Roebuck v. Mayo Clinic

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

FILED 9-19-2023

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.

ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

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

2

ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

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.

3

ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

¶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

4

ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

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.

5

ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

¶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 “anti-

abrogation” 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,

6

ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

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

7

ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

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 COVID-

related 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.

8

ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

¶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

9

ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

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 COVID-

related. 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 COVID-

19, 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).

10

ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

¶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

11

ROEBUCK v. MAYO CLINIC, et al.

Opinion of the Court

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.

AMY M. WOOD • Clerk of the Court

FILED: AA

12