Laura Hudak v. Elmcroft of Sagamore Hills ( 2023 )

RECOMMENDED FOR PUBLICATION
Pursuant to Sixth Circuit I.O.P. 32.1(b)
File Name: 23a0012p.06
UNITED STATES COURT OF APPEALS
FOR THE SIXTH CIRCUIT
┐
LAURA HUDAK, Executrix of the Estate of William P.
│
Koballa, deceased,
│
Plaintiff-Appellee, │
│ No. 21-3836
v. >
│
│
ELMCROFT OF SAGAMORE HILLS; ELMCROFT BY │
ECLIPSE SENIOR LIVING; ECLIPSE SENIOR LIVING, INC.; │
ECLIPSE PORTFOLIO OPERATIONS, LLC; ECLIPSE │
PORTFOLIO OPERATIONS II, LLC; JAMIE ASHLEY │
COHEN, │
Defendants-Appellants. │
┘
Appeal from the United States District Court for the Northern District of Ohio at Akron.
No. 5:21-cv-00060—Sara E. Lioi, District Judge.
Argued: December 7, 2022
Decided and Filed: January 23, 2023
Before: MOORE, GIBBONS, and LARSEN, Circuit Judges.
_________________
COUNSEL
ARGUED: Teresa Pike Tomlinson, HALL BOOTH SMITH, P.C., Columbus, Georgia, for
Appellants. Adam R. Pulver, PUBLIC CITIZEN LITIGATION GROUP, Washington, D.C., for
Appellee. ON BRIEF: Teresa Pike Tomlinson, T. Andrew Graham, HALL BOOTH SMITH,
P.C., Columbus, Georgia, Keith K. Hansbrough, MARSHALL DENNEHEY WARNER
COLEMAN & GOGGIN, Cleveland, Ohio, for Appellants. Adam R. Pulver, Allison M. Zieve,
PUBLIC CITIZEN LITIGATION GROUP, Washington, D.C., Patrick T. Murphy, Christian D.
Foisy, DWORKEN & BERNSTEIN CO., L.P.A., Cleveland, Ohio, for Appellee. Jeffrey S.
Bucholtz, Alexander Kazam, KING & SPALDING LLP, Washington, D.C., Kyle A. Palazzolo,
AMERICAN MEDICAL ASSOCIATION, Chicago, Illinois, for Amici Curiae.
No. 21-3836 Hudak v. Elmcroft of Sagamore Hills, et al. Page 2
_________________
OPINION
_________________
KAREN NELSON MOORE, Circuit Judge. In May 2020, Laura Hudak’s father,
William P. Koballa, died of COVID-19. Hudak, acting as executrix of Koballa’s estate, sued in
state court, asserting negligence and related state-law claims against Elmcroft of Sagamore Hills,
an assisted-living facility in Ohio, and several entities that own or operate the facility
(collectively, “Elmcroft”), for their alleged failure to take care of her father. Elmcroft removed
the case from state court to federal court pursuant to the general removal statute, 28 U.S.C.
§ 1441(a), and the federal-officer removal statute, 28 U.S.C. § 1442(a)(1), based on arguments it
made under the Public Readiness and Emergency Preparedness Act (“PREP Act” or “Act”),
42 U.S.C. § 247d-6d. The district court found that the PREP Act did not provide grounds for
removal under either removal statute and remanded the case to state court for lack of subject-
matter jurisdiction. We AFFIRM.
I. BACKGROUND
A. Statutory Background
The PREP Act lies at the center of this appeal. “Congress enacted the PREP Act in 2005
‘[t]o encourage the expeditious development and deployment of medical countermeasures during
a public health emergency’ by allowing the [Health and Human Services, or HHS] Secretary ‘to
limit legal liability for losses relating to the administration of medical countermeasures such as
diagnostics, treatments, and vaccines.’” Cannon v. Watermark Ret. Cmtys., Inc., 45 F.4th 137,
139 (D.C. Cir. 2022) (quoting KEVIN J. HICKEY, CONG. RSCH. SERV., LSB10443, THE PREP ACT
AND COVID-19, PART 1: STATUTORY AUTHORITY TO LIMIT LIABILITY FOR MEDICAL
COUNTERMEASURES 1 (Apr. 13, 2022)). The Act grants immunity from federal and state liability
to “covered person[s] . . . 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 the HHS Secretary has issued a declaration under the Act “with respect to such
No. 21-3836 Hudak v. Elmcroft of Sagamore Hills, et al. Page 3
countermeasure.” 42 U.S.C. § 247d-6d(a)(1).1 The Secretary’s declaration must identify, among
other things, the threat to public health and the period during which the immunity is in effect. Id.
§ 247d-6d(b)(2).
The PREP Act limits both the reach and effect of its immunity provision. The Act
provides immunity only from “any claim for loss that has a causal relationship with the
administration to or use by an individual of a covered countermeasure[.]” Id. § 247d-
6d(a)(2)(B). This includes “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.” Id. The Act also ensures that its grant of immunity does not foreclose all
possible relief for harms caused by the administration or use of covered countermeasures by
creating a “Covered Countermeasure Process Fund” and a corresponding administrative
compensation scheme. Id. § 247d-6e(a).
