MDL Motion Filed for Lawsuits Over Januvia, Janumet, Byetta, Victoza

A motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all pancreatic cancer lawsuits filed by former users of Januvia, Janumet, Byetta and Victoza, which are all part of a class of diabetes drugs known as incretin mimetics.

At least 53 product liability lawsuits have been filed in 7 different U.S. District Courts alleging that side effects of Januvia, Janumet, Byetta and/or Victoza caused former users of the drugs to develop pancreatic cancer.

The medications are part of a class of diabetes drugs that work the same way, mimicking the incretin hormones that are normally stimulated to release insulin following a meal. However, concerns have emerged about the risk of pancreatic cancer following Byetta, Januvia, Janumet or Victoza use. The medications have been linked to a risk of chronic pancreatitis, which may ultimately cause users to develop pancreatic cancer.

Last month, 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.

In a Motion for Transfer (PDF) filed on April 5, a group of Plaintiffs have requested that all cases involving a diagnosis of pancreatic cancer after use of Byetta, Januvia, Janumet or Victoza be centralized before U.S. District Judge Anthony Battaglia in the Southern District of California for coordinated proceedings as part of a single MDL, or multidistrict litigation.

Request to Include All Incretin Mimetics in MDL

In complex pharmaceutical litigation where a large number of lawsuits are filed alleging similar injuries associated with the use of a prescription medication, it is common for the cases to be centralized for pretrial proceedings before one judge. Such consolidation 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.

Plaintiffs have requested that one single MDL be created for all Byetta lawsuits, Januvia lawsuits, Janumet lawsuits and Victoza lawsuits, rather than asking for four separate MDLs to be established.

According to the Motion for Transfer, there are sufficient overlapping common issues of fact and law to justify combining the cases before one judge. Plaintiffs argue that creating one incretin mimetics MDL will help avoid the risk over inconsistent rulings, overlapping discovery and judicial inefficiency, since many of the cases involve the use of more than one of the drugs. At least 20 of the 53 identified lawsuits involve combinations of different drugs prior to the pancreas cancer diagnosis.

Incretin mimetics are a relatively new class of diabetes drug. 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, with Janumet sales reaching over $1.3 billion in 2011 and Januvia sales hitting $919 million during the first quarter of 2012 alone. Byetta sales were reported at $710 million in 2010 and were expected to reach $1 billion by 2015. Likewise, Victoza sales were about $1 billion in 2011, and reached $748 million during the first half of 2012.

According to allegations raised in the lawsuits, concerns about the link between pancreatic cancer and the diabetes drugs has been known by the manufacturers for years, yet plaintiffs claim that the drug makers failed to provide adequate warnings to physicians or the medical community.

“Defendants’ zeal for blindly manufacturing, marketing and promoting the Incretins, putting corporate profit over patient safety, has left a horrific trail of pancreatic cancer, and often, resulted in the excruciating death of those who ingested these deadly drugs,” according to the Motion for Transfer filed by Plaintiffs Moses Scott and Rosalie Duhon. “Plaintiffs seek to consolidate the [lawsuits] to assist in holding the Defendants accountable for their bad acts and to promote the efficient prosecution and resolution of claims.”

The motion predicts that hundreds or thousands of similar pancreatic cancer cases will be filed by users of Januvia, Janumet, Byetta and Victoza, warranting consolidated handling of the cases during pretrial proceedings.

The U.S. JPML is expected to schedule oral arguments on the motion at an upcoming hearing session on either May 30 in Louisville, Kentucky or on July 25 in Portland, Maine.