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`Case No. CV 20-0958 JCH/LF
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`v.
`
`LIFE CARE CENTERS OF AMERICA, INC.,
`LIFE CARE CENTER OF FARMINGTON,
`PHILLIP NICKSE, in his Individual and Official
`Capacities, and FARMINGTON OPERATIONS, LLC,
`
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`Case 1:20-cv-01083-KG-LF Document 28 Filed 03/24/21 Page 1 of 33
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW MEXICO
`
`
`
`TODD LOPEZ, As Personal Representative
`of the ESTATE OF HELEN BEGAY,
`
`
`Plaintiff,
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`
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`
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`Defendants.
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`
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`MEMORANDUM OPINION AND ORDER
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`Twenty-three cases were previously consolidated with this case for purposes of ruling on
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`the following motions to remand filed in the respective cases:
`
`1. 1:20-cv-00958-JCH-CG, Lopez v. Life Care Centers of America, Inc. et al., Motion to
`Remand (ECF No. 9);
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`2. 1:20-cv-00961-JB-SCY, Lopez v. Life Care Centers of America, Inc. et al., Motion to
`Remand (ECF No. 9);
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`3. 1:20-cv-00962-SCY-LF, Lopez v. Life Care Centers of America, Inc. et al., Motion to
`Remand (ECF No. 9);
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`4. 1:20-cv-00963-LF-GJF, Lopez v. Life Care Centers of America, Inc. et al., Motion to
`Remand (ECF No. 8);
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`5. 1:20-cv-00964-JAP-SCY, Lopez v. Life Care Centers of America, Inc., et al., Motion
`to Remand (ECF No. 9);
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`6. 1:20-cv-01077-LF-SCY, Lopez v. Life Care Centers of America, Inc., et al., Motion to
`Remand (ECF No. 6);
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`7. 1:20-cv-01080-KG-LF, Lopez v. Life Care Centers of America, Inc. et al., Motion to
`Remand (ECF No. 6);
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`Case 1:20-cv-01083-KG-LF Document 28 Filed 03/24/21 Page 2 of 33
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`8. 1:20-cv-01083-KG-LF, Lopez v. Life Care Centers of America, Inc. et al., Motion to
`Remand (ECF No. 6);
`
`9. 1:20-cv-01128-LF-JFR, Lopez v. Life Care Center of America, Inc. et al., Motion to
`Remand (ECF No. 4);
`
`10. 1:20-cv-01129-JB-SCY, Lopez v. Life Care Centers of America et al., Motion to
`Remand (ECF No. 3);
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`11. 1:20-cv-01130-KWR-LF, Lopez v. Life Care Centers of America, Inc. et al., Motion to
`Remand (ECF No. 3);
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`12. 1:20-cv-01131-LF-JFR, Lopez v. Life Care Centers of America, Inc. et al., Motion to
`Remand (ECF No. 4);
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`13. 1:20-cv-01132-CG-GJF, Lopez v. Life Care Centers of America, Inc. et al., Motion to
`Remand (ECF No. 3);
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`14. 1:20-cv-01149-JHR-GJF, Lopez v. Life Care Centers of America, Inc. et al., Motion to
`Remand (ECF No. 7);
`
`15. 1:20-cv-01157-KK-JFR, Lopez v. Life Care Centers of America, Inc. et al., Motion to
`Remand (ECF No. 8);
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`16. 1:20-cv-01158-JFR-SCY, Lopez v. Life Care Centers of America, Inc. et al., Motion to
`Remand (ECF No. 9);
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`17. :20-cv-01159-JFR-SCY, Lopez v. Life Care Centers of America, Inc. et al., Motion to
`Remand (ECF No. 7);
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`18. 1:20-cv-01161-KRS-SCY, Lopez v. Life Care Centers of America, Inc. et al., Motion
`to Remand (ECF No. 7);
`
`19. 1:20-cv-01188-KK-SMV, Lopez v. Life Care Centers of America, Inc. et al., Motion
`to Remand (ECF No. 4);
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`20. 1:20-cv-01189-KK-KRS, Lopez v. Life Care Centers of America, Inc. et al., Motion to
`Remand (ECF No. 4);
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`21. 1:20-cv-1275-JHR-KK, Lopez v. Life Care Centers of America, Inc. et al., Motion to
`Remand (ECF No. 6);
`
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`22. 1:20-cv-1351-JB-LF, Lopez v. Life Care Centers of America, Inc. et al., Motion to
`Remand (ECF No. 6);
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`2 
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`Case 1:20-cv-01083-KG-LF Document 28 Filed 03/24/21 Page 3 of 33
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`23. 1:20-cv-1352-KG-SMV, Lopez v. Life Care Centers of America, Inc. et al., Motion to
`Remand (ECF No. 9);
`
`
`24. 1:21-cv-00042-JHR-SCY, Lopez v. Life Care Centers of America, Inc. et al., Motion
`to Remand (ECF No. 6).
