There Is No Substitute: Arizona Law Does Not Permit FDA Warnings To Stand In For Expert Opinion

We reported last year on a case in which the Arizona Court of Appeals allowed FDA-approved drug warnings to define the standard of care for a physician’s informed consent.  Why does that matter?  Well, in most every jurisdiction, a plaintiff bringing an action for medical negligence has to produce expert opinion that the defendant breached a standard of care.  The Arizona Court of Appeals drove a hole through that requirement and held that the plaintiff could reach a jury with evidence that his physician failed to pass on an FDA-approved black box warning—without the support of any expert testimony that the physician was negligent. 

As we noted, this case was an outlier, and there is much wrong with the rule it erected.  Drug labeling has never been intended to set a nationwide standard of care for medical treatment, and such a rule ignores local standards and individual patient needs. 

The Arizona Supreme Court evidently saw those problems and has now reversed the opinion.  In Francisco v. Affiliated Urologists Ltd., No. CV-23-0152-PR, 2023 WL 11903729 (Ariz. Aug. 16, 2024), the Arizona Supreme Court held that, under the circumstances of the case, Arizona law does not permit an FDA-required warning “to substitute for the required [expert] testimony and independently establish the standard of care.”  Id. at *1.  Since those “circumstances” featured a black box warning, the FDA’s strongest, we doubt there is any FDA-based way around the Arizona expert requirement in malpractice cases.

The plaintiff in Francisco was a retiree who sued his doctor after the doctor prescribed Cipro to prevent post-surgery infection.  Like all prescription drugs, the labeling for Cipro set forth information about the drug, including a black box warning advising of “disabling and potentially irreversible serious adverse reactions.”  These risks included tendon rupture, peripheral neuropathy, and other thoroughly unpleasant-sounding conditions.  It is, however, within a physician’s learned discretion whether and how to discuss prescription drugs with his or her patients, and this physician chose not to discuss these risks or anything else about Cipro with this patient.  Id.

Days after starting on Cipro, the plaintiff experienced tingling and itching, and he eventually suffered “numerous ruptured tendons through his body” and other pain.  All we can say is, Ouch.  Having ourselves passed well beyond middle aged, we feel for this fellow.  The problem for his case though was that he could not find an expert who could opine that his physician breached the standard of care in obtaining informed consent.  An Arizona statute requires expert opinion, but the Court of Appeals gave the plaintiff a pass and allowed the FDA-required black box warning act as a substitute. 

The Arizona Supreme Court closed that door.  To begin with, the Arizona statute at issue (which is similar to other states’ laws) clearly required it.  The plaintiff’s claim for lack of informed consent, even if recast as a claim for “negligent disclosure,” was a claim for alleged negligence in the rendering of health care, i.e., a med mal claim.  The statute requiring expert opinion applied.  Id. at *4-*5. 

Moreover, the circumstances of the case did not warrant creating an exception.  Sure, there are cases where a lay jury does not need expert opinions to understand the issues, but this was not one of them:

[T]he 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 [. . . , which] applies where “the negligence is so grossly apparent that a layman would have no difficulty recognizing it.”

Id. at *5-*6 (quoting Riedisser v. Nelson, 534 P.2d 1052, 1054 (Ariz. 1975)).  Examples include leaving a large “cloth sack” in a surgical patient or a sewing up a patient with a six-inch metal clamp still inside.  Id. at *6.  You get the idea. 

Warnings, however, are different.  Even with a black box warning that addressed the exact complication that allegedly befell this patient, it was the physician’s role to evaluate the risks and benefits and obtain this patient’s informed consent.  Whether that process met the standard of care can be established only through an expert: 

In prescribing Cipro, [the physician] had to evaluate the concomitant risks and benefits of prescribing the drug to determine what information to disclose.  This evaluation considered, among other things, [the plaintiff’s] health . . . .  Although the black box warning indicated significant risks for older patients with a history of corticosteroid use, it could not account for [the plaintiff’s] individual situation, including his presentation as a vigorous and active older adult. 

In such a circumstance, “only health-care professionals are in a position to understand the significance of the risks involved and to assess the relative advantages and disadvantages of a given form of prescription-based therapy.” 

Id. at *6 (emphasis added, quoting Watts v. Medicis Pharm. Corp., 365 P.3d 944, 949 (Ariz. 2016)).  As a result, a lay juror would not know, as a matter of common knowledge, whether the physician’s alleged failure to warn departed from the relevant standard of care.  Id. at *7.  Expert testimony is required. 

This is the rule in other jurisdictions, and for good reason.  Drug manufacturers prepare drug warnings for many reasons, including regulatory compliance, managing potential liability, and providing useful information to physicians.  Drug labeling is not intended to preempt a physician’s judgment, nor is it intended to impose liability if a physician does not follow the label.  Id. at *7-*8.  As we have said more times than we can count, physicians have every right to prescribe drugs off label, and off-label use has itself has become the standard of care in some situations. 

In addition, drug manufactures prepare drug labeling for medical professionals, not the general public.  Drug labeling therefore is not designed to be easily understood by lay jurors, at least not without expert assistance.  Still further, relying on FDA-required warnings “as a substitute for expert testimony . . . may result in drug manufacturers and the FDA determining the standard of care for Arizona medical malpractice claims.”  Id. at *8.  That is contrary to the law in Arizona. 

Finally, the plaintiff argued that requiring him to establish the standard of care through expert testimony violated the anti-abrogation clause of Arizona’s Constitution, which commands that the “right to recover damages for injuries shall never be abrogated.”  Many state constitutions have similar clauses, and plaintiffs often trot out these clauses when challenging tort reform statutes.  Here, it was a losing argument.  Requiring expert testimony did not abrogate the plaintiff’s claim.  He had every right and ability to bring his claim, but he had no constitutional right to prevail.  Id. at *9-*10.  He similarly had no right to bootstrap his claim onto FDA-required warnings.