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Rybelsus® Lawsuit

Rybelsus® Lawsuit

People taking Rybelsus® are reporting severe side effects that can result in long-term health problems, including vision loss, intestinal blockages and gastroparesis.

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Case Overview

Rybelsus is a diabetes drug that some people are also taking off-label for weight loss. Those taking Rybelsus are reporting multiple side effects that can cause significant health issues. Patients are now filing Rybelsus lawsuits alleging improper warnings about these side effects and their broader health implications.

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Important Rybelsus lawsuit updates

  • March 2025: The total number of claims in the Rybelsus multidistrict litigation (MDL) increased to 1,521.
  • December 2024: The Rybelsus warning label was updated to include acute pancreatitis, cholecystitis and new information about the likelihood of developing severe gastrointestinal issues.
  • December 2024: It was announced that the glucagon-like peptide-1 receptor agonist (GLP-1 RA) MDL will not include deep vein thrombosis (DVT) and blood clot injury cases. People with other health complications in connection with Rybelsus usage may still pursue compensation for their injuries. Motley Rice will aggressively represent individuals suffering these conditions. If you took a GLP-1 RA and had a DVT, contact a Motley Rice attorney to better understand your options.
  • November 2024: The U.S. Food and Drug Administration (FDA) updated the warning label for Rybelsus to make users aware that the drug may pose a risk of pulmonary aspiration during deep sedation or general anesthesia.
  • July 2024: A study linked drugs containing semaglutide, including Rybelsus, to vision loss.

Explore the full litigation timeline for Rybelsus lawsuits.

Key takeaways about the Rybelsus lawsuit

  • Rybelsus is an FDA-approved drug for adults with type 2 diabetes, but some people are taking it off-label for weight loss.
  • Rybelsus lawsuits claim that the drug’s manufacturer, Novo Nordisk, didn’t include adequate warnings on the drug’s initial labeling about serious side effects like gastroparesis, intestinal obstruction and vision loss.
  • The court consolidated Rybelsus lawsuits into a multidistrict litigation (MDL No. 3094).

Are there lawsuits against Rybelsus?

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 adequately warn consumers. The lawsuits seek compensation for harmed people and updates to the warning labels.

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

GLP-1 is 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 U.S. District Court for 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, consisting of those 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.
  • 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. If a person wins their lawsuit, the award only goes to them.

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.

Rybelsus multidistrict litigation

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

As of March 3, 2025, the MDL had 1,521 active plaintiffs.

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. MDL defendants, such as Novo Nordisk, could ask to negotiate a settlement agreement with plaintiffs before or during a trial.

Contact a Rybelsus attorney

If you are suffering or a loved one is suffering from severe side effects that the Rybelsus manufacturer failed to warn you about, you may have the right to file a claim against manufacturer Novo Nordisk with a Rybelsus lawsuit.

For more information or to discuss your right to seek a claim, contact Rybelsus attorneys Sara Couch or Jonathan Orent. You can call them at 1.800.768.4026 or complete the webform

What is Rybelsus?

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 marketing materials say 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.

Rybelsus side effects

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:

  • Pulmonary aspiration (before November 2024, when the warning label was updated to include pulmonary aspiration during deep sedation or general anesthesia)
  • Ileus or bowel obstruction, with or without surgical treatment (before January 2023)
  • Gallbladder disease leading to removal before June 2022, when the semaglutide labels were updated to include acute gallbladder disease
  • Pancreatic injuries, including pancreatic cancer and necrotizing pancreatitis (before December 2024, when the label was updated to include acute pancreatitis)
  • Severe gastrointestinal injuries, including those that require surgery (before December 2024, when the Rybelsus label was updated to include the likelihood of developing severe gastrointestinal issues)
  • Stomach paralysis/gastroparesis
  • Vision changes, including sudden blindness, optic nerve stroke, retinal stroke, visual acuity loss, color blindness, blurry vision and loss of blood flow to the eye (Diabetic retinopathy complications were added to the Rybelsus warning label in January 2023 under “Adverse Reactions.”)

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, vision changes 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. 

Rybelsus MDL timeline

MDL plaintiffs claim the makers of these drugs aggressively marketed them for weight loss and diabetes treatment but 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.

