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- Dina Fioretti, 60, from Illinois, claims in a lawsuit that Ozempic caused her to suffer a blocked bowel and vomit so much that her esophagus was torn
- Her case has been added to a nationwide litigation against Novo Nordisk, the maker of the blockbuster weight loss drug, that could include 10,000 patients
It was previously revealed that another woman who is suing the company will suffer from diarrhea forever after using Ozempic
A woman who vomited so much after using Ozempic that she suffered a torn esophagus has joined a growing legal campaign with thousands of patients who claim the blockbuster drug caused horrendous side-effects.
Dina Fioretti, 60, from Illinois, has sued Novo Nordisk over claims Ozempic triggered extreme vomiting, pain and a blocked bowel. Her complaint alleges she developed a Mallory-Weiss tear, the medical term for a torn esophagus, because of the vomiting and spent a week in hospital.
Fioretti’s complaint, which has been reviewed by DailyMail.com, is included in a batch of nearly 60 lawsuits brought against the company by patients who suffered crippling stomach paralysis after using Ozempic.
Other cases include a woman who will suffer diarrhea forever after using Ozempic and a man whose intestine was partially removed after the drug allegedly caused life-threatening stomach paralysis. Another woman previously told DailyMail.com she had her gallbladder removed because of the drug’s side effects.
The legal campaign against Novo Nordisk primarily includes patients who used Ozempic and Wegovy, another of the company’s drugs. Several suits have also been filed against Eli Lilly, which produces Mounjaro, a diabetes and weight loss drug which works in a similar way to Ozempic and Wegovy.
Patients claim they were not warned about the extreme side effects they suffered.
The growing legal action reached a milestone last month when a panel of judges agreed to centralize the lawsuits in a Pennsylvania federal court. This new multidistrict litigation (MDL), which is similar to a class action lawsuit, includes patients from across the United States.
Attorney Ken Moll, president of Moll Law Group, which filed Fioretti’s complaint, told DailyMail.com his firm plans to add a further 100 cases to the litigation – and is one of several across the country investigating claims by thousands more patients.
Paul Pennock, an attorney at Morgan & Morgan who is playing a lead role in the action, said in a statement that he expects up to 10,000 cases will be filed in the litigation.
Moll said it was ‘unconscionable’ that the firms still hadn’t added warnings to their labels which warn about the risk of gastroparesis and stomach paralysis.
Fioretti’s lawsuit was filed in the Northern District of Illinois on January 25. The complaint states that she used Ozempic for diabetes and weight loss from July 2021 until January 2022.
The drug is blamed for causing Fioretti to suffer from ileus, which stops food from moving through the stomach. The ordeal led to ‘sustained severe personal injuries, pain, suffering, and emotional distress’.
Moll said: ‘She went to the hospital, she had a bowel obstruction and developed a tear in her throat from vomiting.
‘She had a small procedure to help her with that tear. She was hospitalized for about a week.
‘In her case she had to get rid of the contents of her stomach and intestines, so she was throwing up and it caused a tear in her throat.’
Fioretti required an upper endoscopy, which involves inserting a tube into the throat to examine the esophagus and stomach. She was also treated with adrenaline and a underwent a ‘lengthy hospitalization requiring medications to alleviate bleeding, vomiting, and abdominal pain’, the lawsuit added.
The complaint alleges that Novo Nordisk ‘did not adequately warn’ about the risks side effects including ileus and stomach paralysis.
Moll added: ‘It’s just unbelievable and it’s so common and very life-threatening. We have a gentleman who was using it, he had 90% [bowel] obstruction, and develop gangrene.
‘He had his intestines partially removed. It was just a terrible situation. And it’s so common. It’s unbelievable that there hasn’t been an update to the warnings by these manufacturers.’
Many of the lawsuits included in the nationwide litigation refer to Novo Nordisk’s ‘aggressive’ marketing of Ozempic and Mounjaro. The firm has spent more than $1 billion advertising the drugs.
‘Unfortunately, this is the type of drug [that] the amount of money that these companies are making is just going up and up every month. Just getting bigger and bigger. It’s too profitable for them to stop,’ Moll said.
Novo Nordisk said it believes the allegations in the lawsuits are ‘without merit’ and that the company will ‘vigorously defend against these claims’.
