On the last full day of the Trump Administration, the Department of Justice (DOJ) submitted a statement of interest in litigation supporting the position that the Public Readiness and Emergency Preparedness (PREP) Act preempts legal claims relating to the administration or use of covered countermeasures with respect to a public health emergency and, therefore, makes such claims removable from state court. However, it remains to be seen whether the views expressed in the statement of interest, which was filed in Bolton v. Gallatin Center for Rehabilitation & Healing, LLC, Civil Action No. 3:20-cv-00683 (M.D. Tenn.), will continue to be the official position of DOJ following the recent change in presidential administration. Notably, the position advanced by DOJ’s statement of interest is consistent with guidance recently issued by the outgoing General Counsel of the Department of Health and Human Services, which concluded that the PREP Act is a “complete preemption” statute.
The PREP Act is a critical component of the concerted federal effort to promote the “[r]apid distribution and administration of medical countermeasures” in response to a public health emergency,” and vests the Secretary of Health and Human Services with the authority to determine the existence or credible future risk of a public health emergency, and to issue a declaration recommending administration of specified countermeasures. 42 U.S.C. § 300hh-1(b)(2). See also id. § 247d-6d(b). In light of the fact that successful distribution and administration of these countermeasures depends upon the cooperation of private-sector partners and state and local officials, Congress provided broad immunity to “covered persons” for claims relating to the administration to, or use by, an individual of countermeasures that aid in that response. See id. §§ 247d-6d(i)(2), 247d-6d(a).
Consistent with these principles, DOJ’s recent statement of interest notes that PREP Act immunity is sweeping, and that all damages actions for conduct relating to covered persons’ administration of countermeasures specified in a PREP Act declaration are preempted. DOJ contends that the PREP Act constitutes a complete-preemption statute with respect to the administration or use of covered countermeasures by covered persons under a declaration by the Secretary, relying on the immunity and exclusive alternative remedy provisions in support of this position.
First, the immunity provision provides for immunity “under Federal and State law with respect to all claims for loss caused by, arising out of, or resulting from the administration” of countermeasures specified by the Secretary. Id. § 247d-6d(a)(1). Second, the “sole exception” to the immunity grant is “an exclusive Federal cause of action” for claims of willful misconduct resulting in death or serious physical injury. Id. §247d-6d(a)(1). DOJ’s statement of interest contends that, together, these provisions show that Congress determined that state-court tort actions are not an appropriate means, in this emergency, to deter tortious conduct, except as provided in the “exclusive” federal cause of action created by the statute itself. See 42 U.S.C. § 247d-6d(d)(1).
In further support of its position, DOJ’s statement of interest relies on existing case law for the proposition that a reference in a statute to an “exclusive” remedy or cause of action is demonstrative of Congress’s intent for a completely preemptive reading of the statute.
Based on the foregoing, the statement of interest argues that the PREP Act provisions supersede state tort laws and create a federal remedy for certain claims of loss related to covered countermeasures that is exclusive, even when premised entirely on state law.