IN THE

ARIZONA COURT OF APPEALS

DIVISION ONE

ROBIN ROEBUCK, Plaintiff/Appellant,

v.

MAYO CLINIC, et al., Defendants/Appellees.

No. 1 CA-CV 22-0508

Appeal from the Superior Court in Maricopa County

No. CV2021-090429

The Honorable Rodrick J. Coffey, Judge

REVERSED AND REMANDED

COUNSEL

Law Office of Robert M. Gregory, P.C., Gilbert

By Robert M. Gregory

Counsel for Plaintiff/Appellant

Quintairos, Prieto, Wood & Boyer, P.A., Scottsdale

By Vincent J. Montell, Rita J. Bustos, Samantha L. Butler

Counsel for Defendants/Appellees

OPINION

Presiding Judge Maria Elena Cruz delivered the opinion of the Court, in 

which Judge James B. Morse Jr. and Judge Daniel J. Kiley joined.

FILED 9-19-2023
ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

2

C R U Z, Judge:

¶1 Robin Roebuck appeals the superior court’s grant of 

summary judgment to Mayo Clinic, Mayo Clinic Arizona, Nicole Secrest,

N.P., and Robert Scott, M.D. (collectively, “the Mayo Clinic defendants”). 

Because Arizona Revised Statutes (“A.R.S.”) section 12-516 does away with 

a patient’s right to recover damages for ordinary negligence we hold that it 

violates the anti-abrogation clause of the Arizona Constitution. 

Accordingly, we reverse and remand.

FACTUAL AND PROCEDURAL HISTORY

¶2 Roebuck had a heart transplant in 1993, and a second heart 

transplant and kidney transplant at Mayo Clinic in 2017. Thereafter, Mayo 

Clinic provided Roebuck’s follow-up care. Roebuck was healthy until he 

contracted COVID-19 in 2020.

¶3 Roebuck was hospitalized on April 20, 2020, at Mayo Clinic

after presenting with COVID-19 symptoms. Because he had previously 

received a heart transplant, Roebuck was placed under the care of Mayo 

Clinic’s congestive heart failure team, standard Mayo Clinic procedure for 

admitted heart transplant patients regardless of the reason for their 

admission.

¶4 On April 23, 2020, a chest x-ray revealed Roebuck had 

developed pneumonia, and he had to be given supplemental oxygen. That 

same day, Dr. Hasan Ashraf, a cardiologist, ordered an echocardiogram to

assess Roebuck’s heart. The echocardiogram confirmed that Roebuck’s 

heart was “doing pretty well” and that he was not having primary cardiac 

issues or signs of rejection. In light of Roebuck’s positive COVID-19 test 

and the results of the echocardiogram, his doctors “proceeded with regards

to the management of COVID” rather than “any cardiac kind of 

management.”

¶5 The next day, Dr. Ashraf ordered an arterial blood gas 

(“ABG”) test. The test, which is drawn from a patient’s radial artery, 

measures the oxygen in the patient’s arterial blood and provides doctors 

with more accurate information than a pulse oximeter. Dr. Ashraf ordered 

the ABG test because Roebuck had COVID-19 and was “becoming 

progressively hypoxic,” and because he was suffering from metabolic 

acidosis as a result of his diarrhea from COVID-19. In addition, Dr. Ashraf 

had consulted with Mayo Clinic’s infectious disease doctors who were 

considering giving Roebuck a monoclonal antibody, tocilizumab, to treat 
ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

3

his COVID-19, and ABG test results would provide necessary “additional 

information that would . . . support giving the tocilizumab.” The results of 

the ABG test revealed that Roebuck had very low oxygen content in his 

blood, warranting treatment with tocilizumab, which he was given shortly 

thereafter.

¶6 The next day, Roebuck developed complications from the 

ABG test, was diagnosed with compartment syndrome, and underwent 

emergency surgery on his right hand, forearm, and wrist. Roebuck was left 

with diminished strength and use of his right hand and arm and significant 

scarring.

