As we prepare to greet 2023, we find ourselves assuming the Janus-ian posture of simultaneously looking backward and forward. Forward is more fun, as we scan a schedule full of motions, MDL decision-trees, and trials in, er, challenging jurisdictions. But it really is folly to plan the future without learning from the past. It is hard to beat Bexis’s lists of the best and worst DDL cases, the latter of which graced us last week, and the former of which will adorn this blog tomorrow, for inventorying what happened and what mattered in our area of the law in 2022. We’ve also been asked in various fora and by various inquisitors to hold forth on trends we espy. Clients and colleagues demand analyses and prognostications. We’ve also worked up presentations for ACI, DRI, and in-house CLEs. As we draw a curtain on a very interesting year (African safari, new house, introduction to pond management, Phillies World Series, and clients who gave us the gifts of trust and humor), so we’ll share some top-line observations and suspicions with you, our loyal readers:
- Since Covid-19 paid our society an unwelcome, prolonged visit, we’ve heard a lot about supply-chains. Enterprising plaintiff lawyers are exploiting the many residents of drug and device supply chains to gin up personal jurisdiction by finding local players (raw material suppliers, clinical trials, etc.) or bolstering liability theories by taking out of context Materials Safety Data Sheets that list risks relevant for OSHA but not FDA issues.
- The assault on non-prescription products continues. Plaintiff lawyers seem to be paying more attention to over the counter and consumer products, alleging dangers from contaminants. These products have lots and lots of users (call them prospective clients), and there’s hardly a pesky learned intermediary in sight to get in the way of a failure to warn claim.
- That assault is aided by “independent” laboratories that masquerade as public-spirited do-gooders, when they are actually in league with plaintiff lawyers and treat science as a game. These labs follow good lab practices erratically if at all, and certainly not good practices that would produce bad results for plaintiffs. The bottom line is that these not-so-independent labs would find contaminants, degradation artifacts, and/or asbestos in unicorn tears.
- You got that reference to asbestos, right? The plaintiff playbook du jour comes from the talc asbestos litigation, and that litigation, in turn, is only the latest wave in the asbestos wars. If the first victim in war is the truth, then the asbestos wars have murdered truth, science, and anything approaching due process. Too many judges presiding over asbestos dockets have given up any gatekeeping, wave frail causation opinions along to juries, and grudgingly consider dispositive motions only on the eve of trial — all of which seems designed to force panic settlements.
- As the asbestos model gets applied to other mass torts, we are starting to see an unfortunate feature of asbestos litigation crop up in those mass torts: the use of bankruptcy proceedings as a necessary refuge from a mass tort run amok. The availability of bankruptcy as such a refuge is replete with controversy, of course. Results have been mixed. The consequences of such bankruptcy filings are obviously profound for the debtor and claimants, but also pose complex implications for codefendants. Some have called such bankruptcy filings a scourge, threat, and mess, but they are really rational responses to a litigation system that has become a scourge, threat, and mess.
- At the same time, some judges are willing to climb on top of the mountain of junk science and call a halt to the nonsense. Yesterday, Bexis summarized the Zantac MDL rulings on Rule 702 and summary judgment. The judge in that case did a heroic job of mastering the evidence and seeing the many ways in which the plaintiff experts practiced “situational science.” Even in advance of the new and improved Rule 702 expected to go into effect next year, the Zantac judge set the standard for testing whether plaintiffs met their burden of offering scientific opinion backed by rigor and reliability. That result should gladden the hearts of those who care about the civil justice system, but it should also remind defense lawyers of their responsibility to do the work necessary to reveal the shortcomings of the other side’s experts and provide the judge with the basis for closing the gate.
The Zantac decision was, without a doubt, a remarkable achievement. When a judicial opinion contains over 300 pages of erudition, one tends to sit up and take notice.
But as we were tidying up around our desk this holiday season, we found another judicial gift, almost as if it was hidden underneath a low-hanging, back bough of the Christmas tree. In re Onglyza and Kombiglyze Prods Liab. Litigation, 2022 WL 3050665 (E.D. Ky. Aug. 2, 2022). Just like the Zantac court, O&K saw through the overreaching by plaintiff experts, held that general causation had not been established, and granted summary judgment in favor if the defendants. (We blogged about an earlier version of this court’s Rule 702 decision in January, and it is possible you will read more about this case later this week.) A single study contained a finding that a diabetes drug was associated with increased hospitalizations for heart failure. Based on that finding, the FDA required new warnings for doctors to consider the risks and benefits of initiating use of the drug with patients facing a higher risk of heart failure. And then, naturally, we were off to the races as plaintiff lawyers filed their cases, created an MDL, and tendered experts happy to opine on both general and specific medical causation.
But there was a problem with general causation. (And if you don’t have general causation, you never get to specific causation.) The plaintiff expert had no support for his opinion beyond the single study that prompted the warning. First, one study might be enough for a warning, but it is usually not enough to establish a cause-and-effect relationship. Second, that single study itself did not claim to present evidence of causation. The authors acknowledged an absence of known mechanisms and the possibility of false positives. The plaintiff expert was forced to agree with the study’s request for further investigation. Fine, but that is a far cry from a causation opinion held to a reasonable degree of scientific certainty. A further-investigation-is-needed result isn’t even “newly acquired information” that can defeat preemption, much less serve as a basis for a causation opinion. In fact, the plaintiff expert admitted that no human study ever confirmed “the hospitalization-for-heart-failure finding.” Goodbye expert. Good-bye general causation. Good-bye case?
Yes, but the plaintiffs went down swinging. They sought leave to submit a new expert on general causation. But the plaintiffs had waited too long, had no decent excuse (merely being surprised that the court actually applied Rule 702 turned out to be a poor explanation), and still could not utter the name of the new expert. Perhaps he didn’t exist, or had not yet been, er, created. The plaintiffs argued that they should be permitted to proceed with their cases despite lacking an expert. But the MDL court looked at the law of all 50 states (as have we) and could not find one that would permit lay opinion where the alleged injuries are “not immediately obvious and the connection between exposure and injury is not a matter of common sense or everyday experience.” Even if expert testimony on general causation were not required, the plaintiffs did not manage to produce evidence from which a jury could infer that the drug was capable of causing heart failure. Again, the single, rather tentative study was not enough. The FDA warnings were not enough to show general causation. (This point is quite useful in cases where plaintiffs lean on FDA warnings, recalls, etc. What is enough to inspire regulatory action might not be enough to prove causation.) Finally, the defendants were not judicially estopped from disputing general causation. They had not made any statements inconsistent with their position in the litigation, and certainly not made such statements in any “judicial or quasi-judicial proceeding.”
So there you have the O&K opinion. Perhaps you can consider it another (well-deserved) gift for the right side of the v. Or perhaps it is a gift to all of us in the Thoreuvian sense (well, we do now live next to a pond) of showing us things we can do without quite nicely. We can all do well without junk science.
Happy almost New Year.