The U.S. Judicial Panel on Multidistrict Litigation (JPML) has agreed to consolidate all Byetta, Januvia, Janumet and Victoza cancer lawsuits, centralizing the litigation as part of an MDL, or Multidistrict Litigation. The JPML issued a Transfer Order on August 26, and these product liability cases involve pancreatic cancer after the use of Byetta, Januvia, Janumet or Victoza as part of the “Incretin Mimetics Product Liability Litigation.”
The product liability cases will be centralized before U.S. District Judge Battaglia in the Southern District of California for coordinated handling during pretrial proceedings. The consolidation is beneficial for all parties in complex pharmaceutical litigation, to reduce repetative discovery and to prevent conflicting rulings from different federal judges.
What are Incretin Mimetics?
Byetta, Januvia, Janumet and Victoza belong to a class of newer diabetic drugs, called incretin mimetics. According to some experts, the side effects of these incretin mimetics have been associated with an increased risk of chronic pancreatitis. Chronic pancreatitis is a known risk factor for the development of pancreatic cancer.
Byetta (exenatide) was approved by the FDA in 2005, and is manufactured by Amylin Pharmaceuticals as a twice daily injection. Januvia (sitagliptin) was approved by the FDA in 2006 and and is manufactured by Merck as an oral medication, and as a combination pill containing Januvia and another diabetic medication metformin, under the brand name Janumet.
Victoza (liraglutide) was approved by the FDA in 2010, and manufactured by Novo Nordisk as a daily injection. Onglyza (saxagliptin) was approved by the FDA in 2009 and is manufactured by Bristol-Myers Squibb and AstraZeneca. Tradjenta (linagliptin) is manufactured by Eli Lilly and Boehringer Ingelheim and approved for sale in 2011.
Incretin Mimetics have blockbuster drug status for treatment of type 2 diabetes, generating billions in annual sales. Merck’s Januvia and Janumet, has over $4 billion in sales last year. Novo Nordisk’s Victoza sales were about $1.8 billion and Amylin Pharmaceuticals’ Byetta earned a reported $149 million last year.
Byetta, Januvia Pancreatic Cancer Allegations
Injured patients allege that the manufacturers of the drugs failed to adequately research the side effects of their products or properly warn consumers and the doctors about the risk of developing pancreatic cancer.
JPML Consolidated all 4 Drugs
According to the JPML, centralization as part of a single MDL was appropriate, for all of the 4 implicated drugs. “Plaintiffs in the cases now before us, however, make highly similar allegations about each of the four drugs that manage blood insulin levels and the propensity of those drugs to cause pancreatic cancer. Several plaintiffs took more than one of the drugs at issue, which suggests that discovery specific to the plaintiffs in those cases will involve many of the same or substantially similar documents and witnesses.”
FDA and EMA Investigations
In March 2013, the FDA and European drug regulators initiated investigations into the potential risk of pancreatic cancer from incretin mimetics after a study found evidence of precancerous cells in the pancreas of these patients. Recently, however the FDA and EMA released statements that their investigation has found no evidence of a connection between pancreatic cancer and use of incretin mimetics. According to the FDA, there is no scientific evidence to confirm that a group of type 2 diabetes drugs called GLP-1 inhibitors is linked to pancreatic cancer. The FDA decision comes on the heels of the European Medicines Agency, which stated that they have been unable to confirm an increased risk of pancreatic cancer linked to side effects of Byetta, Januvia, Janumet, Victoza and other incretin mimetic drugs.