Products Liability
Our lawyers were investigating potential lawsuits throughout claims on behalf of victims who took the drugs and have suffered from pancreatic cancer. These lawsuits alleged product liability, negligence, and failure to warn claims against Merck & Co., Inc., the manufacturer.
In 2023, our law firm is no longer handling these lawsuits. Why? Because most of these lawsuits were dismissed in 2021 by a federal court judge who did not believe there was a proven link between pancreatic cancer and these diabetes drugs.
Is the judge correct? No one knows. His ruling is based on the fact that the science did not currently support the claims and that might be true. But that does not mean there is not an association between diabetes drugs and pancreatic cancer. It means the plaintiffs’ lawyers were unable to prove that connection.
History of Januvia Litigation in 2025
Our law firm previously investigated potential lawsuits on behalf of individuals who developed pancreatic cancer allegedly after taking drugs such as Januvia or Janumet. The claims alleged product liability, negligence, and failure-to-warn against Merck & Co., Inc., the manufacturer.
By 2023 most of these lawsuits were dismissed after a federal court judge ruled that the scientific evidence failed to establish a causal connection between these diabetes medications and pancreatic cancer. That decision remains unresolved… a definitive link has not been found, although a risk cannot be entirely ruled out.
In August 2022, a separate safety concern emerged when Merck’s Januvia was found to contain trace amounts of nitrosamines (NDMA), a potential carcinogen. Although the FDA permitted continued use of the drug to prevent supply shortages, this raised serious alarms about its safety. At this time, our firm does not anticipate new litigation seeking NDMA-related claims against Januvia as dramatically as the lawsuits that followed Zantac or Valsartan.
Understanding Januvia, Janumet, Type 2 Diabetes, and Associated Risks
Januvia, also known by its generic name sitagliptin, is a once-daily prescription pill used to manage blood sugar levels in adults with type 2 diabetes. Janumet is a combination drug that includes sitagliptin and metformin. Both medications are intended to help patients maintain healthier blood glucose levels.
Type 2 diabetes, which is sometimes referred to as adult-onset diabetes or non-insulin-dependent diabetes, occurs when the body becomes resistant to insulin or does not produce enough insulin. As a result, the body cannot regulate glucose levels effectively.
Januvia and Janumet belong to a class of drugs called DPP-4 inhibitors. These medications work by helping the pancreas release more insulin after meals and by reducing the amount of sugar produced by the liver. This helps control blood sugar without causing low blood sugar events in most patients.
However, both medications have been linked to serious health concerns. In 2009, the FDA issued a warning about 88 reported cases of acute pancreatitis in patients taking sitagliptin. These reports included severe forms such as hemorrhagic and necrotizing pancreatitis. The symptoms of pancreatitis include upper abdominal pain, pain that worsens after eating, nausea, vomiting, and tenderness in the abdomen. These symptoms should be addressed immediately, as pancreatitis can be life-threatening.
In addition to pancreatitis, there have been concerns about a potential link between Januvia and pancreatic cancer. One early study reported a 2.7 times higher incidence of pancreatic cancer in patients who used Januvia or Byetta. This study has not been replicated in subsequent research, but the concern has remained a part of the public discussion about these drugs.
New Januvia Concern in 2023
As we just mentioned, in August 2022, a new concern was raised when Merck’s Januvia was found to be contaminated with a potential carcinogen called nitrosamine or NDMA. The FDA is allowing the drug to remain on the market, at least for now, fearing shortages.
It is always a concern when you have potential carcinogens in a drug that you already fear could cause cancer. But our lawyers do not anticipate new NDMA Januvia litigation as we have seen with Zantac and Valsartan.
What Are Januvia and Janumet?
These drugs are used to treat specific types of diabetes. Januvia is a prescribed pill taken once daily to help manage blood sugar in adults with type-2 diabetes. Janumet is a prescription used to manage blood sugar in adults with type-2 diabetes mellitus.
What Is Type-2 Diabetes?
Type-2 diabetes (also known as adult-onset diabetes and non-insulin-dependent diabetes) affects the body’s metabolization of sugar. With type-2 diabetes, the body is either resistant to the effects of insulin or does not manufacture enough insulin. The effect is that the body cannot maintain a normal glucose level.
How Do Januvia and Janumet Work?
Januvia and Janumet are new classes of drugs known as sitagliptin which are dipeptidyl peptidase-4 (DPP-4) inhibitors or blockers. These DPP-4 blockers help the body to manage blood sugar levels. They increase the amount of insulin manufactured by the pancreas when blood sugars are their highest (usually after eating). They also lower the amount of sugar manufactured by the liver after eating, when the body does not need it.
What Are the Warning Signs and Dangers of Januvia and Janumet?
Januvia and Janumet may cause acute pancreatitis and, as you will see below, pancreatic cancer.
On September 25, 2009, the FDA issued a warning to healthcare professionals that the drugs have been associated with 88 cases of acute pancreatitis (including hemorrhagic and necrotizing pancreatitis) by patients using sitagliptin. These 88 cases were found using the FDA’s post-market surveillance and occurred between October 2006 and February 2009.
Acute pancreatitis is the sudden inflammation of the pancreas. It is very dangerous and can be life-threatening. The warning signs of pancreatitis are:
- Upper abdominal pain that may radiate to the back
- Abdominal pain that feels worse after eating
- Nausea
- Vomiting
- Tenderness of the abdomen
Januvia and Pancreatic Cancer
Incredibly, there is a bigger problem with Januvia: pancreatic cancer. There was a study that showed a 2.7-fold increase in pancreatic cancers for those using Januvia and Byetta. What does this mean? It means if you are taking these drugs and you develop pancreatic cancer, it is more likely than not that you got it as a result of using these diabetes drugs. (Update commentary: this study was not replicated.)
What is the expected settlement amount or trial value of a Januvia or Byetta pancreatic cancer case? Well, these cases have not started settling in massive numbers. But, we try to estimate the value of Byetta and Januvia claims to try to give some idea of the potential settlement and trial value of these cases. (2021 Update: this paragraph did not age well. Januvia lawsuit settlements have fallen apart for most victims.)
Why Is the FDA Worried about Januvia and Janumet?
The FDA is concerned about Januvia and Janumet because they have received numerous reports that patients using the drug have developed acute pancreatitis. Sixty-six percent of those patients required hospitalization, and four of the patients were transferred to the intensive care unit.
Many of these Januvia and Janumet patients developed acute pancreatitis shortly after starting the drugs or changing the dosage. Over half of the cases were resolved after Januvia and Janumet were discontinued.
Acute pancreatitis can be fatal. The FDA is warning patients and their healthcare providers to watch for the warning signs listed above, and to closely monitor patient health immediately after starting the drug or changing the dose. They are working to update Januvia and Janumet’s warning labels to reflect these new dangers.
Why the FDA Continues to Monitor Januvia and Janumet
The FDA remains concerned about Januvia and Janumet due to the number of reported cases of acute pancreatitis. More than half of the affected patients were hospitalized, and several required intensive care. Many cases of pancreatitis occurred soon after starting treatment or after a change in dosage. In most cases, the condition resolved after the drug was discontinued.
Given the seriousness of pancreatitis, the FDA recommends that both patients and healthcare providers remain alert for early warning signs. These may include nausea, vomiting, and pain in the upper abdomen. Any new or unusual symptoms should be evaluated promptly.
*Note: some of the content on his page is outdated even though it was updated in part in 2025