Unless you’ve been living in Bilbo Baggins’ Hobbit-burrow, you surely know that GLP1s (Glucagon-like peptide-1) and their “cousin,” GIP (glucose-dependent insulinotropic polypeptide), e.g., Ozempic, Munjaro, Zepbound, etc. have upended the medical- pharmaceutical world and its aesthetic counterpart. Currently five preparations are available to treat Type 2 diabetes and three for weight loss. Nine new GLP-1 drugs are in development by 34 companies, although many are in China.
The drugs are delivering not only for on-label usage but in their off-label capacity as well. Clinical trials are demonstrating highly effective results treating (and even reversing) liver disease, specifically (MASH), formerly non-alcoholic fatty liver disease, reducing heart attacks, strokes, kidney damage, and joint pain from carrying around excess poundage of adipose (fat) tissue, and even lowering the risk of dementia and Alzheimer’s Disease. While the newly-svelte are pummeling the clothe-racks and taking to Tik-Tok to parade their new silhouette, the medical results are equally striking:
“We’ve never seen anything like this. There was a 44% reduction in major cardiovascular issues. There was substantial reduction in osteoporosis, …[and] pneumonia …..”
- Greg Case, CEO of Aon, an employer benefits services firm.
While employee health expenses do skyrocket during the first two years of use (incident to increased physician monitoring); afterward, the return for the outlay is astronomical. According to one study that evaluated 139,000 U.S.-based workers who took GLP-1 medications between 2022 and 2024, health payment increases declined by 50% (from 14% to a 7% increase).
Cracks in the Yellow Brick Road
Alas, not all is rosy in Emerald City. Patients are complaining of Ozempic face and Ozempic butt developing as the fat supporting the outer skin layer rapidly “melts” away, leaving sagging skin. But, there is good news: a new niche market for entrepreneurs rushing to address the sags and bags by providing face creams, ointments, fillers, and surgery. More concerning is protein loss (due to muscle mass reduction), although solutions for prevention are now appearing. However, more serious situations have also surfaced. Like many new drugs, risks of depression and suicidal ideation have been reported:
“despite the hype surrounding the positive clinical outcomes of GLP1 receptor agonists…We urge the clinical prescribing community to proceed with caution to avoid another tragic wave of ‘people dying to lose weight.’”
- Dr. Kenneth Blum, Research Professor at Western University Health Sciences.
Other serious sequelae have also been reported, including a rare type of blindness called non-arteritic anterior ischemic optic neuropathy (NAION), where the optic nerve is damaged due to a sudden decrease in blood flow, resulting in vision loss.
In late April, two plaintiffs filed suit in New Jersey, complaining they suffered bilateral and irreversible blindness due to NAION after a few months of semaglutide (Ozempic and Wegovy) use. They allege that the manufacturer, Novo Nordisk, was liable for failing to warn of “the complications and devastating effects” of the drug, citing a 2025 article in JAMA ostensibly in support.
Novo Nordisk disputes the claim, noting that the condition is rare and unrelated to the drug, and provides both internal studies and research from the University of Southern Denmark in support. It normally would be expected that FDA scientists would have vetted the evidence, both literature and clinical trials, before granting approval, which it did in 2017 for Type 2 diabetes and in June 2021 for weight loss, and agreed the drugs were safe as labeled.
“Wegovy’s safety and efficacy were studied in four 68-week trials. Three were randomized, double-blind, placebo-controlled trials (including 16 weeks of dose increases) and one was a double-blind, placebo-controlled, randomized withdrawal trial in which patients receiving Wegovy either continued with the treatment or switched to a placebo. More than 2,600 patients received Wegovy for up to 68 weeks in these four studies and more than 1,500 patients received placebo.”
One New Jersey plaintiff began Ozempic use in November 2023 and was diagnosed with NAION by June 2024. The JAMA Opthalmology study was not published until February 2025. Given its release date, holding the manufacturers liable based on that information (even if it was relevant) would be a stretch.
Further, the study researched people who were prescribed the drug for diabetes, and NAION is considered an independent risk of diabetes, irrespective of semaglutide use. Additionally, the JAMA study is a retrospective observational meta-analysis, rather low down on the reliability totem pole as epidemiological studies go. And its conclusion is anything but conclusive:
“Results of this study suggest a modest increase in the risk of NAION among individuals with T2D associated with semaglutide use, smaller than that previously reported, and warranting further investigation into the clinical implications of this association.”
