Department of Health and Human Services PREP Act Declaration and Amendments
JAMES M. BECK
Why It Made the List
In 2020, the U.S. Food and Drug Administration’s (FDA’s) regulatory landscape, like the rest of the world, was dominated by the COVID-19 pandemic caused by the SARS-CoV-2 virus. In the COVID-19 era, no decision by a court—at least not yet—has been as important in its impact on COVID-related litigation as the Declaration issued on March 20, 2020 by former Secretary of the U.S. Department of Health and Human Services (HHS) Alex Azar pursuant to the Public Readiness and Emergency Preparedness (PREP) Act, and subsequently amended three times in 2020. This declaration, as amended, has effectively immunized much of the nation’s response to the COVID pandemic from civil litigation under state law.
The PREP Act, enacted in 2005, authorized the secretary of HHS to create immunity from liability for persons responding to public health emergencies, preempting state-law remedies and replacing them with a federal compensation program. The PREP Act was amended in 2013 to expand the scope of available immunity to products receiving FDA emergency use approval in pandemic situations. Its preemption clause invalidates any state and local law that “is different from, or is in conflict with, any requirement applicable under [the PREP Act].”
Once HHS has issued a PREP Act declaration concerning a pandemic “countermeasure,” immunity applies to any “covered person” with respect to all “claims for loss” caused by, arising out of, relating to, or resulting from the “administration” or the “use” of a “covered countermeasure” if a declaration has been issued with respect to that countermeasure. Thus, the HHS definitions of “covered persons” and “covered countermeasures” is key.
The HHS declarations were the first time that the PREP Act’s immunity provisions had been interpreted by the department since that statute had been enacted in 2005. Given the scope of the pandemic and the importance of the immunity issues addressed by these declarations, they are more worthy of inclusion in the top twenty than most judicial decisions.
Discussion of the Facts, Decisions, and Rationale
In mid-March, 2020, as the COVID-19 pandemic was shutting down the United States and much of the world, HHS announced in the Federal Register that it was conferring COVID-19-related tort immunity pursuant to the PREP Act and the Pandemic and All-Hazards Preparedness Reauthorization Act. Accompanying the immunity grant was a “Countermeasures Injury Compensation Program (CICP),” as authorized by the PREP Act. The scope of tort immunity extended to “any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures.” The immunity extended not only to the manufacture and use of drugs and medical devices directly employed to combat COVID-19, but further to “products or technologies intended to enhance the use or effect of a drug, biological product, or device used against the pandemic.”
The only exception to the PREP Act immunity program is for “willful misconduct,” as defined in the PREP Act. In cases of willful misconduct, the PREP Act authorizes “an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by” such actions. Federal claims for willful misconduct can “be filed and maintained only in the United States District Court for the District of Columbia.”
Under the preemption provisions of the PREP Act, the immunity HHS conferred prevails not only over state law, but also supersedes potential liability imposed by other federal laws.
[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 use by an individual of a covered countermeasure.
Several groups of “covered persons” were entitled to claim immunity under HHS’ first declaration. These include “manufacturers,” “distributors,” “program planners,” and “qualified persons.” HHS defined “manufacturer” as:
[A] contractor or subcontractor of a manufacturer; a supplier or licenser of any product, intellectual property, service, research tool or component or other article used in the design, development, clinical testing, investigation or manufacturing of a Covered Countermeasure; and any or all the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.
HHS defined “distributor” as:
[A] person or entity engaged in the distribution of drugs, biologics, or devices, including but not limited to: manufacturers; re-packers; common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies.
HHS defined a “program planner” as:
[A] state or local government, including an Indian tribe; a person employed by the state or local government; or other person who supervises or administers a program with respect to the administration, dispensing, distribution, provision, or use of a Covered Countermeasure . . . . [A] private sector employer or community group or other “person” can be a program planner when it carries out the described activities.
HHS defined a “qualified person” as:
[A] licensed health professional or other individual authorized to prescribe, administer, or dispense Covered Countermeasures . . . ; or a person within a category of persons identified as qualified in the Secretary’s Declaration.
Thus, the scope of the immunity created by HHS’ declaration broadly extends to anyone engaged in manufacturing, distributing, planning for the use of, or actually using a “covered countermeasure.”
Those “covered countermeasures”—what PREP Act immunity actually applies to—consist of “qualified pandemic or epidemic product[s],” “security countermeasure[s],” and “a drug, biological product or device authorized for emergency use.” HHS likewise defined each of these “countermeasures”:
A “qualified pandemic or epidemic product means a drug or device . . . or a biological product [chiefly vaccines] . . . , that is manufactured, used, designed, developed, modified, licensed or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such a pandemic or epidemic might otherwise cause.
The primary example of preempted claims is “liability claims alleging negligence by a manufacturer in creating a vaccine.”
A “security countermeasure” for a pandemic under the PREP Act is:
[A] drug or device . . . or a biological product . . . that [t]he Secretary determines to be a priority to diagnose, mitigate, prevent, or treat harm from any biological . . . agent identified as a material threat . . . , or to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent; and is determined . . . to be a necessary countermeasure to protect public health.
All “countermeasures” must be FDA “approved or cleared,” “investigational” under the FDCA, or else “licensed” or “authorized for emergency use.” These include “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” and “any device used in the administration of any such product, and all components and constituent materials of any such product.”
The scope of immunity extends to preclude claims brought by anyone in a “population” “who should be vaccinated or take a drug or other countermeasure” or “who uses or who is administered a Covered Countermeasure.” In addition, PREP Act “liability immunity is afforded” to “manufacturers and distributors” whether or not a “countermeasure is used by or administered to this population.” Similarly, immunity extends to “program planners and qualified persons when [a] countermeasure” is used by anyone in the “population.” The PREP Act declaration also recognized a causation element, requiring that the “provision of the countermeasures” or other “activities and decisions” must “directly relate to the countermeasure activities”
Off-label use is also immunized, as to “manufacturers and distributors without regard to whether the countermeasure is used by or administered to [the intended] population,” and also if used by others (off-label use), as long as the others “reasonably could have believed the recipient was in this population.” “Further, “liability immunity is afforded . . . to manufacturers and distributors without regard to whether the countermeasure is used by or administered to individuals in [any particular] geographic areas.” The duration of this COVID-related PREP Act immunity “extends . . . through October 1, 2024”—over four and a half years—and possibly longer for products “obtained for the Strategic National Stockpile.” Immunity may extend even to claims brought by persons who are ineligible for the Act’s compensation program.
The import of the original declaration was that the immunity was broad enough so that public and private health professionals would be able to direct and control COVID-related countermeasures immunized from judicial second-guessing. However, almost at once the courts began intruding, drawing a distinction between the alleged “failure” of “program administrators”—mostly nursing homes—to employ COVID countermeasures and the alleged negligent employment of such countermeasures. The first category, claims of nonfeasance, were being allowed to proceed notwithstanding the broad terms of PREP Act immunity.
[T]he complaints do not allege that Plaintiffs’ injuries arose from . . . administration to them of vaccines or medicines (or for that matter protective gear)—activities that the PREP Act promotes by affording immunity. . . . Plaintiffs are claiming (inter alia) that the Defendants committed negligence in that, among other things, they failed to take countermeasures, some of them allegedly federally required.
Nor were defendants facing such nonfeasance claims allowed to remove actions to federal court under the PREP Act’s broad immunization against “all claims for loss caused by, arising out of, relating to, or resulting from” the administration or use of covered countermeasures. Instead, federal district courts were remanding PREP Act immunity litigation to state court, on the rationale that, by allowing anything to survive immunity, Congress could not have intended to create federal jurisdiction under the “complete preemption” doctrine.
Defendants have raised the PREP Act as an affirmative defense here, claiming that the Act provides the sole civil remedy for those circumstances implicating covered countermeasures such that Plaintiff’s sole remedy is to seek compensation from the Covered Countermeasures Process Fund by making requests for benefits under the Countermeasures Injury Compensation Fund (CICP). It is clear, however, that the presence of a federal defense does not make the case removable, even if the defense is preemption and even if the validity of the preemption defense is the only issue to be resolved in the case. . . . Thus, the Act is confined to addressing claims related to the administration of certain countermeasures and does not seek to completely preempt the type of state law negligence claims asserted here.
