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Ozempic Gallbladder Lawsuit

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, and gallstones, or had to have their gallbladder surgically removed, may be able to file a product liability lawsuit and get financial compensation.

Ozempic gallbladder lawsuits are being filed around the country.  If you have an Ozempic lawsuit, call us today at 800-553-8082 or reach out to us online.


UPDATES:

March 18, 2024: The inaugural status conference for the Ozempic multidistrict litigation took place last week, bringing together lawyers from Novo Nordisk and plaintiffs who either have filed cases or are looking for a place in the plaintiffs’ attorney leadership group in the MDL. This initial case management meeting was held in a federal court in Pennsylvania.

Under the supervision of Judge Gene E.K. Pratter in the US District Court for the Eastern District of Pennsylvania, 18 lawsuits have been merged, with another 37 awaiting similar consolidation. The bulk of these cases allege inadequate warnings about the risk of gastroparesis—a digestive disorder characterized by slowed or halted stomach contractions, causing symptoms like nausea and dehydration—associated with Ozempic and other glucagon-like peptide 1-receptor agonists, including Wegovy, Mounjaro, and Trulicity.

To date, no case management order has been issued, though several court orders have allowed out-of-state attorneys involved in the Ozempic lawsuits to participate in the proceedings.

March 15, 2024: A new Ozempic lawsuit was added to the MDL today.  The 50-year-old South Dakota plaintiff used Ozempic in 2020. As a result, the plaintiff was caused to suffer gastroparesis and its consequence.

February 2, 2024:  Judge Gene E.K. Pratter in the Eastern District of Pennsylvania takes charge of a new Ozempic multidistrict litigation (MDL) that combined 18 lawsuits, with an additional 37 lawsuits awaiting potential consolidation. The Ozempic MDL is not exactly a class action lawsuit, yet it shares characteristics of one by consolidating multiple lawsuits into a single proceeding for efficiency and consistency in handling. This approach allows for individual claims to be processed collectively, streamlining pretrial procedures while maintaining the distinct nature of each lawsuit.

January 21, 2024: A resident of Louisiana has filed a lawsuit against Danish companies Novo Nordisk AS and Novo Nordisk North America Operations AS, related to injuries she claims to have sustained from using  Ozempic and Mounjaro.  Judge James D. Cain Jr. of the US District Court for the Western District of Louisiana ruled that the companies’ connections to Louisiana were sufficient to establish jurisdiction in the state.

We have been talking a bit about this case, one of the first Ozempic lawsuits. Bjorklund alleges that she experienced extreme vomiting due to these drugs, resulting in the loss of her teeth.

More importantly, to other plaintiffs who have filed or will file an Ozempic lawsuit, Bjorklund has also petitioned the US Judicial Panel on Multidistrict Litigation to consolidate federal lawsuits involving these medications into a single proceeding. Novo Nordisk supports this consolidation, while Eli Lilly and some plaintiffs oppose including Lilly in a unified proceeding.

The hearing is this week, and we should have a ruling in early February. It is hard to conjure up scenarios where the court would deny an MDL. So a month from this time, we will likely be talking about a new Ozempic class action lawsuit.

January 3, 2024:  There have been some some recent developments have emerged regarding the potential Mounjaro and Ozempic class action lawsuit.

Novo Nordisk, the maker of Ozempic, favors consolidating the litigation, pointing to common factual, scientific, and legal aspects across the over 40 Ozempic lawsuits that have already been filed. For this MDL class action lawsuit, Noro proposes either the Western District of Louisiana or, as an alternative, the Southern District of California.

On the other hand, Eli Lilly, the manufacturer of Mounjaro, does not want to be part of an MDL.  Its position?  Ozempic is what this litigation is about.  It argues the majority of the gallbladder injury lawsuits are centered around Novo Nordisk’s Ozempic and its off-label use for weight loss, which is not a claim associated with Lilly’s products, Mounjaro and Trulicity, both approved for managing type 2 diabetes and not for weight loss.

Eli Lilly also points out that only ten lawsuits involve their products. Should they be included in the multidistrict litigation, they suggest the Southern District of Indiana or the Middle District of North Carolina as suitable venues for these cases.

December 22, 2023:  In Louisiana, a lawsuit involving the diabetes drugs Ozempic and Mounjaro has been filed against Novo Nordisk A/S and Eli Lilly & Co. The plaintiff claims to have suffered from severe health issues, such as extreme vomiting and tooth loss, due to these medications. However, Novo Nordisk and its North American branch are disputing the Louisiana court’s jurisdiction, arguing there is no substantial link between them and the state.

The defendants assert that the lawsuit does not prove their incorporation or main business operations in Louisiana or show significant state interactions. Additionally, the lawsuit lacks specific allegations of the companies’ directed activities towards Louisiana or information about the plaintiff’s history with drugs in the state.

The case also involves the U.S.-based subsidiaries of Novo Nordisk and Eli Lilly. The plaintiff is pushing to merge various federal cases related to these drugs into a single multidistrict litigation. With ongoing coverage of the case, the Judicial Panel on Multidistrict Litigation (JPML) is expected to address this consolidation issue in January. Observers – well us, anyway, anticipate the likelihood of forming an Ozempic class action lawsuit.

