We have posted quite a bit about the Taxotere MDL and some Fifth Circuit decisions on appeals from it. The decisions have mostly been pretty good. We have posted even more about the treatment of broad preemption issues in MDLs in recent years. From our perspective, there have been too many denials of strong defense preemption motions because the MDL format often works against rulings that will knock out a wide swathe of claims. There was a similar denial of defense motions for summary judgment in five cases in the Taxotere MDL several months ago that we did not write about then. However, the district court certified an interlocutory appeal and the Fifth Circuit accepted it last week. So, now we think the decision is Blogworthy.
In re: Taxotere (Docetaxel) Prods. Liab. Litig. (Adams), 2022 WL 16923721 (E.D. La. Aug. 2, 2022), concerned the summary judgment motions of three defendants who manufactured generic versions of the prescription cancer medication at issue in the litigation. The motions were teed up as to the claims of five plaintiffs whose use occurred solely during a period when it was uncontested that the generics had FDA-approved labeling that matched that of the branded drug. In November 2015—eight to forty-six months after the plaintiffs’ use had ended—the branded drug manufacturer submitted a CBE to amend the existing information on alopecia in multiple locations within the labeling. Timing of how long each generic manufacturer took to file its own CBE to match the new labeling varied (but, of course, all occurred well after each plaintiff’s use ended). The preemption issues should have been fairly straightforward: the defendants could not have changed their generic labels before or during each plaintiff’s use of the prescription drug because that would have violated their terms of approval, but plaintiffs argued their warnings claims were not preempted because defendants had some mysterious burden they did not meet.
For once, we are not feeling particularly verbose and we will be waiting to see how the Fifth Circuit addresses the appeal. So, we will shorten up our discussion of how the MDL court managed to fumble the ball on a simple handoff at the end of the game. First, the court tripped itself up trying to come up with a framework for the various burdens in assessing impossibility preemption in the context of a warnings claims against a generic drug. Since Mensing, this is not much of a question. If the generic drug’s label was as approved by FDA and matched the branded drug’s label, then any warning claim would be preempted. Period. The Fifth Circuit has a number of decisions on our scorecard holding exactly that. After a fair amount of unnecessary back and forth, the court settled on the approach to burdens spelled out in a case called Silverstein v. Boehringer Ingelheim Pharms., Inc., No. 19-81188, 2020 WL 6110909 (S.D. Fla. Oct. 7, 2020). Silverstein involved the preemption of warnings claims against the manufacturer of a branded drug. Our italics do not do justice to how misguided we think this whole analysis was.
The Silverstein approach required a two-step analysis, with an initial burden on plaintiffs to identify the information they say should have led to a labeling change and then the defendants had to prove they could not have used the CBE regulation to make such a change. (As the court’s own recounting of the regulations showed—and Mensing makes really clear—generic manufacturers cannot use the CBE regulation to change the label before the branded manufacturer does, so the analysis was way more extensive than it should have been.) Saying preemption is an affirmative defense, Adams did not even require plaintiffs to show that the information they claimed should have led to a labeling change was “newly acquired information” according to FDA regulations. So, the court jumped to defendants’ argument that the plaintiff’s information could not trigger a CBE labeling change because it “was previously submitted to the FDA” and “did not reveal risks of a different type or greater severity than previously included in submissions to the FDA.” These are part of the analysis for preemption for warnings claims against the manufacturer of a branded drug, for sure, but not for cases like this. (Here is one of many of our deep dives into how this plays out with branded drugs.)
But Adams further bungled things by putting the burden on defendants to show they knew at the time plaintiffs’ medical literature was published how it related to the clinical trial data in the branded drug manufacturer’s NDA. We have no idea how some sort of contemporaneous knowledge requirement got engrafted onto the analysis of whether medical literature constituted “newly acquired information” as defined in the CBE regulation, which generic manufacturers cannot use in any event. This fool’s errand got even sillier as Adams walked through plaintiffs’ proposed newly acquired information and determined it “provided further evidence of the potential causal relationship between docetaxel and permanent alopecia” and “could have formed the basis of a CBE change to the Adverse Reactions section of the label.” This could not have been a basis for a CBE change initiated by these generic manufacturers, though. (Adams also looked to when the plaintiffs finished taking the drug, not when prescriptions occurred, but that was a small error compared to the stuff above.) Taking things a step further, Adams offered that the generic manufacturers could have conducted analyses that might have led them to conclude the branded manufacturer’s labeling was inadequate. That would still not, of course, allow the generic manufacturers to use the CBE regulation to make their labeling different than the branded manufacturer’s.
Unlike Georgia in the lopsided National Championship game, we will call off the dogs on the poor preemption analysis in Adams before late in the fourth quarter. But we will point to three last bugaboos that we hope will resonate with the Fifth Circuit. First, very late in the analysis, Adams stated that it was “assuming that under state law [one manufacturer] had a duty to include a warning regarding permanent alopecia, which necessarily means that under state law [the manufacturer] had a duty to know the risk of permanent alopecia existed at the time.” Ruling on summary judgment motions is not the time to assume anything about state law and duty. Decide the law applicable to each plaintiff and rule. Second, Adams followed up with this gem: The generic manufacturer’s “post-marketing pharmacovigilance duties under federal law may be relevant” to the breach of a state law duty, but the court did not need to decide that now. Not correct for several reasons. Third, Adams ended with a series of quotes from Levine about the high bar for preemption and that Congress intended for manufacturers to update their labels because they are ultimately responsible for them. Without even getting into how Levine got it wrong about branded manufacturers using the CBE regulation and what the law is now, we can say this is off-base for the preemption issues in these generic drug cases.