Initial Conference Scheduled in MDL for Byetta, Januvia Cancer Lawsuits

Following the centralization of all federal Byetta, Januvia, Janumet and Victoza pancreatic cancer lawsuits into an MDL, or multidistrict litigation, an initial status conference has been scheduled for next month, at which time the organization and structure of the federal proceedings will be discussed.  

Last month, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all product liability lawsuits brought in U.S. District Courts throughout the country on behalf of former users of a popular class of diabetes drug, known as incretin mimetics, who have been diagnosed with pancreatic cancer.

Complaints filed against several different drug makers have all been centralized before U.S. District Judge Anthony J. Battaglia in the Southern District of California for coordinated pretrial proceedings.

Earlier this month, Judge Battaglia issued an Order (PDF) establishing the first status conference in the litigation, scheduling lawyers involved in the lawsuits to meet on October 17.

Concerns About Pancreatic Cancer from Byetta, Januvia, Janumet and Victoza

Over the course of this year, a growing number of Byetta lawsuits, Januvia lawsuits, Janumet lawsuits and Victoza lawsuits have been filed throughout the country on behalf of former users of the diabetes drugs who allege that the drug makers failed to properly research the side effects of the medications or the risk of developing pancreatic cancer.

All of the medications are part of the same class of drugs, known as incretin mimetics, which work by mimicking the incretin hormones that the body usually produces to naturally stimulate the release of insulin in response to 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.

The number of new cases has sharply increased nationwide since March 2013, when 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.

Although the federal regulators released statements in July 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 number of new cases has continued to increase.

At the time the request was filed for centralization of the litigation before one judge as part an MDL, there were approximately 50 Byetta and Januvia cancer lawsuits pending throughout the federal court system. As additional cases are filed in U.S. District Courts nationwide, they will be tranferred to the MDL and some estimates suggest that several hundred, if not thousands, of lawsuits will eventually be filed.

Increatin Mimetic Litigation Status

During the initial status conference scheduled for October 17, it is expected that Judge Battaglia will discuss the appointment of lawyers to serve in various leadership roles in the litigation, to facilitate in communications between the parties and the Court, as well as promoting the effective management of the cases.

Increatin mimetic pancreatic cancer lawyers representing plaintiffs in the litigation have been directed to confer and discuss the selection of a plaintiffs’ steering comittee (PSC) and lead or liaison counsel, who will take certain actions throughout the litigation that benefit all plaintiffs. If an agreement can not be reached regarding the attorneys to serve in these various leadership roles, Judge Battaglia has indicated that a process and timeline will be established at the Status Conference next month.

Each of the defendant drug makers have also been ordered to designate a single law firm and lead counsel to represent that defendant’s interests in the MDL, with each of these lead counsel serving on what will become the defendants’ steering committee.

During the status conference, the Court is also expected to discuss procedural matters, including the designation of certain lawsuits to serve as “bellwether” cases, which would be set for early trial dates to help focus the case for dispositive motions and trial.

In complex pharmaceutical litigation, a series of bellwether trials are often scheduled to provide a gauge on how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. The preparation for these trials and any outcomes may facilitate potential pancreatic cancer settlements with the makers of Byetta, Januvia, Janumet and Victoza.