¶7 In January 2021, Roebuck filed a medical negligence suit 

against the Mayo Clinic defendants alleging the ABG test was negligently 

performed. He did not allege the Mayo Clinic defendants were grossly 

negligent. In March 2021, the Mayo Clinic defendants removed the action 

to the United States District Court for the District of Arizona, asserting 

federal question jurisdiction under 28 U.S.C. § 1331 based on their 

immunity defense under the Public Readiness and Emergency 

Preparedness (“PREP”) Act, 42 U.S.C. §§ 247d-6d, 247d-6e. Roebuck moved 

to remand to state court. The district court remanded to the superior court 

after finding the case did not raise a federal question because it did not 

involve a state law claim arising under federal law or a state law claim 

completely preempted by a federal statute.

¶8 In May 2021, Roebuck filed an amended complaint and 

additionally alleged that Dr. Ashraf had ordered the ABG test to evaluate 

his heart disease. The Mayo Clinic defendants moved to dismiss the 

complaint, and the superior court denied the motion. The court ordered 

that the scope of discovery would “initially” be limited “to the issues of the 

purpose of the [ABG] blood draw.”

¶9 The parties deposed Roebuck, Dr. Ashraf, and Mayo Clinic 

doctor Robert Scott, M.D. The Mayo Clinic defendants moved for summary 

judgment, and after briefing and oral argument, the superior court granted 

the motion. Although it dismissed Roebuck’s claims, the court expressly 

stated that Roebuck was “not barred from filing an amended complaint 

asserting willful conduct or gross negligence [if] such claims can satisfy the 

requirements of Rule 11 of the Arizona Rules of Civil Procedure.” Roebuck 

did not file an amended complaint.
ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

4

¶10 After the court entered partial final judgment under Ariz. R. 

Civ. P. 54(b), Roebuck timely appealed. We have jurisdiction pursuant to 

A.R.S. §§ 12-120.21(A)(1), -2101(A)(1).

DISCUSSION

¶11 We review a grant of summary judgment de novo, viewing 

the evidence and reasonable inferences in the light most favorable to 

Roebuck as the non-moving party. See Wells Fargo Bank v. Ariz. Laborers, 

Teamsters & Cement Masons Loc. No. 395 Pension Tr. Fund, 201 Ariz. 474, 482, 

¶ 13 (2002). “Summary judgment is appropriate only if no genuine issues 

of material fact exist and the moving party is entitled to judgment as a 

matter of law.” Id. at ¶ 14 (citing Ariz. R. Civ. P. 56(a); Orme Sch. v. Reeves, 

166 Ariz. 301, 309 (1990)). We review de novo the superior court’s 

interpretation of statutes and constitutional issues. Hohokam Irrigation & 

Drainage Dist. v. Ariz. Pub. Serv. Co., 204 Ariz. 394, 397, ¶ 5 (2003). 

“Legislation . . . is entitled to a strong presumption of constitutionality, and 

we construe a statute to give it, if possible, a reasonable and lawful 

meaning.” Governale v. Lieberman, 226 Ariz. 443, 447, ¶ 7 (App. 2011). 

“[C]onstitutional provisions are interpreted in view of the history behind 

the enactment, the purpose sought to be accomplished by its enactment and 

the evil sought to be remedied.” Ruth v. Indus. Comm’n, 107 Ariz. 572, 575

(1971).

I. No Issues of Material Fact

¶12 Roebuck first argues there was a genuine issue of material fact

about the purpose of the ABG procedure that should have precluded 

summary judgment. We disagree. The deposition testimony of Drs. Ashraf 

and Scott unequivocally established that the ABG test was performed to

assess and treat Roebuck for COVID-19. Although Roebuck complains of a 

purported “incongruity” in Dr. Ashraf’s explanation of the reason for the 

ABG test, we find no such incongruity. The fact that Roebuck had 

undergone an ABG test in 2017 for non-COVID-19 related reasons does not 

negate the uncontroverted testimony of Drs. Ashraf and Scott that Dr. 

