We have blogged about class actions; we have blogged about preemption; we have blogged about social media; we have blogged about alleged economic loss; and we have blogged about alleged product defects—endlessly. Rarely, however, have we blogged on all of these topics in a single post.
Today is the day, and the topic is an order dismissing a class action in the District of Connecticut. It all came together in favor of the defendant in a well-reasoned order in Ignacuinos v. Boehringer Ingelheim Pharmaceuticals Inc., No. 3:19-cv-672, 2020 WL 5659071 (D. Conn. Sept. 23, 2020). The plaintiffs alleged that they and a class of patients like them used the defendant's COPD inhalers, but received only about half of the doses than what the labeling represented. Id. at *2-*3. This initially appears to be a typical economic loss class action—a bunch of people who claim they got less than they paid for. There was, however, a twist. These plaintiffs also alleged physical harm in the form of difficulty breathing because their inhalers purportedly ran low. Id.
Let's pause here to consider how this class action is unique in this day and age. We rarely see class actions alleging personal injuries in the drug and medical device space anymore because they are virtually uncertifiable, owing to the many individualized issues on liability, causation, and injury that personal injury cases inevitably present. Purely "economic loss," consumer-style class actions are the name of the game now, and we frankly do not fully understand why the plaintiffs here would submarine their own class action.
It turns out that they did not even get past the pleadings. The district court found that the plaintiffs had standing to sue based on their alleged physical and economic injuries, but the complaint stumbled over preemption. Id. at *3-*4. Implied preemption to be exact, and implied impossibility preemption to be even more exact. Id at *5. That is the type of preemption where state law has to give way when conflicts between state and federal law make it impossible for a party to comply with both. Id.
Here, the defendant argued that the plaintiffs' claims—whether based on inadequate labeling or a design defect—were preempted because it could have changed neither the label nor the "fill volume" of its inhalers without the FDA's prior approval. Id. at *5-*6. FDA regulation therefore displaced the plaintiffs' state-law claims. The plaintiffs countered by claiming that the defendant could have made the plaintiffs' demanded changes under the FDA's "Changes Being Effected," or CBE, regulations and that their demanded changes were "minor" or "moderate" changes that did not require approval in any event.
The district court had little trouble ruling that changes in a drug container or dosage are "major" changes that require prior FDA approval. Id. at *9-*10. The interesting part of the order is the district court's discussion of preemption and the CBE regulations. As we have said multiple times (including here), the CBE regulations allow a drug manufacturer to alter its labeling without prior approval only based on "newly acquired information." The plaintiffs asserted that "newly acquired information" existed in two forms—(1) the plaintiffs' own reports that they received only about half the doses than they expected from each inhaler and (2) a number of online reviews from patients sharing similar observations.
Online reviews? We all know that everything we read on the Internet is absolutely true, right? Ok, we are just kidding (or "jk" in online text speak). But even taking the online reviews at face value, those reviews (and the plaintiffs' own reports) were not "newly acquired information" sufficient to trigger the CBE regulations. That is because "new information" has to be scientifically valid and conclusive:
Case law defining what types of "reports of adverse events" constitute "newly acquired information," provides that "new information must have some degree of scientific validity and conclusiveness to constitute 'newly acquired evidence' under the CBE regulation."
. . . .
Accordingly, "reports of adverse events" must be scientific in nature and provide sufficient evidence that links the alleged defect to the information reported on the drug label.
Id. at *8 (internal citations omitted). In other words, newly acquired evidence must be scientific in nature, and the plaintiffs' self-reporting and collection of online reviews fell short. They are not the least bit scientific. They are certainly not "reports of adverse events" within the meaning of "newly acquired information" because, in the district court's words, "they are not grounded in scientific research":
[T]here is no suggestion that [plaintiffs'] own research was subjected to peer-review or "well-grounded in scientific evidence" as required by the FDA to alter a preapproved label. The same is true for Plaintiffs' reliance on online consumer reviews from website[s] such as WebMD and Drugs.com. Even if the Plaintiffs' reporting and the cited online reviews did constitute "reports of adverse events," the Plaintiffs do not provide any additional scientific analysis to accompany those reports or reviews.
Id. at *9. We share the district court's skepticism over these plaintiffs' attempt to create their own "newly acquired information" and then comb the Internet for anecdotal support. In fact, we think the district court was charitable in discussing this "evidence" as carefully as it did, including by discussing the plaintiffs' self-reporting and online reviews as though they might be "reports of adverse events" in the first place.
This district court correctly set the bar. "Newly acquired information" has to be scientifically valid and provide reasonable evidence of a "causal association of a clinically significant adverse reaction linked to drug." Id. at *8. The plaintiffs in Ignacuinos did not meet that bar. Not even close.
Originally published by Reed Smith, October 2020
This article is presented for informational purposes only and is not intended to constitute legal advice.
