Boyle, J. v. Meyer, J.

J-A17017-25

2025 PA Super 198

JOHN BOYLE AND CHERYL : IN THE SUPERIOR COURT OF

MCKINNEY : PENNSYLVANIA

:

:

v. :

:

:

JUDITH MEYER AND OSPTA @HOME., :

LLC D/B/A OSPTA HOME CARE & : No. 1212 WDA 2024

HOSPICE :

:

Appellants :

Appeal from the Order Entered September 23, 2024

In the Court of Common Pleas of Allegheny County Civil Division at

No(s): No. GD-21-004147

BEFORE: McLAUGHLIN, J., LANE, J., and BENDER, P.J.E.

OPINION BY LANE, J.: FILED: September 9, 2025

Judith Meyer (“Meyer”) and OSPTA @HOME, LLC d/b/a OSPTA Home

Care & Hospice (“OSPTA”) (collectively, “Defendants”) appeals from the order

denying their motion for judgment on the pleadings in this personal injury

action brought by John Boyle (“Boyle”) and Cheryl McKinney (“McKinney”)

(collectively, “Plaintiffs”). We affirm.

On April 20, 2021, Plaintiffs commenced this action by filing a complaint

in the trial court against Defendants, raising negligence claims related to an

incident in which Meyer, a physical therapist employed by OSPTA, allegedly

transmitted the COVID-19 virus to Plaintiffs.1 The complaint averred as

____________________________________________

1For ease of reference, we refer to the SARS-CoV-2 virus that causes the

COVID-19 disease as “the COVID-19 virus.”

J-A17017-25

follows. At the time of the incident, Boyle was recovering from open-heart

surgery at the home he shared with McKinney. Additionally, Plaintiffs were

“both of an advanced age and suffer[ed] from various physical ailments.”

Complaint, 4/20/21, at ¶ 13. As a result of the surgery, Boyle “was required

to take physical therapy.” Id. at ¶ 15. “In order to reduce the likelihood of

contact with any individuals outside of his residence” during the on-going

COVID-19 pandemic, Boyle arranged for OSPTA to provide at-home physical

therapy services. Id. at ¶ 16.

Meyer arrived at Plaintiffs’ home on November 8, 2020 “not wearing

gloves, a face shield, or an appropriate face mask.” Id. at ¶¶ 17-18. Instead,

Meyer “only had [on] a thin, disposable surgical mask.” Id. at ¶ 18. Meyer

“immediately shook . . . Boyle’s hand, despite not having [on] gloves or other

appropriate protective equipment.” Id. at ¶ 19. Meyer “did not wash her

hands upon arrival or before performing physical therapy on” Boyle. Id. at ¶

20.

Although Boyle arranged for Meyer to provide in-home physical therapy

again on November 12, 2020, another OSPTA therapist provided the services

instead. On November 14, 2020, OSPTA informed Plaintiffs that Meyer had

tested positive for the COVID-19 virus. Within days, Plaintiffs “developed

symptoms associated with COVID-19” and they “were both admitted to the

hospital and were put on oxygen.” Id. at ¶¶ 25-27. Plaintiffs each spent

approximately ten days in the hospital and, at the time of the filing of the

-2-

J-A17017-25

complaint, five months later, “continue[d] to suffer adverse effects associated

with the disease.” Id. at ¶¶ 28-29.

Plaintiffs alleged that Meyer was negligent by: breaching her “duty to

wear” proper personal protective equipment (“PPE”) and exposing Plaintiffs to

an unreasonable risk of harm; “initiating skin-to-skin contact with” Boyle

without wearing sufficient PPE; and providing physical therapy following

known exposure to the COVID-19 virus. Id. at ¶¶ 32-34. Plaintiffs alleged

that OSPTA was negligent under a respondeat superior theory. See id. at ¶¶

39-42. In addition, they claimed that OSPTA failed: to properly train and

supervise Meyer on the provision of at-home physical therapy during the

pandemic; and to “provide adequate safeguards and screening of its

employees” to prevent the spread of the virus. See id. at ¶ 44.

Defendants timely filed a notice of removal of the case to federal court.

On December 20, 2021, the United States District Court for the Western

District of Pennsylvania granted Plaintiffs’ motion to remand this case to the

trial court. In doing so, the District Court found that the federal Public

Readiness and Emergency Preparedness Act (“PREP Act”)2 did not completely

preempt Plaintiffs’ state-law negligence claims and therefore “the parties’

dispute regarding the applicability of the PREP Act as a potential defense of

immunity must be resolved in state court.” See Boyle v. Meyer, 2021 WL

6051439, at **3, 6 (W.D. Pa. 2021).

