Francisco v. Affiliated Urologists Ltd

553 P.3d 867

David FRANCISCO, et al., Plaintiffs/Appellants,

v.AFFILIATED UROLOGISTS LTD, et al. Defendants/Appellees.

No. CV-23-0152-PR

Supreme Court of Arizona.

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

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.

JUSTICE MONTGOMERY, Opinion of the Court:

[1, 2] ¶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 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, 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 tendop 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 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 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, 534 P.2d 1052, 1054–55 (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 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...