December 11, 2023: A Louisiana federal judge has mostly rejected Novo Nordisk Inc.’s motion to dismiss a legal challenge concerning insufficient warnings of possible side effects, particularly gastroparesis, related to the diabetes medication Ozempic. This aspect of warning adequacy is crucial in any lawsuit involving Ozempic.

The judge ruled to dismiss the breach of express warranty allegations but permitted the progression of other claims in the case. The judge also highlighted the lawsuit’s points regarding the lack of sufficient warnings for doctors, referencing the learned intermediary doctrine specific to Louisiana law. The decision did not cover comparable allegations against Eli Lilly & Co.’s Mounjaro, with a verdict on those still to come. But it is reasonable to expect that they will break the same way.

December 5, 2023: A group of plaintiffs filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize all federal gastroparesis lawsuits involving Ozempic, Wegovy, Mounjaro, and similar GLP-1 receptor agonist drugs. The motion suggests consolidating pretrial proceedings under U.S. District Judge James D. Cain, Jr. in the Western District of Louisiana. While this process resembles a class action lawsuit, there’s a technical difference. In an MDL, individual lawsuits are combined for pretrial activities but remain separate for trials. In contrast, a class action involves a group of plaintiffs treated as one entity, with outcomes affecting the entire class. Currently, 18 cases are pending in various U.S. District Courts, and given the widespread use of these drugs, it’s likely that an MDL will be established.

November 7, 2023: An Ozempic class action lawsuit has been launched against Novo Nordisk in the Canadian courts by a plaintiff who alleges Ozempic led to severe gastrointestinal issues for her.

October 6, 2023: This new JAMA study will throw gas on the fire of new Ozempic lawsuits.


About Ozempic

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 medications 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.

Credit where credit is due – the drug works. But the question is whether everyone should use it given the risks.  That is what this litigation is about.

Clinical Use

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.

Side Effects

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.

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

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

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.

What Are the Ozempic Lawsuits Really About?

In the lawsuit against Novo Nordisk regarding Ozempic, the main complaint is that the company didn’t properly warn doctors and patients about the risk of gastroparesis, a serious stomach condition, when taking the drug. That is the big issue. The label on Ozempic does mention some effects on stomach emptying but doesn’t specifically say that gastroparesis is a risk. The company’s website also doesn’t include this risk in its safety information section.

Previously, the Ozempic label had a section advising doctors to tell patients about common side effects like nausea and vomiting. However, this section was removed in 2020. This is important because ongoing vomiting can be a sign of gastroparesis. The label also used to say that vomiting usually decreases over time, which could lead doctors to overlook gastroparesis symptoms.

The Ozempic lawsuit also drills down on the idea that Ozempic’s label advises women to stop using the drug at least two months before planning a pregnancy. This indicates that the effects of the drug, like vomiting, can last for a while after stopping it. This point is effectively used to argue that Novo Nordisk should have been more upfront about the risk of gastroparesis and its long-lasting effects.

Since Ozempic was approved, Novo Nordisk is accused of not providing adequate warnings about the link between Ozempic and gastroparesis. The lawsuit claims that the company knew or should have known about this risk based on clinical studies and medical literature. Despite this knowledge, it’s alleged that they didn’t warn the medical community or patients properly.

If Novo Nordisk had provided clear warnings, the lawsuit argues, doctors might have made different decisions about prescribing Ozempic or would have monitored patients more closely for gastroparesis symptoms, potentially avoiding the condition.

The Science

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 individuals 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 was 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 consistent with findings in two prior meta-analysis studies on an 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).

October 2023 Study

A recent study investigated how certain diabetes drugs, such as Ozempic and Liraglutide, affect people when used for weight loss, a purpose different from their original design. This study provides ample fodder for every Ozempic lawsuit.

The research was conducted by a team from the University of British Columbia, Canada, and the results were published in the Journal of the American Medical Association (JAMA). The study included a substantial sample size, analyzing the medical records of 16 million patients from 2006 to 2020, using the PharMetrics Plus for Academics database. This database captures a large proportion of outpatient prescriptions and physician diagnoses in the U.S.

What did they find?  They found exactly what Ozempic lawyers thought they would find.  The study found that those who used diabetes drugs for shedding pounds were at a higher risk of developing several stomach-related issues. These included pancreatitis, a condition where the pancreas becomes inflamed and painful; gastroparesis, a disorder that slows or stops the movement of food from the stomach to the intestines; and bowel obstruction, a blockage in the intestines. However, the study did not link these diabetes medications to an increased risk of biliary disease, which affects the gallbladder and bile ducts.

The findings showed an increased risk of several gastrointestinal issues in patients using GLP-1 agonists for weight loss compared to those using bupropion-naltrexone. These adverse events included pancreatitis (inflammation of the pancreas), gastroparesis (delayed stomach emptying), and bowel obstruction, but not biliary disease (issues related to the gallbladder and bile ducts).

For instance, the incidence rates per 1000 person-years for biliary disease were 18.6 for liraglutide, 11.7 for semaglutide, and 12.6 for bupropion-naltrexone. For pancreatitis, the incidence rates were 7.9 for liraglutide, 4.6 for semaglutide, and 1.0 for bupropion-naltrexone.

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 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.

Get an Ozempic Lawyer

Ozempic gallbladder lawsuits are being filed around the country.  If you have an Ozempic lawsuit, now is the time to act. Call our attorneys today at 800-553-8082 or reach out to us online.

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