U.S. Food & Drug Administration
U.S. District Court
Southern District of California
settlement with the FDA
alleged violations of the False Claims Act
and the U.S. Food, Drug and Cosmetic Act
Victoza injury lawyers at The James Esparza Law Group know that while the drug has proven effective in helping those with type 2 diabetes lower their blood sugar, more than 2,500 complaints have been filed with the U.S. Food & Drug Administration. Patients allege the company misled doctors and patients about the risk of developing cancer while taking the drug.
Though Novo Nordisk has denied any wrongdoing in its marketing of Victoza, it was compelled to pay nearly $59 million in 2017 in a settlement with the FDA for alleged violations of the False Claims Act and the U.S. Food, Drug and Cosmetic Act. Whistleblowers alleged the company paid kickbacks and had sales people posing as medical educators.
There are nearly 1,000 pending cases in Multi-District Litigation (MDL) lawsuits pending in the U.S. District Court for the Southern District of California for incretin-based drug therapies, including Victoza, Byetta, Januvia and Janumet – with the primary side effect of these cases being pancreatic cancer.
What is Victoza?
As noted by the FDA, Victoza is a once-daily injection that, along with proper diet and exercise, works to lower blood sugar (glucose) levels. Controlling glucose is essential to preventing serious complications of diabetes (from which more than 9 percent of the U.S. population suffers, according to the CDC). Diabetes complications include blindness and kidney disease.
Normally, insulin is excreted by the pancreas. However, for someone with type 2 diabetes, the pancreas does not produce enough insulin or the body becomes desensitized to its insulin production. This happens for several reasons, often a result of a poor diet or obesity. Changes in lifestyle can reverse the disease, but often medication is necessary to speed that process.
Victoza was approved by the FDA in 2010. It is one in a class of drugs that works to mimic an incretin hormone called GLP-1 (Glucagon-Like Peptide-1), which triggers insulin production.
Victoza isn’t generally a first-line therapy, but it can be helpful when other medications prove ineffective. Still, the company reports some 1 million people take Victoza, which is the market leader for GLP-1 mimetic drugs. Sales of Victoza in recent years has reached more than $840 million a quarter (or $3.3 billion annually).
Victoza Pancreatic Cancer?
The question of whether Victoza causes pancreatic cancer has been hotly debated. Victoza works by triggering natural insulin production in the pancreas.
Some researchers suspect the drug might overstimulate the pancreas, resulting in a dangerous multiplication of pancreas cells. Growth of pre-cancerous lesions have been discovered by diabetes researchers when this occurs. The American Cancer Society warns patients who have chronic pancreatitis (an inflammation of the pancreas) increases the risk of developing pancreatic cancer. In fact, the New England Journal of Medicinefound that pancreatitis increases the risk of pancreatic cancer by 26-fold.
Novo Nordisk’s own clinical trial participants reported common side effects of upper respiratory infections, back pain and gastrointestinal problems. However, it was known even prior to FDA approval that there was a potential for more serious side effects. In fact, the clinical safety reviewer for the FDA initially voted against approving Victoza because of a possible increased risk of developing thyroid tumors. The FDA also warned doctors in 2011 (the year after it was approved) to carefully monitor patients for both thyroid cancer cell tumors as well as acute pancreatitis. Symptoms of acute pancreatitis include:
- Severe abdominal pain, possibly radiating to the back;
Patients who experience these must immediately seek medical care.
Post-marketing reports (submitted voluntarily by patients) indicated an increased risk for thyroid cancer and possibly thyroid cancer.
Although the FDA hasn’t come to any conclusive results about the connection, it did not that in five clinical trials of more than 3,900 people, there was a 4:1 imbalance of pancreatitis cases. The agency indicated the sample sizes were too small to definitively say whether Victoza causes pancreatitis.
The drug does now come with a black box warning (the strictest warning that can be placed on a prescription label) indicating a possible risk of developing Thyroid C-cell tumors. Such a connection has been discovered in rodents, the warning says, but it’s not clear if that’s relevant to humans using the medication.
A 2013 study published by The American Diabetes Association of numerous GLP-1 drugs (including Victoza/ liraglutide) found there was not firm enough evidence to confirm or rule out a causal connection between those drugs and a higher risk of pancreatic or thyroid cancers.
Another study by the American Diabetes Association in 2015 found that based on a relatively small sample (1,400 patients on Victoza and 5,000 on the control drug), cases of both acute pancreatitis and chronic pancreatitis were greater among those taking Victoza. Researchers however indicated not all variables had been controlled, and thus no firm conclusions could be reached.
A 2016 study of more than 970,000 patients published in the journal BMJfound no increased risk of pancreatic cancer compared with other drugs, though researchers noted the issue still should be monitored because the cancer can have a long latency period.
What Do Victoza Lawsuits Allege?
The lawsuits against Novo Nordisk for Victoza allege some variation of the following:
- The drug increases patients’ risk of developing cancer of the pancreas;
- Manufacturer had a duty to warn patients about the increased risk of pancreatic cancer and failed to do so;
- Manufacturer produced and marketed a drug that is defective and poses an unreasonable risk of serious side effects;
- Manufacturer did not warn doctors of the potential risks associated with Victoza, despite being aware of those risks.
The product liability lawsuits included in the federal multi-district litigation include similar claims against the makers of Januvia and Byetta.
If you have been diagnosed with pancreatic cancer after taking Victoza, you may have grounds for a claim. We can help you weigh your legal options.
Contact a Salt Lake City Victoza injury lawyer at The James Esparza Law Group by calling toll-free 800-745-4050.
Contact our team today
Our dedicated attorneys in Salt Lake City can help you file your Victoza lawsuit and navigate through what is a confusing process.