Estate of Winfred Cowan et al v. LP Columbia KY, LLC et al
MEMORANDUM OPINION AND ORDER by Chief Judge Greg N. Stivers on 3/30/2021; For the reasons discussed, Plaintiffs' Motion to Remand (DN 13 ) is GRANTED, and this matter is REMANDED to Adair Circuit Court. Defendants' Motion to Dismiss (DN 10 ), and Defendants' Motion for Oral Argument (DN 19 ) are DENIED. Defendants' Motion for Leave to Exceed Page Limit (DN 9 ), and Defendants' Motions for Leave to File Supplemental Authorities (DN 22 , 23 , 24 , 25 ) are GRANTED. The Clerk shall strike this matter from the active docket. cc: Counsel; Clerk, Adair Circuit Court (Civil Action No. 20-CI-00077) (certified) (CDF)
UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF KENTUCKY
BOWLING GREEN DIVISION
CIVIL ACTION NO. 1:20-CV-00118-GNS
ESTATE OF WINFRED COWAN, et al.
LP COLUMBIA KY, LLC, et al.
MEMORANDUM OPINION AND ORDER
This matter is before the Court on Defendants’ Motion to Dismiss (DN 10), Defendants’
Motion for Leave to Exceed Page Limit (DN 9), Defendants’ Motion for Oral Argument (DN 19),
Defendants’ Motions for Leave to File Supplemental Authorities (DN 22, 23, 24, 25), and
Plaintiffs’ Motion to Remand (DN 13). The motions are ripe for adjudication. For the reasons
discussed below, Defendants’ Motion to Dismiss and Defendants’ Motion for Oral Argument are
DENIED, and the remaining motions are GRANTED.
STATEMENT OF FACTS
Plaintiffs Billie B. Crosby (“Crosby”), Edna Melson (“Melson”), the late Winfred Cowan
(“Cowan”), and the late Virginia Lee Rowe (“Rowe”) were all residents of a long term care facility
operated by Defendant LP Columbia KY, LLC d/b/a Signature Healthcare at Summit Manor
Rehab & Wellness (“Summit Manor”). (See Defs.’ Notice Removal Ex. A, ¶¶ 8-21, DN 1-1
[hereinafter Compl.]). Melson was staying at Summit Manor when she contracted COVID-19 and
was sent to an urgent care facility where she was diagnosed as dehydrated and malnourished.
(Compl. ¶¶ 11-12). Melson was eventually able to recover from the virus weeks later. (Compl. ¶
12). Cowan was similarly staying at Summit Manor when he developed a high fever, was
transferred to two urgent care facilities, and diagnosed with COVID-19, which later caused his
death. (Compl. ¶¶ 14, 16). Rowe also died from COVID-19 contracted while living at Summit
Manor. (Compl. ¶ 16). Crosby experienced kidney failure and blood clots as a resident of Summit
Manor. (Compl. ¶¶ 8-10).
On June 19, 2020, Plaintiffs filed a lawsuit in the Adair (Kentucky) Circuit Court asserting
claims for negligence, violations of KRS 216.515, negligence per se, wrongful death, and breach
of contract against Summit Manor and Signature Healthcare, LLC (“Defendants”). (See Compl.
¶¶ 22-49). Defendants removed the action to federal court, and moved to dismiss or compel
arbitration.1 ( Notice Removal, DN 1; Defs.’ Mot. Dismiss, DN 10). Plaintiffs moved to remand.2
(Pls.’ Mot. Remand, DN 13). Defendants have also moved to file supplemental authorities.3
(Defs.’ Mot. Leave File Suppl. Authorities, DN 22; Defs.’ 2d Mot. Leave File Suppl. Authorities,
DN 23; Defs.’ 3d Mot. Leave File Suppl. Authorities, DN 24; Defs.’ 4th Mot. Leave File Suppl.
Authorities, DN 25).
This case presents an issue currently percolating through the federal judiciary, namely, to
what extent state law claims implicating the COVID-19 pandemic are subject to federal
jurisdiction via the Public Readiness and Emergency Preparedness (“PREP”) Act, 42 U.S.C. §
247d-6d. Plaintiffs argue the Complaint permissibly eschews federal claims and that, taken as a
whole, it merely involves “‘garden variety’ medical neglect.”
