Rybelsus Lawsuit – April 2024 Update

The Rybelsus Lawsuit is an active lawsuit

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Rybelsus Lawsuit Overview

Rybelsus, the brand-name for an oral semaglutide manufactured by Novo Nordisk, has come under scrutiny after patients have reported serious side effects. Rybelsus, which originally received FDA-approval in 2019 to treat type 2 diabetes, is commonly used for weight loss and acts as a GLP-1 receptor agonist. 

It works by increasing insulin and decreasing blood sugar. The drug also causes delayed gastric emptying which can lead to adverse health issues, including gastroparesis (stomach paralysis) and bowel obstructions.

Lawsuits allege that the manufacturer failed to warn consumers about the potential for adverse health conditions associated with using the drug. Some health issues patients have reported are severe and can lead to long term complications. Individuals who have suffered severe side effects after taking Rybelsus may be eligible to take legal action and should consult with an attorney as soon as possible.

Our firm is currently investigating Rybelsus lawsuits involving a diagnosis of:

• Gastroparesis
• Stomach Paralysis
• Gastrointestinal Obstruction
• Illeus
• Daily vomiting lasting at least 3 weeks

If you have been diagnosed with any of the above conditions, or have experienced severe and prolonged vomiting, please contact us right away for a free Rybelsus lawsuit evaluation.

Rybelsus Lawsuit Update – April 2024

April 1, 2024: Key Developments in Rybelsus Lawsuit – Leadership Motion and New Jersey Filings

There are two important developments in the Rybelsus lawsuit. First, a group of lawyers has made an application to work together as the lead attorneys. The motion filed by plaintiffs’ lawyers seems like a compromise between several law firms. There is one objection to the leadership slate. We expect the group of nearly two dozen lawyers to be approved soon. We are pleased that our litigation partner, Dan Nigh, is a proposed member of the executive committee of the federal Rybelsus lawsuit. The second development is the filing of Rybelsus cases in New Jersey state court. Some lawyers feel it is an advantage to bring their cases away from the large group. The largest group of Rybelsus state court cases will likely be in New Jersey because it is the North American headquarters of Rybelsus manufacturer Novo Nordisk.

March 23, 2024: Leadership Committee Proposed in Rybelsus Lawsuit

Plaintiff lawyers have filed an important motion in the Rybelsus Lawsuit. The motion filed March 22, 2024 asks Judge Pratter to appoint several lawyers to leadership positions in the lawsuit against Rybelsus manufacturer Novo Nordisk. It is no surprise that our litigation partner Daniel Nigh, Esq. appears on the motion as an executive team member. Daniel is an experienced lawyer and has brought several cases against drug companies in the past, including a role as co-lead counsel for the valsartan lawsuit . Judicial appointment of lawyers to leadership roles is an important part of the case because it gives the lawyers to authority to start setting schedules for discovery and requesting documents from the manufacturer. We expect a large portion of the case to center around the marketing tactics used by Rybelsus manufacturer Novo Nordisk.

March 20, 2024: Rybelsus Lawsuit Status Conference Held

The first status conference in the Rybelsus lawsuit was held this last week. The Judge discussed how the plaintiff’s lawyers would work together to move the cases towards a bellwether trial. We expect an order on plaintiff leadership as soon as the end of the month. The judge also requested the parties participate in a Science Day. A science day will allow the lawyers to describe the scientific issues they expect to see in a case involving Rybelsus. Rybelsus is the same active ingredient as Ozempic and Wegovy, but different from Mounjaro. It is however the only drug that is taken in pill form, which will likely be addressed at science day and throughout the lawsuit. Finally, the lawyer for Eli Lilly requested an early motion for summary judgement date. The judge stated that the motion to dismiss was a long way away. There has been a lot of questions about whether Mounjaro and Eli Lilly should be part of the case. It appears the Judge thinks they are an appropriate party.

