Betsy J. Grey1Jack E. Brown Chair in Law, Sandra Day O’Connor College of Law at Arizona State University. I thank Bob Dauber, Zachary Kramer, and Joel Nomkin for their valuable comments on earlier drafts and Sean Krieg for his outstanding research assistance.
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Although Congress has so far declined to enact any immunity protection specifically targeted at COVID-19 claims, that has not stopped the Executive Branch from responding to the pandemic with immunity measures. Invoking its authority to respond to public health emergencies under the 2005 Public Readiness and Emergency Preparedness (PREP) Act, the Department of Health and Human Services (HHS) has declared that the immunity provisions in that Act extend to civil liability claims arising from various COVID-19 countermeasures taken by specified businesses. A critical topic of debate and litigation—and the subject of this Essay—concerns the extent to which this immunity protection should apply to nursing homes.
Estimates suggest that deaths in nursing homes and other long-term care facilities account for approximately one-third of COVID-19 deaths in the United States. Examples abound of significant failures to control the virus in those contained settings. The resulting injuries and deaths have spawned lawsuits against nursing homes. Indeed, a large percentage of the COVID-related personal injury claims filed thus far involve nursing homes.
Significantly, the allegations in these lawsuits have centered more on nursing homes’ failure to take mitigation measures—such as failure to use appropriate medical supplies or personal protective equipment (PPE)—rather than on the quality of their mitigation measures.2See generally, e.g., Lyons v. Cucumber Holdings, LLC, No. CV 20-10571-JFW(JPRx), 2021 U.S. Dist. LEXIS 20838 (C.D. Cal. Feb. 3, 2021), appeal docketed, No. 21-55185 (9th Cir. Mar. 3, 2021). Nursing homes have attempted to defend against these claims based on PREP Act immunity. Until very recently, courts consistently rebuffed this defense, holding that PREP Act immunity does not apply to failure-to-act claims, as the purpose of the Act is to address harm from use of countermeasures. In the waning days of the Trump Administration, however, HHS issued an amendment to the Act (the Amendment) that interprets the Act as extending immunity to at least some claims based on a nursing home’s failure to take mitigation measures if that failure reflects the home’s deliberate choice to allocate resources among victims. HHS subsequently issued an advisory opinion (the Opinion) that extends immunity coverage even more broadly to anything relating to the administration of a covered countermeasure, including the failure to use countermeasures. At least one federal district court has relied upon that Opinion in holding that PREP Act immunity applies to any COVID-related exposure claim against a nursing home, regardless of whether it involved affirmative use of a countermeasure.
This Essay questions the wisdom of HHS’s Opinion and its interpretation of the Amendment. If the Opinion continues to earn respect in the courts, it may close the courthouse to large numbers of victims who have suffered injury because of nursing home neglect. Part I below describes the PREP Act’s immunity coverage and the Executive’s authority to trigger that coverage by declaring a public health emergency, as it has done in response to COVID-19. Part II briefly reviews the early federal district court decisions rejecting federal immunity protection for claims alleging the failure of nursing homes to use mitigation measures during the pandemic. Part III highlights the HHS response to that developing jurisprudence through its Amendment to the PREP Act and its expansive Advisory Opinion. Part IV argues that the Advisory Opinion, in interpreting the Amendment, misreads the words and purpose of the PREP Act’s immunity provisions, undermines accountability of the nursing home industry, creates the wrong incentives for the industry, and may leave worthy victims without any remedy. The Opinion, and if necessary, the Amendment, should be rescinded so that tort law may continue to protect one of society’s most vulnerable populations.
I. Invoking Immunity Measures
Congress enacted the PREP Act in 2005 in reaction to a potential pandemic from the H1N1 avian flu as well as concerns about potential bioterrorism threats like anthrax. The PREP Act contains two provisions of significance here: (1) it empowers the HHS Secretary to trigger PREP Act immunity coverage for manufacturers, distributors, and administrators of critical medical supplies and measures to facilitate the emergency response; and (2) it establishes a compensation program for injuries resulting from use of those measures.
