Earlier this year, we published various articles breaking down the March 10, 2020 Public Readiness and Emergency Preparedness Act (PREP Act) Declaration (the Declaration) related to COVID-19. We’ve also published several pieces since then highlighting subsequent developments for the application of the PREP Act, and you can read our prior publications providing key background on the Declaration, realted herein.
At the time of our last communications, we were not yet able to provide insights on how courts would interpret and apply the Declaration. August finally brought with it the first court decisions construing the Declaration, and they arise in the context of the removal of nursing home negligence actions to federal court. The cases are out of New Jersey and Kansas. While the decisions are far from clear precedent in all contexts, they shed some light on how courts are reading various provisions of the Declaration, and how broadly (or not) they are interpreting the scope of its immunity.
Quick COVID-19 PREP Act Refresher
Enacted in 2005, the PREP Act authorizes the Secretary of Health and Human Services (the Secretary) to provide certain individuals and entities (referred to as “covered persons”) with immunity from liability arising out of or related to the manufacture, distribution, administration, or use of certain covered medical countermeasures (referred to as “covered countermeasures”), except for claims of willful misconduct. The Act defines “covered countermeasures” as “pandemic or epidemic product[s]” or “drug[s] or device[s]” (as defined by the FDA) that are authorized for emergency use.
In March 2020, the Secretary published several declarations providing immunity for certain countermeasure activities related to the COVID-19 pandemic. One of these declarations expanded the definition of “covered countermeasures” to include drugs, diagnostics, devices, or vaccines used to treat, diagnose, or mitigate COVID-19 or its transmission, or any device used in the “administration” of one of those products.[1] The PREP Act also contains an explicit preemption provision prohibiting any state from “establish[ing], enforc[ing], or continu[ing] in effect with respect to a covered countermeasure any provision of law or legal requirement” that is different from, or in conflict with, any requirement under the PREP Act and that relates to any activity involving the development, manufacture, or administration of the covered countermeasures.
In these contexts, the Secretary recently clarified that the term “administration” means: (1) the actual provision of countermeasures to recipients; (2) the activities and decisions directly relating to the distribution and dispensing of countermeasures to recipients; (3) the management and operation of countermeasure programs; or (4) the management and operation of locations for the purpose of distributing and dispensing countermeasures.
First COVID-19 PREP Act Jurisprudence
The first decision was issued in the case Estate of Maglioli v. Andover Subacute Rehabilitation Center I, 2020 WL 4671091 (D.N.J. Aug. 12, 2020), where the U.S. District Court for the District of New Jersey ruled that the PREP Act could not be used to remove to federal court state law claims against a nursing home for its alleged negligent failure to follow appropriate safety precautions relating to COVID-19.[2]
The defendants, a nursing home operator and certain of its employees, argued, inter alia, that the sweeping immunity conferred by the March 2020 PREP Act Declaration created federal jurisdiction by completely preempting the plaintiffs’ state-law negligence claims: [3]
Defendants removed the actions on the basis that the PREP Act “provides liability protections for pandemic and epidemic products and security countermeasures,” including “respiratory protective devices.” Defendants state that they are “covered persons” under the PREP Act and that such “a ‘covered person’ shall be immune 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’ during a health emergency.
[4]
The plaintiffs countered that the defendants’ alleged conduct did not fall within the scope of the PREP Act because their claims were “not directed against Defendants’ role in the manufacturing, distribution, administration, or use of a covered countermeasure.” Ultimately, the Court sided with the plaintiffs and ruled that the PREP Act did not provide a basis for federal jurisdiction.[5] In reaching this decision, the Court imposed two important limitations on the scope of the PREP Act’s immunity and its preemption provision.