____________________________________________

2 See 42 U.S.C. §§ 247d-6d, 247d-6e.

-3-

J-A17017-25

Following remand to the trial court, Defendants filed a joint answer and

new matter. Defendants admitted that Meyer “was not wearing gloves or a

face shield, but she was wearing a face mask.” Answer, 3/25/22, at ¶ 18.

Defendants also admitted that Meyer did not wash her hands at Plaintiffs’

residence but averred that she washed her hands several times earlier in the

day and applied hand sanitizer in her vehicle before entering Plaintiffs’ home.

See id. at ¶ 20. Furthermore, Defendants asserted in their new matter that

they are immune from liability pursuant to the PREP Act. See New Matter,

3/25/22, at ¶ 2. Plaintiffs filed a reply to the new matter.

On May 20, 2024, Defendants filed the instant motion for judgment on

the pleadings, raising the immunity provisions of the PREP Act. Following

briefing and oral argument, the trial court entered an order denying

Defendants’ motion.3 Defendants filed a timely notice of appeal. On

December 17, 2024, the trial court filed an opinion explaining its reasons for

the denial of Defendants’ motion pursuant to Pa.R.A.P. 1925(a).4

Defendants raise the following issue on appeal:

Whether the trial court erred in finding that a genuine issue

of material fact precluding a grant of judgment on the pleadings

based on PREP Act immunity, when it is undisputed that

Defendants used and administered a countermeasure (a surgical

____________________________________________

3 The order was dated September 18, 2024 and entered on the docket on

September 20, 2024, but the trial court prothonotary did not provide notice

of entry of the order pursuant to Pa.R.Civ.P. 236 until September 23, 2024.

4 The trial court did not direct Defendants to file a Rule 1925(b) concise

statement of errors complained of on appeal.

-4-

J-A17017-25

mask) covered by the PREP Act to prevent Plaintiffs from being

infected with the COVID-19 virus?

Defendants’ Brief at 2 (unnecessary capitalization omitted).

Before reaching the merits of this appeal, we must first address whether

it is properly before this Court. Generally, an order denying a motion for

judgment on the pleadings is interlocutory and not appealable. See All-Pak,

Inc. v. Johnston, 694 A.2d 347, 352-53 (Pa. Super. 1997) (quashing appeal

from denial of motion for judgment on the pleadings as a non-final order under

Pa.R.A.P. 341 and holding it is not an interlocutory order appealable as of right

under Pa.R.A.P. 311). This Court per curiam directed Defendants to show

cause why this appeal should not be quashed. In response, Defendants

argued that the order is an appealable collateral order under Pa.R.A.P. 313,

because the order involves the denial of a claim for immunity. This Court then

discharged the rule to show cause order and referred the issue to the merits

panel.

Upon review, we agree that the instant order is appealable under the

collateral order doctrine. “[A]n order is collateral under Rule 313 if: (1) the

order is separable from the underlying cause of action; (2) it involves a right

too important to be denied review; and (3) it presents an issue that will be

irreparably lost if appellate review is postponed until after final judgment.”

Brooks v. Ewing Cole, Inc., 259 A.3d 359, 371 (Pa. 2021) (holding orders

denying summary judgment motion premised on sovereign immunity grounds

were appealable collateral orders). We must construe the collateral order

-5-

J-A17017-25

doctrine narrowly to preserve the integrity of the final order rule and avoid

piecemeal litigation. See McIlmail v. Archdiocese of Philadelphia, 189

A.3d 1100, 1104 (Pa. Super. 2018); see also Pa.R.A.P. 341 (providing that

generally, “an appeal may be taken as of right from any final order”).

