Lawsuit Alleges Ozempic Caused Ileus, Gastroparesis and Intestinal Obstruction for Florida Woman

Side effects of Ozempic caused a Florida woman to suffer painful injuries after it degraded the ability of her intestines to move stomach contents through her digestive system, resulting in intestinal obstructions, as well as a diagnosis of gastroparesis and ileus, according to allegations raised in a new lawsuit.

The complaint (PDF) was brought by Cindy Balsamo in the U.S. District Court for the Eastern District of Pennsylvania on August 23, seeking damages from Novo Nordisk for failing to warn consumers about the risks associated with using the blockbuster diabetes and weight loss drug.

Ozempic (semaglutide) was originally introduced by Novo Nordisk for treatment of type 2 diabetes in December 2017, but it has been heavily marketed as a safe medication that also helps users lose weight. As a result of the benefits provided in promoting weight loss, it has been widely prescribed off-label as a diet drug, and is now used by millions of Americans.

The medication is part of a new class of drugs, known as glucagon-like peptide-1 receptor agonists (GLP-1 RA), which also includes Wegovy, Mounjaro, Zepbound and Trulicity, all of which promote weight loss by delaying gastric emptying, making users feel fuller for extended periods.

Although the drug warning label does indicate that some users experience nausea and vomiting, Balsamo’s Ozempic lawsuit points out that Novo Nordisk failed to disclose that these symptoms may be signs of stomach paralysis from Ozempic, which is a much more severe injury sometimes diagnosed as gastroparesis.

The original warning label also failed to adequately warn users of the risk of ileus from Ozempic, which occurs when the intestines lose the ability to contract properly, causing the intestinal tract to fail to move food through the digestive system and resulting in blockages.

Information about the potential Ozempic ileus and intestinal blockage risks was not added to the drug’s warning label until September 2023, after the FDA identified a number of adverse events during post-approval use of the drug.

As a result of Novo Nordisk’s failure to warn about the severity of these side effects when the drug was first introduced, a rapidly growing number of Ozempic lawsuits are now being filed throughout the federal court system, which is ultimately expected to involve tens of thousands of lawsuits that may be brought in the coming months and years.

Ozempic Caused Ileus, Other Complications After Two Years of Use

Balsamo, of Florida, reports that she used Ozempic from August 2020 to June 2022, before Novo Nordisk updated the drug warning label to warn about the link between Ozempic and ileus. She claims that her injuries were a direct result of the drug maker’s  failure to provide adequate warnings for users and the medical community about Ozempic’s side effects.

“As a result of using Ozempic, Plaintiff was caused to suffer from gastroparesis, ileus and/or intestinal obstruction, and their sequela, which resulted in, for example, constant nausea, vomiting and emergency medical treatment,” her lawsuit states. “(A)s a result of Novo Nordisk’s inadequate warnings, the medical community at large, and Plaintiff’s prescribing physician in particular, were not aware that Ozempic can cause gastroparesis, ileus, and intestinal obstruction, nor were they aware that common adverse reactions’ listed on the label might be sequelae of gastroparesis, ileus, and intestinal obstruction.”

Ileus can be caused by several factors, including abdominal or pelvic surgery, or by conditions such as Parkinson’s disease. However, it can also be caused by certain drugs, resulting in symptoms that include abdominal cramping, bloating, nausea, vomiting, constipation, as well as difficulties eating.

Patients are often treated by taking them off of solid food and giving them a liquid-only, or intravenous, diet to give the intestines a chance to rest and recover. However, in severe Ozempic ileus cases, users can be left with painful and permanent injuries.

Balsamo presents claims of failure to warn, breach of warranty, fraudulent concealment, fraudulent misrepresentation and negligent misrepresentation, seeking both compensatory and punitive damages.

September 2024 Ozempic Lawsuits Update

Given common questions of fact and law raised in complaints similar to the one filed by Balsamo throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings for all Ozempic and other GLP-1 lawsuits earlier this year, transferring complaints to the U.S. District Court for the Eastern District of Pennsylvania, where U.S. District Judge Karen S. Marston is presiding over coordinated discovery.

As part of the management of the MDL, it is expected that Judge Marston will establish a bellwether program, by working with plaintiffs and defendants to determine what Ozempic lawsuits are representative of the greater litigation, and then sending them through case-specific fact discovery before scheduling the first bellwether trials, which will be used to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.

Following coordinated discovery and any early bellwether trials, if the parties are unable to negotiate settlements or another resolution for the litigation, Judge Marston may later remand each claim back to the U.S. District Court where it was originally filed for trial.