The increasing use of nonfeasance allegations to preclude federal adjudication of COVID-related litigation under the terms of the HHS declaration of PREP Act immunity prompted HHS to file an amended declaration on December 9, 2020. That amendment sought to extend PREP Act immunity to certain purely private sector activities related to the administration, and in some cases the non-administration, of COVID counter measures. It increased the scope of immunity for “substantial federal legal and policy interests . . . [that require] a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world.” In particular, PREP Act immunity was declared to reach “situations where not administering a covered countermeasure to a particular individual”—the principle reason courts had been remanding COVID litigation to state court. Other extensions of PREP Act immunity were to “provide liability protections for, among other things, additional private-distribution channels” as well as “an additional category of Qualified Persons . . . [namely] healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are permitted to practice.”
To address the “unprecedented global pandemic,” HHS intended this extension of litigation-related immunity to provide an avenue for “a uniform interpretation of the PREP Act” through recognition of “an exclusive Federal cause of action.” It did so by express reliance on Supreme Court precedent that permitted federal jurisdiction where an overriding federal interest existed:
COVID-19 is a global challenge that requires a whole-of-nation response. There are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable & Sons Metal Products, Inc. v. Darue Eng’g & Mf’g, 545 U.S. 308 (2005), in having a unified, whole-of-nation response to the COVID-19 pandemic among federal, state, local, and private-sector entities . . . and . . . in having a uniform interpretation of the PREP Act.
In making this determination, HHS relied on congressionally “delegated . . . authority to strike the appropriate Federal-state balance with respect to particular Covered Countermeasures through PREP Act declarations.”
In the Fourth Amended Declaration, HHS created an additional “pathway” for immunity by removing a prerequisite in the Declaration’s other Limitations on Distribution that had previously required “covered persons” using anti-COVID “Covered Countermeasures” to have an agreement with the federal government. It recognized a “third distribution channel” allowing a covered manufacturer, distributor, administrator or user of “covered countermeasures” to qualify for immunity even though “there is no federal agreement or authorization” covering those activities. Thus, an entity, manufacturer, distributor, program planner, or qualified person that satisfies the other requirements of the PREP Act and prior HHS declarations is immunized even if there is no federal agreement to cover those activities and those activities are not part of the authorized activity of an Authority Having Jurisdiction. Thus, the Fourth Amendment broadened PREP Act immunity to reach entities, such as nursing homes or manufacturing plants, acting in a purely private capacity, as long as they “manufacture, test, develop, distribute, administer, or use” Covered Countermeasures.
With respect to the judicial distinction between the administration and non-administration of Covered Countermeasures, the Fourth Amendment extended to include non-administration situations where supplies of such countermeasures are “limited.” “[N]ot administering a Covered Countermeasure to one individual in order to administer it to another individual can constitute ‘relating to . . . the administration to . . . an individual.’” As an “example,” HHS cited a scarcity situation where a “person in the vulnerable population was able to receive [a countermeasure] only because it was not administered to the person in the less-vulnerable population.” Thus, HHS recognized that “[p]rioritization or purposeful allocation of a Covered Countermeasure . . . can fall within the PREP Act and this Declaration’s liability protections.”
Nor was PREP Act immunity confined to COVID-19 itself. The Fourth Amended Declaration extends immunity to “other diseases, health conditions, or threats that may have been caused by COVID-19, . . . including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.”
Finally, in response to additional inquiries about preemption, immunity, and allegations of nonfeasance, the HHS Office of General Counsel (OGC) followed up with an Advisory Opinion on the scope of PREP Act preemption on January 8, 2020. HHS AO 21-01 addressed “whether the PREP Act applies where a covered person declined to use a covered countermeasure when it arguably ought to have been used.”
This advisory opinion concluded that the PREP Act supported federal jurisdiction as a “complete preemption statute.”
The sine qua non of a statute that completely preempts is that it establishes either a federal cause of action, administrative or judicial, as the only viable claim or vests exclusive jurisdiction in a federal court. The PREP Act does both.
Recognizing that federal district courts had “labored hard attempting to ordain whether the non-use of a covered countermeasure triggers the PREP Act and its complete preemption regime,” AO 21-01 addressed this issue once again. It recognized a continuum of nonfeasance ranging from a “failed in toto to provide any” COVID countermeasures, at one extreme, to challenges to the quantity, timing, and training related to such countermeasures on the other.
