Arizona Supreme Court Says Black Box Warnings Cannot Replace Expert Testimony

In a win for physicians and other licensed prescribers, the Arizona Supreme Court confirmed the necessity of expert witness testimony, as opposed to FDA black box warnings, to establish the physician’s standard of care in a medical malpractice lawsuit.  

To prevail in an Arizona malpractice case, a Plaintiff must first establish that the Defendant health care professional violated the applicable standard of care. Generally, a Plaintiff must present expert witness testimony to clear this hurdle. In a 2024 case decided by the Arizona Supreme Court,¹ the Plaintiff patient argued that he should not be required to present expert witness testimony to prove that the Defendant urologist violated the standard of care.  

Plaintiff alleged that the urologist failed to obtain informed consent before prescribing Cipro. Specifically, the urologist did not discuss the risks and benefits of the drug or tell the patient about the black box warnings issued by the FDA. Finding in the urologist’s favor, the Supreme Court ruled that Plaintiff could not use FDA black box warnings in place of expert witness testimony for purposes of establishing the standard of care. Read on to understand more about this case and for MICA’s recommendations about limiting liability exposure when prescribing. 

Medical Course of Events Leading to the Lawsuit 

Plaintiff patient was a 66-year-old, physically active, retired endodontist. His pertinent medical history included: 

• • 40 years of corticosteroid use,
    
    
  • hypothyroidism, and
    
    
  • a doxycycline allergy.  

Prior to an upcoming urological procedure, the Defendant urologist prescribed Cipro for the patient to prevent post-surgery infection. He did not discuss the use of Cipro with the patient, nor did he mention the FDA’s black box warning (“warning”) which also appears in the manufacturer’s package insert. 

The FDA warning cautions, in part, that Cipro may cause “disabling and potentially irreversible serious adverse reactions” including: 

• • tendinitis,
    
    
  • tendon rupture,
    
    
  • peripheral neuropathy, and
    
    
  • central nervous effects. 

Furthermore, the warning indicates that geriatric patients with a history of corticosteroid use have an increased risk of complications, including ruptured tendons. The warning directs physicians to warn geriatric patients of the increased risk and to discontinue the medication in response to any symptoms of tendinitis or tendon rupture. 

Two days after the patient started the medication, he reported tingling, itching, and mild joint pain. After taking 5 of the 6 prescribed tablets, the symptoms worsened.  

The patient sued the urologist alleging negligence in failing to disclose the medication’s risks resulting in lack of informed consent. He alleged that if the urologist had told him of the FDA warning, he would have demanded a different antibiotic or refused to undergo the procedure. 

How the Plaintiff’s Case Got to Arizona’s Highest Court 

The trial judge dismissed the case early on because Plaintiff did not have a standard of care expert as required by Arizona law. Arguing against the dismissal, Plaintiff’s attorneys said they should be exempt from the expert witness requirement because a jury of laypeople: 

• • could easily read and understand the FDA warning; and
    
    
  • would not need an expert witness’ specialized knowledge to understand plaintiff’s theory of the case – i.e., that the standard of care required the urologist to adhere to the plain language of the FDA warning and tell the patient that Cipro poses increased risks to geriatric patients who take corticosteroids. 

Plaintiff’s attorneys told the court it would be impossible to find an expert witness to support Plaintiff because guidance issued by the American Urological Association permits the use of Cipro in elderly patients taking corticosteroids. Furthermore, Plaintiff’s attorneys said they consulted two experts who both declined to testify that the urologist fell below the standard of care. 

Plaintiff appealed the trial court’s dismissal to the Arizona Court of Appeals. The Court of Appeals ruled in Plaintiff’s favor, saying that considering the facts of the case, he should be allowed to proceed to trial without a standard of care expert. The defendant urologist appealed this decision to the Arizona Supreme Court. The Supreme Court agreed with the trial court, ruling in favor of the urologist and upholding the dismissal. No further appeals are possible. 

The Requirement for Expert Standard of Care Testimony 

In reaching its decision to uphold the dismissal, the Arizona Supreme Court began by noting that medical malpractice Plaintiffs in Arizona are required by statute to use a qualified expert witness to prove the applicable standard care. The Court confirmed that this requirement applies equally to lack of informed consent cases, where a Plaintiff alleges a prescriber was negligent in disclosing information about the risks of the medication. 

In a case like this one, of the expert’s functions is to educate the jury about what information the prescriber must provide to the patient to meet the standard of care in a particular situation. Citing prior Arizona court decisions, the Court said, “’we leave the precise parameters of the required disclosure for any particular case to be established by expert testimony in accordance with the applicable standard of medical care.’”² 

The Exception to the Expert Witness Requirement 

In rare cases, the law says expert testimony is not required to prove the standard of care because the negligence is “so grossly apparent that a layman would have no difficulty recognizing it.”³ The Court ruled, however, that this was not one of those cases. 

