lawsuit against supplement for implying arthritis claims not preempted

Yamagata v. Reckitt Benckiser LLC, 2020 WL 1505724, No. 17-cv-03529-VC (N.D. Cal. Mar. 30, 2020)

A very clear opinion. Yamagata challenged RB’s advertising for joint supplements under California and NY law. As the court explained: “If the boxes are best understood as making assertions about the ability of the supplements to alleviate the symptoms of arthritis, those assertions violate federal law, and the state law claims attacking them are not preempted. If the boxes are best understood as not making assertions relating to arthritis, those assertions are authorized by federal law, and the state law claims are preempted.” The court found that the former was the case.

The court had certified two classes—one of California buyers and one of New York buyers. RB moved for summary judgment, arguing (1) preemption, (2) its products work as advertised, and (3) the plaintiffs’ full refund theory had to fail because the supplements were not worthless.

Preemption: “The key constraint, for the purposes of this litigation, is a [federal] ban on statements implying that the supplement mitigates, treats, prevents, or cures a specific disease or class of diseases. Some of the assertions on the Move Free Advanced labels do just that, and so they are not protected by the preemption provision.” Generally, federal law allows supplements to make structure/function statements [the court helpfully notes that these are called “claims” by the regs but that’s confusing in this context], but not statements implying that the supplement can “diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.”

First, is this a jury issue? It’s partly a factual question insofar as it depends on what the label statements mean, but the court determined that preemption is nonetheless a question of law and so it would be decided by the court, even if that required resolving factual disputes.  See Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019) (“a judge, not the jury, must decide the preemption question,” and  “courts may have to resolve subsidiary factual disputes that are part and parcel of the broader [preemption] question”).

The FDA says that the key factor distinguishing a structure/function statement from an implied disease statement is “whether the labeling suggests that the product will produce a change in the characteristic signs or symptoms of a specific disease or class of diseases.” The regs then list a series of ten criteria (one with five subparts) relevant to that determination, and then provides examples of statements that would fall on either side of the line: A statement that a supplement “reduces joint pain,” for example, is off limits; a statement that it “helps support cartilage and joint function” is not. The reason is that joint pain is a characteristic symptom of arthritis, so statements about relieving joint pain impliedly claim to mitigate the disease of arthritis. As the court noted, “That may seem like a stretch, and it may even seem that the specific reference to cartilage and joint function draws a closer link to arthritis than does the broader ‘joint pain.’ But the idea that the FDA’s dictates may conflict with intuitions only confirms that this preemption determination, while fact-based, depends ultimately on application of the law.”

front and back

sides

Applying this framework, the accused labels implied that the supplement can mitigate, treat, or prevent arthritis. First, “supports joint comfort” was dangerously close to a statement that a supplement “reduces joint pain;” it’s hard to articulate a meaningful difference between the two. And a statement that is a structure/function statement in isolation “can improperly imply an effect on a disease if other parts of the label associate the supplement with a disease.” Relevant context includes the product name, any pictures or symbols, citations to journal articles, and statements about the formulation of the product, if printed on the label.  Here, the ads contained “elements closely associated with arthritis,” most prominently the Arthritis Foundation logo, accompanied by the following statement: “Move Free™ is a Proud Sponsor of the Arthritis Foundation®: Move Free™ is proud to support the Arthritis Foundation’s efforts to help people take control of arthritis.” Even though the “support” was clearly financial, “the logo and statement nonetheless draw an explicit link between the supplement and arthritis,” which was relevant to the meaning of the other statements on the label.

The court also pointed to the citation to a journal article in the “Journal of Aging and Research,” along with the choice to highlight glucosamine and chondroitin on the front of the box. Osteoarthritis is “nearly universal...by age 80,” so a citation to an aging journal on a joint supplement label was suggestive of arthritis, and industry marketing research finds that about half of arthritis sufferers view “glucosamine &/or chondroitin” as “the most effective arthritis treatment.” For the same reason as “supports joint comfort” was an implied disease statement, the statement that the product “supports 5 signs of joint health: mobility, flexibility, strength, lubrication, and comfort” was also an implied disease statement.

The court highlighted that it was not determining falsity; it was determining whether the claims were technically structure/function statements or implied disease statements solely for purposes of preemption.  RB was not constrained in its ability to argue about whether the labels implied, under state law, that the supplement would mitigate arthritis.

Falsity/misleadingness: RB relied on the purported benefits of calcium fructoborate alone, and not on the effects of glucosamine or chondroitin, but there was a triable issue of fact: RB had some evidence based on randomized control trials that calcium fructoborate can benefit joints, while the plaintiff’s expert called the methodology and reliability of those studies into question and another cultured pig cartilage in various concentrations of calcium fructoborate and found no positive effect. A jury could go either way.

Full refund theory: RB argued that even if the supplements do not help joints, they are not worthless because some of the ingredients can provide benefits unrelated to joint health. “But people purchase joint supplements for the advertised joint health benefits. … If the plaintiffs received none of the advertised joint health benefits, they are entitled to a full refund.”