The PREP Act creates one exception to its grant of immunity. The Act provides for “an
exclusive Federal cause of action against a covered person for death or serious physical injury
proximately caused by willful misconduct . . . by such covered person.” Id. § 247d-6d(d)(1).
The Act defines willful misconduct as “an act or omission that is taken—(i) intentionally to
achieve a wrongful purpose; (ii) knowingly without legal or factual justification; and (iii) 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.” Id. § 247d-6d(c)(1)(A). The Act dictates that this standard “shall be
1
The PREP Act provides that “[t]he term ‘covered person’, when used with respect to the administration or
use of a covered countermeasure, means—”
(A) the United States; or
(B) a person or entity that is--
(i) a manufacturer of such countermeasure;
(ii) a distributor of such countermeasure;
(iii) a program planner of such countermeasure;
(iv) a qualified person who prescribed, administered, or dispensed such countermeasure; or
(v) an official, agent, or employee of a person or entity described in clause (i), (ii), (iii), or (iv).
42 U.S.C. § 247d-6d(i)(2). Elmcroft asserts that it is a “covered person” under the Act because it was designated a
“program planner.” Appellant Br. at 7. Hudak does not challenge that assertion on appeal.
No. 21-3836 Hudak v. Elmcroft of Sagamore Hills, et al. Page 4
construed as establishing a standard for liability that is more stringent than a standard of
negligence in any form or recklessness.” Id. § 247d-6d(c)(1)(B). Beyond creating the cause of
action and defining the applicable standard of liability, the Act provides that “[t]he substantive
law for decision” for claims brought pursuant to the statute “shall be derived from the law . . . of
the State in which the alleged willful misconduct occurred.” Id. § 247d-6d(e)(2). Lastly, the Act
requires all claims asserted under it to be brought before a three-judge panel in the District Court
for the District of Columbia and to meet certain special pleading standards. Id. § 247d-6d(e)(1)–
(9).
In March 2020, the HHS Secretary declared COVID-19 a public-health emergency under
the PREP Act. See Declaration Under the Public Readiness and Emergency Preparedness Act
for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15,198 (Mar. 17, 2020). The
Secretary recommended “the manufacture, testing, development, distribution, administration,
and use of the Covered Countermeasures[,]” which included “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[.]” Id. at 15,201–202. The Secretary stated that immunity under the Act
would extend through October 1, 2024. Id. at 15,202. Since issuing that initial declaration, the
Secretary has amended the declaration several times, including most recently in January 2022.
See Tenth Amendment to Declaration Under the Public Readiness and Emergency Preparedness
Act for Medical Countermeasures Against COVID-19, 87 Fed. Reg. 982 (Jan. 7, 2022).
B. Factual and Procedural Background
As alleged in the complaint, Koballa resided with his wife in Elmcroft’s assisted-care
facility in Northfield, Ohio, prior to his death in May 2020. See R. 1-1 (Compl. ¶¶ 3, 12, 34)
(Page ID #18–19, 22). In late April 2020, Elmcroft suspended family visitation, required its staff
to wear masks and gloves, and instituted other policies in response to the developing COVID-19
pandemic. Id. ¶ 13 (Page ID #19–20). A few days later, on May 4, Koballa started to show
signs of sickness. Id. ¶ 15 (Page ID #20). An Elmcroft employee sent an email to Hudak the
following day stating that a nurse and a doctor had examined her father and that the doctor
believed Koballa was suffering from allergies. Id. ¶¶ 17–18 (Page ID #20). Contrary to that
email, however, Koballa had not been seen by either practitioner. Id. Koballa’s condition
No. 21-3836 Hudak v. Elmcroft of Sagamore Hills, et al. Page 5
continued to deteriorate, and by May 9 he was unable to walk or feed himself. Id. ¶¶ 19–24
(Page ID #20–21). Hudak and her sister, dissatisfied with Elmcroft’s communications, went to
see Koballa in person and “were shocked to observe the physical condition of their father and
insisted that he be taken to the hospital.” Id. ¶¶ 27–28 (Page ID #21). When medics arrived at
the facility, they observed that Elmcroft employees were not wearing masks. Id. ¶ 29 (Page ID
#22). The medics transported Koballa to a hospital, where he tested positive for COVID-19 and
died several days later “from hypoxia and COVID Pneumonia.” Id. ¶ 34 (Page ID #22).
Hudak filed a lawsuit in Ohio state court in December 2020, asserting claims under
state law for (1) negligence; (2) reckless, intentional, willful, and wanton misconduct;
(3) survivorship; (4) wrongful death; and (5) violation of Ohio’s nursing home patient’s bill of
rights. Id. ¶¶ 38–60 (Page ID #23–26). Beyond incorporating by reference the factual
allegations discussed above, Hudak makes few additional allegations in connection with each
claim. Hudak asserts with respect to her negligence claim, for example, that Elmcroft was
negligent in caring for Koballa, assessing its ability to care for him, and in not transferring him to
a hospital earlier. Id. ¶ 40 (Page ID #23). As to her claim of reckless, intentional, willful, and
wanton misconduct, Hudak asserts that Elmcroft engaged in conduct “with heedless indifference
to the consequences” and “disregarded substantial and unjustifiable risks” that its “conduct was
likely to cause[] an unreasonable risk of injury, death, or loss to person or property to others,
including . . . Koballa.” Id. ¶ 44 (Page ID #23–24). Hudak’s other claims include similar
recitations of the elements of her causes of action.
