Francisco v. Affiliated Urologists

IN THE

SUPREME COURT OF THE STATE OF ARIZONA

DAVID FRANCISCO, ET AL.,

Plaintiffs/Appellants,

v.

AFFILIATED UROLOGISTS LTD, ET AL.

Defendants/Appellees.

No. CV-23-0152-PR

Filed August 16, 2024

Appeal from the Superior Court in Maricopa County

The Honorable James D. Smith, Judge (Ret.)

No. CV2020-010470

AFFIRMED

Memorandum Decision of the Court of Appeals, Division One

No. 1 CA-CV 21-0701

Filed May 23, 2023

VACATED

COUNSEL:

Jason M. Kelly (argued), Richard D. Lyons, Kelly & Lyons, PLLC,

Scottsdale, Attorneys for David Francisco and Kimberley Francisco

Eileen Dennis GilBride (argued), Cristina M. Chait, Jones, Skelton &

Hochuli, P.L.C., Phoenix, Attorneys for Affiliated Urologists, Ltd, and

Kevin Art, M.D.

David L. Abney, Ahwatukee Legal Office, P.C., Phoenix, Attorney for

Amici Curiae Arizona Association for Justice/Arizona Trial Lawyers

Association

FRANCISCO, ET AL. V. AFFILIATED UROLOGISTS, ET AL.

Opinion of the Court

Rita J. Bustos, Jones, Skelton & Hochuli, P.L.C., Phoenix, Attorneys for

Amici Curiae Banner Health, Dignity Health, HonorHealth, Phoenix

Children's Hospital, Arizona Medical Association, and American Medical

Association

JUSTICE MONTGOMERY authored the opinion of the Court, in which

CHIEF JUSTICE TIMMER, VICE CHIEF JUSTICE LOPEZ and JUSTICES

BRUTINEL, BEENE, and BERCH (RETIRED) joined. * JUSTICE BOLICK

authored an opinion concurring in part and dissenting in part.

JUSTICE MONTGOMERY, Opinion of the Court:

¶1 To prevail on a negligence claim concerning medical

malpractice, a plaintiff must prove that the defendant doctor failed to meet

the standard of care required of a health care professional in the doctor’s

field of practice. Pursuant to A.R.S. § 12-2603, a plaintiff is required to

certify whether expert testimony is necessary to establish the standard of

care and, if it is, serve a preliminary expert opinion affidavit. In this case,

we consider whether a warning required by the Food and Drug

Administration (“FDA”) regarding the use of prescription medication can

serve to establish the standard of care and obviate the need for expert

testimony. Given the facts of this case, we hold that Arizona law does not

permit such warnings to substitute for the required testimony and

independently establish the standard of care.

I. FACTUAL AND PROCEDURAL BACKGROUND 1

¶2 Following his retirement as an endodontist in 2016, David

Francisco moved to Sedona with his wife. In the summer of 2018, he sought

treatment from Kevin Art, M.D. (“Dr. Art”), an employee of Affiliated

Urologists, Ltd. (collectively, the “Practice”). Aside from the need for

* Justice Kathryn H. King is recused from this matter. Pursuant to article 6,

section 3 of the Arizona Constitution, Justice Rebecca White Berch (Ret.) of

the Arizona Supreme Court was designated to sit in this matter.

1 When reviewing a motion to dismiss, we treat the complaint’s alleged

facts as true. See Summerfield v. Superior Court, 144 Ariz. 467, 470 (1985).

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treatment, Francisco was a very fit and physically active sixty-six-year-old.

His medical history included approximately forty years of taking

corticosteroids, an allergy to the antibiotic doxycycline, and

hypothyroidism. In August, Dr. Art performed a urological procedure on

Francisco and prescribed the antibiotic Ciproflaxin (“Cipro”) to prevent

post-surgery infection. Dr. Art did not discuss the use of Cipro with

Francisco before prescribing it.

¶3 The packaging for Cipro contained an insert providing

information about the drug and its use, which included an FDA “black box”

warning. A black box warning is the gravest warning the FDA can issue

and warns of serious adverse consequences that can result from taking a

particular medication. The warning here advised that Cipro may cause

“disabling and potentially irreversible serious adverse reactions,”

including tendinitis and tendon rupture, peripheral neuropathy, and

central nervous effects. Additionally, the warning included an admonition

to “[s]ee full prescribing information for complete boxed warning,” which

indicated that geriatric patients with a history of corticosteroid use were at

an increased risk of experiencing complications from taking Cipro,

including ruptured tendons. The insert separately instructed prescribing

physicians to warn such patients of the noted risks and discontinue using

Cipro if any symptoms of tendinitis or tendon rupture occur.

¶4 Two days after beginning to take Cipro, Francisco reported

symptoms consistent with an allergic reaction to the drug, including

tingling and itching sensations and mild joint pain. After taking five of the

six prescribed tablets, his symptoms worsened. Eventually, Francisco

suffered numerous ruptured tendons throughout his body, and he suffered

significant pain in his ankles, knees, hips, elbows, and right shoulder. The

symptoms intensified over several months, and he eventually developed

peripheral neuropathy, a form of nerve damage, in his limbs. Two expert

witnesses retained by Francisco determined that his condition was

consistent with Cipro toxicity.

¶5 Francisco and his wife sued the Practice, alleging that he

suffered possibly permanent injuries due to taking Cipro and that if he had

known of the black box warnings, he would have requested a different

antibiotic or refused the urological procedure. The Franciscos additionally

alleged that Dr. Art negligently failed to warn Francisco of any risks

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Opinion of the Court

associated with taking Cipro.

¶6 Along with their complaint, the Franciscos filed a certification

regarding the need for expert testimony, citing A.R.S. §§ 12-2603 and -2604,

the latter statute establishing the qualifications of expert witnesses.

However, the certification did not address whether expert testimony was

needed regarding the standard of care as it related to their claim against Dr.

