Rybelsus® Lawsuit

Yes, people are filing lawsuits against Novo Nordisk, Rybelsus’ manufacturer. The lawsuits claim Novo Nordisk knew of potential long-term side effects related to Rybelsus but didn’t warn consumers. The lawsuits seek compensation for harmed people and updates to the warning labels.

The Rybelsus lawsuit is part of a multidistrict litigation (MDL) involving other similar medications, called GLP-1 RAs. Defendants in the MDL include Novo Nordisk, which manufactures Rybelsus, Ozempic and Wegovy. Another defendant is Eli Lilly, which makes Trulicity, Zepbound and Mounjaro. All MDL cases involve patients who took one or more GLP-1 RA medications and experienced severe unlisted side effects. 

GLP-1is short for glucagon-like peptide 1. It is a hormone that naturally occurs in the human body to help release insulin. When your body isn’t responding to GLP-1 correctly, such as when you have Type 2 diabetes, your blood glucose levels can climb too high. GLP-1 receptor agonist (GLP-1 RA) medications attempt to correct this imbalance. They use a synthetic substance that mimics GLP-1 and aids in insulin release. The active ingredient (specific GLP-1 RA) in Rybelsus is semaglutide.

Rybelsus class action lawsuit

There is currently no Rybelsus class action lawsuit for unlisted side effects. Instead, the individual legal actions involving Rybelsus are in a federal MDL in the Eastern District of Pennsylvania. Class action lawsuits and MDLs are different legal options and should not be confused.

A class action lawsuit involves a single person or small group of individuals filing a lawsuit to represent a larger group of people, known as a class. The people who file the lawsuit represent the interests of the entire group, who have the same injuries that led to the lawsuit. If the plaintiffs win damages, the court notifies each person inside the larger group and distributes any award to each person.

In contrast, an MDL is a legal process where multiple lawsuits with similar complaints are collected in the same federal court. MDLs can make handling complex, large-scale litigation more efficient and consistent. Each member of the MDL has an individual lawsuit. Individuals within the MDL maintain their own legal representation. Each person in the MDL has individual rights of recovery and burdens of proof. Should that person win their lawsuit, the award only goes to that person.

Plaintiffs can file class action lawsuits in either federal or state courts. MDLs only occur in federal court although you can have a consolidation of matters in some state courts.

The MDL related to Rybelsus is MDL No. 3094 IN RE: Glucagon-like Peptide-1 Receptor Agonists Products Liability Litigation. This MDL includes plaintiffs who took GLP-1 RA prescription drugs, including Wegovy, Ozempic, Rybelsus, Mounjaro, Zepbound, Trulicity, Saxenda and Victoza. The plaintiffs reported injuries like gastroparesis, bowel obstruction (also referred to as intestinal blockage), pancreatic cancer, deep vein thrombosis and gallbladder disease.

The Rybelsus MDL allows those suffering from the drug’s side effects to seek damages. The plaintiffs claim Novo Nordisk failed to warn of the risk of certain significant side effects through labeling. Rybelsus contains the generic semaglutide compound, which Novo Nordisk initially claimed was safe.

In the drug’s initial FDA approval application, Novo Nordisk reported the most common adverse event was nausea. But the plaintiffs claim Novo Nordisk knew of far more serious side effects as early as 2019. 

Rybelsus settlement

The possible values of such a case are not yet known. All lawsuits involved in the MDL remain in the early litigation stages. In a MDL a defendant, such as Novo Nordisk, could ask to negotiate a settlement agreement with plaintiffs before or during a trial.

Rybelsus is an oral medication used to improve blood sugar in adults with Type 2 diabetes. Novo Nordisk received FDA approval for Rybelsus in the fall of 2019. 

Rybelsus uses the semaglutide compound, which is the active ingredient and generic name for the drug. It is the specific GLP-1 RA used in Rybelsus, Ozempic and Wegovy. Novo Nordisk makes all three of these drugs based on the semaglutide compound. Rybelsus is an oral tablet. Ozempic and Wegovy are injectables.

GLP-1 is a naturally occurring peptide hormone for humans. As you eat, your digestive organs create GLP-1 hormones. They help your body use the glucose you receive from the meal and limit the amount of glucose your body makes. They signal the pancreas to create insulin, too. These actions maintain the proper glucose levels in the blood.

People with Type 2 diabetes don’t receive the proper level of GLP-1 hormones from the digestive organs. This results in unwanted increases in blood sugar levels. Additionally, the pancreas releases less insulin than people with Type 2 diabetes need.

Rybelsus uses synthetic GLP-1 hormones to release insulin at mealtime. This action can help your body balance its blood glucose sugar. The synthetic GLP-1 hormones also make people feel fuller while eating. That feeling may explain the ability of these diabetes drugs to help people lose weight.

Is Rybelsus used for weight loss?

Rybelsus does not have FDA approval as a weight-loss drug. It only has FDA approval for use in adults with Type 2 diabetes. However, Novo Nordisk does mention in marketing materials that Rybelsus “may help you lose some weight.”

Using Rybelsus for weight loss is considered an off-label use for the drug. Some doctors prescribe Rybelsus for this off-label use, even for adults who do not have Type 2 diabetes. Patients who take Rybelsus off-label and develop complications may be eligible to file a lawsuit.

