This opinion did not go unnoticed; we are just late.

In a medical malpractice case, Arizona law requires expert opinion on standard of care and causation. Francisco was prescribed Cipro after a urologic procedure. His doctor did not discuss the potential adverse consequences before prescribing it. After taking Cipro, Francisco experienced serious adverse complications, including ruptured tendons. He filed suit against his prescribing physician alleging his medical history contraindicated the use of Cipro, and he was not warned of the potential severe adverse effects. Francisco’s attorneys could not find an expert to support this because, they contended, the American Urological Association authorized the use of Cipro for patients with Francisco’s medical history, and no board certified urologist will question this. Because the FDA required a “black box” warning, however, Francisco asserted the statutes requiring expert testimony did not foreclose his failure to warn claim. And if the statutes applied under these circumstances, this violated the anti-abrogation clause of Arizona’s constitution. (You may recall Watts v. Medicis Pharm. Corp., 239 Ariz. 19 (2016), and the learned intermediary doctrine where a manufacturer is not liable after providing warnings to the prescriber. If the prescriber disregards the warnings, this breaks the chain of causation between the manufacturer and the patient.)

Whether expert testimony is required is a question of law and is reviewed de novo. The Arizona Supreme Court holds an FDA black box warning does not substitute for expert testimony on the standard of care including failure to warn or an informed consent claim.  The only exception to these statutory requirements is under the common-law doctrine of res ipsa loquitur. Res ipa loquitur applies when negligence is grossly apparent to a lay person such as instances where surgical cloths, clamps, etc. are left in a patient. Prescribing medications , however, is not a common knowledge situation but includes weighing risks and benefits even if the FDA required a black box warning.  “[A]n FDA warning is not competent evidence, on its own, to establish the standard of care in an Arizona medical malpractice case.” The Court also rejected plaintiff’s contention this is a violation of the anti-abrogation provision because the statute is a permissible regulation.

Justice Bolick dissents, in part, concluding a prima facie case can be established on the black box warning. His dissent is evocative but ill-specified. He diminishes the expert statutes to a procedural requirement curing frivolous lawsuits. He writes: “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.” Thus, would a jury reading a black box warning create the standard of care? And if reading the black box warning is enough, why didn’t the patient read the prescription handout? He suggests this case involves a pharmacology question and not a urology question. “[A] pharmacologist might be equally or more competent than a urologist to articulate a standard of care in a failure to warn case.” Justice Bolick’s advice giving concludes by stating a generally accepted custom defense, i.e, everyone does it, “could bode constitutional ramifications.”   

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