`
`
`See, e.g., Lopez v. Life Care Centers of America, Inc., et al., 20-cv-00958-JH-CG, Orders to
`
`Consolidate, ECF Nos. 16, 25, and 39.1
`
`Each of these cases allegedly arise from deaths from COVID-19 of residents in the care
`
`facilities operated by Defendants. The basis of the respective complaints is that, despite notice of
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`the spread of COVID-19, none of the Defendants did anything to institute an appropriate facility
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`plan to prevent the spread, and Defendants instructed staff not to wear masks, ordered all testing
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`swabs destroyed without being tested, failed to sterilize equipment, reused N95 masks and nursing
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`gowns without sterilization, required staff with COVID-19 symptoms to continue to work, and
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`later, used the same HVAC system for quarantined and non-quarantined residents. See, e.g., 0958,
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`Am. Compl. ¶¶ 11-18, ECF No. 1-1. Defendants in each of these cases removed the cases on the
`
`basis of federal question jurisdiction, asserting that the Public Readiness and Emergency
`
`Preparedness Act (“PREP Act”), 42 U.S.C. §§ 247d-6d, 247d-6e, provides an exclusive remedy
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`for the substance of the allegations and relief sought, and thus, expressly preempts state law. See,
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`e.g., 0958, Notice of Removal ¶¶ 8-9, ECF No. 1.
`
`In each case, the respective plaintiff filed a motion to remand, all of which are nearly
`
`identical to one another, contending that the PREP Act does not completely preempt the respective
`
`plaintiff’s state tort claims. The Court agrees that the PREP Act's provisions creating civil
`
`enforcement remedies do not cover the allegations in these cases, and thus, Congress did not intend
`
`to permit removal of the state law claims asserted by the plaintiffs. Accordingly, the Court, having
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`1 Hereinafter, the Court for ease of reference will cite to the last four digits of the case number only. 
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` 
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`3 
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`Case 1:20-cv-01083-KG-LF Document 28 Filed 03/24/21 Page 4 of 33
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`considered all the motions, responses, replies, pleadings, applicable law, and otherwise being fully
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`informed, concludes that the motions to remand should be granted, that this Court lacks subject
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`matter jurisdiction over the cases, and that each of these cases should be remanded to the First
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`Judicial District Court, County of Santa Fe, State of New Mexico.2
`
`I.
`
`FACTUAL BACKGROUND3
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`Defendant Life Care Centers of America, Inc., (“LCC America”) is in the business of
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`owning, operating, managing, and/or maintaining healthcare facilities, including Life Care Center
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`of Farmington (“LCC Farmington”),4 which is a wholly-owned subsidiary of LCC America and
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`operates in Farmington, New Mexico.5 LCC Farmington is the alter ego of LCC America, or
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`alternatively, they were engaged in a joint venture or enterprise in the undertaking of the LCC
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`Farmington nursing facility.6 Defendant Philip Nickse is the Executive Director of LCC
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`Farmington, and Defendant Farmington Operations, LLC, is licensed to do business for LCC
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`Farmington.7 Plaintiff Todd Lopez is an attorney who was appointed personal representative of
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`the estates of each of the residents in the above-cited cases (collectively, “the Residents”).8 Each
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`of the Residents lived in LCC Farmington and died as a result of contracting COVID-19 at LCC
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`Farmington in either April or May 2020.9
`
` 
`2 Although Defendants requested oral argument, the Court denies the request because a hearing is not necessary to
`resolve the motions. The briefing on the motions was thorough and well done such that additional argument will not
`aid the Court’s resolution of the issues. 
