Januvia, Victoza, Janumet and Byetta are all treatments for type-2 diabetes. They are taken in various different forms and are intended to act in various different ways, but all have an effect on pancreatic function. Although these drugs are different, the deadly side effect for all four of these medications is the same. Each of these drugs have been tied to an increase in pancreatitis. In a worst case scenario, they are alleged to cause pancreatic cancer, which is one of the deadliest forms of cancer. There have been lawsuits filed in connection with all four of these drugs, seeking compensation for the harms suffered by patients. Currently, the number of suits filed in these cases is growing, with new complaints frequently being filed.
Each diabetes medication contributes in some way to lowering blood sugar, mostly by inhibiting something. Januvia is a DPP-4 inhibitor, which assists in producing insulin. Specifically, DPP-4 helps interfere with the production of insulin and Januvia is intended to fight that process. Patients take Januvia orally as opposed to injecting it. Januvia is manufactured by Merck.
Victoza is supposed to act like a GLP hormone. One of the ways that it helps control blood sugar is by stimulating the pancreas to produce more insulin. Specifically, it acts on the beta cells that are in the pancreas. Victozia is taken by injection. Victoza is manufactured by Novo Nordisk.
Janumet is an oral medication contaaining metformin and sitagliptin. It is also a DPP-4 inhibitor. Janumet both stimulates the pancreas and blocks the production of glucagon, which normally allows the liver to produce more glucose. Merck is the manufacturer of Janumet.
Byetta is a non-insulin medicine that is taken by injection. It comes in the form of a pen. Byetta is a glucagon-like peptide-1 receptor agonist. This medication augments certain roles of the pancreas while suppressing others. It is manufactured by Amylin Pharmaceuticals in partnership with Astra Zeneca.
All of these drugs are either DPP-4 inhibitors or GLP-1 receptors. Each of these medications acts on the pancreas in some way. In 2013, it began to become apparent that these medications had dangerous side effects beyond the minor side effects that were listed on the label. Specifically, there was a study that was published in the JAMA Intern Medicine that found that GLP-1-based therapies were associated with higher risks of acute pancreatitis. Later in the year, there was another study that linked these medications to pancreatic tumors, that have among the highest fatality rates of any kind of cancers. Part of the reason why pancreatic cancer is so deadly is because it is often not discovered until it is at an advanced stage.
After these studies were released, the FDA issued a drug safety communication. This informed the public that the FDA was looking more closely at the results of these studies. The FDA had started warning about the risks of pancreatitis from Januvia as far back as 2009. Although the FDA has not communicated that there are any documented links between these medications and pancreatic cancer, studies continue to show connections between the two. In 2016, a study in the European Society for Clinical Investigation Journal reaffirmed the linkage between these medications and pancreatic cancer. Finally, in 2018, the American Diabetes Association Journal published the results of a study that showed that patients who have taken these medications have twice the normal rate of pancreatic cancer.
There have been numerous lawsuits filed against the manufacturers of these drugs. These lawsuits have not yet resulted in the issuance of any decisions on the merits nor have there been any settlements reached in these cases. After some early setbacks, these lawsuits are now proceeding again and will start going to trial shortly.
These lawsuits have been filed under product liability theory. In addition, since the side effects involve pancreatic cancer, which has an extremely low survival rate, there have been wrongful death suits filed against the manufacturers. From a product liability standpoint, the complaints have alleged that each of the manufacturers has designed and sold a defective product that has caused injury to patients. When a drug company sells medications to consumers, they have an obligation to those who purchase them to produce medications that are safe for use and will not cause harm to consumers. These drug companies have an obligation to test the products and if test results reveal that there are any dangers, there is a duty to warn patients of these dangers. Specifically, the warning label for the drugs should have specifically cited the risk of pancreatic cancer. Under this theory, if a drug company sells a medication that causes harm to consumers, they will be held liable.
With regard to the lawsuits against these manufacturers, a court ordered that all of the pancreatic cancer lawsuits be consolidated in the Southern District of California, although they do not have to proceed to one common trial. The lawsuits were dealt a blow when they were dismissed in 2015. The dismissal was on the basis of a ground that is common when medications have been approved by the FDA. The court held that because the product went through the FDA approval process, which included testing, the manufacturer was under no duty to warn patients of side effects.
The plaintiffs appealed this ruling and won a large victory in 2017 when a federal appeals court reversed the district court and reinstated the lawsuits. The 9th Circuit ruled that the district court impermissibly closed off discovery in the case and disallowed key evidence in its analysis that resulted in its finding the case pre-empted by the FDA approval process. In the wake of the ruling, these cases will begin proceeding to trial with decisions being issued possibly in 2020.
If you or a loved one has taken any of these medications and has contracted pancreatic cancer, you should immediately contact an attorney to discuss your legal rights. An attorney can advise you of the possibility of recovery for the harms that you have suffered and what will be necessary in order to obtain that recovery.