The OGC’s advisory opinion concluded that only instances of complete nonfeasance, i.e., where a “defendant’s culpability is the result of its failure to make any decisions whatsoever, thereby abandoning its duty to act as a program planner or other covered person,” would avoid complete preemption under the PREP Act. Lesser degrees of culpability than total inaction did not amount to the sort of “willful misconduct” that was actionable under the PREP Act.
The OGC criticized the judiciary’s fixation with a “black and white” distinction between use and nonuse of covered countermeasures. While reiterating the allocation of scarce countermeasures example from the Fourth Amended Declaration, AO 21-01 pointed out that:
There can potentially be other situations where a conscious decision not to use a covered countermeasure could relate to the administration of the countermeasure. In contrast, 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.
The immunity from suit that the PREP Act’s preemption provisions enforced was broad—extending “to anything “‘relating to’ the administration of a covered countermeasure.”
AO 21-01 found support for this more nuanced distinction between nonuse by allocation and complete nonfeasance in the text of the PREP Act. “Program planners”—persons responsible for “administration, dispensing, distribution, provision, or use” of covered countermeasures—are protected by PREP Act Immunity.
A program planner is someone who is involved in providing or allocating covered countermeasures. Program planning inherently involves the allocation of resources and when those resources are scarce, some individuals are going to be denied access to them. Therefore, 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.
Only a “failure to make any decisions whatsoever,” which effectively “abandon[s]” a defendant’s role that otherwise creates immunity, puts that defendant outside of the PREP Act’s protection. Since complete preemption is not defeated by the “well-pleaded complaint rule,” nonfeasance allegations should be tested by jurisdictional discovery to prevent plaintiffs from pleading arround the PREP Act.
The HHS OGC further concluded that the scope of PREP Act immunity and preemption was the sort of overriding federal issue that conferred federal question jurisdiction under the Grable doctrine:
Here, ordaining the metes and bounds of PREP Act protection in the context of a national health emergency necessarily means that the case belongs in federal court. . . . [T]he [HHS] secretarial determination provides the underlying basis for invoking the Grable doctrine 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.
The Advisory Opinion reiterated that PREP Act determinations are not reviewable “by mandamus or otherwise” by any court. However, AO 21-01 recites that it “is not a final agency action or a final order” and “does not have the force or effect of law.”
While undoubtedly broad, the full impact of PREP Act immunity on COVID-19-related litigation remains to be seen. After the December and January HHS pronouncements, less activist judges have decided to take HHS at its word and to cease second-guessing decisions to employ (or not) COVID countermeasures.
[T]he Court agrees with this administrative agency interpretation of the PREP Act. . . . That the Advisory Opinions are not binding law or formal rules issued via notice and comment does not render them irrelevant. In that most recent guidance [HHS] affirmed that the PREP Act is a complete preemption statute and clarified the scope of the Act relative to the ongoing pandemic.
That is not, however, the majority view. The unfortunate politicization of the national response to the COVID pandemic continues to haunt the interpretation of PREP Act immunity. First, there remains the possibility that the new administration that took office on January 20, 2021 will rescind or otherwise roll back the scope of immunity authorized by its predecessor’s declarations. Second, even in the face of administrative continuity the administration does not so act, most courts continue their inclination to reach the same result through creeping judicial nullification. These courts have either ignored or disagreed with HHS’s declarations and advisory opinion and continue to remand COVID-related litigation over the allocation and/or nonuse of COVID countermeasures to state court. The HHS discussion of allocation of countermeasures as an example of inaction claims has been converted to a strictly limited exception, which of course is never pleaded.
[While] an “inaction claim” is not necessarily beyond the scope of the PREP Act, such claims only fall under the scope of the PREP Act where: (1) there are limited covered countermeasures; and (2) there was a failure to administer a covered countermeasure to one individual because it was administered to another individual.
Since all competent counsel bringing such claims know, by now, to couch them in terms of inaction, the intent of the PREP Act declarations to restrict COVID-related litigation to federal courts applying something approximating uniform federal standards can thus be thwarted.
Thus, it is far from certain that HHS’ efforts to confine litigation over covered COVID countermeasures and PREP Act immunity to federal courts will ultimately be successful, despite its concerted regulatory efforts. Several of the decisions cited herein are now pending on appeal, so the only thing that can be stated with certainty about PREP Act immunity is that the legal landscape will continue to evolve.
