Arizona Supreme Court Decides Cipro’s Black Box Warning Cannot Replace an Expert Opinion

By Brett W. Johnson, Tracy A. Olson, Claudia E. Stedman, and Savannah Wix

In Arizona, civil claims against health care professionals must be accompanied by a certified statement regarding whether “expert opinion testimony is necessary to prove the health care professional’s standard of care or liability for the claim.”¹ While there are a few instances where expert testimony is not necessary, in the vast majority of cases, a plaintiff must secure a qualified health care professional to testify regarding the standard of care, and submit a preliminary expert opinion affidavit at the time the civil complaint is filed (the “expert testimony rule”).²

In Francisco, et al. v. Affiliated Urologists Ltd., et al.³ the Arizona Supreme Court reinforced the expert testimony rule by holding that under the facts of this case, “black box” warnings on the prescription medication cannot independently establish standard of care or replace expert testimony. The Court also held that the Arizona laws requiring a preliminary expert opinion affidavit from a qualified medical expert do not violate the anti-abrogation clause of the Arizona Constitution.

Background. The Defendant-physician prescribed Plaintiff-patient Ciproflaxin (Cipro) following a urological procedure to prevent post-surgical infection. The packaging for Cipro contains a “black box” warning — the most serious type of warning used by the FDA that indicates potential serious adverse outcomes that can result from taking a particular medication. The physician did not discuss the potential side effects or adverse outcomes with the patient before prescribing Cipro. Two days after taking it, the patient developed an allergic reaction. The patient’s symptoms worsened, and he ultimately developed peripheral neuropathy (a form of nerve damage) in his limbs, consistent with Cipro toxicity.

The patient and his wife sued the physician’s practice alleging failure to warn among other negligence claims. The Plaintiffs argued that expert testimony was not required because (1) this case was an informed consent case — not a medical malpractice case; (2) even if it was a medical malpractice case, a jury did not need expert testimony to understand that failure to follow the black box warning was a breach of the standard of care; and (3) requiring expert testimony under these circumstances would preclude any opportunity of recovery in violation of the Arizona Constitution. Plaintiffs argued instead that expert testimony was necessary for the Defendants to establish the applicable standard of care.

The Court disagreed on all three arguments.

The Court’s Reasoning. First, the Court held that even if the case could be characterized as a negligent disclosure or informed consent case — it still fell under the natural scope of Arizona’s medical malpractice statute. Specifically, Arizona defines a medical malpractice claim as any case alleging that a licensed health care provider committed negligence in the course of health-related services.⁴

Second, the Court held that under the facts of this case, a black box warning cannot establish standard of care in place of medical expert testimony. The court reasoned that, unlike the rare instance where it is “so grossly apparent” that the health care provider’s actions were negligent (e.g., leaving an instrument inside the abdomen of a patient), the decision to provide a patient with a black box warning requires a particularized evaluation of risks and benefits.⁵ Because “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,” expert testimony was required.⁶ Not only is this conclusion consistent with other state’s treatment of black box warnings, but it also accounts for the fact that FDA warnings may require medical expertise to understand. Further, a conclusion otherwise would allow the FDA to supplant a health care provider’s determination of the standard of care in Arizona in direct contradiction of the Legislature’s direction.

Third, the Plaintiffs argued that because the American Urology Association issued “guidance authorizing physicians to prescribe Cipro to patients like [this one]” it would be impossible to find a board-certified urologist who would be willing to testify inconsistently with this guidance.⁷ As a result, Plaintiffs argued that the expert testimony rule — as applied to this case — abrogates their right to recovery. The Court disagreed, explaining that the Plaintiffs only contacted two urologists, which was insufficient to prove that all board-certified urologists were unwilling to testify.

The Partial Dissent. Justice Bolick joined in the Court’s opinion as to the first and third arguments, but dissented from the Court’s reasoning regarding the necessity of expert testimony in this case. The dissent reasoned that “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.”⁸ Here, the warning was provided to anyone who prescribed the medicine — not just urologists, so no specialized urology knowledge would be relevant to assess the case. Moreover, the black box warning was “written and intelligible to a layperson in a way that would flash bright danger lights.”⁹ As such, and under the circumstances of this case, the dissent concluded that 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.”¹⁰

Though Justice Bolick would not have required expert testimony, he agreed with Plaintiffs that the Defendant would be free to present expert testimony to rebut the standard set by the FDA warning.¹¹

Final Thoughts. The Court’s decision ultimately confirms the Legislature’s requirement that, unless the negligence is exceedingly obvious, plaintiffs bringing negligence cases against medical professionals must support their claims with expert testimony.

And although the Court concludes that “an FDA warning is not competent evidence, on its own, to establish the standard of care in an Arizona medical malpractice case,”¹² other portions of the opinion seem to leave open the possibility that a black box warning under other facts and circumstances could replace the standard of care.¹³ Thus, it is unclear whether the Court intended to create a blanket rule or will evaluate similar issues on a case-by-case basis. If the latter is true, it is possible that the dissent’s reasoning could be applied in future cases, especially where expert testimony is not required.

Notably, the dissent seemingly questions whether the expert testimony requirement should be considered a part of a plaintiff’s prima facie negligence case. In doing so, the dissent suggests shifting the burden to support the standard of care with expert testimony to the defendant. Accordingly, defendants in medical malpractice cases should consider presenting enough expert testimony to refute allegations that some custom or standard should replace a health care professional’s opinion regarding standard of care.

Moreover, even though the Court sided with the medical professional in this case, the underlying facts highlight the importance of obtaining a patient’s informed consent, and thoroughly explaining and documenting the potential risks associated with treatment. Health care entities and professionals should consider implementing policies and procedures to ensure all applicable warnings and risks are disclosed, discussed, and documented.