Byetta, Januvia Lawyers Meet with MDL Judge

Attorneys involved in the litigation over pancreatic cancer from Januvia, Byetta and other incretin mimetic diabetes drugs are scheduled to meet today with the U.S. District Judge presiding over all cases pending in the federal court system, to review the status of the consolidated pretrial proceedings.

In August 2013, the U.S. Judicial Panel on Multidistrict Litigation centralized all Byetta lawsuitsJanuvia lawsuitsJanumet lawsuits, and Victoza lawsuits filed in U.S. District courts nationwide in the Southern District of California for coordinated discovery and litigation.

There are currently at least 262 cases pending before U.S. District Judge Anthony J. Battaglia, which all involve similar allegations that plaintiffs developed pancreatic cancer after using the diabetes drugs, which are all part of a class of medications known as incretin mimetics. As Byetta and Januvia lawyers continue to review and file new claims, it is ultimately expected that more than a thousand cases will be part of the federal incretin mimetics MDL.

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According to a joint proposed agenda filed in advance of a status conference set for today, the attorneys are expected to review with the Court the status of a Case Management Order that will address the filing of additional cases and service of complaints brought directly in the MDL, which can be filed through a short form complaint approved last month.

The parties have been meeting to discuss an overall schedule for the Byetta and Januvia litigation, including a schedule for preparing a group of “bellwether” cases for early trial dates, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout the litigation. The lawyers for both sides indicate that they plan to reach an agreement on a schedule by February 10, or they will advise the Court of their respective positions.

A science day in the Byetta and Januvia litigation is scheduled in the MDL for February 5 and 6, at which time the parties will make presentations to Judge Battaglia about the issues involved in the link between pancreatic cancer and the diabetes drugs.

Januvia, Janumet, Byetta, Victoza Pancreatic Cancer Concerns

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. A number of studies have linked the medications to an increased risk of pancreatitis, which plaintiffs argue resulted in the development pancreatic cancer in many cases. However, the science over the increased risk of pancreatic cancer from Januvia, Byetta and related drugs has been heavily debated.

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.

Most of the pancreatic cancer lawsuits filed against the makers of Byetta, Januvia, Janumet and Victoza 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 indicated that available evidence does not establish a correlation between the drugs and an increased pancreatic cancer risk.

A series of “bellwether” trials are expected to be held in the incretin mimetic litigation, which could help promote a possible pancreatic cancer settlement agreement or other resolution for the cases.

Many of the drug makers faced prior litigation over the failure to warn about the risk of pancreatitis. While many of those cases have settled, the joint agenda submitted for today’s status conference in the pancreatic cancer litigation indicates that a pancreatitis trial is set to begin in California state court on February 18, 2014.


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