(Pls.’ Mot. Remand 2, 5).
Defendants argue the PREP Act completely preempts any state law claims under its ambit and that
Plaintiffs’ claims fall within the terms of the Act. (See Defs.’ Resp. Pls.’ Mot. Remand 3, DN 17).
Defendants moved for leave to exceed the page limit, which is unopposed. (See Defs.’ Mot.
Leave Exceed Page Limit, DN 9). The motion is granted.
Defendants also moved for oral argument, which is denied because it would not aid the Court in
resolving the pending motions. (Defs.’ Mot. Oral Argument, DN 19).
Because Plaintiffs do not oppose these motions, they are granted.
STANDARD OF REVIEW
In order to invoke the district court’s removal jurisdiction, a defendant must show the
district court has original jurisdiction over the action. See 28 U.S.C. § 1441(a). The Court must
remand the case to state court if the federal court lacks subject matter jurisdiction. 28 U.S.C. §
1447(c). All doubts regarding removal are resolved in favor of remand. Id. In this case,
Defendants rely on 28 U.S.C. § 1441(b), which allows removal for actions “of which the district
courts have original jurisdiction founded on a claim or right arising under the Constitution, treaties
or laws of the United States.” Id. § 1441(b); (Notice Removal 2). In determining removal
jurisdiction under Section 1441, federal courts apply the “well-pleaded complaint” rule, which
allows federal jurisdiction “only when a federal question is presented on the face of the plaintiff's
properly pleaded complaint.” Caterpillar Inc. v. Williams, 482 U.S. 386, 392 (1987) (citation
omitted). Specifically, the Court must examine “the ‘well pleaded’ allegations of the complaint
and ignore potential [federal] defenses . . . .” Beneficial Nat’l Bank v. Anderson, 539 U.S. 1, 6
The Sixth Circuit has generally recognized three exceptions to the well-pleaded complaint
rule. See Mikulski v. Centerior Energy Corp., 501 F.3d 555, 560 (6th Cir. 2007). The first such
exception is the artful-pleading doctrine, which acknowledges plaintiffs may not “avoid removal
jurisdiction by artfully casting their essentially federal law claims as state-law claims.” Id. (citing
Federated Dep’t Stores, Inc. v. Moitie, 452 U.S. 394, 397 n.2 (1981)). Closely related is the second
exception, the complete-preemption doctrine, which recognizes removal is proper “when a federal
statute wholly displaces the state-law cause of action through complete pre-emption.” Id. (citing
Beneficial Nat’l Bank, 539 U.S. at 8). The third exception is the substantial-federal-question
doctrine, which applies “where the vindication of a right under state law necessarily turn[s] on
some construction of federal law.” Id. (alteration in original) (citing Franchise Tax Bd. v. Constr.
Laborers Vacation Tr., 463 U.S. 1, 9 (1983)).
Acknowledging the Complaint does not satisfy the well-pleaded complaint rule,
Defendants raise other exceptions to justify federal jurisdiction. (See Notice Removal 5). Central
to each argument is Defendants’ contention that Congress and the Executive Branch intended
claims like Plaintiffs’ not only be dismissed, but dismissed in federal court.
The PREP Act
“[T]he PREP Act empowers the Secretary of the Department of Health and Human
Services [(“HHS”)] to deem an event a ‘public health emergency’ and then take action to utilize
funds established by the Treasury to manage the emergency.”
Sherod v. Comprehensive
Healthcare Mgmt. Servs., LLC, No. 20cv1198, 2020 WL 6140474, at *6 (W.D. Pa. Oct. 16, 2020)
(citing 42 U.S.C. § 247d(a)). In March 2020, the Secretary of HHS (“the Secretary”) issued a
declaration under the PREP Act regarding the COVID-19 pandemic, which has since been
amended five times. 85 Fed. Reg. 15,198 (Mar. 17, 2020); Fifth Amended Declaration, 86 Fed.
Reg. 7,872 (Feb. 2, 2021).
