Go to Wolters Kluwer VitalLaw.comGo to Wolters Kluwer VitalLaw.com
VitalLaw®
  • Find answers to your questions
  • Log in to access your subscriptions
In depth. On point.
In depth. On point.
  • Home
  • Legal Directory
  • Home
  • Legal Directory
In depth. On point.
  • Articles
  • Articles
  • Law Firms
  • Law Firms
  • Organizations
  • Organizations
    • MEDICAID—D. Mass.: Planned Parenthood dismisses challenge to OBBBA’s Medicaid defunding provision
    • ADMINISTRATION OF FDC ACT —S.D. Fla.: Pharmaceutical company’s action seeking declaratory, injunctive relief against FDA may proceed
    • ADVERTISING (FOOD, DRUG & MEDICAL DEVICES) —E.D. Wash.: Manufacturer has standing to sue compounding pharmacy for false advertising, unfair competition
    • AGENCY NEWS—CMS secures $600 million in voluntary technology support for Medicaid community engagement implementation
    • CONTROLLED SUBSTANCES—NOTICES: DEA publishes notice of import application
    • ELECTRONIC HEALTH RECORDS —S.D. Fla.: Patients obtain final approval of $5 million settlement with billing company after data breach
    • GENERAL HEALTH CARE NEWS —PROPOSED RULES: HHS re-opens public comment period due to administrative technical issues
    • LABELING AND PACKAGING (FOOD, DRUGS & MEDICAL DEVICES)—N.D. Cal.: Claims against Procter & Gamble over retinol products are dismissed without prejudice
    • SKILLED NURSING FACILITIES—DAB DEICSIONS: Civil monetary penalty merited against New York skilled nursing facility
  • Articles
  • Articles
  • Law Firms
  • Law Firms
  • Organizations
  • Organizations

    Health Law Daily Wrap Up, ADVERTISING (FOOD, DRUG & MEDICAL DEVICES) —E.D. Wash.: Manufacturer has standing to sue compounding pharmacy for false advertising, unfair competition, (Feb 3, 2026)

    Law Firms Mentioned:Covington & Burling LLP | Miller Nash LLP
    Organizations Mentioned:Covington & Burling, LLP | Ikon Health LLC d/b/a Invigor Medical LLC | Miller Nash, LLP | Novo Nordisk | Novo Nordisk A/S | Novo Nordisk Inc.

    By Robert Margolis, J.D.

    Novo Nordisk alleged injury based on statements regarding compounded semaglutide products sufficient for standing under Article III, the Lanham Act, and Washington state law.

    Novo Nordisk’s allegations that compounding pharmacy Ikon Health LLC ...

    By Robert Margolis, J.D.

    Novo Nordisk alleged injury based on statements regarding compounded semaglutide products sufficient for standing under Article III, the Lanham Act, and Washington state law.

    Novo Nordisk’s allegations that compounding pharmacy Ikon Health LLC made false and misleading statements that its compounded drugs containing the same semaglutide as used in Novo’s Ozempic®, Rybelsus®, and Wegovy®, are “FDA-approved” or are generic versions of Novo’s FDA-approved products, and that those statements have confused consumers, sufficiently alleged injury to Novo to grant it standing to sue, the federal district court in Washington has held. The court denied Ikon’s motion for judgment on the pleadings under Federal Rule of Civil Procedure 12(c), rejecting Ikon’s arguments that Novo lacks standing under Article III, the Lanham Act, and Washington law (Novo Nordisk A/S v. Ikon Health LLC, No. 4:24-CV-05093-RLP (E.D. Wash. Jan. 26, 2026)).

    Compounding. Novo has developed and markets the FDA-approved semaglutide drugs Ozempic®, Rybelsus®, and Wegovy®, the first two approved for treating type-two diabetes and the third for weight management. Novo is the only U.S. company with FDA-approved products containing semaglutide. The FDA has not approved any generic semaglutide drug products. Ikon markets and sells compounded drugs purporting to contain semaglutide; while not illegal, compounded drugs are neither FDA approved nor generic versions of FDA-approved drugs.

