Kaufman v. CVS Caremark Corp.
2016 U.S. App. LEXIS 16350
| 1st Cir. | 2016Background
- Plaintiff Ronda Kaufman bought CVS-brand Vitamin E (400 IU) in New York; the bottle labeled the supplement as supporting "heart health."
- Kaufman brought a putative class action under N.Y. Gen. Bus. Law § 349 (consumer protection) and a related unjust enrichment claim, alleging the label was deceptive because no scientifically valid studies substantiate the "heart health" claim.
- The district court dismissed under Fed. R. Civ. P. 12(b)(6), ruling federal law (FDCA § 343-1(a)(5) / § 343(r)(6)) preempted the state-law claims because the label complied with federal labeling rules.
- On appeal, the First Circuit reviewed de novo and assumed the complaint’s factual allegations (and referenced studies) as true for 12(b)(6) purposes.
- Central legal question: whether Kaufman plausibly alleged that CVS lacked the required "substantiation" ("truthful and not misleading" competent and reliable scientific evidence) for the structure/function claim "supports heart health," such that federal law would not preempt her state-law claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether FDCA preempts Kaufman's NY § 349 claim | Kaufman: no competent, reliable scientific studies substantiate CVS's "heart health" claim, so state-law claims are not preempted | CVS: complaint cites studies that, on their face, substantiate Vitamin E's antioxidant/heart functions, so FDCA preempts state claims | The allegation that CVS lacks substantiation is plausible; the cited studies do not render that allegation implausible on 12(b)(6), so FDCA preemption does not bar the NY § 349 claim |
| What constitutes "substantiation" for a dietary supplement structure/function claim | Kaufman: FDA-standard "substantiation" requires scientifically valid studies; none exists for CVS's heart-health claim | CVS: the studies cited in the complaint supply competent and reliable scientific evidence supporting the claim | Court: "substantiation" means competent, reliable scientific evidence; the complaint plausibly alleges absence of such evidence and the cited studies do not defeat that allegation at pleadings stage |
| Whether a structure/function claim can be misleading by omission (i.e., failing to disclose evidence of harm at given dosages) | Kaufman: studies suggest Vitamin E may not confer cardiovascular benefit and may increase harm at high doses, so the label omits material adverse information | CVS: structure/function claims are allowed and disclaimer appears; omission does not make the claim actionable where federal law permits such claims | Court: omission of material facts (e.g., evidence of harm at the product dosage) can render a structure/function claim misleading under FDCA § 343(r)(6)(B) and § 321(n); omission-based misleadingness is actionable |
| Whether unjust enrichment claim survives dismissal tied to deceptive labeling | Kaufman: unjust enrichment rests on the deceptive-labeling allegation | CVS: if FDCA preempts or labeling complies with FDCA, unjust enrichment fails too | Court: because the NY § 349 claim survives preemption at pleading stage, the related unjust enrichment claim also survives |
Key Cases Cited
- In re Celexa & Lexapro Mktg. & Sales Practices Litig., 779 F.3d 34 (1st Cir.) (standard of review on Rule 12(b)(6) and assuming complaint facts)
- United States v. Argentine, 814 F.2d 783 (1st Cir. 1987) (waiver principle for appellate arguments)
- Alt. Sys. Concepts, Inc. v. Synopsys, Inc., 374 F.3d 23 (1st Cir.) (Rule 9(b) particularity—who, what, where, when)
- Powers v. Bos. Cooper Corp., 926 F.2d 109 (1st Cir.) (pleading standards for fraud-like claims)
- Giragosian v. Bettencourt, 614 F.3d 25 (1st Cir.) (court may consider documents referenced in the complaint on 12(b)(6))
- Abdallah v. Bain Capital LLC, 752 F.3d 114 (1st Cir.) (no fact-finding on Rule 12(b)(6))
- Cleary v. Philip Morris, Inc., 656 F.3d 511 (7th Cir.) (unjust enrichment tied to related substantive claim)