Ashraf ordered the ABG test in 2020 as part of Roebuck’s treatment for 

COVID-19.

II. Ambiguity

¶13 Roebuck next argues A.R.S. § 12-516 is ambiguous. “If a 

statute’s language is clear and unambiguous, we apply it without resorting 

to other methods of statutory interpretation. Ambiguity exists if there is 

uncertainty about the meaning or interpretation of a statute’s terms.” Hayes 
ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

5

v. Cont’l Ins. Co., 178 Ariz. 264, 268 (1994) (citations omitted). The statute 

provides, in relevant part:

A. If the governor declares a state of emergency for a public 

health pandemic1 pursuant to title 26, chapter 2, a health 

care professional or health care institution that acts in 

good faith is not liable for damages in any civil action for 

an injury or death that is alleged to be caused by the health

professional’s or health care institution’s action or 

omission while providing health care services in support 

of this state’s response to the state of emergency declared 

by the governor unless it is proven by clear and 

convincing evidence that the health professional or health 

care institution failed to act or acted and the failure to act 

or action was due to that health professional’s or health 

care institution’s wilful misconduct or gross negligence.

B. Subsection A of this section applies to any action or 

omission that is alleged to have occurred during a 

person’s screening, assessment, diagnosis or treatment 

and that is related to the public health pandemic that is the 

subject of the state of emergency . . . .

. . . .

E. This section applies to all claims that are filed before or 

after September 29, 2021 for an act or omission by a person 

that occurred on or after March 11, 2020 and that relates to 

a public health pandemic that is the subject of the state of 

emergency declared by the governor.

Roebuck argues subsections A and B of the statute are ambiguous because 

“[i]t is unclear if this language suggests that any medical care rendered 

during a pandemic extends immunity to the healthcare provider, or does 

the medical care in question have to be exclusively done in treatment of a 

pandemic-related condition, or does immunity arise when the assessment, 

diagnosis or treatment is via a medical procedure that was developed 

specifically for the pandemic-related condition?”

1 Governor Ducey declared a state of emergency regarding the 

COVID-19 pandemic on March 11, 2020, and terminated the state of 

emergency on March 30, 2022.
ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

6

¶14 We disagree. The language in subsection A stating “while 

providing health care services in support of this state’s response to the state 

of emergency declared by the governor,” is clear and unambiguous, as is 

the language in subsection B stating that the statute applies “to any action 

or omission that is alleged to have occurred during a person’s screening, 

assessment, diagnosis or treatment and that is related to the public health 

pandemic that is the subject of the state of emergency.” Section 12-516 

unequivocally shields health care providers from ordinary negligence 

claims relating to their provision of pandemic-related medical treatment.

III. Retroactivity

¶15 Roebuck argues that § 12-516 was not in effect in April 2020 

when he was treated by Mayo Clinic defendants. “No statute is retroactive 

unless expressly declared therein.” A.R.S. § 1-244. Roebuck filed suit in 

January 2021, for alleged acts of negligence occurring in April 2020. The 

legislature expressly made § 12-516 retroactive when it enacted the law in 

September 2021. The statute states that it applies “to all claims that are filed 

before or after September 29, 2021 for an act or omission by a person that 

occurred on or after March 11, 2020 . . . .” A.R.S. § 12-516(E).

¶16 For the first time on appeal, Roebuck argues § 12-516 

disturbed his “vested substantive rights” by retroactively increasing the 

burden of proof after he filed his complaint. “[L]egal theories must be 

presented timely to the trial court so that the court may have an opportunity 

to address all issues on their merits. If the argument is not raised below so 

as to allow the trial court such an opportunity, it is waived on appeal.” 

Cont’l Lighting & Contracting, Inc. v. Premier Grading & Utils., LLC, 227 Ariz. 

