Arizona Supreme Court delivers hammer blow to plaintiffs in medical verdict

Phoenix, Arizona: The Arizona Supreme Court has ruled that plaintiffs in medical malpractice cases cannot rely solely on FDA regulations, such as the "black box" warnings, to establish the standard of care. On August 16, the court delivered a decision that upholds the necessity for expert testimony to prove medical negligence, a setback for plaintiffs' lawyers who had hoped to bypass this requirement.

The case involved David Francisco, who alleged that his urologist, Dr Kevin Art, breached the standard of care by prescribing the antibiotic Ciproflaxin without adequately warning him of its risks. Cipro, known for its serious side effects, carries the FDA's strongest warning—a "black box" label. Despite this, Francisco and his attorneys struggled to find an expert to testify that Dr Art’s actions constituted a breach of the standard of care.

Francisco’s legal team, represented by Kelly & Lyons in Scottsdale, argued that the FDA’s warning should suffice as evidence of negligence, thus eliminating the need for expert testimony. However, the court disagreed, with Justice William Montgomery writing for the majority that FDA labeling alone does not establish the standard of care.

The ruling emphasized that expert testimony is required unless the negligence is so evident that a layperson could easily recognize it. The decision is consistent with similar rulings in other jurisdictions, where courts have found that FDA warnings are not meant to dictate medical practice but to guide it.

The Arizona Supreme Court further noted that relying on FDA labels could improperly shift the determination of medical standards from the medical community to regulatory agencies.