Law school taught us that design defect, manufacturing defect, and failure to warn are the big troika of product liability theories.  Real life practice taught us that failure to warn is far and away the most common and dangerous claim we face.  It is easy for plaintiffs to allege and easy for juries to follow – up to a point.  Sometimes expert testimony bolsters the warnings story for one or both sides, but not always.  Of course, on the defense side, we’re usually as happy as clams if we can show that the Food and Drug Administration (FDA) has already decided which warnings are necessary, so let’s call it a day.  

And therein, in a strange way, lies our interest in Francisco v. Affiliated Urologists Ltd., 2023 WL 3589654 (Ariz. App. May 23, 2023).  Francisco is an unpublished, nonprecedential opinion about a medical malpractice, not product liability, case.  So why read this post?  Maybe you should simply get on with your doom-scrolling.

First, Francisco is a flat-out fascinating case.  We need more entertainments in our lives, wherever we can find them.  Second, defense hacks worth the title should expand their taxonomy of warning cases.  Here’s our warning to you: you never know when some weird, one-off case might help you map out a position on a warnings issue. 

In Francisco, the plaintiff sued a medical practice for failing to inform him of the potential risks of taking ciproflaxin.  It is likely that some of you have taken Cipro.  If you have, it likely you have heard about potential adverse reactions relating to tendonitis or tendon rupture.  But, apparently, the plaintiff in Francisco had not heard about such risks.  The doctor prescribed Cipro for the plaintiff after a urological procedure.  The plaintiff alleged that he suffered severe pain as a result of the procedure, that the doctor had not warned him of the risks, and that if the doctor had offered adequate information or prescribed a reasonable alternative, the plaintiff would have requested a different antibiotic.

It is pretty clear that Francisco is a medical malpractice action, right?  The plaintiff tried to say it wasn’t, for reasons that will become clear shortly.  Informed consent seems like a slightly different issue from, say, removing the wrong leg or leaving a sponge in the abdomen, but it is still (in most states)a species of negligence. If a doctor’s treatment of a patient is negligent, that usually spells medical malpractice.  Arizona defines a medical malpractice claim as one based on “the health care professional’s alleged breach of contract, negligence, misconduct, errors or omission in rendering professional services.” There is no carve-out for informed consent.  Consequently, the claim in the Francisco case implicates the Arizona statute (similar to statutes in most states) requiring medical malpractice plaintiffs to furnish up front an expert opinion that the defendant medical provider’s conduct fell below the standard of care.  The plaintiff in Francisco had not supplied such an expert statement, and the defendant moved to dismiss the case on that ground.  The lower court agreed with the defendant and dismissed the case with prejudice.  

But the Arizona Court of Appeals reversed.  Yes, the case was a med-mal case, and yes, the Arizona statute addressing the requirement of an expert opinion regarding deviation from the standard of care applied, but the requirement of an expert affidavit can be relaxed depending “upon the circumstances of the particular case.”  Ugh.  So much for legislatively defined bright-line rules.  In Francisco, the plaintiff argued that there was no need for an expert to explain why the treating doctor needed to inform the patient of the risks of Cipro, because another, bigger expert already furnished that explanation: the FDA.  

In 2016, the FDA “warned in its medication insert that Cipro can cause ‘disabling and potentially irreversible serious adverse reactions’ and instructed doctors prescribing Cipro to use caution ‘when prescribing Cipro to elderly patients, especially those on corticosteroids,’ to inform patients of this potential adverse reaction, and to give instructions ‘to discontinue Cipro use and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur.”  At the time of the Cipro prescription, the plaintiff was 66 years old and had been taking corticosteroids for 40 years.  His point was that the FDA warning instructions applied directly to him, yet the doctor had not given him those warnings.  

More to the point, the plaintiff in Francisco argued that the explicit FDA warnings rendered unnecessary the requirement of an expert affidavit to the effect that the warnings should have been provided.  An expert affidavit goes to standard of care and medical custom.  But the jury does not need help on those issues from an expert “when, as here, the FDA directs physicians to advise patients of all risks associated with prescribed medications, provides physicians with a specific ‘black box’ warning, and the physician does not advise the patient of the specific warning. Here, specialized knowledge is not needed to evaluate whether the FDA instructed the doctor to give certain warnings to patients.”  The FDA’s say-so is enough.

Anyway, the FDA’s say-so is enough to start the case and keep it going.  The defendant has the option of offering “responsive expert testimony that physicians are free to ignore such a directive.”  The point is that the FDA’s position permits the layperson “to determine whether, in the context of all evidence from both sides, the failure to warn constituted negligence.”

To our opportunistic eyes, that conclusion in Francisco suggests that, if not quite the last word, the FDA’s position should be a pretty big word in determining which warnings should be given.  But don’t get too opportunistic.  We’ve looked into this issue before, here, and it appears that Francisco is an outlier, even though that court doesn’t admit it.