`3 The pertinent allegations necessary to resolve the motions to remand in each of these cases are virtually identical.
`This Court has cited to the allegations primarily in the first-filed case, and although it has not given 24 cites for each
`factual allegation, all 24 cases contain the same cited allegations. For ease of reference, the Court will cite each case
`using only the last four digits of its case number, followed by the document and/or electronic filing number.
`4 Although the caption lists one of the defendants as “Life Care Center of Farmington,” the entity’s correct name is
`Life Care Centers of America, Inc., Farmington Operations, LLC d/b/a/ Life Care Center of Farmington.” 0958, Defs.’
`Notice 1 n.1, ECF No. 26.  
`5 See, e.g., 0958, ECF No. 1-1 at 54-55 of 77.
`6 See, e.g., 0958, ECF No. 1-1 at 57-62 of 77.
`7 See, e.g., 0958, ECF No. 1-1 at 55 of 77. 
`8 See, e.g., 0958, ECF No. 1-1 at 54 of 77.  
`9 See, e.g., 0958, ECF No. 1-1 at 55-57 of 77; see, e.g., 0964, ECF No. 1-1 at 50 of 72. 
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`4 
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`Case 1:20-cv-01083-KG-LF Document 28 Filed 03/24/21 Page 5 of 33
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`In March 2020, LCC America learned of the spread of COVID-1910 in its facilities in
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`Kirkland, Washington, yet despite the advance notice, neither LCC America nor LCC Farmington
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`did anything to institute an appropriate facility plan to prevent its spread.11 Defendant Nickse
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`instructed staff at a meeting not to wear face masks so as not to frighten residents.12 Although
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`Medical Director Jerry Monahan ordered staff to obtain COVID-19 tests, Defendant Nickse
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`ordered all the testing swabs destroyed without testing them.13 After COVID-19 arrived at LLC
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`Farmington, Defendants failed to sterilize any equipment, including stethoscopes or blood pressure
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`monitors, and staff were required to reuse nursing gowns and wear N95 masks several days in a
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`row without re-sterilization between shifts.14 Several staff members who exhibited COVID-19
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`symptoms were still required to work, and no additional staff were hired despite a shortage that
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`resulted in staff assigned to multiple units in LCC Farmington, increasing the COVID-19 spread.15
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`Residents who tested positive for COVID-19 and were quarantined were put in rooms that used
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`the same HVAC system for quarantined and non-quarantined residents.16
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`Plaintiffs filed wrongful death suits in the First Judicial District, Santa Fe County, New
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`Mexico, against all Defendants for wrongful death; negligence based on respondeat superior;
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`negligent hiring, retention, and supervision; negligence per se; violation of the Unfair Practices
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`Act; civil conspiracy; and punitive damages.17 According to Plaintiffs, Defendants’ negligence
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` 
`10 Coronaviruses are a family of viruses that cause illnesses like the common cold, but in 2019, a new coronavirus was
`identified called SARS-CoV-2, which causes the coronavirus disease (COVID-19). See Mayo Clinic, Coronavirus
`(COVID-19), https://www.mayoclinic.org/diseases-conditions/coronavirus/symptoms-causes/syc-
`disease 2019
`20479963#:~:text=In%202019%2C%20a%20new,COVID%2D19) (last visited Jan. 29, 2021). In their factual
`allegations, Plaintiffs do not distinguish between the coronavirus and the disease, so the Court will likewise simply
`refer throughout to COVID-19, as Plaintiffs do.
`11 See, e.g., 0958, ECF No. 1-1 at 56 of 77.
`12 See, e.g., 0958, ECF No. 1-1 at 56 of 77.
