Paul Dachauer v. Nbty, Inc.
913 F.3d 844
| 9th Cir. | 2019Background
- Plaintiff Paul Dachauer bought vitamin E supplements labeled to “support cardiovascular health,” “promote[] immune function,” and similar structure/function claims.
- Dachauer sued under California’s Unfair Competition Law (Bus. & Prof. Code § 17200) and Consumers Legal Remedies Act (Civ. Code § 1770), alleging the labels were false or misleading.
- Federal law (FDCA and FDA guidance) distinguishes disease claims (which claim to prevent/treat disease) from structure/function claims (which describe effects on body structure/function and may not claim to prevent disease).
- FDCA § 343-1(a)(5) preempts state-law requirements for labeling claims that are not identical to § 343(r) requirements.
- Plaintiff’s expert testified vitamin E does not prevent cardiovascular disease and may correlate with increased all-cause mortality; Plaintiff argued labels were false or misleading for failing to disclose that.
- The district court granted summary judgment for defendants; the Ninth Circuit affirmed, finding FDCA preemption of many claims and insufficient evidence to show labels omitted a material risk that vitamin E increases mortality.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether California false-advertising claims are preempted by FDCA § 343-1(a)(5) when plaintiff challenges structure/function labels | Dachauer contends labels are false because supplements do not prevent cardiovascular disease (and so state law can require more) | Defendants say FDCA permits structure/function claims and § 343-1(a)(5) preempts conflicting state requirements | Preempted: state law cannot impose a requirement that structure/function claims must be substantiated by disease-prevention evidence; FDCA controls |
| Whether labels claiming to “support/promote heart/cardiovascular/circulatory health” are false because they don’t prevent cardiovascular disease | Dachauer: such claims are false unless the supplement prevents cardiovascular disease | Defendants: those are permissible structure/function claims under FDCA and FDA guidance; they need only substantiation of structural/functional effect, not disease prevention | Held for defendants: plaintiff’s attempt to treat structure/function claims as disease claims is preempted by FDCA |
| Whether immune-health structure/function claim is false because supplements do not reduce all-cause mortality or may increase it | Dachauer: claim misleading because vitamin E fails to reduce or may increase all-cause mortality; omission of that risk makes label misleading under California law | Defendants: FDCA does not require proving reduction in all-cause mortality; no labeling duty to disclose such when not established | Partly not preempted: FDCA does not require mortality-reduction proof, but FDCA and FDA regulations both require disclosure of material risks (e.g., increased mortality) — so nondisclosure of a known increased mortality risk would be actionable |
| Whether Plaintiff produced evidence that the labels omitted a material risk (increased all-cause mortality) sufficient to create a triable issue | Dachauer relies on meta-analyses suggesting a possible small correlation between high-dose vitamin E and increased all-cause mortality | Defendants: the cited studies do not show causation, do not identify causes of death, and do not prove supplements are harmful as opposed to ineffective | Held for defendants: the record lacked sufficient evidence that vitamin E increases mortality such that failure to disclose was misleading; summary judgment affirmed |
Key Cases Cited
- Albino v. Baca, 747 F.3d 1162 (9th Cir.) (standard for de novo review and viewing evidence in light most favorable to nonmoving party)
- Williams v. Gerber Prods. Co., 552 F.3d 934 (9th Cir.) (California law prohibits advertising that is literally true but actually misleading)
- Kasky v. Nike, Inc., 45 P.3d 243 (Cal. 2002) (defining misleading commercial speech standard under California law)
- Kaufman v. CVS Caremark Corp., 836 F.3d 88 (1st Cir.) (structure/function claims can be misleading if they fail to disclose harmful aspects)
- Astiana v. Hain Celestial Grp., Inc., 783 F.3d 753 (9th Cir.) (appellate consideration of alternative grounds raised below)
- Ventura Packers, Inc. v. F/V Jeanine Kathleen, 305 F.3d 913 (9th Cir.) (appellate leave-to-amend arguments raised for first time on appeal are typically denied)
- National Council Against Health Fraud, Inc. v. King Bio Pharm., Inc., 133 Cal. Rptr. 2d 207 (Ct. App. 2003) (private plaintiffs cannot compel substantiation; burden is to produce evidence that statement is false)