Plaintiff Alleging Medical Malpractice Needs Expert Testimony to Claim Physician Negligently Failed to Inform Him of FDA Black Box Warning

Francisco v. Affiliated Urologists Ltd.
Arizona Supreme Court
August 16, 2024
JSH Attorney: Eileen GilBride

The Arizona Supreme Court today held that a plaintiff needs expert testimony to support his claim that a physician was negligent in failing to inform him about an FDA black box warning located on the package insert of an antibiotic the physician prescribed for the plaintiff.

Plaintiff underwent a urological procedure and was prescribed Ciproflaxin (Cipro) to prevent post-surgery infection.  The physician did not discuss the use of Cipro with the plaintiff or advise him of a “black box warning” on the Cipro package insert.  A black box warning warns of serious adverse consequences that can result from taking a medication.  A few days after taking the Cipro, the plaintiff began suffering symptoms like those outlined in the black box warning which were consistent with Cipro toxicity.  Plaintiff sued the physician alleging lack of informed consent.

The physician moved to dismiss the suit because Plaintiff did not provide a preliminary expert affidavit supporting his claim as A.R.S. § 12-2603 requires.  In response, Plaintiff conceded that he was unable to provide an affidavit; the experts he consulted would not support his claim because the American Urological Association recommends the use of Cipro after this procedure.  Plaintiff argued, however, that he did not need expert testimony because the jury could read and understand the FDA warnings for themselves.  Plaintiff also argued that he did not need expert testimony because the court should view a lack of informed consent claim from the patient’s perspective (what a reasonable patient would want to be told) rather than the physician’s perspective (what a reasonable physician would tell the patient).  The trial court, finding expert testimony necessary, granted the physician’s motion to dismiss.

Plaintiff appealed, and the court of appeals reversed.  It held that evaluating “whether the FDA instructed the doctor to give certain warnings to patients” does not require expert testimony, and that a layperson is “well able to determine whether, in the context of all evidence from both sides, the failure to warn constituted negligence.”

The Supreme Court granted the physician’s petition for review and vacated the court of appeals’ decision.  By statute, a plaintiff claiming medical malpractice must prove that the physician fell below the standard of care, and Arizona courts have long held that the standard of care must be established by expert medical testimony.  The only exception is for cases in which the negligence is “so grossly apparent that a layman would have no difficulty in recognizing it.”  In such cases, lack of care or skill is within a layman’s comprehension and common knowledge.

This, said the Court, was not such a case.  In prescribing Cipro and determining what information to disclose, the physician had to evaluate the risks and benefits, taking into account the patient’s medical history and presentation; and only health care professionals are in a position to understand the significance of those risks and benefits.  Therefore, the precise parameters of the required disclosure must be established by expert testimony in accordance with the applicable standard of care.

Furthermore, drug manufacturers do not write black box warnings for laypersons, or to set the physicians’ standard of care.  Instead, drug package inserts are written for physicians, to comply with FDA requirements, and to limit the manufacturers’ liability.  Nor should drug manufacturers or the FDA determine the standard of care for Arizona medical cases.  The FDA itself previously stated that its labeling is not intended to preclude the physician from using his or her best judgment, or to impose liability if the package insert is not followed.

Based on longstanding Arizona law, the Court summarily rejected Plaintiff’s argument that the issue should be assessed from a reasonable patient’s perspective rather than a reasonable physician’s perspective.  It also rejected Plaintiff’s argument that the preliminary affidavit statute unconstitutionally abrogated his right of action, because the record did not support a conclusion that the statute prevented him from obtaining an affidavit.  Concluding, the Court held that the trial court had correctly dismissed Plaintiff’s case for failure to provide the preliminary expert affidavit.

Justice Bolick dissented.  While recognizing that black box warnings are addressed to medical professionals, he opined that they “may” establish a prima facie showing of standard of care in a failure to warn case; and the black box warning in this particular case was clearly written and intelligible to a layperson.  Thus, he concluded, a layperson could “readily conclude that a failure to warn a patient in the circumstances presented would amount to a departure from standard medical practice.”