We conclude that Defendants have satisfied each of the three collateral

order elements. First, the question of Defendants’ immunity from suit — which

turns on the interpretation of the PREP Act — is separate and distinct from the

merits of Plaintiffs’ negligence claims, which implicate traditional Pennsylvania

negligence principles. See Brooks, 259 A.3d at 371-72 (holding that

defendant’s claim of sovereign immunity was separable from underlying

negligence action). Second, Defendants’ claim of federal statutory immunity

from state negligence claims involves a right too important to be denied

review. See id. at 372 (finding that resolution of legislative and constitutional

sovereign immunity claim was too important to defer review as the right has

“deeply rooted and far-reaching implications [that] outweigh the final

judgment rule’s efficiency interests”). Finally, Defendants’ PREP Act immunity

claim will be irreparably lost if postponed until after final judgment because,

to the extent Defendants’ present appellate claims are meritorious, they would

be entirely immune from the instant lawsuit. See id. at 372-73 (concluding

that sovereign immunity claim would be irreparably lost if deferred because

“the protection [of immunity] is from a lawsuit itself not simply a mere shield

from judgment or liability”). As we find that the order denying Defendants’

-6-

J-A17017-25

motion for judgment on the pleadings was an appealable collateral order, we

proceed to reach the merits of their appeal.

Our standard of review of a ruling on a motion for judgment on the

pleadings is de novo, and our scope of review is plenary. See SpiriTrust

Lutheran v. Wagman Constr., Inc., 314 A.3d 894, 904 (Pa. Super. 2024).

A motion for judgment on the pleadings is similar to a demurrer. See

Washabaugh v. Gaudenzia, Inc., 316 A.3d 1008, 1011 (Pa. Super. 2024).

“Judgment on the pleadings is proper only where the pleadings evidence that

there are no material facts in dispute such that a trial by jury would be

unnecessary.” Five Star Bank v. Chipego, 312 A.3d 910, 918 (Pa. Super.

2024) (citation omitted).

Like the trial court, we “must accept as true all well pleaded statements

of fact, admissions, and any documents properly attached to the pleadings

presented by the party against whom the motion is filed, considering only

those facts which were specifically admitted.” Washabaugh, 316 A.3d at

1011. Grant of a motion for judgment on the pleadings is proper “only when

the moving party’s right to succeed is certain and the case is so free from

doubt that the trial would clearly be a fruitless exercise.” Id. (citation

omitted).

In 2005, Congress enacted the PREP Act to “encourage the expeditious

development and deployment of medical countermeasures during a public

-7-

J-A17017-25

health emergency.” Cannon v. Watermark Ret. Communities, Inc., 45

F.4th 137, 139 (D.C. Cir. 2022) (citation omitted).5

. . . The PREP Act protects certain covered individuals —

such as pharmacies and drug manufacturers — from lawsuits

during a public-health emergency. The Act lies dormant until

invoked by the Secretary of . . . Health and Human Services

[(“Secretary”)]. If the Secretary deems a health threat a public-

health emergency, he may publish a declaration in the Federal

Register recommending certain “covered countermeasures.”

When the Secretary makes such a declaration, the covered

individuals become immune from suit and liability from claims

related to the administration of a covered countermeasure.

Estate of Maglioli v. Alliance HC Holdings LLC, 16 F.4th 393, 400-01 (3d

Cir. 2021) (quoting 42 U.S.C. § 47d-6d(b)(1)).6

The immunity provision of the PREP Act provides:

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

[of public health emergency] has been issued [by the Secretary]

with respect to such countermeasure.

____________________________________________

5 While not binding, we find the federal Court of Appeals and District Court

decisions discussed herein persuasive in interpreting the PREP Act. See Cole

v. Pennsylvania Dep’t of Envtl. Prot., 329 A.3d 1228, 1236 n.30 (Pa. 2025)

(stating that “lower federal courts’ interpretations of federal law have only

persuasive value in” Pennsylvania courts).

6 To counteract the effect of the PREP Act immunity provision, which “cuts off

forms of relief that might otherwise have been available to people harmed by

diagnostics, treatments, or vaccines,” the PREP Act “also established a

‘Covered Countermeasure Process Fund’ to compensate for such harms.”

Cannon, 45 F.4th at 139 (citing 42 U.S.C. § 247d-6e(a)(1)).

-8-

J-A17017-25

42 U.S.C. § 247d-6d(a)(1) (emphases added). This immunity provision

“applies to any claim for 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).

The PREP Act defines the terms “covered person” and “covered

countermeasure,” which limit the scope of the immunity provision. See

Cannon, 45 F.4th at 139 (explaining that “[a] court should deny [PREP Act]

immunity if, for example, the defendant is not a covered person, the measure

administered is not covered, or the claim otherwise falls beyond the scope of

the Secretary’s declaration”). A “covered person” includes:

(i) a manufacturer of [a covered] 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)(B)(i)-(v) (emphases added). A “program planner”

is defined as a person:

. . . who supervised or administered a program with respect

to the administration, dispensing, distribution, provision, or use of

a security countermeasure or a qualified pandemic or epidemic

product, including a person who has established requirements,

provided policy guidance, or supplied technical or scientific advice

or assistance or provides a facility to administer or use a covered

countermeasure in accordance with a [public health emergency]

declaration . . . .