382, 386, ¶ 12 (App. 2011) (citation omitted). By not making his argument 

about vested substantive rights below, Roebuck has waived this argument.

IV. Anti-Abrogation Clause

¶17 Roebuck next argues the superior court erred by finding the 

Mayo Clinic defendants immune from liability under A.R.S. § 12-516

because the statute violates the anti-abrogation clause of the Arizona 

Constitution.

¶18 Article 18, Section 6 of the Arizona Constitution, the “antiabrogation” clause, states that “[t]he right of action to recover damages for 

injuries shall never be abrogated, and the amount recovered shall not be 

subject to any statutory limitation . . . .” The anti-abrogation clause protects

a plaintiff’s right of access to the courts and prohibits the “abrogation of all 

common law actions for negligence, intentional torts, strict liability, 
ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

7

defamation, and other actions in tort which trace origins to the common 

law.” Cronin v. Sheldon, 195 Ariz. 531, 538-39, ¶ 35 (1999). “Because a 

medical malpractice action has its origins in the common law, it is protected 

by [the anti-abrogation] clause.” Governale, 226 Ariz. at 447, ¶ 8 (citation 

omitted).

¶19 The legislature may regulate negligence and other common 

law causes of action without offending the anti-abrogation clause. Barrio v. 

San Manuel Div. Hosp. for Magma Copper Co., 143 Ariz. 101, 104 (1984); see 

also Nunez v. Pro. Transit Mgmt. of Tucson, Inc., 229 Ariz. 117, 122-23, ¶ 25 

(2012) (“We have repeatedly noted that the legislature is entitled to regulate 

common law tort actions, as long as a claimant is left a reasonable 

possibility of obtaining legal redress.”) (citations and internal quotation

marks omitted). “We apply the reasonable election test to distinguish 

between regulation and abrogation.” Duncan v. Scottsdale Med. Imaging, 

Ltd., 205 Ariz. 306, 313, ¶ 29 (2003) (citations and internal quotation marks 

omitted). The legislature must “leave[] a claimant reasonable alternatives 

or choices which . . . enable [the claimant] to bring the action.” Barrio, 143 

Ariz. at 106. “It may not, under the guise of regulation, so affect the 

fundamental right to sue for damages as to effectively deprive the claimant 

of the ability to bring the action.” Duncan, 205 Ariz. at 313, ¶ 30 (citations 

and internal quotation marks omitted).

¶20 “[T]he abrogation clause is implicated when the right of 

action is ‘completely abolished.’” Barrio, 143 Ariz. at 106 (quoting Ruth, 107 

Ariz. at 575). A statute does not abrogate a claim merely by making it more 

difficult for a claimant to obtain a recovery. State Farm Ins. Cos. v. Premier 

Manufactured Sys., Inc., 217 Ariz. 222, 225, 229, ¶¶ 14, 34-37 (2007) (rejecting 

argument that A.R.S. § 12-2506, which abolished joint and several liability 

in strict products liability cases violates Article 18, Section 6); Governale, 226 

Ariz. at 447-48, ¶¶ 8-11 (statute limiting potential expert witnesses a 

plaintiff may use “does not abolish the right to bring a medical malpractice 

action and thus is not an abrogation”).

¶21 The superior court found that § 12-516 did not abrogate 

Roebuck’s cause of action because it does not bar his right to recover 

damages, but instead requires him to prove a ”higher evidentiary standard 

in order to prevail by requiring that he prove by clear and convincing 

evidence that [Mayo Clinic defendants] acted with willful misconduct or 

gross negligence.”

¶22 To determine whether a statute impermissibly abrogates a 

claim of action we must perform a two-part analysis. Duncan, 205 Ariz. at 
ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

8

313, ¶ 28. First, we determine whether the cause of action at issue is one 

that is protected by Article 18, Section 6. Id. The anti-abrogation clause

“prevents abrogation of all common law actions for negligence . . . .” 

