The “mesh case of the week” — Robinson v. Ethicon, Inc., 2022 U.S. Dist. LEXIS 36441 (S.D. Texas March 2, 2022)— is a veritable mixed bag. We cannot decide whether to carry that bag from the car trunk to the kitchen table or just heave it in the dumpster.
The issue in Robinson was the admissibility of testimony by the plaintiff’s regulatory expert. In drug and device litigation, plaintiff regulatory experts aim to take the witness stand and deliver the plaintiff lawyer’s closing argument, clothed in jargon. Speaking of clothing, sometimes plaintiff regulatory experts engage in cosplay, donning a quasi-military uniform from their service in the FDA many decades ago. This masquerade occurs despite the fact that the expert’s prior FDA position had little or nothing to do with the subject of the litigation. The plaintiff regulatory expert manages to touch every cause of action and almost every issue in the case, but the main deliverable is that the defendant broke the law – maybe several laws.
Wait a minute, we hear you ask (our hearing is preternaturally sharp), is this regulatory expert essentially supplanting the judge’s role, maybe even issuing a new set of jury instructions? Or is the expert supplanting the jury’s role? Is this regulatory expert really helpful to the finder of fact? We know she (right now, perhaps as a mere accident of the moment, most of the regulatory experts on both sides are women) is helpful to the plaintiff. When we consider the damage a regulatory expert can do, misinterpreting both company documents and FDA regulations to make the company look like Murder, Inc., we almost see the good side of the mesh MDL court’s decision to toss all FDA issues out of the litigation. (Note that we said “almost.” The fact of FDA clearance should clearly be admissible, while a plaintiff regulatory expert’s effort to direct a verdict for the plaintiff should clearly be inadmissible.)
For whatever reason, regulatory issues remained in the Robinson case. The only causes of action remaining in the case were failure to warn and negligent misrepresentation. The plaintiff expert intended to opine that the defendant’s premarket testing was inadequate, that the mesh device labeling inadequately informed doctors, that the labeling precluded patient informed consent, and that the inadequate labeling meant that the mesh device was “misbranded” and “adulterated.” The Robinson court waved those first two opinions through, which is bad, and blocked or at least cut back on the last two opinions, which is good.
One of the primary arguments by mesh plaintiffs is that the mesh manufacturers did not adequately test the devices before unleashing them on the populace. In reality, the FDA’s 510(k) process explains perfectly well what premarket testing was and was not done. But plaintiff experts either demean that 510(k) process as an unholy shortcut or, with the court as an accomplice, pretend that neither the FDA nor its 510(k) process ever existed.
The plaintiff regulatory expert in Robinson had a varying track record in this regard. In one prior case, the court held that the expert’s testing opinions were grounded only in her personal experience and were consequently unreliable. But in Robinson the expert enhanced her opinion by citing the Global Harmonization Task Force guidelines. The defendant pointed out that the expert merely cited those guidelines without actually applying them, and finessed her report to “gerrymander the FDA out.” Moreover, the expert had not reviewed all the clinical data, so her opinion was shot through with holes. No matter, said the court, because that can all be “brought out during cross-examination.”
So much for judicial gate-keeping,
Inadequate Warnings to Doctors
Naturally, the plaintiff expert opined that the mesh device warnings were inadequate. That sort of thing is merely good value for moneys owed and paid. It is what plaintiff experts do. It is, to allude to the now overused fable of the frog and the scorpion, in their nature.
But the defendant pointed to 21 CFR section 801.109(c), which says that labels may omit information “commonly known” to licensed medical practitioners. The plaintiff expert had not conducted any sort of study as to what Texas doctors knew concerning the relevant risks in the device, so her opinion on the label’s inadequacy seemed … inadequate. The court discounted the defense argument, observing that the label already contains some risks that are commonly known, so why couldn’t it contain more? (We are exaggerating only slightly.)
The defendant correctly identified a big problem with the plaintiff expert testifying “about a standard that is different from the standard the court will ask the jury to apply,” but the court replied that “[s]omes cases are just complex, and juries decipher complex information and apply different laws and standards all the time.” It is up to the lawyers’ closing arguments and the jury instructions to help the jury sort these things out.
That sounds like more judicial abnegation to us. It also reminds us of the wonderfully nihilistic aphorism by economist John Maynard Keynes that in the long run we are all dead. Thanks.
At this point the Robinson opinion fills us with despair. But then it gets better.
No Informed Consent
The plaintiff regulatory expert pronounced that in her “professional opinion, professional and patient labeling did not support adequate consenting of patients” for the mesh implants. The Robinson court held that the plaintiff expert “cannot testify about whether patients underwent implantation without true informed consent because under Texas law the manufacturer only has a duty to inform the learned intermediary, who must then provide the warnings to patients.” The adequacy of any warnings provided to the patient are not at issue in this product liability case and are not relevant. Thus, while the expert will have the opportunity at trial gleefully to trash the warnings provided to physicians, she cannot go further and hold forth about the alleged effect upon the patient’s informed consent.
Score one for the good guys.
Legal Conclusions of “Adulterated” and “Misbranded”
Let’s all agree that the terms “adulterated” and “misbranded” sound plenty bad. Let’s also agree that the FDA regulatory definitions of those terms are a bit murkier than one might expect. Finally, let’s agree that it would be crazily prejudicial for a plaintiff expert (whether or not she is wearing epaulets and ribbons) to gaze solemnly at the jury and tut-tut disapproval of how the medical device at issue was “adulterated” and “misbranded.”
Indeed, the Robinson court did agree that such a performance would be inappropriate, and held that the plaintiff expert could not “make the final legal conclusions in her testimony” that the mesh device was adulterated or misbranded. That is a major victory for the defense and a solid ruling by the court.
But do not yank the cork out of the bottle just yet. At the same time, the Robinson court held that the plaintiff expert “may use the terms ‘adulterated’ and ‘misbranded’ to demonstrate to the jury what the regulations would require.” Why? How does such testimony meet the relevance requirement of Fed. R. Evidence 402? It does not make any relevant proposition in the case more or less likely. It is true that under 21 U.S.C. Section 352, a medical device is “misbranded” if its label is false or misleading, among other things. But the jury will directly answer the question of whether the label was misleading and will be guided by jury instructions on that issue. What does the “misbranded” appellation add besides prejudice? Perhaps the Robinson court believed it was simply addressing the Rule 702 issue of expert admissibility and was reserving the 402 (relevance) and 403 (prejudice) issues for another day.
We hope so. Until we find out for sure, the Robinson mixed bag will stay in purgatory (the garage). Or perhaps it is kind of like a Schroedinger’s cat legal opinion – useful and awful at the same time.