Eli Lilly said ‘patient safety is Lilly’s top priority’ and also added that it will ‘vigorously defend against these claims’.
The multidistrict litigation currently includes at least 55 lawsuits. US District Judge Gene E Pratter will oversee the litigation in the Eastern District of Pennsylvania.
Novo Nordisk has supported the multi district litigation but Eli Lilly objected to its inclusion because it is a defendant in only about a fifth of the cases. Judges ultimately decided complaints against both companies can be grouped together.
Cameron Stephenson, an attorney at Levin Papantonio Rafferty, told DailyMail.com in January that his firm currently has around 100 clients who were diagnosed with gastroparesis after using the drugs, and it is investigating 1,000 more.
Stephenson said he had ‘no doubt’ that thousands of cases would be added to the MDL over time.
Ozempic has FDA approval for the treatment of type 2 diabetes but has been prescribed off-label for weight loss to millions of Americans. Mounjaro also has approval for diabetes but can also be prescribed off label for weight loss.
Novo Nordisk’s Wegovy has FDA approval for chronic weight management.
Attorneys leading the cases have suggested that Novo Nordisk sought initial approval for its GLP-1 medicines as a diabetes treatment with the intention of later pushing them as weight-loss treatments.
The legal cases also make extensive references to the ‘aggressive’ marketing by Novo Nordisk and Eli Lilly.
Zakareeya Gregory, 46, from Walker Mill, Maryland, also has her case filed in the multidistrict litigation.
She previously told DailyMail.com that her gallbladder was removed after she suffered side effects which were allegedly caused by Ozempic, which she used for seven months until February 2020.
Gregory, who was prescribed Ozempic to treat type 2 diabetes, said the drug initially helped her drop from 220lb to 170lb and lowered her blood sugar, while only causing minor complications such as stomach pain.
The severe side effects like extreme stomach pain started ‘all of a sudden’ at the end of 2022, more than two years after she stopped taking Ozempic. Her legal complaint said she also used Rybelsus, a tablet form of the drug also made by Novo Nordisk, for a period of time during 2022.
Gregory was taken to the emergency room in December, where scans revealed an issue with her gallbladder, which surgeons removed during her four-week hospital stay.
‘I went home with a tube in my side that I had to keep changing [for] drainage. I kept that in for maybe like two weeks,’ said Gregory, who also needed a blood transfusion.
‘It was very horrible, it was horrible to have your gallbladder taken out. I never thought I would have to have my gallbladder taken out. I never had any issues with that. It was a dramatic change in my life.’
She has since regained the weight that she lost and said she also suffers from gallbladder attacks, crippling pains which can still occur after the organ has been removed.
‘I was never told [about the side effects]. All I [was told] is that it will make me healthy, it will make my A1C [blood sugar] go down, which it did. And I was never told the rest. I just know, I will look good. I was gonna be healthy. And I was excited about it.’
Her lawsuit states that her injuries were caused by Ozempic.
In a statement to DailyMail.com, Novo Nordisk said: ‘Novo Nordisk believes that the allegations in these lawsuits are without merit, and we intend to vigorously defend against these claims. However, we are pleased with the Judicial Panel on Multidistrict Litigation’s decision to coordinate federal lawsuits related to GLP-1RA medicines in a multidistrict litigation proceeding before Judge E.K. Pratter in the Eastern District of Pennsylvania.
‘Patient safety is our top priority at Novo Nordisk, and we work closely with the U.S. Food and Drug Administration to continuously monitor the safety profile of our medicines.
‘GLP-1 medicines have been used to treat type 2 diabetes (T2D) for more than 18 years, and for the treatment of obesity for 8 years. This includes Novo Nordisk GLP-1 products such as semaglutide and liraglutide that have been on the market for more than 13 years.
‘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.
‘The known risks and benefits of semaglutide and liraglutide medicines are described in their FDA-approved product labeling. Novo Nordisk stands behind the safety and efficacy of all of our GLP-1 medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional.’
Eli Lilly said: ‘Patient safety is Lilly’s top priority, and we actively engage in monitoring, evaluating, and reporting safety information for all our medicines.
‘Our FDA-approved label clearly warns that tirzepatide may be associated with gastrointestinal adverse reactions, sometimes severe. The label further states that tirzepatide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.
‘These risks were communicated to and widely known by healthcare providers. We will vigorously defend against these claims.’