`13 See, e.g., 0958, ECF No. 1-1 at 56 of 77.
`14 See, e.g., 0958, ECF No. 1-1 at 56 of 77.
`15 See, e.g., 0958, ECF No. 1-1 at 56-57 of 77.
`16 See, e.g., 0958, ECF No. 1-1 at 56 of 77.
`17 See, e.g., 0958, ECF No. 1-1- at 62-76 of 77.
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`5 
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`Case 1:20-cv-01083-KG-LF Document 28 Filed 03/24/21 Page 6 of 33
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`included failing to properly assess each Resident; failing to provide a safe environment, including
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`proper protection from COVID-19; failing to hire a sufficient number of trained and competent
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`staff; and failing to enact proper policies and procedures to prevent the spread of COVID-19.18
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`They allege that Defendants’ conduct was willful and/or wanton.19
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`Defendants filed Notices of Removal in the respective cases. According to Defendants, the
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`allegations in the complaints present federal questions under the PREP Act because they reflect a
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`“covered person” involved in a “recommended activity” relative to a “covered countermeasure”
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`under the Act.20 Defendants assert that the PREP Act completely preempts Plaintiffs’ claims
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`because it created an exclusive federal remedy for claims of loss arising out of, related to, or
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`resulting from the administration or use of a covered countermeasure where the Secretary of the
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`Department of Health and Human Services (“HHS”) issues a declaration of a public health
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`emergency, which he did for the COVID-19 outbreak.21
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`Plaintiffs filed motions to remand in their respective cases, arguing that their claims are
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`based solely on state law. They contend the PREP Act does not apply to their cases because it only
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`applies to the administration and use of covered countermeasures, not to cases like these that allege
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`negligence based on the failure to use such countermeasures or failures to act in other ways not
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`linked to covered countermeasures.
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`II.
`
`SUMMARY OF DECISION
`
`Complete preemption is rare and occurs only where a plaintiff’s state law claims fall within
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`the scope of federal statutes that Congress intended completely to displace all state law on the issue
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`and substitute a federal cause of action for the state cause of action. The Court will thus examine
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` 
`18 See, e.g., 0958, ECF No. 1-1 at 62-63 of 77.
`19 See, e.g., 0958, ECF No. 1-1 at 63-64, 66-68, 70-72, 74-76 of 77.
`20 See, e.g., 0958, ECF No. 1 at 3 of 11.  
`21 See, e.g., 0958, ECF No. 1 at 3-10 of 11. 
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`6 
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`Case 1:20-cv-01083-KG-LF Document 28 Filed 03/24/21 Page 7 of 33
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`the language of the PREP Act in detail to determine the scope of the federal remedies, focusing
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`especially on the language of the provisions creating the federal remedies. As explained more
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`thoroughly herein, the PREP Act provides for an “exclusive” federal cause of action and an
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`“exclusive” administrative remedy, but the Court declines to decide whether Congress thereby
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`intended to remove state law claims to federal court because it concludes that the claims in this
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`case do not fall within the scope of the PREP Act’s civil enforcement scheme.
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`The Court reaches this conclusion after examining the statutory language of 42 U.S.C. §
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`247d-6e(a) and § 247d-6d(d)(1), which created the federal administrative remedy and federal cause
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`of action for willful misconduct claims, respectively. While the PREP Act defines willful
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`misconduct to include both acts and omissions, this opinion addresses why the exception for willful
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`omissions only arises if the claim for loss first falls within the ambit of § 247d-6d(a) – “claims for
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`loss caused by, arising out of, relating to, or resulting from the administration to or the use by an
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`individual of a covered countermeasure.” Id. § 247d-6d(a)(1) (italics added). The Court then
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`examines guidance issued by the Secretary of the HHS regarding the meaning of “administration”
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`and the circumstances in which a covered person may be immune from suit under the PREP Act
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`for certain failures to administer a covered countermeasure. This decision distinguishes the HHS
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`guidance because it is limited to situations in which the failure to use a covered countermeasure in
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`short supply is closely connected to the administration of the covered countermeasures to others
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`with greater priority pursuant to a CDC-approved prioritization plan. The Court looks at Supreme
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`Court authority that differentiates between the immunity provisions that permit an ordinary
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`preemption defense and the provisions creating a federal cause of action that may invoke the
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`complete preemption defense. Finally, the Court turns to the allegations of Plaintiffs’ complaints,
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`setting forth its reasons for determining that the factual allegations do not involve the direct “use”
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`7 
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`Case 1:20-cv-01083-KG-LF Document 28 Filed 03/24/21 Page 8 of 33
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`or “administration” of a covered countermeasure on any of the Plaintiffs, as required for complete
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`preemption under the PREP Act.
