The opinion
If this opinion indicates that it is “FOR PUBLICATION,” it is subject to
revision until final publication in the Michigan Appeals Reports.
STATE OF MICHIGAN
COURT OF APPEALS
DN, a legally incapacitated person, by FOR PUBLICATION
Guardian/Conservator MARK NOWACKI and April 08, 2025
KATHLEEN NOWACKI, 11:20 AM
Plaintiffs-Appellees,
v No. 367271
Washtenaw Circuit Court
GILEAD SCIENCES, INC., LC No. 22-001761-NP
Defendant-Appellant,
and
ST. JOSEPH MERCY CHELSEA, INC., doing
business as ST. JOSEPH MERCY CHELSEA,
Defendant.
DN, a legally incapacitated person, by
Guardian/Conservator MARK NOWACKI and
KATHLEEN NOWACKI,
Plaintiffs-Appellees,
v No. 368026
Washtenaw Circuit Court
GILEAD SCIENCES, INC., LC No. 22-001761-NP
Defendant,
and
ST. JOSEPH MERCY CHELSEA, INC., doing
business as ST. JOSEPH MERCY CHELSEA,
Defendant-Appellant.
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Before: BOONSTRA, P.J., and LETICA and RICK, JJ.
RICK, J.
The Spanish flu pandemic of 1918 and the recent COVID-19 pandemic of 2020-2021
constituted two devastating global health crises. According to the Pan American Health
Organization, by the time it was contained, the Spanish flu spread around the world in a matter of
four months, bringing death and destruction to an estimated 21 million lives.1 Witnesses described
unthinkable circumstances: in some instances, the dead were left in their homes for days;
indigenous populations, particularly those in remote areas, were entirely snuffed out; large urban
areas depleted proper burial equipment and turned streetcars into hearses to hold the dead.2
In contemporary times, the World Health Organization reports that the COVID-19
pandemic was responsible for more than 1 million deaths in the US, and over 7 million deaths
globally.3 The magnitude of the disruption is still being experienced, long after the pandemic itself
was declared over. Many lost loved ones, some of whom died alone because of restrictions that
prevented anyone from visiting them. Some individuals who contracted the disease now live with
“long COVID.”4 The Mayo Clinic reports that persons afflicted with long COVID also see an
increased risk of diseases, including heart disease, stroke and blood clots, myalgic
encephalomyelitis-chronic fatigue syndrome, also called ME-CFS, to name a few.5 There is much
debate now, and will likely be in the future, about the governmental response and courses of
treatment provided as the world grappled with the COVID-19 healthcare crisis.
These consolidated appeals6 arise out of the alleged dissemination of contaminated doses
of remdesivir, an antiviral medication, to plaintiffs’ ward, DN. DN was designated a legally
incapacitated individual. He was hospitalized and treated for COVID-19, and allegedly received
two contaminated doses of the FDA-approved medication. He thereafter suffered two strokes. In
1
Sarah Francis Fujimura, Purple Death: The Great Flu of 1918, <https://www.paho.org/en/who-
we-are/history-paho/purple-death-great-flu-1918> (accessed March 25, 2025).
2
Id.
3
World Health Organization, World Health Organization COVID-19 Dashboard
<https://data.who.int/dashboards/covid19/deaths?n=o> (accessed March 25, 2025).
4
Mayo Clinic, Long COVID: Lasting Effects of COVID-19
<https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/coronavirus-long-term-
effects/art-20490351> (accessed March 25, 2025).
5
Id.
6
DN v Gilead Sciences, Inc, unpublished order of the Court of Appeals, entered March 8, 2024
(Docket Nos. 367271 and 368026).
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Docket No. 367271, defendant-appellant, Gilead Sciences, Inc. (Gilead), appeals by leave granted7
an order denying its motion for summary disposition under MCR 2.116(C)(8) (failure to state a
claim). In Docket No. 368026, defendant-appellant, St. Joseph Mercy Chelsea, Inc., doing
business as St. Joseph Mercy Chelsea (St. Joseph), also appeals by leave granted8 an order denying
its motion for summary disposition under MCR 2.116(C)(8). We reverse and remand.
