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Diabetes Drug Manufacturers Sued Over "Stomach Paralysis" Side Effects
A 44-year-old Louisiana woman has filed a lawsuit against Eli Lilly & Co. and Novo Nordisk, alleging that the companies failed to warn that Mounjaro and Ozempic, type 2 diabetes drugs in the same class as Victoza, increase the risk of a rare but severe stomach condition called gastroparesis (commonly known as stomach paralysis), according to Bloomberg News [3.].
Plaintiff Jaclyn Bjorklund claims in the suit that she developed stomach problems so severe that she was admitted to an emergency room multiple times, and threw up so violently that she lost her teeth. Bjorklund further alleges that Lilly and Novo were aware that Mounjaro and Ozempic could cause gastroparesis, which paralyzes the stomach, resulting in vomiting, abdominal pain, bloating, and undigested food hardening in the stomach.
Industry insiders predict that Bjorklund's suit will be the first of many similar complaints to be filed in the coming weeks and months, with many expecting the claims to eventually be consolidated in multidistrict litigation (MDL).
Bjorklund's complaint includes claims for inadequate warning and breach of express warranty, and she is seeking unspecified compensatory and punitive damages.
What’s the Problem?
Recent studies suggest that the diabetes drug Victoza has been linked to an increased risk of acute pancreatitis and pancreatic cancer.
A study published by a clinical safety reviewer in the journal Diabetes [1] found that users of incretin mimetic drugs like Victoza are more likely to have increased pancreatic mass and precancerous cells, which may eventually evolve into tumors or cancer.
Earlier that month, the Food and Drug Administration (FDA) issued a drug safety alert stating that they were evaluating the study's data and planned to conduct additional testing on the samples collected by researchers to determine whether the drug's risks outweigh their benefits.
Manufactured by Novo Nordisk, the Victoza pen is a medical device that was approved by the FDA in January 2010 for the treatment of type 2 diabetes. The drug works by increasing the blood sugar levels the body produces.
However, the FDA approval of Victoza came against the advice of two reviewing pharmacologists and a clinical safety review.
Victoza Side Effects
Victoza has been linked to the following serious side effects:
- Pancreatic cancer
- Pancreatitis
- Life-threatening allergic reactions
- Kidney failure
- Thyroid cancer/thyroid tumors
- Increased blood sugar levels
How Can Victoza Cause Cancer?
Clinical trials have found clear evidence that Victoza can create changes within the pancreas, thus leading to cancer.
A 2011 study published in the journal Gastroenterology determined that Byetta, another incretin mimetics in the same class as Victoza, was associated with 2.9 times increased risk of pancreatic cancer.
Peter Butler, one of the authors of the study, has called for additional research to better understand the link between incretin mimetics and cancer.
Signs and Symptoms
Due to the fact that the pancreas lies deep in the abdomen in front of the spine, pancreatic cancer often goes undetected until its later stages. Once the tumor grows large enough to press on other nearby structures such as nerves, symptoms may include:
- Pain
- Loss of appetite
- Nausea
- Weight loss
- Jaundice (yellowing of the skin and eyes)
- Itching
Treatment
Treatment options depend on the stage and location of the tumor(s), as well as the patient’s age, overall health, and preferences. The primary goal of treatment is to destroy the tumors and eliminate the disease.
Tests & Diagnosis
In patients taking Victoza suspected of having cancer, a number of tests may be performed to confirm the diagnosis. These examinations may include ultrasound photographs, dye injections into the pancreatic duct, and tissue biopsies.
If cancer is confirmed, the patient will be treated according to the stage and type of the disease.
If the results of these studies indicate a tumor in the pancreas, a positive diagnosis of cancer is likely but not 100% definite. Only a biopsy in which actual tissue is extracted from the mass can identify the disease positively.
A variety of different treatments and drugs are available to individuals diagnosed with cancer. Some treatments are standard (those currently in use by the medical community), and some are considered experimental and tested in clinical trials.
For most individuals diagnosed with cancer, the primary method of treatment is to surgically remove the tumor.
However, if cancer has spread to other parts of the body and cannot be removed, the following types of palliative care may be implemented to relieve symptoms:
- Surgical biliary bypass – If a tumor is obstructing the small intestine and bile is accumulating in the gallbladder, a biliary bypass operation may be performed. During the procedure, the gallbladder or bile duct is cut and sewn into the small intestine to create a new path around the obstructed area.