-9-

J-A17017-25

42 U.S.C. § 247d-6d(i)(6). A “qualified person” means

(A) a licensed health professional or other individual who is

authorized to prescribe, administer, or dispense [covered]

countermeasures under the law of the State in which the

countermeasure was prescribed, administered, or dispensed; or

(B) a person within a category of persons so identified in a

[public health emergency] declaration by the Secretary . . . .

42 U.S.C. § 247d-6d(i)(8).

The PREP Act defines a “covered countermeasure” to include a “qualified

pandemic or epidemic product,” “a security countermeasure,” a drug or

biological product approved for emergency use, and “a respiratory protective

device” approved by the National Institute for Occupational Safety and Health.

42 U.S.C. § 247d-6d(i)(1). As relevant here, a “covered countermeasure”

also includes a “device (as such term is defined [in] the Federal Food, Drug

and Cosmetic Act [(“FD&C Act”)] that is authorized for emergency use in

accordance with section 564, 564A, or 564B of the” FD&C Act. 42 U.S.C. §

247d-6d(i)(1)(C).

On March 17, 2020, the Secretary declared COVID-19 a public health

emergency under the PREP Act. See Declaration Under the PREP Act for

Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (Mar. 17,

2020).7 Since that date, the Secretary amended the public health emergency

____________________________________________

7 We take judicial notice of the public health emergency declaration, as well

as the emergency use authorizations discussed infra. See 42 Pa.C.S.A. §

5327(b) (providing that when “determining the law of any jurisdiction or

governmental unit thereof outside this Commonwealth, the tribunal may

(Footnote Continued Next Page)

- 10 -

J-A17017-25

declaration on multiple occasions to clarify the extent of the public health

emergency and PREP Act immunity. See, e.g., Amendment to Declaration

Under the PREP Act for Medical Countermeasures Against COVID-19, 85 Fed.

Reg. 21012 (Apr. 15, 2020).

On April 24, 2020, the United States Food and Drug Administration

(“FDA”) issued an emergency use authorization (“EUA”) to permit “the use of

face masks” by members of the general public and health care personnel in

healthcare settings “as source control” to prevent the spread of the COVID-

19 virus. FDA Face Mask EUA Letter, at 3 (Apr. 24, 2020), available at

____________________________________________

consider any relevant material or source, . . . whether or not submitted by a

party or admissible under the rules of evidence”); see also Sch. Express,

Inc. v. Upper Adams Sch. Dist., 303 A.3d 186, 195-96 (Pa. Cmwlth. 2023)

(holding trial court properly took judicial notice of enactment of COVID-19

school closure legislation and Governor’s school closure executive orders when

considering motion for judgment on the pleadings); Ruff v. York Hosp., 257

A.3d 43, 60 n.7 (Pa. Super. 2021) (providing while “[t]his Court is not bound

by decisions of the Commonwealth Court[,]” we may rely on its decisions as

persuasive authority).

However, we decline to take notice of, or consider, the Department of

Health and Human Services (“HHS”) advisory opinions upon which Defendants

rely. See Motion for Judgment on the Pleadings, 5/20/24, Exhibits B-16 to B-

21; see also Defendants’ Reply Brief, Addendum B. As the Court of Appeals

for the Third Circuit has explained, the PREP Act “does not empower the

Secretary to regulate the scope of the judicial power vested by the statute.”

Estate of Maglioli, 16 F.4th at 403 (citation omitted). Accordingly,

“[d]eference is not owed to [the advisory opinions] for the simple reason that

HHS is not delegated authority under the PREP Act to interpret the scope of”

the statute’s immunity provisions. Id. (declining to afford deference to HHS

advisory opinions and statements in emergency declaration amendments that

the PREP Act operates as a complete preemption of state law); see also

Martin v. Petersen Health Operations, LLC, 37 F.4th 1210, 1214 (7th Cir.

2022) (same).

