HHS Secretary Azar Announces Certain Protections From Liability For Covered Medical Countermeasures to Combat COVID-19

U.S. Health and Human Services Secretary Alex Azar has issued a declaration addressing a range of potential liability protections for those engaged in medical countermeasures to combat COVID-19, effective February 4, 2020.  

Secretary Azar issued the declaration under the Public Readiness and Emergency Preparedness Act (PREP Act), 42 U.S.C. § 247d-6d. The act gives the Secretary the authority to declare that specified “covered countermeasures” are needed to combat a public health emergency. Such declarations under the PREP Act provide “immun[ity] from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure.” Id. § 247d-6d(a)(1). The act also expressly preempts any state law that “is different from, or is in conflict with, any requirement” established regarding the covered countermeasures. Id. § 247d-6d(b)((8).  It provides that the “sole exception to the immunity from suit and liability” is “an exclusive federal cause of action” for “death or serious physical injury proximately caused by willful misconduct.” The act also creates a pathway to federal compensation for individuals injured by “covered countermeasures” whose suits are preempted. The PREP Act was enacted in 2005 and has been used a handful of times — although not in incidents of this potential scale in the United States.  

The Secretary’s invocation of the PREP Act provides immunity for “the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures.” Covered countermeasures are defined as “any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19 … or any device used in the administration of any such product…,” limited to activities related to federal agreements or to “activities authorized in accordance with the public health and medical response” of state or local public agencies. There remain unanswered questions about the scope and applicability of the declaration as well as uncertainty about how courts will interpret the underlying statutory preemption provision.