Preparing for the COVID-19 Immunity Preemption Defense

As manufacturers of vaccines, pharmaceutical medicines, ventilators and respirators engage substantial resources and ramp up production to help fight COVID-19, many have presumably done so under the immunity protections afforded by the federal Public Readiness and Emergency Preparedness Act (the PREP Act codified at 42 USC §247d-6d), and Coronavirus Aid, Relief, and Economic Security Act (the CARES Act). Because of industry-wide uncertainty surrounding PREP Act immunity and the need for immediate and urgent action on the part of manufacturers, the U.S. Department of Health and Human Services (HHS) recently issued a non-binding Advisory Opinion explaining the scope of PREP Act coverage, its immunity provisions in the context of COVID-19 countermeasures, and informal guidance on the preemptive effect of the federal law.