Ozempic and Mounjaro makers could be hit with 10,000 lawsuits over claims the drugs cause life-threatening side effects

The pharma firms behind blockbuster weight loss drugs could face up to 10,000 lawsuits from patients who claim the drugs caused debilitating side effects like stomach paralysis and 'tearing holes' in the food pipe.

Ozempic and sister shots like Wegovy and Mounjaro have recently come under fire over claims that the injections cause a roster of complications patients were allegedly not warned about. 

One woman told DailyMail.com that she suffered life-threatening stomach paralysis after taking Mounjaro, and has now joined a massive lawsuit against its maker Eli Lilly and Ozempic manufacturer Novo Nordisk. She claims she may never eat a solid meal again. 

Another said Ozempic caused so much internal damage she had to have her gallbladder removed, while another said the drug induced such violent vomiting it tore a hole in her esophagus. 

Now, Robert Peirce & Associates, a law firm based in Pittsburgh, estimates that the number of plaintiffs could explode to as many as 10,000, the firm told local news outlet Trib Total Media. 

Ozempic and Wegovy contain the active ingredient semaglutide. This mimics the hormone GLP-1 (glucagon-like peptide-1) which slows the movement of food through the digestive system, signalling to the body that it's full.

Mounjaro and Zepbound, meanwhile, use the active ingredient tirzepatide, which targets GLP-1 and the hormone glucose-dependent insulinotropic polypeptide (GIP), which has a similar hunger-surpressing effect. 

Wegovy and Zepbound are the only two approved by the FDA for weight loss alone, while the others are only meant to be taken for managing type 2 diabetes. 

However, some can be prescribed off-label, or for another purpose beyond FDA's approval, for example to help people lose weight.

All of the drugs have been hailed for helping patients control their appetite and quickly drop weight, but the Robert Peirce & Associates team warns that lawyers are now seeing a surge of multidistrict litigation (MDL) cases related to the medications. 

An MDL is a lawsuit comprised of multiple civil cases that share common issues. 

In addition to lawsuits, some patients have also claimed the drugs caused  suicidal thoughts, psychosis, and appearance issues like deflated breasts. 

'Unfortunately, the manufacturers of Ozempic and other GLP-1 agonists failed to adequately warn of the associated risks,' the Robert Peirce & Associates team wrote. 

The team pointed to an MDL filed in February in the Eastern District of Pennsylvania (which includes Philadelphia), which combined 55 lawsuits alleging that Ozempic and similar drugs led to gastrointestinal injuries like intestinal blockages and stomach paralysis. 

According to Lawsuit Information Center, as of June 3, there are 101 pending cases in the Ozempic MDL, including a dozen that were added in May. 

Stomach paralysis, or gastroparesis, occurs when the stomach cannot properly empty. GLP-1 agonists like Ozempic slow down stomach emptying to keep patients feeling full for longer, which could increase the risk of the condition.

 While the condition itself is not fatal, gastroparesis has been shown to lead to potentially deadly intestinal blockages and severe nutrient deficiencies. 

Meredith Hotchkiss, 56, of Idaho, joined nearly 100 patients in a lawsuit against Eli Lilly and Novo Nordisk after she was diagnosed with gastroparesis.

Ms Hotchkiss had been taking Mounjaro and Trulicity, another Eli Lilly injection for type 2 diabetes. She was prescribed Mounjaro from July 2022 until around June 2023. She was also briefly prescribed Trulicity from December 2022 to March 2023.

Though she has diabetes, her condition is 'well-controlled,' so she was given the drugs off-label for weight loss. 'I thought if I could lose weight and get Mounjaro, then I could try because everybody you see everybody's doing it,' she previously told DailyMail.com. 

'The doctor told me that I could lose weight and that it works really well. He said that I would get really sick for four weeks and then after four weeks I'd feel a lot better.' 

Within weeks of starting the medications, her condition deteriorated and she couldn't stomach anything other than cottage cheese, mac and cheese, and yogurt. 

Ms Hotchkiss was fitted with a central line, a tube inserted into the vein to deliver liquid food directly into the bloodstream. She has also been hospitalized three times, including with life-threatening sepsis. 

The side-effects have changed her life and stopped her from doing the things she loves. Doctors have also told her she can no longer travel overseas because of her health conditions.

'I can't swim, I can't go in the water. I love swimming, I have a boat, I can't go in the water at all. I used to love swimming in the ocean,' she said.

'It affects me socially, because you go out with your friends and what do you do? You go out to dinner, or you go to barbecues… all the holidays, everything revolves around food.

'The other thing I worry about is will I be alive long enough to pay off the house with my husband, because I worry about him.'

Zakareeya Gregory, 46, from Maryland, said that she had to have her gallbladder removed seven months after starting Ozempic. She alleges the drug may be to blame. 

Dina Fioretti, 60, from Illinois, told DailyMail.com that she is suing Novo Norisk after Ozempic allegedly caused her to vomit so much that she tore a hole through her esophagus. 

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. 

Mr 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. 

Cameron Stephenson, an attorney at Levin Papantonio Rafferty, told DailyMail.com his firm currently has around 100 clients who were diagnosed with gastroparesis after using the drugs, and it is investigating 1,000 more.

'There's no doubt in my mind that there are going to be thousands of cases that will be filed in the MDL over time,' said Mr Stephenson, who floated the possibility that the number of individuals could run into the tens of thousands.

Eli Lilly said in a statement: '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 labels clearly warn that tirzepatide and dulaglutide may be associated with gastrointestinal adverse reactions, sometimes severe.

'The labels further state that tirzepatide and dulaglutide have not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and are therefore not recommended in these patients.

'These risks were communicated to and widely known by healthcare providers. We are vigorously defending against these claims.'

There has been little research done so far on the long-term side effects of these weight loss drugs,  

Novo Nordisk said: 'Novo Nordisk believes that the allegations in these lawsuits are without merit, and we intend to vigorously defend against these claims.

'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 clinical experience.

'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.'