Rybelsus lawsuit updates timeline

3.03.25

MDL numbers increased in March

As of March 3, 2025 there were 1,521 pending actions in the GLP-1 MDL.

2.04.25

MDL continues to grow in February

Plaintiffs continued to file GLP-1 lawsuits, bringing the number of cases in the docket to 1,443.

1.03.25

Lawsuit numbers increase

January 2025: Plaintiffs continued to file GLP-1 lawsuits, bringing the number of cases in the docket to 1,331.
December 2024: More GLP-1 lawsuits were filed in the MDL, bringing the number of active cases to 1,300.
November 2024: There were 1,221 pending cases in the MDL on the first business day of the month. This coincided with an amended complaint being filed in the MDL, as plaintiffs continued to allege that GLP-1RA manufacturers misled patients and doctors about potential harms
October 2024: The GLP-1RA MDL continued to grow, bringing the number of cases in the docket to 1,090 at the start of October.
August 2024: The number of pending actions in MDL No. 3094 reached 346 by the first business day of the month.
June 2024: More than 100 actions were pending in the MDL.
April 2024: The number of pending actions in the MDL grew to 74 by the first business day of the month.

12.09.24

New updates come to warning label

The warning label for Rybelsus was updated to include acute pancreatitis and cholecystitis. The label was likewise amended to include new information about the likelihood of developing severe gastrointestinal issues. People who took Rybelsus during clinical trials were more likely to develop severe gastrointestinal issues than people who took a placebo.

12.01.24

DVT and blood clots won’t be included as injuries in MDL

Deep vein thrombosis and blood clot cases will not be included injuries in the GLP-1 RA MDL. People who experienced these injuries may still pursue these cases. Contact GLP-1 RA attorney Sara Couch or Jonathan Orent.

11.01.24

New warning added to Rybelsus label

The FDA expanded the warning on Rybelsus to include the risk of pulmonary aspiration for patients during sedation or while undergoing general anesthesia. This risk was added to other semaglutide drugs, including Ozempic and Wegovy.

07.01.24

FDA reporting system records 66 Rybelsus deaths

The FDA Adverse Events Reporting System (FAERS) recorded a total of 3,310 adverse events involving patients who took Rybelsus. This includes 66 death cases.

07.01.24

Study links semaglutide drugs to serious eye condition

The Journal of American Medicine published a study that links semaglutide drugs to an eye condition called non-arteritic anterior ischemic optic neuropathy (NAION). This is an eye condition that occurs when blood flow to the optic nerve is blocked. NAION can lead to vision loss and other symptoms. There is no cure for this condition.

05.01.24

Motley Rice attorneys appointed to MDL leadership roles

Motley Rice attorneys Jonathan Orent and Sara Couch were court-appointed to MDL No. 3094 leadership. Jonathan Orent serves as co-lead counsel of the Executive Committee. Sara Couch is the Chair of Marketing Discovery on the Plaintiffs Executive Committee (PSC).

04.01.24

MDL grows, attorneys join leadership selection committee

The number of pending actions in MDL No. 3094 grew to 74. Attorneys from multiple firms joined a committee designed to select the leadership for the Rybelsus MDL. Attorneys from Motley Rice were among those who joined the committee.

03.01.24

MDL conference sets procedures for agreeing on case facts

A status conference set up the procedural details for the lawsuits and the establishment of facts.

02.01.24

Attorneys argue for selecting jurisdiction

Attorneys argued for MDL No. 3094 to be sent to the Eastern District of Pennsylvania. Jonathan Orent of Motley Rice was one of the attorneys who argued for the choice of jurisdiction.

12.31.23

2023’s total number of Rybelsus-related adverse events

FAERS recorded 894 adverse events involving patients who took Rybelsus.

12.31.22

2022’s total number of Rybelsus-related adverse events

FAERS recorded 860 adverse events involving patients who took Rybelsus.

12.31.21

2021’s total number of Rybelsus-related adverse events

FAERS recorded 741 adverse events involving patients who took Rybelsus.

12.31.20

2020’s total number of Rybelsus-related adverse events

FAERS recorded 445 adverse events involving patients who took Rybelsus.

12.31.19

First Rybelsus-related adverse events reported to FDA

FAERS recorded two adverse events involving patients who took Rybelsus.

