Dozens of patients are suing the manufacturer of the blockbuster weight loss drug Ozempic on the grounds that it caused them to experience debilitating stomach paralysis. Among them is a woman who will have permanent diarrhoea after using the drug.
Nationwide, Novo Nordisk, the manufacturer of Ozempic and Wegovy, is being sued by patients alleging that they were not warned of severe adverse effects. The plaintiffs have filed the claims in court.
Thousands of additional patients have come forward alleging adverse drug reactions, and attorneys predict that many more will soon join the expanding legal movement.
Allegations of Negligence
The majority of patients report experiencing gastroparesis, the medical term for gastrointestinal paralysis. The potentially fatal condition is characterised by a buildup of food in the gastrointestinal tract. Symptoms include vertigo, vomiting, and excruciating pain.
Dozens of lawsuits filed by patients who received gastroparesis diagnoses subsequent to using Ozempic and Wegovy. Among these claims are several that detail ‘life-threatening’ gastrointestinal injuries and the potential long-term repercussions.
Across all lawsuits, Novo Nordisk is held liable for allegedly neglecting to adequately caution on the drug packaging regarding the potential for gastroparesis.
Eli Lilly’s Involvement
Additionally, Eli Lilly, the manufacturer of Mounjaro, a diabetes medication that functions similarly to Ozempic and Wegovy and is off-label for weight loss, has been the subject of at least ten lawsuits. Eli Lilly is additionally charged with neglecting to provide adequate warnings regarding the hazards associated with Mounjaro.
Specific Cases
A woman who utilised Ozempic and Mounjaro asserts that she received a diagnosis of gastroparesis, a condition characterised by excessive vomiting that resulted in the discomfort of certain teeth.
A woman who used Ozempic and was subsequently diagnosed with a “life-threatening bowel injury” required nearly nine hours of surgery. She would experience agony “for the remainder of her life” and “will never have another solid bowel movement,” according to the doctors.
A woman who used Wegovy filed a third lawsuit alleging she was hospitalised with symptoms including a week without a bowel movement and a diagnosis of “severe gastroparesis.”
Legal Proceedings and Anticipation
In federal courts throughout the United States, over forty cases have been filed, and attorneys are reviewing thousands more. It is anticipated that the cases will be consolidated into a multidistrict litigation (MDL) later this month. This consolidation will bring them under the jurisdiction of a single judge.
Cameron Stephenson, an attorney at Levin Papantonio Rafferty, informed that his firm is investigating an additional one thousand clients who have been diagnosed with gastroparesis subsequent to drug use. Currently, Stephenson represents approximately one hundred clients.
Stephenson stated, “There is no doubt in my mind that thousands of cases will be filed in the MDL over time.” He further suggested that the number of participants could reach tens of thousands.
Safety Concerns and Allegations
He further stated that the legal proceeding targets patients who were “medically diagnosed with gastroparesis or obstruction and required emergency treatment or hospital intervention.”
Stephenson stated that for many patients who wish to control their diabetes or lose weight, there is “absolutely no doubt” that the medications are extremely effective.
However, he continued, “The point is that if these medications have an adverse effect that is potentially permanent or has life-threatening consequences, then… That must be included in the warning label.’
FDA-Approved Labels and Responses
Millions of Americans have been prescribed Ozempic for weight loss despite its FDA approval for type 2 diabetes. Mounjaro is also approved for the treatment of diabetes and may be off-label for weight loss.
Wegovy by Novo Nordisk is approved by the FDA for the management of chronic weight.
Stephenson asserts that the pharmaceutical companies pursued preliminary approval for the medications as remedies for diabetes. The explicit aim was to endorse them for weight reduction.
“I anticipate seeing documentation indicating that off-label marketing and promotion beyond the realm of diabetes was planned,” he stated.
“I anticipate that the clinical trials and activities that were conducted during the different stages of developing these drugs prior to filing with the FDA will demonstrate that there was a risk of gastroparesis, which is not mentioned on the label and continues to be omitted,”
Novo Nordisk stated that the lawsuits contain “without merit” allegations and that the organisation will “vigorously defend against these claims.”
“Patient safety is Lilly’s highest priority,” stated Eli Lilly, adding that the company will “vigorously defend against these claims.”
