DAVID FRANCISCO, ET AL., Plаintiffs/Appellants, v. AFFILIATED UROLOGISTS LTD, ET AL. Defendants/Appellees.
No. CV-23-0152-PR
SUPREME COURT OF THE STATE OF ARIZONA
August 16, 2024
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
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.
¶1 To prevail on a negligence claim concerning medical malpractice, a plaintiff must prove that the defendant dоctor failed to meet the standard of care required of a health care professional in the doctor‘s field of practice. Pursuant to
I. FACTUAL AND PROCEDURAL BACKGROUND1
¶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 treatment, Frаncisco 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
¶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 associated with taking Cipro.
¶6 Along with their complaint, the Franciscos filed a certification regarding the need for expert testimony, citing
¶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
¶8 In response to the Practice‘s
¶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 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
¶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
¶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 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 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,
¶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
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
¶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
¶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 detеrmination 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 cаses). 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 malpractice action is a question of law, dismissal of a case based on the failure to comply with
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
¶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
¶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
¶23 Our interpretation of
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 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 testimоny 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 [
¶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
¶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 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 Riedisser, 111 Ariz. at 545 (There is, of course, no clear rule as to what information must be disclosed in what circumstances; medicаl 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 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
¶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.
¶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
¶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
¶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
D. The Anti-Abrogation Clause
¶37 The Franciscos argue that
¶38 The Practice counters that the preliminary affidavit and expert qualification requirements in
¶39
¶40 Sections
¶41 We rejected a similar constitutional challenge to
¶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
III. CONCLUSION
¶43 For the reasons stated, we vacate the court of appeals’ memorandum decision and affirm the trial court‘s judgment.
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
¶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
¶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, 251 Ariz. at 311 ¶ 16 (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 Sсhool of Medicine) (available at https://elischolar.library.yale.edu/cgi/viewcontent.cgi?article=1199&context=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
¶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
¶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 reactiоns,’ including 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 рrovide 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
¶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 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 undеr the res ipsa loquitor doctrine. Id. at 210–11.
¶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.
¶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
¶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, 231 Ariz. at 388 ¶ 35 (quoting Barrio, 143 Ariz. at 106). 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
¶61 For the foregoing reasons, I conclude thаt 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.