2014 may be a watershed year for federal lawsuits related to Januvia, a type 2 diabetes treatment manufactured by the drug giant Merck. Legal action has been consolidated into multidistrict litigation, known as an MDL, claiming that the company is liable for a defective product. The action is centered in Southern California, and has been spurred on by study published in the Journal of the American Medical Association associating Januvia exposure to pancreatitis. The federal judge gathered the case into an MDL because of widespread charges that Januvia may cause pancreatic cancer.
Judge Anthony Battaglia, the presiding judge, will decide about 157 lawsuits related to a 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 now, Merck has not said anything publicly about aiming to settle with the plaintiffs.
An example of the lawsuits is one filed by a woman from Connecticut naming Merck as a defendant. She claims that she has been diagnosed with pancreatic cancer due to taking Januvia for no less than two years, implying an extreme danger 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."
Additionally, to add insult to injury to the giant drug maker, the suit also argues that Merck had wilfully "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."
Merck lists substantial warnings related to Januvia on the drug's website. Among these are:
"... pancreatitis, which may be severe and lead to death."
"Do not take JANUVIA if you are allergic to any of its ingredients, including sitagliptin. Symptoms of serious allergic reactions to JANUVIA, including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, can occur."
"Kidney problems, sometimes requiring dialysis, have been reported."
However, the warning perhaps the most important for the litigation related to the drug is:
"If you take JANUVIA with another medicine that can cause low blood sugar (hypoglycemia), such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you use JANUVIA. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heart beat, sweating, and feeling jittery."
The FDA, or the Food and Drug Administration, has been active in its investigation into Januvia. Last year it announced that, while unable to conclusively prove a link to cancer, the FDA would relook at certain medications after alternative research suggested that the incretin mimetic drugs like Merck's could cause hazardous mutations in the cells of the pancreas.
Other but related drugs being reviewed by the federal agency include (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto).