Monday, March 20, 2023

two melatonin class actions alleging higher doses than needed survive

Mack v., 2023 WL 2538706, No. C22-1310-JCC (W.D. Wash. Mar. 16, 2023)

Plaintiffs alleged they bought and used Solimo, a melatonin supplement manufactured and sold by Amazon. Each product purports to provide a specific dose of melatonin per serving (e.g., 3mg or 5mg). Melatonin is commonly used as a sleep-aid. Plaintiffs alleged that Solimo falsely substantially understates Solimo’s true melatonin dosage in each serving, exceeding what would be a “reasonable excess” allowed by the FDA. Plaintiffs alleged that a “reasonable excess” is any amount greater than that needed for a supplement to meet “the amount specified on the label throughout the product’s shelf life.” They alleged that, had they known Solimo’s true melatonin dosage, they would not have purchased it at any price. They sued for violations of Washington’s Consumer Protection Act, breach of contract, breach of express warranty, and breach of implied warranty. The court denied Amazon’s motion to dismiss.

The court found standing, including for injunctive relief: Plaintiffs alleged that, if not for the fact that they cannot confidently rely on Solimo’s labeling, they would purchase the product again. 

Amazon argued preemption because (1) the FDA permits melatonin overages and (2) Plaintiffs’ allegations are supported by a test that deviates from the FDA’s 12-sample testing protocol. The court disagreed. It’s true that, because supplements like melatonin degrade over time, the FDA allows manufactures to formulate the supplement with some overages to ensure “that the finished produced can meet the label declaration for that dietary ingredient through the product’s shelf life.” But the FDA doesn’t “allow the manufacturer to add excess dietary ingredients in unspecified amounts that would be in excess of the amount actually needed to meet the label declaration.” Thus, if a product’s label falsely states the dosage, relative to this permissible excess, the product is mislabeled. Plaintiffs sufficiently alleged that this was the case. The complaint recognized that some overage is allowed, but contended that the amount in Solimo “increases the risk of adverse side effects” and puts at issue its “long-term safety” and, for these reasons, it is an “unreasonable excess...prohibited (not permitted) by FDA regulations.”

The FDA also requires that compliance with food labeling requirements be determined through a 12-sample testing protocol. The complaint didn’t allege that plaintiffs actually used this protocol when testing Solimo, so Amazon argued that it was preempted. But “plaintiffs are generally not expected to provide evidence in support of their claims at the pleading stage...nor are they required to plead the ‘probability’ of their entitlement to relief.” 

Murphy v. Olly Public Benefit Corporation, --- F.Supp.3d ----, 2023 WL 210838, No. 22-cv-03760-CRB (N.D. Cal. Jan. 17, 2023)

Plaintiffs alleged that Olly’s products include significantly more melatonin than the label asserts, and therefore violate state consumer protection laws. Plaintiffs’ usual California claims, plus claims based on New York’s GBL and other consumer protection laws of various states mostly survived.

Murphy allegedly selected a 3 mg dose “because she did not want to take more than 3 mg of melatonin from the product, “due to increased concerns about side effects and safety” and would not have purchased the melatonin had she known that it “was inaccurately labeled and unreasonably overdosed.” Plaintiffs’ liquid chromatograph-mass spectrometry analysis on four non-expired bottles and four expired, or nearly expired, bottles and alleged that the true amount of melatonin in the bottles was 165% to 274% of the amount claimed. They alleged that this was “far more melatonin than the ‘reasonable excess’ permitted by the FDA.”

There was no preemption. The complaint properly alleged nothing different than what the FDA requires: “if a manufacturer includes materially more melatonin than is actually needed to ensure that by the time the shelf life ends, the product has approximately the amount of melatonin that is declared on the label, this violates the FDA’s mandates.” They weren’t trying to establish a percentage mandate, but alleged that “other U.S. manufacturers” who sell melatonin supplements put their products on the shelf with a 10–15% overage, which is “reasonable because, by the time the shelf life ends, the product has approximately the amount of melatonin that is declared on the label.”

Also, federal pleading standards don’t require plaintiffs to allege that they complied with FDA’s sampling practices. As the court pointed out, quoting a different case, it is “uncertain how a plaintiff, prior to discovery, would have access to ‘randomly chosen shipping cases’ from which he could have selected 12 consumer samples that he could be sure had come ‘from a single lot.’ ” Plaintiffs would eventually have to prove that Olly failed to comply with the FDA overage regulations, but not yet.

A state law claim also doesn’t exist if the state claim wouldn’t exist if the FDCA didn’t exist. (In California, though, the state has adopted the FDCA and its regs as its own law.) Olly argued that was exactly what plaintiffs were arguing. “Plaintiffs are not bringing suit because Olly’s conduct allegedly violates the FDCA; they are bringing suit because Olly’s conduct allegedly violates state consumer protection laws in such a way that is consistent with the FDCA.”

The primary jurisdiction doctrine also didn’t bar the claim; the FDA has already provided helpful guidance that “the amount of overage should be limited to the amount needed to meet the amounts listed.” Nor did this require hyper-technical expertise to apply. 

Olly argued that reliance was implausible because plaintiffs alleged they wanted the exact amount of melatonin listed on the label, but they also alleged that they wouldn’t have purchased if they knew about the unreasonable overdose. It further argued that customers do not care about overages because they “do not possess technical and scientific knowledge regarding melatonin, degradation, or what constitutes a ‘reasonable overage.’ ” But the complaint plausibly alleged otherwise, e.g., “consumers don’t want to unwittingly take excessive amounts of a neurohormone that alters brain chemistry” and “consumers want to make their own, informed decision about the dosage that is right for them.... This choice is reflected by their decision to purchase 3 mg, instead of a higher dose.” Maybe consumers also care about form (gummy, powder, soft gels) and flavors, ingredients and branding, but the complaint plausibly alleged that the melatonin dosage is material to consumers in selecting an Olly melatonin product.

The court declined to dismiss the requests for equitable remedies at the pleading stage, even though plaintiffs were also seeking damages.

Olly also argued that the plaintiffs failed to allege “why they were economically injured when they got more melatonin than advertised and they do not contend that the Products were not effective sleep aids.” “That is a rather disingenuous take on Plaintiffs’ allegations. It is not as if Plaintiffs got a box with 11 chocolates in it when they were expecting 10. Plaintiffs allege that they wanted to take an accurate amount of a neurohormone that affects their brains, that they trusted the label’s representation of how much of that neurohormone they were getting, and that the inaccuracy of that label was ‘alarming,’ such that the product was essentially worthless to them.”

However, plaintiffs didn’t plausibly allege that non-purchased, non-tested Olly melatonin products were overdosed. Although the fact that the products all contain the same ingredient can sometimes satisfy the pleading standard, the issue here was not the presence of a particular ingredient, but the quantity of that ingredient.

Plaintiffs also had standing to seek injunctive relief. The complaint didn’t allege that plaintiffs “now know[ ] how to interpret” Olly’s melatonin labels, “other than to assume that they are dangerously inaccurate,” which was not enough to deprive them of standing. The continuing inability to rely on the label provided standing.

Other states’ laws: In light of the minimal briefing, and because the complaint only asserted claims based on the laws of   four additional states “(far outweighed by the populations of California and New York),” the court would wait for a class certification motion.

Express warranty and unjust enrichment claims also survived.

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