Francisco v. Affiliated Urology Ltd, No. CV-23-0152-PR (August 16, 2024) (J. Montgomery) https://www.azcourts.gov/Portals/0/OpinionFiles/Supreme/2024/CV230152PR.pdf

FAILURE TO WARN PATIENT OF RISKS OUTLINED IN DRUG PACKAGING BEFORE PRESCRIBING MEDICATION INADEQUATE WITHOUT EXPERT TESTIMONY TO ESTABLISH A BREACH OF THE STANDARD OF CARE IN MEDICAL NEGLIGENCE ACTION

Defendant doctor performed a urological procedure upon plaintiff, who while very fit for a 66 year-old had been taking corticosteroids for 40 years. Following the procedure defendant doctor prescribed  the antibiotic Ciproflaxin [Cipro] to prevent infection. Cipro came with  a “black box” warning (“gravest” warning the Federal Drug Administration [FDA] issues ) that the drug may cause “disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathy, and central nervous effects .  .  . patients with a history of corticosteroid use are at an increased risk of experiencing complications from taking Cipro, including ruptured tendons.” The doctor did not talk to plaintiff about any of this before prescribing the drug. Plaintiff took the drug and, sure enough, suffered Cipro toxicity including ruptured tendons throughout his body pain and peripheral neuropathy.

Plaintiff sued the doctor and his practice for negligent failure to warn of the risks and alleged had he been warned he would have asked for a different drug.  With the complaint he filed a certification regarding the need for expert testimony under A.R.S. §§ 12-2603 and -2604 stating the defendant and not the plaintiff would be required to provide expert testimony on the standard of care in order to defeat the claim in the face of the doctor's failure to share the black box warning with his patient. Plaintiff moved for partial summary judgment to establish a breach of the standard based upon the black box warning. The practice moved to dismiss based upon plaintiff's failure to identify an expert to establish a breach of the standard of care. Plaintiff responded arguing the jury could understand the black box warning without an expert and the uncontroverted fact that the doctor did not share the black box warning with plaintiff established the breach. Plaintiff further claimed that if ordered to provide an expert affidavit, this would be impossible because the American Urological Association [AUA]  informed its members they were authorized to use Cipro with elderly patients on corticosteroids. Finally, plaintiff argued the statutes violated the Arizona Constitution anti-abrogation clause. The trial court granted the defendant's motion to dismiss with prejudice. The Arizona Court of Appeals reversed and remanded and the Arizona Supreme Court vacated the court of appeals decision and affirmed the superior court dismissal.

Arizona' s medical malpractice statutes require plaintiffs establish a breach of the standard of care by the defendant doctor with  an expert affidavit authored by an expert in the same  specialty as the defendant doctor to maintain a medical malpractice action. Medical malpractice is defined as “an action for injury . . . against a licensed health care provider based upon such provider's alleged negligence . . . in the rendering of health care . . . or other health-related services.” A.R.S. §§ 12-561 through 12-563.  Plaintiff's argument that this is a negligent “informed consent” or “negligent disclosure” claim and not a medical malpractice claim governed by the statutes fails. The claim, however labeled, still involves “negligence in the rendering of health care and health-related services which falls squarely within the definition of a medical malpractice action.” Expert testimony is required to perfect a lack of informed consent case.

Further, this is not one of the “rare” res ipsa loquitur cases where expert testimony is not required in that “unskilled persons” on a jury “of ordinary intelligence are able to understand” the basis of the claim. The res ipsa loquitur doctrine only applies where “the negligence is so grossly apparent that a layman would have no difficulty in recognizing it.”  The defendant doctor in this case was required to evaluate the risks enumerated by the FDA in the context of this patient's age, health, fitness and physical condition. While the black box warning may be admissible evidence, here the doctor  had to exercise medical judgement in determining what if anything to discuss with the patient about the use of the drug. The FDA has previously stated, in a rulemaking proposal, that “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.” The FDA alone cannot establish the standard of care in Arizona  where medical negligence must be established by the “custom of the profession or class to which the physician belongs within the state.” Additionally the black box warning is written for individuals in the medical profession and not the lay public. They may indeed require expert testimony to understand it.

Finally, Article 18, § 6 of the Arizona Constitution anti-abrogation clause does not render the medical malpractice statutes unconstitutional, even as applied to the facts of this case and this plaintiff. The fact plaintiff claims it was impossible to find an expert due to the AUA position does not except the plaintiff from the statutory requirements nor does it render the statutes unconstitutional.  The statute does not abrogate the medical negligence claim, it simply regulates such claims in a permissible manner.