Master Complaint Approved for Byetta, Victoza, Januvia Lawsuits

In the consolidated federal litigation for all pancreatic cancer lawsuits stemming from the use of the diabetes drugs Byetta, Januvia, Janumet and Victoza, a master complaint and short form complaint have been approved for use in all future claims brought in the federal court system on behalf of individuals nationwide.

In August, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established centralized proceedings before U.S. District Court Judge Anthony J. Battaglia for all Byetta lawsuits, Januvia lawsuits, Janumet lawsuits, and Victoza lawsuits filed in U.S. District Courts nationwide, which all involve individuals who allege they developed pancreatic cancer from side effects of the popular diabetes drugs.

For coordinated pretrial proceedings, the cases have been centralized in the Southern District of California as part of an MDL, or Multidistrict Litigation, which is designed to stream line the cases, reduce duplicative discovery, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

On December 2, Judge Battaglia issued an Order (PDF) approving the use of a master complaint and short form complaints to standardize the process of filing lawsuits against the makers of the four diabetes drugs, which are all part of a class of medications known as “incretin mimetics”.

The master complaint (PDF) outlines the common allegations raised in all of the complaints, claiming that the drug makers failed to adequately research the medications or provide proper warnings to consumers and the medical community about the risk of pancreatic cancer from Januvia, Janumet, Byetta and Victoza.

Following adoption of the master complaint, plaintiffs are now able to utilize a short form complaint (PDF) to bring future lawsuits, outlining the specific allegations of that plaintiff’s claim, indicating which portions of the master complaint they are adopting, which medications were used and information about their pancreatic cancer diagnosis or other alleged injury.

There are currently only about 150 cases pending before Judge Battaglia. However, as incretin mimetic lawyers continue to review and file additional cases for individuals diagnosed with pancreatic cancer, it is ultimately expected that there will be hundreds, or even thousands, of lawsuits added to the MDL.

Pancreatic Cancer Concerns with Januvia, Janumet, Byetta, Victoza

Incretin mimetics are used to treat type 2 diabetes, working by mimicking the incretin hormones the body usually produces to naturally stimulate the release of insulin in response to a meal.

Byetta (exenatide) was the first member of the incretin mimetic 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 impact the medications have on the pancreas and whether users may face an increased risk of pancreatic cancer following long-term use of the diabetes drugs.

In February, researchers from Johns Hopkins in Baltimore found that taking Januvia or Byetta may double the risk of hospitalization due to pancreatitis, which raised concerns about whether this may also suggest an increased risk of pancreatic cancer.

In March, the risk of pancreatic cancer from Januvia, Byetta and other incretin mimetics gained additional attention after another study published in the medical journal Diabetes found that pancreas tissue from organ donars found that those who took an incretin mimetic were more likely to have increased pancreatic mass and precancerous cells, which are cells with the potential to evolve into tumors.

Most recently, a study was published last month by Italian researchers who indicated that a review of 1,169 adverse drug reaction reports identified at least 90 cases of users of incretin mimetics suffering from pancreatitis and elevated pancreatic enzymes. Acute or chronic pancreatitis can lead to the development of pancreatic cancer.

Incretin Mimetic Litigation

Given the complex medical and scientific issues in the litigation, Judge Battaglia has scheduled a Science Day for February 2014, at which time plaintiffs and defendants will both have an opportunity to educate the court on the issues surrounding the medication.

As part of the coordinated pretrial proceedings in the MDL, it is expected that a small number of cases will be selected for early trial dates. Known as “bellwether” cases, this process is designed to help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout a large number of cases. Judge Battaglia has ordered the parties to submit a Joint Motion by January 10, 2014, which is to detail how Bellwether trials should be used in the MDL and proposed deadlines for various motions.

Unfortunately, given the low survival rate associated with pancreatic cancer, many plaintiffs may not live long enough to reach the end of their case, and it is expected that many of the complaints filed will become Byetta wrongful death lawsuits and Januvia wrongful death lawsuits. To address this mounting issue, Judge Battaglia has established a process that provides plaintiffs with the ability to preserve their testimony as they approach end of life.

As the first trial dates approach, it is likely that Judge Battaglia will push the parties to consider potential settlement agreements that may resolve the lawsuits without the need for hundreds of individual trials to be scheduled nationwide.