Everything You Need to Know About The Dangerous Side-Effects of Janumet and Januvia

Janumet and Januvia are a pair of prescription drugs that have been linked to pancreatic cancer and pancreatitis. Several studies have found that taking either Januvia or Janumet is correlated to an increase of pancreatitis and pancreatic cancer. Soon thereafter, a series of lawsuits were filed against Merck, the manufacturer of both drugs. This article will review the science behind Janumet and Januvia, specifically, why they are prescribed and what they are supposed to do, and the later discovered issues linked to using Januvia and Janumet. It will continue with a review of the various legal techniques and strategies used to recover compensation from Merck if you or a loved one suffered harm as a result of using either of these drugs. Finally, it will end with a broad overview of product liability law which will likely form the basis of any future lawsuit if you or a loved one suffered harm from Januvia or Janumet.

What are Janumet and Januvia?

Janumet and Januvia are a pair of drugs that help people manage their blood sugar levels when they suffer from diabetes. Diabetes is a disease in which the body is in a state of prolonged exposure to high blood sugar which causes a broad range of complications such as increased thirst and hunger. Over the long-term diabetes can cause more severe problems such as diabetic ketoacidosis, stroke, foot ulcers, and even death. Diabetes is caused by two issues, either, (1) the body isn’t producing enough insulin or (2) the body’s cells are no longer responding to insulin.

Janumet and Januvia treat diabetes by attacking both causes. These drugs are known as incretin mimetics. An incretin mimetic is a family of diabetes drugs which stimulate the pancreas’ production of insulin which helps manage blood sugar levels and reduce your body’s resistance to insulin. These drugs, when combined with diet and exercise, help control the symptoms of diabetes.

How Do These Drugs Work?

As stated above, diabetes is all about sugar, specifically, glucagon. Glucagon is a natural hormone produced by the pancreas to increase sugar (i.e. glucose) levels. The pancreas also produced incretins to decrease glucose levels. So, think of the pancreas as a soundboard operator, constantly turning knobs and dials to manage the sound mixing at a concert. You can’t have too much bass, too little tremble, etc. The pancreas is constantly adjusting glucose levels in your body.

Januvia and Janumet assist the pancreas by increasing incretin levels (specifically, GLP-1), by impairing the production of DPP-4, a protein which breaks down GLP-1. Januvia therefore increases incretin levels which helps keep glucose under control, a common problem for diabetes patients.

Hormone Production is Linked to Cancer

Januvia and Janumet both alter the hormone levels in the human body. It is commonly understood in the medical community that hormones are the primary driver of cancer. Cancer results from the abnormal development of cells. Cells develop and grow based on the hormones they receive. So, if hormone production is erratic, the risk for cancer increases. Januvia and Janumet alter hormone production in the human body which increases the opportunity for the accumulation of genetic errors which can result in cancer. The medical community links hormone production to cancer in a broad range of disease including breast cancer, ovarian, testis, prostate, and thyroid. The pancreas is no different than these organs when it comes to the link between hormone production and cancer.

Janumet vs. Januvia: What is the Difference?

Januvia was first approved by the Food and Drug Administration (“FDA”) in 2006. It is the brand name version of the generic drug sitagliptin, which is an incretin mimetic (see above). Janumet is a variation of Januvia which is a mix of sitagliptin and metformin (another drug that treats diabetes). The big difference between the two drugs is the incorporation of metformin in Janumet. In fact, Janumet has a black box warning (the most serious FDA warning to consumers and doctors) because it can cause lactic acidosis. Lactic acidosis is a disease that can cause abdominal and respiratory stress.

Risk of Pancreatic Cancer and Pancreatitis is Studied and Exposed

Both of these drugs have been dogged by suspicion that they could result in an increased risk of pancreatic cancer and pancreatitis. In 2009, the FDA announced that it was revising the prescribing information for all sitagliptin drugs (including Januvia and Janumet) to include that pancreatitis can result from taking these drugs. Pancreatitis is a condition in which the pancreas is inflamed, the severity can range from mild to life-threatening. A few years later, in 2013, the FDA announced that it was investigating incretin mimetics to determine if they are linked to an increase of pancreatic cancer. The investigation is ongoing and consists of working with medical researchers to review their findings.