A. The PREP Act’s Immunity Provisions
The PREP Act encourages the production of countermeasures in a health emergency by creating immunity from tort liability for their development, distribution, and use following an emergency declaration. The Act defines countermeasures as devices, products, and drugs that are used or procured to mitigate a pandemic or epidemic. They can include diagnostic tests, protective equipment, vaccines, and treatments authorized for emergency use under the Federal Food, Drug, and Cosmetic Act. Immunity relating to countermeasures extends to “covered person[s]” for “all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use” of countermeasures. The scope of this immunity is broadly defined:
The immunity . . . applies to any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure, including a causal relationship with the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of such countermeasure.
The only exception to this immunity is for serious injuries or death stemming from “willful misconduct” that can be proven by clear and convincing evidence. Notably, the immunity terms of the Act only address harms relating to the administration or use of countermeasures and make no mention of omissions.
The PREP Act enables HHS to trigger immunity protections by declaring a public health emergency. Pursuant to this authority, on March 17, 2020, HHS published a PREP Act Declaration that will last until October 2021 unless terminated earlier. In a series of amendments to its original March 2020 COVID-19 declaration, HHS has continued to expand the scope of PREP Act immunity in the COVID-19 context. These expansions have broadly extended the definition of countermeasures and qualified persons, as well as the preemptory scope of the PREP Act. For purposes of nursing home coverage,3While this Essay centers on the ambiguity over the PREP Act’s immunity (or lack of it) for nursing homes, far clearer is the Act’s immunity coverage for vaccine development and administration, which are the primary focus of its immunity coverage and were some of the first countermeasures listed in the original declaration. Extending immunity to vaccine development incentivized the industry, and vaccines have been a major success story of the pandemic. Within months after the outbreak in the United States, three vaccines, developed by Pfizer-BioNTech, Moderna, and Johnson & Johnson, received emergency approval by the Food and Drug Administration (FDA) and the United States undertook the largest mass inoculation campaign in its history. the amendment most relevant is Section IX of the Amendment, which says that not administering a covered countermeasure in order to administer it to another individual could be considered “relating to” the administration of a countermeasure if it is the result of a deliberate decision to allocate scarce countermeasures.
As noted, the PREP Act preempts civil law claims against certain covered individuals. The Act states that 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 . . . of a covered countermeasure.” Further, during the effective period of the public health emergency, the Act preempts state laws that create standards regarding covered countermeasures that are “different from, or . . . in conflict with, any requirement applicable” under the Act. Although the PREP Act may offer complete preemption and thus provide a basis for federal question jurisdiction, courts have split on when the PREP Act immunity is triggered, and vests exclusive jurisdiction in federal court.4Compare Jackie Saldana v. Glenhaven Healthcare LLC, No. CV205631FMOMAAX, 2020 WL 6713995 (C.D. Cal. Oct. 14, 2020), appeal docketed, No. 20-56194 (9th Cir. Nov. 13, 2020) with Garcia v. Welltower OpCo Group LLC, No. SACV2002250JVSKESX, 2021 WL 492581 (C.D. Cal. Feb. 10, 2021), appeal docketed, No. 21-55224 (9th Cir. Mar. 10, 2021).
B. The Prep Act’s Compensation Program
The PREP Act tries to balance its immunity protection with provisions in the Countermeasures Injury Compensation Program (CICP). This program is intended to compensate anyone seriously injured by covered countermeasures, including but not limited to vaccines, following a PREP Act Declaration. Other than claims of willful misconduct, all claims for injuries “directly caused by the administration or use of a covered countermeasure” must be pursued through the CICP. HHS advises claimants that they may need to “demonstrate” that the injury occurred from the administration or use of a countermeasure “based on compelling, reliable, valid, medical and scientific evidence.” Further, the CICP only provides “compensation to eligible individuals for covered injuries directly caused by the administration or use of a covered countermeasure” (emphasis added). Similar to the section creating tort immunity under the Act, the CICP provision makes no mention of claims for the failure to use countermeasures. Thus, unless the Advisory Opinion’s interpretation of “use” is carried over to the CICP, nursing home victims who suffer harm from the failure to use a countermeasure—as opposed to harm from an implemented countermeasure—would not be eligible for any compensation, either in tort or under the statute.