Examples of Arizona malpractice cases where courts have said no expert testimony is necessary include: 

• • In a patient with a history of abdominal surgery, a 10x16 cloth sack was surgically removed from the patient’s abdomen.
    
    
  • A six-inch metal clamp was left in the patient’s abdomen during gallstone surgery.
    
    
  • A child undergoing heart surgery sustained a leg burn.
    
    
  • A post-hysterectomy patient complained of incisional pain for 9 months. The physician prescribed pills and urged the patient to gain weight but never ordered an x-ray or performed an exam. A different physician later discovered and removed steel sutures inside the patient. 

Why the Court Ruled that Plaintiff in this Case Needed an Expert to Survive Dismissal 

Arizona courts have long recognized that physicians have a duty to disclose information to patients about risks and benefits of a recommended treatment. If the disclosure is insufficient to meet the applicable standard of care, the physician or other health care professional may be liable for medical negligence based on lack of informed consent. 

The disclosures required by the standard of care are “measured by the usual practices of the medical profession.”⁴ To establish these “usual practices,” qualified expert witness testimony is required. 

In refusing to allow Plaintiff in this case to substitute an FDA warning in place of such testimony, the Arizona Supreme Court recognized prescribers must conduct an individualized risk/benefit analysis each time they prescribe a certain drug for a particular patient. This analysis requires medical knowledge and involves the exercise of medical judgement. The court said, “’only health care providers are in 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.’”⁵ Therefore, the Court determined laypeople on a jury would need expert guidance to determine what the standard of care required and whether the prescriber’s disclosure complied. 

In further support of its decision that, under the facts of this case, FDA warnings cannot substitute for expert testimony to establish the standard of care, the Court noted: 

• • The FDA has said, “labeling is not intended either to preclude the physician from using his best judgment in the interest of the patient, or to impose liability if he does not follow the package insert.”⁶
    
    
  • Warnings in package inserts are written for medical professionals with specialized knowledge and may not be easily understood by layperson jurors.
    
    
  • Drug makers do not write package inserts to set the standard of care. Rather, they are written to limit manufacturer liability, provide information for prescribers, and for regulatory compliance.
    
    
  • Allowing drug makers or the FDA to set the standard of care for Arizona malpractice cases would contradict Arizona’s statutory requirements. 

One Judge Disagrees 

One justice on the Supreme Court panel disagreed with his colleagues. He wrote a separate dissenting decision explaining why he believed Plaintiff should have been allowed to move forward with his case without an expert standard of care witness. While it has no effect on the final disposition of the case, it is important to consider. In a nutshell, Justice Bolick reasoned:   

• • Black box warnings “may” establish the standard of care such that a plaintiff can survive summary dismissal and advance to trial.
    
    
  • The FDA’s Cipro warning was clearly written and understandable for laypeople.
    
    
  • A juror could “readily conclude that a failure to warn a patient in the circumstances presented would amount to a departure from standard medical practice.” 

MICA Risk Team Risk Mitigation Recommendations for Prescribers 

The Supreme Court’s decision was a win for prescribers, but the road to get there was a long one spanning 4 years. Implementing risk management strategies in your practice setting may reduce the risk of litigation, saving time, money, and emotional strain. For example, prescribers and practices could reduce the risk of similar lawsuits by implementing a policy and procedure to standardize medication informed consent discussions and documentation.  

Prescribing involves a multitude of risks. In a study of 30,000 closed malpractice cases involving medication errors, prescribing was the second most common cause of lawsuits. In the outpatient setting, the top specialties named in these lawsuits were: 

• • Primary care 63%
    
    
  • Cardiology 39%
    
    
  • Orthopedics 38%
    
    
  • Ob/gyn 35% 

Prescribers and practices seeking to reduce liability exposure associated with prescribing and other medication errors should review MICA’s Medication Errors and Medical Malpractice Guide.  

MICA’s Risk Team consultants are also available to consult with MICA members on medication-related risk management strategies. Reach us at rm_info@mica-insurance.com or call 800-705-0538 Monday through Friday, 8 a.m. to 5 p.m.

^{[1] Francisco v. Affiliated Urologists Ltd, 553 P.3d 867, 2024 Ariz. LEXIS 204}

^{[2] Hales v. Pittman, 118 Ariz. 305, 311 n.4, 576 P.2d 493, 499 n.4}

^{[3] Riedisser v. Nelson, 111 Ariz. 542, 544, 534 P.2d 1052, 1054 (1975).}

^{[4] McGrady v. Wright, 151 Ariz. 534, 537, 729 P.2d 338, 341 (App. 1986)}

^{[5] Watts v. Medicis Pharm. Corp., 239 Ariz. 19, 24, 365 P.3d 944, 949 (2016) (citations omitted).}

^{[6] Legal Status of Approved Labeling for Prescription Drugs; Prescribing for Uses Unapproved by the Food and Drug Administration, 37 Fed. Reg. 16503, 16504 (proposed Aug. 15,1972).}