Notwithstanding their findings, the study authors report that “The American Diabetes Association recommends GLP-1s as a preferred therapy for patients with T2D with atherosclerotic cardiovascular disease, chronic kidney disease, or obesity.”
This is the stuff that propels lawsuits, whether truly causally related or a convenient excuse on which to blame a life-shattering condition, inviting (pressuring) a settlement from a manufacturer eager to avoid adverse publicity. And the cases against GLP-1/GIP manufacturers are mounting.
Seven other injuries are being claimed:
- Gastroparesis or stomach paralysis – the signature injury of the litigation
- Hospitalization for over one day for GI issues
- Esophageal injury requiring surgery
- Ileus or bowel obstruction
- DVT and related injuries, including death
- Pulmonary aspiration
- Gallbladder injury with surgery
As of May 2, 1,685 active cases had been filed in a Multi-District Litigation (in the Eastern District of Pennsylvania, a plaintiffs’ litigation haven), a jump of over 500 filings from the prior month —one of the sharpest increases across any current mass tort litigation.
The claim raises a broad barrage of claims for failure to disclose dangers incident to use. On April 22, the court heard a motion by defendants Eli Lilly and Novo Nordisk seeking to dismiss the complaint on lack of specific misrepresentations (We should be hearing shortly; stay tuned). The plaintiffs’ bar dismisses their assault, claiming:
“These drugs were marketed to the public in a uniform, heavily branded manner. Plaintiffs contend that these promotions, which saturated digital, print, and broadcast media, consistently omitted meaningful warnings—an omission that became especially problematic as internal safety signals and international regulatory developments surfaced.”
Knew or Shoulda Known
To prevail in a failure to warn case, the plaintiffs must do more than flag wave “The Drugs Are Dangerous.” Typically, they must establish that the defendants had actual knowledge of the dangers- or should have known of these – meaning they should have investigated further based on troubling (but not necessarily indicting) information. The claimed harm must be detailed – as the disclosure requirement also centers on the risk-utility-and magnitude of reasonably anticipated harm – which varies by the harm arguably concealed.
It is highly unlikely GLP-1/GIP manufacturers had any actual knowledge of any of the harms claimed (although not impossible). [1] The real question facing the court would be: should they have known (and undertaken further research) an allegation seemingly hovering around the Zantac cases. We won’t have definitive answers until discovery is completed if the case gets that far. The published literature doesn’t seem to establish a basis for conducting further tests or investigation, although whether internal information raises that specter remains to be seen.
Further, the harms the manufacturer must investigate must be specific- and this is where the plaintiffs’ lawyers go astray. To prove such a claim, clinical studies must demonstrate that these risks are realistic enough to warrant warnings. To conduct such tests, the precise endpoint (harm) being alleged to justify the warning must be delineated. i.e., does consumption of this product increase a particular risk? What risk? If a disease is claimed, the parameters for diagnosing that disease must be detailed in order to establish the reliability of the results (are we all diagnosing the same condition?). (A prospective cohort study, like the NHANES study, may disclose this information- but its results wouldn’t be available for years).
I Woulda Done It Anyway
Even if the plaintiffs can establish that a reasonable manufacturer would have investigated and that had they done so, they would have been on notice that these drugs do cause the claimed conditions prior to the plaintiff’s consumption, the plaintiff would have to prove that had they known the risks, they would have eschewed consumption.
The decision must be made prospectively; the plaintiffs must prove they would have declined the drug had they known of the risk prior to consumption – not after the harm occurred. Monday morning quarterbacking isn’t accepted. So, what would you have done – had you not known the future, is the critical question.
Given the huge demonstrable benefits of the drugs, the rarity of the claimed events, and that gorgeous size eight dress hanging in your closet that you can now wear after 20 years, to me, it would be a hard sell.
GLP-1 drugs may be reshaping medicine and sculpting bodies—but the lawsuits are reshaping the narrative. As science surges ahead, the people ask: at what cost, and the lawyers ask at what premium?
[1] In one reported set of cases involving MER-29 (used to treat arthritis), the manufacturer, Richardson Merrell, made a calculated cost-benefit analysis that they would lose less in lawsuits than they would if they disclosed the known hazard- blindness. In a related set of cases, DuPont’s apparent knowledge, at least by the 1990s, of the dangers of dumping its C-8 (PFOA) chemical has been impressively established.
