Dan Brown speaks on “Immunity for COVID Countermeasures: HHS Declaration under PREP Act Provides Immunity to Countermeasures Manufacturers, in Certain Circumstances” during the Association for Corporate Counsel Greater Philadelphia chapters’ 12th Annual In-house Counsel Conference.
There is a critical need at this time to develop drugs and devices designed to prevent and treat COVID-19 as quickly as possible. However, conducting an accelerated clinical trial inherently carries more risk, and no company developing potentially life-saving treatments wants to become the target of a product liability lawsuit down the road. In order to foster the speedy development of treatments for COVID-19 and address liability concerns, on March 10, 2020, the Department of Health and Human Services issued a declaration pursuant to the Public Readiness and Emergency Preparedness (PREP) Act. This presentation provides an overview of the scope of tort immunity under the PREP declaration, limitations, and steps companies engaged in activities relating to treatments for COVID-19 can take to remain covered.