Personal Accounts and Impact
Brea Hand, 23, from Ponca City, Oklahoma, experienced vertigo, vomiting, and constipation weeks after taking Ozempic in May 2023.
Hand, a mother of two who was prescribed the medication to manage her pre-diabetes and weight fluctuations, was hospitalised five times before doctors diagnosed her with the potentially fatal conditions gastroparesis and diabetic ketoacidosis.
During her final visit to the hospital, she was transferred to intensive care.
“They stated that my body was so acidotic that I would not have survived if I had waited an additional day,” Hand, whose lawsuit was filed on December 28, explained.
“It was terrifying.” It caused severe agony. That type of pain has never before been experienced in my entire existence. And I have no intention of ever having to endure it again.
Hand, a student of behaviour science, stated that she was not informed of the adverse effects she experienced while taking Ozempic and wishes to caution others about the dangers.
Personally, I would not recommend it to anyone. “JUST taking that risk would be beyond my comfort zone after everything I’ve been through,” she said.
On November 28, Robin Kelly, 49, initiated legal proceedings against Novo Nordisk in her state of residence of Mississippi, alleging that the use of Ozempic precipitated a severe case of gastroparesis. She reported not being informed that the condition could potentially develop as an adverse effect.
A teaching assistant, Kelly, reported vomiting and diarrhoea within weeks after commencing medication in December 2021. She continued to take Ozempic without realising it was the cause of her symptoms for several months.
“You could pretty much set your watch by the fact that if I received my injection on Sunday, I would be vomiting and having diarrhoea by Tuesday,” she explained.
Kelly was administered Ozempic for her type 1 diabetes, which she had since fourth grade and was controlled with insulin. She reported that her endocrinologist advised her to obtain an off-label prescription for Ozempic. Despite the drug’s FDA approval being limited to the treatment of type 2 diabetes.
Kelly stated, “At each doctor’s appointment I attended, she would say, ‘I really wish you would participate in this Ozempic.'”
Initially mistaking the adverse symptoms for acid reflux, she discontinued Ozempic use in September 2022. A gastroenterologist diagnosed gastroparesis following an emergency room visit.
“My terrible illness prevented me from working, which nearly cost me my job.” Physically speaking, I was incapable of reporting to work.
There were occasions when I would report to work, make an effort to report to work, and remain at work. My job clothes would get filthy, so I couldn’t do it.
“I would merely soiled my clothes and become ill.” Additionally, I would be required to return home. I had to bring a bag of clothes to work in case I became sick.
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According to the lawsuit filed by Kelly, she incurred medical expenses and suffered “severe and permanent personal injuries, pain, suffering, and emotional distress.”
The lawsuit added that Novo Nordisk “knew or should have known that Ozempic was unreasonable dangerous” and “failed to adequately warn of the risk of gastroparesis.”
“Gastroparesis flare-ups continue to occur despite my return from Ozempic,” Kelly explained. “I simply believe it is something I will be forced to live with for the remainder of my life.”
Kelly is legally represented by Morgan & Morgan, a prominent law firm that has over 13,000 clients under retainer nationwide. The firm is playing a leading role in the litigation against Novo Nordisk and Eli Lilly.
A litigator for the firm, Paul Pennock, told Reuters that an additional 40,000 individuals whose alleged injuries were not considered grievous enough to participate in the action were denied entry.
He stated that the labels “do not clearly indicate what could happen to you.” Some clients have remained ill after treatment ceased, experiencing “constant nausea.”
Origins of the Litigation
Jaclyn Bjorklund, 45, of DeRidder, Louisiana, may have started the growing lawsuit in August. She was off-label prescribed Ozempic and Mounjaro for approximately one and a half years prior to discontinuing use last summer.
According to the legal complaint, she experienced “severe gastrointestinal events, including severe vomiting, stomach pain, and gastrointestinal burning; hospitalisation on multiple occasions for stomach issues, including visits to the emergency room; and tooth loss due to excessive vomiting.”
Pennock declared, “Ms. We believe that because Bjorklund placed her faith in Novo Nordisk and Eli Lilly and Company. She has endured an ordeal that ought not to be endured by anyone.
He stated that certain patients may sustain permanent injuries.
