Diabetes Drug Manufacturers Sued by Woman Who Claims She Suffered ‘Severe Gastrointestinal Events’

Diabetes drug Ozempic is shown at a pharmacy in Toronto on April 19, 2023. The Canadian Press/Joe O'Connal

The manufacturers of diabetes drugs Ozempic and Mounjaro have been sued by a Louisiana woman who claims they failed to adequately warn users that the medications can cause severe gastrointestinal problems including gastroparesis, effectively a paralysis of the stomach.

The 26-page lawsuit (pdf) was filed by personal injury law firm Morgan & Morgan on behalf of the woman, 44-year-old Jaclyn Bjorklund, in a Louisiana court on Aug. 2.

Ms. Bjorklund claims that she was left “severely injured” as a result of using the two injectable prescription medications which are used to control blood sugar in adults with type 2 diabetes but which have soared in popularity as an off-label weight loss aid.

According to the lawsuit, Ms. Bjorklund took Ozempic, also known as semaglutide, for more than a year before stopping and switching instead to Mounjaro, also known as tirzepatide, in July 2023.

However, “as a result of using Defendants’ Ozempic and Mounjaro” Ms. Bjorklund suffered “severe gastrointestinal events, and as a result sustained severe and permanent personal injuries, pain, suffering, and emotional distress, and incurred medical expenses,” her lawyers said.

Those severe gastrointestinal events resulted in “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,” according to the lawsuit.

In this photo illustration, boxes of the diabetes drug Ozempic rest on a pharmacy counter in Los Angeles, California, on April 17, 2023. Mario Tama/Getty Images

Paralyzed Stomach

Ozempic works by stimulating insulin production and reducing glucose production in the liver, helping to lower blood sugar levels. Mounjaro works by targeting the body’s receptors for the hormone GIP (glucose-dependent insulinotropic polypeptide) and a natural gut hormone called GLP-1 (glucagon-like peptide-1), thus suppressing appetite and reducing food intake.

They belong to a class of drugs called GLP-1 receptor agonists.

Both Ozempic and Mounjaro are manufactured by Danish pharmaceutical company Novo Nordisk and Indiana-based American pharmaceutical firm Eli Lilly, respectively.

The lawsuit claims that both manufacturers “acknowledge that gastrointestinal events are well-known side effects of the GLP-1 class” but that they 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.”

It further notes that neither manufacturer noted the risks of severe gastrointestinal events including gastroparesis and gastroenteritis when they announced they had received approval from the Food and Drug Administration.

According to the National Institutes of Health, gastroparesis, also known as “delayed gastric emptying,” is a disorder that slows or stops the normal movement of food from the stomach to the small intestine, even when there is no visible blockage in either.

While strong muscular contractions would normally carry food through the digestive tract, an individual suffering from gastroparesis would typically feel full soon after beginning a meal, may feel fuller for longer, and may experience nausea, vomiting, and abdominal pain because of the delayed movement in food that prevents the stomach from emptying properly.

A woman with diabetes uses a glucometer to measure the glycemia in her blood in Paris on March 24, 2020. Franck Fife/AFP via Getty Images

‘Willful, Fraudulent, Reckless Acts’

Gastroparesis, for which there is currently no cure, is also caused by diabetes itself.

Both Ozempic and Mounjaro note on their labels that the drugs may cause “delayed gastric emptying.”

Ms. Bjorklund, in her lawsuit, claims to have been left with severe and permanent injuries that will require frequent health care visits and continuous medical monitoring and treatments.

The lawsuit is seeking an unspecified amount in compensatory damages and punitive and/or exemplary damages for what Ms. Bjorklund and her lawyers say are the “wanton, willful, fraudulent, reckless acts of the defendants who demonstrated a complete disregard and reckless indifference for the safety and welfare of the general public and to the plaintiff.”

At a press conference announcing the lawsuit, Paul Pennock and Jonathan Sedgh, the attorneys leading the lawsuit for Morgan & Morgan, said they are also probing 400 other inquiries from clients who took Ozempic and Mounjaro across 45 states.  

A spokesperson for Novo Nordisk told The Epoch Times in an emailed statement, “Semaglutide has been extensively examined in robust clinical development programs, large real world evidence studies and has cumulatively over 9.5 million patient years of exposure.

“Gastrointestinal (GI) events are well-known side effects of the GLP-1 class. For semaglutide, the majority of GI side effects are mild to moderate in severity and of short duration.

“Patient safety is of utmost importance to Novo Nordisk. We recommend patients take these medications for their approved indications and under the supervision of a healthcare professional. 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.”

An Eli Lilly spokesperson told the publication that patient safety is the company’s “top priority,” and that the company “actively engages in monitoring, evaluating and reporting safety information for all our medicines.”

The Epoch Times has contacted spokesperson for Eli Lilly for further comment.