I. FACTUAL BACKGROUND
In November 2021, 83-year-old DN presented to St. Joseph Hospital, where he was
diagnosed with COVID-19. Hospital staff administered monoclonal antibodies and discharged
him. DN went to the emergency room the following day because his symptoms were worsening.
DN received two doses of remdesivir. Within the next week, he suffered a stroke. DN was
discharged to a skilled nursing facility, where he began suffering from hematomas and swelling of
the face, thighs, and arms. DN suffered another stroke in December 2021.
In April 2022, DN’s guardian received a letter from St. Joseph confirming that DN had
received remdesivir during his hospital stay. The letter indicated that two of the five doses of
remdesivir administered to DN involved recalled lot numbers of the drug. The voluntary recall
was dated December 3, 2021, and pertained to two lots—approximately 55,000 vials—of
remdesivir. The recall was published on the Food and Drug Administration’s (FDA) website,
warning:
Gilead Sciences Inc. received a customer complaint, confirmed by the
firm’s investigation, of the presence of glass particulates.
Risk Statement: The administration of an injectable that contains glass
particulates may result in local irritation or swelling in response to the foreign
material. If the glass particulate reaches the blood vessels it can travel to various
organs and block blood vessels in the heart, lungs or brain which can cause stroke
and even lead to death. To date, Gilead Sciences Inc. has not received any reports
of adverse events related to this recall.
Plaintiffs sued St. Joseph and Gilead in December 2022, asserting claims for breach of
implied warranty, breach of express warranty, negligence, gross negligence, intentional
misrepresentation, and loss of consortium. They argued that, although the FDA had approved
remdesivir to treat COVID-19, the remdesivir administered in this case “was not in accordance
with Gilead’s FDA approval for the drug in terms of its manufacturing quality” because it
contained glass particles. They alleged that the glass particles in the drug caused DN to suffer two
strokes and that he later had to have a leg amputated. Plaintiffs stated that as a result, DN was left
bedridden and required around-the-clock care.
7
DN v Gilead Sciences, Inc, unpublished order of the Court of Appeals, entered March 8, 2024
(Docket No. 367271).
8
DN v Gilead Sciences, Inc, unpublished order of the Court of Appeals, entered March 8, 2024
(Docket No. 368026).
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In February 2023, Gilead, with consent from St. Joseph, removed this action to the federal
district court on the basis that the federal Public Readiness and Preparedness (PREP) Act, 42 USC
247d-6d, preempted plaintiffs’ state-law claims against Gilead. The federal district court
determined that the PREP Act completely preempts state-law claims that fall within its scope. It
further observed that “[t]he sole cause of action created by the PREP Act is an exclusive Federal
cause of action against a covered person for death or serious physical injury proximately caused
by willful misconduct . . . by [a] covered person[.]” Nowacki for Nowacki v Gilead Sciences, Inc,
unpublished order of the United States District Court for the Eastern District of Michigan, entered
June 13, 2023 (Case No. 23-10276), p 13 (quotation marks and citation omitted, first alteration in
original). Taking that into account, the court determined that the only claim over which it had
original jurisdiction was plaintiffs’ claim for intentional misrepresentation because the federal
PREP Act “completely preempts”9 claims alleging death or serious injury caused by willful
misconduct. Id., unpub order at 14. However, the court noted that under the PREP Act, a plaintiff
asserting a willful misconduct claim is required to first exhaust all administrative remedies before
bringing the claim in the U.S. District Court for the District of Columbia. See 42 USC 247d-
6e(d)(1) and (e)(1). Nowacki, unpub order at 21. The court thus opined that dismissal of that claim
without prejudice was required because plaintiffs had not yet exhausted their administrative
remedies for the claim. Id. The court declined to exercise supplemental jurisdiction over
plaintiffs’ remaining claims. Id., unpub order at 22.
In its opinion and order, the federal district court rejected plaintiffs’ argument that the
remdesivir doses were not a covered countermeasure under the PREP Act as a result of a
manufacturing defect. The court explained:
This argument is unsupported by any authority and contrary to the plain text
of the PREP Act. The Act’s broad grant of immunity from suit and liability with
respect to all claims relating to the administration to or use of a covered
countermeasure, see 42 USC 247-6d(a)(1), makes clear that a product’s alleged
departure from FDA-approved manufacturing specifications does not remove it
from the Act’s protection.
