from liabilities that could stem from the use of countermeasures to combat disease and/or threats deemed to constitute a public health emergency. HHS recently issued a declaration under the PREP Act granting immunity from liability under state and federal law against all claims “caused by, arising out of, relating to, or resulting from” the “manufacture, testing, development, distribution, administration, and use” of a countermeasure that is aimed at responding to COVID-19 (the “Prep Act Declaration”).
As applicable to COVID-19, the PREP Act Declaration defines countermeasures broadly as “qualified pandemic or epidemic product[s],” which are generally drugs, devices, and biological products manufactured, used, designed, developed, or otherwise procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic disease, and other “drugs, biological products, or devices authorized for investigational or emergency use.” Accordingly, the PREP Act Declaration contemplates countermeasures in the forms of an “antiviral” or “other drug,” a “biologic,” diagnostic,” and/or “vaccine used to treat, diagnose, cure present, or mitigate COVID-19.” Additional countermeasures include the components and constituent materials of the above products, as well as devices used to administer the above products. Immunity generally applies to manufacturers and suppliers of countermeasures and, significantly, to those who “prescribe, administer, deliver, distribute, or dispense” such counter-measures, thus providing protection downstream for healthcare professionals and pharmacists.
The only exception to this immunity is for claims of willful misconduct on the part of manufacturers, suppliers, or persons administering the countermeasure. In fact, the PREP Act itself generally strikes a balancing act in encouraging the production of countermeasures—a clear benefit to society in times of public health crisis—by providing the above immunity, while providing relief to eligible claimants in the form of a federally-funded Countermeasures Injury Compensation Program.
Takeaway for Product Manufacturers and Distributors
Manufacturers and suppliers of countermeasures designed to treat, respond to, and prevent the spread of COVID-19—including masks, drugs, vaccines, and devices—provide important defenses in combatting the current national public health crisis. In turn, the federal government has enacted protective measures to provide these manufacturers and distributors with defenses to liability in the form of immunity to suit. Though product manufacturers should continue to employ reasonable care in designing, developing, creating, and distributing countermeasures, the immunity granted in the above laws provides those engaged in the production, supply, and administration of countermeasures with a robust defense in the event of a lawsuit.
