648 F. App'x 609
9th Cir.2016Background
- ThermoLife sued competitor Gaspari Nutrition, alleging false advertising under the Lanham Act and Arizona unfair competition based on GNI’s 2005–2010 marketing of testosterone boosters as “safe,” “natural,” “legal,” and DSHEA-compliant.
- District court excluded four of ThermoLife’s experts, granted summary judgment for GNI on preclusion/preemption and on falsity, materiality, and injury grounds, and denied discovery sanctions and Rule 59(e) relief.
- ThermoLife appealed; Ninth Circuit reviewed FDCA preclusion/preemption de novo and expert exclusions for abuse of discretion.
- Ninth Circuit held FDCA did not preclude Lanham Act claims nor preempt the state unfair-competition claim, relying on Pom Wonderful and related principles.
- The court reversed exclusion of Dr. Sox (safety opinion) and Berger (consumer survey on materiality) as improperly excluded, but affirmed exclusion of Hornbuckle (subjective injury methodology) and Epperson (damages model tied to excluded opinion).
- Ninth Circuit concluded triable issues exist on falsity (legal-compliance claims, safety, and natural-origin claims), materiality, and injury; vacated summary judgment and remanded for further proceedings.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether FDCA precludes Lanham Act claims | FDCA does not preclude ThermoLife’s Lanham Act suit | FDCA (and PhotoMedex rule) bars Lanham suits that require litigating alleged FDCA violations | FDCA does not preclude Lanham Act claims (Pom Wonderful controls) |
| Whether FDCA preempts state unfair-competition claim | State claim parallels federal duties and is not preempted | FDCA’s express and implied preemption displaces state claim | Unfair-competition claim not preempted; district court erred in finding abandonment |
| Admissibility of expert evidence (Dr. Sox, Berger, Hornbuckle, Epperson) | Dr. Sox and Berger admissible; Hornbuckle and Epperson unreliable | Court should exclude all four as unreliable/irrelevant | Reversed exclusion of Dr. Sox and Berger; affirmed exclusion of Hornbuckle and Epperson |
| Sufficiency of evidence for falsity, materiality, and injury under Lanham Act | Evidence (emails, recall, Dr. Sox, Berger survey, internet posts) creates triable issues on falsity, materiality, injury | Statements are nonactionable opinion or presumed safe; no proof of consumer harm | Triable issues exist on all six Lanham Act claims (falsity, materiality, injury); summary judgment vacated |
Key Cases Cited
- PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010) (FDCA preclusion analysis and limits on Lanham claims)
- Pom Wonderful LLC v. Coca-Cola Co., 134 S. Ct. 2228 (U.S. 2014) (FDCA generally does not preclude Lanham Act false-labeling claims)
- Omnicare, Inc. v. Laborers Dist. Council Constr. Indus., 135 S. Ct. 1318 (U.S. 2015) (opinion statement actionable if speaker lacks honest belief)
- Southland Sod Farms v. Stover Seed Co., 108 F.3d 1134 (9th Cir. 1997) (survey evidence probative on materiality and admissibility principles)
- Fortune Dynamic, Inc. v. Victoria's Secret Stores Brand Mgmt., Inc., 618 F.3d 1025 (9th Cir. 2010) (standards for admissibility of survey evidence)
- TrafficSchool.com, Inc. v. Edriver Inc., 653 F.3d 820 (9th Cir. 2011) (presumption of commercial injury where direct competitors and likelihood of deception)
- Gen. Elec. Co. v. Joiner, 522 U.S. 136 (U.S. 1997) (analytical gap standard for expert testimony)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (U.S. 1999) (trial court discretion on expert reliability)
- Harper House Inc. v. Thomas Nelson, Inc., 889 F.2d 197 (9th Cir. 1989) (evidence of causation and deception required for Lanham injury)