PHILADELPHIA (LN) — A new complaint filed in the GLP-1 receptor agonists multidistrict litigation alleges that Novo Nordisk knew its diabetes drug Ozempic could cause ileus and intestinal obstruction but failed to warn patients or doctors of the risks.
Sharon Nolan, a 70-year-old Louisiana resident, filed the suit in the U.S. District Court for the Eastern District of Pennsylvania, accusing the Danish pharmaceutical company of downplaying the severity of gastrointestinal side effects associated with semaglutide.
The complaint alleges that while Novo Nordisk acknowledged gastrointestinal events as common side effects, it never warned users of the risk of ileus, a condition where intestinal muscle contractions stop, or intestinal obstruction, which can lead to rupture or death.
The complaint cites the Merck Manual to define ileus as “a temporary lack of the normal muscle contractions of the intestines.” It states that when ileus occurs, peristalsis is slowed or stopped, preventing food, gas, and liquids from passing through the digestive tract.
Nolan claims she suffered from ileus and intestinal obstruction after using Ozempic, requiring hospitalization, surgical intervention for a small bowel obstruction, and gallbladder removal.
The suit asserts that Novo Nordisk had notice of these risks from clinical trials and medical literature as early as 2008, when a New England Journal of Medicine study noted “suspected ileus” as a serious complication for exenatide, another GLP-1RA.
The complaint highlights a 2012 warning from Japan’s Pharmaceutical and Food Safety Bureau that intestinal obstruction may occur in patients taking GLP-1RAs, and a 2013 European Medicines Agency review that retrieved 59 cases of intestinal obstruction linked to the drug class.
Despite this alleged knowledge, the complaint says Novo Nordisk spent $884 million on television ads for its semaglutide drugs since 2018, promoting Ozempic as having “proven safety.”
The suit also alleges that Novo Nordisk spent $11 million in 2022 on food and travel for doctors to promote its drugs, buying more than 457,000 meals for nearly 12,000 physicians.
Novo Nordisk did not add “ileus” to the Ozempic label until September 2023, and only in the “Adverse Reactions” section under “Postmarketing Experience,” the complaint notes. The drug maker did not include the condition in the “Warnings and Precautions” section.
The complaint cites a July 2023 Rolling Stone article in which Novo Nordisk acknowledged that gastrointestinal reactions are common. The complaint alleges that despite this acknowledgment, the company failed to warn consumers about ileus or intestinal obstruction.
Nolan is represented by Morris Bart, L.L.C., of New Orleans. The firm has been active in mass tort litigation involving pharmaceutical products.
The case is part of the broader GLP-1 MDL, which consolidates lawsuits alleging that drugs like Ozempic and Wegovy cause serious side effects including pancreatitis, gastroparesis, and intestinal obstruction.