Kroessler v. CVS Health Corp., 2020 WL 5987498, --- F.3d ----, No. 19-55671 (9th Cir. Oct. 9, 2020)
Kroessler alleged
that CVS glucosamine-based supplements didn’t provide the advertised benefits;
the district court dismissed his California claims on preemption grounds. The
court of appeals reversed and remanded.
The express marketing message—which CVS concedes—states that CVS’s
glucosamine-based supplements maintain or support joint health. Kroessler
alleges that the implied marketing message—which CVS contests—states that the supplements
ameliorate the cardinal symptoms of arthritis, namely joint pain, discomfort,
stiffness, and lack of mobility or flexibility. Kroessler alleges that the
supplements do not provide the advertised benefits.
Label claims included
“[s]upports flexibility & range of motion,” “help[s] support and maintain
the structure of joints,” and “work[s] to support joint comfort while helping
to promote joint mobility.” The label also states that the supplement “is not
intended to diagnose, treat, cure, or prevent any disease” and that
“[i]ndividual results may vary.” Another label stated that the supplement
“[n]ourishes cartilage and promotes comfortable joint movement” and “[s]upports
cartilage health & joint comfort.”
Kroessler alleged that
glucosamine neither supports healthy joint function nor ameliorates joint pain,
discomfort, stiffness, or other symptoms of joint disease, and alleged that
good studies supported his claims.
The FDCA expressly
preempts “state-law requirements for claims about dietary supplements that
differ from the FDCA’s requirements.” Private plaintiffs may bring only actions
to enforce violations of “state laws imposing requirements identical to those
contained in the FDCA.” But: The FDCA requires manufacturers of dietary
supplements to ensure that the labels on their products are not “false or
misleading in any particular.”
The FDA specifies
that a supplement’s label is misleading if, among other things, it “fails to
reveal facts that are: (1) Material in light of other representations made or
suggested by statement, word, design, device or any combination thereof; or (2)
Material with respect to consequences which may result from use of the article
under: (i) The conditions prescribed in such labeling or (ii) such conditions
of use as are customary or usual.” The FDCA distinguishes between “disease
claims” and “structure/function claims”; the latter requires (1) substantiation
of truth/nonmisleadingness; (2) prominent disclaimers of FDA evaluation and of
lack of disease claims; and (3) avoidance of a disease claim. Appropriate
structure/function claims don’t require FDA preapproval.
FDA guidance recognizes
that structure/function claims may use general terms such as “strengthen,”
“improve,” and “protect,” as long as the claims “do not suggest disease
prevention or treatment.” For example, the FDA states that “ ‘joint pain’ is
characteristic of arthritis ... [but] [t]he claim ‘helps support cartilage and
joint function,’ on the other hand, would be a permissible structure/function
claim, because it relates to maintaining normal function rather than treating
joint pain.” Supplement makers “can substantiate structure/function claims with
evidence of an effect on a small aspect of the related structure/function,
rather than with evidence of an effect on the main disease that consumers might
associate with a given bodily structure or function.”
Previous case law
has found preemption when plaintiffs challenged structure/function claims
without sufficient evidence of misleadingness. Moreover, even though the FDCA
requires substantiation, California private plaintiffs can’t bring pure lack of
substantiation claims. “But just because California law prohibits private
plaintiffs from forcing defendants to substantiate their advertising claims,
that does not mean California law prohibits those plaintiffs from attacking
defendants’ substantiation.” There isn’t preemption “when a plaintiff attempts
to hold a defendant to the same substantiation standard required by the FDCA.”
In a footnote, the
court pointed out that the FDA said structure/function claims have to be
truthful and not misleading, which counsels in favor of adequate substantiation
“for each reasonable interpretation of the claims,” consistent with the FTC’s
view. The FDA also considers whether, if multiple studies exist, the most
reliable of them point in a particular direction, and it considers the totality
of the evidence; the court commented that “[t]his implies that a defendant’s
substantiation may be evaluated and challenged.”
The district court
interpreted past precedent to preempt any state law claim “seeking to challenge
the substantiation of a structure/function claim … so long as the
manufacturer’s claims are proper structure/function claims.” It thus rejected citations
to studies alleging that glucosamine is “ineffective at supporting or
benefiting joint health.” This was error. Kroessler alleged that the
structure/function claims themselves were false “because scientific studies
directly refute them.” To be sure, many of the studies didn’t match the exact
terms of the labels, and many of the titles suggested that they narrowly
address glucosamine’s effects on osteoarthritis, rather than its wider efficacy
in supporting or maintaining joint health. But he alleged that the contents of
the studies support the conclusion that glucosamine is “ineffective” at
“supporting, maintaining, or benefiting the health of human joints.” If true,
CVS’s explicit claims would be false.
“The FDCA does not
preempt California false advertising causes of action simply because the
challenged label contains a proper structure/function claim; instead,
preemption applies only if the plaintiff’s legal claims and factual allegations
would hold a defendant to a different ‘substantiation’ standard than the FDCA.”
Ultimately, “the
district court erred by greatly expanding the present state of federal
preemption jurisprudence under the FDCA, contrary to public policy.” It isn’t
enough for a supplement maker to make “proper structure/function claims.”
Rather (quoting a treatise), “it is well established that ‘supplement makers
can be sued for false claims, and no federal preemption exists under the FDCA
either by statute or by implication, since the FDA does not occupy the field
and its controls are unaffected by private false advertising suits against
supplement makers.’” The FDCA explicitly leaves open a path for non-FDA
enforcers against false or misleading statements.
In addition,
Kroessler should have been allowed leave to amend to add an “implied disease”
claim. “The FDA recognizes that products
marketed as supplements may nevertheless implicitly claim to impact a disease
or the signs of symptoms of a disease.” Its definition says that
structure/function claims aren’t disease claims “unless the statement implies
disease prevention or treatment,” which can depend on context. Implication can
come from words or images, and there can be implied disease claims even without
anything specific on the label. “We need not delineate what types of evidence
courts may consider when evaluating implied disease claims. It is sufficient to
state that many other courts have considered extra-label material when
identifying implied disease claims and that those considerations are best made
by district courts on a case-by-case basis.” In a footnote, the court mentions
“factors such as the product’s advertisements, the consumer’s experience with
the product, and market research showing consumer’s typical uses of the
product.”
The district court
erred when it “considered only the objective representations on the label of
the glucosamine-based supplement that Kroessler purchased,” and found that no
implied disease claim could be stated because the label had only proper
structure/function claims. Kroessler
should have been allowed to amend his complaint, even though the district court
was correct to hold that the label on its face didn’t present implied disease
claims. E.g., “the images on the labels show an elderly couple leisurely
walking along a beach, far from suffering with the symptoms of arthritis,” and
there weren’t before and after comparisons. But Kroessler might be able to allege
extra-label evidence showing that CVS’s glucosamine-based supplements present
implied disease claims.
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