Incretin Mimetics Lawsuits

August 2021 Update: We are no longer actively taking Incretin Mimetics cases.

Incretin Mimetics include Byetta, Byuderon, Victoza, Janumet, Januvia, Kombiglyze, Nesina, Onglyza and Tradjenta

If you or a loved one have taken diabetes medication, such as incretin mimetics, only to later develop pancreatitis, pancreatic cancer, or other adverse effects, you may be eligible to participate in an incretin mimetics lawsuit.

For more than half a century, the accomplished personal injury attorneys of Gerling Law have fought passionately to help their clients who have been harmed through no fault of their own and deserve compensation for their injuries.

Contact Gerling Law today for a free, no-obligation consultation with one of our knowledgeable incretin mimetics lawyers. We will thoughtfully listen to your story and evaluate the details of your case to determine whether we can help you. If so, we will zealously represent you by holding the pharmaceutical companies accountable for the damage they caused and help you receive the maximum compensation you deserve for your injuries and suffering.

What Are Incretin Mimetics?

Incretin mimetics are a class of type-2 diabetes medication which mimic the naturally-occurring human hormones called incretins.  The incretins in the body, produced by the small intestine, effectively lower blood sugar after eating by stimulating the production of insulin.  There are two types of incretin mimetics:  GLP-1’s and DPP-4’s.

GLP-1 receptor agonists work by mimicking one type of the incretins in the human body, GLP-1’s, which alert the pancreas when to create more insulin after eating.  GLP-1 receptor agonists come as a liquid, which a person can inject under their skin, on their abdomen, on their thigh, or on their upper arm. Depending on which medicine they use, they can inject it either once or twice daily, or once weekly. GLP-1 receptor agonists can be used alone or along with other diabetes medication.  Some popular GLP-1 incretin mimetics are:

• Byetta (exenatide) manufactured by Astrazeneca
• Byuderon (exenatide) manufactured by AstraZeneca
• Victoza (liraglutide) manufactured by Novo Nordisk

The second type of incretin mimetics are called DPP-4 inhibitors.  While GLP-1 incretins create insulin production, the natural effects only last a few minutes because of the DPP-4 enzyme in the body.  DPP-4 breaks down the GLP-1 in the blood, which prevents leftover glucose from being used.  DPP-4 inhibitors work to block the action of DPP-4 enzymes, allowing for higher GLP-1 in the blood and less glucose build-up.  Higher GLP-1 numbers leads to a higher insulin level, which leads to a higher uptake of glucose.

DPP-4 inhibitors come in pill form and are taken by mouth. Like GLP-1s, they can be used alone or in combination with other diabetes medicines. They are also available in combination pills that contain a DPP-4 inhibitor and another type of diabetes medicine.  Some popular DPP-4 incretin mimetics are:

• Janumet (sitagliptin) manufactured by Merck & Co.
• Januvia (sitagliptin) manufactured by Merck & Co.
• Kombiglyze XR (saxagliptin) manufactured by AstraZeneca and Bristol Myers Squibb
• Nesina (alogliptin) manufactured by Takeda Pharmaceuticals
• Onglyza (saxagliptin) manufactured by AstraZeneca and Bristol Myers Squibb
• Tradjenta (linagliptin) manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.

Why Are Incretin Mimetics Unsafe?

There is substantial evidence that the use of incretin mimetics can lead to pancreatic disease and even death.

88 cases of acute pancreatitis were linked to Januvia from 2006 to 2009 — a mere three years.  Half of the affected patients reported that their pancreatic inflammation lessened after they stopped taking Januvia.  The FDA Adverse Events Reporting System (FAERS) reports that in just the past five years (2015 – 2020), a total of 10,788 cases have been linked to Januvia–including 1,522 death cases.

The Food and Drug Administration (FDA) first raised concern about incretin mimetics in 2007.  They warned that incretin mimetics, especially exenatide (Byetta and Byuderon) and sitagliptin (Janumet and Januvia), could cause pancreatic disease.  The warning followed reports that a rising number of incretin mimetics users were being diagnosed with acute pancreatitis and pancreatic cancer.