* * *
Plaintiffs’ argument also runs counter to the PREP Act’s purpose: to
encourage the expeditious development and deployment of medical
countermeasures during a public health emergency by allowing the [Health and
Human Services (HHS)] Secretary to limit legal liability for losses relating to the
9
Complete preemption is distinct from the concept of ordinary preemption. “Complete
preemption, really a jurisdictional rather than a preemption doctrine, confers exclusive federal
jurisdiction in certain instances where Congress intended the scope of a federal law to be so broad
as to entirely replace any state-law claim.” Franciscan Skemp Healthcare, Inc v Central States
Joint Bd Health & Welfare Trust Fund, 538 F3d 594, 596 (CA 7, 2008).
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administration of medical countermeasures such as diagnostics, treatments, and
vaccines. The Act’s broad immunity provisions were intended, in part, to remove
uncertainty and risk for individuals and organizations on the front lines combating
a pandemic. [Nowacki, unpub order at 18, 20. (quotation marks and citations
omitted.)]
Following remand to the state circuit court, Gilead moved for summary disposition under
MCR 2.116(C)(8). Gilead argued that the PREP Act provided it with immunity from suit because
remdesivir was a covered countermeasure.10 Gilead further argued that, as remdesivir’s
manufacturer, it was immune from liability with respect to all claims for loss caused by the use of
remdesivir. Gilead noted that the PREP Act’s plain language granted immunity from
manufacturing defect claims, such as the allegedly contaminated remdesivir administered in this
case. St. Joseph moved for summary disposition under MCR 2.116(C)(8) on essentially the same
grounds, arguing that under the PREP Act, the hospital was a “covered person” immune from
liability for injuries related to the administration of a “covered countermeasure” such as
remdesivir.
Plaintiffs responded to Gilead’s motion, arguing that the PREP Act did not afford
protection to Gilead. Plaintiffs reasoned that because the FDA did not approve or license
remdesivir in a form that contained glass particles, the allegedly contaminated remdesivir doses
did not constitute a covered countermeasure. Following a hearing, the trial court denied Gilead’s
motion for summary disposition, reasoning as follows:
While Congress sought to protect companies who were developing
treatments and putting them on the market without the rigorous testing requirements
that usually are in place, the government, I don’t believe, sought to protect a
negligent manufacture of the product. And when the product has some contaminant
in it, it is not meeting the requirements to avail itself of the PREP Act. It is no
longer a covered countermeasure. It is an attempt at a covered countermeasure, but
it is contaminated, and that’s different from it being a formula that, for whatever
reason, ends up harming a person because it hasn’t been well tested or there’s
some—some problem with the formula itself. That’s—it’s not claimed here that
there was a problem with the formula; it’s claimed that there was a problem with
the product that was ultimately delivered. And under those circumstances I don’t
see that the PREP Act applies here to bar the claims that are made by the Plaintiff
of a negligent manufacture.
10
It bears noting that the federal district court’s application of the complete preemption doctrine
to plaintiffs’ intentional misrepresentation claim does not mean that the PREP Act only applied to
that claim; rather, preemption may still apply as a defense to the remaining claims in state court,
as Gilead and St. Joseph alleged here. See Franciscan Skemp Healthcare, Inc, 538 F3d at 601
(quotation marks, brackets, and citation omitted) (“A federal court’s order remanding a case to
state court based on the inapplicability of the complete preemption doctrine leaves open the
question whether the plaintiff’s claims are nevertheless defensively preempted”).
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The court thereafter entered an order denying the motion “for the reasons stated on the record . . . .”
Plaintiffs subsequently responded to St. Joseph’s motion for summary disposition, arguing
that because St. Joseph brought essentially the exact same motion as Gilead, and Gilead’s motion
was denied, St. Joseph’s motion should also be denied. At a hearing on St. Joseph’s motion, the
court again agreed with plaintiffs, largely for the same reasons it denied Gilead’s motion. An order
to that effect was later entered. This appeal followed.
II. ANALYSIS
Gilead and St. Joseph argue that the trial court erred by denying their motions for summary
disposition because the PREP Act’s plain language grants immunity from manufacturing defect
claims. We agree.