Once the Secretary has issued an emergency declaration, the PREP Act provides that “a
covered person shall be immune from suit and liability under Federal and State law with respect
to all claims for loss caused by, arising out of, relating to, or resulting from the administration to
or the use by an individual of a covered countermeasure . . . .” 42 U.S.C. § 247d-6d(a)(1). At the
same time, “[u]pon the issuance by the Secretary of a declaration under section 247d-6d(b) . . .
there is hereby established in the Treasury an emergency fund . . . for purposes of providing timely,
uniform, and adequate compensation to eligible individuals for covered injuries directly caused by
the administration or use of a covered countermeasure pursuant to such declaration . . . .” 42
U.S.C. § 247d-6e(a). Accordingly,
[w]hen the PREP Act applies, it provides broad immunity “from suit and liability
under Federal and State law,” and the remedy available to an injured plaintiff is an
administrative “Covered Countermeasure Process Fund” (“Process Fund”),
administered by the Secretary, that provides “timely, uniform, and adequate
compensation to eligible individuals for covered injuries directly caused by the
administration or use of a covered countermeasure.”
Dupervil v. All. Health Operations, LLC, No. 20-CV-4042 (PKC) (PK), 2021 WL 355137, at *6
(E.D.N.Y. Feb. 2, 2021) (internal citation omitted) (citation omitted).
The only exception to the Act’s immunity is when the injury occurs through willful
misconduct. 42 U.S.C. § 247d-6d(d)(1). In these instances, the PREP Act provides procedural
rules and exhaustion requirements that govern the injured person’s claim. See 42 U.S.C. § 247d6d(e). For example, the plaintiff must file suit in the U.S. District Court for the District of
Columbia; claims must be proven by clear and convincing evidence; and the plaintiff may elect to
accept compensation from the Process Fund, if the Secretary determines that the plaintiff qualifies.
Id. §§ 247d-6d(e)(1), 247d-6d(c), 247d-6e(d)(5).
The PREP Act also expressly preempts state laws that conflict with its terms:
During the effective period of a declaration  [by the Secretary], or at any time
with respect to conduct undertaken in accordance with such declaration, 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
is different from, or is in conflict with, any requirement applicable
under this section; and
relates to the design, development, clinical testing or investigation,
formulation, manufacture, distribution, sale, donation, purchase, marketing,
promotion, packaging, labeling, licensing, use, any other aspect of safety or
efficacy, or the prescribing, dispensing, or administration by qualified
persons of the covered countermeasure, or to any matter included in a
requirement applicable to the covered countermeasure under this section or
any other provision of this chapter, or under the [FDCA] . . . .
Id. § 247d-6d(b)(8).
Finally, the remaining elements of the PREP Act were succinctly described in a recent
district court decision:
In sum, the PREP Act—with one limited exception for “willful misconduct”—
provides covered persons with immunity from suit for all claims of loss caused by,
arising out of, relating to, or resulting from the administration to or use by an
individual of covered countermeasures, which include certain drugs, biological
products, and devices. Covered persons broadly include individuals as well as
private and public entities, and the administration of a covered countermeasure can
include “purposeful allocation” of the countermeasure, including decisions not to
provide a countermeasure to an individual. The Act [also] expressly preempts
conflicting state laws . . . .
Dupervil, 2021 WL 355137, at *7.
Defendants contend the PREP Act completely preempts Plaintiffs’ state law claims, such
that federal question jurisdiction exists under Section 1331. (Notice Removal 5). The complete
preemption doctrine applies in extraordinary circumstances where Congress intended that “any
claim purportedly based on [a] pre-empted state law is considered, from its inception, a federal
claim, and therefore arises under federal law.” Caterpillar Inc., 482 U.S. at 393. Complete
preemption requires that courts answer affirmatively whether the federal statutes at issue “provided
the exclusive cause of action for the claim asserted and also set forth procedures and remedies
governing that cause of action.” Beneficial Nat’l Bank, 539 U.S. at 7-8 (citations omitted). The
Sixth Circuit has recognized the limited applicability of complete preemption. Mikulski, 501 F.3d
at 564. To illustrate, the Supreme Court has found complete preemption in only three classes of
cases: Section 301 of the Labor Management Relations Act of 1947, 29 U.S.C. § 185; the
Employee Retirement Income Security Act of 1975, 29 U.S.C. §§ 1001-1461; and the National
Bank Act, 12 U.S.C. § 38. See Beneficial Nat’l Bank, 539 U.S. at 7-9.
