The Department of Health and Human Services (“HHS”) recently issued a declaration under the Public Readiness and Emergency Preparedness (“PREP”) Act to provide immunity to liability for activities related to medical countermeasures against COVID-19. The declaration is effective retroactively to February 4, 2020.
The declaration provides liability immunity to covered individuals and entities “against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures.” More specifically, the declaration covers “products or technologies intended to enhance the use or effect of a drug, biological product, or device used against the pandemic or epidemic or against adverse events from these products.” The Covered Countermeasure must be a qualified or epidemic product, or security countermeasure, or a drug, biologic or device authorized for emergency use.
The liability immunity applies to “Covered Persons” with respect to the administration or use of Covered Countermeasures. The declaration defines “Covered Persons” as “manufacturers, distributors, program planners and qualified persons, and their officials, agents, and employees, and the Unites States.” The declaration further defines “manufacturer,” “distributor,” “program planner,” and “qualified person.”
The declaration provides some specific examples of when liability immunity would be in effect, including claims alleging negligence against a manufacturer in developing a vaccine, claims alleging negligence against a healthcare provider in prescribing the wrong dose, and claims relating to the management and operation of a countermeasure site (for example, a slip-and-fall injury or vehicle collision). However, a liability claim alleging injury not directly related to the countermeasure is not covered.
In addition, the declaration provides liability immunity for the administration of Covered Countermeasures “without geographic limitation.” That is, the liability protection includes claims related to the use of the countermeasure in the US and in countries outside the US that may, for example, be resolved under US law.
HHS notes that individuals who sustain a serious injury or die as a result of the administration of a Covered Countermeasure are eligible tor receive benefits from the Countermeasures Injury Compensation Program (“CICP”). To do so, the individual must show “direct causation” between the Covered Countermeasure and a serious physical injury with “compelling, reliable, valid, medical and scientific evidence.”
The declaration does not provide immunity to liability for “willful misconduct.” In addition, HHS notes that the declaration is subject to amendment if circumstances warrant. Liability immunity extends through October 1, 2024.