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`III.
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`STANDARD OF REVIEW FOR REMOVAL
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`“Federal courts are courts of limited jurisdiction, possessing only that power authorized by
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`Constitution and statute.” Gunn v. Minton, 568 U.S. 251, 256 (2013). Congress gave federal courts
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`removal jurisdiction over cases initially brought in state court if the federal court could have
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`exercised original jurisdiction. Garley v. Sandia Corp., 236 F.3d 1200, 1207 (10th Cir. 2001)
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`(citing 28 U.S.C. § 1441(a)). The burden to show federal jurisdiction is on the party invoking it.
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`Salzer v. SSM Health Care of Oklahoma Inc., 762 F.3d 1130, 1134 (10th Cir. 2014). Removal
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`statutes must be strictly construed with all doubts resolved against removal. Fajen v. Foundation
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`Reserve Ins. Co., Inc., 683 F.2d 331, 333 (10th Cir. 1982). A district court must remand a case to
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`state court whenever the district court lacks subject matter jurisdiction over the case. See 28 U.S.C.
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`§ 1447(c) (“If at any time before final judgment it appears that the district court lacks subject
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`matter jurisdiction, the case shall be remanded.”).
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`IV.
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`LAW ON COMPLETE PREEMPTION
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`A federal district court has jurisdiction over cases in which “a federal question is presented
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`on the face of the plaintiff’s properly pleaded complaint.” Caterpillar Inc. v. Williams, 482 U.S.
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`386, 392 (1987). Under the well-pleaded complaint rule, if the federal question does not appear on
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`the face of the plaintiff’s complaint, there is no federal question jurisdiction. See Garley, 236 F.3d
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`at 1207. In determining whether a claim arises under federal law, courts examine the well-pleaded
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`allegations of the complaint and ignore potential defenses. Beneficial Nat’l Bank v. Anderson, 539
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`U.S. 1, 6 (2003).
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`8 
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`Case 1:20-cv-01083-KG-LF Document 28 Filed 03/24/21 Page 9 of 33
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`Complete preemption is an exception to the well-pleaded complaint rule, in which federal
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`preemption makes the state claim federal in character. Salzer, 762 F.3d at 1134. “When the federal
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`statute completely pre-empts the state-law cause of action, a claim which comes within the scope
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`of that action, even if pleaded in terms of state law, is in reality based on federal law.” Anderson,
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`539 U.S. at 8. See also Metro. Life Ins. Co. v. Taylor, 481 U.S. 58, 63-64 (1987) (“Congress may
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`so completely pre-empt a particular area that any civil complaint raising this select group of claims
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`is necessarily federal in character.”). “There are three forms of preemption that are frequently
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`discussed in judicial decisions—express preemption, conflict preemption, and field preemption.”
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`Devon Energy Prod. Co., L.P. v. Mosaic Potash Carlsbad, Inc., 693 F.3d 1195, 1203 n.4 (10th
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`Cir. 2012). “[F]ederal statutes can preempt state statutes either by an express statement of
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`preemption or by implication.” Id. (citation omitted). While express preemption arises from
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`explicit statutory language about preemption, implied preemption includes field preemption or
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`conflict preemption. Id.
