Notification:
Novo Nordisk announced on Thursday that it had sued nine more medical spas, wellness clinics, and pharmacies in the U.S. for selling products claiming to contain semaglutide, the key ingredient in its popular weight-loss drug Wegovy.
The Danish drugmaker has now filed 21 lawsuits since June over the sale of copycat versions of semaglutide. Five sellers have been barred from selling their disputed products. One lawsuit was amended after samples tested were found to be up to 33% impure. The new lawsuits name Aesthetic Maison, BOF Medical Center, DoctorsRx, G2 Telemedicine, GenericOzempic.com, MD Exam, c, Midtown Express, and Weight Loss MD as defendants.
The lawsuits were filed in federal courts in Colorado, Florida, Illinois, Montana, Texas, and Tennessee. The defendants did not immediately respond to requests for comment.
"Non-FDA-approved compounded drugs claiming to contain semaglutide with high levels of known and unknown impurities pose significant risks to patients and may lead to serious and life-threatening reactions," said Doug Langa, Novo's head of North American operations.
In its lawsuit against Aesthetic Maison, Novo alleged that the company was selling products claiming to contain semaglutide directly to patients without any prescription from a medical professional. Testing showed that Midtown Express's drug contained no semaglutide, and MediOAK's product was of a far lower strength than advertised, according to Novo's lawsuits against those entities.
Novo also filed new allegations against Florida-based pharmacies TruLife and WellHealth, which it first sued in July.
Novo stated that when it tested the products being sold by WellHealth, it found impurities of up to 24%, including formaldehyde adduct, dimers, and other unknown impurities. Impurities were also found in TruLife's products, according to Novo.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, emphasized that legitimate compounded drugs should not be confused or conflated with counterfeit or sub-par substances created by entities seeking to exploit patient demand.
Novo's primary competitor in the obesity drug market, Eli Lilly, has also taken legal action against several medical spas, weight-loss clinics, and compounding pharmacies over the past year to prevent them from selling products claiming to contain tirzepatide, the active ingredient in its weight-loss drug Zepbound. At least four of these lawsuits from Lilly have either been settled, withdrawn, or dismissed. (Reporting by Patrick Wingrove; editing by Chizu Nomiyama and Richard Chang)