March 13, 2024: Novo Nordisk touts new weight loss pill

Novo Nordisk, the manufacturer of Rybelsus, has received a lot of press for a potential weight loss pill. Rybelsus was the first pill form of Semaglutide, a diabetes medicine that promotes weight loss. The drug was approved in 2019 and is typically taken in 7 or 14 milligram doses. Novo Nordisk confirmed they are testing a similar pill that would be 50 milligrams of Semaglutide and be approved for weight loss. Some indications are that higher doses lead to more severe side effects. This week Novo Nordisk also confirmed they have completed a Phase 1 trial of Amycretin, another pill designed specifically for weight loss. The Rybelsus lawsuit alleges that Novo Nordisk has not properly warned of the dangers associated with the use of the drug. The lawsuit also alleges that extreme marketing tactics have led to unreasonable risk of off label use.

March 10, 2024: Key Date In Rybelsus lawsuit

This is an important week in the Rybelsus lawsuit. On Thursday there will be the first status conference before the Honorable Gene E.K. Pratter. We expect that several plaintiff’s lawyers will ask the judge to appoint them a leadership role in the case. The average Multi District Litigation lasts three to five years, so it is a big commitment for the lawyers. We also expect there to be millions of documents produced related to the design, testing and adverse event reports around the drugs included in the lawsuit. The burden of proof is on the plaintiffs and it is a large undertaking. One of the first important issues to address will be what drugs will be part of the lawsuit. We expect that at a minimum Rybelsus, Wegovy, and Ozempic will be included because they have the same active ingredient Semaglutide, which is patented by Novo Nordisk.

March 2024: There are currently 58 lawsuits filed against Novo Nordisk, the manufacturer of Ozempic, Rybelsus, and Wegovy.

February 2024: The U.S. Judicial Panel on Multidistrict Litigation ordered all federal Ozempic lawsuits to be centralized in the Eastern District of Pennsylvania. Ozempic is an injectable semaglutide manufactured by the same company as Rybelsus. 

September 2023: The U.S. Food and Drug Administration requires Novo Nordisk to add warnings to Ozempic that the semaglutide may cause serious gastrointestinal issues such as intestinal blockage and ileus.

January 2023: The U.S. Food and Drug Administration approves a label update for Rybelsus tablets. The update allows Rybelsus to be used as a first-line treatment for type 2 diabetes, removing a previous requirement that it not be the initial therapy for patients with the condition.

On this page:

What Is Rybelsus?

Rybelsus was the first glucagon-like peptide (GLP-1) receptor protein oral treatment approved in the United States. It is a semaglutide like Ozempic and Wegovy, but does not need to be injected. The drug was approved by the U.S. Food and Drug Administration (FDA) on September 20, 2019 to help treat type 2 diabetes in adults. It is a non-insulin treatment taken in 7-mg or 14-mg once-daily oral doses.

The drug, manufactured by Novo Nordisk, helps to improve blood sugar levels and has been known to promote weight loss by regulating appetite and slowing digestion. It mimics the GLP-1 hormone causing a delay in gastric emptying resulting in patients feeling fuller longer. 

Reports have emerged showing a link between the drug and serious side effects such as gastroparesis and bowel obstruction. Lawsuits allege that it has a higher risk of gastrointestinal issues compared to other weight loss drugs. Accusations against the manufacturer include that they knew of the increased risk for adverse health issues, especially with long-term use, and failed to warn consumers.

How Does Rybelsus Work?

Rybelsus works as a glucagon-like peptide (GLP-1) receptor antagonist. It mimics a hormone that regulates a person’s blood sugar and their appetite. The drug enhances insulin production after a meal and reduces glucagon secretion which lessens glucose production by the liver. Patients report a longer feeling of fullness since the oral tablet helps to slow digestion.

While the primary use of Rybelsus is to treat type 2 diabetes by preventing the liver from making too much sugar and helping the pancreas to produce more insulin, many people use it to help promote weight loss. The drug signals the brain to regulate appetite, which can lead to a reduction in calorie intake. 

It can have a significant impact on the digestive system since it delays gastric emptying which may affect the absorption of other oral medications. Despite patient reports of serious gastrointestinal issues after use, the label does not give a specific warning for gastroparesis or stomach paralysis.

Rybelsus Side Effects and Symptoms

Concerning reports have emerged alleging severe side effects after the use of Rybelsus and other semaglutide drugs. Lawsuits allege that the manufacturer of Rybelsus, Novo Nordisk, knew of these side effects and failed to inform consumers. Side effects associated with use of the drug can cause long-term health complications that can have a personal and financial impact on patients. 

