Eli Lilly and Company v. Willow Health Services, Inc.
2:25-cv-03570
| C.D. Cal. | Aug 29, 2025Background
- Willow Health Services operates an online telehealth/pharmacy platform marketing compounded, oral tirzepatide products ("Tirzepatide Drops" and "Tirzepatide Plus").
- Eli Lilly manufactures the only FDA‑approved tirzepatide medicines (MOUNJARO® and ZEPBOUND®), which are injectable and approved for certain serious conditions, not for "cosmetic" weight loss or oral administration.
- Lilly sued Willow (Apr. 23, 2025) under the Lanham Act (15 U.S.C. § 1125) and California law (UCL and FAL), alleging deceptive advertising across three theories: safety/effectiveness, personalization, and compliance/quality.
- Willow moved to dismiss under Rule 12(b)(6) (June 20, 2025), arguing Lilly lacks statutory standing and that the challenged statements are nonactionable puffery/opinion or otherwise not false.
- The Court took judicial notice of FDA documents and granted Willow’s motion: dismissed Lilly’s Lanham Act and state claims without prejudice, explaining Lilly failed to plead (1) a commercial injury and proximate cause for Lanham Act standing and (2) lost money/property for UCL/FAL standing; alternatively many challenged statements were nonactionable or not plausibly false. Lilly was given 30 days to amend.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Lanham Act statutory standing (zone of interests) | Lilly says Willow competes by advertising the same active ingredient and so suffers reputational and sales injury. | Willow says its compounded oral products are different (oral, with additives, marketed for cosmetic use) and Lilly pleads only consumer harm and vague reputational injury. | Court: Lilly alleged direct competition but failed to plead a commercial injury (no lost‑sales data or plausible chain of inference); zone‑of‑interests not satisfied. |
| Lanham Act proximate cause | Lilly claims Willow's ads will steer patients away from Lilly, lessening goodwill and sales. | Willow argues prescriptions and prescribing physicians are intervening causes; Lilly alleges no 1:1 diversion or causal chain. | Court: Lilly failed to plead proximate causation (no close link between Willow ads and lost Lilly sales); Lanham claim dismissed. |
| UCL/FAL standing (California law) | Lilly contends it lost goodwill and profits from unfair competition. | Willow says Lilly has not alleged lost money or property as required for private UCL/FAL suits. | Court: Lilly did not plead economic injury (lost money/property); state claims dismissed for lack of standing. |
| Actionability of challenged statements (safety/effectiveness, personalization, compliance) | Lilly contends numerous specific claims ("clinical trials," sublingual efficacy, superior results, "personalized" blends, rigorous partner pharmacies) are false/misleading. | Willow contends many statements are nonactionable puffery/opinion or refer to general tirzepatide science rather than claiming its products were clinically tested; 503A compounding law supports personalization claim. | Court: Many safety/effectiveness complaints rest on lack of substantiation (not provable falsity) and fail; personalization claims are consistent with 21 U.S.C. § 353A and thus not false; the "rigorous evaluations" claim is puffery. Complaint fails to state a claim. |
Key Cases Cited
- Lexmark Int’l, Inc. v. Static Control Components, Inc., 572 U.S. 118 (2014) (sets Lanham Act standing standards: zone of interests and proximate cause)
- TrafficSchool.com, Inc. v. Edriver Inc., 653 F.3d 820 (9th Cir. 2011) (presumption of commercial injury when parties are direct competitors)
- Kwan v. SanMedica Int’l, 854 F.3d 1088 (9th Cir. 2017) (private consumer suits cannot rest solely on lack of substantiation under California consumer protection laws)
- Kwikset Corp. v. Superior Ct., 51 Cal.4th 310 (2011) (UCL/FAL standing requires lost money or property)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (pleading must be plausible and give fair notice)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (conclusory allegations insufficient to survive Rule 12(b)(6))
- Southland Sod Farms v. Stover Seed Co., 108 F.3d 1134 (9th Cir. 1997) (distinguishes puffery from actionable advertising claims)
- Newcal Indus., Inc. v. Ikon Office Solution, 513 F.3d 1038 (9th Cir. 2008) (elements of a Lanham Act false advertising claim)