567 F.Supp.3d 1172
S.D. Cal.2021Background
- Plaintiffs (Corbett, Luciano, Dobbs) sued PharmaCare over Sambucol elderberry dietary supplements, alleging misleading labels and advertising and asserting putative national and state subclasses (CA, MA, MO).
- Two core theories: (1) "illegal products" — elderberry extract is a new dietary ingredient (NDI) for which no FDA pre‑notification was made, rendering products adulterated/misbranded under the FDCA; (2) false/misleading labels/omissions — claims such as “scientifically tested,” “virologist developed,” and “supports immunity” imply disease‑treatment/prevention.
- Plaintiffs allege they saw and relied on label/website/TV/Amazon representations and suffered economic loss (would not have purchased otherwise).
- PharmaCare moved to dismiss under Rules 9(b), 12(b)(1) and 12(b)(6), raising standing, preemption, Rule 9(b) particularity, warranty/privity, and pre‑suit notice challenges.
- Court denied most dismissal grounds (standing, preemption, Rule 9(b), warranty claims) but granted dismissal without prejudice of CLRA damages and the Mass. Gen. Laws ch. 93A claim for failure to comply with statutory pre‑suit notice requirements; plaintiffs may amend within 45 days.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Statutory standing under UCL/FAL/CLRA (reliance/causation) | Plaintiffs relied on alleged misrepresentations and suffered economic loss; reliance is pled. | Regulatory violations alone can't confer standing absent reliance. | Plaintiffs adequately pled actual reliance/causation; dismissal denied. |
| FDCA/NLEA preemption (structure/function vs. implied disease claims; field/conflict) | Claims rest on state law parallel to FDCA or on extra‑label advertising that, in context, implies disease claims not protected by NLEA preemption. | FDCA/NLEA preempts state claims that conflict or would enforce FDCA; structure/function statements (e.g., "supports the immune system") are permitted. | Court finds plaintiffs’ collective label/extra‑label allegations can amount to implied disease claims and are not expressly or impliedly preempted; dismissal denied. |
| Fraud particularity (Rule 9(b)) | FAC narrows time/places, identifies specific statements relied on, and alleges who saw/relied when; cures prior defects. | Plaintiffs fail to plead falsity and the who/what/when/where/how with required specificity. | FAC satisfies Rule 9(b) specificity (who/what/when/where identified); dismissal denied. |
| Breach of implied warranty — privity and food/drug exception | Plaintiffs invoke food/drug exception (and third‑party beneficiary theory) to avoid privity; economic loss is compensable. | Privity required; exceptions limited and apply chiefly where physical injury alleged. | Court accepts food/drug exception can apply without allegations of physical injury and denies dismissal of implied warranty claim. |
| CLRA and Mass. ch.93A pre‑suit notice | Plaintiffs sent demand letters and gave opportunity to cure; seek damages. | CLRA letter not sent to defendant’s California principal place of business and failed to specify §1770 provisions; Mass. notice filed <30 days before suit. | CLRA damages claim dismissed without prejudice for improper content/place of notice (leave to amend once notice cured). Mass. ch.93A claim dismissed without prejudice for failing 30‑day requirement (content of MA letter was adequate). |
Key Cases Cited
- Hinojos v. Kohl's Corp., 718 F.3d 1098 (9th Cir. 2013) (Prop 64 limited standing under UCL/FAL to those who lost money or property and require causation/reliance)
- Kwikset Corp. v. Superior Ct., 51 Cal.4th 310 (Cal. 2011) (actual reliance required for UCL/FAL standing in fraud‑based consumer claims)
- In re Tobacco II Cases, 46 Cal.4th 298 (Cal. 2009) (materiality of misrepresentation generally a factual question)
- Moore v. Mars Petcare U.S., Inc., 966 F.3d 1007 (9th Cir. 2020) (inference of reliance from material misrepresentation survives motion to dismiss)
- Greenberg v. Target Corp., 985 F.3d 650 (9th Cir. 2021) (NLEA/DSHEA framework and preemption analysis for dietary supplements)
- Kroessler v. CVS Health Corp., 977 F.3d 803 (9th Cir. 2020) (courts may consider extra‑label materials when assessing implied disease claims)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (U.S. 2001) (fraud‑on‑the‑FDA claims implicate federal enforcement and may be preempted in other contexts)
- In re Farm Raised Salmon Cases, 42 Cal.4th 1077 (Cal. 2008) (state law analogous claims permitted unless preempted by FDCA/NLEA)
- Burr v. Sherwin‑Williams Co., 42 Cal.2d 682 (Cal. 1954) (foodstuffs exception to privity for implied warranty of fitness for human consumption)
- Clemens v. DaimlerChrysler Corp., 534 F.3d 1017 (9th Cir. 2008) (privity exceptions and scope under California Commercial Code)