If drugs and medical devices undergo a product life cycle, so do drug and medical device litigations. We are currently laboring in the relatively early stage of a Multidistrict Litigation, where the court seems terrified of making any substantive decisions. We get no rulings. Rather, the parties are forced to listen to lectures about the need for everyone to work nicely together and, oh, while we’re at it, wouldn’t settlement be a grand idea? It is feckless judicial “management.”
By contrast, we are also in the mature stage of an MDL. There have been many inventory settlements, and the remaining cases have been remanded to judges who have little patience for bottom-feeders. Most remand cases are marked by sheer greed and craziness. There is little merit and judges are starting to … judge. We are seeing dismissals.
And we are thankful.
There are large numbers of pelvic mesh post-remand decisions these days that have been favorable for the defense. One cannot help but wonder why these cases could not have taken a ride in the ejection seat earlier. Thacker v. Ethicon, Inc., 2021 WL 5362076 (E.D.Kentucky Nov. 17, 2021), is particularly thoughtful – and favorable.
As is typical with these mesh cases, the plaintiff included every tort theory under the sun in her complaint. The defendant filed a motion for summary judgment on all claims and won across the board. As is also typical with these cases, the main action was with respect to failure to warn and design defect.
On warning, the defendant argued that the plaintiff had not mustered adequate evidence that a different warning would have made any difference. That is, there was a lack of warning causation. On this warning causation point, the Thacker decision goes through a number of causation-related bases for summary judgment (failure to read, not remembering reading, non-reliance, prior physician knowledge) before concluding that the implanting surgeon’s affirmative testimony on whether he would have done something differently was sufficiently strong that the plaintiff was obligated to come forward with some evidence to create an issue of fact. The plaintiff did not, so the court granted summary judgment on warnings.
Note that the Thacker court allowed that it might have arrived at a different result if there was a tabula rasa on warning causation. We do not agree with that. No evidence means no evidence and should mean no valid claim. A tie goes to the defendant. But the Thacker court says that a defendant first needs to come forward with evidence that a different warning would not have produced a different prescribing decision. Fine. We’ll deal with it. Consequently, the lesson for defendants is that, when in Kentucky, do not simply rest on absence of evidence of warning causation. Instead, the defense should ask questions of the treater to show absence of warning causation. In Thacker, the defense elicited from the treating physician that he believed the benefits of the mesh outweighed its risks, and he stood by his decision to use the mesh even with whatever additional information the plaintiff claimed should have been disclosed. Almost all treaters will give you that, so ask those questions at the deposition. If you get bad answers, don’t blame us. At least you’ll know you have a weak case. Alert settlement counsel. And give the case to someone else to take to trial. Surely, there is a young, eager lawyer down the hall hankering for trial experience. You can stay home and occasionally offer avuncular advice.
On design defect, most of the usual alternatives proposed by the usual plaintiff medical expert were not alternative products at all. Kentucky law turns out to be quite good on the need for a safer, feasible alternative product. The plaintiff’s expert (who shows up in many, many, many of these pelvic mesh cases and has made many, many, many dollars from this enterprise — $8 million at last count) suggested three other surgical procedures that did not use polypropylene mesh. Those were not alternative products; they were completely different altogether. They weren’t remotely in the same product category. It is like suggesting in a motorcycle accident case that the safer alternative was a car. Or walking.
The one product listed by the plaintiff expert that arguably could qualify as an alternative design under Kentucky law was a mesh that was lighter and contained less polypropylene. But the Thacker court held that the plaintiff did not establish a submissible case that such mesh was feasible. The plaintiff expert’s report was ipse dixit on that point, and the plaintiff didn’t offer anything else (another manifestation of the “don’t do anything” post-remand problem of the MDL plaintiff’s business model that we’ve discussed elsewhere). The Thacker court’s decision on this issue is important because it squarely holds that the expert’s mere say-so that the alternative was feasible and safer is not enough to fend off summary judgment.
There is a lengthy footnote discussing both sides of the FDA approval issue for alternative designs of FDA approved/cleared products. The plaintiff’s proposed safer alternative mesh had not been approved or cleared by the FDA for the indication at issue in the case. To our mind, that fact should render the product not feasible. The jury has no basis to speculate that a regulatory submission would have garnered positive action by the FDA. In any event, that issue did not drive the Thacker decision either pro or con. The Thacker court indicated that the effect of FDA silence probably turns on how a particular jurisdiction lays out the requirement of a safer, feasible alternative. But it didn’t matter in Thacker. With or without FDA approval/clearance, there simply was nothing of substance in the record to show feasibility or increased safety, so the Thacker court granted summary judgment on design defect as well.
The failure of the warning and design defect claims doomed the entire case. The various labels of the remaining causes of action, whether styled as negligence, strict liability, or anything else, were immaterial. Accordingly, the Thacker court dismissed the entire case case with prejudice.
Happy Thanksgiving. Save some spuds, cranberries, and a spot on the couch for us.