Importantly, complete preemption supporting removal is not the same as “ordinary
preemption”, which provides a federal defense. Warner v. Ford Motor Co., 46 F.3d 531, 535 (6th
Cir. 1995) (en banc). “Ordinary preemption” denotes the classic methods of establishing federal
supremacy through express, implied, conflict, or field preemption. But “[a] case may not be
removed to federal court on the basis of a federal defense, including the defense of
pre-emption . . . .” Caterpillar Inc., 482 U.S. at 393 (citation omitted). Instead, “the 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.” Strong v. Telectronics Pacing Sys., Inc., 78 F.3d 256, 260 (6th Cir. 1996) (citing Warner,
46 F.3d at 534-35).
Defendants contend that the PREP Act preempts any state law claims covered by its terms
and correspondingly extends immunity to covered individuals. (Defs.’ Resp. Pls.’ Mot. Remand
4-5). Further, Defendants argue the PREP Act creates a parallel cause of action because the
“exclusive” remedy for claims based on non-willful conduct is compensation from the Federal
Covered Countermeasures Process Fund. (Defs.’ Resp. Pls.’ Mot. Remand 5). Similarly, for
claims based on willful misconduct, suits may only be heard in the United States District Court for
the District of Columbia. (Defs.’ Resp. Pls.’ Mot. Remand 5).
It is evident here that the PREP Act does not provide a cause of action for Plaintiffs’ claims.
The PREP Act simply extends immunity, i.e., a federal defense, and directs a federal agency, not
a federal court, to provide the remedies. Apart from willful conduct claims, a plaintiff cannot bring
a claim under the PREP Act in any court. Instead, as immunity extends to suit in both state and
federal court, the Secretary has primary jurisdiction for most claims under the Act, potentially
including Plaintiffs’. Consider the logical inconsistency, for example, of allowing an action to be
removed to federal court because it may have been originally brought there, yet also requiring the
same court to dismiss it because an administrative agency has primary jurisdiction.
Nearly every district court to consider this issue has concluded the PREP Act is not a
complete preemption statute, or at least does not have such an effect on claims like those presented
Defendants dispute these holdings due to their disregard of the difference between
“complete” and “ordinary” preemption and their narrow reading of the PREP Act’s coverage
regarding “inaction claims.” (Defs.’ Resp. Pls.’ Mot. Remand 6-8). In support, Defendants cite
to a Statement of Interest (“SOI”) filed on behalf of the United States in Bolton v. Gallatin Center
for Rehabilitation & Healing, LLC, No. 3:20-cv-00683 (M.D. Tenn. Aug. 7, 2020). (Defs.’ 3d
Mot. Leave File Suppl. Authority 6, DN 24-2). The SOI partially relied upon In re WTC Disaster
Site, 414 F.3d 352, 375 (2d Cir. 2005), where the Second Circuit held the Air Transportation Safety
and System Stability Act (“ATSSSA”), a scheme with a similar framework to the PREP Act,
completely preempted state law claims arising out of the September 11 attacks. Notice of Filing
by United States at 9-10, Bolton v. Gallatin Ctr. for Rehab. & Healing, LLC, No. 3:20-cv-00683
(M.D. Tenn. Jan. 19, 2021) (citing In re WTC Disaster Site, 414 F.3d at 375). But the difference
between the ATSSSA and the PREP Act is that, although the ATSSSA created an administrative
compensation fund, it also created an alternative, exclusive, federal cause of action for the same
See, e.g., Est. of Maglioli v. Andover Subacute Rehab. Ctr. I, 478 F. Supp. 3d 518 (D.N.J. 2020);
Eaton v. Big Blue Healthcare, Inc., No. 2:20-CV-2291-HLT-JPO, 2020 WL 4815085 (D. Kan.