First, despite recognizing the PREP Act’s “explicit provision regarding preemption” in Section 247d-6d(b)(8), the court somewhat confusingly applied implied—rather than express—preemption principles in concluding that the PREP Act’s preemption clause does not “mandate a federal forum.” It then incorrectly concluded that the express preemption provision in the Act, “at most, restricts a state from passing a law that would conflict with the federal government’s requirements for . . . covered countermeasures.”[6]
Second, the Court held that preempted conduct under the Act is limited to the “‘physical provision of the countermeasures to recipients,” or “relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for purpose of distributing and dispensing countermeasures.’”[7] In other words, “the Act, as extended by the declarations, covers the administration and distribution of products meant to curb the spread of COVID-19 but does not, by its plain terms, cover more generally the care received by patients in healthcare facilities.”[8] The Court, therefore, agreed with the plaintiffs that their claims that countermeasures that were not used [9] did not fall within the scope of the PREP Act and “would not be preempted by the PREP Act, which is designed to protect those who employ countermeasures, not those who decline to employ them.”[10]
Following the Maglioli Court’s decision, additional COVID-19 PREP Act removal rulings were issued in a different set of 12 cases in the United States District Court of Kansas involving similar allegations of negligence against a nursing home facility for COVID-19-related injuries.[11] The rulings in these cases are legally identical to one another and the Court reached similar conclusions as the Maglioli Court, remanding the cases upon finding the PREP Act inapplicable because it applies to action, not inaction, as alleged in the plaintiffs’ complaints.
Comment
These initial decisions certainly cast doubt on the ability of nursing homes, and perhaps healthcare providers/facilities more broadly, to obtain PREP Act immunity for state-law claims for alleged COVID-19-related failures to act or, at the very least, to remove these claims to federal court. The courts’ refusals to apply the PREP Act to negligent omissions are, however, not particularly surprising given the language of the Declaration and the separate state-enacted executive orders (as recognized by the Maglioli Court) conferring broader civil liability immunity upon healthcare workers for COVID-19-related claims, as discussed earlier[12]. Though the law in this area is still far from developed, these removal decisions may set the stage for other courts to adopt a similar line of reasoning going forward in this context. As separate state-enacted immunity provisions vary widely from one state to the next (if they exist at all), healthcare facilities and practitioners should take care to review any such separately-applicable protections and should not count on the PREP Act as a mechanism for removal or likely source of immunity, especially when it comes to conduct not directly related to the use or administration of covered countermeasures.
[1] The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) then further expanded this definition by including OSHA-approved respiratory protective devices (i.e., face masks) as a “covered countermeasure.”
[2] Specifically, the plaintiffs claimed the nursing home failed to monitor outside visitors, food preparation, employees and other residents and also failed to implement proper protocols and procedures, such as providing personal protective equipment, including face masks, to certain staff members.
[3] Magioli, 2020 WL 4671091, at *2. The other basis was federal officer jurisdiction under 28 U.S.C. §1442(a)(1), though it is the first ground that is the focus of this piece.
Id.
[4] Id. (citing 42 U.S.C. § 247d–6d(a)(1)).
[6] As noted elsewhere, this overly-narrow interpretation that the preemption clause “at most” restrict a state from passing a conflicting law is incorrect, as it is already well-established that an express preemption provision preempting state “requirements” includes preemption of conflicting state tort law/common law duties, not just legislation.
Riegel v. Medtronic, Inc., 552 U.S. 312, 324 (2008) (citations omitted);
see also https://www.druganddevicelawblog.com/2020/08/first-prep-act-immunity-decision-that-weve-seen.html.
[7] Id. at *6 (quoting HHS “supplemental information”).
[8] The Court also noted that “acts such as social distancing, quarantining, lockdowns, and [the like] . . . are not covered ‘countermeasures’ under the PREP Act at all.”
Id. at *10 (citation and quotation marks omitted).
[10] Id. The Court reasoned that this interpretation of the Act’s limited scope is further supported by the fact that several states, including New Jersey, have “filled the gap” by issuing separate executive orders providing for immunity from civil liability for damages alleged to have been sustained as a result of an act or omission undertaken in good faith in the treatment of COVID-19.
[11] Id. See, e.g.,
Lutz v. Big Blue Healthcare, Inc., 2020 WL 481500, at *8 (D. Kan. Aug. 19, 2020).
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