Recently, a class action lawsuit targeting the diabetes and weight loss drug Ozempic has been making waves in Canada. Ozempic is a medication that falls under the category of glucagon-like peptide-1 (GLP-1) receptor agonists. It is often prescribed to manage blood sugar levels in individuals with type 2 diabetes. As a relatively new drug, it has garnered substantial attention due to its active ingredient, semaglutide, for its ability to help people lose weight. The lawsuit, initiated by a patient who experienced various side effects after taking Ozempic, raises questions about the drug’s safety and long-term effects. As someone who was diagnosed with gastroparesis after developing COVID-19, I am very interested in following this case. So, let’s delve into Ozempic and the Canadian class action lawsuit.
What is Ozempic?
Ozempic, a semaglutide-based injectable medication, was originally designed as a diabetes medication. Its core functions involve regulating insulin levels and reducing blood sugar, and is primarily used in the treatment of Type 2 diabetics. However, the drug is also being used for weight loss, primarily in diabetics or those at risk of developing diabetes.
Ozempic belongs to a drug class called GLP-1 agonists. GLP-1 agonists work by mimicking a hormone called glucagon-like peptide-1 (GLP-1) to lower blood glucose levels. It also signals to the body that it’s satiated, making you feel full longer.
In a significant development in 2021, the U.S. Food and Drug Administration (FDA) expanded its approval of semaglutide. While it was initially prescribed as Ozempic for diabetes management, a higher-dose variant was introduced under the name Wegovy. This extension recognized the far-reaching potential of semaglutide beyond diabetes control. Its effectiveness in promoting weight loss positioned it as a promising option for individuals dealing with obesity. Ozempic may also help prevent heart attacks and benefit those with heart disease.
Ozempic is available as a pre-filled pen injector. The injectable drug is taken once a week. Semaglutide is also available as an oral tablet under the brand name Rybelsus. Wegovy, the higher dose version, is used for chronic weight management in people both with or without diabetes.
According to Global News, Health Canada approved Ozempic and Rybelsus as medications to treat diabetes. While Wegovy was approved for weight loss in Canada, it has never actually been sold here due to supply shortages. As such, Ozempic still gets prescribed off-label for weight loss.
Does Ozempic Help You Lose Weight?
When you eat, cells in your intestines release GLP-1. This results in an insulin release, and blocks glucose production. Ozempic also results in delayed gastric emptying, slowing down how fast food leaves your stomach, making you feel full longer. GLP-1 also affects the part of your brain involved in appetite control.
By mimicking the effects of GLP-1, Ozempic curbs your appetite and makes you feel full longer. As such, many people eat smaller portions, consuming fewer calories, and thus lose weight due to their diet change. Many have reported significant weight loss while taking the drug.
Recent years have witnessed the burgeoning popularity of semaglutide-based medications, with Ozempic and Wegovy at the forefront. Their rise to prominence can be attributed to their off-label use, indicating their application beyond the intended scope. This trend came into the spotlight when reports circulated about celebrities, such as Mindy Kaling, hosting gatherings known as “Ozempic parties”. Celebrities would allegedly gather together and inject each other with the drug. The drug started trending on social media, including on TikTok where #Ozempic went viral, with millions of views.
The allure of Ozempic as a weight loss catalyst led to an unexpected consequence—a very high demand, causing a shortage of the drug. This scarcity left many individuals dependent on Ozempic for diabetes management grappling with limited access. As those who really needed it could go no longer get it, celebrities and TikTokers were blamed for buying it up faster than manufacturers could produce it.
Background Context:
There have been several reports of Ozempic causing extreme gastrointestinal issues, such as gastroparesis, in the past few months. For example, in August, a woman in the United States launched a lawsuit alleging that she “sustained severe and permanent personal injuries, pain, suffering, and emotional distress, and incurred medical expenses”. That lawsuit says that the makers knew of “the risk of developing severe gastrointestinal issues, including gastroparesis and gastroenteritis”. Her lawyers stated that they intend on filing many more lawsuits against these drug manufacturers for a “failure to warn”, and are looking into at least 400 other cases in the United States.
