Since June, Novo Nordisk has filed over 20 lawsuits against pharmacies, spas, and wellness clinics for selling copycat versions of its popular drug Wegovy, whose key ingredient is semaglutide. According to Novo Nordisk, these firms have been selling drugs containing impurities that can prove life-threatening for users.
In one of these cases, the situation was dire enough that after testing some samples of the disputed drug, the lawsuit had to be amended to show that as much as 33% impurities were found in the drug. Additionally, 5 of these lawsuits have resulted in defendants being barred from selling the drugs in question.
Most recently, this week, Novo has brought cases against 9 establishments in federal courts in Florida, Illinois, Montana, Colorado, Tennessee, and Texas.
Aesthetic Maison is a Texas-based wellness firm that, according to Novo, has been selling drugs containing semaglutide without a prescription from medical practitioners. Moreover, they have allegedly been comparing their drugs to Novo’s Wegovy to prove their safety and effectiveness.
While the Food and Drug Administration has not yet approved a compounded form of Wegovy, Novo has brought a case against the defendant on the grounds that they have been claiming to sell products compounded from its drug Wegovy.
Given the controversies surrounding compounded drugs in these lawsuits, CEO of the Alliance for Pharmacy Compounding, Scott Brunner, was quick to point out that while some entities produce counterfeit or sub-par substances to exploit patient demand, these drugs should not be confused with legitimate compounded drugs.
In the case of Nashville-based pharmacy Midtown Express, Novo declared that the pharmacy had been selling a drug it marketed as containing semaglutide, while the reality was different. According to the legal complaint filed against MediOAK, the company was sued for trying to sell a drug it claimed was compounded with semaglutide, which was also found to be 20% weaker than what was claimed on the label.
Although not necessarily confirmed, according to the Food and Drug Administration’s database, as of March 31st, there have been over 440 cases of adverse events reported in association with compounded drugs containing semaglutide. Of these, 9 resulted in death and 99 in hospitalizations.
Doug Langa, Novo’s head of North America operations, commented on the situation by saying, “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.”
The goal of these lawsuits for Novo is to ensure that companies selling impure drugs containing semaglutide cease their sales and marketing activities. Moreover, the company is also requesting up to $75,000 in compensation.