Furthermore, numerous studies have found that Januvia and Janumet can increase the rate of tumors and that patients who use incretin drugs (including Januvia and Janumet) can suffer from higher rates of pancreatic cancer and pancreatitis(however, this study was a small sample size and far from conclusive). Furthermore, a statistical analysis of over one million medical records found a correlative link between the use of sitagliptins (like Januvia and Janumet) with higher rates and risk of pancreatic cancer. Another analysis conducted in 2016 found that Januvia is “significantly associated” with an increased risk of pancreatic cancer. So, the studies and findings keep piling up indicating that sitagliptins increase the rate of pancreatic cancer and pancreatitis which resulted in a cascade of lawsuits against Merck. Keep in mind that Januvia and Janumet are cash cows for Merck, generating several billion dollars a year in revenue therefore the number of people exposed to this risk likely number in the millions.

Why is Pancreatic Cancer so Dangerous?

Pancreatic cancer is one of the deadliest forms of cancer, 93% of patients do not survive for more than five years. In fact, only 20% of patients survive the first year for any diagnosis of pancreatic cancer (of which, there are several possible types of pancreatic cancer). A persistent problem for pancreatic cancer is that it is often undiagnosed for months or years. The symptoms of pancreatic cancer are mild, resulting in weight loss and vague abdominal pains. Moreover, doctors do not perform regular screenings unless there is a history of pancreatic cancer in the family or the patient carries one of the genetic markers for the disease.

If you are diagnosed with pancreatic cancer, the most common treatment is immediate surgery — the Whipple procedure (e.g. “pancreaticoduodenectomy”) which removes the cancerous portion of the pancreas. Furthermore, the medical community isn’t even sure what causes pancreatic cancer. There are several culprits including gene markers, however, those markers are also present in many people who never develop the disease. The medical community knows that it is linked to abnormal gene mutation (but then again, so is every form of cancer) and is studying the which gene mutations result in pancreatic cancer but the likeliest candidates are also present in many people who never develop the disease. People undergo gene mutation every day for all sorts of benign reasons, so tracing one gene mutation to one particular cause is incredibly difficult.

Finally, the medical community is not in agreement on whether to pancreatic lesions. Lesions develop as a part of pancreatic function, the pancreas produces both hormones and digestive enzymes which can cause lesions. Many people develop lesions without ever developing pancreatic cancer. Doctors measure the lesions one a 1 to 3 grade scale. The higher the grade, the higher risk of cancer the lesion poses. For grade 2 or 3 lesions, doctors sometimes refer to these as “precancerous” lesions. However, most people develop lesions without any negative side-effects.

In short, pancreatic cancer is hard to detect, doctors don’t know what causes it, and don’t agree on preventative procedures to stop it – that is why pancreatic cancer is so dangerous.

How Do Federal Prescription Drug Lawsuits Work?

The federal court system deals with massive prescription drug lawsuits every year and has developed a system for quickly and efficiently dealing with them. There is a panel of federal judges that coordinate most of the federal prescription drug lawsuits. In 2013, this panel consolidated the pancreatic cancer lawsuits for pretrial and discovery purposes in the Southern District of California (i.e. San Diego).

Pretrial refers to the motions (i.e. briefs) filed by the various sides to either dismiss the lawsuit, expand it, narrow the scope, or other related issues. Discovery refers to the investigative process undertaken in lawsuits. Both sides to a lawsuit are entitled to collect “discovery” (i.e. documents, pictures, evidence, names of witnesses, etc.) that could provide evidence that might be of use at trial (that isn’t the full legal definition, but that is the basics). Since the case is consolidated for these purposes in San Diego, that means that all pretrial and discovery fights must happen in San Diego federal courts, however, the actual trials and appeals can proceed in their various states and jurisdictions.

