We call ourselves the Drug and Device Law Blog, but sometimes we cover cases outside the drug and device field because such cases can sometimes be helpful or inspiring. Perhaps it is an example of thinking outside of the box.
Jackson-Mau v. Walgreen, Inc., 2023 U.S. Dist. LEXIS12057 (EDNY Jan. 24, 2023), is a dietary supplement/food FDCA preemption case with a couple of points that can be of value to drug/device defendants as well. Jackson-Mau is one of several cases around the country in which plaintiffs sued manufacturers and sellers of glucosamine supplements, complaining that the product contained a glucosamine blend instead of a single crystal glucosamine. What difference does that make? None, as far we can tell, and that nondifference is part of why the case was dismissed. The plaintiffs did not allege any physical injury. But preemption was another reason why the plaintiffs lost and since when has this blog been able to resist the temptation to talk about a good preemption case?
The plaintiffs in Jackson-Mau alleged violations of New York’s consumer protection statute, as well as breach of contract and unjust enrichment. The defendant moved for summary judgment, arguing that the Food, Drug and Cosmetic Act preempted the claims, both expressly and via conflict, and that, in any event, the New York State law claims failed on the merits. The court agreed with the defendant and dismissed the case.
The heart of the defendant’s preemption argument is that the complaint sought to impose labelling requirements different from the federal ones. The plaintiff argued that the product was mislabeled because it called itself glucosamine sulfate, suggesting single crystal glucosamine when in reality it contained a glucosamine blend. According to the plaintiff, the alleged misnomer existed both in the “supplemental facts” as well as other parts of the label.
Was it a misnomer, or even a lie, for the manufacturer to identify the product as glucosamine sulfate in the supplemental facts section? Not according to the FDA, given that the product passed the test for such nomenclature under both the U.S and European Pharmocopeia and the FDA had chosen to rely upon those reference points. The Jackson-Mau court held that “[o]nce the FDA has chosen to rely on official compendiums” — here, to establish the proper names of dietary supplement active ingredients — “Plaintiffs cannot disregard those compendiums, and it is not this Court’s role to second guess the scientific and technical judgment of the FDA.” The plaintiff found some excerpts where the FDA seemed to suggest that a compendium’s identification of a particular ingredient is not necessarily the last word on what identification is “scientifically valid,” but the court saw that point as a non sequitur: “The excerpt does not change, but further clarified the fact that glucosamine’s inclusion in compendial sources blessed by the FDCA and its regulations controls how it can be identified on the Product’s ‘supplemental facts’ label. The Court therefore finds that Jackson-Mau’s claims are expressly preempted insofar as they concern the ‘supplemental facts’ panel.”
This aspect of the Jackson-Mau holding is potentially helpful to us, because, in the drug/device area, the government (Medicare and other programs) likewise relies on official compendia of valid off-label uses to determine the reimbursabilty of the cost of drugs/devices that are used off label.
The defendant in Jackson-Mau also argued that the plaintiffs’ claims were preempted to the extent such claims were premised on product testing at odds with FDA regulations, which specifically mandated use of different product testing. We similarly see instances of plaintiffs making claims against drugs (not devices, as far as we know) based on their own questionable testing. We have certainly seen such claims by plaintiffs in talc litigation. To the extent that the FDA has made regulatory decisions based on different types of testing, preemption could also be a defense.
Finally, the Jackson-Mau court held that the plaintiffs failed to allege an actual injury. The plaintiffs argued that they would not have purchased the glucosamine, or would have paid less, if they knew it was the blend. But the plaintiffs came up with no evidence that there was no demand for the blend, and did not even raise a genuine issue of fact supporting their “premium price theory.” Thus, on grounds wholly independent from express and conflict preemption, the Jackson-Mau case was a goner.
Perhaps the plaintiffs in Jackson-Mau will appeal, but they cannot succeed unless they turn a triple-play, and the odds of that happening are long indeed.