Court Opinion

ID: 9882491
Source: CourtListenerOpinion
Date Created: 2023-10-05 22:10:36.862351+00
Date Added: 2024-06-11T15:00:10.830760
License: Public Domain

[Cite as Pugh v. Okuley's Pharmacy & Home Med., 2023-Ohio-3208.]

                     IN THE COURT OF APPEALS OF OHIO
                         THIRD APPELLATE DISTRICT
                             DEFIANCE COUNTY

HARRY PUGH,

       PLAINTIFF-APPELLANT,                                    CASE NO. 4-23-04

       v.

OKULEY’S PHARMACY AND HOME
MEDICAL, ET AL.,                                               OPINION

       DEFENDANTS-APPELLEES.

               Appeal from Defiance County Common Pleas Court
                         Trial Court No. 22-CV-45717

                     Judgment Reversed and Cause Remanded

                        Date of Decision: September 11, 2023

APPEARANCES:

       Michelle L. Traska for Appellant

       David R. Hudson and Taylor Knight for Appellees
Case No. 4-23-04

WALDICK, J.

         {¶1} Plaintiff-appellant, Harry Pugh (“Pugh”), brings this appeal from the

February 23, 2023, judgment of the Defiance County Common Pleas Court granting

the motion to dismiss of defendants-appellees, Okuley’s Pharmacy and Home

Medical, Inc., Okuley’s Pharmacy, Inc., Unique Prescriptions, Inc., Kieu M.

Okuley, and John Does 1-8 (collectively, “Okuley defendants”). For the reasons that

follow we reverse the judgment of the trial court.

                                               Background1

         {¶2} Appellee Kieu Okuley is a pharmacist and owns the defendant

companies. Appellee Okuley operated labs with the purpose of synthesizing

pharmaceuticals or other medical materials. Pugh was an employee of the Okuley

defendants.

         {¶3} Around March of 2020, due to the COVID-19 pandemic creating a

shortage of hand sanitizer, the Okuley defendants began to manufacture and sell

hand sanitizer. Initially the Okuley defendants produced hand sanitizer from

isopropyl alcohol.

         {¶4} Eventually, the Okuley defendants determined that using ethanol from

a local bio-refinery would be more cost-effective than isopropyl alcohol. However,

1
 The “factual” narrative herein is taken largely from the complaint. As this matter concerns the review of a
motion to dismiss, we must accept as true all the facts in the complaint for purposes of this appeal. Perrysburg
Twp. v. Rossford, 103 Ohio St.3d 79, 2004-Ohio-4362, ¶ 5.

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Case No. 4-23-04

the ethanol would need to be filtered to “remove odors,” so Pugh devised a filtration

process that did not utilize any electrical power. According to Pugh, this process

was too slow for the Okuley defendants and the Okuley defendants sought to make

the filtration process faster through the use of an electric-powered pump. This

filtration process was conducted in the basement lab of the Okuley defendants

“compounding pharmacy.”

       {¶5} On April 15, 2020, the first day Pugh used the ethanol in combination

with an electric pump, “some combination of ethanol vapors, spray, or both caught

fire, exploded, and severely burned” Pugh. Notably, Pugh was not provided with

any training and he was not given any protective equipment.

       {¶6} On April 18, 2022, Pugh filed a complaint against the Okuley

defendants “for monetary damages arising out of employer’s intentional tort.” (Doc.

No. 1).

       {¶7} Before filing an answer, the Okuley defendants filed a motion to

dismiss pursuant to Civ.R. 12(B)(1), and Civ.R. 12(B)(6). The Okuley defendants

argued that Pugh’s claims were barred by the immunity and preemption provisions

of the federal Public Readiness and Emergency Preparedness Act (“PREP Act”).

The Okuley defendants contended that manufacturing hand sanitizer was expressly

authorized, approved and requested by the FDA and the Ohio Board of Pharmacy

as an emergency response effort to COVID-19. The Okuley defendants argued that

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Case No. 4-23-04

under the PREP Act, they were immune from “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 * * * has been issued with respect to

such countermeasure.” 42 U.S.C. 247d-6d(a)(1). The Okuley defendants indicated

that they were covered under the PREP Act and thus immune from suit. Further, the

Okuley defendants argued that the PREP Act also preempted any state court claim

for negligence or a violation of a state law that arose out of the administration or use

of covered countermeasures.