As plaintiffs began to file lawsuits against nursing homes, courts struggled with whether the PREP Act protections are triggered by claims arising from the non-use of countermeasures. This Essay now turns to those decisions.
II. Recent Decisions Examining PREP Act Preemption for Nursing Homes
The claims alleged in most of the COVID-19 lawsuits brought against nursing homes include failing to use sufficient mitigation measures such as testing or social distancing, failing to provide sufficient protective gear, failing to staff adequately, or failing to prevent infected employees from entering the facility. These lawsuits have been brought in state court based on state common law theories.5Although this Essay focuses on federal immunity, immunity protections for nursing homes also exist on the state level. A week after invoking the PREP Act, HHS Secretary Alex Azar urged governors to extend tort immunity to health care professionals treating COVID-19 patients. Over half of the states have issued orders extending some immunity from civil liability to health care providers and other parties involved in fighting the COVID-19 pandemic. These immunity shields generally do not completely preempt tort litigation. Instead, they generally raise the level of culpability and pleading standards for suits brought against certain defendants. Over twenty-six states and the District of Columbia have provided immunity from tort liability specifically for nursing homes. Some states have rolled back that protection, however. In response, nursing homes have removed the suits to federal court and then moved to dismiss them based on the PREP Act’s preemption and immunity provisions. Thus far, most federal courts that have considered these removal efforts have rejected them. These courts held that claims based on the failure to use countermeasures are outside the preemptive reach of the PREP Act and remanded the cases back to state court for litigation of the state common law claims.6See, e.g., Lyons, 2021 LEXIS 20838.
One of the first cases on point is Estate of Maglioli v. Andover Subacute Rehabilitation Center I. There, the defendants removed wrongful death, negligence, and medical malpractice claims brought by the estates of residents at two senior living facilities, arguing that complete preemption applied under the PREP Act. The federal district court disagreed and remanded, finding that the purpose of the PREP Act was to encourage the use of countermeasures: “Nothing in the language of the Act suggests that it was intended to more broadly displace state-law causes of action for, e. g., malpractice or substandard care—even if proper care possibly would have entailed administration of such countermeasures.” It held that the PREP Act does not protect those who decline to use available remedies or fail to take other mitigation measures, such as social distancing, quarantines and lockdowns.
Citing Maglioli, a Kansas district court in Jackson v. Big Blue Healthcare, Inc. remanded twelve related wrongful death cases brought by the estates of persons who had been residents in an assisted living facility. The court held that the “PREP Act’s provisions regarding the administration or use of covered countermeasures” were not applicable to a case arising from an alleged “failure to follow certain policies, procedures, and guidelines regarding COVID-19.” It found that claims protected under PREP Act would have to allege that the decedent’s death was caused by the use of a covered countermeasure for the treatment of COVID-19 but that this “claim seems to be precisely the opposite: that inaction rather than action caused the death.” As the district court stated, “[t]here is simply no room to read [the PREP Act] as equally applicable to the non-administration or non-use of covered countermeasures.”
A district court in California also remanded to state court a suit brought by the estate of a man who died of COVID-19 while living in the defendants’ rehabilitation facility. Plaintiffs alleged that the defendants failed to staff the facility adequately and failed to take proper infectious disease control measures, which led to the decedent’s death. Although the court acknowledged that defendants could raise preemption as an affirmative defense in response to the state court complaint, it rejected the argument of complete preemption by the PREP Act.
Finally, a district court in Pennsylvania remanded a wrongful death case brought by the estate of a nursing home worker who died of COVID-19 allegedly contracted while working at the home. The complaint alleged failures to follow and take appropriate protective measures, including use of countermeasures like PPE. Citing both Jackson and Maglioli, the court found the PREP Act protects those who use covered countermeasures, not those who do not.