- 11 -

J-A17017-25

https://www.fda.gov/media/137121/download?attachment (last accessed

Aug. 12, 2025). The EUA applied to “single or multiple use[]” masks and

“cloth face coverings” but specifically exempted “[s]urgical masks.” Id. at 1

n. 1, 2. The EUA additionally provided that the authorized facemasks “are not

intended to be used as PPE” and imposed labeling requirements on authorized

facemasks, including “recommendations against use in a clinical setting where

the infection risk level through inhalation exposure is high.” Id. at 3-4.

“On August 5, 2020, the [FDA] granted [EUA] for disposable, single-use

surgical masks . . . for use in healthcare settings by healthcare personnel” as

PPE to prevent the spread of COVID-19. FDA Surgical Mask EUA Letter, at 1

(Mar. 6, 2023), available at https://www.fda.gov/media/140894/

download?attachment (last accessed Aug. 12, 2025). The surgical mask-EUA

did not include all single-use surgical masks, however, as it only applied to

masks which met certain “performance criteria,” such as fluid resistance and

particulate filtration requirements. See id. at 2-4. Over time, the FDA added

surgical masks (identified by product name and manufacturer) to the

approved list of surgical masks, which appeared in Appendix A of the EUA.

See id. at Appendix A. On March 6, 2023, the FDA withdrew the August 5,

2020 surgical mask-EUA and reissued it in its entirety but removed the

eligibility criteria such that no additional masks could be added to Appendix

A. See id. at 2 & n.9.

On appeal, Defendants argue that the trial court erred by not finding

that the PREP Act bars Plaintiffs’ negligence claims; Defendants assert that

- 12 -

J-A17017-25

they met each of the four requirements of the statutory immunity provision.

First, Defendants note that on March 17, 2020, the Secretary declared a public

health emergency, triggering PREP Act immunity related to COVID-19

countermeasures. Second, Defendants aver that they are “covered person[s]”

under the statute, as they fall within both the “program planner” and “qualified

person” categories of the statutory definition. 42 U.S.C. § 247d-6d(a)(1),

(i)(2)(B)(iii)-(iv), (6), (8). Defendants contend that a “program planner”

broadly includes any “person or entity, like . . . OSPTA [or Meyer, an OSPTA

employee], who develops a program to reduce the spread of COVID[-19].”

Defendants’ Brief at 20. Defendants were also “qualified person[s]” “because

they are healthcare providers authorized to administer and/or use FDA

approved medical devices, such as face masks, to prevent or mitigate the

spread of COVID[-19].” Id. at 21.

Third, Defendants contend that Plaintiffs’ complaint on its face alleges

that Meyer utilized a “covered countermeasure,” the “thin, disposable surgical

mask” Meyer was wearing when she performed physical therapy on Boyle. 42

U.S.C. § 247d-6d(a)(1); see also Complaint, 4/20/21, at ¶ 18. Defendants

assert that Meyer’s surgical mask constituted a “device” approved for

emergency use by the FDA, as required under the PREP Act. See 42 U.S.C. §

247d-6d(i)(1)(C).

Fourth, Defendants argue that Meyer’s use of a covered countermeasure

bears a “causal relationship” with Plaintiffs’ “claim for loss” based on their

COVID-19 illness. 42 U.S.C. § 247d-6d(a)(2)(B). Defendants contend that

- 13 -

J-A17017-25

the PREP Act establishes a liberal causation standard to invoke immunity,

requiring only that a covered countermeasure has “played some role in

bringing about or contributing to the plaintiff’s injury.” Defendant’s Brief at

24 (quoting Hampton v. California, 83 F.4th 754, 764 (9th Cir. 2023)).

According to Defendants, Plaintiffs’ allegation that Meyer wore a surgical mask

while treating Boyle demonstrated that a covered countermeasure played a

role in bringing about Plaintiffs’ injuries.

Defendants argue that the trial court erred by taking an “overly

restrictive” view of PREP Act immunity by focusing on Plaintiffs’ allegations

concerning “countermeasures not taken,” such as Meyer’s alleged failure to

wash her hands or wear gloves or a face shield, rather than the undisputed

fact that she wore a surgical mask when treating Boyle. Defendants’ Brief at

12-13. Defendants aver that Plaintiffs’ allegations that Meyer could have

employed “different type[s] of countermeasure[s] that may have been more

effective at preventing infection” are “immaterial as a matter of law” under

the PREP Act. Id. at 28 (emphasis omitted). Instead, Defendants asserts

that, exactly because Plaintiffs allege that “Meyer used the wrong covered

countermeasure,” their claims have “the necessary ‘causal connection’

between the injury and the use of a covered countermeasure” to trigger PREP

Act immunity. Id. at 33.

