One day last week, we were sitting at our computer watching a torrential rainstorm through the windows of our home office. It occurred to us, based on some recent seepage, that we should check our basement. We opened the door to the most-unwelcome sound of rushing water. Momentarily confused, we identified the source: a new hole in a window leading from a (very full) window well into the basement. We kid you not: it was as if a fire hose were trained on the hole. We won't bore you with the incomplete gutter replacement of the day before that essentially directed the full force of the downpour into the window well, or with our quickly-aborted effort to run outside and address that. Nor can we adequately capture the image of us attempting to catch the flow in buckets (which were filling in a matter of seconds). Luckily, a neighbor responded to a mayday call with plywood and caulking and similar items and quickly boarded up the window. (We may change our will to include this individual.) Once the hole was blocked, all that was left was the cleanup: we counted that we emptied our shop vac thirteen times in the space of the next several hours, but all's well that ends well.
And it is not nearly as difficult as it sometimes is to scratch out an analogy that allows us to transition to discussion of today's case, Willet v. Johnson and Johnson, — F. Supp. 3d —, 2020 WL 2988299 (S.D. Iowa June 3, 2020). Willet is a decision on a Daubert motion in a pelvic mesh case, addressing a motion to exclude a charter member of the "ubiquitous plaintiffs' experts" club - here, a causation expert. Sweeping aside the noise and distraction, the court had only to focus on the gaping holes (see?) in the expert's opinion to hold that the expert was all wet (sorry). (Shout out to the Butler Snow team for the great result.)
The plaintiff in Willet suffered from pelvic organ prolapse and was implanted with a pelvic mesh device manufactured by the defendant. She underwent subsequent revision surgeries and ultimately joined the queue of plaintiffs alleging mesh injuries and asserting the familiar litany of product liability complaints. Iowa law governed the plaintiff's substantive claims (the case was pending in the mesh MDL but has now been remanded to the Southern District of Iowa). By the time of this decision, the defendant had won summary judgment on a number of the plaintiff's claims, and all that remained were claims for design defect and breaches of express and implied warranties, along with a loss of consortium claim and a prayer for punitive damages.
Iowa is a Third Restatement state. As the court explained, this meant that "expert testimony [was] necessary to establish a reasonable alternative design" for the plaintiff's mesh device and to establish "the ability of such design to reduce the foreseeable harm of the challenged product." Willet, 2020 WL 2988299 at *6. In other words, the plaintiff could not prevail upon her design defect claims without an admissible expert opinion that a safer, feasible alternative design existed at the time she was implanted with her mesh device.
The expert clearly had read the "Mesh Mouthpiece Playbook." Like everyone else, he opined that three categories of "reasonable alternative designs" were available to the defendant at the time of the plaintiff's 2011 implant surgery: 1) "native tissue" surgical repairs (using the plaintiff's own tissue, not an implanted device, to repair her prolapse); 2) allografts/xenografts (tissue from human and animal cadavers), and 3) a mesh product the defendant began developing in 2011 but never sold, which, according to the expert, would have addressed issues created by the "small pore size" of the plaintiff's mesh.
The defendant argued that native tissue and donor (human or animal) tissue repairs were not "alternative designs" for the plaintiff's mesh device; rather, they were entirely different surgical procedures. As such, the defendant argued, the expert's "opinion about these procedures really [took] issue with the treating physician's choice of the appropriate procedure, rather than identifying a safer alternative design of the product at issue." Id. at *8. The plaintiff conceded that native tissue repairs were not "products" and could not satisfy the "alternative design" requirement, but they contended that allografts and xenografts were product — just products that used natural rather than synthetic mesh.
The court disagreed, "agree[ing] with the MDL court that, as a general matter, "whether an alternative procedure could have been performed without the use of the device does nothing to inform the jury on the issue of an alternative, feasible design for the device." Id. (internal punctuation and citation omitted). The court concluded:
I agree with the defendants that allografts and xenografts are not "comparable products" or "comparable design concepts" to [the plaintiff's] device, when, for example, allografts are regulated by the FDA as human tissues for transplantation and xenografts are regulated as biologic products for transplantation. Neither is classified as a medical device. . . . Thus, [the expert's] opinions about allografts and xenografts are not relevant or reliable, because they do not relate to an alternative product or alternative design concept for a product. [The expert's] opinions about native tissue repair, allografts, and xenografts as safer alternative designs are excluded.
Id. at *8-9 (citations omitted).
"Alternative" Mesh Product
That left the expert's opinion about a mesh product that the defendant had begun developing but had never commercialized. The defendant argued that the expert did "not support his opinion with any reliable scientific evidence" that the alternative mesh product "could [have been] marketed at a reasonable cost, would have been effective, and would have reduced the foreseeability of harm to Mrs. Willet." Id. at *9. The plaintiff responded that a "reasonable, safer alternative design" could be hypothetical and did not have to be a commercialized product. The court held. "The greatest problem with [the expert's] opinion . . . is not that [the alternative product] was not completed, or even that it was never approved by the FDA and never commercialized. Rather, the greatest problem . . . is the complete lack of scientifically adequate evidence to support a reliable expert opinion." Id. (citations omitted). The court explained that, where an "alternative" was not in use, testing of the product was important to the reliability of an expert's opinion about it, and there was no evidence that any such testing had been performed on the this expert's proposed "alternative." While the expert cited literature discussing problems with small-pore meshes, he cited nothing showing that a larger-pore mesh would be safer. Nor had he cited evidence about the potential rate of error or failure of the "alternative" or shown that the "alternative" enjoyed general acceptance within the medical community.
The court concluded,
Failure to satisfy any of these considerations would not necessarily be fatal in the applicable "flexible" [Daubert] inquiry, if [the expert] pointed to 'principles and methodology' supporting his conclusions about and anticipated outcomes for [the 'alternative' product]. Unfortunately, he does not do so. . . . Because [the expert] simply leaps from the problems with [the plaintiff's mesh device] to the conclusion that [the alternative] would be safer, without adequate support for an expert opinion that a product with any alternative material, even a material with larger pores, would have been a safer alternative . . . , he has established only a speculative hypothesis, not an adequately supported expert opinion. . . . In short, [the expert's] opinions about any alternative safer designs . . . are excluded.
Id. at *10. The court similarly dispatched the expert's other opinions: that the plaintiff was not able to give informed consent and that the defendant's marketing of the plaintiff's mesh device constituted a "non-consented clinical trial," the latter (resoundingly) pursuant to Fed. R. Evid. 403. Because none of the plaintiff's remaining claims could survive her expert's exclusion, the court granted the defendant's motion for summary judgment in its entirety.
This opinion brings us great joy. We have dealt with this very expert, and these very issues, over and over again. And, as we frequently emphasize in these pages, much of our professional lives revolve around MDL plaintiffs who clog dockets with claims that should never reach a jury. It seems to us that remand courts may be more prone - and more able - to analyze complicated issues raised by individual cases, while MDL courts often simply ride herd over the thousands of cases on their dockets. We are delighted every time a judge wades through a plaintiff's quagmire to zero in on the deficiencies in the claims or the evidence.
We will continue to keep you posted on the good and the bad. Meanwhile, stay safe, and check your basement windows.
This article is presented for informational purposes only and is not intended to constitute legal advice.