Attorneys involved in the federal incretin mimetic diabetes drug litigation are scheduled to make presentations this week as part of two “Science Days”, which are designed to educate the judge presiding over the cases about the potential link between pancreatic cancer and Januvia, Janumet, Byetta and Victoza.
During the early stages of the litigation, U.S. District Judge Anthony J. Battaglia has scheduled “Science Days” for February 5 and 6, at which time both plaintiffs and defendants will present background information to the Court about type 2 diabetes, the science behind the various diabetes drugs that are part of a class of medications known as incretin mimetics, and information about the development of pancreatic cancer.
Judge Battaglia is currently presiding over more than 262 Januvia lawsuits, Janumet lawsuits, Byetta lawsuits and Victoza lawsuits filed in U.S. District Courts throughout the country by former users of the diabetes drugs who allege that they developed pancreatic cancer due to side effects of the medications.
The federal cases are centralized before Judge Battaglia in the Southern District of California as part of an MDL, or Multidistrict Litigation, since all of the complaints involve similar allegations that the makers of the popular diabetes drugs failed to adequately warn consumers and the medical community about the risk of pancreatic cancer from Byetta, Januvia, Janumet and Victoza.
Los Angeles County Superior Court Judge William F. Highberger, who is presiding over a number of similar cases filed in California state court, is also expected to participate in the Science Days.
Byetta, Januvia Pancreatic Cancer Science Days
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.
In November 2013, Judge Battaglia scheduled the Science Days for the Januvia and Byetta litigation, indicating that the presentations will be “to apprise the Court, in a non-adversarial manner, of the following issues: (a) the nature of Type 2 Diabetes; (b) pharmacological issues, i.e. the role of Incretin-based therapies in treating Type 2 Diabetes; (c) pancreatic cancer and associated mortality and morbity rates; and (d) data regarding the effects of the Incretin-based therapies on the pancreas.”
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 and it may not be used to impeach any future testimony at trial.
Incretin Mimetic Litigation Status
Byetta (exenatide) was the first member of the incretin mimetic class of diabetes drugs, which was 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, the pancreatic cancer litigation over the drugs has emerged following several studies that raised concerns about the impact the medications may have on the pancreas.
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 late last year 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.
In addition to pancreatic cancer cases, there are currently at least 35 Byetta thyroid cancer lawsuits being pursued in the federal court system, which are not currently part of the MDL. However, a motion was filed last month with the U.S. Judicial Panel on Multidistrict Litigation (JPML), asking that these cases also be centralized before Judge Battaglia to reduce duplicative discovery into common issues, to avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.