Art. Instead, it “certifie[d] that expert testimony will be necessary for

Defendants to provide the applicable standard of care and liability as to [the]

Defendants in the . . . matter.” (Emphasis added.) 2

¶7 The Franciscos thereafter sought partial summary judgment

regarding Dr. Art’s alleged breach of the standard of care based on the black

box warnings and Francisco’s medical history. In turn, the Practice filed a

motion to dismiss, arguing that the Franciscos were required to establish

the standard of care for their claims with expert medical testimony. The

Franciscos objected to the Practice’s motion to dismiss because the Practice

had not first sought an order to determine whether expert testimony was

necessary. See § 12-2603(D) (providing that a “health care

professional . . . may apply by motion to the court for an order requiring the

claimant . . . to obtain and serve a preliminary expert opinion affidavit”).

Ultimately, the superior court struck the pending motions and ordered the

Practice to file a motion pursuant to § 12-2603(D).

¶8 In response to the Practice’s § 12-2603(D) motion, the

Franciscos argued that an expert opinion affidavit was not necessary for

two main reasons. First, the jury did not need expert testimony to

understand the FDA warnings. Second, a jury was likewise capable,

without expert testimony, of determining if information in the FDA

warnings would have been material to Francisco in deciding whether to

take Cipro.

¶9 The Franciscos further asserted that, if ordered by the court to

provide an expert affidavit, they would not be able to comply because

guidance provided by the American Urological Association (“AUA”) to its

2 The Franciscos later filed an amended certification stating that expert

testimony was not necessary for them “to prove the applicable standard of

care and liability.”

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Opinion of the Court

physician members authorized the use of Cipro for elderly patients with a

history of corticosteroid use. Therefore, according to the Franciscos, the

guidance made it impossible for them to find a board-certified urologist

willing to testify that prescribing Cipro to Francisco under these

circumstances violated the standard of care. In support of this conclusion,

the Franciscos’ counsel stated that he had contacted two potential experts

who said they would not testify that Dr. Art acted below the standard of

care. The Franciscos consequently argued that §§ 12-2603 and -2604 were

unconstitutional as applied to them under the anti-abrogation clause of

Arizona’s Constitution. See Ariz. Const. art. 18, § 6.

¶10 The superior court granted the Practice’s motion to compel.

The Franciscos filed a motion for reconsideration, which the court denied.

The Practice then moved to dismiss the case pursuant to § 12-2603(F), which

the court granted, dismissing the case with prejudice. 3

¶11 The court of appeals reversed the superior court’s judgment

and remanded for further proceedings. Francisco v. Affiliated Urologists Ltd,

No. 1 CA-CV 21-0701, 2023 WL 3589654, at *3 ¶ 13 (Ariz. App. May 23, 2023)

(mem. decision). The court first rejected the Franciscos’ argument that their

claim was not a medical malpractice claim and that the expert testimony

requirements of § 12-2603 did not apply. Id. at *2 ¶¶ 6–7. Next, the court

considered whether, in light of Cipro’s black box warning and Francisco’s

medical history, expert testimony was required to prove that Dr. Art’s

failure to warn Francisco of Cipro’s risks fell below the standard of care.

Id. ¶ 8. The court reasoned that although expert testimony is usually

required to establish the medical profession’s standard to inform patients

of risks, no legal rule requires expert testimony in every case. Id. Rather, a

duty to warn “depends ‘upon the circumstances of the particular case and

upon the general practice followed by the medical profession.’” Id.

at *3 ¶ 10 (quoting Riedisser v. Nelson, 111 Ariz. 542, 544-45 (1975)).

¶12 Accordingly, the court of appeals concluded that “[c]ustom

alone is not the standard. All relevant circumstances should be considered,

including whether the FDA has specified in a medication’s package insert

3 Section 12-2603(F) provides that such a dismissal shall be without

prejudice. However, nothing in the record indicates this was brought to the

superior court’s attention or subsequently challenged.

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Opinion of the Court

that the prescriber should give a warning.” Id. ¶ 11. The court then further

concluded that evaluating whether the FDA instructed physicians to give a

specific warning, and whether a physician gave the specific warning, does

not require expert testimony. Id. ¶ 12. Thus, § 12-2603 did not mandate

dismissal of the case. Id.

¶13 We granted review because whether an FDA black box

warning can substitute for expert testimony to establish the standard of care

under Arizona law in medical malpractice cases is an issue of statewide

importance and likely to recur. We have jurisdiction pursuant to article 6,

section 5(3) of the Arizona Constitution.

II. DISCUSSION

A. Standard Of Review

¶14 Before turning to the arguments presented, we first address

the applicable standard of review. Although nearly all appellate courts that

have considered a trial court’s dismissal for failure to comply with

§ 12-2603’s preliminary expert affidavit requirements have concluded that

the standard for review is de novo, the reasons have varied. Some courts

have relied on the fact that a motion to dismiss is subject to de novo review.

See, e.g., Romero v. Hasan, 241 Ariz. 385, 386 ¶ 6 (App. 2017). Others have

focused on the application of § 12-2603’s statutory requirements to

conclude that statutory construction calls for a de novo review. See, e.g.,

Gorney v. Meaney, 214 Ariz. 226, 228 ¶ 4 (App. 2007); Sanchez v. Old Pueblo

Anesthesia, P.C., 218 Ariz. 317, 319 ¶ 5 (App. 2008), disapproved on other

grounds by Rasor v. Nw. Hosp., LLC, 243 Ariz. 160 ¶¶ 17–19 (2017). Finally,

one court engaged in a de novo review after concluding that the failure to

comply with § 12-2603 is a pleading failure. See Boswell v. Fintelmann, 242

Ariz. 52, 54 ¶ 5 (App. 2017). Only one case involving a failure to comply

with a preliminary expert affidavit requirement has applied an abuse of

discretion standard. See Warner v. Sw. Desert Images, LLC, 218 Ariz. 121, 128

¶ 14 (App. 2008) (concluding that the same standard that applies to a trial

court’s exercise of discretion in admitting expert testimony should apply to

a decision whether expert testimony is required pursuant to § 12-2602,

which deals generally with claims against licensed professionals).

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Opinion of the Court

¶15 After we heard oral argument in this case, the court of appeals

considered the standard of review issue in Fong v. City of Phoenix, No. 1

CA-CV 23-0520, 2024 WL 2855191 (Ariz. App. June 6, 2024). The case

involved the dismissal of a plaintiff’s claim for failing to present expert

testimony regarding the standard of care, albeit in the context of § 12-2602.