Aug. 19, 2020); Sherod v. Comprehensive Healthcare Mgmt. Servs., LLC, No. 20CV1198, 2020
WL 6140474 (W.D. Pa. Oct. 16, 2020); Gunter v. CCRC Opco-Freedom Square, LLC, No. 8:20CV-1546-T-36TGW, 2020 WL 8461513 (M.D. Fla. Oct. 29, 2020); Dupervil v. All. Health
Operations, LCC, No. 20-CV-4042 (PKC) (PK), 2021 WL 355137, at *1 (E.D.N.Y. Feb. 2, 2021);
Lyons v. Cucumber Holdings, LLC, No. CV 20-10571-JFW(JPRx), 2021 WL 364640, at *4-5
(C.D. Cal. Feb. 3, 2021).
claims in the United States District Court for the Southern District of New York. Dupervil, 2021
WL 355137, at *10-11. By contrast, claims under the PREP Act were provided immunity,
preemption, and an administrative remedy. The only exclusive federal cause of action afforded by
the PREP Act involves claims for willful misconduct, and even those claims require administrative
exhaustion. See 42 U.S.C. §§ 247d-6d(d)(1), 247d-6d(e). Simply put, there is no federal cause of
action conferring the federal courts with original exclusive jurisdiction over these claims.
The Sixth Circuit has declined to extend complete preemption to various statutes that fail
to confer original exclusive jurisdiction on the federal courts. See Mikulski, 501 F.3d at 564. As
the Sixth Circuit in Mikulski noted, “Congress knows how to enact exclusive private rights of
action when it chooses to do so . . . .” Id. (citation omitted). The Mikulski court applied this
principle in recognizing several provisions in the IRS tax code which expressly prescribe an
exclusive, private, federal remedy, except for the statute relied upon by the plaintiffs, and therefore,
inter alia, the plaintiffs’ claims were not completely preempted. Id. Accordingly, Congress’
decision to provide an exclusive federal cause of action for willful misconduct under the PREP
Act underscores its decision not to do so for the remaining claims. See 42 U.S.C. § 247d-6d(d)(1)
(“[T]he sole exception to the immunity from suit and liability of covered persons . . . shall be for
an exclusive Federal cause of action against a covered person for . . . injury proximately caused by
willful misconduct . . . by such covered person.”).
Defendants also cite the HHS Office of General Counsel (“OGC”) Advisory Opinion 2101, which states the PREP Act is a “complete preemption” statute because it supposedly establishes
exclusive jurisdiction in federal court and creates the only viable claim as a federal cause of action,
either administratively or judicially. (Defs.’ 2d Mot. Leave File Suppl. Authorities 1, DN 23-2
(citing OGC Advisory Opinion 21-01, at 2)). Defendants argue this letter requires federal courts
grant jurisdiction because the Fourth Amended Declaration, which is afforded Chevron deference,5
incorporated the Advisory Opinions. (Defs.’ 2d Mot. Leave File Suppl. Authorities 2-3). The
letter, however, states “it does not have the force or effect of law.” (OGC Advisory Opinion 2101, at 5). Accordingly, although some Advisory Opinions may be entitled to Chevron deference,
this letter explicitly states “[i]t is not a final agency action or a final order.” (OGC Advisory
Opinion 21-01, at 5); see Gilbert Garcia v. Welltower OpCo Grp. LLC, No. SACV2002250JVS(KESx), 2021 WL 492581, at *6 (C.D. Cal. Feb. 10, 2021) (holding Advisory Opinion
21-01 is not entitled Chevron deference); Dupervil, 2021 WL 355137, at *10 (same).
Furthermore, the letter is unpersuasive. See Skidmore v. Swift & Co., 323 U.S. 134, 140
(1944). Defendants cite to Garcia for the proposition that the Advisory Opinion is at least
persuasive authority for finding “complete preemption (Defs.’ 4th Mot. Leave File Suppl.