Shortly after Hudak filed her complaint in state court, Elmcroft removed the case to the
District Court for the Northern District of Ohio pursuant to § 1441(a) and § 1442(a)(1). See R. 1
(Notice of Removal ¶ 16) (Page ID #6). Elmcroft argued in its notice of removal that removal
was appropriate under § 1441(a) for two reasons: Hudak’s claims were completely preempted
by the PREP Act and the claims necessarily raised substantial federal issues. Id. ¶¶ 16–38 (Page
ID #6–12). Elmcroft did not address § 1442(a)(1) in depth, but instead merely asserted that the
case was removable under the statute. Id. ¶ 16 (Page ID #6). Hudak moved to remand the case
back to state court for lack of subject-matter jurisdiction, R. 8 (Mot. to Remand at 1) (Page ID
#125), and the district court granted the motion, Hudak v. Elmcroft of Sagamore Hills, 566 F.
No. 21-3836 Hudak v. Elmcroft of Sagamore Hills, et al. Page 6
Supp. 3d 771, 775 (N.D. Ohio 2021). Elmcroft appeals. R. 34 (Notice of Appeal) (Page ID
#484).
II. APPELLATE JURISDICTION
At the outset, Hudak challenges our appellate jurisdiction to hear Elmcroft’s challenge to
the district court’s remand order. Federal law provides as a general rule that “[a]n order
remanding a case to the State court from which it was removed is not reviewable on appeal or
otherwise[.]” 28 U.S.C. § 1447(d). But one exception to that rule is relevant here: “an order
remanding a case to the State court from which it was removed pursuant to section 1442 . . . of
this title shall be reviewable by appeal or otherwise.” Id.; see also BP P.L.C. v. Mayor & City
Council of Baltimore, 141 S. Ct. 1532, 1537–43 (2021) (holding that appellate jurisdiction under
§ 1447(d) extends to all issues decided in the remand order). Here, Elmcroft asserted in its
notice of removal that the case was removable under § 1442(a)(1), R. 1 (Notice of Removal ¶ 16)
(Page ID #6), so we have appellate jurisdiction to review the district court’s order under
§ 1447(d). See Hudak v. Elmcroft of Sagamore Hills, No. 21-3836 (6th Cir. Mar. 25, 2022)
(order) (reaching the same conclusion).
III. SUBJECT-MATTER JURISDICTION
Turning to Elmcroft’s challenge, Elmcroft argues that the district court erred in finding
that the case could not be removed from state court to federal court under either § 1441(a) or
§ 1442(a)(1). We address Elmcroft’s arguments under the two statutes in turn.
A. Standard of Review
“We review de novo the district court’s determination that it lacked subject-matter
jurisdiction and its consequent decision to issue a remand order.” Mays v. City of Flint, 871 F.3d
437, 442 (6th Cir. 2017) (citing Smith v. Nationwide Prop. & Cas. Ins. Co., 505 F.3d 401, 404
(6th Cir. 2007)). “As the party requesting a federal forum,” Elmcroft “bears the burden of
establishing federal jurisdiction.” Siding & Insulation Co. v. Acuity Mut. Ins. Co., 754 F.3d 367,
369 (6th Cir. 2014) (citing McNutt v. Gen. Motors Acceptance Corp. of Ind., 298 U.S. 178, 189
(1936)).
No. 21-3836 Hudak v. Elmcroft of Sagamore Hills, et al. Page 7
B. General Removal Under § 1441(a)
Elmcroft first invokes the general removal statute. Pursuant to § 1441(a), “[a] civil action
filed in a state court may be removed to federal court if the claim is one ‘arising under’ federal
law.” Beneficial Nat’l Bank v. Anderson, 539 U.S. 1, 6 (2003). We determine whether a claim
“arises under” federal law using the well-pleaded complaint rule. Aetna Health Inc. v. Davila,
542 U.S. 200, 207 (2004). “Under this rule, a federal question must appear on the face of the
complaint rather than as part of a defense, even if a federal-law defense is anticipated.” Chase
Bank USA, N.A. v. City of Cleveland, 695 F.3d 548, 554 (6th Cir. 2012).
1. Complete Preemption
Elmcroft’s primary argument in support of removal under § 1441(a) is that Hudak’s state-
law claims arise under federal law because they are completely preempted by the PREP Act.
Generally, preemption provides a defense, not a basis for removal. See Caterpillar Inc. v.
Williams, 482 U.S. 386, 392–93 (1987). Ordinary preemption, for instance, flows from the
Supremacy Clause of the United States Constitution and provides only a defense that can be
invoked in state or federal court. See Matthews v. Centrus Energy Corp., 15 F.4th 714, 720 (6th
Cir. 2021). The “misleadingly named doctrine” of complete preemption, by contrast, refers to a
jurisdictional doctrine that is distinct from ordinary preemption. Hogan v. Jacobson, 823 F.3d
872, 879 (6th Cir. 2016) (quoting Hughes v. United Air Lines, Inc., 634 F.3d 391, 393 (7th Cir.