Id. at *2 ¶ 8. In concluding that a de novo standard of review applied, the

court addressed Warner and declined to follow it for two reasons.

¶16 First, the court noted that Warner’s discussion of the abuse of

discretion standard of review concerning expert testimony was

unnecessary. Id. ¶ 11. The basis for the appellate court’s reversal of the trial

court’s judgment in Warner was the trial court’s failure to adhere to

statutory procedural requirements. Id. The case did not involve a

determination of whether expert testimony was required in the first place.

Id. Therefore, the discussion of the standard of review was dictum and

non-binding. Id.

¶17 Second, the court of appeals concluded that “Warner

erroneously conflated the standard of review that applies to a

determination that expert evidence is admissible with the standard that

applies to a determination that a claim is not viable without expert

support.” Id. at *3 ¶ 12. Thus, Warner’s reliance on this Court’s discussion

in State v. Mosley, 119 Ariz. 393, 400 (1978), regarding the discretion a trial

court has in determining whether to allow expert testimony at trial was

misplaced. Id. We agree with the distinction made by the Fong court that

“whether expert testimony is admissible and whether it is required ‘are

meaningfully different questions.’” Id. ¶ 13 (quoting KS Condo, LLC v.

Fairfax Vill. Condo. VII, 302 A.3d 503, 508 n.1 (D.C. 2023)).

¶18 With respect to the former question, the Fong court noted that

“the admissibility of expert testimony is reviewed for abuse of discretion.”

Id. However, with respect to the latter question, the court observed that

“the majority of courts that have addressed the issue have held that whether

expert testimony is required to prove a plaintiff’s claim is a question of law

that is reviewed [de novo].” Id. ¶ 15 (collecting cases). Accordingly, the

court held that “whether a plaintiff’s failure to present expert testimony is

fatal to [a] claim is a question of law that is reviewed [de novo].” Id. at *4

¶ 17. We concur and hold that, because determining whether evidence,

without expert testimony, can establish the standard of care in a medical

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Opinion of the Court

malpractice action is a question of law, dismissal of a case based on the

failure to comply with § 12-2603 is subject to de novo review.

B. Nature Of The Franciscos’ Claim

¶19 We next turn to the Franciscos’ initial argument that the

statutory requirements for expert testimony do not apply to their claim

against Dr. Art. The Franciscos argue that this is an “informed consent”

case involving a “negligent disclosure” claim and not a “medical

negligence” or medical malpractice claim. Therefore, according to the

Franciscos, because the expert testimony requirements of §§ 12-2603 and

-2604 only apply to medical malpractice claims, they do not apply here. The

Practice argues that a lack of informed consent case falls within the

definition of a medical malpractice action, which requires expert testimony

to establish the standard of care. 4

¶20 We begin by considering the text of the relevant statutes.

“Absent ambiguity, we interpret statutes according to their plain

language.” In re Drummond, 543 P.3d 1022, 1025 ¶ 5 (Ariz. 2024).

¶21 Section 12-2603(A) addresses the need for preliminary expert

opinion testimony to prove the standard of care in instances where “a claim

against a health care professional is asserted in a civil action.” Section

12-2603(H) defines a “claim” as “a legal cause of action against a health care

professional under [A.R.S.] §§ 12-561 through 12-563.” Section 12-561(2)

defines a “[m]edical malpractice action” as “an action for injury . . . against

a licensed health care provider based upon such provider’s alleged

negligence . . . in the rendering of health care . . . or other health-related

services.” Section 12-2604(A) establishes the requirements for expert

testimony “[i]n an action alleging medical malpractice.”

4 The Practice also argues that this argument was waived because it is not

the underlying issue, was not the question presented in the petition for

review, and that we granted review on how to prove the standard of care,

not what the standard of care is. To the extent waiver is an issue, we

exercise our discretion to consider the argument because it is inherent to

the analysis for resolving the issues before us. See, e.g., City of Phoenix v.

Fields, 219 Ariz. 568, 574 ¶ 23 (2009) (exercising discretion to consider an

issue arguably waived).

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¶22 The Franciscos allege that Dr. Art failed to provide sufficient

information regarding the risks of Cipro. The claim therefore falls within

the class of “true ‘informed consent’ claims, i.e., those involving the doctor’s

obligation to provide information,” which “must be brought as negligence

actions.” See Duncan v. Scottsdale Med. Imaging, Ltd., 205 Ariz. 306, 310 ¶ 13

(2003). But even if we characterized the claim as a “negligent disclosure”

claim, as the Franciscos assert, it is still based on a health care provider’s

alleged negligence in rendering health care or health-related services,

which falls squarely within the definition of a medical malpractice action.

See § 12-561(2); see also Jeter v. Mayo Clinic Ariz., 211 Ariz. 386, 403–05

¶¶ 76–84 (App. 2005) (explaining medical malpractice requires negligent

acts in “the rendering of medical or health care-related services” and

“depends on a number of factors, including whether the wrong involved

the exercise of professional judgment in the treatment of the patient by

health care providers”). We conclude that the Franciscos’ claim is a medical

malpractice claim and, therefore, the provisions of §§ 12-2603 and -2604

apply.

¶23 Our interpretation of § 12-2603 as requiring expert testimony

in lack of informed consent cases is consistent with this Court’s previous

reading of the statute. See, e.g., Seisinger v. Siebel, 220 Ariz. 85, 94 ¶ 33, 95

¶ 39 (2009) (“Arizona courts have long held that the standard of care

normally must be established by expert medical testimony.”); Duncan, 205

Ariz. at 310 ¶ 13 (“[T]he precise parameters of the required disclosure for

any particular informed consent case [are] to be established by expert

testimony in accordance with the applicable standard of care.” (cleaned up)

(quoting Hales v. Pittman, 118 Ariz. 305, 311 n.4 (1978))); Riedisser, 111 Ariz.

at 544–45 (explaining that “the custom of the medical profession to warn

must be established by expert medical testimony” but it “depends upon the

circumstances of the particular case”) (citation omitted).