Cronin, 195 Ariz. at 538, ¶ 35. Article 18, Section 6 of the Arizona 

Constitution protects the right to bring suits for negligence. Then, we must 

determine whether § 12-516 regulates a patient’s right to recover damages 

for ordinary negligence or completely does away with that right. Duncan, 

205 Ariz. at 313, ¶ 29.

¶23 If § 12-516 did nothing more than raise the burden of proof 

for medical malpractice claimants from a “preponderance of the evidence” 

to “clear and convincing evidence,” we would agree that the statute does 

not offend the anti-abrogation clause. The legislature, after all, “is 

empowered to set burdens of proof,” Seisinger v. Siebel, 220 Ariz. 85, 93, ¶ 30 

(2009), and the evidentiary standard necessary for a claimant to prevail may 

be raised without implicating Article 18, Section 6. Cf. Nunez, 229 Ariz. at 

122-23, ¶¶ 24-25 (holding that abandoning doctrine imposing heightened 

standard of care on common carriers did not violate the anti-abrogation 

clause).

¶24 Section 12-516 does more, however, than simply raise 

plaintiffs’ burden of proof for COVID-related medical malpractice claims.

Instead, the statute bars all claims for ordinary negligence arising out of the 

provision of COVID-related medical treatment. While “[t]he legislature 

may regulate the cause of action for negligence so long as it leaves” 

claimants “reasonable alternatives or choices” for bringing their claims, 

Barrio, 143 Ariz. at 106, § 12-516 leaves no such alternative available to those 

injured by the negligence of medical professionals in providing COVIDrelated treatment. Although the statute does not limit the right to assert a 

claim for gross negligence, the availability of relief for gross negligence is 

not a reasonable alternative to a claim for ordinary negligence. Ordinary 

negligence and gross negligence are, after all, distinct theories of liability.

Walls v. Ariz. Dep’t of Pub. Safety, 170 Ariz. 591, 595 (App. 1991) (“Gross 

negligence differs from ordinary negligence in quality and not degree.”). A 

claim for gross negligence requires “a showing of gross, willful, or wanton 

conduct” that is not required of a plaintiff asserting a claim for ordinary 

negligence. See Noriega v. Town of Miami, 243 Ariz. 320, 326, ¶ 23 (App. 2017) 

(citations and internal quotation marks omitted). Section 12-516 thus denies 

relief to patients injured by negligence in the provision of COVID-related 

medical treatment who cannot make the additional showing required to 

establish gross negligence.
ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

9

¶25 Article 18, Section 6 does not permit the legislature to wholly 

extinguish a particular type of claim available at common law even if 

alternative causes of action remain available to injured claimants. For 

example, in Hazine v. Montgomery Elevator Co., 176 Ariz. 340 (1993), the 

plaintiff who suffered personal injuries while working on an escalator 

brought products liability and negligence claims against the manufacturer. 

Id. at 341. Because the plaintiff sustained the injury more than twelve years 

after the manufacturer sold the escalator, the manufacturer argued that the 

plaintiff’s products liability claim was barred by the twelve-year statute of 

repose for products liability claims. Id. Our supreme court held that the 

statute of repose violated Article 18, Section 6 because it extinguished the 

plaintiff’s products liability claim before he sustained the injury that gave 

rise to his claim. Id. at 342. In so holding, the Hazine court expressly found

that “[t]he fact that the [plaintiff] could still sue on” alternative theories of 

“express warranty or negligence” did not render the statute of repose a 

permissible regulation rather than unconstitutional abrogation. Id. at 342-

43. “[A] right to sue in negligence or express warranty,” the Hazine court 

found, “is not a reasonable alternative to a products liability action.” Id. at 

343.

¶26 Similarly, in Rubino v. De Fretias, 638 F. Supp. 182, 185-86 (D.