These early decisions thus uniformly rejected application of the PREP Act protection to nursing homes when the claims involved harm from the failure to use countermeasures rather than from the implementation and use of countermeasures.
III. HHS Response to Early Decisions
On the heels of these decisions, HHS issued its Amendment to the PREP Act on December 3, 2020, expanding immunity protection in the COVID-19 context. In Section IX, it interpreted the statutory language of “relating to” the administration of a countermeasure to extend to “situations where not administering a covered countermeasure to a particular individual” could potentially fall within the PREP Act liability protections if it resulted from a deliberate choice. Using vaccine administration as an example, it explained:
Where there are limited Covered Countermeasures, not administering a Covered Countermeasure to one individual in order to administer it to another individual can constitute “relating to . . . the administration to . . . an individual” under 42 U.S.C. 247d–6d. . . . Prioritization or purposeful allocation of a Covered Countermeasure, particularly if done in accordance with a public health authority’s directive, can fall within the PREP Act and this Declaration’s liability protections.
Thus, although nothing in the language of the PREP Act suggests that “allocation” decisions are the basis for immunity, the Amendment found that a claim for inaction might receive immunity if there are limited covered countermeasures and defendants failed to administer them to an individual because they chose to administer them to others. In contrast, claims of the failure to use a countermeasure, “if not the outcome of some form of decision-making process” may not receive PREP Act immunity.
After issuing the Amendment, HHS received numerous inquiries about the Amendment’s application to the developing jurisprudence in lawsuits against nursing homes described above. To address questions concerning “whether the PREP Act applies where a covered person declined to use a covered countermeasure when it arguably ought to have been used,” HHS decided to issue an advisory opinion. Consequently, on January 8, 2021, a month after publishing the Amendment and at the very end of the Trump administration, HHS published an advisory opinion. Characterizing the jurisprudence as advancing a “black and white” view of PREP Act immunity, Advisory Opinion 21-01 broadened interpretation of the “relating to” language relied upon by the Amendment to extend immunity “to anything ‘relating to’ the administration of a covered countermeasure,” including the failure to act (emphasis added).
Although the language of the PREP Act can support a distinction between affirmative actions and omission in certain settings—namely, where a program planner or other covered person under the statute “abandon[s] its duty to act” by failing to make any decisions on using countermeasures whatsoever—the Opinion emphasized a “distinction between allocation which results in non-use by some individuals, on the one hand, and nonfeasance, on the other hand, that also results in non-use.” Advisory Opinion 21-01 thus found that prioritization or purposeful allocation of a covered countermeasure, like a vaccine, could fall within the PREP Act immunity protections. This may include the “conscious decision not to use a covered countermeasure.” But “the failure to purchase any PPE, if not the outcome of some form of decision-making process, may not be sufficient to trigger the PREP Act.” Accordingly, the failure to act could be actionable in tort, depending on whether the failure to use countermeasures was a deliberate choice based on limited resources.
Importantly, the opinion further explained that “covered persons,” who are entitled to immunity under the Act, include “program planners.” By definition, a program planner (including those who supervise or administer programs involving countermeasures) is someone who would provide and allocate countermeasures. Accordingly, “decision-making that leads to the non-use of covered countermeasures by certain individuals is the grist of program planning, and is expressly covered by PREP Act.” Under this view, any time program planners are involved in running a facility, their actions would be interpreted as a deliberate choice and entitled to PREP Act immunity protection.
The implications of the Amendment and Advisory Opinion 21-01 are far-reaching. Most significantly, they suggest that PREP Act immunity could extend to claims for the failure to use some or any protective countermeasures if it is the result of resource decision-making. They do leave open the possibility, however, that claims alleging the non-use of countermeasures not based on prioritization could potentially avoid preemption under the PREP Act.