C. Exception To Requirement For Expert Testimony

¶24 The Franciscos alternatively argue that “[t]his lawsuit is

simply one of those rare cases” in which expert testimony to establish the

standard of care is not required. Specifically, they assert that Dr. Art’s

failure to warn Francisco of Cipro’s potential adverse effects described in

the black box warning is something “that unskilled persons of ordinary

intelligence are able to understand.” Although the Practice does not

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dispute that there are cases in which expert testimony is not required, it

argues that this is not such a case. Furthermore, the Practice argues that

because the degree of disclosure required under these circumstances

involves the exercise of medical judgment, this case is distinguishable from

those where expert testimony was not required to establish the standard of

care.

¶25 Assuming that the black box warning for Cipro is admissible,

an issue not explicitly before us, the pertinent question is whether the

warning may be used instead of testimony from an expert witness to

establish the standard of care. The only exception to the statutory

requirement for expert testimony lies within the common-law doctrine of

res ipsa loquitur. See Sanchez, 218 Ariz. at 321 ¶ 14 (noting that “neither

[§§ 12-2603 nor -2604] expressly requires expert testimony in those res ipsa

cases where none was previously required”); see also Seisinger, 220 Ariz.

at 94 ¶ 33 n.8 (“Section 12-2604(A) does not purport to abolish the

common-law res ipsa loquitur doctrine. Rather, the statute applies only to

those cases in which expert testimony is otherwise required.”).

¶26 The res ipsa loquitur doctrine applies where “the negligence

is so grossly apparent that a layman would have no difficulty in recognizing

it.” Riedisser, 111 Ariz. at 544. In such circumstances, no expert testimony

is generally required. Id. In other words, courts do not require expert

testimony “where the lack of skill or care is such as to be within the

comprehension and common knowledge of laymen to understand and

judge it.” Faris v. Drs. Hosp., Inc., 18 Ariz. App. 264, 270 (1972); see also

Seisinger, 220 Ariz. at 94 ¶ 33.

¶27 Circumstances constituting grossly apparent negligence

include an instance where “a cloth sack approximately ten inches wide by

sixteen or eighteen inches long” was removed from a patient’s abdomen

after a previous abdominal surgery. Tiller v. Von Pohle, 72 Ariz. 11, 14–15

(1951). Another instance arose from a physician leaving steel sutures in a

patient for months after an operation and ignoring her complaints

regarding the pain. Revels v. Pohle, 101 Ariz. 208, 208–11 (1966) (stating

further that “expert testimony is not required where ‘the negligence is so

grossly apparent that a layman would have no difficulty in recognizing it’”

(quoting Boyce v. Brown, 51 Ariz. 416, 421 (1938))). In yet another case, a

six-inch metal clamp was left in a patient’s abdomen following surgery for

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gallstones. Landgraff v. Wagner, 26 Ariz. App. 49, 52 (1976). The Landgraff

court had no trouble concluding that “[t]he error [was] so self-evident that

a jury [could] determine the question of negligence without reliance upon

the opinion of an expert.” Id. at 57; see also Carranza v. Tucson Med. Ctr., 135

Ariz. 490, 491–92 (App. 1983) (concluding expert testimony was not

required where a child suffered a burn on her leg after heart surgery). The

facts of this case, though, are very different.

¶28 In prescribing Cipro, Dr. Art had to evaluate the concomitant

risks and benefits of prescribing the drug to determine what information to

disclose. This evaluation considered, among other things, Francisco’s

health, which included a history of hypothyroidism, corticosteroid use, and

allergies to other antibiotics. Although the black box warning indicated

significant risks for older patients with a history of corticosteroid use, it

could not account for Francisco’s individual situation, including his

presentation as a vigorous and active older adult.

¶29 In such a circumstance, “only health-care professionals are in

a position to understand the significance of the risks involved and to assess

the relative advantages and disadvantages of a given form of

prescription-based therapy.” Watts v. Medicis Pharm. Corp., 239 Ariz. 19, 24

¶ 12 (2016) (quoting Restatement (Third) of Torts: Prod. Liab. § 6 cmt. b

(Am. L. Inst. 1998)); see also Riedesser, 111 Ariz. at 545 (“There is, of course,

no clear rule as to what information must be disclosed in what

circumstances; medical judgment is primarily involved.”); McGrady v.

Wright, 151 Ariz. 534, 537 (App. 1986) (“The duty of a physician in a

malpractice case is the duty to disclose the risks as measured by the usual

practices of the medical profession.”). Therefore, “we leave the precise

parameters of the required disclosure for any particular case to be

established by expert testimony in accordance with the applicable standard

of medical care.” Hales, 118 Ariz. at 311 n.4; see also Sampson v. Surgery Ctr.

of Peoria, LLC, 251 Ariz. 308, 312 ¶ 19 (2021) (stating that “[i]n a case where

the standard of care or the cause of death is disputed on a matter requiring

medical knowledge to resolve, it is difficult, if not impossible, to imagine a

situation where lay jurors, untrained in medicine or medical procedure,

could properly determine liability absent expert guidance”).

¶30 Consequently, a layperson would not know, as a matter of

“common knowledge,” whether Dr. Art’s alleged failure to warn Francisco

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of certain risks associated with Cipro constitutes a departure from the

relevant standard of care. Therefore, reliance on the res ipsa loquitur

doctrine under these facts is misplaced. When the standard of care consists

of a duty to warn that requires medical judgment, “the custom of the

medical profession to warn must be established by expert medical

testimony.” Riedisser, 111 Ariz. at 545 (citation omitted).