Reported side effects and symptoms associated with the use of Rybelsus:

• Gastroparesis or stomach paralysis
• Bowel and intestinal obstruction
• Deep vein thrombosis (DVT)
• Severe, chronic vomiting
• Injury to the esophagus
• Ileus or intestinal blockage
• Inoperative pulmonary aspiration
• Pancreatitis
• Pancreatic cancer
• Serious allergic reactions
• Thyroid tumors, including cancer
• Disorders related to malnutrition
• Hypoglycemia or low blood sugar
• Kidney failure
• Vision changes

Individuals who suffered these or other side effects after using Rybelsus may be able to take legal action against the manufacturer for a failure to adequately warn consumers of the adverse effects of using the drug. It is believed that there is an increased risk of severe medical conditions associated with the long-term use of Rybelsus.

Most Common Side Effects of Rybelsus

While there are wide ranging reports of dangerous side effects linked to the use of Rybelsus, some health risks are more common than others. The severity, however, varies from mild gastrointestinal issues to severe health concerns such as gastroparesis and the potential to develop thyroid tumors. 

Common side effects associated with Rybelsus:

• Constipation and diarrhea
• Stomach or abdominal pain
• Nausea and vomiting
• Decreased appetite
• Heartburn
• Gas and bloating
• Flu-like symptoms
• Gallbladder issues

When side effects are undisclosed or patients are not made aware of the potential for adverse health complications, doctors and consumers are unable to make informed decisions.

Rybelsus FDA-Approval and Its Black Box Warning

On September 20, 2019, the FDA approved Rybelsus as the first oral GLP-1 treatment for type 2 diabetes. Prior to that date, only injectable GLP-1 treatments had been approved such as Ozempic. While it is currently used off-label for weight loss, it is not approved for this use through the FDA. 

In January 2023, Novo Nordisk announced that the FDA had approved a label update for the drug. The updated label allows Rybelsus to be used as a first-line treatment option for adults with type 2 diabetes. Prior to this date, it was not approved for use as the initial therapy for patients with the condition. 

Rybelsus Black Box Warning

Due to the potential of serious adverse reactions when using the drug, Rybelsus is required to carry a black box warning. Black box warnings are required by the FDA when there is a serious risk of harm to patients. 

As indicated by the label, studies on lab animals showed an increased risk in the development of thyroid cancer, including cancer. Patients with a family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2,0 (MEN 2) are at higher risk of thyroid C-cell tumors and should not use Rybelsus.

Manufacturer of Rybelsus – Novo Nordisk

Novo Nordisk is the manufacturer of Rybelsus, Ozempic, and Wegovy. Semaglutide, the generic name for the drug, was tested in clinical trials from 2016 to 2017, prior to approval by the FDA to treat type 2 diabetes in adults. Ozempic, an injectable semaglutide was approved in 2017, while Rybelsus, an oral version of the drug was approved in 2019. 

Wegovy, an injectable semaglutide, is the only drug of the three approved by the FDA for weight loss. Rybelsus is in clinical trials to determine if it is a safe and effective weight loss treatment. All three drugs have faced scrutiny after numerous patients reported serious side effects with their use. Nationwide lawsuits allege that Novo Nordisck knew of the gastrointestinal risks associated with the use of semaglutide and failed to warn consumers.

Rybelsus and Its Ingredient Breakdown

The active ingredient in Rybelsus is 14 mg of semaglutide, produced using DNA technology. However, there are a number of inactive ingredients in the oral tablet that are kept in pill-form and stored in a bottle.

Inactive ingredients in Rybelsus:

• Magnesium stearate
• Microcrystalline cellulose
• Povidone
• Salcaprozate sodium – 23 mg

The active ingredient in Rybelsus has been linked to a number of severe health risks. Individuals who have experienced adverse health conditions after using Rybelsus or another semaglutide are strongly encouraged to consult with a legal representative.

Semaglutide Usage Linked to Severe Health Risks

There have been several serious health risks linked to the use of semaglutide, the generic name for Rybelsus. These health risks include stomach paralysis, and bowel obstruction. Prolonged use of the medication may increase the likelihood that a patient will develop one or more of these conditions. 