In late September 2023, the FDA began warning users that semaglutide has been linked to ileus, or intestinal blockage, meaning food can’t pass through your intestines. The FDA updated its warning label after at least 16 people reported serious intestinal blockages linked to Ozempic. The FDA says that while there is not yet evidence that Ozempic caused the blockages, they have been linked to Ozempic.
And on October 5, 2023, a study released out of British Columbia found that people taking injectable medications for weight loss, including Ozempic and Wegovy, among others, may be at a higher risk of developing serious digestive problems including stomach paralysis, pancreatitis, and bowel obstructions, compared to those taking other types of weight loss medications. The study found that approximately 1% of people taking Ozempic were diagnosed with stomach paralysis. However, there were some issues with this study, including that it was retrospective.
Now, a class action lawsuit has been filed in Canada.
What is Gastroparesis?
Gastroparesis literally translates to stomach paralysis. Gastroparesis is a stomach disorder that slows or stops the movement of food from your stomach into your small intestine. It is also known as delayed gastric emptying.
One of the effects of Ozempic is to slow down gastric emptying. For some, it’s almost as if Ozempic works too well, slowing down their stomach too much.
A complicating factor is that Ozempic is usually prescribed to help treat and manage diabetes. Diabetes is also one of the leading causes of gastroparesis. So, for lawsuit purposes, it may be difficult to determine whether someone’s gastroparesis was caused by Ozempic or their diabetes.
The Canadian Ozempic Lawsuit:
The Ozempic lawsuit in Canada centers on claims of harmful side effects experienced by some users. Despite Ozempic’s potential benefits in managing blood sugar levels and aiding weight loss. It’s most common side effects are nausea, vomiting, and diarrhea. These side effects are common among GLP-1 receptor agonists. Novo Nordisk, the pharmaceutical company that makes Ozempic, has mentioned these side effects on their warning labels. However, they are now facing allegations of negligence and insufficient warning about all of the medication’s possible risks.
On October 6, 2023, a proposed class action lawsuit was filed in British Columbia for alleged damages arising from Novo Nordisk’s drugs Ozempic, Rybelsus, and Wegovy. According to the lawsuit, Novo Nordisk was “negligent” in sufficiently warning healthcare professionals and patients about the serious risks linked to these drugs, and used “deceptive practices”.
The lawsuit is being filed on behalf of all Canadians that have taken Ozempic. One of the lawyers on the case, Jill McCartney, of Siskinds LLP, explained that the lawsuit alleges people have suffered problems relating to “gastrointestinal issues… notably stomach paralysis and intestinal blockages”, and that the “manufacturer failed to warn about the risks associated with taking the drug”.
McCartney explicitly states that 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”.
Details of the Lawsuit:
The plaintiff in the proposed class action lawsuit is Suzanne Talbot, a 57-year-old B.C. resident. She started taking Ozempic in 2021. She immediately began experiencing chronic diarrhea, later developing pain, heartburn, and shortness of breath. In August 2023, she was admitted to hospital where she was diagnosed with a blockage in her biliary system, or cholangitis. Doctors told her that the blockage was due to Ozempic, which she promptly stopped using.
The lawsuit alleges that Novo Nordisk misrepresented its product as safe, which “in fact, these medications cause serious injuries, conditions and complications.” It states that patients were misled about its safety and efficacy, leading to serious 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”.
Suzanne Talbot, the plaintiff, is bringing the action on behalf of all Canadians that have taken Ozempic. She is seeking damages in the amount of $500,000, but that could change as the lawsuit progresses.
What is a Class Action?