¶31 Likewise, the Franciscos’ reliance on Rodriguez v. Jackson, 118

Ariz. 13 (App. 1977), is misplaced. The Franciscos cite Rodriguez for the

proposition that “FDA warnings are admissible evidence that a jury may

consider when determining the standard of care, but the ultimate decision

remains with the jury.” While it may be true that, in appropriate cases, FDA

warnings may be admissible, the Rodriguez court concluded that a manual

for “The Tuberculosis Control Program in Arizona, March 1969,” was

insufficient to establish the standard of care. Id. at 17–18. The court further

noted that the plaintiff had “presented no testimony by a medical doctor as

to the custom of the medical profession relative to these warnings.” Id.

at 18. In short, although FDA warnings may be admissible in conjunction

with expert testimony, they are not conclusive on their own. See id. (“While

the package insert is admissible into evidence, it does not establish

conclusive evidence of the standard or accepted practice in the use of the

drug by physicians and surgeons, nor that a departure from such directions

is negligence.”); see also Ramon v. Farr, 770 P.2d 131, 135 (Utah 1989) (“[W]e

think the better rule is that manufacturers’ inserts and parallel P.D.R.

entries do not by themselves set the standard of care, even as a prima facie

matter. A manufacturer’s recommendations are, however, some evidence

that the finder of fact may consider along with expert testimony on the

standard of care.”), overruled in part on other grounds by Miller v. Utah Dept.

of Transp., 285 P.3d 1208 (Utah 2012). Thus, aside from issues regarding

admissibility, an FDA warning is not competent evidence, on its own, to

establish the standard of care in an Arizona medical malpractice case. 5

5 The resolution of this issue moots the Franciscos’ argument that we

should determine the disclosure of information from the patient’s point of

view. As § 12-563(1) and our caselaw make clear, the perspective for

assessing what should be disclosed is from the healthcare professional’s

point of view.

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¶32 Other jurisdictions have also concluded that package-insert

warnings are insufficient to establish the standard of care and we find their

reasoning compelling. First, medication manufacturers write the warnings

“for many reasons including compliance with FDA requirements,

advertisement, the provision of useful information to physicians, and an

attempt to limit the manufacturer’s liability.” Morlino v. Med. Ctr. of Ocean

Cnty., 706 A.2d 721, 729 (N.J. 1998); see also Spensieri v. Lasky, 723 N.E.2d 544,

548 (N.Y. 1999); Ramon, 770 P.2d at 135–36 (“The American Medical

Association . . . has repeatedly alleged that inserts are an inadequate

standard for medical practice, pointing to the inconsistent purposes served

by the document[s]—advertising for the manufacturer, regulation by the

government, and information for the doctor—and to the poor quality of

past inserts.” (citation omitted)).

¶33 Second, the FDA has previously stated, in a rulemaking

proposal, that “labeling is not intended either to preclude the physician

from using his best judgment in the interest of the patient, or to impose

liability if he does not follow the package insert.” Legal Status of Approved

Labeling for Prescription Drugs; Prescribing for Uses Unapproved by the Food and

Drug Administration, 37 Fed. Reg. 16503, 16504 (proposed Aug. 15, 1972); see

also Labeling Requirements for Systemic Antibacterial Drug Products Intended for

Human Use, 68 Fed. Reg. 6062, 6071 (same). It has even suggested that

“off-label” practices “may . . . constitute a medically[-]recognized standard

of care.” See United States v. Caronia, 703 F.3d 149, 153 (2nd Cir. 2012)

(second alteration in original) (quoting U.S. Food & Drug Admin., Draft

Guidance, Good Reprint Practices for the Distribution of Medical Journal Articles

and Medical or Scientific Reference Publications on Unapproved New Uses of

Approved Drugs and Approved or Cleared Medical Devices 3 (2009)).

¶34 Third, “the FDA-required labeling . . . may not be easily

understood by the jury without expert assistance because these materials

are written for the medical profession, not the general public.” Richardson

v. Miller, 44 S.W.3d 1, 16 (Tenn. Ct. App. 2000); see also Watts, 239 Ariz. at 24

¶ 13 (discussing premise for the learned intermediary doctrine and noting

that “certain types of goods (such as prescription drugs) are complex and

vary in effect, depending on the end user’s unique circumstances, and

therefore can be obtained only through a qualified intermediary like a

prescribing physician, who can evaluate the patient’s condition and weigh

the risks and benefits”).

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¶35 Furthermore, relying on FDA black box warnings as a

substitute for expert testimony, as the Franciscos urge, may result in drug

manufacturers and the FDA determining the standard of care for Arizona

medical malpractice cases. See Richardson, 44 S.W.3d at 16; Spensieri, 723

N.E.2d at 548. This directly contravenes the requirement in Arizona law

that the standard of care be determined by the custom of “the profession or

class” to which the physician “belongs within the state.” See § 12-563(1)

(emphasis added); see also Riedisser, 111 Ariz. at 544 (recognizing that “in

[medical] malpractice, the duty of disclosure of the risks by the

physician . . . is measured by the usual practices of the medical profession”

(emphasis added)).

¶36 Given all the foregoing, we decline to equate a failure to

disclose a black box warning in a case involving medical judgment with

incidents constituting grossly apparent negligence, thereby expanding the

application of the res ipsa loquitur doctrine to excuse the statutory

requirement for expert testimony pursuant to § 12-2603. We therefore

conclude that expert witness testimony was necessary to establish the

standard of care in this case. The trial court correctly dismissed the

Franciscos’ claim for failure to provide a preliminary expert opinion

affidavit as required. The court of appeals erred in finding otherwise.

D. The Anti-Abrogation Clause

¶37 The Franciscos argue that §§ 12-2603 and -2604 violate the

anti-abrogation clause of Arizona’s Constitution as applied to them. See

Ariz. Const. art. 18, § 6. Specifically, they argue that because board-certified

urologists “refus[e] to comply with the FDA’s warnings” and would be

unwilling to testify against the AUA’s guidance authorizing physicians to

prescribe Cipro to patients like Francisco, requiring the expert testimony of

a board-certified urologist prevents them from prosecuting this case and

unconstitutionally abrogates the right to recover in this negligence action.

¶38 The Practice counters that the preliminary affidavit and

expert qualification requirements in §§ 12-2603 and -2604, respectively, do

not abrogate the Franciscos’ right of action. The Practice maintains that the

statutes were designed to help weed out frivolous cases before significant

resources are wasted on fruitless litigation, and that here they are simply

serving their intended purpose. See Gorney, 214 Ariz. at 229 ¶ 8. The

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Opinion of the Court

Practice concludes by asserting that “[i]t is not the statute that is preventing

Plaintiffs from finding a qualified urologist to testify. It is the invalidity of

their claim.”