“We review de novo a trial court’s decision on a motion for summary disposition,
reviewing the record in the same manner as must the trial court to determine whether the movant
was entitled to judgment as a matter of law.” Bronson Methodist Hosp v Auto-Owners Ins Co, 295
Mich App 431, 440; 814 NW2d 670 (2012). “A motion under MCR 2.116(C)(8) tests the legal
sufficiency of a claim based on the factual allegations in the complaint.” El-Khalil v Oakwood
Healthcare, Inc, 504 Mich 152, 159; 934 NW2d 665 (2019). “When considering such a motion,
a trial court must accept all factual allegations as true, deciding the motion on the pleadings alone.”
Id. at 160. “A motion under MCR 2.116(C)(8) may only be granted when a claim is so clearly
unenforceable that no factual development could possibly justify recovery.” Id. We likewise
review de novo “questions concerning the proper interpretation of contractual or statutory
language[.]” Dobbelaere v Auto-Owners Ins Co, 275 Mich App 527, 529; 740 NW2d 503 (2007).
Generally, “[a] court’s primary purpose in interpreting a statute is to ascertain and
effectuate legislative intent. Courts may not speculate regarding legislative intent beyond the
words expressed in a statute.” Mich Ed Ass’n v Secretary of State (On Rehearing), 489 Mich 194,
217; 801 NW2d 35 (2011) (quotation marks and citation omitted). “As far as possible, effect
should be given to every phrase, clause, and word in the statute.” Sun Valley Foods Co v Ward,
460 Mich 230, 237; 596 NW2d 119 (1999). “[C]ourts must interpret statutes in a way that gives
effect to every word, phrase, and clause in a statute and avoid an interpretation that would render
any part of the statute surplusage or nugatory. A statute is rendered nugatory when an
interpretation fails to give it meaning or effect.” Esurance Prop & Cas Ins Co v Mich Assigned
Claims Plan, 507 Mich 498, 508-509; 968 NW2d 482 (2021). “When the plain and ordinary
meaning of statutory language is clear, judicial construction is neither necessary nor permitted.”
Pace v Edel-Harrelson, 499 Mich 1, 7; 878 NW2d 784 (2016).
“Congress enacted the PREP Act in 2005 to encourage the expeditious development and
deployment of medical countermeasures during a public health emergency by allowing the [HHS]
Secretary to limit legal liability for losses relating to the administration of medical
countermeasures such as diagnostics, treatments, and vaccines.” Hudak v Elmcroft of Sagamore
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Hills, 58 F4d 845, 849 (CA 6, 2023) (quotation marks, citation, and alterations omitted).11 Under
the plain language of the Act,
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 under subsection (b) has been issued with respect
to such countermeasure. [42 USC 247d-6d(a)(1).]
There is no dispute that the HHS Secretary declared COVID-19 a public-health emergency in
March 2020. See Hudak, 58 F4d at 850. Immunity under the Act was extended through October 1,
2024. Id. See also Department of Health and Human Services, Office of the
Secretary, Declaration Under the Public Readiness and Emergency Preparedness Act for Medical
Countermeasures Against COVID-19, Fed Reg 15198, 15202 (March 17, 2020).
As relevant to this appeal, “loss” is defined as including losses caused by death or by
“physical, mental, or emotional injury, illness, disability, or condition[.]” 42 USC 247d-
6d(a)(2)(A)(i) and (ii). The PREP Act additionally defines the phrase “covered person” to include
entities that manufacture, distribute, prescribe, and administer a covered countermeasure. See 42
USC 247d-6d(i)(2)(B)(i), (ii) and (iv). Plaintiffs agree that Gilead and St. Joseph are covered
persons in this case. The PREP Act also defines the phrase “covered countermeasure” as “a
qualified pandemic or epidemic product” or “a drug . . . that is authorized for emergency use in
accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act[.]” 42
USC 247d-6d(i)(1)(A) and (C). On this point, plaintiffs agree that in general, remdesivir is
considered a covered countermeasure. However, they argue that the remdesivir administered to
DN should not be considered a “covered countermeasure” because Gilead manufactured, and St.
Joseph administered, a product containing microscopic glass particles. Plaintiffs maintain that it
is the glass particles, and not the remdesivir itself, that caused DN’s lasting injuries.