 85 Fed. Reg. 15198 (HHS March 20, 2020), as amended, 85 Fed. Reg. 21012 (April 15, 2020); 85 Fed. Reg. 35100 (June 8, 2020); 85 Fed. Reg. 52136 (Aug. 24, 2020); 85 Fed. Reg. 79190 (Dec. 9, 2020); 86 Fed. Reg. 7872 (Feb. 2, 2021); and 86 Fed. Reg. 9516 (Feb. 22, 2021). See HHS OGC, Advisory Opinion 21-01 (Jan. 8, 2021).
 James M. Beck is a Senior Life Sciences Policy Analyst at Reed Smith LLP.
 42 U.S.C. § 247d-6d et. seq.
 Public Law 109-148, Div. C, §2.
 See 42 U.S.C. § 247d-6d–63.
 See Pandemic & All-Hazards Preparedness Reauthorization Act, Public Law 113-5, amending 42 U.S.C. § 300hh-1.
 42 U.S.C. § 247d-6d(b)(8).
 42 U.S.C. § 247d-6d(a)(1).
 Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (HHS March 17, 2020).
 21 U.S.C. §§ 564A-B.
 85 Fed. Reg. at 15201.
 Id. at 15198.
 Id. The PREP Act defines “willful misconduct” as “an act or omission” that is “intentionally to achieve a wrongful purpose; knowingly without legal or factual justification; and in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.” 42 U.S.C. § 247d-6d(c)(1)(A) (emphasis in original). Congress intended this “standard for liability [to be] more stringent than a standard of negligence in any form or recklessness.” Id. at § 247d-6d(c)(1)(B).
 42 U.S.C. § 247d-6d(d)(1).
 Id. §247d-6d(e)(1). The burden of proof is clear and convincing evidence. Id. 42 U.S.C. § 247d-6d(c).
 85 Fed. Reg. at 15199.
 See id. at 15201–02 (listing as “qualified persons” all persons “authorized” “to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures” under several circumstances, including as provided in an FDA Emergency Use Authorization).
 Id. at 15199.
 Id. at 15199. In addition, this definition encompasses products designed to prevent, cure, or mitigate the adverse effects of other “qualified” products, as well as other products intended to “enhance” the effect of another “qualified” product. Id.
 Id. at 15200.
 Id. at 15199 (numbering removed).
 Id. at 15202.
 Id. at 15200, 15202.
 Id. at 15200.
 Id. at 15200.
 Id. at 15201, 15202.
 Id. at 15201, 15202.
 Id. at 15201 (“requirements for compensation . . . may not align with the requirements for liability immunity”); id. at 15202 (“immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population”).
 Estate of Maglioli v. Andover Subacute Rehabilitation Center I, 478 F. Supp.3d 518, 532 (D.N.J. 2020) (emphasis in original). See Lutz v. Big Blue Healthcare, Inc., 480 F. Supp.3d 1207, 1216–17 (D. Kan. 2020); Brown v. Big Blue Healthcare, Inc., 480 F. Supp.3d 1196, 1206–07 (D. Kan. 2020); Eaton v. Big Blue Healthcare, Inc., 480 F. Supp.3d 1184, 1195 (D. Kan. 2020); Gunter v. CCRC OPCO-Freedom Square, LLC, 2020 WL 8461513, at *4 (M.D. Fla. Oct. 29, 2020); Sherod v. Comprehensive Healthcare Mgmt. Servs., LLC, 2020 WL 6140474, at *7–8 (W.D. Pa. Oct. 16, 2020); Estate of Jones v. St. Jude Operating Co., LLC, 2020 WL 8361924, at *9 (D. Or. Oct. 14, 2020); Martin v. Serrano Post Acute LLC, 2020 WL 5422949, at *2 (C.D. Cal. Sept. 10, 2020); Jackson v. Big Blue Healthcare, Inc., 2020 WL 4815099, at *6 (D. Kan. Aug. 19, 2020).
 42 U.S.C. § 247d-6d(a)(1).
 Gunter, 2020 WL 8461513 at *3 (citation and quotation marks omitted). See Parker v. St. Jude Operating Co., LLC, 2020 WL 8362407, at *5–6 (D. Or. Dec. 28, 2020); Saldana v. Glenhaven Healthcare LLC, 2020 WL 6713995, at *2 (C.D. Cal. Oct. 14, 2020); Martin, 2020 WL 5422949, at *2.
 Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 and Republication of the Declaration, 85 Fed. Reg. 79190 (HHS Dec. 9, 2020).
 Id. at 79191.
 Id. at 79192 (this extension immunized treatments for COVID-19 provided by means of telemedicine).
 Id. at 79174.
 Id. at 78197. Grable found federal subject matter jurisdiction over ostensibly state-law claims that “necessarily raise” “important” federal issues for which a federal forum was needed to “vindicate [federal] administrative action.” Grable, 514 U.S. at 314–15. Such situations are “rare,” id. at 315, but a once-in-a-century pandemic could well qualify.
 85 Fed. Reg. at 78198 & n.25 (citing 42 U.S.C. § 247d-6d(b)(7), providing that “[n]o court of the United States, or of any State, shall have subject matter jurisdiction to review, whether by mandamus or otherwise, any action by the Secretary under this subsection”).
 85 Fed. Reg. at 79194.
 Id. at 79197.
 Id. (quoting 42 U.S.C. § 247d-6d).
 See Advisory Opinion 21-01 on the Public Readiness and Emergency Preparedness Act Scope of Preemption Provision, U.S. Dep’t of Health & Human Servs. (Jan. 8, 2021), https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/2101081078-jo-advisory-opinion-prep-act-complete-preemption-01-08-2021-final-hhs-web.pdf.
 Id. at 1.
 Id. at 2.
 Id. at 4.
 Id. at 3, 5.
 Id. at 3.
 Id. at 4 (quoting 42 U.S.C. § 247d-6d(i)(6)).
 Id. at 5.
 Id. (quoting 42 U.S.C. § 247d-6d(b)(7)).
 Garcia v. Welltower OpCo Grp. LLC, 2021 WL 492581, at *6–7 (C.D. Cal. Feb. 10, 2021).
 To date, the new administration has continued, rather than repudiated, prior PREP Act declarations. See Sixth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 86 Fed. Reg. 9516 (Feb. 22, 2021); Fifth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 86 Fed. Reg. 7872 (Feb. 2, 2021).
 See Mitchell v. Advanced HCS, LLC, 2021 WL 1247884, at *4–5 (N.D. Tex. April 5, 2021); Schuster v. Percheron Healthcare, Inc., ___ F. Supp.3d ___, 2021 WL 1222149, at *3–4 (N.D. Tex. April 1, 2021); Estate of Cowan v. LP Columbia KY, LLC, No. 1:20-CV-00118-GNS, 2021 WL 1225965, at *5 (W.D. Ky. March 31, 2021); Stone v. Long Beach Healthcare Center, LLC, 2021 WL 1163572, at *6 (C.D. Cal. March 26, 2021); Lopez v. Life Care Centers of America, Inc., 2021 WL 1121034, at *14 (D.N.M. March 24, 2021); Estate of McCalebb v. AG Lynwood, LLC, 2021 WL 911951, at *5–6 (C.D. Cal. March 1, 2021); Estate of Jones v. St. Jude Operating Co., LLC, 2021 WL 900672, at *6–7 (Mag. D. Or. Feb. 16, 2021), adopted, 2021 WL 886217 (D. Or. March 8, 2021); Dupervil v. Alliance Health Operations, LCC, 2021 WL 355137, at *10 (E.D.N.Y. Feb. 2, 2021); Grohmann v. HCP Prairie Village KS OPCO LLC, ___ F. Supp.3d ___, 2021 WL 308550, at *9 (D. Kan. Jan. 29, 2021); Anson v. HCP Prairie Village KS OPCO LLC, 2021 WL 308156, at *10 (D. Kan. Jan. 29, 2021); Estate of Smith v. Bristol at Tampa Rehabilitation & Nursing Center, LLC, 2021 WL 100376, at *2 (M.D. Fla. Jan. 12, 2021).
 Lyons v. Cucumber Holdings, LLC, 2021 WL 364640, at *4 (C.D. Cal. Feb. 3, 2021). See Robertson v. Big Blue Healthcare, Inc., 2021 WL 764566, at *8–9 (D. Kan. Feb. 26, 2021) (“no allegations . . . that Plaintiff . . . suffered any loss caused by the prioritization or purposeful allocation of a countermeasure”) (citation and quotation marks omitted); Grohmann, 2021 WL 308550, at *9 (inaction must be “paired closely” to HHS example).