We are patrolling the advance sheets for Rule 702 decisions as part of our preparation for an upcoming DRI panel. Not all of the cases are brand-spanking new and not all are wonderful. Consider Wood v. American Medical Systems Inc., 2021 WL 1178547 (D. Col. March 26, 2021), for example. It is a vaginal mesh case that was remanded to federal court in Colorado.
As we have pointed out more than once, the decisions in the pelvic mesh litigation generally improved with remands. Any right thinking judge would rather get rid of a meritless case than waste tax dollars and juror time. But the remand courts were still stuck with some bad prior decisions. In Wood, the plaintiffs moved to exclude testimony by the defense regulatory expert, while the defense moved to exclude or limit materials science and medical causation experts.
Let’s start with the plaintiff’s motion, just to get it out of the way. Don’t stop us if you’ve heard this before; you have. The defendant proposed to bring in an FDA expert who would explain to the jury how the vaginal mesh product had been cleared through FDA’s 510(k) process. The plaintiff argued that such testimony was irrelevant and confusing, because the 510(k) clearance had nothing to do with safety. The plaintiff prevailed in this argument, even though it is plainly wrong.
The 510(k) process looks for substantial equivalence to another product on the market, and that substantial equivalence is a proxy for safety. But the vaginal mesh MDL court, the Fourth Circuit, the Eleventh Circuit, and several disappointing district courts over read the SCOTUS decision in Lohr, which contrasted the rigorous Pre-Market Approval process for medical devices with the 510(k) “shortcut” (not everyone agrees with that characterization). The Lohr decision was about preemption, not admissibility. Moreover, Lohr’s analysis of 510(k) was outdated, as subsequent FDA pronouncements made clear that the purpose of the 510(k) process was to assure safety. Otherwise, why is “substantial equivalence” relevant?
But the Wood case was hemmed in by bad precedents, so it excluded the defense regulatory expert —even though Colorado law provides a rebuttable presumption of no defectiveness if the product complied with federal or state regulations. The mesh complied with section 510(k), but the Wood court followed a case interpreting a (somewhat) similar Utah statute and concluded that “the 510(k) process is focused on equivalence rather than safety, and therefore provides little protection to the public.” Ugh.
The defendant also argued that the jury should at least learn of the “biocompatibility standards entailed in section 510(k) approval” since the issue of biocompatibility was front and center in the plaintiff’s claims. But the Wood court did not see how that issue would have been treated any differently in those rotten precedents. (But was that issue even raised in those precedents? Don’t we have a valid point of distinction?)
Oh well. You cannot mold gold out of clay, and you cannot make a good legal ruling out of Wood.
Or can you? The Wood court did clamp down on some of the plaintiff experts, so let’s sample some of those rulings, if only to rinse the bad taste of the disappearing 510(k) out of our mouths. First, the Wood court held that the plaintiff expert could not propose alternative medical procedures. They had nothing to do with whether the product at issue was defective. Second, the Wood court held that a plaintiff medical expert was not qualified to testify about the technical aspects of the mesh that allegedly caused medical harm. Third, the Wood court held that the plaintiff medical expert’s opinions regarding complication rates were unreliable. That expert seemingly plucked a 15% complication rate out of the air. He could not adequately explain the basis for that figure, so the court excluded it. Fourth, the Wood court held that a plaintiff medical expert (who seems to show up in every one of the pelvic mesh trials) was not qualified to criticize the defendant’s “testing deficiencies.” Fifth, the Wood court held that the plaintiff expert’s preference for different materials was both irrelevant and impermissible, because those other materials were unavailable to American patients for the indication at issue in Wood.
To be sure, the Wood court let in some plaintiff expert opinions that, like the 510(k) exclusion, will paint a counterfactual, absurd picture for the jury. For example, the Wood court permitted a plaintiff urology expert to hold forth on the (fictional) significance of a Material Safety Data Sheet.
The Wood case is an illustration of the defects in the MDL process. Theoretically, an MDL achieves efficiencies by facilitating centralized discovery and motion practice, followed by ready-to-go trials. But what if the MDL rulings are bungled? Efficient injustice is still injustice.