The introduction of the glucagon-like peptide 1 (GLP-1) receptor agonist class of type 2 diabetes drugs (also known as incretin mimetics) was met with enthusiasm by doctors and the millions of patients who suffer from diabetes. Byetta (exenatide) was the first drug in this class to be approved and prescribed to diabetes patients.
Byetta may increase the risk of pancreatic cancer, which has led to lawsuits against the drug's manufacturers.
But not long after Byetta’s 2005 approval, studies raised concerns that GLP-1 drugs may heighten the risk of pancreatic cancer. This research formed the backbone of legal claims that Byetta’s makers, Amylin Pharmaceuticals and Eli Lilly, concealed this risk from patients and doctors.
Byetta lawsuits—along with similar suits against the makers of incretin mimetics Januvia, Janumet, and Victoza—gained traction and were consolidated in California federal court as part of multidistrict litigation (MDL). A 2015 judge’s ruling in favor of drug companies appeared to put an end to these cases, but a December 2017 ruling has given the lawsuits new life.
If you or a loved one took Byetta and developed pancreatic cancer, you may have a claim against Eli Lilly/Amylin. Contact us to learn your rights during a free consultation.
How Does GLP-1 Work?
More than 30 million Americans suffer from diabetes. Type 2 diabetes accounts for 90-95 percent of all cases.
Diabetics suffer from excessive blood sugar levels (hyperglycemia) because their insulin deficiencies prevent blood sugar from entering cells. Glucose accumulation in the blood (instead of in the cells) causes a dangerous short-term drop in energy and damages the body over time.
Byetta is derived from a compound found in Gila monster saliva.
Diabetes cannot be cured but it can be managed with medication, diet, and exercise. There are at least a dozen classes of medications used to treat diabetes. They are used alone or in combination with other diabetes drugs, depending on the patient and their symptoms.
Glucagon-like peptide 1 (GLP-1) mimics the actions of one of the body’s naturally occurring incretin compounds, which are released from the gut during digestion. GLP-1 lowers glucose levels and allows the body to maximize use of its own insulin. Drugs in this class have the added benefit of carrying a low risk of hypoglycemia and promoting weight loss.
Byetta is derived from a compound found in Gila monster saliva and is administered via two daily injections. The result of a collaboration between Amylin Pharmaceuticals and Eli Lilly, Byetta was the first GLP-1 diabetes drug to gain FDA approval, in 2005. Amylin and Eli Lilly ended their partnership in 2011. Amylin paid Lilly to obtain the rights to Byetta.
What Are Byetta’s Pancreatic Side Effects?
Pharmaceutical companies spend many millions of dollars and many years getting new drugs to market. To ensure a return on investment, they heavily market these drugs and attempt to influence doctors’ prescribing patterns. But when new drugs—and especially new classes of drugs—are introduced, their long-term consequences are often not fully understood.
Data linking Byetta and pancreatic side effects gained public attention with the 2007 publication of an FDA alert linking Byetta to acute pancreatitis. The warning was based on 30 post-marketing reports of acute pancreatitis in patients taking the drug. It urged physicians to discontinue the drug if pancreatitis was suspected. The alert also resulted in an updated product warning label about the risk of pancreatitis.
Several studies have uncovered a possible link between Byetta and pancreatic cancer.
Concerns began to arise in 2009 that GLP-1 drugs could trigger not only pancreatitis, but also pancreatic cancer. A study published by UCLA researchers in the journal Diabetes found that sitagliptin (Januvia)—another GLP-1 drug—causes pancreatic abnormalities that are recognized as risk factors for pancreatic cancer. The study authors suggested that the link between GLP-1 drugs and pancreatic side effects could relate to the rate of formation of cells that line the pancreatic ducts.
A 2011 study published in Gastroenterology also cautioned about the long-term potential of GLP-1 drugs to promote pancreatic cancer. Additional concerns about changes to the pancreas from GLP-1 therapy were raised in a 2012 study published in Diabetes, as well as a 2013 JAMA study.
Subsequent research has not found a link between GLP-1s and pancreatic cancer. Conflicting data about this adverse effect promises to be hotly contested in Byetta litigation.
What Do Byetta Lawsuits Allege?
Hundreds of lawsuits have been filed against the manufacturers of GLP-1s Byetta, Januvia, Janumet, and Victoza. The lawsuits are centralized in U.S. District Court for the Southern District of California in multidistrict litigation (MDL), a type of mass tort. MDLs join together many similar claims to simplify pretrial proceedings such as discovery (the gathering and sharing of evidence and other case documents).
The lawsuits against drugmakers Merck, Novo, Amylin, and Eli Lilly similarly claim that patients took GLP-1s and as a result developed pancreatic cancer that caused personal injuries and, in some cases, death.
According to a master complaint filed on behalf of all plaintiffs against the defendants, the plaintiffs were unaware at the time they were prescribed the drugs that using them carried a risk of pancreatic cancer. The plaintiffs say that had they been aware of the risk of pancreatic cancer, they would not have taken GLP-1 drugs.
Plaintiffs allege GLP-1 drugs are unreasonably dangerous and that drugmakers did not properly disclose the pancreatic cancer risks associated with the drugs’ use.
Contact Us for a Free Consultation
Our attorneys have taken on—and succeeded against—the biggest drug companies in the world. We’ve recovered billions of dollars on behalf of plaintiffs and are ready to fight for you if you were injured by a dangerous drug. Michael Goetz has even been appointed to a leadership role on behalf of all plaintiffs in the incretin mimetics MDL.
Diabetes patients who took Byetta and developed pancreatic cancer should contact us for a free legal consultation.