The Institute for Safe Medication Practices (ISMP) analyzed data from the FDA Adverse Event Reports between July 1, 2011, and June 30, 2012, from 1,723 patients taking incretin mimetics. The ISMP concluded that the increased risk of developing pancreatic cancer for patients on incretin mimetics could be as much as 20% higher than those who were taking other medications to control their type-2 diabetes.

In 2013, the FDA was still investigating the link between incretin mimetics and  pancreatic disease.  They released a drug safety communication reporting the possibility of incretin mimetics increasing the risk of pancreatitis as well as causing pre-cancerous changes in the pancreas.  They based their statement on a 2013 study published in JAMA Intern Med.

A 2013 study in the medical journal Diabetes found that patients using incretin mimetics had a higher rate of pancreatitis and pancreatic cancer than patients using other diabetes medications.

More recently, a 2018 study revealed a connection between incretin mimetics and pancreatic disease again. Researchers compared data from over 33,000 diabetes patients on incretin mimetics with over 525,000 other diabetes patients treated with other medication. They found that patients taking the incretin mimetics had double the risk of developing pancreatic cancer as those taking other medication.

An additional concern is the quality of incretin mimetics considering that their manufacturers are profiting significantly from rushing them to the market.  In the United States, the Institute for Safe Medication Practices estimated that more than 3 million diabetics were taking the top five selling incretin mimetics in 2013.  Because incretin mimetics are top sellers for their manufacturers, concerns have been raised that the manufacturers pay less attention to what is in the medications than the money they bring in.  For example, Merck’s global sales increased from $2.39 billion in 2010 to $3.7 billion in 2017.  Unfortunately but unsurprisingly, the research over the past ten years has shown that manufacturers continue to value profit over the quality of human life when they conduct inadequate testing and allow unsafe drugs to exist on the market.

Merck offered to fund research about the effect of sitagliptin (Januvia) in order to dismiss claims that their medication was unsafe.  The research took place at the University of California in Los Angeles on rats which had diabetes.  The results were eye-opening.  After giving the rats sitagliptin (Januvia), metformin, or a combination for 12 weeks, the researchers concluded that every single rat which had sitagliptin suffered from enlarged pancreases.  Furthermore, one rat had acute pancreatitis and 3 out of 16 had acinar to ductal metaplasia, a pathological change which can be a precursor of pancreatic cancer.

Other Adverse Effects of Incretin Mimetics

Byetta:  an increased risk of pancreatitis, pancreatic cancer, and thyroid cancer.

Bydureon:  an increased risk of pancreatitis, pancreatic cancer, and thyroid cancer.  The FDA has required a black box warning on Bydureon due to its connection to thyroid cancer.

Victoza:  an increased risk of pancreatitis, pancreatic cancer, and thyroid cancer.  The FDA has required a black box warning on Victoza due to its connection to thyroid cancer.

Janumet:  an increased risk of pancreatitis, pancreatic cancer,  thyroid cancer, and rhabdomyolysis (the breakdown of muscle tissue into the blood).

Januvia:  an increased risk of pancreatitis, pancreatic cancer,  thyroid cancer, and rhabdomyolysis.

Kombiglyze XR:  an increased risk of pancreatitis, pancreatic cancer, thyroid cancer, rhabdomyolysis, and heart failure.

Nesina:  an increased risk of pancreatitis, pancreatic cancer, thyroid cancer, rhabdomyolysis, and heart failure.  Nesina was included in the FDA’s 2016 Safety Announcement regarding updating certain incretin mimetic warning labels to include the risk of heart failure.

Onglyza:  an increased risk of pancreatitis, pancreatic cancer,  thyroid cancer, and rhabdomyolysis.  Studies have also linked Onglyza to heart failure.  The FDA reviewed the data on Onglyza and heart disease based on the findings of a clinical trial (the SAVOR study). And in April 2016, the FDA issued a Safety Announcement, advising that the manufacturer was required to add new warnings to the Onglyza labels about the potential risk of heart failure.

Tradjecta:  an increased risk of pancreatitis, pancreatic cancer, and heart failure.

