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Woman Sues Drug Makers of Mounjaro Over Severe ‘Stomach Paralysis’

A Louisiana woman, Jaclyn Bjorklund, has filed a lawsuit against Novo Nordisk and Eli Lilly, the makers of Ozempic and Mounjaro, respectively. The legal action comes after Bjorklund, who is 44 years old, claims to have suffered severe injuries as a result of using these injectable medications. Initially, she was prescribed Ozempic, which she used for over a year until around July 2023, and then she switched to Mounjaro. 

These drugs, primarily developed for diabetes management, have also become popular for their weight loss benefits. However, Bjorklund’s attorneys allege that the drug manufacturers failed to adequately warn consumers about the potential risk of severe gastrointestinal events associated with the medications. This case highlights the importance of being aware of these possible side effects and risks of any drug, especially those used for off-label purposes such as weight loss. In this blog, we’ll discuss the case and the opinions of experts and other professionals. With this, we’ll also see if the company has taken any steps to make the public aware of the side effects of their medications. 

The Allegations

Jaclyn Bjorklund, a 44-year-old woman from Louisiana, has raised allegations against the makers of Ozempic and Mounjaro. She claims that the companies did not adequately inform users about potential health issues linked to the medications, including severe gastroparesis, also known as stomach paralysis. Additionally, she has reported experiencing persistent vomiting as a side effect. Paul Pennock, an attorney from Morgan & Morgan, a law firm based in Orlando, Florida, is representing Bjorklund in this legal matter. 

About the Medications

Ozempic and Mounjaro belong to an innovative category of medications known as GLP-1 agonists. These drugs play a crucial role in assisting individuals with Type 2 diabetes in regulating their blood sugar levels. Additionally, they are often prescribed “off-label” to support weight loss efforts. This means that while they are not explicitly approved for weight loss, many healthcare providers recommend them for this purpose based on their effectiveness in helping patients shed excess pounds.

GLP-1 medications help with weight management by slowing down the rate at which food passes through the stomach, leading to a feeling of fullness that lasts longer. However, these medications can also cause some gastrointestinal issues, such as abdominal pain, nausea, and vomiting. These side effects have been well documented in clinical trials and are listed as potential or possible side effects on the labels of these drugs.

More About Gastroparesis and GLP-1 Medications

Gastroparesis is a medical condition that slows down or halts the process of moving food from the stomach to the small intestines. This condition is also known as “delayed gastric emptying,” as per the National Institute of Diabetes and Digestive and Kidney Diseases. Various underlying health issues can cause gastroparesis, with diabetes being one of the more common culprits, according to the American College of Gastroenterology. Infections or certain medications like narcotics and antidepressants can also lead to this condition. Now, let’s come back to our main topic and know what the response of drugmakers is.

Response from Drugmakers and FDA

The prescribing information for both Ozempic and Mounjaro does not specifically mention “gastroparesis.” However, both medications’ labels do state that they can “delay gastric emptying,” which is crucial because it can impact how the body absorbs other medications. The Food and Drug Administration (FDA) has not provided any comments on the lawsuit. Moreover, Chanapa Tantibanchachai, a spokesperson for the FDA, mentioned in a statement that it is currently unclear whether GLP-1 medications, which include drugs like Ozempic and Mounjaro, play a role in causing gastroparesis. 

A representative from Eli Lilly has yet to respond to inquiries regarding the lawsuit. On the other hand, Novo Nordisk’s spokesperson, Natalia Salomao, mentioned that the company hadn’t been informed of the lawsuit as of Wednesday morning. Salomao also highlighted that gastroparesis, a condition affecting stomach movement, is a recognized risk for individuals with diabetes. She further emphasized that patient safety is a top priority for Novo Nordisk. She also advised that patients should use these medications only for their approved purposes and under the guidance of a healthcare professional. Also, they should follow important safety information given by their doctors.

The Impact on Bjorklund

Around 400 individuals have reported experiencing gastrointestinal issues they believe are linked to diabetes medications. Attorney Pennock anticipates that this number could rise into the thousands as more cases come to light. Bjorklund was diagnosed with Type 2 diabetes in 2017 and initially prescribed Ozempic before later switching to Mounjaro. In her lawsuit, Bjorklund alleges that the medications caused her severe injuries, leading to multiple visits to the emergency room for stomach issues. She claims that the violent vomiting caused by the medications led to the loss of her teeth. 

Although Bjorklund has not been officially diagnosed with gastroparesis, her attorney, Pennock, mentioned that her symptoms suggest the condition. He also clarified that her symptoms are not a result of her diabetes. He further added that Bjorklund is seeking a substantial amount of compensation from the drug manufacturers. But, he did not specify the exact amount she was seeking. 

Legal and Medical Perspectives

Dr. Shauna Levy, an expert in obesity medicine and the medical director of the Tulane Bariatric Center in New Orleans, expressed surprise at the lawsuit. Dr. Levy, who is not involved in Bjorklund’s treatment, mentioned that while the medications might lead to gastroparesis, this condition could also stem from an undiagnosed illness or the patient’s diabetes itself, with the medicines potentially worsening the issue. He also expressed that, as a healthcare provider, he is not overly concerned about this issue being widespread. 

Tantibanchachai stated that the FDA will keep an eye on any possible side effects from the medications. She added that if new safety concerns are discovered, the FDA will decide on the appropriate actions after reviewing all the evidence carefully. 

Conclusion

The lawsuit filed by Jaclyn Bjorklund against the makers of Ozempic and Mounjaro raises essential questions about patient safety and the responsibility of drug manufacturers to provide adequate warnings about potential side effects. While these medications have shown promise in managing diabetes and aiding in weight loss, it is crucial for both patients and healthcare providers to be aware of the risks involved. 

As the legal and medical communities continue to investigate and address these concerns, patients need to communicate openly with their healthcare providers and make informed decisions about their treatment options. The outcome of this lawsuit and ongoing research may influence future guidelines and recommendations for the use of GLP-1 agonists in the treatment of diabetes and obesity. 


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