In Francisco v. Affiliated Urologists Ltd., the Arizona Supreme Court affirmed the dismissal of a medical malpractice case after the plaintiffs failed to provide an expert affidavit establishing the applicable standard of care. The court held that even when a prescription medication includes a black box warning from the FDA, expert testimony is still required to define the standard of care in claims involving medical judgment.
David Francisco was prescribed ciprofloxacin (Cipro) following a urological procedure. The drug included an FDA black box warning regarding risks of tendon rupture, particularly in older patients with a history of corticosteroid use. Francisco, who had such a history, later developed multiple ruptured tendons and nerve damage. He and his wife sued the prescribing physician and medical practice, alleging failure to warn of Cipro’s known risks.
The plaintiffs argued that no expert testimony was needed because the black box warning clearly outlined the relevant risks and instructed physicians to inform patients. They maintained that this was within a jury’s ability to assess without medical expertise.
The trial court dismissed the case for failure to comply with Arizona Revised Statute § 12-2603, which requires a preliminary expert opinion affidavit in malpractice actions. The plaintiffs challenged the ruling on several grounds, including constitutional claims and arguments that their case did not require expert opinion.
The Arizona Court of Appeals initially agreed with the plaintiffs, finding that the need for expert testimony could be evaluated based on the FDA warning. However, the Arizona Supreme Court reversed.
The Supreme Court ruled that while black box warnings may be admissible as evidence, they cannot substitute for expert medical testimony when determining whether a physician met the standard of care. The justices emphasized that prescribing medication and deciding what risks to disclose involve individualized medical judgment that depends on the patient’s condition and medical history.
The court concluded that only trained professionals are equipped to interpret whether the information in a warning warrants disclosure under the standard of care. In this case, Francisco’s medical history—including allergies and long-term steroid use—required expert interpretation. As a result, the court found that a lay jury could not assess negligence based solely on the FDA warning.
The court also rejected the plaintiffs’ reliance on the res ipsa loquitur doctrine, which permits an inference of negligence in obvious cases. The court found that determining what a physician should have disclosed in this scenario was not within the realm of common understanding.
Finally, the court rejected the plaintiffs' argument that the expert affidavit requirement violated Arizona's anti-abrogation clause. The justices concluded that the procedural rules did not eliminate the right to sue but regulated how a plaintiff must proceed.
Claims involving prescription drug risks and disclosure duties often require expert analysis of medical standards. The attorneys at Whitcomb, Selinsky, PC assist clients with navigating Arizona’s statutory procedures in malpractice litigation, including expert affidavit requirements and evidentiary standards.