2011)); see also Matthews, 15 F.4th at 720–21 (distinguishing between forms of preemption).
Complete preemption occurs where “the pre-emptive force of a [federal] statute is so
‘extraordinary’ that it ‘converts an ordinary state common-law complaint into one stating a
federal claim for purposes of the well-pleaded complaint rule.’” Caterpillar Inc., 482 U.S. at
393 (quoting Metro. Life Ins. Co. v. Taylor, 481 U.S. 58, 65 (1987)). “Once an area of state law
has been completely pre-empted, any claim purportedly based on that pre-empted state law is
considered, from its inception, a federal claim, and therefore arises under federal law.” Id.(citing Franchise Tax Bd. v. Constr. Laborers Vacation Tr., 463 U.S. 1, 24 (1983)). Thus, a
state-law claim that is completely preempted may be removed from state court to federal court
pursuant to § 1441(a).
No. 21-3836 Hudak v. Elmcroft of Sagamore Hills, et al. Page 8
The Supreme Court has found only three provisions of federal law to be completely
preemptive: § 301 of the Labor Management Relations Act (“LMRA”), § 502(a)(1)(B) of the
Employee Retirement Income Security Act (“ERISA”), and §§ 85 and 86 of the National Bank
Act. See AmSouth Bank v. Dale, 386 F.3d 763, 776 (6th Cir. 2004) (collecting authorities). In
each instance, the federal statute “provided the exclusive cause of action for the claim asserted
and also set forth procedures and remedies governing that cause of action.” Roddy v. Grand
Trunk W. R.R. Inc., 395 F.3d 318, 323 (6th Cir. 2005) (quoting Beneficial Nat’l Bank, 539 U.S.
at 8). Consistent with the Court’s precedent, we have observed that “[t]he congressional intent
necessary to confer removal jurisdiction upon the federal district courts through complete
preemption is expressed through the creation of a parallel federal cause of action that would
‘convert’ a state cause of action into the federal action for purposes of the well-pleaded
complaint rule.” Id. (quoting Strong v. Telectronics Pacing Sys., Inc., 78 F.3d 256, 260 (6th Cir.
1996)).
Importantly, a federal statute will completely preempt only those state-law claims that
fall within the scope of the federal cause of action. See Davila, 542 U.S. at 210 (holding that
§ 502(a)(1)(B) of ERISA completely preempts a state-law claim only if the state claim “could
have [been] brought” under § 502(a)(1)(B) and “there is no other independent legal duty that is
implicated by [the] defendant’s actions”); Beneficial Nat’l Bank, 539 U.S. at 8 (explaining that
the Supreme Court has found complete preemption only where “the federal statutes at issue
provided the exclusive cause of action for the claim asserted”); see also Roddy, 395 F.3d at 323
(explaining that complete preemption arises where a federal cause of action converts the state-
law claim into a federal one for the purposes of the well-pleaded complaint rule).
Although our court has not previously considered whether the PREP Act completely
preempts state-law claims within its ambit, several federal courts of appeals have addressed the
issue in similar cases involving claims against assisted-living facilities and nursing homes during
the COVID-19 pandemic. See Maglioli v. All. HC Holdings LLC, 16 F.4th 393, 406–13 (3d Cir.
2021); Mitchell v. Advanced HCS, L.L.C., 28 F.4th 580, 584–88 (5th Cir. 2022); Manyweather v.
Woodlawn Manor, Inc., 40 F.4th 237, 242–46 (5th Cir. 2022); Martin v. Petersen Health
Operations, LLC, 37 F.4th 1210, 1213–14 (7th Cir. 2022); Saldana v. Glenhaven Healthcare
No. 21-3836 Hudak v. Elmcroft of Sagamore Hills, et al. Page 9
LLC, 27 F.4th 679, 687–88 (9th Cir. 2022). These courts have taken different views as to
whether the PREP Act completely preempts any state-law claims, but the courts have all held
that the Act does not completely preempt claims, like Hudak’s, that do not allege willful
misconduct related to the administration or use of covered COVID-19 countermeasures.
We agree.
At the outset, there is no question that the PREP Act has significant “pre-emptive force.”
Caterpillar Inc., 482 U.S. at 393. The Act’s general immunity provision, for instance, provides
immunity to “covered person[s]” from “suit and liability under Federal and State law with
respect to all claims for loss caused by” the use of a “covered countermeasure.” 42 U.S.C.
§ 247d-6d(a)(1). But this immunity provision reflects “an ordinary rule of preemption, a defense
to liability under state law.” Martin, 37 F.4th at 1213. It does not create a federal cause of
action that completely preempts covered state-law claims. Thus, the immunity provision might
or might not provide Elmcroft with a viable defense in state court, but it does not transform
Hudak’s state-law claims into federal ones for purposes of “arising under” jurisdiction. Id.; see
also Beneficial Nat’l Bank, 539 U.S. at 9 (explaining that a provision of the National Banking
Act would completely preempt state-law claims “[o]nly if Congress intended [the provision] to
provide the exclusive cause of action” for the claims); Gardner, 715 F.3d at 612 (observing that
ERISA’s express-preemption clause, in contrast with § 502(a)(1)(B), “is no basis to remove [a]
case from state court to federal”).
