Byetta and Bydureon Lawsuit Attorney

Byetta and Bydureon are both medications containing the active ingredient and GLP-1-like receptor agonist, exenatide. This active ingredient functions to decrease dietary intake, facilitate a delay in gastric emptying, inhibit the secretion of glucagon, and boost glucose-stimulated insulin secretion from pancreatic beta cells. Exenatide is a drug included in the list of incretin mimetics. It enhances glycemic regulation through multiple mechanisms associated with glucose control. These include decreased food consumption, delayed gastric emptying, and suppression of glucagon levels that are inappropriately high.

Byetta and Bydureon are injectable drugs. According to the Federal Drug Administration (FDA), the drugs are not indicated for the management of diabetic ketoacidosis or type 1 diabetes mellitus (TD1M). These exenatide-based drugs are generally not indicated for use in pregnant women, children, or nursing mothers. In the case of pregnant women, the drug may only be used during pregnancy if the intended benefit provides a justification of potential fetal harm. Furthermore, due to the lack of well-controlled studies for drug use in these specific populations, there is no clinical data establishing efficacy and safety.

Byetta and Bydureon are both utilized in the management of Type 2 Diabetes Mellitus (T2DM). Other drugs used in T2DM treatment include Januvia, Janumet, and Victoza. In type 2 diabetes, an individual’s body has decreased insulin sensitivity. The human body breaks down glucose through insulin secretion. A series of biochemical reactions occur for glucose breakdown and release energy to be used by the body in the form of adenosine triphosphate (ATP).

When glucose is not used for energy, it is stored in the body, generally in the skeletal muscle and liver. A small amount of unused glucose is stored in the brain. Glycogen stored in the brain is used as an emergency source during extreme cerebral events. Skeletal muscle glycogen is used as a main substrate when the body is under high-intense activity. Glycogen in the liver serves to maintain appropriate blood glucose levels.

To maintain metabolic needs and dietary intake, the body releases insulin in regulation. With type 2 diabetes mellitus, the human body does not produce enough insulin or does not utilize it as it should. When the cells are unresponsive to insulin, or there is insufficient insulin, excess blood sugar may accumulate and remain in the bloodstream. Furthermore, insulin deficiency may prevent cells from utilizing glucose as a source of energy.

High blood glucose levels may cause damage to the organs of the human body over time. Possible long-term effects may include microvascular and macrovascular blood vessels. This may lead to the risk of stroke and heart attack. Furthermore, it may cause problems with the nerves, feet, gums, eyes, and kidneys. The top causes of renal failure in the United States are high blood pressure and diabetes mellitus. According to the Centers for Disease Control and Prevention, high blood pressure and diabetes account for approximately three out of four new cases of kidney failure.

In response to food consumption, the body releases a hormone that triggers the pancreas to produce insulin. An enzyme is also produced in response to break down this hormone. This later stops the signal to produce more insulin. Incretin mimetic drugs, such as Bydureon and Byetta, work by adding an artificial hormone intended to increase insulin production in the body. Other incretin mimetics may add a drug intended to block the enzyme that breaks down insulin. This stimulates a longer-lasting effect of the hormone that signals the body to produce more insulin.

Since Bydureon was not introduced until 2010, it was not mentioned in the initial updates and reports. In 2013, the FDA reported that a review of unpublished studies on the entire class of incretin mimetic drugs, including exenatide, would be conducted. In September 2020, the maker of Bydureon, AstraZeneca, announced that the product would discontinue in 2021 because of business reasons. The company indicated that the discontinuation did not result from manufacturing, product quality, or efficacy concerns. The Bydureon BCise Pen will remain accessible on the market.

As of the FDA’s last announcement in March 2023, they have not yet arrived at any new conclusions regarding incretin mimetics and the associated safety risks. However, recent research found that the use of sitagliptin or exenatide may double the risk of developing acute pancreatitis. Other studies have indicated that this category of diabetes medications may increase the risk of patients developing pre-cancerous cells, acute pancreatitis, pancreatic cancer, and thyroid cancer. Medical professionals and patients are urged to report adverse events involving the use of incretin mimetic drugs to the FDA.

