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The U.S. Judicial Panel on Multidistrict Litigation (JPML) has decided to consolidate all Byetta lawsuits, Januvia lawsuits, Janumet lawsuits and Victoza lawsuits filed throughout the federal court system involving allegations that the popular diabetes drugs caused users to develop pancreatic cancer, centralizing the litigation before one judge as part of an MDL, or Multidistrict Litigation.
Following oral arguments last month, a Transfer Order (PDF) was issued on August 26, designating all cases filed in U.S. District Courts nationwide involving pancreatic cancer following use of Byetta, Januvia, Janumet or Victoza as part of the “Incretin Mimetics Product Liability Litigation.”
The cases will be centralized before U.S. District Judge Anthony J. Battaglia in the Southern District of California for coordinated handling during pretrial proceedings to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.
Byetta, Januvia, Janumet and Victoza belong to the same class of diabetes drugs, known as incretin mimetics. Side effects of the medications have been linked to an increased risk of chronic pancreatitis, which several recent studies have suggested may cause some users to develop pancreatic cancer.
A growing number of product liability lawsuits have been filed this year by former users of the medications who allege that the manufacturers of the drugs failed to adequately research the side effects of their products or properly warn consumers and the medical community about the potential risk of developing pancreatic cancer.
There are currently at least 53 pancreatic cancer lawsuits involving incretin mimetics pending in seven different districts, with most of the cases are already in the U.S. District Court for the Southern District of California. However, as product liability lawyers continue to review and file additional cases, it is expected that the MDL will ultimately involve hundreds, if not thousands, of lawsuits.
All Parties Wanted Centralization
Centralization of complex pharmaceutical litigation before one judge as part of an MDL is common. However, in recent years, the U.S. JPML has often established separate proceedings for cases involving different manufacturers.
In this case, all of the manufacturers of the diabetes drugs, as well as many plaintiffs, called for the litigation to be centralized as part of one MDL before a single judge, as many individuals have used a combination of the different diabetes medications before developing pancreatic cancer.
Following oral arguments heard on July 25, the U.S. JPML determined that centralization as part of a single MDL was appropriate.
“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,” the panel wrote. “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.”
Byetta (exenatide) was the first member of this class approved by the FDA, introduced by Amylin Pharmaceuticals in 2005 as a twice daily injection. Januvia (sitagliptin) was introduced by Merck the following year as an oral medication, and a combination pill containing Januvia and the older diabetes medication metformin was introduced in 2007 under the brand name Janumet. Victoza (liraglutide) was introduced by Novo Nordisk in 2010 as a daily injection.
The medications are widely used among individuals with type 2 diabetes, generating billions in annual sales. Januvia and Janumet are among the best selling medications for the global pharmaceutical company Merck, generating about $4 billion in sales last year. Victoza sales were about $1.8 billion last year for Novo Nordisk and Byetta earned a reported $149 million for Amylin Pharmaceuticals.
In March 2013, the FDA and European drug regulators launched investigations into the potential risk of pancreatic cancer from incretin mimetics after results of a small, independent study found evidence of precancerous cells in the pancreas of users of the drugs.
Late last month, the federal regulators released statements indicating that their review of all available data has found no evidence of a connection between pancreatic cancer and use of Byetta, Januvia or other incretin mimetics.
The findings seem to be having little, if any, impact on the number of new cases filed, with at least two dozen new complaints brought throughout the federal court system over the past few weeks involving the drugs.