We understand plaintiffs’ argument. Nevertheless, Congress acted to prevent suits like this
in the face of a serious public health emergency. Gilead and St. Joseph are ultimately correct:
under the PREP Act, no liability can attach here. The immunity granted under the PREP Act
applies to any claim for loss that has a causal relationship with the administration
to or use by an individual of a covered countermeasure, including a causal
relationship with the design, development, clinical testing or investigation,
manufacture, labeling, distribution, formulation, packaging, marketing, promotion,
sale, purchase, donation, dispensing, prescribing, administration, licensing, or use
of such countermeasure. [42 USC 247d-6d(a)(2)(B) (emphasis added).]
“The PREP Act creates only one exception to its grant of immunity[,]” Hudak, 58 F4d at 849. The
sole basis for which liability can be imposed under the PREP act is “for death or serious physical
injury proximately caused by willful misconduct,” 42 USC 247d-6d(d)(1) (emphasis added). The
11
Opinions of the lower federal courts are not binding, but may be considered for their persuasive
value. Truel v Dearborn, 291 Mich App 125, 136 n 3; 804 NW2d 744 (2010).
-7-
Act defines willful misconduct as “ ‘an act or omission that is taken—(i) intentionally to achieve
a wrongful purpose; (ii) knowingly without legal or factual justification; and (iii) in disregard of a
known or obvious risk that is so great as to make it highly probable that the harm will outweigh
the benefit.’ ” Hudak, 58 F4d at 849-850, quoting 42 USC 247d-6d(c)(1)(A)(i) through (iii). Thus,
under the plain language of the PREP Act, Gilead and St. Joseph cannot be held liable for any
alleged wrongdoing short of “willful misconduct.” 42 USC 247d-6d(d)(1). Plaintiffs did not plead
in avoidance of the PREP Act by alleging that Gilead or St. Joseph engaged in willful misconduct
in this case, nor does it appear that an unintentional error allegedly causing contamination of the
remdesivir during the manufacturing process rises to the level of willful misconduct for which
Gilead and St. Joseph can be held liable. 42 USC 247d-6d(a)(1); 42 USC 247d-6d(a)(2)(B).
Additionally, as Gilead pointed out in the federal district court, “Congress’s explicit
extension of PREP Act immunity to claims involving a covered countermeasure’s ‘manufacture’
would be rendered meaningless if, as Plaintiffs suggest, the presence of a manufacturing defect
prevented a product from being a covered countermeasure in the first place.” Nowacki, unpub
order at 19. To accept plaintiffs’ argument and conclude that manufacturing defects prevent
products from being considered “covered countermeasures” under the PREP Act, we would
necessarily have to render some of the language of the PREP Act nugatory, in violation of our
principles of statutory interpretation. Esurance Prop & Cas Co, 507 Mich at 508-509. We decline
to do so here.
The plain language of the PREP Act clearly grants Gilead and St. Joseph immunity from
all liability for injuries that were not caused by willful misconduct. Because plaintiffs have not
alleged that Gilead or St. Joseph engaged in willful misconduct by manufacturing or administering
remdesivir to DN, plaintiffs’ claims cannot prevail.12 Congress has unequivocally extended
immunity to scientists, pharmaceutical companies, and other healthcare providers who grappled
with the unprecedented nature of the COVID-19 pandemic. The PREP Act also extends immunity
to those entities vis-à-vis any potential future health crises, barring allegations of willful
misconduct. The trial court thus erred by declining to grant summary disposition under
MCR 2.116(C)(8). On remand, the trial court shall enter an order granting summary disposition
to Gilead and St. Joseph under MCR 2.116(C)(8) and dismissing plaintiffs’ claims in their entirety.
Reversed and remanded for further proceedings consistent with this opinion. A public
question being involved, no costs may be taxed under MCR 7.219. We do not retain jurisdiction.
/s/ Michelle M. Rick
/s/ Mark T. Boonstra
/s/ Anica Letica
12
Although the PREP Act generally precludes covered persons from liability, it does not leave
injured parties without recourse; under the Act, eligible individuals may seek aid through the
“Covered Countermeasure Process Fund,” which was established to provide compensation “for
covered injuries directly caused by the administration or use of a covered countermeasure[.]” 42
USC 247d–6e(a).
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