Authorities 1, DN 25-2). The court in Garcia, however, did not explain the reason for its
agreement with the letter. See Garcia, 2021 WL 492581, at *6 (“[T]he Court agrees with this
administrative agency interpretation of the PREP Act.” (citations omitted)). Ultimately, the letter
claims an exclusive administrative remedy is a sufficient substitute for an exclusive federal cause
of action. The same argument was raised by the SOI in Bolton, which asserted the proper inquiry
“does not focus on the nature of any remedy the federal court or law may or may not provide.”
Notice of Filing by United States at 6, Bolton v. Gallatin Ctr. for Rehab. & Healing, LLC, No.
“When Congress has ‘explicitly left a gap for an agency to fill, there is an express delegation of
authority to the agency to elucidate a specific provision of the statute by regulation,’ and any
ensuing regulation is binding in the courts unless procedurally defective, arbitrary or capricious in
substance, or manifestly contrary to the statute.” United States v. Mead Corp., 533 U.S. 218, 227
(2001) (internal citation omitted) (quoting Chevron, U.S.A. Inc. v. NRDC, Inc., 467 U.S. 837, 84344 (1984)). This binding effect, known as Chevron deference, applies when “it appears that
Congress delegated authority to the agency generally to make rules carrying the force of law, and
that the agency interpretation claiming deference was promulgated in the exercise of that
authority.” Id. at 226-27.
3:20-cv-00683 (M.D. Tenn. Jan. 19, 2021) (citing Caterpillar Inc., 482 U.S. at 391 n.4). The
Supreme Court in Caterpillar did not hold a federal cause of action was irrelevant to a
determination of complete preemption, however, but that it was unnecessary for the “federal cause
of action relied upon [to] provide the plaintiff with a remedy.” Id. Furthermore, the Sixth Circuit
has rejected simply pointing to the existence of a federal administrative remedy. For example, in
Strong, the Sixth Circuit held that where the Food, Drug, and Cosmetic Act (“FDCA”) disclaimed
any private cause of action, claims under the FDCA’s Medical Device Amendments were not
completely preempted and that the availability of federal administrative remedies did not change
that result. Strong, 78 F.3d at 261; see also Dillon v. Medtronic, Inc., 992 F. Supp. 2d 751, 760
(E.D. Ky. 2014).
The PREP Act affords immunity and preempts all state claims within its limited ambit.
“Like the defense of federal claim preclusion, however, preemption alone ‘does not transform the
plaintiff's state-law claims into federal claims but rather extinguishes them altogether.’ Absent a
federal remedy, preemption remains merely a defense and thus cannot satisfy the well-pleaded
complaint rule.” Dillon, 992 F. Supp. 2d at 758 (citing Rivet v. Regions Bank of La., 522 U.S. 470,
476 (1998)). As the PREP Act does not also provide a corresponding federal cause of action
conferring federal courts with jurisdiction, the PREP Act does not completely preempt Plaintiffs’
Defendants also passingly reference the “artful pleading” exception. (Defs.’ Resp. Pls.’ Mot.
Remand 9). This exception prohibits a plaintiff from “artfully” avoiding a federal cause of action
as the real basis of its complaint, and therefore, begs the question at the heart of the “complete
preemption” analysis: whether a federal cause of action exists. Having determined that the PREP
Act does not completely preempt state law claims, and Plaintiffs do not allege willful misconduct,
the analysis remains the same. See Mikulski, 501 F.3d at 561 (“[A]rtful pleading and preemption
are closely aligned.”).
Substantial Federal Question
Defendants also maintain the PREP Act presents a substantial federal question that allows
the federal courts to exercise jurisdiction. (Defs.’ Resp. Pls.’ Mot. Remand 8). Under the
substantial-federal-question doctrine, federal jurisdiction exists when “a state-law claim
necessarily state[s] a federal issue, actually disputed and substantial, which a federal forum may
entertain without disturbing a congressionally approved balance of federal and state judicial
responsibilities.” Grable & Sons Metal Prods., Inc. v. Darue Eng’g & Mf’g, 545 U.S. 308, 309
(2005). “[T]he federal interest in providing a forum for an issue [must be] weighed against the
risk that the federal courts will be unduly burdened by a rush of state law cases.” Mikulski, 501
F.3d at 565. In support of its argument, Defendants cite the Fourth Amended Declaration, which
[T]here are . . . 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 uniform interpretation of the PREP Act. Under the PREP Act, the sole
exception to the immunity from suit and liability of covered persons 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. In all
other cases, an injured party’s exclusive remedy is an administrative remedy under
section 319F-4 of the PHS Act. Through the PREP Act, Congress delegated to me
the authority to strike the appropriate Federal-state balance with respect to
particular Covered Countermeasures through PREP Act declarations.