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`“Ordinary preemption,” the affirmative defense that state claims have been substantively
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`displaced by federal law, does not make the case removable, even if the validity of the preemption
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`defense is the only issue to be resolved in the case. Id. In contrast, “complete preemption makes a
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`state-law claim purely a creature of federal law, and thus removable from state to federal court
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`from the outset.” Id. (citations and internal quotation marks omitted). Complete preemption is a
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`“rare doctrine” that “represents an extraordinary pre-emptive power.” Id. at 1204 (internal citations
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`omitted). Complete preemption occurs where the claims fall within the scope of federal statutes
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`that Congress intended completely to displace all state law on the issue and comprehensively to
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`regulate the area, so that there is no room for state-law claims. Id. at 1205. In other words, for
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`complete preemption to apply, “a federal law not only preempts a state law to some degree but
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`9 
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`Case 1:20-cv-01083-KG-LF Document 28 Filed 03/24/21 Page 10 of 33
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`also substitutes a federal cause of action for the state cause of action, thereby manifesting
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`Congress’s intent to permit removal.” Id. (quoting Schmeling v. NORDAM, 97 F.3d 1336, 1342
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`(10th Cir. 1996)). The Supreme Court has recognized the complete preemption doctrine in only a
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`few instances and warned that it should not be “lightly implied.” Id. at 1204-05 (quoting Bill
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`Johnson’s Rests., Inc. v. NLRB, 461 U.S. 731, 752 (1983) (Brennan, J., concurring)) (noting three
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`areas are § 301 of the Labor Management Relations Act of 1947 (“LMRA”), § 502 of the Employee
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`Retirement Income Security Act of 1974 (“ERISA”), and actions for usury against national banks).
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`A court analyzing whether complete preemption applies should consider two questions: (1)
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`whether the federal regulation at issue preempts the state law relied on by the plaintiff; and (2)
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`whether Congress intended to allow removal in such a case, as manifested by whether it provided
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`a federal cause of action to enforce the federal regulation. See id. at 1205. Courts should address
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`the second prong first for reasons of comity and prudence, because the first prong will often require
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`a discussion of the merits of the preemption defense. Id. For complete preemption to apply, the
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`federal cause of action must provide a federal remedy that vindicates “the same basic right or
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`interest that would otherwise by vindicated under state law.” Id. at 1207.
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`V.
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`THE PREP ACT, THE DECLARATION OF A PUBLIC HEALTH
`EMERGENCY REGARDING COVID-19, AND
`SUBSEQUENT
`AMENDMENTS TO THE DECLARATION
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`The PREP Act empowers the Secretary of HHS to declare that a disease constitutes a public
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`health emergency and then utilize funds established by the Treasury to manage the emergency. 42
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`U.S.C. § 247d(a)-(b). The Act also authorizes the Secretary to “facilitate and accelerate, as
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`applicable, advanced research and development of security countermeasures ..., qualified
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`countermeasures ..., or qualified pandemic or epidemic products ..., that are applicable to the public
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`health emergency or potential public health emergency....” Id. § 247d(b)(2)(C). The Secretary may
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`Case 1:20-cv-01083-KG-LF Document 28 Filed 03/24/21 Page 11 of 33
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`recommend the manufacture, testing, development, distribution, administration, or use of one or
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`more covered countermeasures. Id. § 247d-6d(b)(1).
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`The PREP Act provides for targeted liability protections for pandemic and epidemic
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`products and security countermeasures. See id. § 247d-6d. The Act’s immunity provision states:
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`Subject to the other provisions of this section, 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 if a declaration [by the Secretary
`of a public health emergency] has been issued with respect to such countermeasure.
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`Id. § 247d-6d(a)(1), § 247d-6d(b).22 The scope of this immunity “applies to any claim for loss that
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`has a causal relationship with the administration to or use by an individual of a covered
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`countermeasure, including a causal relationship with the … distribution, … administration, … or
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`use of such countermeasure.” Id. § 247d-6d(a)(2)(B).