The federal panels also appointed a group of attorneys to represent the victims as the “Plaintiffs Steering Committee.” The Plaintiffs Steering Committee is responsible for gathering the scientific and factual evidence that you and other plaintiffs can use in their various lawsuits against Merck. For example, if Merck tried to dismiss your suit for lack of scientific evidence, the Plaintiffs Steering Committee would have already addressed this and you would be provided with the briefings and cases to overcome that challenge. Basically, this Committee is getting all of the evidence and procedural issues addressed so, if you need to file a lawsuit, it will focus on (1) whether you were harmed and (2) to what extent rather than on the scientific question of whether Januvia or Janumet are linked with cancer or on legal issues, like if you have standing or jurisdiction to bring a claim.

Is This A Class Action?

No, it isn’t. You probably see commercials for class actions on commercials or hear about “class actions” on television shows but this is not a class action. In a class action, 99.9% of plaintiffs never need to file a lawsuit. Rather, the lawsuit is filed by the “named” class member, who is a prototypical example of someone who likely suffered the same injury as you. Once the class action is successful or settles, you may apply to the class to receive compensation for your injuries. Class actions are used when a lot of people suffer the same type of injury and therefore are entitled to the same or similar compensation.

For example, if you owned a cell phone who advertised its battery life at 10 hours but your phone’s battery only lasted 5 hours and you weren’t the only one, but everyone who bought your phone had the same problem – that would be the ideal situation for a class action.

Here, the Januvia and Janumet lawsuits are not ideal for class actions because everyone’s injuries will be different. Some people will develop more deadly forms of pancreatic cancer, others will only develop pancreatitis. Still others will develop issues which haven’t even been discovered but are linked to these drugs.

Mass Tort

The Januvia and Janumet lawsuits lend themselves more to “mass torts.” A mass tort, which sounds like another name for class action, is different in a few key ways. First, each person who is injured must file a lawsuit in their own name. Second, you have to engage in litigation to recover compensation. But, unlike a standard lawsuit, you usually only have to prove that (1) you took the drug and (2) suffered harm. Since the Plaintiffs Steering Committee is handling most of the procedural and factual issues, your individual case will focus on how the drug affected you. So, while the hard work of reviewing the studies, meeting with experts, and overcoming the procedural hurdles is handled by the Plaintiffs Steering Committee, if you think you were injured by Januvia or Janumet, you will need to find your own lawyer to help you file a case and negotiate a settlement.

Product Liability

You’re probably thinking, “what mass tort isn’t a theory of liability, it's just a legal procedure, how do I win my own case against Merck?” Okay, you probably weren’t thinking that exact phrase, that would be remarkable. But the question nonetheless stands. You’re correct, mass tort is merely a vehicle for bringing a lawsuit, it doesn’t actually explain how Merck is responsible for your particular injury. Product liability refers to a subset of laws that are designed to assign responsibility for those who sell defective or dangerous products (like prescription drugs that cause cancer). Product liability removes some of the burdens that plaintiffs ordinarily face and make it easier for people to recover against companies.

Can Sue Any Party in the Distribution Chain

Specifically, under product liability, the responsibility for selling a defective product to a consumer rests with all sellers of the product (including the manufacturer and retailer). It also includes all parties in the distribution chain, so any type of warehouse or clearinghouse company could also be liable. The innovation here is that under the old rule, a consumer could only hold parties responsible if they had a contract with the other party. But, a problem would develop for products because the retailer sells the product but it the defect was unlikely to result from the seller, it probably occurred with the manufacturer. So, a consumer would be injured by a defective product and could only sue the retailer who wasn’t responsible. The consumer was prohibited from suing the manufacturer because the consumer didn’t have a contract with the manufacturer. The current regime of law doesn’t require “privity” of contract between consumers and manufacturers.

