By Emily Joshu Health Reporter for Dailymail.Com
6:45 p.m. June 12, 2024, updated 6:51 p.m. June 12, 2024
Pharmaceutical companies 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 “holes.” heartbreaking” in the food pipe.
Ozempic and his brothers like Wegovy and Mounjaro were recently criticized for claiming that the injections came with a list of complications that patients were allegedly not warned about.
A woman told DailyMail.com she suffered life-threatening stomach paralysis after taking Mounjaro and has now joined a massive lawsuit against its maker Eli Lilly and the maker of Ozempic Novo Nordisk. She says she may never eat a solid meal again.
Another said Ozempic caused so much internal damage that she had to have her gallbladder removed, while another said the drug caused her to vomit so violently that it tore a hole in her esophagus.
Now Robert Peirce & Associates, a Pittsburgh-based law firm, estimates the number of plaintiffs could explode to 10,000, the firm told local newspaper 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, signaling the body that it is 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-suppressing effect.
Wegovy and Zepbound are the only two approved by the FDA for weight loss only, while the others are only intended to be taken to manage type 2 diabetes.
However, some may be prescribed off-label or for other purposes beyond FDA approval, such as to help people lose weight.
All medications have been lauded for helping patients control their appetite and lose weight quickly, but the team at Robert Peirce & Associates warns that attorneys are now seeing an increase in multidistrict litigation (MDL) cases related to medications.
An MDL is a trial made up of several civil cases that share common issues.
In addition to the lawsuits, some patients also claimed the drugs caused suicidal thoughts, psychosis and appearance problems such as deflated breasts.
“Unfortunately, the manufacturers of Ozempic and other GLP-1 agonists have not adequately warned of the associated risks,” the team at Robert Peirce & Associates 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 caused gastrointestinal injuries such as intestinal blockages and paralysis of the ‘stomach.
According to the Lawsuit Information Center, as of June 3, there were 101 pending cases in MDL Ozempic, including a dozen that were added in May.
Stomach paralysis, or gastroparesis, occurs when the stomach cannot empty properly. GLP-1 agonists like Ozempic slow stomach emptying so patients feel full longer, which could increase the risk of this condition.
Although the disease itself is not fatal, gastroparesis has been shown to lead to life-threatening intestinal blockages and serious nutritional 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 was taking Mounjaro and Trulicity, another Eli Lilly injection for type 2 diabetes. She was prescribed Mounjaro from approximately July 2022 to June 2023. He was also briefly prescribed Trulicity from December 2022 to March 2023.
Although she has diabetes, her condition is “well controlled,” which is why she was given off-label medications to lose weight. “I thought if I could lose weight and have Mounjaro, then I could try because everyone, you see, everyone does it,” she previously told DailyMail.com.
“The doctor told me I could lose weight and it worked really well. He said I would be very sick for four weeks and after four weeks I would feel much better.
Click here to resize this module
A few weeks after starting treatment, her condition deteriorated and she could no longer tolerate 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 was also hospitalized three times, including for life-threatening sepsis.
The side effects changed her life and stopped her from doing the things she loves. Doctors also told her that she could no longer travel abroad due to her health.
“I don’t know how to 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 loved 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…every vacation, it’s all about the food.
“The other thing I worry about is whether I’ll be alive long enough to pay off the house with my husband, because I worry about him.”
Zakareeya Gregory, 46, of Maryland, said she had to have her gallbladder removed seven months after starting Ozempic. She claims drugs could be the cause.
Dina Fioretti, 60, of Illinois, told DailyMail.com she is suing Novo Norisk after Ozempic allegedly made her vomit so much it cut a hole in her esophagus.
Click here to resize this module
Attorney Ken Moll, president of the Moll Law Group, which filed Fioretti’s suit, told DailyMail.com that his firm plans to add 100 more cases to the litigation – and that he is one of several cases across the country investigating the claims of thousands of other patients.
Mr Moll said it was “unacceptable” that companies had still not added warnings to their labels warning of the risk of gastroparesis and stomach paralysis.
Cameron Stephenson, a lawyer at Levin Papantonio Rafferty, told DailyMail.com his firm currently has about 100 clients diagnosed with gastroparesis after using the drugs, and is investigating another 1,000.
“There is no doubt in my mind that there will be thousands of cases filed with the MDL over time,” said Stephenson, who raised the possibility that the number of individuals could reach numbers. tens of thousands.
Eli Lilly said in a statement: “Patient safety is Lilly’s top priority, and we are actively engaged in monitoring, evaluating and reporting safety information for all of our medicines.
“Our FDA-approved labels clearly warn that tirzepatide and dulaglutide may be associated with gastrointestinal adverse reactions, sometimes serious.
Click here to resize this module
“The labels further state that tirzepatide and dulaglutide have not been studied in patients with serious gastrointestinal disease, including severe gastroparesis, and therefore are not recommended in these patients.
“These risks have been communicated and widely known to health care providers. We vigorously defend ourselves against these assertions.
Until now, little research has been done on the long-term side effects of these weight loss drugs.
Novo Nordisk stated: “Novo Nordisk believes that the allegations contained in these lawsuits are without merit and we intend to vigorously defend ourselves against these allegations.
“Patient safety is our top priority at Novo Nordisk, and we work closely with the U.S. Food and Drug Administration to continually monitor the safety profile of our medicines.
“GLP-1 drugs have been used for over 18 years to treat type 2 diabetes (T2D) and for 8 years to treat obesity. This includes Novo Nordisk GLP-1 products such as semaglutide and liraglutide which have been on the market for over 13 years.
“Semaglutide has been extensively investigated in robust clinical development programs, large real-world evidence studies, and has a total of over 9.5 million patient years of clinical experience.
“The known risks and benefits of semaglutide and liraglutide medications are described in their FDA-approved product labeling.”
“Novo Nordisk guarantees the safety and effectiveness of all our GLP-1 medications when used as directed and when taken under the care of a licensed healthcare professional.