Ariz. 1986), the court held unconstitutional a statute abrogating the right of 

patients to sue doctors on an assault and battery theory. In so holding, the 

Rubino court rejected the argument that the statute constituted permissible 

regulation of claims arising out of medical treatment because it did not bar 

negligence-based claims, and so “merely limit[ed] the theories upon which” 

relief may be sought. Id. at 185. Because battery and negligence claims 

“constitute separate causes of action” that arise out of “distinct societal 

interest[s] in the physician-patient relationship,” the court concluded, the 

preservation of negligence claims was not enough to render the abrogation 

of battery claims a “mere[] regulat[ion] [of] the right to sue.” Id. at 185-86.

¶27 Pursuant to Hazine and consistent with Rubino, we find the 

fact that A.R.S. § 12-516 preserves claims for gross negligence insufficient

to render the statute’s absolute bar to ordinary negligence claims a 

permissible “regulation” of the right to sue for medical malpractice. 

Accordingly, we hold that A.R.S. § 12-516’s prohibition on the assertion of 

ordinary negligence claims in providing COVID-related medical treatment 

constitutes an abrogation of a common law right of action in violation of 

Article 18, Section 6.

¶28 Our holding is consistent with cases finding unconstitutional 

statutes that raise “an absolute bar to recovery of damages by a particular 
ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

10

category of persons who otherwise could proceed with an action for 

damages.” City of Tucson v. Fahringer, 164 Ariz. 599, 603 (1990). For 

example, in Little v. All Phoenix S. Cmty. Mental Health Ctr., Inc., 186 Ariz. 97 

(App. 1995), this Court held unconstitutional a statute absolving mental 

health providers of liability for injuries inflicted by patients on third parties 

unless the patient communicated to the mental health provider “an explicit 

threat” to a “clearly identified or identifiable victim.” Id. at 102, 105 (citation 

omitted). We found that, by allowing recovery only to plaintiffs who were 

targets of “explicit threat[s]” by mental health patients, the statute 

“effectively abolishe[d] a cause of action” otherwise available to other 

plaintiffs who did not “fit within the confines of the statute” but were still 

“subject to probable risk of the patient’s violent conduct.” Id. at 105 (citation 

omitted). Similarly, in Young Through Young v. DFW Corp., 184 Ariz. 187 

(App. 1995), abrogated on other grounds as recognized by Torres v. JAI Dining 

Servs. (Phoenix), Inc., 253 Ariz. 66, 77, ¶ 37 (App. 2022), we held that a statute 

limiting dramshop liability to instances where alcohol was served to an 

“obviously intoxicated” patron violated Article 18, Section 6 by denying 

recovery to those who were injured by drivers who had been over-served 

but were not “obviously intoxicated.” Id. at 190.

¶29 A.R.S. § 12-516 bars claims for medical negligence by a 

subcategory of patients, i.e., those whose medical treatment was COVIDrelated. Accordingly, we hold that denying recovery to a subcategory of 

medical negligence plaintiffs who would otherwise be entitled to assert a 

claim violates Article 18, Section 6 of the Arizona Constitution.

V. PREP Act

¶30 The Mayo Clinic defendants argue that Roebuck’s claims are

also barred by the PREP Act, 42 U.S.C. §§ 247d-6d, 247d-6e. They contend

that as covered persons administering a countermeasure to combat COVID19, the Act provides them immunity from suit under federal and state law. 

See 42 U.S.C. § 247d-6d(a)(1). The Act states in relevant part:

[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 U.S.C. § 247d-6d(a)(1).
ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

11

¶31 In disregarding the PREP Act as a basis to grant the Mayo 

Clinic defendants’ motion for summary judgment, the superior court ruled 

that Roebuck’s state law claims are not barred by the PREP Act. To reach 

this conclusion, the superior court relied on the district court’s jurisdictional 

determination that “[t]he PREP Act does not satisfy the Ninth Circuit’s 

complete preemption test because it does not completely replace state laws 

related to COVID-19 and does not provide a substitute cause of action for 

Mr. Roebuck’s medical negligence claim.” But the question of whether the 

Mayo Clinic defendants were entitled to remove the action to federal court, 

as permitted by one of the two exceptions to the well-pleaded complaint 

rule that the Ninth Circuit Court has articulated, is separate from the 

question of whether the PREP Act offers the Mayo Clinic defendants 

immunity from suit in state court. See City of Oakland v. BP PLC, 969 F.3d 

895, 903-06 (9th Cir. 2020).