The sole cause of action created by the PREP Act is “an exclusive Federal cause of action
against a covered person for death or serious physical injury proximately caused by willful
misconduct . . . by such covered person.” 42 U.S.C. § 247d-6d(d)(1). Unlike the general
immunity provision, it is debatable whether § 247d-6d(d)(1) completely preempts certain state-
law claims. The PREP Act defines certain (but not all) elements of the claim that may be
asserted under the federal cause of action, see id. § 247d-6d(c)(1)(A), and dictates that such
claims “shall be filed and maintained only in the United States District Court for the District of
Columbia,” id. § 247d-6d(e)(1). Yet the Act also incorporates substantive state law into actions
brought under its federal cause of action, see id. § 247d-6d(e)(2), making it “unlike other
instances of complete preemption[,]” Matthews, 15 F.4th at 721. Other federal courts of appeals
No. 21-3836 Hudak v. Elmcroft of Sagamore Hills, et al. Page 10
have not reached a consensus as to whether the PREP Act completely preempts state-law claims
that fall within the scope of § 247d-6d(d)(1)’s federal cause of action. Compare Maglioli,
16 F.4th at 409–10 (suggesting it does), with Saldana, 27 F.4th at 688 (suggesting it does not),
with Mitchell, 28 F.4th at 586 (assuming but not deciding it does), and Manyweather, 40 F.4th at
245 n.6 (same).
We decline to decide whether § 247d-6d(e)(1) is completely preemptive because we hold
that Hudak’s claims do not fall within the scope of the federal cause of action for two reasons.
First, Hudak does not allege that Elmcroft engaged in willful misconduct within the meaning of
the PREP Act. The gravamen of Hudak’s terse complaint appears to be that Elmcroft failed to
ensure that its employees wore masks, to assess whether it could care for Koballa after he
became sick, or to transfer him to another facility that could provide the appropriate care. See R.
1-1 (Compl. ¶¶ 29, 36–37, 40) (Page ID #22–23). To be sure, Hudak labels one of her claims as
one for “reckless, intentional, willful and wanton misconduct.” R. 1-1 (Compl. ¶¶ 42–45) (Page
ID #23–24). But “distinguishing between pre-empted and non-pre-empted claims based on the
particular label affixed to them would ‘elevate form over substance[.]’” Davila, 542 U.S. at 214(quoting Allis-Chalmers Corp. v. Lueck, 471 U.S. 202, 211 (1985)). Aside from its labels,
Hudak’s complaint is devoid of allegations that Elmcroft took actions “(i) intentionally to
achieve a wrongful purpose; (ii) knowingly without legal or factual justification; and (iii) 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). Accordingly, Hudak could not bring
her claims under the PREP Act’s federal cause of action.
Elmcroft challenges this initial basis for our decision on the ground that it is error to
focus on the PREP Act’s standard of liability when determining whether Hudak’s claims fall
within the scope of the Act’s federal cause of action. In Elmcroft’s view, “the PREP Act creates
a civil cause of action—regardless of the liability standard—for a ‘person who suffered an
injury’ relating to a COVID-19 countermeasure,” and the Act thereby completely preempts all
claims that relate to covered countermeasures irrespective of whether the claims allege
negligence or willful misconduct. Appellant Br. at 30 (citing 42 U.S.C. § 247d-6d(d)(1), (d)(2),
(e)(1)). Elmcroft draws its argument from Davila, in which the Supreme Court stated that it
No. 21-3836 Hudak v. Elmcroft of Sagamore Hills, et al. Page 11
would be inconsistent with the Court’s precedent “to conclude that only strictly duplicative state
causes of action are pre-empted.” 542 U.S. at 216. We find Elmcroft’s view to be unpersuasive.
To begin, Elmcroft’s argument cannot be reconciled with the PREP Act’s plain text.
Contrary to Elmcroft’s assertion, the PREP Act does not create a federal cause of action for all
claims arising under the Act. Rather, as discussed, the Act begins by creating a rule of ordinary
preemption, providing immunity to covered persons from all federal and state claims for loss
caused by the administration or use of covered countermeasures. See 42 U.S.C. § 247d-6d(a)(1).
The Act then provides that “the sole exception to the immunity from suit and liability of covered
persons set forth in subsection (a) shall be for an exclusive Federal cause of action against a
covered person for death or serious physical injury proximately caused by willful misconduct[.]”
Id. § 247d-6d(d)(1) (emphases added). Congress could have created an exclusive federal cause
of action for any claim implicating the PREP Act, or it could have provided for the removal of
any claim arising under the Act, but it chose not to do so. Cf. Miller v. Bruenger, 949 F.3d 986,
995 (6th Cir. 2020). Elmcroft asks us to override Congress’s choice. We cannot do so.
Further, Elmcroft’s reliance on Davila is misplaced. Elmcroft suggests that Davila
requires us to ignore the elements of Hudak’s claims when determining whether her claims fall
within the scope of the PREP Act’s federal cause of action. But Davila makes clear that a state
claim will be completely preempted only if it falls within the scope of an exclusive federal cause
of action. 542 U.S. at 210. If a plaintiff could have brought a claim under the federal cause of
action (and the claim does not rest on an independent legal duty), then the fact that state law
imposes additional pleading requirements will not save their claim from complete preemption.
