Incretin Mimetics Lawsuits
Drugs in the incretin mimetic class are used to treat type 2 diabetes and are alleged to cause an increased risk of pancreatic cancer. Learn about the ongoing i
Drugs in the incretin mimetic class are used to treat type 2 diabetes and are alleged to cause an increased risk of pancreatic cancer.
The incretin mimetics lawsuit against the manufacturers of incretin mimetic diabetes drugs, once dismissed for the manufacturers, was remanded to the lower court for further discovery. The role of the Federal Drug Administration played a role in the summary judgment for the manufacturers. The evidence is inclusive whether Victoza, Januvia, and similar drugs cause pancreatic cancer.
When you're first diagnosed with type 2 diabetes, your doctor urges you to exercise and change your diet to control your blood sugar. Your pancreas still produces insulin, but your tissue cells resist the insulin in your blood stream. Only in type 1 diabetes, the pancreas no longer produces insulin, and injected insulin is the only way to control glucose from digested food.
Type 2 Diabetes Drug Therapy
If drug therapy becomes necessary, drugs for type 2 diabetes reduce spikes of glucose in your bloodstream, increase the production of insulin, or open your cells to insulin. Excess glucose in your bloodstream damages blood vessels and nerves, which can lead to heart disease and stroke, kidney disease, and damage to your eyes. Metformin and sulfonylureas are frequently prescribed separately or in combination. Metformin may cause lactic acidosis in alcoholics, and sulfonylureas may accelerate liver and kidney disease in alcoholics.
Incretin Mimetics as a Treatment
Novo Nordisk's Victoza, approved by the U.S. Food and Drug Administration (FDA) in 2010, is an incretin mimetic. Incretin mimetic lowers blood sugar even in individuals with type 1 diabetes. The result of obesity and too much sugar in your diet can be that your pancreas stops producing insulin. Liraglutide, generic Victoza, acts as a synthetic glucagon peptide-1 (GLP-1) protein to the cause production of insulin.
Benefits of Incretin Mimetics
The usually conservative Mayo Clinic embraced the incretin mimetics finding them capable of modulating the immune system, replacing insulin, and acting as incretins, your pancreatic hormones. The incretin mimetics control the functions of the pancreas and improve weight loss. Colloquially, incretin mimetics mimic your abdominal hormone incretin and cause insulin to be released when your blood sugar is high. Incretin mimetics type 1 or type 2 diabetes drugs control blood sugar naturally and restore your body's vital functions.
Most patients well tolerate incretin mimetics. Some patients experience mild nausea which improves with continued use. Occasionally patients experience vomiting, loss of appetite, constipation, and lightheadedness. Novo Nordisk, Merck, Eli Lilly, and AstraZeneca subsidiary Amylin Pharmaceuticals, LLC, manufacture:
- Byetta, Bydureon (exenatide)
- Victoza (liraglutide)
- Tanzeum (albiglutide)
Diabetes Medications Lawsuit Timeline
The diabetes medications lawsuit differs from most class action defective product litigation in that the cases have been consolidated into multidistrict litigation across manufacturers and medications. The suits were consolidated because the incretin mimetic medications are mostly the same with the same serious complications.
The multidistrict litigation consolidated 700 federal cases against Novo Nordisk for Victoza, Merck for Januvia and Janumet, and Eli Lilly for Tradjenta alleging that the manufacturers failed to warn doctors and patients of the severe health risks of their products. Product liability consolidation is atypical. Manufacturers are almost always sued separately.
Novo Nordisk successfully defended Victoza stating that the FDA did not let them list pancreatic cancer as a possible side effect of their incretin mimetic product because there was not enough evidence that this was the case. Judge Anthony J. Battaglia dismissed the consolidated cases in the United States District Court for the Southern District of California.
Merck faced 1,260 product liability claims in June 2018 for Januvia and Janumet. Like Victoza, the Januvia claims were consolidated into a federal Januvia lawsuit. The allegations were dismissed by the U.S. District Court for the Southern District of California.
The U.S. Ninth Circuit Court of Appeals reversed the trial court’s ruling regarding all manufacturers' incretin mimetic drugs including Victoza and Januvia. The Ninth Circuit did not address issues raised in the appellate or appellee's briefs, but they decided that the district court made errors during discovery. The Ninth Circuit appellate court reversed and remanded the summary judgment for the manufacturers to the U.S. District Court for the Southern District of California for further investigation or discovery. Briefs for manufacturers and complainants were filed as of December 11, 2018, but stays of the court protect all claims against the manufacturers.
Incretin Mimetics Side Effects
Incretin mimetic medications put some patients at increased risk of pancreatic severe conditions. The incretin mimetics increase the risk of acute pancreatitis, inflammation of the pancreas, and acute pancreatic cancer which is quickly fatal.
In Victoza’s clinical trials submitted to the FDA, one patient died of pancreatitis developed while taking the incretin mimetic. The clinical trials demonstrated aggressive pre-cancerous cells in several patients taking Victoza, but the FDA decided that ongoing investigations into the occurrence of pancreatic cancer were not conclusive.
The benefits of Victoza outweighed the possible unidentified incretin mimetics side effects in less than one percent of the drug trial patients. One or two patients in the clinical trials died of thyroid cancer. Whether Victoza precipitated the thyroid cancer or merely co-occurred with the onset of the cancer was impossible to determine.
Participating in the Diabetes Medications Lawsuit
If you have pancreatic cancer or the death of a loved one who took one of the four medications included in the diabetes drug lawsuit, you may be able to file a defective product personal injury or wrongful death case against the manufacturer. You may be able to recover money lost on high medical bills, lost wages, or loss of what your loved one might have earned until retirement.
The outcome of the litigation is not clear with judicial stays on the lawsuit and multiple appeals. It may be your doctor rather than the manufacturer who erred if you or your loved one took two of the possibly defective drugs concurrently. None of the manufacturers intended that. All of the diabetes drugs produced heightened side effects in individuals predisposed to specific medical conditions. All diabetes drugs interact with steroids and may create undesirable effects in those who consumed large volumes of alcohol or controlled substances in their lifetimes.