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.”

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