Id. at 216. Far from directing us to ignore the elements of Hudak’s state claims, Davila instead
makes clear that we must begin our analysis by “examin[ing] [Hudak’s] complaint[]” and the
basis for her claims to determine whether federal law provides a substitute cause of action for the
claims. Id. at 211. Because Hudak does not allege willful misconduct within the meaning of the
PREP Act, the Act does not provide her with a federal cause of action and her claims are not
completely preempted.
Even if we were to agree that Hudak asserts a willful misconduct claim, we would hold
that Hudak’s claims fall outside the scope of the PREP Act’s federal cause of action for a second,
No. 21-3836 Hudak v. Elmcroft of Sagamore Hills, et al. Page 12
independent reason. As noted, a willful misconduct claim brought under the PREP Act must be
for a loss that has a “causal relationship with the administration to or use by an individual of a
covered countermeasure[.]” 42 U.S.C. § 247d-6d(a)(2)(B). Examples of the “administration to
or use of” a covered countermeasure under the Act include: “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.” Id. To state a willful misconduct claim under the Act, a plaintiff must
“plead with particularity . . . each act or omission, by each covered person sued, that is alleged to
constitute willful misconduct relating to the covered countermeasure administered to or used by
the person on whose behalf the complaint was filed[.]” Id. § 247d-6d(e)(3)(A) (emphasis
added).
Nowhere in the complaint does Hudak allege that “the administration to or use by
[Koballa] of a” COVID-19 countermeasure caused his illness or death. Id. § 247d-6d(a)(2)(B).
The closest Hudak comes to making such a claim is her allegation that Elmcroft’s staff failed to
wear masks or follow infection-control procedures. R. 1-1 (Compl. ¶¶ 29, 36–37) (Page ID #22).
But an allegation that Elmcroft failed to use a COVID-19 countermeasure (facemasks) or to
administer another (an infection protocol) differs in kind from an allegation that Elmcroft’s
administration or Koballa’s use of those countermeasures caused Koballa’s death. See
Manyweather, 40 F.4th at 245–46 (making a similar point); Martin, 37 F.4th at 1213–14 (same).
Put differently, Hudak alleges that Elmcroft was wrong not to use medical countermeasures, not
that it engaged in wrongful actions that had a causal relationship with the administration to or use
by Koballa of a countermeasure. The PREP Act’s federal cause of action does not provide an
avenue for asserting Hudak’s theory of liability and therefore cannot completely preempt her
claims.2 See Martin, 37 F.4th at 1213–14 (drawing a similar distinction and holding that
comparable claims were “not even arguably preempted”).
2
We express no opinion as to whether allegations relating to the non-use of a covered medical
countermeasure could ever fall within the scope of the PREP Act’s federal cause of action. Cf. Manyweather,
40 F.4th at 246 (reserving decision on this issue). We hold only that Hudak’s particular claims fall outside the
federal cause of action’s scope.
No. 21-3836 Hudak v. Elmcroft of Sagamore Hills, et al. Page 13
Elmcroft disputes this straightforward reading of the PREP Act by pointing to a portion
of the HHS Secretary’s March 2020 declaration that addressed the “administration” of covered
countermeasures. Appellant Reply Br. at 12–15 (citing Declaration Under the Public Readiness
and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed.
Reg. 15,198 (Mar. 17, 2020)). Under the PREP Act, the Secretary has the authority under certain
circumstances to issue a declaration recommending “the manufacture, testing, development,
distribution, administration, or use of one or more covered countermeasures, and stating that [the
Act’s immunity provision] is in effect with respect to the activities so recommended.” 42 U.S.C.
§ 247d-6d(b)(1). Pursuant to that provision, the Secretary’s declaration recommends the
administration of covered countermeasures, Declaration Under the Public Readiness and
Emergency Preparedness Act, 85 Fed. Reg. at 15,201, which the declaration defines as the
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 purpose of distributing
and dispensing countermeasures.
Id. at 15,202. Seizing on the final clause of this paragraph, Elmcroft argues that Hudak’s claims
allege a causal connection between Koballa’s death and Elmcroft’s management and operation.
The Secretary’s declaration, though broad, does not rescue Elmcroft from the
fundamental flaw in its argument. Setting aside the issue of what, if any, deference we owe to
the Secretary’s reading of the PREP Act, the declaration does not suggest that the term
“administration” extends to all activities associated with the management or operation of a
facility. Cf. Appellant Reply Br. at 14. Rather, the declaration states that the term encompasses
management and operation activities that are taken for the purpose of distributing and dispensing
countermeasures. The declaration suggests that an entity that dispenses an antiviral medication
(a covered countermeasure) might be immune from a claim for loss sustained while waiting in
line for the medication that alleges that the facility failed to design and implement an appropriate
waiting procedure (the administration of the countermeasure). Cf. Declaration Under the Public
Readiness and Emergency Preparedness Act, 85 Fed. Reg. at 15,200 (discussing a similar
example). But that same entity would not receive immunity under the PREP Act for injuries
No. 21-3836 Hudak v. Elmcroft of Sagamore Hills, et al. Page 14
unrelated to its provision of the covered countermeasure solely because it provides
countermeasures. That distinction demonstrates why Hudak’s claims do not fall within the
PREP Act’s exception to that immunity. Hudak does not allege that Koballa’s illness or death
was caused by Elmcroft’s distribution or dispersal of countermeasures, but rather by its failure to
use countermeasures or to take appropriate care of him. Thus, even on the Secretary’s expansive
reading of the PREP Act, Hudak does not assert a willful-misconduct claim related to the
“administration” of covered countermeasures.
