Issues in the MDL
The MDL focuses on concerns about glucagon-like peptide-1 receptor agonists (GLP-1 RAs). This class of drugs includes Ozempic, Wegovy, and Reybelsus, all produced by Novo Nordisk. It also includes Mounjaro and Trulicity, produced by Eli Lilly.
Ozempic (semaglutide) and related GLP-1 RAs were originally formulated to help manage blood glucose levels and blood A1c levels in patients with type 2 diabetes. As physicians and patients begin using the medication, however, they realized it also aids in weight loss for some patients by mimicking the hormones that signal the body to stop eating and by slowing the rate at which digestion occurs.
Wegovy, a semaglutide formulation similar to Ozempic, was approved by the FDA in 2021 for chronic weight management. Both medications were designed for long-term use.
Plaintiffs in the MDL allege that GLP-1 RAs cause various gastric injuries, including gastroparesis, ileus, intestinal obstruction, and intestinal pseudo-obstructions. Some cases allege that the drugs cause or exacerbate gallstones and gallbladder disease, in some cases requiring surgical removal of the gallbladder. They also allege that Novo Nordisk and Eli Lilly did not adequately warn patients or providers of these risks.
Gastroparesis slows or stops the movement of muscles in the upper digestive tract, resulting in food and water failing to pass through properly. The condition can cause a variety of symptoms, including nausea, vomiting, abdominal bloating and pain, dehydration, malnutrition, and weight loss. Ileus occurs when the flow of intestinal contents stops for reasons other than a mechanical blockage, while an intestinal obstruction involves a mass, adhesion, hernia, or other object preventing the flow of intestinal contents.
In one case, a patient experienced gastroparesis leading to severe vomiting. The patient was hospitalized several times for her symptoms and lost teeth due to the effects of gastric acids brought up by severe vomiting.
Details of the Consolidated Cases
As of early February 2024, 55 cases had been consolidated into the MDL. The cases were consolidated in the U.S. District Court for the Eastern District of Pennsylvania in part because thirteen of the 55 cases were already pending in that court - more than in any other single US district.
The Eastern District of Pennsylvania is also geographically convenient for Novo Nordisk, which is headquartered in nearby Plainfield, New Jersey, according to the consolidation order. A Novo Nordisk spokesperson said the company was pleased with the choice of court, although it considers the plaintiffs’ claims without merit.
Plaintiffs’ attorneys also approved of the choice of court and judge. “Judge Pratter’s background and experience will help the parties navigate through this important MDL,” said plaintiffs’ counsel Paul Pennock of Morgan & Morgan PA.
Cases alleging injuries from GLP-1 RAs have appeared in 11 district courts nationwide to date, with related cases appearing in 15 additional courts.
What Attorneys Can Expect as the Cases Proceed
At issue in the consolidated cases is whether GLP-1 RA drugs cause gastroparesis, ileus, and related gastrointestinal issues. These conditions share the common feature of slowed or stopped movement in the gastrointestinal tract, whether due to a blockage or for other reasons.
The MDL against Novo Nordisk and Eli Lilly will include expert witnesses discussing how GLP-1 RAs work, how they affect the movement of the gastrointestinal tract, and to what extent the defendants fulfilled their duties to warn patients and physicians about potential side effects, including gastroparesis, ileus, and intestinal obstructions or pseudo-obstructions.
Experts may be asked to opine on studies of GLP-1 RA use that, in some cases, are still underway or are recently published. A January 2024 study in BMJ, for instance, found that while the class of drugs is effective in treating type 2 diabetes and “significantly improved weight management,” side effects are more likely at higher doses. Researchers found “the results prompt safety concerns for GLP-1 RAs, especially with high dose administration, regarding gastrointestinal adverse events.” Expert witnesses may be asked to review these studies and weigh in on their applicability in the MDL.
Additional cases may be included in the MDL in the coming months. Some estimates indicate the total number of lawsuits in the MDL may top 10,000.
