Nary a day goes by without new benefits being attributed to the GLP-1 family of drugs.
In addition to fostering weight loss and alleviating Type 2 Diabetes, these include the following:
- Addressing addiction
- decreased risk of dementia, and possibly Alzheimer’s
- increased cognitive and behavioral health,
- significant benefits to neurological and behavioral health,
- reduced risks of seizures
- decreased risks of suicidal ideation, self-harm, bulimia, and psychotic disorders such as schizophrenia.
- Reduced brain inflammation
- Migraine Benefits
- Lowered risk of heart attack, stroke, and other cardiovascular concerns.
These effects could significantly improve health metrics, although the magnitude of the associated benefits is modest, with a 10 percent to 20 percent reduction across most outcomes. Since one in eight Americans has taken or is currently using the drugs (primarily to treat diabetes, heart disease, or obesity), the collective benefit may be much higher.
But all is not rosy in weight-loss land. One large study suggested an increased risk of kidney, pancreatic, and gastrointestinal problems, as well as arthritis. [1] The study evaluated 175 health outcomes among 2 million veterans compared with those taking more traditional oral medications for diabetes. The study does not prove a causal relationship between the GLP compounds and these diseases, but it does suggest that vigilance is necessary, especially as doses increase.
That has not stopped the influx of lawsuits alleging that the drugs are harmful and have injured thousands of plaintiffs. The consolidated Multidistrict Litigation (MDL) pending in Philadelphia alleges that these drugs caused various other conditions. In addition to those I reported earlier (including nausea, vomiting, diarrhea, and, in rare cases, paralysis of the stomach), the MDL's new claims menu includes:
- severe vision loss (NAION),
- bowel injury
- necrotizing pancreatitis
- pulmonary embolisms
- deep vein thrombosis
- death
- New claims are still proliferating, including thyroid cancer.
Interestingly, plaintiffs’ bar sites are advising against pursuing claims other than visual loss and bowel injury cases, which they consider lucrative and sufficiently definitive, without resorting to claims that would be speculative or difficult to prove: thereby diluting the strength of their two primary claims, noting that:
“There is a real temptation in fast-moving pharmaceutical litigation to allege that a blockbuster drug causes every serious medical event reported after use. But that is dumb. These drugs are helping some people. …. Plaintiffs are far better served focusing on injury categories where the scientific signal appears stronger and more consistent, such as, again, NAION vision loss... We predict the NAION cases will be worth a great deal” [emphasis added]
- Litigation Information Center, Miller & Zois
Unsurprisingly, Lilly and Novo Nordisk have moved to dismiss the 17 claims raised in the Philadelphia MDL. In August, the judge ruled that most of the claims will survive this preliminary stage. However, five of the 17 claims were stricken because they were vague and non-specific, particularly regarding when and where more specific information should have been provided. The court allowed the plaintiffs to amend their complaint when and if more information becomes available.
Although the judge rejected the alleged omissions in the drugs’ marketing, the complaint adequately alleged claims of fraudulent omission regarding information that should have been disclosed. The judge also upheld claims of express and implied warranties of safety and efficacy, based on the manufacturers’ “guaranteeing that the GLP-1s were safe and effective as part of a weight loss treatment.”
Safety first, last, or non-existent?
The law is ill-equipped to assess safety claims unless they are framed comparatively – a process that, for all intents and purposes, no longer exists. Nothing is 100% safe. Not even being born. The real question: is the drug, with whatever alleged side effects it carries, “safer” than an obese person with a heart condition carrying 300 pounds of excess weight, for whom the drug reduces that weight?
It is here that true informed consent, performed by the “learned intermediary,” once known as the doctor, played an integral role before direct-to-consumer advertising became the norm. Today, however, as these drugs become available via the internet or on patient demand, or in an insurance-limited 15-minute visit, the in-depth discussion of risks and benefits is foreclosed by the health system, whether by pharma, insurance, medical, or medical freedom demands by the individual consumer. In other words, the “safety,” which can only be relative, sought by the plaintiffs is no longer part of the system, in no small measure because of patient demands.
What’s next?
The plaintiffs’ bar is actively recruiting claimants seeking damages for severe vision loss and bowel injury, likely in hopes of an omnibus settlement. However, we can expect extensive discovery to determine exactly when the manufacturers knew or should have known about these conditions. So, for now, we wait.
Ultimately, the GLP-1 saga underscores a familiar but uncomfortable truth: no drug is categorically “safe” or “dangerous” in the abstract. Therapies that meaningfully reduce the burdens of obesity, diabetes, and cardiovascular disease can simultaneously carry measurable risks that only become visible at scale. As litigation advances and more data emerge, the central question will not be whether adverse events exist, but whether the overall risk–benefit balance was fairly studied, transparently conveyed, and thoughtfully weighed in real-world clinical settings increasingly defined by speed, marketing, and patient demand. Sadly, deliberative informed consent seems to have left the arena.
[1] Although another study claims it reverses osteoarthritis.
