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Mounjaro Gastroparesis Lawsuit Filed Against Eli Lilly For Failing To Warn About Stomach Paralysis Side Effects
Eli Lilly faces a new product liability lawsuit, which claims that users and the medical community have not been adequately warned about potential Mounjaro gastroparesis side effects, which have caused some users of the blockbuster drug to develop severe vomiting, dehydration and other injuries.
The complaint (PDF) was brought last week by Robert McDonald in the U.S. District Court for the Southern District of Mississippi, indicating that the manufacturer of the diabetes and weight loss drug knew or should have known about the potential risks from clinical trials, medical literature and case reports submitted by users, yet withheld the critical information to boost sales.
Mounjaro (tirzepatide) was just introduced in 2022, as part of a new generation of treatments for diabetes, which is a chronic and progressive condition that causes insulin resistance and insufficiency. It is part of the same class of new drugs as Ozempic (semaglutide), and both medications have been widely prescribed “off-label” for weight loss, given the positive effect they have helping to reduce hunger, decease food intake and promote feelings of fullness.
A separate version of Ozempic was previously approved by the FDA specifically for weight loss, which is marketed under the brand name Wegovy (semaglutide), and Eli Lilly just recently obtained approval to market a weight-loss version of Mounjaro under the brand name Zepbound.
Although advertisements promote the drugs as safe and effective, with few long-term side effects, former users are now pursuing Mounjaro lawsuits, Ozempic lawsuits and Wegovy lawsuits against the manufacturers, each raising similar allegations that the widespread use of the drugs has made it clear that the drug label fails to adequately warn about the risk of severe and long-lasting gastroparesis side effects.
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According to the complaint, McDonald was prescribed Mounjaro in July 2022, and received injections of the diabetes drug until November 2022. However, side effects of Mounjaro caused him to develop a painful paralyzed stomach, which led to severe vomiting, diarrhea, dehydration and kidney failure.
As a result of the injury, McDonald had to undergo multiple hospitalizations, incurred medical expenses, and has been been left permanent injuries.
Although the drug maker was aware of reports involving gastroparesis from Mounjaro, the lawsuit indicates that McDonald and other users, as well as the medical community, were unaware of the severity of risks, due to a lack of adequate Mounjaro label warnings.
“Communications made by Defendant to Plaintiff and Plaintiff’s prescribing physician(s) were inadequate because Defendant failed to warn and/or adequately warn of all possible adverse side effects causally associated with the use of Mounjaro, including the increased risk of gastroparesis and its sequelae,” the lawsuit states. “Plaintiff had no way to determine the truth behind the inadequacies of Defendant’s warnings as identified herein, and Plaintiff’s reliance upon Defendant’s warnings was reasonable.”
Mounjaro Gastroparesis Risks
Experts have also raised concerns about the lack of specific warnings for users and the medical community about the increased risk of stomach paralysis from Mounjaro, as well as other similar drugs, which appear to be a direct side effect of the primary mechanism of action that makes the drugs effective weight loss treatments.
Mounjaro, Zepbound, Ozempic and Wegovy all work by delaying gastric emptying, which makes the user feel full longer and less hungry. However, a growing number of reports suggest that these side effects can cause gastroparesis for some users, slowing gastric emptying to the extent that it results in stomach paralysis.
In 2017, researchers with the Mayo Clinic conducted a study involving a similar diabetes medication known as Victoza, which found that the drug caused significantly slower digestion in users, taking about 70 minutes for half the food they ate to leave their stomachs, compared to four minutes for people who did not take the drug. However, the study found that people’s bodies tended to adjust over time.
In September, the U.S. Food and Drug Administration (FDA) issued new label warnings for Ozempic, indicating that it can increase the risk of intestinal blockages. The warning links Ozempic to a condition known as ileus, which can cause abdominal cramps, bloating, nausea, vomiting, constipation, difficulty passing gas and difficulty eating.
January 2024 Mounjaro Gastroparesis Lawsuit Update
McDonald’s lawsuit comes as a growing number of similar complaints are being filed in U.S. District Courts nationwide, each describing similar circumstances were users experienced permanent injuries from gastroparesis caused by Ozempic, Wegovy and Mounjaro side effects.
Given common questions of fact and law raised in the cases, a group of plaintiffs filed a motion to centralize all Ozempic and Mounjaro gastroparesis lawsuits on December 1, asking the U.S. Judicial Panel on Multidistrict Litigation (JPML) to transfer claims brought throughout the federal court system to the U.S. District Court for the Western District of Louisiana, for coordinated management before one judge during discovery and pretrial proceedings. The panel will hear oral arguments on the motion later this month.
While the motion indicated there were less than two dozen cases filed in different U.S. District Courts at the time, Ozempic and Mounjaro gastroparesis lawyers are currently investigating more than 10,000 additional claims that may be filed in the coming months and years.
In complex pharmaceutical litigation, where large numbers of claims are brought by users of the same medication or medical product, each experiencing the same or similar injuries, it is common for the U.S. JPML to centralize the litigation to reduce duplicative discovery into common issues that will arise in all claims, avoid conflicting pretrial rulings and to serve the convenience of certain witnesses and parties who will be required to testify in each of the lawsuits.
If an MDL is established, McDonald’s lawsuit will be transferred to wherever the U.S. JPML centralizes the pretrial proceedings. However, if the parties fail to negotiate Mounjaro settlements for gastroparesis injuries during the MDL proceedings, each individual claim may later be remanded back to the U.S. District Court where it was originally filed for trial.
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