Summary
The Ninth Circuit reversed the dismissal of James Kroessler’s putative class action against CVS Health Corporation concerning allegedly false or misleading claims on glucosamine-based dietary supplement labels. The court held that the Federal Food, Drug, and Cosmetic Act did not preempt California claims challenging substantiation of structure/function claims where the allegations and evidence matched those claims. The court also held that amendment was not necessarily futile and remanded for further proceedings.
Topics
Practice areas
Questions Presented
- Whether the FDCA expressly preempted Kroessler's California claims challenging CVS's glucosamine supplement structure/function claims.
- Whether the FDCA preempted the claims when the plaintiff's factual allegations and proposed evidence directly matched and challenged the substance of the structure/function claims rather than asserting a different disease claim or mortality claim.
- Whether the district court erred in denying leave to amend as futile when the plaintiff could allege extra-label evidence supporting an implied disease claim.
- Whether CVS's supplement labels, considered alone, presented implied disease claims.
Holdings
- The FDCA does not preempt California false-advertising and related state-law causes of action merely because the challenged dietary-supplement label contains a proper structure/function claim. Preemption applies only when the state-law claim would impose a substantiation standard different from the FDCA's standard.
- Dachauer did not require preemption here because Kroessler's allegations matched CVS's structure/function claims and did not concern effects on all-cause mortality.
- The district court erred in denying leave to amend as futile because the FDCA permits courts evaluating implied disease claims to consider extra-label evidence, and Kroessler could potentially allege such evidence.
- The district court correctly concluded that CVS's glucosamine supplement labels did not present implied disease claims on their face alone.
Key quotations
“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.” (19)
“Because Kroessler may have been able to “bolster” his complaint with allegations of extra-label evidence showing that CVS’s glucosamine-based supplements present implied disease claims, the court erred by denying him leave to amend his complaint based on futility.” (26)
Factual background
Kroessler purchased a CVS glucosamine-based supplement believing it would provide advertised joint-health benefits. He alleged that CVS's labels represented that the supplements supported or maintained joint health, flexibility, cartilage health, and joint comfort, but that scientific studies showed glucosamine was ineffective for those purposes. He asserted California Unfair Competition Law, Consumer Legal Remedies Act, and breach-of-express-warranty claims on behalf of a putative class.
Procedural history
Kroessler filed a putative class action alleging that CVS glucosamine-based supplements made false or misleading structure/function claims. The Southern District of California granted CVS's motion to dismiss and denied leave to amend. Kroessler timely appealed under the Class Action Fairness Act, and the Ninth Circuit reversed and remanded.
Remand instructions
The district court must allow the state-law claims to proceed beyond dismissal on FDCA-preemption grounds and give Kroessler an opportunity to amend to allege extra-label evidence supporting an implied disease claim. The court may evaluate the sufficiency of the evidence at a later procedural stage.