       {¶8} Pugh filed a response contending, inter alia, that Pugh was not “using”

the covered countermeasure or having it “administered” to him, thus the PREP Act

was not relevant here under its own plain language. Simply put, Pugh argued that

the claims granted immunity under the PREP Act involved the “use or

administration” of the hand sanitizer, which was not what occurred here.

       {¶9} On February 23, 2023, the trial court filed a judgment entry analyzing

the issues and ultimately granting the Okuley defendant’s motion to dismiss. The

trial court determined that under the PREP Act, the Okuley defendants were a

“covered person,” and that the hand sanitizer they produced constituted a “covered

countermeasure.” The trial court then indicated the question that remained was

whether the claims here were for “loss caused by, arising out of, relating to, or

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Case No. 4-23-04

resulting from the administration to or the use by an individual of a covered

countermeasure.”

       {¶10} The trial court focused on the phrase “relating to,” determining that

this phrase broadened the scope of immunity, and would include injuries that

occurred during the manufacturing of the ethanol-based hand sanitizer. Thus the

trial court granted the Okuley defendant’s motion to dismiss. Pugh now appeals the

trial court’s judgment, asserting the following assignments of error for our review.

                            First Assignment of Error

       The trial court erred by extending the PREP Act language beyond
       the scope contemplated by the statute to include employee injuries
       outside of the administration or use of a covered countermeasure.

                           Second Assignment of Error

       The trial court was mistaken to conclude the PREP Act preempts
       all causes of action, including those for employer intentional tort.

                             First Assignment of Error

       {¶11} In his first assignment of error, Pugh argues that the trial court erred

by dismissing his complaint. More specifically, he contends that the trial court erred

by extending the PREP Act language beyond the use or administration of a covered

countermeasure to the manufacturing of a countermeasure.

                                Standard of Review

       {¶12} An order granting a motion to dismiss is subject to de novo review,

without any deference to the trial court’s determination. Perrysburg Twp. v.

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Case No. 4-23-04

Rossford, 103 Ohio St.3d 79, 2004-Ohio-4362, ¶ 5. Further, in reviewing whether a

motion to dismiss should have been granted, we accept as true all factual allegations

in the complaint. Id. Moreover, in order to dismiss a complaint under Civ.R. 12(B),

“it must appear beyond doubt from the complaint that the plaintiff can prove no set

of facts entitling him to recovery.” O’Brien v. University Community Tenants

Union, Inc., 42 Ohio St.2d 242 (1975), at syllabus.

                                      Analysis

       {¶13} The PREP Act provides a general grant of immunity in 42 U.S.C.

247d-6d(a)(1) as follows:

       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 * * * has been issued with
       respect to such countermeasure.

       {¶14} Here, the parties do not dispute on appeal that the Okuley defendants

fall under the definition of a “covered person” pursuant to the PREP Act. Similarly,

the parties do not dispute that hand sanitizer constitutes a “covered countermeasure”

under the PREP Act. The primary dispute between the parties concerns whether

Pugh was injured by the “administration to” or “use by an individual” of the covered

countermeasure.

       {¶15} Unfortunately, the PREP Act does not specifically define

“administration to or the use by an individual of a covered countermeasure.”

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Case No. 4-23-04

However, the PREP Act does assign the Secretary of Health and Human Services

the responsibility to define pertinent conditions of the PREP Act, and the Secretary

did define “administration” of a covered countermeasure as follows:

       Administration of a Covered Countermeasure means 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.

       The definition of “administration” extends only to physical provision
       of a countermeasure to a recipient, such as vaccination or handing
       drugs to patients, and to activities related to management and
       operation of programs and locations for providing countermeasures to
       recipients, such as decisions and actions involving security and
       queuing, but only insofar as those activities directly relate to the
       countermeasure activities. Claims for which Covered Persons are
       provided immunity under the Act are losses caused by, arising out of,
       relating to, or resulting from the administration to or use by an
       individual of a Covered Countermeasure consistent with the terms of
       a Declaration issued under the Act. Under the definition, these
       liability claims are precluded if they allege an injury caused by a
       countermeasure, or if the claims are due to manufacture, delivery,
       distribution, dispensing, or management and operation of
       countermeasure programs at distribution and dispensing sites.

