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Date: 08-19-2024
Case Style:
David Francisco, et al. v. Affiliated Urologists, Ltd., et al.
Case Number: CV2020-010470
Judge: James D. Smith
Court: Superior Court, Maricopa County, Arizona
Plaintiff's Attorney:
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Defendant's Attorney: Elieen Dennis GilBride, Cristina M. Chait
Description:
Phoenix, Arizona personal injury medical malpractice lawyer represented the Plaintiffs.
To prevail on a negligence claim concerning medical malpractice, 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 this case, we consider whether a 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.
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¶2 Following his retirement as an endodontist in 2016, David Francisco moved to Sedona with his wife. In the summer of 2018, he sought treatment from Kevin Art, M.D. ("Dr. Art"), an employee of Affiliated Urologists, Ltd. (collectively, the "Practice"). Aside from the need for treatment, Francisco was a very fit and physically active sixty-six-year-old. His medical history included approximately forty years of taking corticosteroids, an allergy to the antibiotic doxycycline, and hypothyroidism. In August, Dr. Art performed a urological procedure on Francisco and prescribed the antibiotic Ciproflaxin ("Cipro") to prevent post-surgery infection. Dr. Art did not discuss the use of Cipro with Francisco before prescribing it.
¶3 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 here 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.
¶4 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.
¶5 Francisco and his wife sued the 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 Dr. Art negligently failed to warn Francisco of any risks
associated with taking Cipro.
Franci
Outcome: "The superior court granted the Practice's motion to compel. The Franciscos filed a motion for reconsideration, which the court denied. The Practice then moved to dismiss the case pursuant to § 12-2603(F), which the court granted, dismissing the case with prejudice.
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.
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