The popular prescription drugs Januvia and Janumet are oral medications commonly used to treat patients with type-2 diabetes. However, increasing reports of dangerous side effects and complications from the drug have raised questions about whether the medications’ risks outweigh their benefits for patients. Claims of dangerous side effects include pancreatitis (inflammation of the pancreas) and pancreatic cancer, one of the most deadly and aggressive forms of cancer.
California Judge Merges Widespread Lawsuits into MDL
Many of the patients who’ve experienced these side effects have filed personal injury lawsuits against the drugs’ manufacturer, Merck. Merck is responsible for manufacturing and distributing Januvia and Janumet. As of early 2014, legal actions have been consolidated into multidistrict litigation (MDL) claiming that Merck is financially responsible for a dangerous and defective product. The MDL is centered in Southern California, and was formed in part due to a study published in the Journal of the American Medical Association linking Januvia exposure to pancreatitis.
Judge Anthony Battaglia, the presiding judge, is set to decide as many as 157 civil claims related to the class of drugs known as incretin mimetics, which includes Januvia. The California MDL is titled:
“In Re: Incretins Products Liability, Sales and Marketing Litigation, MDL 2452.”
As of mid-January, Merck has declined to issue any public statements regarding the claims or any intent on settling with the plaintiffs. As the weeks progress, additional lawsuit filings are anticipated in California and other state courts. New Jersey may also emerge as a second epicenter for case filing since it is the location of Merck’s US headquarters.
Personal Injury Suits Include Claims of Pancreatic Cancer
One of several lawsuits filed against Merck involving a catastrophic diagnosis was filed by a woman from Connecticut. In her suit, the woman claims she has been diagnosed with pancreatic cancer as a result of taking Januvia for only two years, alleging an extreme and direct health risk for patients taking the drug. She also claims to have suffered horrible physical, financial and emotional injuries since taking the drug.
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 U.S. Food and Drug Administration (FDA) approved Januvia and Janumet in 2006. Since approving the drugs, the FDA has issued multiple warnings about known links between Januvia and serious complications like pancreatic diseases. However Januvia and Janumet remain on the market and have not been recalled.
The FDA is conducting an active investigation into Januvia. In 2013, it announced that, while unable to conclusively prove a direct link to pancreatic cancer, the FDA would re-evaluate certain medications after alternative research suggested that the incretin mimetic drugs like Merck’s could cause harmful mutations in the cells of the pancreas.
Other drugs related to the MDL which have been linked to similar pancreatic diseases and subsequent lawsuits are also being reviewed by the FDA. This list of drugs includes:
- Byetta (Bydureon)
- Liraglutide (Victoza)
- Sitagliptin (Januvia, Janumet, Janumet XR, Juvisync)
- Saxagliptin (Onglyza, Kombiglyze XR)
- Alogliptin (Nesina, Kazano, Oseni)
- Linagliptin (Tradjenta, Jentadueto)
