Novo Nordisk files nine more lawsuits over compounded semaglutide

Novo Nordisk filed nine new lawsuits against medical spas, weight-loss clinics, pharmacies and others in six states over products marketed as compounded semaglutide, the company announced at the end of May 2024 ^[1]. The states are Colorado, Florida, Illinois, Montana, Tennessee and Texas, and the new cases bring the company's total to 21 lawsuits ^[1].

What the company alleges

The nine new cases are in addition to 12 earlier lawsuits, five of which have ended in judgments barring the defendants from deceptive and illegal marketing practices related to compounded versions of Novo Nordisk's semaglutide ^[1]. Novo Nordisk is currently the only US company with FDA-approved medications containing semaglutide, and it does not sell the ingredient for use in compounding. Its semaglutide products are Ozempic, Rybelsus and Wegovy ^[1].

The new lawsuits claim the pharmacies, spas and clinics unlawfully marketed and sold compounded products that claimed to contain semaglutide. According to Novo Nordisk, testing of compounded medications from pharmacies found no semaglutide at all in some products and impurities of up to 24% ^[1]. The company also claims that one defendant, an online retailer, sold "semaglutide" directly to patients without requiring a prescription, and it raised concerns about "potentially dangerous advertisements by retailers on how to make your own injectable semaglutide at home" ^[1].

Novo Nordisk also pointed to FDA Adverse Event Reporting System data. As of March 31, 2024, the system had 442 cases of adverse events associated with compounded medications claiming to contain semaglutide. Of those, 319 were classified as "serious," with 99 hospitalizations and 7 deaths ^[1]. The reporting does not establish that the compounded products caused those events, and no such finding is described ^[1].

Doug Langa, executive vice president for North America Operations and president of Novo Nordisk, said: "Non-FDA approved compounded drugs claiming to contain semaglutide with high levels of known impurities and unknown impurities pose significant risks to patients and may lead to serious and life-threatening reactions" ^[1]. Langa said the company would continue to pursue legal action against compounded semaglutide products ^[1].

Why it matters for patients

Compounded products are not FDA-approved, and the FDA-approved semaglutide drugs are Ozempic, Rybelsus and Wegovy ^[1]. If Novo Nordisk's testing is accurate, a person who buys a product labeled as compounded semaglutide may receive a preparation that contains none of the active ingredient, or one with impurity levels the company describes as high ^[1]. A patient generally cannot confirm the contents of a compounded vial by looking at it.

Novo Nordisk's claims about prescriptions also matter: the company says one online retailer sold "semaglutide" to patients without requiring a prescription ^[1]. A compounded product sold without a prescription has not gone through the same review as an FDA-approved drug, and the company's account does not describe any oversight of that seller's product.

Only company allegations are described in this account of the filings. The lawsuits' individual claims against each named defendant, the names of the defendants, their responses and any court rulings in the new cases have not been reported ^[1]. Nor has it been disclosed which products were tested, how many samples were tested, or which laboratory performed the testing ^[1]. The 12 earlier cases and the five judgments described cover marketing practices, not patient harm ^[1].

What happens next

No hearing dates, trial schedules or further filing deadlines for the nine new lawsuits have been reported ^[1]. Novo Nordisk has said it intends to keep pursuing legal action over compounded semaglutide products ^[1].