¶39 Article 18, section 6 of the Arizona Constitution states: “The

right of action to recover damages for injuries shall never be

abrogated . . . .” The provision prohibits the “abrogation of all common law

actions for negligence,” including medical malpractice. See Baker v. Univ.

Physicians Healthcare, 231 Ariz. 379, 388 ¶ 34 (2013) (internal quotation mark

omitted) (quoting Cronin v. Sheldon, 195 Ariz. 531, 538 ¶ 35 (1999)).

However, the legislature may “regulate the cause of action for negligence

so long as it leaves a claimant reasonable alternatives or choices which will

enable him or her to bring the action.” Id. (quoting Barrio v. San Manuel Div.

Hosp. for Magma Copper Co., 143 Ariz. 101, 106 (1984)).

¶40 Sections 12-2603 and -2604 are part of a statutory framework

intended “to curb frivolous medical malpractice lawsuits by imposing a

stricter standard of pleading and setting deadlines for the early

involvement of the plaintiff’s expert witness.” Gorney, 214 Ariz. at 229 ¶ 8.

Section 12-2603 “defines specific tasks that must be completed by specific

deadlines to prosecute claims against health care professionals, along with

specific procedures whereby plaintiffs may obtain extensions of time and

opportunities to cure deficiencies.” Passmore v. McCarver, 242 Ariz. 288, 292

¶ 9 (App. 2017). The record before us reflects that the Franciscos’ counsel

only contacted two experts to offer the requisite opinion. Furthermore, the

record is unclear as to what aspects of Dr. Art’s alleged negligence the

experts were asked to offer an opinion about (whether prescribing Cipro was

negligence or the failure to warn of Cipro’s risks was negligence), and to what

degree the AUA guidance may have affected their willingness to testify that

Dr. Art acted negligently. Thus, the record does not support a conclusion

that § 12-2603 prevented the Franciscos from securing the requisite

affidavit.

¶41 We rejected a similar constitutional challenge to § 12-2604 in

Baker, 231 Ariz. at 388 ¶¶ 36–37. There, the plaintiff argued that § 12-2604

violated the anti-abrogation clause because it limited the class of qualified

experts to persons who are board certified in the same specialty as the

defendant-physician, and the plaintiff could therefore not have his expert

of choice who was not certified as required. See id. at 387 ¶¶ 31–32. This

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Opinion of the Court

Court held that “[a]lthough the statute might deny a plaintiff his expert of

choice, the record [did] not show that [plaintiff] lack[ed] ‘reasonable

alternatives or choices which [would] enable him or her to bring the

action.’” Id. at 388 ¶ 35 (quoting Barrio, 143 Ariz. at 106). Importantly, the

Court explained that “[a]lthough plaintiffs might face greater difficulties in

finding a qualified expert because of a smaller expert pool, § 12-2604 does

not bar medical malpractice lawsuits or preclude plaintiffs from recovery

in such actions.” Id. ¶ 37. Accordingly, § 12-2604 permissibly regulated the

plaintiff’s right to bring a medical malpractice suit. Id. ¶ 35.

¶42 We acknowledge that, unlike in Baker, the Franciscos claim

they cannot present any expert because no board-certified urologist will

testify due to the guidance issued by the AUA. Nevertheless, given the

previous discussion regarding the need for expert testimony concerning

medical judgment, see Part II(C) ¶¶ 28–30, and our previous analysis and

holding in Baker, we conclude that the provisions of §§ 12-2603 and -2604

constitute permissible regulation of medical negligence causes of action.

Accordingly, we hold that §§ 12-2603 and -2604 do not violate the Arizona

Constitution’s anti-abrogation clause as applied to the Franciscos.

III. CONCLUSION

¶43 For the reasons stated, we vacate the court of appeals’

memorandum decision and affirm the trial court’s judgment.

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FRANCISCO, ET AL. V. AFFILIATED UROLOGISTS, ET AL.

Justice Bolick, Concurring in Part and Dissenting in Part

BOLICK, J., concurring in part and dissenting in part:

¶44 I join the majority opinion except for Part II(C). I dissent from

that portion of the opinion because I believe that the failure to follow the

black box warning under the facts presented here presents a prima facie

case of negligent failure to warn leading to a lack of informed consent, and

therefore agree with the court of appeals that dismissal inappropriately

deprived the Franciscos of their day in court.

¶45 Arizona Revised Statutes § 12-2603(A) requires a plaintiff in a

case against a health care professional to certify “whether or not expert

opinion testimony is necessary to prove the health care professional’s

standard of care or liability.” The statute does not provide a substantive

standard for that determination. If a plaintiff certifies that expert opinion

testimony is necessary, or if the court deems it necessary upon motion by

the defendant, the plaintiff must serve a preliminary expert opinion

affidavit. See § 12-2603(B), (D), (E). Subsection (C) provides a procedural

option short of dismissal—an extension of time for compliance—but

subsection (F) directs the court to dismiss the case without prejudice if the

plaintiff fails to comply. Ultimately, A.R.S. § 12-563(1) establishes as a

necessary element of proof in a negligence claim that “[t]he health care

provider failed to exercise that degree of care, skill and learning expected

of a reasonable, prudent health care provider in the profession or class to

which he belongs within the state acting in the same or similar

circumstances.”

¶46 The statutes do not mandate a particular outcome in this case.

Rather, it is the Court that has spelled out when a preliminary expert

opinion affidavit is necessary to move a case forward. The majority’s

reasoning is not inconsistent with our precedents in this context, but the

courts have repeatedly noted that the point of § 12-2603 is to curb frivolous

lawsuits by imposing stricter standards of pleading and setting deadlines

for the involvement of the plaintiff’s expert witnesses. See, e.g., Rasor v. Nw.

Hosp., LLC, 243 Ariz. 160, 164–65 ¶ 22 (2017); Rasor v. Nw. Hosp. LLC, 244

Ariz. 423, 426–27 ¶ 13 (App. 2018). This case, on its face, is not frivolous.

For the reasons below, I conclude that the rationale underlying our

precedents supports allowing this case to proceed without expert testimony

on the standard of care.