Defendants rely on Maney v. Brown, 91 F.4th 1296 (9th Cir. 2024).

In Maney, inmates sued government officials in federal court over their

decision to prioritize prison staff for the receipt of the COVID-19 vaccine over

- 14 -

J-A17017-25

the inmates. See id. at 1298-99. The District Court denied the officials’

motion to dismiss based on the PREP Act, and the officials appealed. See id.

at 1299. The Court of Appeals reversed, finding that the PREP Act immunized

claims related to the vaccine prioritization scheme at issue in the case, which

it determined was a “policy-level” decision to not administer a covered

countermeasure. Id. at 1301. In arriving at this conclusion, the Maney court

found that the PREP Act had “a sweeping statutory reach” “to extend immunity

to persons who make policy-level decisions regarding administration or use of

covered countermeasures and do not directly administer countermeasures to

particular individuals.” Id. at 1301-02 (citation omitted).

Defendants argue that “Maney is instructive” and that the trial court

“misunderstood the proper context of the term ‘administration’ as set forth in

the PREP Act.” Defendants’ Brief at 30. Applying the lessons of Maney to the

present case, Defendants maintain that their “[d]ecision making as to which

countermeasures to use [when treating Boyle], i.e., which mask or other

countermeasure should be used . . . goes . . . to ‘administration’ of a covered

countermeasure.” Id. Defendants assert that, because the trial court failed

to recognize that PREP Act protected their “good[-]faith” efforts “to protect

their patients from the COVID[-19] virus,” this Court must reverse the trial

court’s denial of their motion for judgment on the pleadings. Id. at 37.

In its opinion, the trial court explained that it denied Defendants’ motion

for judgment on the pleadings based on “the absence of a causal connection”

between Defendants’ use of a covered countermeasure and Plaintiffs’ injuries.

- 15 -

J-A17017-25

Trial Court Opinion, 12/17/24, at 12. The court reasoned that PREP Act

immunity only “applies to claims involving action, i.e. the administration or

use of covered countermeasures,” while “[c]laims of nonuse or inaction are

excluded from the PREP Act.” Id. The court concluded that in this matter,

Plaintiffs have “not claimed that the administration or use of a countermeasure

resulted in the harm” but instead that “the failure to utilize a countermeasure

or inaction led to the injury.” Id. The court found that:

. . . Plaintiff[s’ allegations that Defendants] failed to

implement or properly execute [proper] safety measures or

protocols related to the COVID-19 pandemic . . . do not amount

to the administration of countermeasures under the PREP Act. . .

. The complaint does not allege that [Defendants] failed to

properly administer vaccines, biological agents, drugs, or devices,

which would have triggered the PREP Act’s immunity provisions,

but rather that [D]efendants negligently failed to protect Plaintiffs

from contracting the disease due [to Defendants’ failure to use]

PPE[] and [they] otherwise violated the standard of care in [their]

treatment of [Boyle].

Id. at 9. The court explained that Defendants’ arguments to the contrary that

Meyer “was implementing countermeasures” while treating Boyle merely

shows that a genuine dispute of material facts existed warranting denial of the

motion for judgment on the pleadings. Id. at 13.

Based on our review, we find no error in the trial court’s denial of

Defendants’ motion for judgment on the pleadings. See SpiriTrust

Lutheran, 314 A.3d at 904. In undertaking our review, we reiterate that, like

the trial court, our review is confined to the well-pleaded allegations of the

- 16 -

J-A17017-25

complaint and Defendants’ admissions.8 See Washabaugh, 316 A.3d at

1011. Moreover, a court may only grant judgment on the pleadings when

there is no dispute about a material fact such that the moving party’s success

on the merits is certain. See id.; see also Five Star Bank, 312 A.3d at 918.

Here, there are several disputed facts that prevent the grant of

judgment in favor of Defendants.9 First, it is unclear on the pleadings whether

Meyer’s “thin, disposable surgical mask” was a covered countermeasure under

the PREP Act. 42 U.S.C. § 247d-6d(a)(1); see also Complaint, 4/20/21, at ¶

18. The FDA’s April 24, 2020 EUA established that certain “single or multiple

use[]” “face masks” constituted covered countermeasures under the PREP Act,

as “device[s] . . . authorized for emergency use in accordance with” the FD&C

Act. 42 U.S.C. § 247d-6d(i)(1)(C); see also FDA Face Mask EUA Letter, at 3

(Apr. 24, 2020). However, the April 24, 2024 EUA only applied to face masks

that met certain labeling requirements and entirely excluded surgical masks.

