To prevail on a negligence claim concerning medical malpractice in Arizona, a plaintiff must prove that the defendant doctor failed to meet the standard of care required of a health care professional in the doctor’s field of practice. Pursuant to A.R.S. § 12-2603, a plaintiff is required to certify whether expert testimony is necessary to establish the standard of care and, if it is, serve a preliminary expert opinion affidavit. In a case that the Arizona Supreme Court decided on August 16, 2024, the Arizona Supreme Court considered whether a black box warning required by the Food and Drug Administration (“FDA”) regarding the use of prescription medication can serve to establish the standard of care and obviate the need for expert testimony. The Arizona Supreme Court held: “Given the facts of this case, we hold that Arizona law does not permit such warnings to substitute for the required testimony and independently establish the standard of care.”
Ciproflaxin (“Cipro”)
The packaging for Cipro contained an insert providing information about the drug and its use, which included an FDA “black box” warning. A black box warning is the gravest warning the FDA can issue and warns of serious adverse consequences that can result from taking a particular medication. The warning advised that Cipro may cause “disabling and potentially irreversible serious adverse reactions,” including tendinitis and tendon rupture, peripheral neuropathy, and central nervous effects. Additionally, the warning included an admonition to “[s]ee full prescribing information for complete boxed warning,” which indicated that geriatric patients with a history of corticosteroid use were at an increased risk of experiencing complications from taking Cipro, including ruptured tendons. The insert separately instructed prescribing physicians to warn such patients of the noted risks and discontinue using Cipro if any symptoms of tendinitis or tendon rupture occur.
Plaintiff David Francisco had a medical history included approximately forty years of taking corticosteroids. Nonetheless, a urologist prescribed him Cipro. Two days after beginning to take Cipro, Francisco reported symptoms consistent with an allergic reaction to the drug, including tingling and itching sensations and mild joint pain. After taking five of the six prescribed tablets, his symptoms worsened. Eventually, Francisco suffered numerous ruptured tendons throughout his body, and he suffered significant pain in his ankles, knees, hips, elbows, and right shoulder. The symptoms intensified over several months, and he eventually developed peripheral neuropathy, a form of nerve damage, in his limbs. Two expert witnesses retained by Francisco determined that his condition was consistent with Cipro toxicity.
Francisco and his wife sued the urology practice, alleging that he suffered possibly permanent injuries due to taking Cipro and that if he had known of the black box warnings, he would have requested a different antibiotic or refused the urological procedure. The Franciscos additionally alleged that the urologist negligently failed to warn Francisco of any risks associated with taking Cipro.
The Arizona Supreme Court stated: “Assuming that the black box warning for Cipro is admissible, an issue not explicitly before us, the pertinent question is whether the warning may be used instead of testimony from an expert witness to establish the standard of care. The only exception to the statutory requirement for expert testimony lies within the common-law doctrine of res ipsa loquitur … In prescribing Cipro, Dr. Art had to evaluate the concomitant risks and benefits of prescribing the drug to determine what information to disclose. This evaluation considered, among other things, Francisco’s health, which included a history of hypothyroidism, corticosteroid use, and allergies to other antibiotics. Although the black box warning indicated significant risks for older patients with a history of corticosteroid use, it could not account for Francisco’s individual situation, including his presentation as a vigorous and active older adult … a layperson would not know, as a matter of “common knowledge,” whether Dr. Art’s alleged failure to warn Francisco of certain risks associated with Cipro constitutes a departure from the relevant standard of care. Therefore, reliance on the res ipsa loquitur doctrine under these facts is misplaced. When the standard of care consists of a duty to warn that requires medical judgment, “the custom of the medical profession to warn must be established by expert medical testimony.””
The Arizona Supreme Court held: “we decline to equate a failure to disclose a black box warning in a case involving medical judgment with incidents constituting grossly apparent negligence, thereby expanding the application of the res ipsa loquitur doctrine to excuse the statutory requirement for expert testimony pursuant to § 12-2603. We therefore conclude that expert witness testimony was necessary to establish the standard of care in this case. The trial court correctly dismissed the Franciscos’ claim for failure to provide a preliminary expert opinion affidavit as required. The court of appeals erred in finding otherwise.”
Source Francisco v. Affiliated Urologists, No. CV-23-0152-PR.
If you or a loved one have been injured as a result of prescription drug malpractice in Arizona or in another U.S. state, you should promptly find an Arizona medical malpractice attorney, or a medical malpractice attorney in your state, who may investigate your prescription drug malpractice claim for you and represent you or your loved one in a prescription drug malpractice case, if appropriate.
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