In sum, because Hudak does not allege that Elmcroft engaged in willful misconduct in
the administration or use of a covered COVID-19 countermeasure, the PREP Act does not
“provide[] the exclusive cause of action for the claim asserted” and does not completely preempt
Hudak’s state-law claims. Beneficial Nat’l Bank, 539 U.S. at 8. Accordingly, the district court
did not err in finding that Elmcroft could not remove the case on that basis under § 1441(a).3
2. Substantial Federal Question
Elmcroft next argues that removal to federal court was appropriate under § 1441(a)
because Hudak’s state claims “turn on substantial questions of federal law[.]” Grable & Sons
Metal Prods., Inc. v. Darue Eng’g & Mfg., 545 U.S. 308, 312 (2005).4 We are unpersuaded.
The Supreme Court has “identified a ‘special and small category’ of cases in which
arising under jurisdiction” lies over claims originating in state rather than federal law. Gunn v.
Minton, 568 U.S. 251, 258 (2013) (quoting Empire Healthchoice Assur., Inc. v. McVeigh,
547 U.S. 677, 699 (2006)). Under Grable, “federal jurisdiction over a state law claim will lie if a
federal issue is: (1) necessarily raised, (2) actually disputed, (3) substantial, and (4) capable of
3
We express no view as to whether § 247d-6d(d)(1) completely preempts state-law claims that fall within
its scope.
4
Hudak argues that Elmcroft forfeited its Grable argument by failing to raise it in the district court in
opposition to Hudak’s motion to remand. Notwithstanding Elmcroft’s failure to raise the issue at that time, the
district court resolved the issue on the merits and both parties have briefed it on appeal. Under these circumstances,
we decline to address forfeiture or waiver and will instead proceed to the merits of Elmcroft’s argument. See
Bledsoe v. Tenn. Valley Auth. Bd. of Dirs., 42 F.4th 568, 588 n.4 (6th Cir. 2022) (considering argument that may
have been forfeited where the district court resolved it on the merits and the parties fully briefed it on appeal);
United States v. Clariot, 655 F.3d 550, 556 (6th Cir. 2011) (“When a district court resolves an issue, the losing party
can challenge it. Otherwise, the more surprising a district court decision in terms of resolving unbriefed and
unargued points, the more insulated from review that decision would be.”).
No. 21-3836 Hudak v. Elmcroft of Sagamore Hills, et al. Page 15
resolution in federal court without disrupting the federal-state balance approved by Congress.”
Id.Elmcroft’s argument fails at Grable’s first prong. Hudak’s claims are grounded in state
common law and will turn on such issues as whether Elmcroft failed to comply with its COVID-
19 policies, to provide adequate medical and other care to Koballa, and to take appropriate action
once it became clear that Koballa was sick. See R. 1-1 (Compl. ¶¶ 36–37, 40) (Page ID #22–23).
None of Hudak’s claims necessarily raises a federal issue or requires a court to address or resolve
one. Although Elmcroft suggests that it will raise a federal-preemption defense under the PREP
Act to Hudak’s claims, the assertion of a federal defense does not transform a state claim into
one that “arises under” federal law. See Metro. Life Ins. Co., 481 U.S. at 63. Accordingly, in
line with the courts of appeals that have addressed similar claims, we hold that Hudak’s state-law
claims do not arise under federal law and could not be removed under § 1441(a). See Maglioli,
16 F.4th at 413; Mitchell, 28 F.4th at 588–89; Martin, 37 F.4th at 1214–15; Saldana, 27 F.4th at
688–89.
C. Federal-Officer Removal Under § 1442(a)(1)
Turning to the second removal statute at issue, Elmcroft argues that the case is removable
under the federal-officer removal statute.5 Section 1442(a)(1) permits a defendant to remove to
federal court a state-court action brought against:
[t]he United States or any agency thereof or any officer (or any person acting
under that officer) of the United States or of any agency thereof, in an official or
individual capacity, for or relating to any act under color of such office or on
account of any right, title or authority claimed under any Act of Congress for the
apprehension or punishment of criminals or the collection of the revenue.
28 U.S.C. § 1442(a)(1). Federal courts have subject-matter jurisdiction over claims that are
properly removed under § 1442(a)(1). See Mesa v. California, 489 U.S. 121, 136 (1989).
5
As above, Hudak argues that Elmcroft forfeited this argument by failing to raise it in opposition to
Hudak’s motion to remand. See supra n.4. Because the district court addressed the issue on the merits and the
parties have fully briefed it on appeal, we again address Elmcroft’s argument on the merits.