A class action is a form of civil action where one or a few plaintiffs can sue one or more defendants on behalf of a larger group of people who claim the same type of loss. The representative plaintiff, in this case Suzanne Talbot, can pursue the claim on behalf of the entire class. If the plaintiff recovers money or other remedies, all class members share in that recovery. The costs of the litigation are also shared by the group.
In Canada, class actions can be brought in multiple jurisdictions against the same defendants for the same claims. Unlike in the United States, Canada does not necessarily consolidate these cases. As such, it’s possible that in addition to this class action lawsuit filed in British Columbia, another one could be filed elsewhere, like in Ontario.
In most provinces, an action must be “certified” to proceed as a class action, a representative plaintiff must be appointed by the court, and common issues or questions of fact or law must be certified by a judge to be determined at trial before a case can proceed as a class action. This process can take over a year, but the test for granting certification is relatively easy to meet.
Once an action is certified as a class proceeding, it proceeds to a common issues trial where a judge resolves the certified issues that apply to all class members. The decision binds all members of the class. Alternatively, the class proceeding may be settled before trial.
Who Can Join the Ozempic Class Action?
In British Columbia, where this lawsuit was filed, the rules allow class members to include both residents and non-residents of the province. Residents must take steps to opt out of the class if they do not wish to be bound by the result. Non-residents, however, must opt in if they’d like to participate and be bound by the result.
According to their website:
Siskinds LLP is seeking to recover compensation for Canadians who suffered injuries arising from Ozempic and other semaglutide drugs. Siskinds has filed a proposed national class action alleging that semaglutide drugs expose patients to risks of serious harms, including gastrointestinal complications, which were not sufficiently warned of.
If you or a member of your family has suffered injuries or complications from Ozempic, Rybelsus, or Wegovy, our class action team is available to try to assist you in seeking compensation.
You can contact them via their website, email ([email protected]), or phone (519-672-2121).
Other Side Effects of Ozempic:
Ozempic and Your Menstrual Cycle:
An emerging question in the Ozempic discourse revolves around its potential impact on the menstrual cycle. At present, there is limited data on this subject, as clinical trials have not extensively examined the drug’s effects on menstruation. However, some users have reported changes in their menstrual patterns while taking Ozempic. The exact mechanisms behind these changes remain unclear, and more research is needed to establish a definitive connection. It is crucial to consult with your healthcare provider if you experience any unexpected changes in your menstrual cycle while using Ozempic.
Other Illnesses:
Ozempic and Wegovy have a risk of pancreatitis, gallbladder disease, and kidney problems. They are also not recommended for people with certain types of thyroid cancer in their family, due to some of the results in animal studies showing an increased risk of thyroid C-cell tumours.
As mentioned above, the FDA recently amended its warning label for Ozempic to include the risk of ileus, or intestinal blockage.
Stopping Ozempic:
Another issue that many face comes when they stop taking Ozempic. Because Ozempic is only approved for Type 2 diabetes and chronic weight management, these drugs are meant for long-term use to keep your blood glucose under control. Individuals that continue using Ozempic have reported significant weight loss benefits as it has resulted in dietary changes.
So far, there hasn’t been sufficient scientific research into what happens if you stop taking Ozempic. However, many individuals have reported that the feeling of fullness will go away, and they start feeling just as hungry, or even hungrier, than before. As such, many start eating more, resulting in much weight gain. Some have reported that they gained back even more than they had initially lost. Some Wegovy clinical studies found that people gained approximately 2/3 of lost weight one year after stopping the drug.
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Wrapping Up:
The Ozempic lawsuits in Canada and the U.S. have sparked discussions and raised questions about the drug’s safety and potential side effects. While some users have reported alarming side effects, it is crucial to remember that the effects of medications can vary from person to person. If you are considering taking Ozempic, always consult with your healthcare provider first. They can offer personalized advice based on your medical history, current health condition, and individual needs. Medications like Ozempic can play a valuable role in diabetes management, but they should be used carefully, under the supervision of your doctor. Reach out to your healthcare provider for guidance on the best course of action.