- Endoscopic stent placement – In the event that a tumor is obstructing the bile duct, a stent may be inserted to drain bile that has accumulated.
- Gastric bypass surgery – If a tumor is obstructing the flow of food, the stomach may be sewn directly to the small intestine so the patient can continue eating normally.
Complications
- Jaundice – Cancerous tumors in the pancreas can cause jaundice, which manifests as yellow skin and eyes, dark urine, and pale-colored stools.
- Pain – Pancreatic tumors may grow so large that they press against the abdomen, resulting in severe pain.
- Bowel obstructions – If tumor cells travel into or press against the small intestine, they can interfere with the patient’s digestive system.
- Weight loss – Complication resulting from nausea, vomiting, loss of appetite, digestive issues, or a tumor pressing against the abdomen.
Public Citizen to FDA: Recall Victoza Now
Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, believes that when considering the high number of serious side effects including pancreatic cancer that have been linked to Victoza, the drug should be pulled off the market immediately.
“The FDA’s frequent solution to serious safety issues identified with new drugs is reckless: The agency simply describes the risks in the drug label and hopes that physicians and patients will pay attention. But more and more people are taking this drug, and more people are developing pancreatic cancer as a result. Clearly, the FDA’s warning system is not sufficient. The drug should be taken off the market by Novo Nordisk immediately.”
LEADER Trial Finds Increased Rate of Pancreatic Cancer with Victoza
A June 2016 study published in the New England Journal of Medicine (NEJM) [2] designed to assess the cardiovascular safety of Victoza found an increased risk of developing pancreatic cancer in patients treated with the drug.
Specifically, 13 Victoza users were diagnosed with pancreatic cancer compared to 5 patients treated with a placebo. Given that the drug has been previously associated with pancreatitis, the new findings seem to reinforce the link between Victoza and patients who developed pancreatic cancer, according to the researchers.
Black Box Warning for Victoza and Thyroid Cancer
Novo Nordisk failed to warn initially that Victoza and other similar drugs approved to treat diabetes cause thyroid cancer in rats and mice. Since the drug is fairly new and thyroid cancer is rare in humans, the FDA has stated that it is difficult to say whether there is a Victoza thyroid cancer risk in humans. Several cases of thyroid cancer have been reported in Victoza users, but it is unclear if these cases were caused by Victoza.
However, Novo Nordisk has applied a black box warning on the labeling of Victoza for putting patients at risk for thyroid cancer, including medullary thyroid carcinoma.
Victoza Class Action Lawsuits
Although we are a nationally recognized class action firm, the Pharmaceutical Litigation Group at our law firm has decided against the filing of a Victoza medical malpractice suit and is currently filing individual claims on behalf of injured individuals and/or their family members who have been diagnosed with pancreatic cancer after taking Victoza.
A class action medical malpractice suit is a type of lawsuit filed in a federal court on behalf of a large group of people or “class” of individuals who have been injured or wronged. The class is represented by the law firm and the case is generally decided upon a single member of the class who is sometimes referred to as the “class representative or class rep.”
In 2013, the U.S. Judicial Panel on Multidistrict Litigation consolidated Victoza lawsuits in California federal court in multidistrict litigation (MDL) No. 2452, In Re: Incretin Mimetics Products Liability Litigation.
In 2015, the trial judge dismissed all the cases. But an appeals court reinstated them. As of Sept. 17, 2018, there were 948 cases pending in the reopened MDL.
Related Articles:
- Saxenda Weight Loss Medication Lawsuit
- Rybelsus Stomach Paralysis Litigation
- Weight Loss Drug Stomach Paralysis Lawsuit
See all related dangerous drug lawsuits our attorneys covered so far.
Do I have a Victoza Lawsuit?
The Pharmaceutical Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Victoza lawsuits. Our dangerous drugs lawyers are handling individual litigation nationwide and currently investigating pancreatic cancer, kidney failure, and stomach paralysis cases in all 50 states.
Again, if you were diagnosed with pancreatic cancer, kidney failure, or stomach paralysis (gastroparesis) after you were prescribed Victoza or similar drugs, you should contact our law firm immediately by using the form below or dialing (866) 588-0600 for a free case evaluation and legal action. You may be entitled to financial compensation for medical bills / medical expenses, pain and suffering, and other economic damages by filing a class-action suit, and our defective medical device lawyers can help.
