Ozempic maker Novo Nordisk is facing a proposed class action lawsuit that alleges the company has not properly warned Canadians about severe side effects, including stomach paralysis and gallbladder disease.
The proposed class action lawsuit was filed on Oct. 6 in British Columbia for alleged damages arising from Novo Nordisk’s drugs Ozempic, Rybelsus and Wegovy. The lawsuit claims the pharmaceutical company was “negligent” in sufficiently warning health-care professionals and the public about the “dangerous” risks linked with the drugs.
“It’s filed as a national class on behalf of all Canadians that have taken Ozempic,” said Jill McCartney, a lawyer and partner at Siskinds, the London, Ont.-based law firm behind the litigation.
“The alleged risks with the drug and injuries that people have suffered relate to problems with gastrointestinal issues… notably stomach paralysis and intestinal blockages.”
None of the claims laid out in the proposed class action lawsuit have been proven in court.
Ozempic and Rybelsus were approved by Health Canada as medications to treat diabetes, but not weight loss. However, they are heavily marketed as weight loss drugs. Wegovy, a higher-dose version of Ozempic, was approved for weight loss in Canada but has never been sold in the country due to high global demand and supply shortages.
Since Ozempic’s approval in 2018, it has gained significant popularity in Canada. The drug’s medical ingredient, semaglutide, works by mimicking a hormone called glucagon-like peptide-1 (GLP-1). This stimulates the release of insulin and helps to reduce blood sugar spikes. It’s also effective at regulating diet by targeting areas of the brain that make a person feel fuller.
On Ozempic’s website, the main side effects listed include nausea, diarrhea, vomiting, constipation and abdominal pain.
The proposed class action lawsuit alleges Novo Nordisk does not make the “dangerous side effects” (such as stomach paralysis) more prominent for providers and patients.
“Part of manufacturing a drug is there’s a duty to warn of the risks,” McCartney said. “The manufacturer failed to adequately warn about the risks associated with taking the drug.”
In an email to Global News on Tuesday, a spokesperson from Novo Nordisk said the company stands behind the safety of all its GLP-1 medicines “when used by appropriate patients consistent with the product labelling and approved indications.”
“Our team is continuously monitoring the safety profile of our products and collaborating closely with health authorities to ensure patient safety information, including adequate information on side effects, is included in the product labelling,” the spokesperson said when asked to comment on the proposed class action.
“GLP-1 has been used to treat type 2 diabetes for more than 15 years, and for treatment of obesity for eight years… Semaglutide has been extensively examined in robust clinical development programs, large real-world evidence studies and has cumulatively over 9.5 million patient years of exposure.”
However, McCartney said she does not believe the warnings for gastroparesis and gallbladder disease issues have been properly featured by the company (such as in the product monograph, which is intended to provide information for the safe and effective use of a new drug).
For example, gastroparesis (also known as stomach paralysis) is not mentioned in Ozempic’s Canadian product monograph, she said.
“The warnings for gastroparesis are not adequately warned of. In terms of the gastrointestinal issues, there are things that are missing and there are things that are not described in sufficient detail,” McCartney said.
On Oct. 5, a University of British Columbia (UBC) study published in JAMA, linked popular weight loss drugs, such as Ozempic, to stomach paralysis and other serious gastrointestinal conditions.
The UBC researchers found that when people take these drugs strictly for weight loss, it can cause a serious risk of medical conditions, such as stomach paralysis.
However, Global News talked with one expert outside the study who said he was skeptical of the findings, saying there may be biases in the data.
For example, one of the concerns raised was that the study was retrospective, which means it relied on information from events that have already occurred and might contain more biases compared to a randomized control trial.
And although the side effects raised in the UBC study are rare, the authors said because millions of people around the world use the drugs, “it could lead to hundreds of thousands of people experiencing these conditions.”
About the proposed lawsuit
The plaintiff in the proposed class action lawsuit, Suzanne Talbot, is a 57-year-old resident of Jaffray, B.C., who started taking Ozempic in 2021, according to the civil claim.
After taking Ozempic, the clam alleges she immediately started experiencing chronic diarrhea. Later she began to experience pain, heartburn and shortness of breath, “which have resulted in hospital admissions and have worsened over time,” the lawsuit states.
In August 2023, Talbot was admitted to the hospital and was diagnosed with a blockage in her biliary system (also called cholangitis), it states.
“Health-care professionals indicated to the plaintiff that the blockage was linked to her Ozempic use. Shortly following that hospital admission, the plaintiff ceased her use of Ozempic,” the lawsuit says.
After taking Ozempic, Talbot said she continued to experience symptoms, such as shortness of breath, pain and heartburn.
“The plaintiff brings this action on her own behalf and on behalf of a class of persons in Canada who are similarly situated,” the lawsuit says.
The lawsuit then alleges that Novo Nordisk misrepresented its product as safe, which “in fact, these medications cause serious injuries, conditions and complications.”
It added that patients who were prescribed semaglutide products, like Ozempic, were misled about its safety and efficacy leading to serious adverse side effects “with significant consequences, such as the development of gallbladder-related diseases and other hepatobiliary complications, gastrointestinal paralysis, gastrointestinal obstruction, malnutrition, and death, especially in certain special populations,” it states.
The plaintiff is seeking damages in the amount of $500,000, but McCartney said this number could change as the class action is only in the early stages.
The lawsuit is currently going through the court system to get certified, she said.
“In the meantime, we’re getting contacted by different Canadians who have taken the drug and suffered injury or harm,” she said.
The exact number of Canadians using these weight loss drugs is not known, but Ozempic has become so popular that in August, its manufacturer, Novo Nordisk, announced a shortage of the medication in Canada.