By Barbara Anderman  |  September 4, 2014

Category: Legal News

Januvia Diabetes LawsuitIn August 2013, 53 Januvia, Byetta, Victoza and Janumet lawsuits in Southern California were brought together into a multidistrict litigation (MDL) against Januvia and other diabetes drug manufacturers, alleging that the drugs caused pancreatic cancer.

Traditionally, the U.S. Judicial Panel on Multidistrict Litigation is hesitant to centralize litigation against multiple defendants, but the plaintiffs’ claims were similar regardless of which company’s drug they took.

The alleged Januvia pancreatic cancer victims have put forward a motion to require discovery of further “adverse event” information regarding the link between their drugs and pancreatic cancer. Last week, the manufacturers took to California federal court to fight it.

Plaintiffs believe that the documents related to pancreatic cancer events can shift the Januvia lawsuit’s tide. The drug manufacturers in the MDL include Eli Lilly and Amylin Pharmaceuticals, producers and sellers of Byetta; Novo Nordisk, Victoza maker; and Merck Sharp & Dohme Corp., manufacturer of Januvia and Janumet.

All are calling the request an “unnecessary burdensome fishing expedition,” and are asking the court not to force them to produce the documentation. The defendants say, pertaining to the diabetes drugs they produce, that “adverse event reports themselves cannot establish general causation and are irrelevant to preemption, the source files are even less meaningful.”

Plaintiffs allege the class of diabetes drugs that Januvia belongs to caused them or their loved ones to develop pancreatic cancer. The drugs have been under scrutiny since initial research showed cancer risks.

In early 2013, academic scientists proposed that incretin-influencing drugs could enhance chances of pancreatitis and cause precancerous changes in the pancreas.

Meant to help lower blood sugar in people with type-2 diabetes, incretin mimetics work by supplementing the body’s natural incretin hormones to stimulate the insulin releases that occur after eating.

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) looked into the drugs post-study, but to date have found no causal link between incretin mimetics and pancreatic issues. However, a 2013 study showed a much higher chance of developing pancreatic cancer in patients who had taken incretin drugs compared to those who took other drugs.

The Januvia MDL is In re: Incretin-Based Therapies Products Liability Litigation, Case No. 3:13-md-02452, in the U.S. District Court for the Southern District of California.

Diabetes Control with Incretin Mimetics

Diabetes sufferers around the world depend on medications like Januvia and Byetta to help control their diabetic symptoms. Managing high blood sugar can help prevent kidney damage, blindness, nerve problems, and loss of limbs. Proper control of diabetes may also lessen the risk of a heart attack or stroke.

The newest of the incretin drugs specified for type-2 diabetes treatment are dipeptidyl peptidase-4 (DPP-4) inhibitors, also known as incretin mimetics. These drugs work by signaling incretins to produce insulin when needed. In so doing, Januvia, Victoza and other DPP-4 inhibitors help maintain or lower blood-sugar levels, thereby averting diabetic attacks.

Byetta was approved by the FDA in 2005, and Januvia in 2006 to treat type-2 diabetes symptoms, but the question has arisen as to whether the Januvia side effects outweigh the benefits. The drugs’ recent connection with pancreatic cancer has gotten the attention of diabetes sufferers, their physicians and the public.

In general, Januvia, Byetta, and Victoza lawsuits are filed individually by each plaintiff and are not class actions.

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