Januvia Litigation Busy Year Ahead

Sacramento, CANearing the end of 2013, federal litigation regarding Januvia claims is moving forward in multidistrict litigation (MDL) products liability claims in Southern California, on the heels of a recent study published in the Journal of the American Medical Association linking Januvia with pancreatitis.

Januvia multidistrict litigation

By November 18, 2013, about 157 lawsuits involving the class of drugs known as incretin mimetics, of which the diabetes drug Januvia is a member, had been consolidated into the California MDL (In Re: Incretins Products Liability, Sales and Marketing Litigation, MDL 2452). That number more than doubled - from 60 Januvia, Janumet, Byetta or Victoza cases filed in September.

The MDL in the U.S. District Court for the Southern District of California was approved by a federal judiciary panel due to common allegations that this class of drugs may cause pancreatic cancer.

Judge Anthony Battaglia, who is overseeing the litigation, issued orders last fall to Januvia lawyers that included deadlines regarding dates, which a Master Consolidated Complaint and Master Answer involving the allegations must be filed.

All the plaintiffs in the Januvia lawsuits claim that they and their doctors were not provided with adequate warnings regarding a potential association between the drugs and pancreatitis, life-threatening pancreatic cancer and other dangerous side effects.

FDA reviews Januvia

In 2013, Januvia was also on the FDA’s radar. Last March, the agency announced that, although unable to prove the risk, it would review certain medications after another study showed the incretin mimetic drugs could cause dangerous changes in the cells of the pancreas. Specifically, the drugs to be reviewed are exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto).

Further, an FDA official announced that another study recently published that examined insurance records also found the use of sitagliptin could double the risk of developing acute pancreatitis. Since the study, the Warnings and Precautions section of the drug labels and the patient Medication Guides for incretin mimetics now contain warnings about the risk of acute pancreatitis.

Januvia lawsuit filed

One lawsuit filed by a Connecticut woman against Merck Sharp & Dohme Corp. has brought a number of allegations on behalf of herself and other Januvia consumers. The woman claims she has been diagnosed with pancreatic cancer as a result of taking Januvia for less than two years (around July 2009 until January 2011). According to court documents, she has suffered severe physical, economic and emotional injuries as a result of using Januvia.

Her lawsuit alleges that “As a result of the defective nature of Januvia, persons who were prescribed and ingested Janumet, which contains Januvia, for even a brief period of time, including Plaintiff herein, were at increased risk for developing life-threatening pancreatic cancer…Once that cancer spreads, a patient stands just a 1.8 percent chance of surviving for longer than five years.”

The lawsuit further claims that Merck “concealed their knowledge that Janumet, can cause life threatening pancreatic cancer from Plaintiff, other consumers, the general public, and the medical community. Indeed, the manufacturers of Januvia and Janumet do not even mention pancreatic cancer in their drug's respective product inserts.”

To date, Januvia defendant Merck has not brought any public settlement offers. However, now that the MDL is moving forward, the coming year may see Januvia settlements.