The coronavirus (COVID-19) pandemic has made the development and use of drug and device products to diagnose, treat, or prevent COVID-19 essential. Companies and healthcare providers that develop, manufacture, distribute, or use COVID-19 countermeasures, such as diagnostic tests, ventilators, and personal protective equipment, have had the benefit of potential broad liability protection under the federal Public Readiness and Emergency Preparedness (PREP) Act. Early on in the pandemic, the US Department of Health and Human Services (HHS) issued a declaration to provide liability protection for COVID-19 countermeasures.
With vaccines on the horizon amid the surging pandemic, HHS has acted to expand the scope of PREP Act liability protections. On December 3, 2020, HHS issued its Fourth Amendment (Amendment) to the PREP Act declaration. The Amendment expands PREP Act liability protections to the following:
- Telehealth providers
- Private distribution
- Prioritization decisions
- Vaccine administration and distribution
For more information on the PREP Act, see our July 2020 LawFlash, The PREP Act: Critical Liability Immunity for Critical Products, and August 2020 webinar, The PREP Act and Other Immunities: Provider Relief for COVID-19-Related Claims.