The basis of the lawsuits is that Novo Nordisk did not adequately disclose severe Rybelsus side effects on the drug’s label. People who have experienced these side effects may be eligible to file a case:

• Intraoperative pulmonary aspiration
• Ileus or bowel obstruction, with or without surgical treatment (before September 2023)
• Gallbladder disease leading to removal before March 2022, when the semaglutide labels were updated to include acute gallbladder disease
• Pancreatic injuries, including pancreatic cancer and necrotizing pancreatitis 
• Severe gastrointestinal injuries, including those that require surgery
• Stomach paralysis / gastroparesis
• Vision changes, including sudden blindness, optic nerve stroke, retinal stroke, visual acuity loss, color blindness, and loss of blood flow to the eye

Certain side effects listed on the Rybelsus label may also be named in lawsuits. For example, the drug’s label warns of nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation as the most common reactions. However, some patients have such severe and ongoing cases of these side effects that they require ER visits and hospitalizations. In those cases, patients may be able to file a Rybelsus lawsuit. 

MDL plaintiffs claim the makers of these drugs aggressively marketed them for weight loss and diabetes treatment but they didn’t disclose the severe known side effects or the limitations of the benefits of these drugs. The plaintiffs also claim the Rybelsus labels lacked crucial information such as risks of gastroparesis or intestinal obstruction. 

Several law firms, including Motley Rice, have cases filed in the Rybelsus MDL. The formation of MDL No. 3094 includes the following milestones.

What is the issue with Rybelsus?

Plaintiffs allege Novo Nordisk did not adequately warn patients about serious possible side effects. Additionally, although Rybelsus only has FDA approval for use for adults with Type 2 diabetes, some patients use it to help with weight loss.

The labels on Rybelsus never warned of gastroparesis, and intestinal obstruction was added to the drug’s label in September 2023 postmarketing. The plaintiffs allege Novo Nordisk did not disclose the severe injuries Rybelsus could cause. They failed in this responsibility despite knowing about these dangers, according to plaintiffs.

Is Rybelsus a high-risk medication?

Rybelsus may be a high-risk medication as 66 deaths related to Rybelsus have been reported to the FDA. This stems from its alleged adverse effects, including gastroparesis and ileus (bowel obstructions). Some patients with these side effects required hospitalization and extensive treatment, including surgery. Gastroparesis and ileus can lead to secondary long-term conditions. 

The FDA only issues a boxed warning when a medication contains a severe risk for patients. This is the most serious type of warning that the FDA places on a medication’s label. Side effects like gastroparesis did not generate a boxed warning for Rybelsus under the FDA rules. But plaintiffs in the semaglutide lawsuit claim that the drug caused severe injuries.

Does Rybelsus cause gastroparesis?

Many Rybelsus lawsuits filed by plaintiffs claim Rybelsus causes gastroparesis. Research conducted by The University of British Columbia seems to support these claims. Researchers studied records of about 16 million patients in the United States. They found GLP-1 RAs like semaglutide caused a 3.67 times greater risk of gastroparesis in people taking these drugs. Rybelsus consists of the semaglutide compound. 

Gastroparesis affects the movement of the stomach muscles and their ability to fully empty the stomach. Frequently, people interchangeably use gastroparesis and stomach paralysis to describe this condition. 

In gastroparesis lawsuits, plaintiffs claim that Novo Nordisk did not warn users of the risk of gastroparesis. 

Some of the symptoms of gastroparesis include:

• Abdominal bloating and pain
• Acid reflux
• Malnutrition
• Nausea
• Vomiting, especially of undigested food

If you experience these or any other adverse reactions while taking Rybelsus, speak with your doctor.

Is there a recall on Rybelsus?

As of June 2024, there is no Rybelsus recall. If a recall of Rybelsus happens in the future, it could occur by FDA request or through the manufacturer’s decision. The FDA recommends that patients talk to their healthcare professionals about what to do if a medication recall happens.

What are the grounds for filing a Rybelsus lawsuit?

The grounds for filing a Rybelsus lawsuit include suffering physical harm and financial loss after taking this drug. As a victim, you must show that you did not know about serious side effects related to taking semaglutide and Rybelsus. You must also show that the manufacturer did not do enough to adequately notify patients about the side effects.

If you are unsure whether you qualify to be a plaintiff in a lawsuit, speak to a Rybelsus lawyer. You can learn more about your options and qualifications.

Thousands of victims of dangerous drugs received representation from Motley Rice medical attorneys. We represent patients who suffered harm from both prescription and over-the-counter medication.

If you believe that a drug caused hardships for your health, you may have the right to file a lawsuit and seek financial awards. Our prescription drug attorneys will take numerous steps on your behalf, including the following:

• We delve deeply into information about the drug that you believe harmed you.
• We look for evidence that the drug creates harmful effects in people.
• We review the manufacturer’s warnings and marketing materials to see if you received adequate warning about any side effects.
• We investigate the manufacturer to verify its compliance with all FDA regulations regarding the drug.

We then use that information to explore your legal options. Reach out to our Rybelsus lawyers to discuss your case today.

Read more on our medical drug litigation experience.

Do not stop taking a prescribed medication without first consulting with your doctor. Discontinuing a prescribed medication without your doctor's advice can result in injury or death. Rybelsus, Ozempic, Wegovy, Trulicity, Zepbound and Mounjaro remain approved by the U.S. Food and Drug Administration.