       Thus, it is the Secretary’s interpretation that, when a Declaration is in
       effect, the Act precludes, for example, liability claims alleging
       negligence by a manufacturer in creating a vaccine, or negligence by
       a health care provider in prescribing the wrong dose, absent willful
       misconduct. Likewise, the Act precludes a liability claim relating to
       the management and operation of a countermeasure distribution
       program or site, such as a slip-and-fall injury or vehicle collision by a
       recipient receiving a countermeasure at a retail store serving as an
       administration or dispensing location that alleges, for example, lax
       security or chaotic crowd control. However, a liability claim alleging

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Case No. 4-23-04

       an injury occurring at the site that was not directly related to the
       countermeasure activities is not covered, such as a slip and fall with
       no direct connection to the countermeasure's administration or use. In
       each case, whether immunity is applicable will depend on the
       particular facts and circumstances.

Declaration Under the Public Readiness and Emergency Preparedness Act for

Medical Countermeasures Against COVID-19, 85 FR 15198-01.

       {¶16} In reviewing the definition provided, we emphasize that at the outset

the Secretary states: “The definition of “administration” extends only to physical

provision of a countermeasure to a recipient.” (Emphasis added.) Under this plain,

clear, and unambiguous language, the PREP Act was designed to prevent lawsuits

that would arise from the physical provision of covered countermeasures to the end-

user (such as a vaccine recipient or the person using the hand sanitizer). There is no

indication that the PREP Act intended to preclude liability of manufacturers to its

employees who are not being administered or using the covered countermeasure.

       {¶17} However, the Okuley defendants contend that a portion of the

definition above does provide immunity to manufacturers. The Okuley defendants

rely on the portion that states: “these liability claims are precluded * * * if the claims

are due to manufacture * * * of countermeasure programs at distribution and

dispensing sites.” The Okuley defendants argue that since they were engaged in the

manufacture of a covered countermeasure, they should be immune from any

lawsuits absent willful misconduct.

                                           -8-
Case No. 4-23-04

       {¶18} We find that the Okuley defendants take the “manufacture” phrase out

of its context, which still requires the administration to or use by, effectively, an

end-user (or “recipient”). A manufacturer would be protected from a negligent act

that impacted the end-user or recipient, such as (potentially) faulty manufacturing

of a vaccine that caused an injury to a vaccine recipient or faulty manufacturing of

hand sanitizer that caused burns to the individual receiving the hand sanitizer. But

we see no indication in the PREP Act itself that it was intended to protect employers

from any and all workplace injuries so long as the injuries occurred while

manufacturing a covered countermeasure.

       {¶19} In reaching our decision, we note, as the trial court did, that there is no

caselaw directly addressing the issue in this case. There are cases, primarily federal,

that touch on issues in the PREP Act, but they are readily distinguishable and do not

further define “administration to, or the use by an individual.” See, e.g., Hudak v.

Elmcroft of Sagamore Hills, 58 F.4th 845, 856 (6th Cir.2023); Friedman v.

Montefiore, 6th Cir. No. 22-3703, 2023 WL 4536084, *1. Thus we must revert to

our interpretation of the plain language of the PREP Act, and here, we find that the

injuries to Pugh were not related to the “administration to” or “use by an individual”

of the covered countermeasure because Pugh was not “administering” or “using”

hand sanitizer at the time of his injury. Therefore, Pugh’s first assignment of error

is sustained.

                                          -9-
Case No. 4-23-04

                            Second Assignment of Error

       {¶20} In his second assignment of error, Pugh argues that the trial court erred

by concluding that the PREP Act preempted the claims in this case. As we have

already found that the PREP Act does not cover the acts alleged in this case, the

PREP Act cannot preempt the claims raised by Pugh. Therefore, this assignment of

error is also sustained.

                                     Conclusion

       {¶21} Having found error prejudicial to Pugh, the assignments of error are

sustained and this cause is reversed and remanded to the trial court for further

proceedings.

                                                            Judgment Reversed and
                                                                 Cause Remanded

WILLAMOWSKI and ZIMMERMAN, J.J., concur.

/jlr

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