It remains to be seen how the Amendment and especially Advisory Opinion 21-01 will be interpreted by the courts, particularly in the context of failure-to-act claims. Some district courts have continued to reject PREP Act immunity for claims against nursing homes that are premised on inaction.7See, e.g., Est. of McCalebb v. AG Lynwood, LLC, No. 2:20‑CV‑09746‑SB‑PVC, 2021 WL 911951, at *5 (C.D. Cal. Mar. 1, 2021), appeal docketed, No. 21‑55302 (9th Cir. Mar. 31, 2021). In Saunders v. Big Blue Healthcare, Inc., the claims brought against a nursing home in a wrongful death action alleged failure to follow certain policies, procedures, and guidelines regarding protections against infections, including COVID-19. The court found that the plaintiff’s claims did not involve prioritization or purposeful allocation of covered countermeasures and thus the Amendment did not apply. As it stated: “There are no allegations in this case that the loss was caused by the non-use or non-administration of covered countermeasures linked to the use or administration of that countermeasure to another person instead.”
Nonetheless, at least one federal district court has taken a broad view.8See generally Garcia v. Welltower OpCo Group LLC, No. SACV2002250JVSKESX, 2021 WL 492581 (C.D. Cal. Feb. 10, 2021), appeal docketed, No. 21-55224 (9th Cir. Mar. 10, 2021). In Garcia v. Welltower OpCo Group LLC, a resident of an assisted living community, Gilbert Garcia, contracted COVID-19 and then died from the virus. His family brought suit, alleging that the facility failed to “implement appropriate infection control measures or follower[sic] local or public health guidelines in preparing for and preventing COVID-19 spread.” The family alleged that the facility had insufficient supplies of PPE, implemented inadequate visitation and group dining policies, and inappropriately relaxed mitigation policies even after Garcia had tested positive for the virus. Although the court acknowledged that these allegations represented failures to abide by appropriate health guidelines, the court found that the PREP Act granted the facility immunity and dismissed the case.
In so ruling, the court gave Chevron deference to Advisory Opinion 21-01 (though it is questionable whether an advisory opinion actually demands Chevron deference) and said that previous courts had taken too limited a view regarding use or non-use of a covered countermeasure and immunity protection. According to Garcia, immunity reaches the attempt but failure to adhere to infection control protocols. And while it acknowledged that the PREP Act would not cover allegations of total inaction, it nonetheless regarded the allegations before it as “momentary lapses” and unsuccessful attempts at compliance with state or federal guidelines, not a total failure to act.
The “momentary lapse” test applied by the Garcia court opens more questions than it answers. Is a “lapse” a gentle word for a negligent omission? What does “momentary” mean, if during the relevant time period, nursing home residents die or fall ill because of the absence of a mitigation measure? Garcia gives no guidance on these questions, but future defendants are sure to seize on the “momentary lapse” defense as a basis for immunity.
IV. Should PREP Act Immunity Extend to Failure-to-Act Claims Against Nursing Homes?
Nursing homes have a long history of deficiencies, especially in containing infectious diseases in their confined setting. These deficiencies—which long predate the COVID-19 pandemic—are typically explained by the pursuit of profit in an industry with slim profit margins. Slim profit margins result in underpaid staff and lack of safety equipment. The effectiveness of regulation in addressing these issues has been repeatedly questioned.
The pandemic has served to expose these deficiencies. As noted earlier, a disproportionately high number of deaths during the pandemic has occurred in nursing homes. Existing problems were exacerbated and exposed by temporary measures taken in light of the pandemic. Federal officials curtailed routine inspections of nursing homes starting in March 2020 and, following federal guidelines, nursing homes restricted outside visitors during the pandemic, a restriction that gradually is being lifted. These measures meant that the traditional formal and informal methods of monitoring the safety of nursing homes have fallen by the wayside. This lack of oversight left tort law as the only regulatory backstop to fill the void. That regulatory backstop is substantially curtailed if courts adopt Advisory Opinion 21-01, especially as interpreted by Garcia.