No. 21-3836 Hudak v. Elmcroft of Sagamore Hills, et al. Page 16
Where, as here, “the removing party is not a federal officer, we apply a three-part test to
determine whether removal is proper.” Nappier v. Snyder, 728 F. App’x 571, 574 (6th Cir.
2018). “The removing party must demonstrate that: (1) it is a ‘person’ within the meaning of the
statute who ‘acted under a federal officer’; (2) ‘it performed the actions for which it is being sued
under color of federal office’; and (3) ‘it raised a colorable federal defense.’” Id. (quoting
Bennett v. MIS Corp., 607 F.3d 1076, 1085 (6th Cir. 2010)). We limit our discussion to the first
prong.
To demonstrate that it was acting under a federal officer, the removing party must show
that it was “in a relationship with the federal government where the government [was]
functioning as the defendant’s superior.” Mays, 871 F.3d at 444. This relationship “typically
involves ‘subjection, guidance, or control’” exercised by the government over the removing
party. Watson v. Philip Morris Cos., 551 U.S. 142, 151 (2007) (quoting Webster’s New
International Dictionary 2765 (2d ed. 1953)). “In addition, precedent and statutory purpose
make clear that the private person’s ‘acting under’ must involve an effort to assist, or to help
carry out, the duties or tasks of the federal superior.” Id. at 152 (emphasis in original).
Here, Elmcroft has not met its burden of establishing that it was “acting under” a federal
officer within the meaning of § 1442(a)(1). Elmcroft argues that it was acting under a federal
officer because it was subject to a series of regulations and other federal guidance. There is no
question, however, that “the help or assistance necessary to bring a private person within the
scope of the statute does not include simply complying with the law.” Watson, 551 U.S. at 152(emphasis in original); see also Martin, 37 F.4th at 1212–13. Elmcroft also argues that it
performed a governmental function by helping to contain the spread of the COVID-19 virus. But
this argument merely repackages Elmcroft’s earlier one. Elmcroft has not shown that it was
hired or enlisted by the federal government to perform a containment function. Rather, Elmcroft
asserts that it came under a duty to take certain preventative measures while carrying out its
preexisting duties to its residents, including “quarantining and isolating seniors through
restricting visitation, canceling communal dining, and implementing active screening of staff for
fever and respiratory symptoms.” Appellant Br. at 50. Elmcroft’s compliance with these
mandates, as discussed above, does not demonstrate that it was “acting under” a federal officer.
No. 21-3836 Hudak v. Elmcroft of Sagamore Hills, et al. Page 17
See Maglioli, 16 F.4th at 404–06; Mitchell, 28 F.4th at 589–91; Martin, 37 F.4th at 1212–13;
Saldana, 27 F.4th at 684–86.
Elmcroft’s reliance on Bennett, 607 F.3d 1076, and Caver v. Central Alabama Electric
Cooperative, 845 F.3d 1135 (11th Cir. 2017), is misplaced. In both cases, private entities had
agreements with the federal government under which the entities provided a service subject to
the government’s extensive direction and control. In Bennett, for instance, we held that a mold
remediation firm hired by the Federal Aviation Administration (“FAA”) was “acting under” the
FAA for purposes of removal under § 1442(a)(1). 507 F.3d at 1082, 1086–88. We observed that
the remediation firm had submitted evidence demonstrating that FAA officers had the authority
to dismiss the remediation firm’s employees for cause, controlled the working hours of the firm’s
employees, and were required to escort the employees on and off the worksite. Id. at 1087–88.
Similarly, the Eleventh Circuit held in Caver that a rural electric cooperative was “acting
under” a federal officer within the meaning of § 1442(a)(1). 845 F.3d at 1138. Although the
court observed that the electric cooperative received loans from and was heavily regulated by the
federal government, it concluded that the “federal regulations alone [were] not enough to satisfy
the federal removal statute[.]” Id. at 1143. The court therefore looked beyond the applicable
federal regulations to historical evidence showing that “rural electric cooperatives are something
more than public utilities; they are instrumentalities of the United States.” Id. The court found,
consistent with that historical tradition, that the electric cooperative “helps assist or carry out the
duties” of the federal government and “works closely with [the federal government] to fulfill the
congressional objective of bringing electricity to rural areas that would otherwise go unserved.”
Id. at 1144. Based on that evidence, the court concluded that the electric cooperative was “acting
under” the federal government within the meaning of § 1442(a)(1). Id.
Here, by contrast, Elmcroft asserts only that it operated a facility that came under
significant federal regulation as part of the federal government’s response to the COVID-19
pandemic. Elmcroft did not have an agreement with the federal government, did not produce a
good or perform a service on behalf of the government, and has not shown that the federal
government exercised control over its operations to such a degree that the government acted as
No. 21-3836 Hudak v. Elmcroft of Sagamore Hills, et al. Page 18
Elmcroft’s superior. The district court did not err in finding that the case could not be removed
under §1442(a)(1) and thus that it lacked subject-matter jurisdiction over Hudak’s claims.
IV. CONCLUSION
Elmcroft may invoke the PREP Act as a potential defense to Hudak’s claims in state
court, but it has not met its burden of showing that the Act supports removal of her claims to
federal court under either § 1441(a) or § 1442(a)(1). We therefore AFFIRM the judgment of the
district court.