Panel to Consider MDL for More than 50 Lawsuits Over Januvia, Byetta

The U.S. Judicial Panel on Multidistrict Litigation is scheduled to hear oral arguments on July 25 to determine whether more than 50 Byetta lawsuits, Januvia lawsuits, Janumet lawsuits and Victoza lawsuits filed in U.S. District Courts throughout the country should be centralized before one judge for coordinated pre-trial proceedings.

In April, a group of plaintiffs filed a motion to centralize all pancreatic cancer lawsuits filed by users of incretin mimetic diabetes drugs, asking that the cases involving the use of Byetta, Januvia, Janumet or Victoza be transferred into an MDL, or multidistrict litigation, for coordinated management during pretrial proceedings.

According to a scheduling order (PDF) issued last week, there are currently 53 product liability lawsuits filed in seven different U.S. District Courts involving plaintiffs who claim that they developed pancreatic cancer after using one of the drugs. However, the size of the litigation is expected to continue to increase over the coming months as pancreatic cancer lawyers continue to review and file cases, with estimates suggesting that hundreds, if not thousands of cases may ultimately be filed.

Pancreatic Cancer Concerns with Byetta, Januvia, Janumet and Victoza

Byetta, Januvia, Janumet and Victoza all work in a similar way, mimicking the incretin hormones that are normally stimulated to release insulin following a meal.

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.

Over the past year, concerns have emerged about the risk of pancreatic cancer following Januvia, Janumet, Victoza or Byetta use. Side effects of the diabetes drugs have previously been linked to a risk of pancreatitis, and several studies have suggested that this may cause some users to subsequently develop pancreatic cancer.

In March, the FDA launched an investigation into the potential pancreatic cancer risk associated with incretin mimetics. The safety review was initiated after results of a recent study identified pre-cancerous cellular changes in pancreatic tissue taken from individuals treated with one of the drugs. European health officials have also launched a similar review.

Incretin Mimetic Litigation

The U.S. Judicial Panel on Multidistrict Litigation will be considering whether to establish one centralized proceeding for all lawsuits over any of the four diabetes drugs.

The manufacturers of the drugs have all filed responses indicating that they consent to the consolidation of all of the cases before one judge as part of a single MDL, as many of the lawsuits involve plaintiffs who used more than one of the medications.

Oral arguments will be heard by the U.S JPML on July 25 at the Edward T. Gignoux Federal Courthouse in Portland, Maine, after which the panel will decide whether to grant the request and determine the most appropriate venue to transfer the litigation.

All of the cases involve similar allegations that the drug makers knew or should have known about the risk of pancreatic cancer and failed to adequately warn users or the medical community. Plaintiffs claim that if they had known about the potential side effects they may have elected to use other diabetes treatments or to carefully monitor for any changes to their pancreas during treatment with Byetta, Januvia, Janumet or Victoza.

Consolidating the cases as part of an MDL is designed to reduce duplicative discovery among a large number of cases, avoid conflicting rulings from different judges and to serve the convenience of the witnesses, parties and the courts. If a settlement or other resolution for the litigation is not reached following pretrial proceedings any any bellwether trials held in the MDL, each case may ultimately be remanded back to the U.S. District Court where it was originally filed for a separate trial.