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Justice Bolick, Concurring in Part and Dissenting in Part

¶47 I agree with the majority that our decisions dictate that where

medical judgment is required and the circumstances are beyond an

ordinary layman’s grasp, expert testimony is required. See, e.g., Sampson v.

Surgery Ctr. of Peoria, LLC, 251 Ariz. 308, 311 ¶ 16 (2021) (noting that “in

most instances the applicable standard of care, and the probable

consequences of failing to meet that standard, are beyond ordinary lay

knowledge”). But as the majority points out, supra ¶¶ 25–26, neither our

statutes nor case law eliminated the common law doctrine of res ipsa

loquitor, which provides that no expert testimony is necessary where

negligence is grossly apparent.

¶48 This appears to be a case of first impression. I agree with the

majority that most of the copious, small-print warnings contained in

prescription drug package inserts, which are drafted by drug companies

and not subject to FDA approval, are inadequate to establish a standard of

care. 6 But I am aware of no case determining whether a black box warning,

mandated and approved by the FDA, may state a prima facie case in a

failure to warn case. I believe that in this case, it should.

¶49 As the majority acknowledges, “[a] black box warning is the

gravest warning the FDA can issue and warns of serious adverse

consequences that can result from taking a particular medication.” Supra

¶ 3. As the FDA’s most significant cautionary statement, the black box

warning appears in bold print at the beginning of the package insert under

“Highlights of Prescribing Information,” and then again under “Full

Prescribing Information.” Andrew T. Georgi, The FDA Black Box Warning

System: The Utmost in Drug and Patient Safety? 7 (Sept. 27, 2010) (M.D. thesis,

Yale University School of Medicine) (available at

https://elischolar.library.yale.edu/cgi/viewcontent.cgi?article=1199&con

text=ymtdl). It is issued only for “the most serious warnings necessary to

ensure the safe use of the product.” Id. (Citation omitted). It is based,

among other things, on evidence of an adverse reaction that is serious in

proportion to the potential benefit of using the drug, including life

threatening or potentially disabling adverse reactions. Id. at 9; see also 21

C.F.R. § 201.57(c)(1) (providing that “[c]ertain . . . serious warnings,

6 For those reasons, the opinions rejecting the use of generic drug package

insert warnings as a basis for setting a standard of care, see supra ¶¶ 31–32,

34, although correctly decided, are largely irrelevant to the question here.

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Justice Bolick, Concurring in Part and Dissenting in Part

particularly those that may lead to death or serious injury, may be required

by the FDA to be presented in a box”). Unlike learned treatises, of course,

the black box warnings accompany all of the drugs for which they are

mandated.

¶50 I agree with the majority that by mandating black box

warnings for a particular medication, the FDA does not purport to preempt

determinations regarding negligence or standard of care, which are matters

of state law. See supra ¶¶ 33–35. But in the context of establishing an

applicable standard of care, FDA black box warnings bear indicia of

reliability and clarity such that expert testimony may be unnecessary for a

plaintiff to move forward with his or her negligent failure to warn claim.

See City of Glendale v. Farmers Ins. Exch., 126 Ariz. 118, 120 (1980) (holding

that “in order to avoid a directed verdict, the non-movant must establish a

prima facie case,” that is, “there must be evidence sufficient to justify,

although not necessarily compel, an inference of liability”).

¶51 I pause to note circumstances here that are particularly

relevant. This case involves the negligent failure to warn of Cipro’s

dangers, which is precisely within the scope of the FDA’s expertise and the

exact purpose of the black box warnings. Relatedly, and in light of the fact

that expert medical testimony here would necessarily have to be provided

by a licensed health care professional in the same specialty as the defendant,

see A.R.S. § 12-2604(A)(1), the black box warning pertains primarily to

pharmacology, not urology; that is, it is a warning provided to all

physicians who might prescribe the medication, so that a urologist would

not possess any specialized knowledge pertaining to the medication at

issue. To the extent that specific circumstances pertaining either to the

particular patient or procedure here would negate the need to heed the

black box warning, the defendant would be free, as the court of appeals

pointed out, to present expert testimony to that effect. Francisco v. Affiliated

Urologists Ltd, No. 1 CA-CV 21-0701, 2023 WL 3589654, at *3 ¶ 12 (Ariz.

App. May 23, 2023) (mem. decision).

¶52 At the same time, although black box warnings are addressed

to medical professionals, the one at issue here is clearly written and

intelligible to a layperson in a way that would flash bright danger lights.

As the majority recites, supra ¶ 3, the warning stated “that Cipro may cause

‘disabling and potentially irreversible serious adverse reactions,’ including

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FRANCISCO, ET AL. V. AFFILIATED UROLOGISTS, ET AL.

Justice Bolick, Concurring in Part and Dissenting in Part

tendinitis and tendon rupture, peripheral neuropathy, and central nervous

effects.” It referred to the full prescribing information for a complete

warning, “which indicated that geriatric patients with a history of

corticosteroid use were at an increased risk of experiencing

complications . . . including ruptured tendons.” Supra ¶ 3. The insert

“instructed prescribing physicians to warn such patients of the noted risks

and [to] discontinue using Cipro if any symptoms of tendinitis or tendon

rupture occur.” Supra ¶ 3. The warning thus identified not only the risks

but also the most at-risk patients, and instructed physicians to warn such

patients of the risks and to discontinue using the medication if the

symptoms occurred. Dr. Art failed to give any Cipro-related warning to

Francisco.

¶53 In my view, this objective instruction, directed to all

prescribing physicians by the federal agency that monitors and regulates

prescription drugs, is at least sufficient to require the defendants to explain

why Dr. Art did not provide such a warning, or why it was reasonable to

not do so. And, as the majority observes, supra ¶ 4, Francisco took the

prescribed medication, developed symptoms, and later suffered ruptured

tendons and peripheral neuropathy (nerve damage) that, according to

expert witnesses, were consistent with Cipro toxicity.

¶54 Defendants articulate numerous reasons why it was

appropriate for Dr. Art to fail to heed the black box warning and inform

Francisco of Cipro’s dangers. Those explanations may well be sufficient to

deny liability—but not to prevent Francisco from presenting his case.