¶32 Federal courts have held that “preemption is a defense that 

does not present a federal question,” meaning that the fact that a defendant 

may raise an immunity defense by way of federal preemption does not 

mean that a federal question is necessarily involved. Shapnik v. Hebrew 

Home for the Aged at Riverdale, 535 F. Supp. 3d 301, 320 (S.D.N.Y. 2021). 

Immunity as a defense can exist independently of whether there is a federal 

question that would allow the defendant to remove a case to federal court.

¶33 In determining whether a plaintiff’s complaint raised a 

federal issue, the United States District Court for the Central District of 

California found that although the PREP Act was not an essential element 

of any of the plaintiff’s state law claims, “nothing preclude[d] [d]efendants 

from raising PREP Act immunity defensively before a court of competent 

jurisdiction . . . .” Hopman v. Sunrise Villa Culver City, No. 2:21-cv-01054-

RGK-JEM, 2021 WL 1529964, at *6 (C.D. Cal. Apr. 16, 2021). Notably, the 

United States District Court for the Western District of Texas recognized 

that “PREP Act immunity is a defense that must be pled in an answer or 

asserted in a motion to dismiss . . . .” Perez v. Se. SNF LLC, 533 F. Supp. 3d 

430, 436 (W.D. Tex. 2021).

¶34 The PREP Act is primarily an immunity statute. Mitchell v. 

Advanced HCS, LLC, No. 4:21-cv-00155-P, 2021 WL 1247884, at *3 (N.D. Tex. 

Apr. 5, 2021). It provides immunity to “covered persons” engaged in the 

administration of “covered countermeasures.” 42 U.S.C. § 247d-6d(b)(1). 

The Mayo Clinic defendants have asserted immunity under the Act. But, 

although the superior court determined the Mayo Clinic defendants fall 

within the Act’s definition of a “covered person,” it failed to decide whether 

the actions that resulted in injuries to Roebuck fall within the Act’s 
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Opinion of the Court

12

definition of “covered countermeasures.” Regardless of this omission, the 

record would not support such a finding.

¶35 While the Mayo Clinic defendants argue that “[a]ny 

diagnostic testing performed to assess, mitigate and treat the effects of 

COVID-19 during [Roebuck’s] hospitalization would necessarily be a 

covered countermeasure under the Prep Act,” the PREP Act requires more 

than that. According to the March 17, 2020 Declaration Under the Act, to 

qualify as a “covered countermeasure” under the Act, a countermeasure

must be a “qualified pandemic or epidemic product,” or a 

“security countermeasure,” as described immediately below; 

or a drug, biological product or device authorized for 

emergency use in accordance with Sections 564, 564A, or 564B 

of the FD&C Act.

Declaration Under the Public Readiness and Emergency Preparedness Act 

for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198-01, 

2020 WL 1245193 (F.R.) (March 17, 2020).

¶36 The ABG procedure at issue here is not a ”qualified pandemic 

or epidemic product,” a “drug,” a “biological product,” or a “device.” 

Under the Act, a qualifying countermeasure must also be one for which a 

declaration under subsection (b) of the Act has been issued. See 42 U.S.C. 

§ 247d-6d(b)(1). The Mayo Clinic defendants have not argued, and we have 

found no support for the proposition that a declaration with respect to the 

ABG procedure was ever issued under subsection (b) of the Act.

¶37 We affirm the superior court’s judgment that the PREP Act 

does not bar Roebuck’s state law claims.

CONCLUSION

¶38 For the foregoing reasons, we reverse the grant of summary 

judgment and remand to the superior court for further proceedings 

consistent with this decision.