Semaglutide is used to regulate blood sugar levels and increase insulin secretion, however it may also provide a longer feeling of fullness aiding in weight loss. Unfortunately, the drug is usually prescribed in a higher dose when used for weight loss, increasing the risk that a patient will develop severe side effects such as gastroparesis, malnutrition-related disorders, deep vein thrombosis, and bowel obstruction.

Eligibility for Filing a Rybelsus Lawsuit

In order to file a Rybelsus lawsuit, you must first meet certain criteria, including proof of use of the drug. Working with an attorney can help you determine whether you may qualify for damages. 

Eligibility criteria for a Rybelsus lawsuit:

• You must be able to show that you were actively using Rybelsus.
• You suffered adverse health conditions including ileus, gastroparesis, gastro-intestinal blockage, or another serious side effect after taking Rybelsus.
• You have evidence from a doctor or gastroenterologist linking your condition to the use of Rybelsus.
• You used the drug for weight loss purposes.
• You required medical intervention as a result of using the drug such as hospitalization, emergency room visits or a consultation with a gastroenterologist.

The best way to determine if you meet the criteria for filing a Rybelsus lawsuit is to contact an attorney. It is important to note that you only have a limited amount of time to take legal action.

Evidence to Collect Before Filing Your Lawsuit:

If you have experienced significant health problems after taking Rybelsus, you may qualify for a personal injury lawsuit. Eligibility may depend on a number of factors including your ability to prove how long you were taking Rybelsus and the injuries you experienced.

Evidence that may strengthen your Rybelsus lawsuit:

• Medical records
• Proof of prescription
• Emergency room visits and hospitalizations
• Doctor’s notes
• Documentation of missed work

The more evidence you can collect, the stronger your case will be. It is important to consult an attorney as early in the process as possible to determine your legal options.

Statute of Limitations for Filing a Rybelsus Lawsuit

All personal injury lawsuits are restricted by a statute of limitations, or legal time limit. Statutes of limitations are state-specific. An attorney can help determine if there are any exclusions or exceptions to the statute of limitations that may apply to your case. In many instances, the statute of limitations ranges between one and three years. 

How to File a Rybelsus Lawsuit

You will need to follow several steps before filing a Rybelsus lawsuit. A lawyer can help you navigate the process and ensure you receive the best possible outcome in your case.

Steps for filing a Rybelsus lawsuit:

• Determine eligibility: In order to determine eligibility you should contact a lawyer for a free case review. During the initial consultation an attorney will help determine if you have a valid claim for damages.
• Gather evidence: The second step in a Rybelsus lawsuit is evidence gathering. In order to strengthen your case, you will need to collect evidence such as medical records, proof of out-of-pocket expenses, prescription documents, and expert testimonies.
  
• Filing the lawsuit: An attorney can aid you in filing the lawsuit in the correct jurisdiction and within the statute of limitations. 
• Negotiations: Your attorney may enter into negotiations with the defendant to secure a favorable settlement in your case. If a settlement cannot be reached, your attorney may set the case for trial to obtain the outcome you deserve.

Throughout the proceedings, it is strongly recommended that you work with a qualified Rybelsus lawsuit attorney.

Rybelsus Settlement Amounts

The anticipated settlement range for serious injuries related to a Rybelsus lawsuit is between $400,000 and $700,000, however the amount will vary greatly depending on the case. Since there is no standardized settlement amount, the value of your case will be determined by your individual damages. 

Damages generally reflect the extent of your losses and the severity of your injuries. An attorney can help ensure that you receive the maximum compensation allowed by state or federal law.

Contact a Rybelsus Lawyer to File a Lawsuit

If you have suffered injuries related to your use of Rybelsus, it is strongly recommended that you contact a qualified attorney. At King Law, our legal team has decades of combined experience handling prescription drug claims. We are well-versed in handling complex lawsuits and will help you secure the compensation you deserve. Contact our office today to schedule a free, no-obligation consultation.

Frequently Asked Questions (FAQs)

Find answers to any major questions you have regarding eligibility in the Rybelsus lawsuits below.