See FDA Face Mask EUA Letter, at 3-4 & n.2 (Apr. 24, 2020). The subsequent

August 5, 2020 EUA applied to surgical masks but only designated masks that

____________________________________________

8 Although a court deciding a motion for judgment on the pleadings may also

consider documents attached to the non-moving party’s pleadings, Plaintiffs

did not attach any documents to their complaint or reply to Defendants’ new

matter. See Washabaugh, 316 A.3d at 1011.

9 While the trial court did not reach whether Meyer’s surgical mask was a

covered countermeasure or whether Defendants were covered persons,

Plaintiffs opposed Defendants’ motion for judgment on the pleadings on those

grounds. Furthermore, we may affirm the trial court’s order on any basis

supported by the record. See O'Brien v. Beatty, 329 A.3d 685, 690 n.3 (Pa.

Super. 2024).

- 17 -

J-A17017-25

met certain performance specifications and that appeared in Appendix A of

the EUA. See FDA Surgical Mask EUA Letter, at 1-4, Appendix A (Mar. 6,

2023). Thus, based simply on the complaint’s allegation that Meyer wore a

“thin, disposable surgical mask,” we are unable to determine whether the

mask met the requirements of either EUA. Complaint, 4/20/21, at ¶ 18.10

Second, the pleadings do not conclusively establish that Defendants are

covered persons under the PREP Act. Defendants argue that they fall under

the “program planner” or “qualified person” definitions of a covered person.

Each of these definitions requires that the individual in question had authority

over the administration or use of a covered countermeasure. See 42 U.S.C.

§ 247d-6d(i)(6) (defining a “program planner” as a person who, inter alia,

supervised or administered a program involving the use of a covered

countermeasure or who “provide[d] a facility to administer or use a covered

countermeasure”), (8)(A) (defining a “qualified person” as a health

professional or other individual who prescribes, administered, or dispensed a

covered countermeasure in a state in which they have the authority to do

____________________________________________

10 Indeed, the confusion regarding which EUA, if any, applied to Meyer’s

surgical mask is evident in Defendants’ motion and briefing, as they relied

solely on the April 24, 2024 EUA in their motion for judgment on the pleadings

and initial appellate brief and raised the August 5, 2020 EUA for the first time

in their reply brief. See Motion for Judgment on the Pleadings, 5/20/24, at

¶¶ 63-65, Exhibit C; see also Defendants’ Brief at 23; Defendant’s Reply Brief

at 10-11, Addendum A.

- 18 -

J-A17017-25

so).11 Yet, as noted above, it remains in dispute whether Meyer’s surgical

mask — the only covered countermeasure raised in the pleadings — met the

statutory definition. Therefore, at this juncture of the proceedings, it is

unclear whether Defendants are covered persons under the PREP Act. While

development of the factual record in this case may bear out that Defendants

are in fact covered persons, the pleadings alone do not resolve this question.

Finally, even if the pleadings indisputably established that Defendants

are covered persons and the surgical mask Meyer wore while treating Boyle

was a covered countermeasure, we agree with the trial court that judgment

on the pleadings was not appropriate. The overwhelming consensus within

the federal courts is that “the PREP Act provides immunity only from claims

that relate to ‘the administration to or the use by an individual of’ a covered

countermeasure — not such a measure’s non-administration or non-use.”

Hampton, 83 F.4th at 764 (citation omitted and emphasis in original); see

also, e.g., Martin, 37 F.4th at 1213-14 (concluding that claims concerning

nursing home’s staffing levels, allowing sick nurses to continue working,

failure to isolate infected patients, and failure to provide sufficient PPE were

“the opposite of a contention that a covered countermeasure caused harm”

and thus were “not even arguably preempted” by the PREP Act); Testa v.

____________________________________________

11 A program planner also includes an individual “within a category of persons

so identified in a declaration by the Secretary.” 42 U.S.C. § 247d-6d(i)(8)(B).

Defendants have not cited a declaration that identified them as program

planners.