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`The PREP Act also contains a “Preemption of State law” provision that applies during the
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`effective period of a Secretary’s declaration and says in relevant part:
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`no State or political subdivision of a State may establish, enforce, or continue in
`effect with respect to a covered countermeasure any provision of law or legal
`requirement that—
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`(A) is different from, or is in conflict with, any requirement applicable under this
`section; and
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`(B) relates to the … use, … dispensing, or administration by qualified persons of
`the covered countermeasure, or to any matter included in a requirement
`applicable to the covered countermeasure….
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`Id. § 247d-6d(b)(8).
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`The PREP Act further provides an “Exception to immunity of covered persons” whereby
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`“the sole exception to the immunity from suit and liability of covered persons set forth in
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`22 The parties do not appear to contest that each Defendant is a “covered person” within the meaning of the PREP Act,
`so the Court will presume they are for purposes of resolving the motions to remand.  
`11 
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`Case 1:20-cv-01083-KG-LF Document 28 Filed 03/24/21 Page 12 of 33
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`subsection (a) shall be for an exclusive Federal cause of action against a covered person for death
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`or serious physical injury proximately caused by willful misconduct … by such covered person.”
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`Id. § 247d-6d(d)(1). Congress defined “willful misconduct” as “an act or omission that is taken--
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`(i) intentionally to achieve a wrongful purpose; (ii) knowingly without legal or factual justification;
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`and (iii) in disregard of a known or obvious risk that is so great as to make it highly probable that
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`the harm will outweigh the benefit.” Id. § 247d-6d(c)(1)(A). These federal suits must be filed only
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`in the United States District Court for the District of Columbia. Id. § 247d-6d(e)(1).
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`The PREP Act also created a “Covered Countermeasure Process Fund,” an emergency fund
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`established in the Treasury and funded by Congressional appropriations, “for purposes of
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`providing timely, uniform, and adequate compensation to eligible individuals for covered injuries
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`directly caused by the administration or use of a covered countermeasure pursuant to such
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`declaration.” Id. § 247d-6e(a). “The remedy provided by subsection (a) shall be exclusive of any
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`other civil action or proceeding for any claim or suit this section encompasses, except for a
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`proceeding under section 247d-6d of this title.” Id. § 247d-6e(d)(4).
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`The parties agree that the Secretary issued a declaration regarding the COVID-19 pandemic
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`under the PREP Act. See, e.g., 0958, Pl.’s Mot. to Remand, ECF No. 9 at 5 (citing Declaration
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`Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures
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`Against COVID-19, 85 Fed. Reg. 15,198 (Mar. 10, 2020) (“the Declaration”); and Notice of
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`Removal, ECF No. 1 at 6-9 of 11. Amendments to the Declaration added any respiratory protective
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`devices approved by the National Institute for Occupational Safety and Health (“NIOSH”) as a
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`covered countermeasure. See Dep’t of HHS, Am. to Decl. Under the Public Readiness and
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`Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg.
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`21014
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`(April 15, 2020), https://www.govinfo.gov/content/pkg/FR-2020-04-15/pdf/2020-
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`Case 1:20-cv-01083-KG-LF Document 28 Filed 03/24/21 Page 13 of 33
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`08040.pdf (last visited Mar. 9, 2021). The Secretary further amended the Declaration on June 8,
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`2020 to clarify that a covered countermeasure must be a “qualified pandemic or epidemic product,”
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`a “security countermeasure,” a drug, biological product, or device authorized for emergency use
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`under the Federal Food, Drug, and Cosmetic Act (“FDC Act”), or a respiratory protective device
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`approved by NIOSH; and covered countermeasures include “qualified products that limit the harm
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`COVID-19 might otherwise cause.” Second Am. to Decl. under the PREP Act for Medical
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`Countermeasures against COVID-19, 85 Fed. Reg. 35100, 35101.
