Amylin, Eli Lilly Support Centralization of Byetta Pancreatic Cancer Lawsuits

In response to a request filed last month by a group of plaintiffs asking to consolidate all Byetta lawsuits, Januvia lawsuits, Janumet lawsuits and Victoza lawsuits filed in the federal court system by individuals who allege they developed pancreatic cancer, Amylin Pharmaceuticals and Eli Lilly have indicated that they agree that complaints involving the various different diabetes drugs should be centralized as part of a single MDL, or Multidistrict Litigation.

Amylin and Eli Lilly jointly sold Byetta, which is a member of a relatively new class of diabetes drugs known as incretin mimetics that also includes the blockbuster medications Januvia, Janumet and Victoza.

In recent months, a mounting number of lawsuits have been filed alleging that side effects of Byetta and other increatin mimetic diabetes drugs increase the risk of pancreatic cancer. At least 53 complaints have already been filed in U.S. District Courts throughout the country alleging that plaintiffs developed pancreatic cancer after using one or more of the popular medications.

Diabetes Drug Pancreatic Cancer Litigation

On April 5, a group of plaintiffs filed a motion to establish a diabetes drug pancreatic cancer MDL, asking that all lawsuits filed throughout the federal court system involving allegations that Victoza, Januvia, Janumet or Byetta caused pancreatic cancer, be centralized before one judge for coordinated handling during pretrial proceedings.

Plaintiffs requested that the litigation be transferred to the U.S. District Court for the Southern District of California, where the majority of the lawsuits are already pending.

Following responses filed earlier this week by Merck (the manufacturer of Januvia and Janumet) and Novo Nordisk (the manufacturer of Victoza), consenting to the establishment of a single MDL in the Southern District of California, a response (PDF) filed by Amylin and Eli Lilly has now been posted by the courts.

Amylin and Lilly have also indicated that the they agree that all complaints involving pancreatic cancer from any of the four diabetes drugs should be combined for pretrial proceedings to reduce duplicative discovery, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the courts.

“The requested transfer is warranted because the actions involve common questions of fact, and centralization into a single MDL for pancreatic cancer injuries would promote efficiency and justice,” said Amylin and Eli Lilly in the response.

According to the drug makers, Lilly and Amylin are included as co-defendants in at least 42 of the 53 pancreatic cancer lawsuits identified in the original motion, with 40 of those cases already pending in the Southern District of California. Many of the complaints involve allegations that plaintiffs developed pancreatic cancer after taking more than one of the incretin mimetic diabetes drugs.

Pancreatic Cancer Side Effects of Byetta, Januvia, Janumet and Victoza

Incretin mimetics are a relatively new class of diabetes drug, 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 and Eli Lilly in 2005 as a twice daily injection. Januvia was introduced by Merck the following year as an oral medication, and a combination pill containing Januvia and 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, with Janumet sales reaching over $1.3 billion in 2011 and Januvia sales hitting $919 million during the first quarter of 2012 alone. Byetta sales were reported at $710 million in 2010 and were expected to reach $1 billion by 2015. Likewise, Victoza sales were about $1 billion in 2011, and reached $748 million during the first half of 2012.

Side effects of incretin mimetics have been linked to a risk of pancreatitis, which could remain asymptomatic for a prolonged period of time, potentially resulting in the development of pancreatic cancer among some users, according to allegations raised in the lawsuits.

In March 2013, the FDA announced it was launching an investigation into whether Byetta, Januvia, Janumet and Victoza increase the risk of pancreatic cancer. The investigation came following studies that indicated that pancreas tissue of former users contained pre-cancerous cellular changes. European health officials have also launched a similar review.