    Novo sued Ikon for making false and misleading statements in its advertising about its compounded semaglutide products, that “claim[] or impl[y] that its Unapproved Compounded Drugs are FDA-approved and contain the same semaglutide that the FDA evaluated in the context of reviewing and approving Novo Nordisks’s” drugs. Novo alleged Ikon has advertised “semaglutide” as “FDA-approved,” has stated its drugs have the “same active ingredient as Wegovy, Ozempic, and Rybelsus,” and has stated or implied its drugs are generic versions of the Novo drugs. Novo alleged these statements are false and misleading, since the FDA only approves complete medications, not molecules like semaglutide, has never approved Ikon’s products, and Ikon’s products cannot be deemed generic because such a designation requires specific FDA findings and no generics of Novo’s drugs have been designated. Novo alleged these false and misleading statements confuse consumers in the marketplace and pointed to social media postings by consumers evidencing their confusion.

    Novo sued Ikon for false advertising in violation of the Lanham Act, 15 U.S.C. § 1125(a)(1)(B), common law unfair competition, and violation of Washington’s Consumer Protection Act, RCS 19.86.010 et seq. Ikon moved for judgment on the pleadings, seeking dismissal for lack of standing and contending Novo had not alleged any actionable injury.

    Article III. Article III standing requires a plaintiff to establish an injury-in-fact, causation, and that the injury can be redressed in the lawsuit. In a false advertising lawsuit, these elements are established when the plaintiff alleges that some consumers who purchased the defendant’s products under a mistaken belief fostered by the false or misleading statements otherwise would have purchased the plaintiff’s products. Novo met that requirement, the court held, by alleging Ikon improperly suggests to consumers its drugs are the same as Novo’s FDA-approved products. The social media posts Novo cited in its complaint indicate at least some consumers have purchased Ikon’s products believing them to be the same as Novo’s, and it stands to reason that there are more such consumers. This suffices to allege the requisite injury for Article III standing the court held.

    Lanham Act. Standing to bring a Lanham Act claim requires (1) commercial injury, and (2) proximate cause. The commercial injury element is satisfied where the plaintiff and defendant are direct competitors and the defendant’s misrepresentations tend to mislead consumers. Novo and Ikon clearly are competitors, as evidenced by Ikon’s own marketing materials, which compare its products to Novo’s brand name drugs. Further, Novo has alleged consumers have purchased Ikon’s products under the mistaken belief they either were Novo’s products or identical thereto.

    The court rejected Ikon’s argument that Novo cannot establish proximate cause because the sale of Ikon’s drugs requires a doctor’s prescription, which is an intervening act that breaks the chain of causation. It noted that other courts have addressed and rejected that argument.

    Washington law. For standing under the Washington Consumer Protection Act (“CPA”), a plaintiff must allege an injury to business or property caused by the defendant’s unfair or deceptive acts. By alleging Ikon’s deceptive advertising cuts into Novo’s market share, Novo met the requirements for standing under the CPA, the court held.

    No preemption. The court also gave short shrift to Ikon’s argument that Novo’s claims are preempted by federal law. Novo did not allege Ikon’s sale of its compounded drug products violates federal law or regulation concerning the manufacture or sale of drugs, instead bringing claims related solely to allegedly false and misleading statements.

    The case is No. 4:24-CV-05093-RLP.

    Judge: Pennell, R.

    Attorneys: Francoise N. Djoukeng (Covington & Burling LLP) for Novo Nordisk A/S and Novo Nordisk Inc. Daniel J. Oates (Miller Nash LLP) for Ikon Health LLC d/b/a Invigor Medical LLC.

    Companies: Novo Nordisk A/S; Novo Nordisk Inc.; Ikon Health LLC d/b/a Invigor Medical LLC

    Cases: CaseDecisions AdvertisingNews GCNNews PrescriptionDrugNews WashingtonNews

    © 2026 CCH Incorporated and its affiliates and licensors. All rights reserved.

    • Manage Cookie Preferences
    • Privacy Statement
    • Terms of Use