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`The Secretary explained the reason for adding “qualified pandemic or epidemic” products
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`as follows:
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`Qualified pandemic and epidemic products that limit the harm that COVID-19
`might otherwise cause are those that would not have been manufactured,
`administered, used, designed, developed, modified, licensed, or procured but for
`the COVID-19 pandemic, even when the products are manufactured, administered,
`used, designed, developed, modified, licensed, or procured to diagnose, mitigate,
`prevent, treat, or cure health threats or conditions other than COVID-19. For
`example, the COVID-19 pandemic has resulted in shortages of certain drugs and
`devices that the FDA has authorized. These drugs and devices may be used for
`COVID-19 and other health conditions. Those shortages are “harm[s] [COVID-19]
`might otherwise cause.” Filling those shortages caused by COVID-19 reduces the
`strain on the American healthcare system by mitigating the escalation of adverse
`health conditions from COVID-19 and non-COVID-19 causes. And mitigating that
`escalation conserves limited healthcare resources—from personal protective
`equipment to healthcare providers—which are essential in the whole-of-Nation
`response to the COVID-19 pandemic.
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`85 Fed. Reg. at 35,101-02.
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`
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`On December 9, 2020, the HHS Secretary issued a Fourth Amendment to the Declaration
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`(“Fourth Amendment”). See Fourth Am. to the Decl. under the PREP Act for Medical
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`Countermeasures against COVID-19 and Republication of the Decl., 85 Fed. Reg. 79,190. The
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`Fourth Amendment clarifies that the Declaration must be construed in accordance with the
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`advisory opinions on the PREP Act issued by the HHS Office of the General Counsel (“OGC”)
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`Case 1:20-cv-01083-KG-LF Document 28 Filed 03/24/21 Page 14 of 33
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`and it “expressly incorporates the Advisory Opinions for that purpose.” Id. at 79,192. It further
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`made explicit that “there can be situations where not administering a covered countermeasure to a
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`particular individual can fall within the PREP Act and this Declaration’s liability protections.” Id.
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`at 79,194. The Fourth Amendment explained the meaning of “administration” under the PREP
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`Act:
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`physical provision of the countermeasures to recipients, or activities and decisions
`directly 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 the purpose of distributing
`and dispensing countermeasures.
`
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`Id. at 79,197. It then offered an example of the type of situation where an injured person complains
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`of not having been administered a covered countermeasure that may fall within the PREP Act’s
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`liability protections:
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`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. For example, consider a situation where there is only one dose of a
`COVID-19 vaccine, and a person in a vulnerable population and a person in a less
`vulnerable population both request it from a healthcare professional. In that
`situation, the healthcare professional administers the one dose to the person who is
`more vulnerable to COVID-19. In that circumstance, the failure to administer the
`COVID-19 vaccine to the person in a less-vulnerable population “relate[es] to …
`the administration to” the person in a vulnerable population. The person in the
`vulnerable population was able to receive the vaccine only because it was not
`administered to the person in the less-vulnerable population. 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.
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`Id. (internal footnote omitted).
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`VI. ANALYSIS
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`
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`Defendants argue that the PREP Act expressly preempts Plaintiffs’ claims because they
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`relate to Defendants’ use and administration of covered countermeasures and are against covered
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`persons for covered losses during the declared public health emergency. While Plaintiffs counter
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`that their claims relate to the failure to use countermeasures, not their use, Defendants assert that
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`the allegations challenge when and how Defendants used countermeasures, and thus fall within
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`the PREP Act. Moreover, Defendants argue that the PREP Act also covers omissions because its
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`purpose is to encourage the efficient use of critical resources during a national health crisis when
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`there is a threat of critical supply shortages. According to Defendants, the PREP Act “preempts
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`state law claims and funnels all alleged injuries into a uniform federal remedial regime so that
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`persons at every level of the health system can respond to a highly contagious, highly dangerous,
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`and novel disease like COVID-19 without the distraction of scattered litigation.” E.g., 0958, Defs.’
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`Resp. 8, ECF No. 13.
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`A. Whether Congress intended to allow removal in a case like this one, as manifested
`by the provision of a federal cause of action to enforce the federal regulation
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`A court in analyzing the meaning of a statute or regulation should first look at its “plain
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`and unambiguous meaning,” and if the language is clear, the analysis ends. Robinson v. Shell Oil
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`Co., 519 U.S. 337, 340 (1997). “The plainness or ambiguity of statutory language is determined
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`by reference to the language itself, the specific context in which that language is used, an