Under traditional law, nursing home facilities facing negligence claims would be held to a relatively high standard of care, given the contained environment, the increased dangers to a vulnerable population, and the critical need for adequate infectious disease control. The standard of care would incorporate federal and state guidelines for nursing homes. Factors, such as the difficulty of maintaining social distancing when caring for patients with severe health conditions and the novelty of the COVID-19 virus, would be considered in determining the appropriate level of care, but they would not serve as an excuse for the failure to meet that standard of care. The “momentary lapse” test provides such an excuse. On the other hand, a nursing home that meets the appropriate standard of care to provide a safe environment, which includes the proper use of countermeasures under the circumstances, would not need immunity protection because it could defeat claims of negligence.
Granting immunity comes at a high cost; it contravenes a primary justification for the implementation of tort law. Immunity removes the incentive to provide the level of care required to adequately protect nursing home residents and workers. Recognizing this problem, a report by the New York State Attorney General on nursing homes during the pandemic found that immunity protection on the state level may have led nursing home facilities to make “financially motivated, rather than clinically motivated” decisions. One example of this was increasing the number of new patients admitted, even when the facilities lacked sufficient staff and equipment to handle the added workload.
Immunity also places the burden of avoiding infection during a pandemic directly on patients, who cannot control their own daily activities. Unlike other business patrons, nursing home residents may not have had the choice of leaving the establishment or the ability to assess the risk.
Cloaking nursing homes with immunity in these circumstances on the grounds that their failure to use a mitigation measure is the result of deliberate “prioritization” is particularly troubling given the track record of nursing homes. As stated previously, nursing homes were already experiencing considerable problems due to faulty practices even before the pandemic. If the reason that nursing homes must make a “choice” among mitigation measures is because of their past failures to plan and devote appropriate resources for health emergencies, then COVID-19 should not give them a free pass for those failures or excuse substandard behaviors already in place. So too, immunity protection removes a level of transparency and oversight that would result from exposure to liability. This transparency is critical to monitoring the facilities.
Nor can nursing home immunity for failure to act be reconciled with the plain purpose behind PREP Act immunity: to encourage the development and use of countermeasures to combat public health emergencies. That goal is not served by blocking lawsuits for non-use of countermeasures—even when defendants characterize such non-use as a mere “momentary lapse.” The “momentary lapse” defense threatens to allow defendants to escape liability even for harms that a reasonable nursing home could and should have avoided.
Advisory Opinion 21-01’s immunity for failure-to-act claims should be rescinded so that tort law can do its work to help deter unsafe nursing home practices and to compensate victims when nursing homes fall short. At a minimum, courts should be loath to grant immunity based on an alleged prioritization defense before assessing whether the need to prioritize stems from a failure to plan and devote the resources that would have made prioritization unnecessary. To be sure, this sort of inquiry may well require judicial probing beyond the pleadings stage, which could undermine a purpose of granting immunity. But the cost of review would achieve a fairer result and one that comports with the purpose of the PREP Act. Moreover, if the Advisory Opinion’s view about failure to act continues to stand, then the same interpretation should apply to a claimant’s right to compensation under CICP for a nursing home’s failure to use countermeasures.
The benefits of the tort system outweigh the questionable need to provide federal immunity for the nursing home industry for the failure to act, especially when deaths in nursing homes account for about one-third of the lives lost during the pandemic and given the industry’s long history of neglectful practice. Providing PREP Act immunity from tort suits for the failure to use countermeasures does not serve the purpose of the Act, which was designed to promote the use and development of countermeasures. Further, extending total immunity to nursing homes comes at too great a cost. It creates the wrong incentives to the industry by shifting loss away from responsible parties, and it deprives victims of recourse to compensation for their injuries. Although nursing homes would surely prefer to stop lawsuits at the pleadings stage, they have an excellent chance of success if they acted reasonably and met the appropriate standard of care during the public health emergency, including complying with federal and state guidelines. If they failed to act with appropriate countermeasures, they should be held responsible for their actions.
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Betsy J. Grey is the Jack E. Brown Chair in Law at the Sandra Day O’Connor College of Law at Arizona State University. She thanks Bob Dauber, Zachary Kramer, and Joel Nomkin for their valuable comments on earlier drafts and Sean Krieg for his outstanding research assistance.