Types of Product Defects

TThere are three basic types of product defects. First, design defects which refer to products which were flawed at the planning stages (i.e. the entire product is flawed). Second, manufacturing defects, which means that there was an error in the manufacturing process resulting in some or a lot of the products having a defect which is different from other similarly-manufactured products. Finally, marketing or warning defects, which means the company failed to warn or advise consumers on how to use the product (a common example of warning defects is a failure to warn that a particular toy is small and could be a choking hazard for young children).

  • Liability

There are two theories which empower plaintiffs in product liability suits. First, res ipsa loquitur which means “the thing speaks for itself” or, more plainly, the burden is on the defendant to prove it wasn’t responsible. For example, you take a drug to treat diabetes that causes cancer. The drug manufacturer was likely responsible because medicine shouldn’t give you cancer and it is up to the drug manufacturer to either prove (1) it warned you or (2) its drug didn’t cause cancer.

These questions are resolved and addressed by the Plaintiffs Steering Committee (see above). So, you only have to prove that (1) you took the drug and (2) suffered harm after taking the drug. Merck can choose to fight you on your individual claim but, if you establish those two factors you will likely either win or extract a fair settlement.

The other theory is strict liability. Strict liability is similar as to how the Plaintiffs Steering Committee works. Specifically, under strict liability you aren’t required to prove that the defendant acted negligently, you only need to prove that you purchased the product and suffered harm from using it. For practical purposes, if the Plaintiffs Steering Committee is successful, your case will proceed like a strict product liability case.

  • Defense – Unavoidably Unsafe Products

Some products cannot be made safe, like chainsaw or axes, and it is up to the consumer to use them responsibly. The law generally adopts the approach that consumers are best placed to manage the risk in using these unavoidably dangerous products. Some drugs can be classified as unavoidably unsafe products. However, the other side of the coin of that argument is that consumers are aware that the product is unavoidably dangerous. Unlikely a chainsaw, a pill or tonic is not immediately clear it if it is harmless like Advil or can cause severe side effects like chemotherapy.

Merck may argue that Januvia and Janumet are unavoidably unsafe products and therefore the burden is on the patient to use the drugs cautiously. However, Merck never provided warnings that Januvia and Janumet could cause pancreatitis or pancreatic cancer therefore, patients and doctors were never given an opportunity to evaluate the risks fully. Like chemotherapy and other dangerous drugs, patients are warned of possible side-effects and that taking the prescription could cause more harm than the disease it seeks to treat (like some antibiotics).

  • Wrongful Death

Finally, if your loved one passed away due to complications linked to the use of Januvia or Janumet, you and your family may bring a wrongful death suit against Merck. You can still use the law and research generated by the Plaintiffs Steering Committee but rather than fighting a products liability suit, you’ll be fighting a wrongful death claim. In a wrongful death action, you must show that the defendant was responsible or a contributing factor to your loved one’s death. Your family would be entitled to receive compensation for the loss of your loved one. Typically, it would include lost anticipated wages if your loved one had not passed away.

Status of Ongoing Lawsuits

There are two main lawsuits proceedings against Merck over Januvia and Janumet. There is a multidistrict federal lawsuit in San Diego, California and a consolidated state suit in Los Angeles, California. There are also individual and smaller cases throughout the country. As of this writing, no jury trials have been held and settlements haven’t been reached. Merck continues to vociferously deny any responsibility for any resulting harm from taking Janumet or Januvia.

Help Finding a Janumet or Januvia Lawsuit Attorney Near Me

If you need help finding a professional to assist you with a potential Lyrica (Pregabalin) lawsuit near you, contact Consumer Alert Now at (800) 511-0747 for assistance. Consumer Alert Now informs all of its clients of ongoing, major lawsuits involving medications, treatments and other complex multi-jurisdiction litigation matters. Consumer Alert Now can tell you everything you need to know about the dangerous side-effects of Janumet or Januvia and what to do if you suffered harm anywhere in the United States.