Zakareeya Gregory, 46, of Walker Mill, Maryland, told that her gallbladder was removed subsequent to the occurrence of adverse effects purportedly attributable to the use of Ozempic, which she administered for a duration of seven months until February 2020.
Gregory, who was prescribed Ozempic for the treatment of type 2 diabetes, reported that the medication briefly reduced her body weight from 220 to 170 pounds and stabilised her blood sugar levels, with the occurrence of minimal side effects including stomach pain.
Beyond two years after discontinuing Ozempic, the severe side effects. Including severe abdominal discomfort, appeared “immediately” at the conclusion of 2022. Her civil complaint claims she used Novo Nordisk’s Rybelsus pill formulation in 2022.
Gregory was transported to the emergency room in December, where scans identified a condition requiring gallbladder surgery.
The operation was performed over the course of her four-week hospitalisation.
“I returned home with a drainage tube in my side that required frequent replacement.” Gregory remarked, “I harboured that for approximately two weeks.” He also required a blood transfusion.
“It was abhorrent, having your gallbladder removed was abhorrent.” I never anticipated that my gallbladder would need to be removed. That never presented any difficulties for me. A profound transformation occurred in my existence.
Since then, she has reclaimed the weight she previously lost. Additionally, she disclosed that she endures gallbladder attacks, which are excruciating sensations that may persist even after the organ has been removed.
No information was provided to me regarding the potential side effects.” It was only stated that it would improve my health and lower my A1C [blood sugar], and it did just that. The remainder was never disclosed to me. I am certain that I will appear good. I had intended to be robust. And I was also quite enthusiastic about it.
Her lawsuit alleges that Ozempic was responsible for her injuries.
In December, Billie Farley, age 47, initiated legal proceedings against Novo Nordisk subsequent to her utilisation of Ozempic for an estimated duration of three months. According to her lawsuit, she was off-label prescribed the medication for weight loss in October 2022 after viewing advertising for the medication.
Her complaint stated, “About three months after beginning Ozempic, she developed severe abdominal pain and vomiting.”
In January 2023, a CT scan revealed “a life-threatening bowel injury” that necessitated nearly nine hours of extensive surgery and led to Farley’s hospitalisation.
The lawsuit stated, “The doctors informed her that Ozempic was likely the cause of her bowel injuries and that she should discontinue use of the medication immediately.”
Farley was informed that the persistent agony she endured would have a lasting impact on her life.
The lawsuit further stated, “Since her surgery, she has not had a regular bowel movement, and her medical professionals have informed her that this will never happen again for the remainder of her life.”
Additionally, her complaint asserts that the label and marketing did not sufficiently inform her and her healthcare provider about the actual hazards associated with using Ozempic.
“Her life is irrevocably altered as a result of her use of Ozempic,” stated the lawsuit.
Anticipated Legal Consolidation
The pending litigation is anticipated to be consolidated into a multidistrict litigation on January 25 during a hearing in California. Attorneys assert that as additional cases are presented, they will be added to the MDL.
Novo Nordisk’s ‘aggressive’ marketing of its diabetes and weight loss medications is the subject of numerous lawsuits. This marketing strategy included $884 million spent on television advertisements over a five-year period. The grievances also pertain to the corporation’s lobbying effort targeting physicians in the United States, which cost millions of dollars.
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Additionally, the lawsuits mention the extensive advertising that Eli Lilly conducted for Mounjaro, which included digital and television commercials.
Wegovy and Ozempic contain semaglutide as their active ingredient. This compound replicates the actions of glucagon-like peptide-1 (GLP-1), a hormone that regulates appetite in the brain.
Tirzepatide, the active ingredient in Mounjaro, also functions on GLP-1 receptors.
Research has demonstrated that the medications, which are typically administered via weekly injections, are extraordinarily effective in treating diabetes and promoting weight loss.
The FDA declined to comment on “potential, pending, or ongoing litigation.” However, the agency stated that it monitors medications “along their entire life cycle, including after they have been approved.”
The FDA stated, “If newly identified safety signals are identified, appropriate actions will be determined by the FDA after a comprehensive review of the body of evidence.”
Novo Nordisk issued the following statement: “Novo Nordisk asserts that the lawsuit’s allegations are baseless. And we are resolved to mount a resolute defence against these claims.”
