James Kroessler v. Cvs Health Corporation
977 F.3d 803
| 9th Cir. | 2020Background
- Plaintiff James Kroessler, a California consumer, bought a CVS glucosamine supplement (2017) and sued CVS under California UCL, CLRA, and breach of express warranty on behalf of a putative class, alleging the products falsely claim to support/maintain joint health and relieve arthritis symptoms.
- Complaint identified six CVS glucosamine-based products whose labels make structure/function claims such as ‘supports flexibility & range of motion’ and include the standard dietary-supplement disclaimer.
- Kroessler alleged (by citing clinical studies in the complaint) that glucosamine is ineffective at supporting joint health or ameliorating osteoarthritis symptoms.
- CVS moved to dismiss, arguing federal preemption under the FDCA; the district court dismissed with prejudice, finding FDCA preempted the state-law claims and denied leave to amend. Kroessler appealed.
- The Ninth Circuit reviewed de novo whether the FDCA preempts Kroessler’s state-law claims and whether the district court abused its discretion by denying leave to amend.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether FDCA preempts state-law claims challenging the truthfulness/substantiation of structure/function claims on dietary-supplement labels | Kroessler: California UCL/CLRA/warranty claims may proceed because they challenge substantiation of CVS's structure/function claims with matching evidence; state law enforces standards identical to FDCA where appropriate | CVS: Allowing the suit would effectively impose a higher/different substantiation standard and blur structure/function vs disease distinction; Dachauer supports preemption where evidence mismatches the label claim | Reversed. FDCA does not automatically preempt state claims simply because a label uses permissible structure/function language; preemption applies only if the state cause would impose different substantive substantiation requirements than the FDCA. Plaintiffs with evidence that ‘matches’ the structure/function claim may proceed beyond the pleading stage |
| Whether denying leave to amend to allege extra-label evidence supporting an implied disease claim was proper | Kroessler: Should be allowed to amend to add extra-label allegations showing the labels imply disease treatment/prevention | CVS: Denial was proper because labels are structure/function claims and thus preempted; amendment would be futile | Reversed. District court erred by denying leave to amend as futile; plaintiff may plead extra-label facts to support an implied disease claim, although the labels alone do not on their face state disease claims |
Key Cases Cited
- POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102 (recognizing private plaintiffs cannot directly enforce the FDCA)
- Dachauer v. NBTY, Inc., 913 F.3d 844 (9th Cir. 2019) (FDCA preemption where plaintiff's evidence mismatched structure/function claims; distinguishing disease vs structure/function claims)
- Farm Raised Salmon Cases, 175 P.3d 1170 (Cal. 2008) (state claims may enforce labeling so long as requirements are identical to federal law)
- Nat'l Council Against Health Fraud v. King Bio Pharm., 133 Cal. Rptr. 2d 207 (Ct. App. 2003) (private plaintiffs cannot shift burden to defendants to produce substantiation but can challenge defendants' substantiation)
- Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (plausibility standard for Rule 12(b)(6) pleadings)