Florida courts are handling a lot of lawsuits.  Lots and lots of lawsuits, and for a convergence of reasons.  Backlogs from pandemic-related closures and delays.  The highest per capita rate of federal court personal injury cases in the country by some measures.  Claims over last year’s Category 4 Hurricane Ian.  Recent tort law changes that sparked a run to the courthouse by plaintiffs’ lawyers trying to beat the new law’s effective date. In short, volume is up.

At the same time, the Florida Supreme Court insists that all cases must be actively managed and promptly moved toward trial, meaning many judges are stretched thin.  Some of the more creative docket management strategies we’ve seen of late have included state court judges referring cases—even personal injury cases—to non-binding arbitration per Fla. Stat. 44.103 and Fla. R. Ct. 1.820 (sometimes sua sponte and without opportunity for the parties to be heard on the issue); mandatory stays of the pre-tort reform bolus of cases, to help judges manage how many cases must be actively managed and to allow them to stagger trial dates; and referral of discovery disputes to “discovery mediation”.

While these docket management techniques certainly keep litigation interesting, there are tried-and-true methods for case and docket management.  Like summary judgment.  It is a really effective, if a bit old school, way to dispose of meritless cases that otherwise clog the docket.  Unfortunately, courts don’t actually grant it in every case where it is warranted, sometimes preferring to kick the can down the road in the hope the parties will settle or the jury ultimately will make the call.

Which brings us to a particularly clear-headed, recent decision, Cates v. Zeltiq Aesthetics, Inc., ___ F.4th ___, 2023 WL 4671283 (11th Cir. July 21, 2023), in which a published Eleventh Circuit opinion reminds all of us that Florida product liability law allows for the grant of summary judgment when a medical device has warnings and a design that are adequate as a matter of law. 

In Cates, the medical device was intended to minimize the appearance of fat, and the plaintiff alleged it caused “Paradoxical Adipose Hyperplasia”—in other words, it “maximized the fat” the plaintiff wanted to minimize.  Id. at *1.  Plaintiff’s description actually isn’t that far off, which is why the condition is called “paradoxical.”

However, (1) the medical device carried a specific warning about the risk of Paradoxical Adipose Hyperplasia; (2) the health care provider who used the device knew that it was a potential risk; and (3) the plaintiff actually signed a consent form that identified the potential risk of Paradoxical Adipose Hyperplasia.  Three strikes.

Plaintiff nevertheless argued that the device warnings were insufficient, and asserted claims for strict liability failure to warn, as well as negligence, negligent misrepresentation, and fraudulent misrepresentation and concealment, all of which the district court and Eleventh Circuit quite correctly treated as mere variations of the failure to warn claim.  Id. at *2.

First, the Eleventh Circuit acknowledged that the learned intermediary doctrine means a device manufacturer’s duty is to warn the physician who prescribes the device, so the confirmed warning given directly to the patient was a good thing but not legally necessary.  Id. at *3. 

Next, the Eleventh Circuit acknowledged that the Florida Supreme Court has held that adequacy of a warning “can be resolved as a question of law where the warning is accurate, clear, and unambiguous” because it makes apparent the potential harmful consequences of the product.  Id. at *4 (internal quotes, alterations, and citations omitted).  And helpfully, adequacy of a warning is an objective, reasonable learned intermediary standard that disregards “any individual’s ‘subjective appreciation of the danger.’”  Id. (internal quotes and citation omitted).  (Although the Eleventh Circuit hastened to add, again quite correctly, that a medical provider’s acknowledgement that he or she subjectively understood these warnings would be helpful on the distinct issue of warnings causation, in that it would defeat any contention that an inadequate warning proximately caused the harm.  Id. at *5.)

Applying that objective accuracy test, although the plaintiff contended the warning failed accurately to convey the severity of the risk or to correct the health care provider’s subjective misunderstanding that the Paradoxical Adipose Hyperplasia risk could be minimized with patient adherence to post-treatment procedures, the Eleventh Circuit agreed the warning was adequate as a matter of law.  Id. at *5.  So, warnings-based claims were gone.

Then, as to the remaining claim for design defect, the inquiry centered on whether Florida’s test for a design defect is measured by the consumer’s expectations, or the risk-utility test.  Although Florida’s Supreme Court adopted the consumer expectations test in Aubin v. Union Carbide Corp., 177 So. 3d 489, 515 (Fla. 2015), an intermediate appellate court later distinguished it and held the risk utility test applied when a “complex product” like a medical device is at issue.  Cavanaugh v. Stryker Corp., 308 So. 3d 149, 156 (Fla. 4th DCA 2020) (see our post here) .  While the district court in Cates had held that Cavanaugh applied, the Eleventh Circuit concluded that it “need not decide which design defect test applies to medical devices under Florida law” because the plaintiff’s claim flunked both of them.

First, he merely had identified a “known, but rare, side effect”—and a known potential side effect is not a design flaw.  Id. at *7. 

Second, the risk-utility test requires evidence of a suitable, safer alternative design, and the plaintiff failed to identify any.  In fact, his own expert’s acknowledgement that the device is safe and effective so long as its potential risks and benefits are known was an acknowledgement that the “design defect” claim really was just another failure to warn claim in disguise.   

As to the consumer expectations test, the learned intermediary doctrine instructs that the “consumer” is the health care provider, and plaintiff had “no evidence that an objectively reasonably medical provider” would believe there was no risk of Paradoxical Adipose Hyperplasia—it is right in the label. 

Finally, the Eleventh Circuit noted that even if the consumer was the plaintiff, there still was no design defect under the consumer expectations test.  Of course the plaintiff “did not subjectively anticipate developing Paradoxical Adipose Hyperplasia”—because he wouldn’t have agreed to the treatment if he “had known that he would be one of the few” patients who would develop that.  But the device performed as any objectively reasonable patient would have expected, given that the device carried warnings that it could cause Paradoxical Adipose Hyperplasia.

So hats off to the Eleventh Circuit for a thorough understanding of the nuances of medical device product liability, and in particular the learned intermediary doctrine.  Even if the court engaged in more “even if” discussions than we think was strictly necessary, they came out the right way straight down the line.

And now bringing this post around full circle, it is gratifying when, as in Cates, both the trial and appellate court parse through the law and the evidence and recognize that summary judgment is appropriate and do what needs to be done. Docket management, without the need for procedural gymnastics.  How about that!

Our thanks to victorious defense counsel Kyle Cummins and Amy Pepke from Butler Snow for sending us the opinion.