- 19 -

J-A17017-25

Broomall Operating Co., L.P., 622 F.Supp.3d 4, 10 (E.D. Pa. 2022) (stating

that District Courts in the Third Circuit “have resoundingly found that the PREP

Act does not shield a covered individual from claims arising out of its failure

to administer or use a covered countermeasure”). While Maney found that

immunity attached to a prison’s “policy-level” failure to administer a covered

countermeasure, the COVID-19 vaccine, the court recognized that the case

stood as an exception to the general rule that the PREP Act does not apply to

non-administration or non-use of a countermeasure, as it involved the

“prioritization of a scarce countermeasure.” Maney, 91 F.4th at 1301.

Additionally, the mere fact that a defendant used a covered

countermeasure in a manner unrelated to the claims at issue is insufficient

grounds to invoke PREP Act immunity. The Court of Appeals for the Ninth

Circuit has stated:

At the very least, . . . for PREP Act immunity to apply, the

underlying use or administration of a covered countermeasure

must have played some role in bringing about or contributing to

the plaintiff’s injury. It is not enough that some countermeasure’s

use could be described as relating to the events underpinning the

claim in some broad sense.

Hampton, 83 F.4th at 764-65 (footnote omitted) (holding, in action

challenging transfer of COVID-19-infected inmates into prison leading to

another inmate’s death, that provision of COVID-19 tests — a covered

countermeasure — to transferred inmates did not immunize prison officials

because complaint did “not describe a causal relationship between the

administration of . . . the tests and [the decedent’s] death”); see also Brown

- 20 -

J-A17017-25

v. Big Blue Healthcare, Inc., 480 F.Supp.3d 1196, 1206 & n.13 (D. Kan.

2020) (holding that allegation in complaint that defendant used diagnostic

tests — a covered countermeasure — in its facility was not “sufficient to invoke

the PREP Act as to all claims that arise in that facility” because the plaintiff did

“not tie the claim of loss to the administration or use of those tests”).

Here, Plaintiffs alleged that Meyer was negligent based on her failure to

wear gloves, not washing her hands at Plaintiffs’ home, shaking Boyle’s hand

upon arrival, and touching numerous objects in the home. See Complaint,

4/20/21, at ¶¶ 18-21. Plaintiffs further averred OSPTA was negligent for

failing to screen its employees for the COVID-19 virus or properly train or

supervise employees in providing physical therapy during the pandemic. See

id. at ¶ 44. Plainly, these allegations do not relate to Defendants’ use or

administration of a covered countermeasure, but rather to Meyer’s failure to

wear proper PPE and maintain sanitary conditions, as well as OSPTA’s failure

to screen, train, and supervise its employees. As such, they fall outside the

class of state-law claims preempted by the PREP Act. See Hampton, 83 F.4th

at 764. While Maney found that immunity attaches to certain “failure-to-

administer claims,” the present case does not involve the provision of a scarce

countermeasure that would trigger the exception to the general rule that

claims involving the non-use and non-administration of countermeasures do

not fall under the PREP Act. See Maney, 91 F.4th at 1301.

Furthermore, Plaintiffs’ claims are sufficiently unrelated to Meyer

wearing a surgical mask to evade PREP Act immunity, as they allege

- 21 -

J-A17017-25

negligence based upon Meyer’s and Defendant’s failure to take additional

actions beyond the mask she had on when she treated Boyle. See Hampton,

83 F.4th at 764. We note only one exception to our holding as it appears that

Plaintiffs’ allegations that Meyer failed to wear “a face shield[] or an

appropriate face mask” relates to the same purpose as a surgical mask, i.e.

to prevent the airborne transmission of the COVID-19 virus. Complaint,

4/20/21, at ¶ 18. However, it is premature on the present record to ascertain

whether Defendants are immune from a claim that Meyer was negligent based

upon her decision to wear a disposable surgical mask instead of a different

kind of mask or face shield. Instead, we leave that determination to the trial

court, following the development of the factual record regarding whether

Meyer’s mask was in fact a covered countermeasure.

Accordingly, we conclude, in light of the pleadings filed in this particular

matter, that the trial court properly found that material facts remain in dispute

regarding the application of PREP Act immunity to Plaintiffs’ claims. See Five

Star Bank, 312 A.3d at 918. We therefore affirm the court’s denial of

Defendants’ motion for judgment on the pleadings and remand for further

proceedings.

Order affirmed. Case remanded. Jurisdiction relinquished.

- 22 -

J-A17017-25

9/9/2025

- 23 -