145 F. Supp. 3d 986
S.D. Cal.2015Background
- Plaintiff John Sandoval filed a putative nationwide consumer class action over the supplement IntenseX, alleging labeling and advertising falsely promise aphrodisiac/sexual-performance benefits.
- Claims: violations of California UCL (unlawful, unfair, fraudulent), FAL, CLRA; breach of express and implied warranties; violation of Magnuson-Moss Warranty Act. Relief sought includes corrective advertising, disgorgement, restitution, damages, and injunctive relief.
- Key facts: product labels and website contain statements like “Sexual Power and Performance,” “designed to intensify your endurance, stamina, and sexual performance,” and website claims linking ingredients (e.g., tribulus, ginseng, ginkgo) to impotence/libido improvements. Plaintiff purchased IntenseX in California and alleges it did not deliver promised effects.
- Plaintiff relies on scientific literature and FDA guidance indicating limited or no reliable evidence for many listed ingredients and that aphrodisiac claims may invoke drug/new-drug regulation.
- Defendant moved to dismiss and to strike portions of the FAC, arguing (inter alia) FDCA/NLEA preemption, failure to plead falsity (only lack of substantiation), Rule 9(b) defects, and lack of standing for injunctive relief. The court denied the motion in full.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Express preemption under FDCA/NLEA | Sandoval: state claims are parallel to federal law or challenge false/misleading labeling (not preempted) and some website statements are disease claims invoking Sherman Law | Pharma-Care: labeling is permissible structure/function claims per FDA guidance, so state-law claims imposing greater/ conflicting requirements are preempted | Court: label-based structure/function theories preempted to extent they conflict with FDA guidance; other theories (website disease claims, aphrodisiac/new-drug theory, and false/misleading claims) survive because they parallel or fall outside §343(r)(6) preemption |
| Implied preemption (§337 / Buckman) | Sandoval: consumer protection claims are a permissible state-law enforcement mechanism parallel to federal law | Pharma-Care: Buckman implies preemption of state claims that intrude on FDA enforcement/regulation | Court: Buckman inapplicable; district and California supreme precedent reject implied preemption for consumer food-labeling claims; claims survive |
| Sufficiency vs. lack of substantiation | Sandoval: alleges falsity and cites studies showing ineffectiveness; FDA regulation warns aphrodisiac claims unsupported | Pharma-Care: allegations amount only to lack of substantiation (a task for AG/FDA), not provable falsity | Court: complaint alleges both lack of substantiation and affirmative factual allegations of falsity; dismissal for this reason denied (factual disputes for summary judgment) |
| Reasonable consumer / plausibility | Sandoval: consumers reasonably rely on product/website representations about sexual performance | Pharma-Care: no reasonable consumer would be deceived; claims implausible | Court: resolved factual; reasonable-consumer inquiry not appropriate at dismissal; claims plausible |
| Rule 9(b) particularity for fraud-based claims | Sandoval: alleges who (defendant), what (specific label and website statements), when (purchase), reliance, and injury | Pharma-Care: fraud not pleaded with particularity | Court: allegations sufficiently particular; Rule 9(b) satisfied |
| Breach of express and implied warranties; MMWA | Sandoval: label/representations formed basis of bargain; product failed to perform; MMWA borrows state warranty claims | Pharma-Care: descriptions are non-warranty puffery; FDCA governs labeling so MMWA inapplicable | Court: express and implied warranty claims adequately pleaded; MMWA claim survives at pleading stage (statutory interplay better suited to summary judgment) |
| Standing for injunctive relief | Sandoval: seeks injunctive relief to stop misleading labeling; alleges continued injury risk | Pharma-Care: Sandoval lacks standing because he won’t repurchase and knows the truth | Court: plaintiff has standing; motion to dismiss injunctive relief denied at this stage |
| Motion to strike punitive damages, class definition, website statements | Sandoval: alleges corporate knowledge/reckless disregard supporting punitive damages; class defined nationwide | Pharma-Care: punitive allegations insufficient; other matters immaterial | Court: decline to strike; allegations not clearly irrelevant or prejudicial at pleadings stage |
Key Cases Cited
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (pleading standard: facts must plausibly show entitlement to relief)
- Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308 (2007) (courts may consider documents incorporated by reference and judicially noticed materials on a motion to dismiss)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (state-law fraud-on-the-FDA claims impliedly preempted when they conflict with FDA enforcement)
- Williams v. Gerber Prods. Co., 552 F.3d 934 (9th Cir. 2008) (reasonable consumer test governs UCL/FAL/CLRA false advertising claims)
- Vess v. Ciba-Geigy Corp. USA, 317 F.3d 1097 (9th Cir. 2003) (Rule 9(b) requires who, what, when, where, and how for fraud allegations)
- Navarro v. Block, 250 F.3d 729 (9th Cir. 2001) (standards for Rule 12(b)(6) motions)
- In re Farm Raised Salmon Cases, 42 Cal.4th 1077 (2008) (California Supreme Court: §337(a) does not impliedly preempt state Sherman Law consumer food-labeling claims)