Januvia Lawsuit Consolidation Being Considered

januvia_lawsuitsJanuvia injury lawsuits alleging serious illnesses such as pancreatitis and pancreatic and thyroid cancer, are on the rise across the United States.

In a class known as incretin mimetics, Januvia has been named in 53 lawsuits that have been filed in federal court. Januvia is a drug used in the treatment of Type 2 diabetes.

Incretin mimetics include Byetta and Bydureon (exenatide); Victoza (liraglutide); Januvia, Janumet, Janumet XR, and Juvisync (sitagliptin); Onglyza and Kombiglyze XR (saxagliptin); Nesina, Kazano, and Oseni (alogliptin); and Tradjenta and Jentadueto (linagliptin). Incretin mimetics include natural substances that lower raised blood sugar levels. The drugs are used in patients diagnosed with abnormally low insulin levels or patients whose bodies do not utilize insulin efficiently. These drugs imitate the body’s incretin hormones, which stimulate the release of insulin after meal consumption.

The United States Judicial Panel on Multidistrict Litigation on will be discussing these Januvia lawsuits on July 25th. The Panel will specifically discuss whether or not to transfer the Januvia cases to a multidistrict litigation (MDL) in one federal court for pre-trial proceedings.

An MDL enables lawsuits associated with one particular product, such as the incretin mimetic, Januvia, to be coordinated under one judge for pre-trial litigation. The MDL process helps to avoid duplicative discovery and inconsistent rulings and also conserves the resources of the involved parties, witnesses, and the court. When consolidated as an MDL, each lawsuit retains its own identity. Should the MDL process does not resolve the cases, they are transferred back to the court in which they originated.

The Januvia cases involve allegations that the makers of this incretin mimetic failed to provide sufficient warnings about Januvia’s connection with increased risks for serious adverse health reactions such as pancreatic and thyroid cancer and pancreatitis. Pancreatitis is painful, potentially fatal, a known risk factor for pancreatic cancer, and linked to kidney failure.

Other serious side effects associated with incretin mimetics, such as Januvia, include low blood sugar; anaphylaxis and other allergic reactions, such as hives, rash, swelling of the face, lips, tongue, and/or throat; diseases of the pancreas such as acute, necrotizing, or hemorrhagic pancreatitis; vomiting and nausea; anorexia; persistent, severe abdominal pain, sometimes radiating to the back; and death.

A recently published piece in the journal BMJ, revealed that drugs such as Januvia might be riskier than first thought. The report also indicated that drug makers have withheld data on the potentially dangerous effects of incretin mimetics.

After analyzing thousands of pages of regulatory documents it obtained under Freedom of Information rules, BMJ located unpublished data that indicated “unwanted proliferative or inflammatory pancreatic effects,” associated with use of Januvia and other incretin mimetics.” On their own, the individual pieces of unpublished evidence may seem inconclusive, but when considered alongside other emerging and long-standing evidence, a worrying picture emerges, posing serious questions about the safety of this class of drug,” wrote Deborah Cohen, Investigative Editor for BMJ. Cohen noted that drug makers have not conducted critical safety studies and regulators have never requested these studies, according to MedPage Today. She also noted that access has been denied to the raw data that would have shed light on the safety of incretin mimetics.

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