09.20.19

Rybelsus enters the market as type 2 diabetes treatment

Novo Nordisk launched Rybelsus to improve glycemic control for adults with type 2 diabetes.

View Full Timeline

Frequently asked questions about Rybelsus

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 is not formally considered a high-risk medication. High-risk or high-alert medications are defined as medications “drugs that bear a heightened risk of causing significant patient harm when they are used in error.” GLP-1 RAs like Rybelsus are not classified as such currently. However, injectable insulin is considered a high-risk medication and Rybelsus does affect insulin levels. 

Rybelsus may informally be considered high-risk, based on the amount of serious adverse reactions and deaths reported to the FDA. More than 2,000 serious reactions including 80 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 March 2025, there was 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.

Our medical drug litigation experience

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 your doctor. Discontinuing a prescribed medication without your doctor's advice can result in injury or death. Ozempic, Rybelsus, Saxenda, Victoza, Wegovy, Mounjaro, Trulicity and Zepbound remain approved by the U.S. Food and Drug Administration.
 

Important Rybelsus lawsuit updates

Key takeaways about the Rybelsus lawsuit

Are there lawsuits against Rybelsus?

Rybelsus multidistrict litigation

What is Rybelsus?

Rybelsus side effects

Updates on the Rybelsus MDL

Frequently asked questions about Rybelsus

Rybelsus lawsuit updates timeline

Our medical drug litigation experience

About the Author

Sources
  1. American Academy of Ophthalmology. Can Ozempic Affect Eye Health? Here’s What Ophthalmologists Want You to Know.
  2. Cleveland Clinic. Gastroparesis.
  3. Global Newswire: Novo Nordisk Files for Regulatory Approval of Once Weekly Semaglutide in the US and EU for the Treatment of Type 2 Diabetes.
  4. Hathaway JT, Shah MP, Hathaway DB, Zekavat SM, Krasniqi D, Gittinger JW, et al. Risk of nonarteritic anterior ischemic optic neuropathy in patients prescribed semaglutide. JAMA Ophthalmology. 2024 Jul 3;142(8):732–739.
  5. Law360. Ozempic MDL Plaintiffs Say Eli Lilly, Novo Nordisk Hid Risks.
  6. Mayo Clinic. Gastroparesis.
  7. Nakatani Y, Maeda M, Matsumura M, Shimizu R, Banba N, Aso Y, Yasu T, Harasawa H. Effect of GLP-1 receptor agonist on gastrointestinal tract motility and residue rates as evaluated by capsule endoscopy. Diabetes & Metabolism. 2017 Oct;43(5):430-437.
  8. NovoCare: Type 2 Diabetes and the Role of GLP-1.
  9. Rybelsus. Rybelsus Results.
  10. Rybelsus.com. What to Expect With RYBELSUS® (semaglutide) tablets.
  11. Sodhi M, et al. Risk of Gastrointestinal Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss. JAMA. 2023 Oct 5;330(18):1795-1797.
  12. The University of British Columbia. Weight-Loss Drugs Linked to Stomach Paralysis, Other Serious Gastrointestinal Conditions.
  13. United States District Court for the Eastern District of Pennsylvania. In Re: Glucagon-like Peptide-1 Receptor Agonists Products Liability Litigation, Case Management Order No. 16.
  14. United States Food and Drug Administration. Drug Safety-related Labeling Changes (SrLC).
  15. United States Food and Drug Administration. FAERS Public Dashboard for Rybelsus.
  16. United States Food and Drug Administration. FDA Adverse Events Reporting System (FAERS) Public Dashboard.
  17. United States Food and Drug Administration. FDA’s Role in Drug Recalls.
  18. United States Food and Drug Administration: FDA Approval Letter for Rybelsus.
  19. United States Food and Drug Administration. Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss.
  20. United States Food and Drug Administration. Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format.
  21. United States Judicial Panel on Multidistrict Litigation. MDL Report Date: 10/1/24 MDL Statistics Report - Distribution of Pending MDL Dockets by Actions Pending.
  22. United States Judicial Panel on Multidistrict Litigation. Pending MDLs by Actions Pending (June 3, 2024).
  23. United States Judicial Panel on Multidistrict Litigation. Pending MDL by Actions Pending (April 1, 2024).
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