(Defs.’ Mot. Leave File Suppl. Authorities 4, DN 22-2). Further, HHS Advisory Opinion 21-01
asserts: “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.” (OGC Advisory Opinion at
5). The letter states “the 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.” (OGC
Advisory Opinion 21-01, at 5).
Although the Secretary’s view on the federal interests underlying the PREP Act are
compelling, neither the Fourth Amended Declaration nor the Advisory Opinion address whether
Plaintiffs’ claims necessarily state a federal issue, such that a “disputed question of federal law is
a necessary element of one of the well-pleaded state claims . . . .” Mikulski, 501 F.3d at 565
(emphasis added). The Complaint asserts state common law and statutory claims, none of which
require interpretation of the PREP Act. The PREP Act, instead, provides only a defense of
immunity. See Ohio ex rel. Skaggs v. Brunner, 549 F.3d 468, 474-76 (6th Cir. 2008) (holding that
issues raised in defenses do not satisfy the first prong of the substantial-federal-question test
because they are not an “essential element” of the plaintiff’s claim). Accordingly, this Court joins
numerous federal courts in holding that the PREP Act does not present a substantial federal
The mere fact that questions of federal statutory law may need to be resolved in the course
of litigation is not sufficient to confer federal question jurisdiction. See Merrell Dow Pharms.,
Inc. v. Thompson, 478 U.S. 804, 813 (1986). Indeed, “even if both parties concede that the federal
defense is the only question truly at issue,” removal is still improper. See Robinson v. Mich.
Consol. Gas Co. Inc., 918 F.2d 579, 585 (6th Cir. 1990) (citation omitted). Rather, to the extent
Defendants are concerned about state court interpretation of the PREP Act coverage, and therefore
the application of immunity, the proper interpretation of a federal statute is protected by the
See, e.g., Dupervil, 2021 WL 355137, at *14; Anson v. HCP Prairie Vill. KS OPCO LLC, No.
20-2346-DDC-JPO, 2021 WL 308156, at *1 (D. Kan. Jan. 29, 2021); Est. of Smith ex rel. Smith v.
Bristol at Tampa Rehab. & Nursing Ctr., LLC, No. 8:20-CV-2798-T-60SPF, 2021 WL 100376, at
*1 (M.D. Fla. Jan. 12, 2021); Saldana v. Glenhaven Healthcare LLC, No. CV 20-5631 FMO
(MAAx), 2020 WL 6713995, at *1 (C.D. Cal. Oct. 14, 2020).
Supreme Court’s power to review state court decisions involving such issues. Merrell Dow
Pharms., 478 U.S. at 816 n.14.
Furthermore, while other federal district courts have directly or alternatively held that
negligent “inaction” claims, like Plaintiffs’, are not covered by the PREP Act and thus do not
extend immunity to defendants, this Court does not determine the issue. Accordingly, once this
action is remanded, Defendants can marshal the same arguments in state court that they raised here
regarding their immunity from suit. The Court, therefore, grants Plaintiffs’ motion to remand and
denies Defendants’ motion to dismiss.
For the reasons discussed above, IT IS HEREBY ORDERED as follows:
Plaintiffs’ Motion to Remand (DN 13) is GRANTED, and this matter is
REMANDED to Adair Circuit Court.
Defendants’ Motion to Dismiss (DN 10), and Defendants’ Motion for Oral
Argument (DN 19) are DENIED.
Defendants’ Motion for Leave to Exceed Page Limit (DN 9), and Defendants’
Motions for Leave to File Supplemental Authorities (DN 22, 23, 24, 25) are GRANTED.
The Clerk shall strike this matter from the active docket.
March 30, 2021
counsel of record
Clerk, Adair Circuit Court (Civil Action No. 20-CI-00077)
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