Pugh v. Okuley's Pharmacy & Home Med. , 2023 Ohio 3208 ( 2023 )

[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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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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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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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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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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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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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.
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{¶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.
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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.
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