Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—S.D.N.Y.: Novo Nordisk's complaint against patient-healthcare provider connector dismissed, (Aug 7, 2026)
Law Firms Mentioned:Hunton Andrews Kurth LLP
Organizations Mentioned:Covington & Burling, LLP | Hunton Andrews Kurth, LLP | Novo Nordisk | Novo Nordisk A/S | Zealthy Inc.
By Kenneth H. Ryesky, M.B.A., J.D.
Internet-based matchmaker asserts that Novo Nordisk has shifted its litigation focus from compounding pharmacies to clinics and technology companies that do not make any of the drugs at issue.
The federal district court in New York City has dismissed a complaint filed by pharmaceutical company Novo Nordisk against an operator of a middleman website that refers patients to healthcare professionals. The complaint alleged misrepresentation regarding the pharmaceutical manufacturer's drugs. The court dismissed the Lanham Act anchor claim, but deferred ruling on the pendant New York State deceptive business practices statute claim. The drug manufacturer was given leave to replead its complaint (Novo Nordisk A/S v. Zealthy Inc., No. 1:25-cv-06391-ALC (S.D.N.Y. Jul. 31, 2026)).
Background. Novo Nordisk has developed medications containing semaglutide, a GLP-1 receptor agonist used medically to manage blood sugar levels in the treatment of diabetes and/or weight control. Novo Nordisk has developed semaglutide-based proprietary medications Ozempic®, Wegovy®, and Rybelsus®, which are FDA-approved; the FDA has not approved any generic equivalents to these proprietary drugs.
Zealthy, Inc. (Zealthy) operates an online platform that functions as an intermediary to connect patients with independent healthcare providers, and to facilitate the logistics inherent in bringing prescribed medications to the patients. Zealthy has connected patients who have been prescribed semaglutide-based medications with compounding pharmacies. Compounded medications, while tailored to an individual patient's specific situation, are not approved by the FDA.
Novo Nordisk sued Zealthy, alleging that Zealthy has misrepresented the status of the drugs compounded by the compounding pharmacies and supplied to the patients Zealthy has connected with the compounding pharmacies. Novo Nordisk brought false advertising claims under the Lanham Act, and under New York's deceptive business practices statute. Zealthy moved to dismiss the complaint for failure to state a valid cause of action.
Lanham Act-false advertising. The judge ruled that Novo Nordisk did not plausibly plead false advertising under the Lanham Act. Zealthy's website stated that "GLP-1 medications, with active ingredient semaglutide, are FDA-approved for type 2 diabetes and have proven effective for weight loss." This statement was not literally false because it could be diversely construed by the reader as pertaining to Novo Nordisk's own proprietary medications, and not only medications compounded by a compounding pharmacy. Even if that statement had been misleading, Novo Nordisk did not plead actual confusion on the part of the customer deliberate deception by Zealthy, so no implied falsity was pleaded.
Novo Nordisk had alleged that Zealthy's statements regarding the clinical efficacy of the drugs, asserting that such statements were made without any supporting clinical studies "this allegation goes to lack of substantiation, rather than serving as an affirmative claim of literal or implied falsity." Likewise, Zealthy's statement comparing Ozempic® and Wegovy® to the compounded medication as "the same medication, semaglutide, and it works just the same" does not allege any falsehood.
The court thus found that Novo Nordisk's complaint did not support its standing to sue under the Lanham Act, but noted that there would be standing if Novo Nordisk had plausibly pleaded false or misleading misrepresentations on the part of Zealthy.
Lanham Act-FDCA preemption. The court found that Novo Nordisk's claim regarding FDA approval would not be preempted by the Food, Drug, and Cosmetic Act (FDCA) [FDCA, 21 U.S.C. § 301 et seq.] had it been properly pleaded. Although there is some practical overlap between the Lanham Act and the FDCA, a court's decision regarding the truth or falsity of Zealthy's advertising assertions "does not demand a level of complex scientific expertise more appropriate for the FDA."
The court found it unnecessary to address the preemption issues regarding the advertised drugs' clinical efficacy or equivalence. Inasmuch as the court was granting Novo Nordisk leave to amend its complaint, there might well be future occasion to analyze those issues. For similar reasons of judicial economy, the court also declined to rule on the New York state deceptive business practices pendant claim.
The Case is No. 1:25-cv-06391-ALC.
Judge: Carter, Jr., A.
Attorneys: Neil Kenneth Roman (Covington & Burling, LLP) for Novo Nordisk A/S. Armin Ghiam (Hunton Andrews Kurth LLP) for Zealthy Inc.
Companies: Novo Nordisk A/S; Zealthy Inc.
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