First Federal Lawsuit Filed Alleging Severe Gastroparesis from Ozempic and Mounjaro Use

A recent lawsuit filed in the U.S. District Court for the District of Louisiana marks the first federal legal action alleging that the manufacturers of Ozempic and Mounjaro failed to adequately warn consumers about serious gastrointestinal side effects, including gastroparesis, also known as stomach paralysis. The plaintiff, Jacklyn Bjorklund, claims she suffered severe gastrointestinal distress after using these drugs, which are prescribed for type 2 diabetes and increasingly used off-label for weight loss.

The lawsuit accuses Novo Nordisk and Eli Lilly of knowing about the risks associated with their GLP-1 receptor agonist drugs but failing to disclose this information to patients and healthcare providers. This case highlights emerging legal challenges surrounding the safety disclosures of popular diabetes and weight loss medications.

Key Takeaways

• The first federal lawsuit alleges Novo Nordisk and Eli Lilly failed to warn about gastroparesis and other severe gastrointestinal side effects linked to Ozempic and Mounjaro.
• The plaintiff reports serious injuries including repeated hospital visits, severe vomiting, and related complications such as tooth loss.
• The case raises critical questions about pharmaceutical companies’ duty to warn and the adequacy of drug labeling for widely used GLP-1 receptor agonists.

Background: Ozempic and Mounjaro’s Medical Use and Side Effects

Ozempic (semaglutide) and Mounjaro (tirzepatide) are injectable medications approved to manage blood sugar in adults with type 2 diabetes. Both drugs mimic the GLP-1 hormone, which slows gastric emptying to increase feelings of fullness and reduce calorie intake. While effective for diabetes and weight loss, this mechanism can cause serious gastrointestinal side effects if the stomach slows excessively.

Reported side effects include nausea, vomiting, diarrhea, abdominal pain, and constipation. More severe conditions such as gastroparesis—a paralysis of stomach muscles leading to delayed emptying—have been linked to these drugs. Gastroparesis can cause persistent vomiting, malnutrition, and other complications.

Despite these risks, the lawsuit alleges that manufacturers downplayed the severity of gastrointestinal events and failed to adequately warn patients or the medical community, even as adverse event reports accumulated.

The Lawsuit Against Novo Nordisk and Eli Lilly

Filed in August 2023, the lawsuit centers on plaintiff Jacklyn Bjorklund, who used Ozempic for over a year before switching to Mounjaro. She alleges suffering severe gastrointestinal symptoms including vomiting, stomach pain, and gastroenteritis, which led to multiple emergency room visits. The excessive vomiting reportedly caused some of her teeth to fall out, requiring further medical treatment.

The complaint claims that both drug makers knew about the association between GLP-1 receptor agonists and severe gastrointestinal issues but failed to provide adequate warnings. It also highlights aggressive marketing efforts by Novo Nordisk, including nearly $900 million spent on television ads and millions in perks to doctors, which allegedly promoted off-label use without sufficient safety disclosures.

Warning Labels, Evidence, and Legal Issues in the Case

A key legal issue is whether the defendants breached their duty to warn by not adequately disclosing the risk of gastroparesis and related gastrointestinal harms. While Mounjaro’s label mentions gastroparesis, it does not warn of the risk, only advising against use in patients with severe gastrointestinal disease. Ozempic’s label lists common side effects but only added gallbladder disease warnings in 2022, and does not explicitly warn about gastroparesis.

Evidence such as adverse event reports, prescribing information, marketing materials, and internal company knowledge will be critical. The case also raises questions about the impact of aggressive off-label marketing on patient safety and informed consent.

Why This Lawsuit Matters for Personal Injury Litigation

This lawsuit underscores the growing scrutiny of pharmaceutical companies’ responsibilities to warn about serious side effects of popular medications, especially those increasingly used off-label. It highlights the importance of thorough investigation into drug safety disclosures, marketing practices, and the adequacy of warnings provided to patients and healthcare providers.

For California injury claims involving prescription drugs, similar issues can arise regarding manufacturer liability, evidence preservation, and damages related to long-term health impacts. Cases involving serious drug side effects often require detailed medical documentation and expert testimony to establish causation and damages.

As the use of GLP-1 receptor agonists expands, more lawsuits are expected, making this an important development for personal injury and pharmaceutical litigation.

Frequently Asked Questions

What is gastroparesis and how is it linked to Ozempic and Mounjaro?

Gastroparesis is a condition where the stomach empties slowly or not at all, causing nausea, vomiting, and digestive problems. Ozempic and Mounjaro slow gastric emptying as part of their effect, which can lead to gastroparesis in some patients.

Why are plaintiffs alleging failure to warn in these lawsuits?

Plaintiffs claim the drug manufacturers knew or should have known about the risk of severe gastrointestinal side effects but did not adequately disclose these risks to patients or doctors, violating their duty to warn.

Are these drugs approved for weight loss?

Wegovy, a semaglutide drug by Novo Nordisk, is FDA-approved for weight loss. Ozempic and Mounjaro are approved for type 2 diabetes but are often used off-label for weight loss.

What should patients do if they experience side effects?

Patients experiencing severe gastrointestinal symptoms after using these drugs should seek medical attention and consult with a qualified attorney to evaluate potential legal claims.

Cases involving serious medication side effects require careful evaluation of liability, evidence, and damages. For assistance with similar claims, contact experienced California personal injury attorneys for a free case review.

Original reporting on this development can be found at LawyersandSettlements.com.