As the litigation involving claims of pancreatic cancer from Byetta, Januvia and similar diabetes drugs continues to move forward in the federal court system, the U.S. District Judge presiding over the cases has scheduled a “science day” to allow both parties to explain to the Court the medical and scientific issues that are likely to come up.
Following a Status Conference held last month, U.S. District Judge Anthony J. Battaglia issued an Order (PDF) on November 25, which indicates that a Science Day will be held on February 5 and 6 2014.
This hearing will allow each side to present information to the court in a non-adversarial manner involving the nature of Type 2 Diabetes, the role of the medications in treating diabetics, data regarding the effects of the medications on the pancreas and information concerning pancreatic cancer, including the associated mortality and morbidity rates.
In August, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated proceedings before Judge Battaglia for all Byetta lawsuits, Januvia lawsuits, Janumet lawsuits, and Victoza lawsuits filed in U.S. District Courts nationwide involving individuals who allege they developed pancreatic cancer from side effects of the popular diabetes drugs, which are all part of a class of medications known as incretin mimetics.
More than 150 cases are currently centralized in the U.S. District Court for the Southern District of California as part of an MDL, or Multidistrict Litigation, which is designed to reduce duplicative discovery, avoid conflicting pretrial rulings from different judges and to serve the convenience of the witnesses, the parties and the courts.
In complex pharmaceutical litigation, where a large number of claims have been brought alleging that individuals suffered similar injuries or medical issues as a result of the side effects of the same medications, it is not uncommon for the Court to schedule such science conferences.
Attorneys assigned to leadership roles for plaintiffs and defendants in the litigation will designate non-expert individuals to present information during the Science Day. These presenters will not be under oath and will not be subject to cross examination. The testimony will be considered “off the record”, and it will not be transcribed or used to impeach any future testimony at trial.
While the drug makers had requested the opportunity to submit briefs in advance of the Science Day, Judge Battaglia declined such written submissions. However, the parties were invited to submit a joint glossary of relevant terms that may be referred to throughout the proceedings.
A joint submission regarding the organization of the Science Day is to be filed by the parties before January 10, 2014.
Incretin Mimetics Pancreatic Cancer Concerns
All of the complaints centralized before Judge Battaglia involve similar allegations that the makers of Byetta, Januvia, Janumet and Victoza failed to adequately research the medications or provide sufficient warnings for users and the medical community about the risk of pancreatic cancer.
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.
Most of the pancreatic cancer lawsuits filed against the drug makers have come since March 2013, when the FDA and European drug regulators announced an investigation into the effect of the medications on the pancreas. The investigation came after the results of a small, independent study found evidence of precancerous cells in the pancreas of users of the drugs. Since that time both agencies have said they found no correlation between the drugs and an increased pancreatic cancer risk.
Side effects of Byetta, Januvia and other increatin mimetics have previously been linked to a risk of acute pancreatitis, which several studies have suggested may develop into pancreatic cancer among some users. The complaints allege that the drug makers ignored information about the link to pancreatic cancer and withheld information about the potential risk.
Byetta, Januvia Litigation Status
As part of the coordinated pretrial proceedings in the incretin mimetics MDL, it is expected that a small number of cases will be prepared 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.
The preparation and outcomes of these early trial dates may facilitate further negotiations to settle the pancreatic cancer lawsuits without the need for hundreds of individual trials to be scheduled.
Given the low survival rate associated with pancreatic cancer, it is expected that many of the cases may become Byetta wrongful death lawsuits or Januvia wrongful death lawsuits as the litigation progresses. Last month, an order was issued in the MDL that allows plaintiffs to schedule early depositions when they are “reasonably near the end of life,” which is designed to preserve their testimony for trial.
It will likely be at least a couple years before the first trial dates are held in the pancreatic cancer litigation over Byetta, Januvia and other incretin mimetics. As Byetta and Januvia lawyers continue to review and file additional cases in the coming months and years, it is ultimately expected that there could be a few thousand lawsuits centralized in the federal litigation.
The next status conference in the MDL is scheduled for January 16, 2014.