A judicial panel centralized several lawsuits filed against weight loss drugs like Ozempic and Wegovy, alleging that the medications failed to warn about potential gastrointestinal side effects.
The lawsuits claim that the companies failed to adequately warn users and doctors about the dangerous potential gastrointestinal side effects of the drug.
GLP-1 RA drugs mimic a natural human glucagon-like peptide (GLP-1) in order to slow down the passing of food through the stomach.
Individuals who suffer from gastroparesis can experience dehydration from repeated vomiting, difficulty in controlling blood sugar levels, and malnutrition due to poor nutrient absorption—consequences that can be life-threatening.
“I predict that we are just beginning to understand the permanency that could be associated with these injuries,” Mr. Stephenson said.
The lawsuits also allege other gastrointestinal issues like ileus and intestinal obstructions suffered by the plaintiffs. Ileus is a condition in which the intestine is unable to push food and waste out of the body.
Novo Nordisk said in a statement to The Epoch Times that they are “pleased with the … decision to coordinate federal lawsuits related to GLP-1RA medicines in a multidistrict litigation proceeding.”
However, “Novo Nordisk believes that the allegations in these lawsuits are without merit, and we intend to vigorously defend against these claims.”
The known risks and benefits of semaglutide “are described in their FDA-approved product labeling,” it said. Semaglutide is the active ingredient in Ozempic, Wegovy, and Rybelsus.
“Novo Nordisk stands behind the safety and efficacy of all of our GLP-1 medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional.”
Eli Lilly objected to the MDL. Fifty-five cases have been filed against the companies so far. Novo Nordisk is facing the majority of lawsuits, with 42 out of the 55 cases against the company and the remaining 13 against Eli Lilly.
Ozempic’s Gastrointestinal Issues
In an interview with lifestyle publication The Cut, endocrinologist Dr. Caroline Messer said that gastroparesis is more than a side effect and is actually part of the reason why people who take GLP-1 drugs like Ozempic lose weight. “It’s one of the mechanisms of action.”“They reduce the transitive food through the gut, which is literally the definition of gastroparesis. No one’s trying to keep it a secret. That’s why you feel more full.”
Gastroenterologist Dr. Will Blackett said that the first step in treating gastroparesis would be to stop taking any medications contributing to the condition, like GLP-1 drugs.
Ozempic doesn’t list gastroparesis explicitly as a side effect of taking the drug. However, it does list symptoms like nausea, stomach pain, constipation, and vomiting.
In September last year, the U.S. Food and Drug Administration (FDA) added ileus as a gastrointestinal side effect of Ozempic.
“They (Novo Nordisk) don’t allow this drug for obesity in Europe. Almost all of Novo Nordisk’s revenue is coming from taking advantage of Americans. This is not the first line of defense for obesity in any European country. It’s not approved by the government regulators,” he said. “They are saying on their stock calls that all of their growth is coming from the United States. They’re taking advantage of a broken U.S. system.”
MDL Litigation
According to the ruling, 13 out of the 55 lawsuits have been filed in the Eastern District of Pennsylvania, the most in any district. As such, the panel decided Pennsylvania would be an “appropriate transferee district” where the single MDL would be litigated.“Novo Nordisk Inc.’s headquarters is in nearby Plainfield, New Jersey, and it is alleged that many of the witnesses and documents relating to the sales and marketing, regulatory affairs, and safety and pharmacovigilance of Novo Nordisk’s products will be located there. The Eastern District of Pennsylvania also provides a convenient and accessible location for this nationwide litigation.”
Those who opposed creating an MDL argued that the drugs manufactured by Novo Nordisk and Eli Lilly contain different molecules and have different regulatory histories, labeling, marketing conduct, and side effects.
However, the panel concluded that the medications “share a mechanism of action and physiologic effect.” Claims against both firms “are likely to involve some common discovery, particularly with respect to the alleged biological mechanism of injury and may entail overlapping expert witnesses.”
As such, centralizing the lawsuit into an MDL would be an “efficient pretrial approach to this litigation.”
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