Ozempic is a popular drug for type-2 diabetes management and it is also popular for use as a weight loss drug. New evidence from the FDA has recently shown that taking Ozempic can significantly increase the risk of gallbladder disease, often resulting in gallbladder removal or other health consequences.
The manufacturer of Ozempic did not adequately warn patients and doctors about the risk of gallbladder disease. Individuals who used Ozempic and subsequently developed gallbladder disease, gallstones, or had to have their gallbladder surgically removed, may be able to file a product liability lawsuit and get financial compensation. Our firm is not currently seeking new cases. But that could change. This page is to give you the lay of the land of the issues in these cases.
September 18, 2023: There are currently 7 pending cases in the newly formed Ozempic class action MDL litigation. This number will increase significantly as we move forward.
Ozempic is the brand name for semaglutide, an antidiabetic medication that is primarily used for the treatment and management of type-2 diabetes. Ozempic works by prompting the body to increase insulin secretion and the disposal of blood sugar, which improves glycemic control. Although Ozempic is only approved for use in the treatment of diabetes, it has recently gain popularity for off-label use as a weight loss and anti-obesity drug. Ozempic is typically taken in the form of injections 2 times per month.
Ozempic was developed by Novo Nordisk, an international pharmaceutical company headquartered in Denmark that specializes in mediations for the treatment of diabetes. Novo Nordisk first developed Ozempic in 2012 and it was approved for use by the FDA and released on the U.S. market in late 2017. In 2021, a higher-dose version of Ozempic (sold under the brand name Wegovy) was approved by the FDA.
How It Works
Ozempic works by mimicking the function of GLP-1. After a person eats, the body’s natural response is to release insulin to manage the increase in blood sugar. In people with type 2 diabetes, this system may not function effectively, leading to high blood sugar levels. Ozempic triggers insulin production after meals, reducing blood sugar levels. It also slows down digestion, which helps to lower glucose levels in the blood further. Furthermore, it decreases the amount of glucose produced by the liver, maintaining a balance in the blood sugar levels.
This medication is usually prescribed when diet and exercise alone do not provide adequate control of blood sugar levels in people with type 2 diabetes. It may be used as a standalone treatment or in combination with other diabetic medications such as metformin. It is not used for treating type 1 diabetes or for people with diabetic ketoacidosis.
Administration and Dosage
Ozempic is not a pill but a subcutaneous injection, typically given once a week. It’s injected into the skin of the abdomen, thigh, or upper arm. The initial dosage is usually 0.25 mg per week for the first month, serving as a period for the body to adjust to the medication. This dose is then increased to 0.5 mg per week. Depending on the patient’s response and tolerability, the dose may be further increased to a maximum of 1 mg per week.
As with any medication, Ozempic comes with potential side effects. The most common ones include nausea, vomiting, diarrhea, abdominal pain, and constipation. Many of these side effects are more common when a person first starts taking the drug and may lessen over time. Other side effects may include reduced appetite, indigestion, bloating, and fatigue. More severe but less common side effects include pancreatitis, changes in vision, and kidney problems.
Ozempic Linked to Gallbladder Problems
In August 2022, a Research Letter published in the journal JAMA Internal Medicine revealed that Ozempic (and other similar drugs) appeared to be linked to higher rates of gallbladder problems such as gallstones and acute gallbladder disease. The findings were based on a review conducted by the Food and Drug Administration using data from the FDA Adverse Event Reporting System (FAERS).
The FDA data showed that individual who used Ozempic for type-2 diabetes treatment displayed a significantly higher rate of gallbladder health conditions, particularly acute gallbladder disease (acute cholecystitis). Acute gallbladder disease is characterized by sudden inflammation of the gallbladder. It is usually caused by gallstones blocking the tube leading out of the gallbladder. It is a serious condition that must be treated in the hospital to avoid further injury. In many cases, treatment involves surgical removal of the gallbladder.
The study concluded that there was an increased risk of both gallstones (cholelithiasis) (RR 1.27; and acute gallbladder disease (cholecystitis) with Ozempic compared to placebo or active comparator. The researchers also concluded that the risk of gallbladder problems from Ozempic were higher when the drug was at higher doses, for longer durations, and when the drug was used for weight loss.
The conclusions published in the 2022 Research Letter were consist with findings in 2 prior meta-analysis studies on association between drugs like Ozempic and gallbladder problems and gallstones. These prior studies were published in Diabetes Research and Clinical Practice (2020) and Diabetes, Obesity & Metabolism (2017).
About Gallbladder Disease
Gallbladder disease encompasses a broad spectrum of disorders, including gallstones (cholelithiasis), inflammation of the gallbladder (cholecystitis), and cancer of the gallbladder, among others. Ozempic lawsuits are not alleging a link to cancer. But there is a concern about whether these other injuries are liked to the drug.
Gallstones (cholelithiasis) are the most common form of gallbladder disease. These are hard, pebble-like deposits that form inside the gallbladder. They can range in size from a grain of sand to a golf ball. There are two types of gallstones: cholesterol stones, which are the most common and are made up of excess cholesterol, and pigment stones, which are composed of bilirubin, a substance created when the liver breaks down red blood cells.
Risk factors for gallstones include being female, being overweight or obese, being pregnant, having a family history of gallstones, being of Native American or Hispanic descent, and certain dietary factors, such as eating a high-fat or high-cholesterol diet.
Many people with gallstones do not experience symptoms. However, if a stone blocks a bile duct, it can cause sudden, intense pain in the right upper part of the abdomen. This pain may radiate to the back or the right shoulder. Other symptoms can include nausea or vomiting, fever or chills, jaundice, and light-colored stools.
Cholecystitis is an inflammation of the gallbladder that can occur suddenly (acute) or persist over time (chronic). It’s usually caused by gallstones blocking the tube leading out of the gallbladder, which results in a buildup of bile that can cause inflammation and swelling. Symptoms are similar to those of gallstones and include severe pain in the upper right or center abdomen, pain that radiates to the right shoulder or back, tenderness over the abdomen when it’s touched, nausea and vomiting, and fever.
Ozempic Gallbladder Lawsuits
In March 2022, the warning label for Ozempic was modified to include a specific warning about the potential risk of gallbladder disease associated with the drug. Prior to this point, however, the label made no mention of any gallbladder disease risk. Prior to March 2022, patients and doctors were not properly warned that Ozempic involved a risk of gallbladder disease or gallstones.
Individuals who used Ozempic prior to the addition of the new warning label and subsequently developed gallbladder disease (acute cholecystitis), gallstones, or other gallbladder-related problems, may be entitled to bring a product liability lawsuit and get financial compensation. The drug manufacturer can be held liable based on a various product liability theories, including negligent failure to warn and strict liability.
Settlement Value of Ozempic Lawsuits
It is way too early in the litigation to make any meaningful estimations of the potential settlement value of Ozempic gallbladder injury lawsuits. These claims are very new and the admissibility of the scientific causation evidence has not yet been tested. We can, however, make an educated guess as to the potential settlement value range for these cases based on prior settlements in cases involving similar injuries.
Assuming that the causation evidence holds and these cases are otherwise successful, we think that the average settlement value of the top tier Ozempic lawsuits could be $400,000 to $700,000. The top tier cases will primarily be those in which the plaintiff had to have their gallbladder removed and the link between the Ozempic use and the injuries is solid.
There is a huge “but” here. “If” these cases are successful. We are still not sold on the science yet. This is all very new. Our lawyers are not taking these cases right now. But we are looking into them.