Lawsuit highlights the dangers of GLP-1 Drugs - Part 1

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I received requests from a number of you to write about this situation. Jaclyn Bjorklund, a 44 year old woman from Louisiana is suing both Novo Nordisk and Eli Lilly.

Content note: this piece will include details of severe gastrointestinal symptoms and conditions. 

Bjorklund was prescribed Novo’s GLP-1 agonist drug, Ozempic for over a year after which she started Eli Lilly’s GLP-1/GIP co-agonist drug Mounjaro. She is now suing both Novo Nordisk and Eli Lilly, claiming that they failed to adequately warn about the possible side effects of severe gastrointestinal events (of which she had many, but we’ll get into that in a moment.) 

Now, I’ve read every news report I could find on this story and one thing that is very clear to me is that there are reporters out there who are super confused about these drugs, so instead of just yelling at my computer screen and hoping someone absorbs the information, I thought I would offer a quick explanation to anyone who was confused before, is confused, and/or has become more confused after, reading about this situation.

Drug Name: Semaglutide
Manufacturer: Novo Nordisk
Type: GLP-1 agonist
Brand Names:
Ozempic = Type 2 Diabetes, weekly injection (approved December, 2017)
Rebylsus = Type 2 Diabetes, daily pill (approved September, 2019)
Wegovy = Weight Loss, weekly injection (approved June, 2021)

Drug Name: Tirzepatide
Manufacturer: Eli Lilly
Type: GLP-1/GIP co-agonist
Brand Names:
Mounjaro = Type 2 Diabetes, weekly injection (approved May, 2022)
Zepbound = Weight Loss Application, weekly injection (approved November, 2023)
(No pill form exists as of this writing)

The short story is that both drugs were originally introduced as effective Type 2 Diabetes medications. When it was noticed that they had a side effect of a small amount of weight loss, the manufacturers got the idea to give people higher doses to see if that would cause more of whatever side effects created the weight loss. It did and here we are. (Even prior to this use, doctors could prescribe the diabetes versions drug off label for weight loss.) I wrote about this more here. 

Back to Ms. Bjorklund. According to her lawsuit  (content warning, link includes weight stigmatizing language) which appears to have been filed on 8/2/2023 it appears to me that she was prescribed the drugs for Type 2 Diabetes based on the language used: 

“This is an action for damages suffered by Plaintiff, JACLYN BJORKLUND, who was severely injured as a result of her use of Ozempic and Mounjaro, two injectable prescription medications that are used to control blood sugar in adults with type 2 diabetes.”

This is significant because the doses for weight loss are often larger (in some cases about 5 times as much) as those for Type 2 Diabetes.  

Per the complaint, Ms. Bjorklund experienced:

“severe gastrointestinal events, and as a result sustained severe and permanent personal injuries, pain, suffering, and emotional distress, and incurred medical expenses. As a result of using Defendants’ Ozempic and Mounjaro, Plaintiff was caused to suffer from severe gastrointestinal events, which resulted in, for example, severe vomiting, stomach pain, gastrointestinal burning, being hospitalized for stomach issues on several occasions including visits to the emergency room, teeth falling out due to excessive vomiting, requiring additional medications to alleviate her excessive vomiting, and throwing up whole food hours after eating.”

The lawsuit explains:

“Defendants acknowledge that gastrointestinal events are well known side effects of the GLP-1 class. However, Defendants have downplayed the severity of the gastrointestinal events caused by Ozempic and Mounjaro, never, for example, warning of the risk of gastroparesis (“paralyzed stomach”) or gastroenteritis.“

To clarify, two of the mechanisms by which these drugs work are slowing gut motility and, in the case of Tirzepatide, reducing stomach acid. Both of these mechanisms cause food to travel through the digestive system more slowly. This can cause these well known gastrointestinal side effects. If digestion slows too much, gastroparesis (also known as delayed gastric emptying) and gastroenteritis (among other side effects, some life-threatening like ileus which is similar to gastroparesis but happens in the intestines,) can occur. 

The lawsuit claims that Novo Nordisk’s and Eli Lilly’s:

“failure to disclose information that they possessed regarding the association between the use of GLP-1 receptor agonists and the risk of developing severe gastrointestinal issues, including gastroparesis and gastroenteritis, rendered the warnings for this medication inadequate. 

The lawsuit asserts that because of this failure

“Plaintiff was and still is caused to suffer from severe gastrointestinal issues, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain, and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications, and fear of developing any of the above-named health consequences.”

In a statement to CNN for their article “Woman sues drug makers of Ozempic and Mounjaro over severe gastrointestinal issues” by Jamiel Lynch and Jamie Gumbrecht, Novo Nordisk claimed:

“Patient safety is of utmost importance to Novo Nordisk. “We are continuously monitoring the safety profile of our products and collaborate closely with authorities to ensure patient safety, including adequate information on gastrointestinal side effects in the label.”

In a statement to The Hill for their article “Ozempic, Mounjaro manufacturers sued over risk of stomach paralysis” by Julia Shapero an Eli Lilly spokesperson claimed:

“patient safety is the company’s “top priority,” noting that it “actively [engages] in monitoring, evaluating and reporting safety information” for all of its medicines.”

There is something important here that I’ve seen misinformation floating around about for years. It’s possible, even probable, that negative side effects will stop when the medication is discontinued. But it’s not certain. Some people will have horrific side effects that impact their lives and, even if they are not fatal, they will also not end when they stop taking the medication. For some, even if the side effects stop, the damage will have been done.

These are, of course, not the only medications that can have rare but extremely severe, even fatal side effects, and it doesn’t meant that they aren’t solid Type 2 Diabetes medications. But given that Novo Nordisk and Eli Lilly have announced their desire to make these blockbuster drugs for their shareholders, and that they are actively working to increase the market for them to be as large as possible, I think it does mean that these drugs should be highly scrutinized and that emphasis should be placed on giving clear, accurate informed consent, including and especially for the larger weight loss doses. In part 2 we’ll look at the case of Juanita Gantt. 

Medical Students for Size Inclusivity have created an excelled GLP-1 informed consent guide here.

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*Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings: Fearing the Black Body – the Racial Origins of Fat Phobia and Da’Shaun Harrison: Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.