Antitrust Law Daily Wrap Up, ADVERTISING—M.D. Fla.: Court dismisses Novo Nordisk’s adulteration, misbranding claims against compounding pharmacy, (May 20, 2025)

By Sherri M. Schroeder, J.D.

The pharmaceutical company claimed that a Florida pharmacy sold adulterated and misbranded compounded versions of Novo Nordisk’s semaglutide in violation of state law.

The U.S. District Court for the Middle District of Florida has dismissed the claims of Novo Nordisk, Inc., against Brooksville Pharmaceuticals, Inc. The international pharmaceutical company claimed that the compounding pharmacy manufactured and sold adulterated and misbranded versions of Nordisk’s semaglutide products in violation of the Florida Drug and Cosmetic Act (Florida DCA) and the Florida Deceptive and Unfair Trade Practices Act (FDUTPA). The court, however, granted summary judgment to Brooksville, finding that although Novo Nordisk had Article III standing to bring suit because it did suffer an injury in fact, its claims were moot because the drug shortage that allowed Brooksville to compound the semaglutide products had ended and Brooksville had reverted to only compounding such drugs according to statutory limitations. Furthermore, the court found that Nordisk’s FDUTPA claims were preempted by federal law and that Nordisk could not show that anyone was injured by Brooksville’s alleged adulteration and misbranding of semaglutide (Novo Nordisk, Inc. v. Brooksville Pharmaceuticals, Inc., No. 8:23-cv-1503-WFJ-TGW (M.D. Fla. May 12, 2025)).

Background. Novo Nordisk is an international pharmaceutical company with FDA approval to produce drugs containing semaglutide (Wegovy®, Ozempic®, Rybelsus®). Brooksville Pharmaceuticals, Inc. is a pharmacy that sells compounded drugs containing semaglutide. From approximately March 31, 2022, until February 21, 2025, Ozempic® and Wegovy® were on the FDA’s drug shortage list, meaning that compounding pharmacies like Brooksville were allowed to compound essentially copies of the drugs without a patient-specific prescription. Novo Nordisk’s central claim was that Brooksville was manufacturing and selling adulterated and misbranded drugs (compounded injectable semaglutide), and could continue to do so, in violation of the Florida DCA and the FDUTPA. Brooksville moved for summary judgment, arguing a lack of Article III standing, mootness because Wegovy® and Ozempic® were no longer on the FDA’s shortage list, implied preemption by the federal Food, Drug, and Cosmetic Act (FDC Act), and a failure to establish certain elements of Novo Nordisk’s FDUTPA claim.

Article III standing. Because Novo Nordisk is the only pharmaceutical company with express FDA approval to create, manufacture, and sell drugs containing semaglutide, each sale of compounded semaglutide “is likely a sale taken from Novo Nordisk,” according to the court. Therefore, Novo Nordisk met the requirement of injury-in-fact.

Mootness. However, the court also found that even if Novo Nordisk had standing to brings its claims, those claims have now become moot because the FDA removed Wegovy® and Ozempic® from the FDA’s drug shortage list, meaning compounding pharmacies like Brooksville must revert to traditional statutory limitations on compounding. Furthermore, applying the Eleventh Circuit’s three factors for determining whether a case has been rendered moot by a private actor’s voluntary cessation, the court first found that any alleged violation was isolated and not a continuing practice. Second, the “change in the FDA’s shortage list during litigation shows Brooksville was likely ‘motivated by a genuine change of heart’ (to comply with the [FDC Act] and avoid federal penalties) and not necessarily a cessation to avoid litigation with Novo Nordisk,” according to the court. Finally, although the third factor weighed against mootness because Brooksville had not acknowledged liability, the court still found it “absolutely clear that the allegedly wrongful behavior (i.e., compounding misbranded and adulterated semaglutide in bulk) could not reasonably be expected to reoccur” given that Brooksville’s decision to do so was made in response to the shortage and Brooksville had already stopped compounding copies of the drugs. Therefore, the court found that it could no longer provide “meaningful relief” to Novo Nordisk because the case was moot.

Implied preemption. Even if not moot, the court found that the FDUTPA claim would be impliedly preempted by the FDC Act. Novo Nordisk contended that its FDUTPA claim survives implied preemption since its theory was untethered to any federal law or state statute besides FDUTPA. The court, however, disagreed, finding it clear that the FDUTPA claim was based on predicate violations of the Florida DCA. The terms “adulterated” and “misbranded” used by Novo Nordisk in its pleadings were “not pulled out of thin air,” according to the court, and were “clearly drawn from the Florida DCA.” The court found that because the existence of the FDC Act was a critical element of the case, Novo Nordisk’s FDUTPA claim that Brooksville was selling adulterated and misbranded semaglutide was impliedly preempted. The court found support for this position in the express purpose of the Florida DCA, which is conformity and uniformity with the FDC Act; the mirroring of the Florida DCA’s definitions for “adulteration” and “misbranding” with the FDC Act’s definitions; and multiple references and incorporations throughout the Florida statute to the “federal act.” Finally, the court found that Brooksville’s duty not to produce adulterated and misbranded semaglutide did not predate the FDC Act, as claimed by Nordisk, and it was a duty that Brooksville owed to the FDA, not Novo Nordisk.

FDUTPA claim. The court also found that summary judgment was warranted on the merits because, under the standard for a motion for summary judgment, Florida law requires Novo Nordisk to prove that Brooksville’s adulterated semaglutide inflicted actual harm on at least one Florida consumer. Here, however, Nordisk failed to identify a single instance in which a patient was injured from the use of Brooksville’s compounded semaglutide. Additionally, according to the court, Novo Nordisk’s “hypothetical possibility of some future injury to Florida consumers based on impurities in compounded semaglutide (which could be materially different given that Brooksville is only providing patient-specific prescriptions post-shortage) is insufficient to survive summary judgment.” Nordisk’s deceptive trade practice claim based on Brooksville’s allegedly misbranding fared no better because although Nordisk could point to five (out of 24,000) Brooksville customers who reported their semaglutide prescriptions were “ineffective,” Nordisk had not tested the potency on the compounded semaglutide they received.

Therefore, the court granted Brooksville’s motion for summary judgment and closed the case.

The case is No. 8:23-cv-1503-WFJ-TGW.

Judge: Jung, W.

Attorneys: Gregory L. Halperin (Covington & Burling LLP) for Novo Nordisk Inc. Matthew J. Modafferi (Frier Levitt LLC) for Brooksville Pharmaceuticals Inc.

Companies: Novo Nordisk Inc.; Brooksville Pharmaceuticals Inc.

Cases: Advertising StateUnfairTradePractices FloridaNews