We are headed to Guitar Town. That’s Nashville to you. Guitars are played and guitars (including the magnificent Gibson ES-335) are made there. We aim to sample plenty of live music and hot chicken. But the reason for our trip is the Defense Research Institute (DRI) Drug and Medical Device Conference. Tomorrow we will be on a panel with two people who are much smarter than we are. The subject will be challenges to expert testimony. As a tune-up for that panel, today we’ll go through a recent case that addressed such issues.
Fisher v. Ethicon, Inc., 2022 U.S. Dist. LEXIS 158201 (C.D. Illinois Sept. 1, 2022), is yet another pelvic mesh case yielding notable rulings on expert admissibility. In general, defendants have done fairly well in pelvic mesh remand cases. Fisher is consistent with that trend. But it was not a complete across-the-board defense win. One of the plaintiff experts offered opinions that the pelvic mesh was defective both in itself and because of the surgical technique required to implant it. The defendant moved to exclude the opinion on the surgical technique, reasoning that the issue was the product not the technique. The Fisher court sided with the plaintiff because the “product design includes not only the mesh sling that remains implanted in a patient’s body but inexorably the custom helical passers and specially selected surgical technique with which it was paired.” Thus, according to the court, the safety of the surgical technique was relevant, because the product was sold as a kit to facilitate that technique and the technique was apparently part of the FDA’s approval of the product. Inexorably, we are not delighted with that part of the opinion. Inexorably, we will move on to the other, better parts.
Aside from that ruling on surgical technique, the defendant prevailed in its efforts to limit the plaintiff experts. Perhaps most important, the defense succeeded in excluding a plaintiff expert’s speculative opinion that hypothetical additional clinical trials would have exposed product defects. This issue is at the heart of the pelvic mesh litigation. Putting aside all the nonsense about medical grade material and Material Safety Data Sheets, the key argument by plaintiff mesh lawyers is that the mesh should have gone through full-blown clinical trials instead of the 510(k) “shortcut.” Besides the fact that such argument seeks to use jury verdicts to upend a well-established FDA regulatory regime, it also is an example of putting the rabbit into the hat. The rabbit is the assumption that clinical trials would have produced results that would have persuaded the FDA not to approve the product. That is at least two would-haves. In Fisher, the defendant pointed out that the expert had no support for those would-haves. What was the plaintiff’s response? The plaintiff said that the fault was the defendant’s for not asking the right questions at the deposition. The Fisher court quite rightly rejected the plaintiff’s argument on this point was “sophistry at its worst.” The plaintiff expert simply had “not made any showing that further clinical studies would show the existence of the flaws he alleges” in the product.
The defense also stopped the plaintiff experts from testifying on corporate motive or intent. The pelvic mesh MDL court had already entered this ruling, but the Fisher plaintiffs attempted “to wriggle out of that prohibition” based on the theory that the expert was not rendering “state of mind evidence” but was, rather, merely sharing factual testimony about the defendant’s party admissions. Talk about sophistry! The Fisher court saw through this ruse as “another attempt to allow a ‘so-called’ expert to usurp the role of the jury.” The “so-called” expert lacked first-hand knowledge of the company’s knowledge or intentions, had never been employed by the defendant, and had no qualifications to “divine” the defendant’s mental state. The jury could read and interpret the defendant’s alleged admissions at least as well as the paid expert could.
In many pelvic mesh cases the plaintiff trots out a pathologist to opine that pelvic mesh degrades. The degradation theory is unproven, but that does not stop these plaintiff experts from solemnly intoning on them, though the specifics vary. In Fisher, the expert was a repeat player who likes to show the jury alleged mesh degradation via histological dyes “revealing cracks akin to bark on a tree.” The Fisher court excluded the “bark” degradation theory because it lacked peer review, published support, and general acceptance. The expert admitted that there was a way he could easily have physically tested the theory, but the expert did not do so. Oops.
Finally, that same non-clinician pathologist wanted to tell the jury that the product Instructions for Use (IFU) were inadequate and misleading. The Fisher court held that the experience of a pathologist did “not appear to qualify him to opine about the specific risks of implanting mesh and whether those risks appeared on the relevant IFU.” As is often the case with plaintiff mesh experts, ambition exceeded reality. Plaintiff lawyers like to talk about corporate greed, but few things show more greed than expert opinions.
We are mostly content with the Fisher opinion. That should not surprise you. Johnny Cash wrote a song called “This Side of the Law.” Surely, you know on which side of the law we and our fellow DRI attendees sit.