Eli Lilly and Company v. Mochi Health Corp., et al.

Background

Eli Lilly and Company sued Mochi Health Corp., Mochi Medical CA, P.C., Mochi Medical P.A., and Aequita Pharmacy LLC. Lilly alleged that the defendants misled consumers into buying compounded versions of Lilly’s FDA-approved MOUNJARO® and ZEPBOUND® medications, which contain the active ingredient tirzepatide.

Lilly asserted four causes of action: violations of California’s Unfair Competition Law and False Advertising Law by Mochi Health; a claim under the Lanham Act, a federal law addressing certain false or misleading commercial statements; and a civil-conspiracy claim against all defendants. The complaint alleged that Mochi Health changed medication dosages and added ingredients without patient consent or a clinical indication, and made misleading statements about the source, safety, effectiveness, personalization, and compounding of its medications.

Standing and Subject-Matter Jurisdiction

The defendants moved to dismiss all claims under Federal Rule of Civil Procedure 12(b)(6), which allows dismissal when a complaint does not adequately state a claim. The court instead focused on whether Lilly had constitutional standing, meaning a concrete injury that could be connected to the defendants’ conduct and addressed by a court order. The court raised that issue during the proceedings even though the parties had not addressed it in their briefs.

The court held that Lilly had not plausibly alleged an injury in fact. Lilly alleged harm to consumers and reputational harm to itself. Its theory was that consumers who had poor results or harmful experiences with Mochi’s compounded tirzepatide might draw negative conclusions about Lilly’s FDA-approved products.

The court found that the complaint did not allege that any Mochi customer failed to achieve expected weight-loss results. It also found no facts supporting an inference that compounded tirzepatide was inferior merely because it was compounded. The court noted that compounding is a federally recognized and regulated practice, so the existence of compounded medication alone did not plausibly establish reputational harm to Lilly.

The court also rejected Lilly’s reliance on a single Better Business Bureau complaint from an unidentified customer who allegedly developed a rash that a dermatologist attributed to niacinamide. The court explained that the customer knew niacinamide had been added, and the complaint did not support an inference that customers would attribute that problem to Lilly’s products, which do not contain niacinamide. Because Lilly had not plausibly alleged an injury, the court concluded that it lacked subject-matter jurisdiction over the case.

Disposition

The court granted the defendants’ motion to dismiss, without prejudice and with leave to amend, on grounds different from those urged by the defendants. The court allowed Lilly to amend all previously asserted claims and required any amended complaint to be filed by November 14, 2025. Lilly must seek further leave of court to add new claims or defendants.

The defendants also asked the court to take judicial notice of 12 documents. Because the court did not need material outside the pleadings to resolve the standing issue, it denied that request as moot, without prejudice to a later request in a subsequent motion.