PHOENIX (Legal Newsline) - Arizona's supreme court has delivered a blow to plaintiff lawyers hoping to use FDA regulations to satisfy the requirement for an expert in medical malpractice cases.
Ruling on a lawsuit that drew briefs both from Arizona's trial lawyers group and the American Medical Association, Justice William Montgomery and the majority decided Aug. 16 med-mal plaintiffs must still find experts to testify as to the applicable standard of care and whether it was breached.
Thousands of Cipro cases have alleged side effects, though plaintiff David Francisco and his lawyers at Kelly & Lyons in Scottsdale couldn't find an expert to testify his urologist had breached a standard of care by prescribing it.
They had hoped to use a warning required by the Food and Drug Administration regarding the antibiotic Ciproflaxin. The FDA has required a "black box" warning included in instructions about the drug.
It is the strongest warning the FDA can require. It said Cipro may cause "disabling and potentially irreversible serious adverse reactions." Still, Francisco was prescribed the drug after a urological procedure, allegedly leading to numerous ruptured tendons throughout his body and pain in several joints.
Francisco and his lawyers had experts conclude this was consistent with Cipro toxicity. However, they also needed testimony that Dr. Kevin Art breached the standard of care by prescribing it without warning Francisco of side effects.
The plaintiffs' certification regarding the need for expert testimony did not address the need for testimony against Dr. Art. It said expert testimony would be necessary for the defendants to provide the applicable standard of care and liability.
At summary judgment, Art's practice said Francisco was required to establish the standard of care with expert testimony. Plaintiff lawyers said it wasn't necessary because the jury didn't need it to understand the FDA black box warning and whether it would have been material to Francisco in deciding to take Cipro.
And, plaintiff lawyers said, they could not obtain an expert affidavit because guidance from the American Urological Association authorizes Cipro for elderly patients with a history of corticosteroid use.
The practice's motion to compel was granted, but a state appeals court reversed. That court found that although expert testimony is usually required in med-mal cases, no legal rule requires it in every case.
The Supreme Court said otherwise. Expert testimony is required unless "the negligence is so grossly apparent that a layman would have no difficulty in recognizing it."
"Other jurisdictions have also concluded that package-insert warnings are insufficient to establish the standard of care and we find their reasoning compelling," Justice Montgomery wrote.
The FDA has said labeling is not intended to preclude physicians from using their best judgment or to impose liability. And a Tennessee court has found FDA-required labeling may not be easily understood by a jury without expert assistance because they are written for medical professionals, not the general public.
"Furthermore, relying on FDA black box warnings as a substitute for expert testimony, as the Franciscos urge, may result in drug manufacturers and the FDA in determining the standard of care for Arizona medical malpractice cases," Montgomery wrote.
"This directly contravenes the requirement in Arizona law that the standard of care be determined by the custom of 'the profession or class' to which the physician 'belongs within the state.'"