How to Get Away with Immunity: FDA's Emergency Use Authorization Scheme and PREP Act Liability Protection in the Context of COVID-19

Abstract

The U.S. Food and Drug Administration (FDA) plays a vital role in our country’s response to biological agents that threaten public health and safety. On December 31, 2019, officials in Wuhan, China confirmed dozens of cases of pneumonia caused by an unknown pathogen. Chinese officials later identified that pathogen as severe acute respiratory syndrome coronavirus (SARS-CoV-2), which causes the disease COVID-19. The COVID-19 pandemic has created a perfect storm for unprecedented and litigation-provoking health harms in the United States. As the country’s death toll rises and states seek to reopen, many Americans are assessing their COVID-19-related health status based on the results of diagnostic and antibody tests, which have been cleared through the FDA’s emergency use authorization scheme notwithstanding their concerning inaccuracy rates.

This paper argues that the unacceptably high inaccuracy rates of these COVID-19 tests are a direct result of lax FDA regulation and oversight under current federal law. The Public Readiness and Emergency Preparedness Act of 2005 (PREP Act) established a framework that extends blanket immunity from liability to the manufacturers of medical products, including blood assays and serology tests, that are used to diagnose and treat COVID-19. The breadth and scope of the statute’s immunity make it nearly impossible for an injured plaintiff to recover from injuries sustained from their use of or reliance on diagnostic tests. This paper details and critiques PREP Act immunity and proposes several PREP Act reforms aimed at enhancing public health and safety during a infectious disease pandemic. As special interest groups ramp pressure of the federal and state legislatures to enact additional immunity protection as the states reopen, the quality of COVID-19 related care and treatment is likely to continue to worsen unless and until the country implements reforms that authorize meaningful medical device regulation and oversight.

Keywords: FDA Law, Medical Devices, COVID-19, Diagnostic Devices, In Vitro devices