According to the National Institute of Health – National Cancer Institute (NCI), there is a 5-year survival rate of 98.5 percent, according to data from 2013 to 2019. The lifetime likelihood of a thyroid cancer diagnosis stands at approximately 1.2 percent for both men and women, based on data from 2017 to 2019. The signs of thyroid cancer include firm neck nodules, neck immobility, pain in the throat and neck, presence of lymph nodes in the neck, difficulty swallowing, and changes to the voice.

Acute pancreatitis (AP) represents an acute response to pancreatic injury. Chronic pancreatitis may lead to permanent damage to the exocrine and endocrine functions in addition to the structure of the pancreas. Pancreatic cancer may develop from years of chronic pancreatitis, where cells release toxins and growth factors in response to inflammation of the pancreas. This is attributed to uncontrolled pancreatic cell growth from genetic damage. The annual incidence of AP is an estimated 40 individuals to 100,000 population and accounts for approximately 130,000 new acute pancreatitis cases annually.

While pancreatic cancer is uncommon, it is considered one of the deadliest types of cancer. In the United States, pancreatic cancer is the fourth leading cause of death associated with cancer. The overall survival rate for pancreatic cancer patients is approximately six percent. The five-year survival rate is within five to 15 percent. Pancreatic cancer occurs when a tumor forms from cell mutation in the pancreas. All known risk factors include specific genetic syndromes, family history, chronic pancreatitis, diabetes, and smoking. Most patients are diagnosed with this type of cancer after the age of 65.

An individual who developed cancer or experienced harm from the side effects of Byetta and Bydureon may be entitled to compensation. Many people who used these medications and other drugs in this class and developed thyroid cancer, pancreatic cancer, pancreatitis, and other conditions have brought lawsuits forward against the manufacturer. With so many lawsuits filed across the United States, the cases were later bundled into federal multi-district litigation. The lawsuits were heard by Anthony Battaglia, a Federal Judge in San Diego.

Some individuals who took Bydureon, Byetta, and other diabetes medications in this drug class filed lawsuits in California state courts. The matters were brought together in a judicially coordinated proceeding in Los Angeles. They have been administered under state court Judge William Highberger. The original medication marketer, Eli Lilly and Company, and the original drug maker, Amylin Pharmaceuticals, may be held liable. Other possible defendants include AstraZeneca and Bristol-Meyers Squibb. This is due to their purchases in 2012 for the rights to market and manufacture these drugs.

A product liability case against a drug manufacturer for adverse side effects and the development of pancreatic cancer or pancreatitis may seek compensation for economic and non-economic damages. These may include but are not limited to:

• Past and future costs of medical care that are necessary and reasonable
• Past and future loss of earnings for the temporary or permanent inability to work
• Pain and suffering from the physical pain and emotional distress from the resulting injuries
• Loss of consortium if the harm from the product use caused damage to the claimant’s marital relationship

Punitive damages may be recoverable in cases of product liability. However, they are rare and are solely awarded at the court’s discretion. To seek punitive damages, there must be clear evidence demonstrating that the entity of the defective product acted egregiously.

If you or a family member suffered harm because of Bydureon or Byetta use, contact an experienced product liability lawyer from our law office to discuss your case in detail in a free consultation. Our legal team has years of collective experience in ensuring that drug manufacturers are held responsible for the dangers their products pose for consumer use. We are available to take your call and provide free, friendly case advice at (916) 921-6400 or (800) 404-5400. Our law firm operates on contingency, meaning clients do not owe us a dime unless we successfully resolve their case.

^{Image Source: ekaterinabolovtsova through Pexels ds llo [cs 1514]}

^{DISCLAIMER: This document is for informational purposes only and does not constitute a Retainer/Services Agreement. No attorney-client relationship will exist between you and our firm unless and until we enter into a signed Retainer/Services Agreement. The information you obtain at this site is not, nor is it intended to be medical or legal advice. Do not stop taking any medication without consulting your physician.}