Indeed, the preliminary expert opinion affidavit requirement set forth in

§ 12-2603 is a procedural requirement—not a necessary element of a prima

facie case for the standard of care. See Rasor, 243 Ariz. at 164 ¶ 22

(characterizing § 12-2603’s requirement as “a threshold procedural

requirement for a plaintiff” (emphasis added)).

¶55 Although there are no cases precisely on point, the one I find

most instructive is Revels v. Pohle, 101 Ariz. 208 (1966), which the majority

cites, supra ¶ 27. There, a physician performed a hysterectomy, after which

the patient complained about pain around the incision for about nine

months. Revels, 101 Ariz. at 209. The doctor prescribed pills and urged the

patient to gain weight, but did not conduct an x-ray or other examination,

and the pain persisted. Id. Eventually a different physician discovered steel

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Justice Bolick, Concurring in Part and Dissenting in Part

sutures inside the patient, removed them, and the pain dissipated. Id.

Because the plaintiff failed to provide expert testimony regarding the

defendant physician’s failure to more carefully examine the patient, the trial

court directed judgment against the plaintiff. Id. at 209–10.

¶56 This Court reversed, not because of the presence of the

sutures, but rather because the failure to more carefully examine the patient

was sufficient to establish a prima facie case of negligence under the res ipsa

loquitor doctrine. Id. at 210–11. Certainly, diagnosis and treatment of pain

involves skill and judgment on the part of a medical professional and

would therefore ordinarily require expert testimony. Id. at 210. But the

Court concluded that “laymen can say that in all cases where there [are]

continual complaints of pain from a patient over a substantial period of

time, that it is a departure from standard medical practice for the doctor to

fail to examine the patient in any manner.” Id. at 211.

¶57 Both Revels and this case involve situations that ordinarily

require the exercise of medical judgment. But Revels’ facts removed that

case from the ordinary. So too do the facts presented here. A layperson

reading the black box warning could readily conclude that a failure to warn

a patient in the circumstances presented would amount to a departure from

standard medical practice. See, e.g., Natale v. Camden Cnty. Corr. Facility, 318

F.3d 575, 580 (3rd Cir. 2003) (“While laypersons are unlikely to know how

often insulin-dependent diabetics need insulin, common sense—the

judgment imparted by human experience—would tell a layperson that

medical personnel charged with caring for an insulin-dependent diabetic

should determine how often the diabetic needs insulin.”); Brouwer v. Sisters

of Charity Providence Hosps., 763 S.E.2d 200, 204 (S.C. 2014) (holding that

plaintiff did not need to provide expert testimony where patient with

known latex allergy was exposed to latex during surgery); Sanzari v.

Rosenfeld, 167 A.2d 625, 633 (N.J. 1961) (observing that “it is within the

common knowledge of laymen that a reasonable man . . . who knows a

drug is potentially harmful to a certain type of patient should take adequate

precaution before administering the drug or deciding whether to

administer it”). Granted, in Revels the conclusion would be based on a

juror’s experience, whereas here it would be based on reading a warning;

but in both cases it would be grounded in common sense and in neither

case would expert testimony be necessary to discern a baseline professional

standard.

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Justice Bolick, Concurring in Part and Dissenting in Part

¶58 I agree with the majority that the statutes on their face do not

violate the anti-abrogation clause of Arizona’s Constitution, as this Court

has expansively interpreted it. See, e.g., Torres v. JAI Dining Servs. (Phx.),

Inc., 256 Ariz. 212 (2023). But the circumstances here suggest that the more

stringent we are in requiring expert medical testimony to establish a prima

facie case, the more likely that such a constitutional violation will occur. As

the majority observes, supra ¶ 9, the Franciscos assert that the American

Urological Association has provided guidance to its members authorizing

the use of Cipro for elderly patients with a history of corticosteroid use.

Urologists following that guidance are unlikely to provide contrary expert

testimony. The Franciscos reported that they unsuccessfully sought

testimony from two (but only two) urologists. Supra ¶ 9. And because

§ 12-2604 allows testimony only from medical professionals in the same

area of specialty, they could not provide such testimony through a

pharmacologist, even though a pharmacologist might be equally or more

competent than a urologist to articulate a standard of care in a failure to

warn case.

¶59 The Court has held that no anti-abrogation violation occurs so

long as “the record does not show that [plaintiff] lacks ‘reasonable

alternatives or choices which will enable him or her to bring the action.’”

Baker v. Univ. Physicians Healthcare, 231 Ariz. 379, 388 ¶ 35 (2013) (quoting

Barrio v. San Manuel Div. Hosp. for Magma Copper Co., 143 Ariz. 101, 106

(1984)). If we require expert testimony and no experts within the area of

specialization are willing to testify, and if we are unwilling to allow highly

probative alternative methods to establish a prima facie case, that

confluence of statutory and judicial constraints may indeed amount to an

as-applied violation of the anti-abrogation clause, for it may foreclose a

cause of action recognized at common law.

¶60 Moreover, and relatedly, I agree with the court of appeals that

“[c]ustom alone is not the standard.” Francisco, 2023 WL 3589654, at *3 ¶ 11;

see § 12-563(1) (defining the appropriate standard of care as “that degree of

care, skill and learning expected of a reasonable, prudent health care provider

in the profession or class to which he belongs within the state acting in the

same or similar circumstances” (emphasis added)). We recently held in the

criminal context that rendering incorrect advice regarding a plea agreement

constituted ineffective assistance of counsel “even if other attorneys were

giving similarly incorrect advice at the time.” State v. Anderson, 547 P.3d

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Justice Bolick, Concurring in Part and Dissenting in Part

345, 352 ¶ 31 (Ariz. 2024); see also id. ¶ 30 (noting that “[l]egal community

standards ‘may be valuable measures of the prevailing professional norms

of effective representation,’ but they are not ‘inexorable commands’”

(quoting State v. Miller, 251 Ariz. 99, 103 ¶ 14 (2021))). Here, too, viewing

custom as dispositive could bode constitutional ramifications.

¶61 For the foregoing reasons, I conclude that a black box warning

may establish a prima facie showing of standard of care in a failure to warn

case. I would reverse the trial court and allow the matter to proceed. With

great respect to my colleagues, I concur in part and dissent in part,

including from the disposition.

23