Joining the Incretin Mimetics Lawsuit

Plaintiffs throughout the United States have claimed that they now suffer from pancreatic disease, including pancreatic cancer, as a result of taking incretin mimetics.   In August 2013, a panel of federal judges consolidated all current and future Byetta, Januvia, Janumet, and Victoza cases in the Southern District of California under the title In re: Incretin Mimetics-Based Therapies Products Liability Litigation due to the increasing number of lawsuits against manufacturers Merck, Amylin (former manufacturer), Eli Lilly (former manufacturer), AstraZeneca, Bristol Myers Squibb, and Novo Nordisk.  Thus, Multidistrict Litigation (MDL) 2452 was created under Justice Anthony J. Battaglia.

The individuals involved in MDL 2452 claim that the “defendants willfully, wantonly, and with malice withheld the knowledge of an increased risk of pancreatic cancer in users of the Drugs to prevent any chances of their products’ registration being delayed or rejected by [the] FDA.”

The Complaint further alleges that:

1. the defendants manufactured defective drugs which caused “unreasonable and dangerous side effects,”
2. the defendants failed to conduct adequate research and test the incretin mimetic drugs before making them available on the market,
3. the defendants failed to warn healthcare professionals and consumers of these potential side effects, even concealing the risks of pancreatitis and pancreatic cancer from the public,
4. the manufacturers failed to include specific wordage, such as “pancreatic cancer”, on the drugs’ labels, and
5. the plaintiffs allege that the current warnings for the drugs are still inadequate.

If you have a claim, your case may not be litigated in the MDL.  Below is a list of where current lawsuits are filed and who they are against for some of the most popular incretin mimetics:

• Byetta:  MDL 2452 against Bristol-Myers Squibb
• Bydureon:  MDL 2452 against AstraZeneca
• Victoza:  MDL 2452 against Novo Nordisk
• Janumet:  MDL 2452 against Merck & Co.
• Januvia:  MDL 2452 against Merck & Co.
• Kombiglyze XR:  included in the Onglyza MDL proceeding in the U.S. District Court for the Eastern District of Kentucky (heart failure claims)
• Onglyza:  In February 2018, the U.S. Judicial Panel on Multidistrict Litigation consolidated all federally filed Onglyza lawsuits into one court in the U.S. District Court for the Eastern District of Kentucky (federally filed containing heart failure claims).  The lawsuit is against Bristol-Myers Squibb and AstraZeneca.

If you have suffered from taking incretin mimetics, you are not alone.  Here are a few examples of people who have started taking action to right the wrongs done to them.

Guy Riley sued Merck, Amylin and Eli Lilly after his wife, Kathleen, died of pancreatic cancer in 2009.  She had been taking Januvia and Byetta for her type 2 diabetes ever since 2005.  Riley filed a wrongful death claim in October 2012, which included claims of negligence, strict liability, misrepresentation, and deceit by concealment.  In his complaint, he alleged that Januvia and Byetta caused Kathleen “severe mental and physical pain and suffering prior to her death, along with economic loss.” The case was removed to the U.S. District Court for the Southern District of California, where it is now pending.

The estate of Regina Kelly filed a suit against Merck, Amylin and Eli Lilly as well following Kelly’s death. Like Kathleen Riley, she developed pancreatic cancer after taking Januvia and Byetta.  Her estate’s claim alleged that her medication “permanently and severely injured” her, and is seeking damages for her physical and emotional injuries, medical expenses, and more.  The case is also pending in California.

Joel Whitley’s mother, Marcia Whitley, was taking Januvia in August 2007. The following month her doctor prescribed Janumet with the Januvia she was already taking.  Whitley died of pancreatic cancer in August 2009, and now Joel Whitley, Marcia’s son, has filed a wrongful death claim on her behalf. The case is also pending in the federal MDL.

Linda Jean Howard suffered from acute pancreatitis after taking her prescribed Victoza and Byetta and filed a lawsuit in August 2013.  In her claim, Howard stated that if she or the doctor who prescribed her the medication had known about the risk of pancreatitis, she would have never taken Victoza or Byetta.  Also in her claim were the damages she was seeking, which were expenses for “physicians, surgeons, nurses, hospital care, medicine, hospices, X-rays, medical supplies and other medical treatment” as well as “actual and future income.”

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