Illinois Appeals Court Denies Merck’s Motion to Dismiss Januvia Pancreatic Cancer Lawsuit

Published on January 3, 2019 by Sandy Liebhard

An Illinois appeals court has denied Merck & Co.’s motion to dismiss a lawsuit involving Januvia and pancreatic cancer.

According to HarrisMartin.com, the lawsuit was filed in Cook County Circuit Court by the survivors of four Januvia patients who died from disease.

Among other things, the plaintiffs claim that Merck knew of the alleged link between Januvia  and pancreatic cancer when their loved ones used the medication . Yet the company failed to include any warnings about this potential side effect on the drug’s label.

Merck Argued Januvia Lawsuit Was Preempted by Federal Law

Merck had filed a motion for summary judgment, arguing that the plaintiffs’ failure-to-warn claims were preempted by federal law. In doing so, the company asserted that there was “clear evidence” that the U.S. Food & Drug Administration (FDA) would have rejected a pancreatic cancer warning when Januvia was approved.

Merck’s argument was based on the U.S. Supreme Court’s decision in Wyeth vs Levine. That ruling bars plaintiffs from pursuing state failure-to-warn claims when clear evidence shows the agency would have prohibited a label warning for the injuries or side effects alleged in a lawsuit.

The trial court denied Merck’s Motion for summary judgement. However, it asked the Illinois Appellate Court, 1st District, to determine if the company had proven that the FDA would have rejected a cancer warning.

In an Opinion issued on December 26^th, the appellate court ruled that a jury should decide the matter.

“Doing so requires the decision-maker — who, whether judge or jury, normally has no expertise in the substantive subject matter — to discern from the totality of evidence presented by the parties whether it is clear what the FDA’s substantive action would have been in the first instance,” the Opinion states. “The substance of the FDA’s decision is what matters, not the FDA’s compliance with the law in reaching that decision. Thus, we perceive these inquiries to be different and believe that the Wyeth inquiry presents a question for the jury in this case.”

Januvia and Pancreatic Cancer

The FDA approved Januvia in 2006. It belongs to a class of Type 2 diabetes drugs called incretin mimetics, which affect the action of incretin hormones in the gut. Other incretin mimetic diabetes medications include Byetta, Victoza, and Onglyza, among others.

Incretin hormones stimulate the pancreas to release insulin in response to a meal.

Januvia blocks the action of dipeptidyl peptidase IV (DPP-IV), an enzyme that normally breaks down an incretin hormone called glucagon-like peptide-1 (GLP-1). Onglyza is also a DPP-IV inhibitor.

GLP-1 agonists, including Byetta and Victoza, actually mimic that action of GLP-1.

Pancreatic cancer lawsuits involving Januvia and other incretin mimetics began to mount in 2013. That year, the medical journals JAMA Internal Medicine and Diabetes published studies suggesting the drugs might increase risks for  pancreatitis and pancreatic cancer.

That same year, the FDA warned that incretin mimetic diabetes drugs might cause pancreatitis, as well as pre-cancerous changes to pancreatic tissue.

Although research published in 2016 contradicted earlier findings, doctors were advised to continue monitoring incretin mimetics patients for signs of pancreatic cancer.

1,200+ Pancreatic Cancer Lawsuits Involving Januvia, Similar Diabetes Drugs

Federally-filed diabetes drug lawsuits involving Januvia, Victoza, and Byetta were eventually centralized in the U.S. District Court, Southern District of California.  In November 2015, however, the judge overseeing the consolidated proceeding dismissed all claims, finding that they were preempted by federal law.

Fortunately for plaintiffs, the U S. Court of Appeals for the 9^th Circuit reversed that decision in December 2017.

The federal litigation now includes more than 900 lawsuits involving Januvia, Victoza, and Byetta. An additional 300 Byetta pancreatic cancer lawsuits are pending in a centralized proceeding underway Los Angeles Superior Court.