It is always nice to win a case, whether by motion or trial. But just in terms of pure exhilaration, it is hard to beat hearing the jury foreperson announce that, after a hard-fought trial, you win. But note that term “hard-fought.” Most trials really are hard. They really are expensive. They really are stressful. The road to even the most resoundingly wonderful verdict probably had a couple of nasty potholes. That was the case with Horrillo v. Cook Inc., 2016 U.S. App. LEXIS 21026 (11th Cir. Nov. 23, 2016). Prior to trial, there was at least one Daubert ruling that couldn’t have pleased the defense. Also, as reported by our friends in the Abnormal Use blog, there was a learned intermediary ruling that we do not like one bit. But all’s well that ends well, right?
In Horrillo, the plaintiff brought a product liability action on behalf of his deceased mother, who had undergone a surgery to clear her renal artery. The surgery went terribly wrong, as the patient sustained a stroke. The opinion also does not tell us whether the plaintiff ever sued the doctor. The surgeon used a stent manufactured by the defendant. That stent was designed for use in bile ducts, but the surgeon used it off-label in this case. That off-label use was apparently not all that uncommon. The plaintiff’s legal theories included negligence and negligent failure to warn, strict products liability and strict failure to warn, and breach of warranty. After a nearly four-week trial, the jury returned a verdict in favor of the defendant. The plaintiff then moved for a judgment notwithstanding the verdict, or, in the alternative, a new trial. The trial court denied those motions, and the plaintiff appealed to the 11th Circuit. Applying the appropriate standards of review, the 11th Circuit affirmed the trial court’s rulings and the defense verdict.
First, the appellate court upheld the trial court’s exclusion of evidence that four patients in a post-incident clinical trial of the defendant’s renal stent suffered strokes. The court held that such evidence was both irrelevant and prejudicial, and that nothing had occurred during the course of the trial to “open the door” to such evidence being introduced on rebuttal. Clearly, post-incident evidence could not possibly support an allegation that the defendant was on notice of the strokes and should therefor have enhanced the label’s warnings. We cannot tell from the opinion whether the plaintiff also argued that the post-incident evidence should have been admissible to prove medical causation. If that argument was made, it was obviously rejected, and rightly so; four strokes hardly proves causation.
Second, the appellate court held that the district court did not abuse its discretion when it excluded from evidence the label attached to the defendant’s stent years after the decedent’s surgery. Federal Rule of Evidence 407 provides: ‘When measures are taken that would have made an earlier injury or harm less likely to occur, evidence of the subsequent measures is not admissible to prove: negligence; culpable conduct; a defect in a product or its design; or a need for a warning or instruction. But the court may admit this evidence for another purpose, such as impeachment or–if disputed–proving ownership, control, or the feasibility of precautionary measures.” The defendant almost certainly did not assert lack of feasibility of adding a warning, so Rule 407 properly operated to exclude the later label. Moreover, the trial court understood how incredibly prejudicial evidence of the later label would be, and the 11th Circuit agreed.
Third, the record showed that the jury’s verdict was “overwhelmingly supported by evidence presented at trial.” The defendant introduced “compelling and significant testimony and documents that would easily allow the jury to conclude that the defendant did not promote off-label uses of the biliary stent, was unaware of any risk of stroke associated with its use in renal arteries at the time of the decedent’s procedure, did not violate any alleged duty to warn, and did not cause the injury from either a medical or legal perspective.” Reversing a jury’s verdict on strength of evidence is difficult to do anyway, but the 11th Circuit’s endorsement of the defense verdict is quite strong and across-the-board.
Finally, the appellate court held that the jury instructions and verdict form together “accurately instructed the jury on the applicable law, and were not misleading or confusing in any way.” The 11th Circuit’s decision does not supply details that might mislead or confuse us, so we are in no position to disagree (not that there’s any chance we would).
The Horrillo trial itself, and getting to trial, might have been a drawn-out, unpleasant ordeal, but the folks on the defense side must have enjoyed reading the Eleventh Circuit’s opinion – almost as much as they enjoyed hearing the jury verdict in open court.