We were going back through some old cases the other day and came across a gem from our hometown court right here in in San Francisco. It caught our eye because it deals with an angle of federal preemption on which we have written before and which we think is underappreciated, so we're going to write about it again. The issue is implied preemption, more specifically implied preemption where the plaintiff cannot produce "newly acquired information" supporting the drug warning that the plaintiff claims a drug manufacturer should have added to its labeling. This is a pathway to implied preemption separate and apart from introducing "clear evidence" that the FDA would not have allowed the warning purportedly required by state law.
We will get more into these two pathways in a minute, but it all matters because of the FDA's Changes Being Effected regulations and ultimately Wyeth v. Levine, where the Supreme Court held that a drug manufacturer could comply with both federal drug regulation and state-law duties to warn by unilaterally strengthening its labeling under the CBE regs. No impossibility, no preemption.
We have always thought that the Supreme Court was far too generous in its reading of the CBE regulations and the extent to which they actually allow drug manufacturers to change their labels. But even taking Wyeth v. Levine at face value, it was not the end of implied preemption. Prescription drug manufacturers most commonly try to invoke implied preemption with "clear evidence" that the FDA considered and rejected the warning purportedly required by state law. The example that most readily comes to mind is Dolin v. GlaxoSmithKline LLC, 901 F.3d 803 (7th Cir. 2018), where the Seventh Circuit held that federal law preempted the plaintiff's state law warnings claims because the FDA had repeatedly instructed the company not to add the warning that the plaintiff wanted.
There is, however, more than one way to skin a cat. Another avenue to implied preemption is to argue that the drug manufacturer could not have changed the drug warnings as the plaintiffs command because there is no "newly acquired information" to support the warning. That too is grounded in the CBE regulations, which do not allow additional warnings based on information already submitted to the FDA when the drug labeling was approved.
This was the way to summary judgment late last year in a Pradaxa case in California state court. See Pradaxa Cases, No. CJC-16-004863, 2019 WL 6043513 (Cal. Super. Ct. Nov. 8, 2019). We have written on Pradaxa cases before—most recently Roberto v. Boehringer Ingelheim here, and another post here covers "newly acquired information" cases, too. The California summary judgment order is the most succinct, particularly in setting forth a very helpful two-prong framework.
Like all Pradaxa plaintiffs, the California plaintiff alleged that the product—which is an anticoagulant—placed her at an increased risk of bleeding, and that the defendant manufacturer should have warned more strongly about that risk. The court, however, found those claims to be impliedly preempted. Here is the quote that you will want to focus on:
Warning preemption analysis is a two-prong analysis, assessed by the Court. (See Merck Sharp & Dohme Corp. v. Albrecht (2019) 139 S. Ct. 1668, 1676. . . .) "First, the plaintiff must show that there existed 'newly acquired information' such that the defendants could unilaterally change the label pursuant to the CBE regulation without FDA approval. . . ." . . . Second, "if the plaintiff can point to the existence of 'newly acquired information' to support a labeling change under the CBE regulation, the burden then shifts to the manufacturer to show by 'clear evidence' that the FDA would not have approved the labeling change made on the basis of this newly acquired information."
Pradaxa, 2019 WL 6043513, at *2 (some citations omitted). We saw this two-prong formulation for the first time in Roberto, but we repeat it here because it so cleanly captures two avenues to implied preemption in one gloss. The plaintiff has to produce "newly acquired information" to support the demanded change. And it can't be just any old evidence—it has to be meaningful, concrete, and not previously submitted to the FDA:
"[N]ewly acquired information" is defined as: "data, analyses, or other information not previously submitted to the [FDA], which may include (but is not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events, or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA." (21 C.F.R. § 314.3(b) [emphasis supplied].)
. . . [I]t also cannot be rooted in conjecture or hypothesis. Rather, it must conclusively establish, by scientifically valid measurable and statistically significant data, that the different or increased risks are actual and real.
Id. at *3. If the plaintiff cannot make this showing, i.e., demonstrate that the CBE regs can apply in the first instance, only then does the burden shift to the defendant to produce "clear evidence" that the FDA would not have permitted the proposed stronger warning.
From there, it was a short walk to summary judgment. Plaintiffs produced evidence that they claimed would support a stronger warning, but with regard to all of it, the court found (repeatedly) that the manufacturer "submitted this information to the FDA before Pradaxa's warning was initially approved." Id. at *4-*5. The information therefore was not "newly acquired" and it could not support a label change under the CBE regulations. Because the manufacturer therefore could not have complied with the alleged state law duties without violating federal law, the state law claims were preempted.
Not every case will involve the same factual and regulatory history as Pradaxa, but we still think these are very useful cases in understanding and applying implied preemption.
This article is presented for informational purposes only and is not intended to constitute legal advice.