Science Day Hearings Scheduled for Januvia Lawsuits

U.S. District Judge Anthony J. Battaglia issued a November 25 order calling for “Science Day” hearings for all Byetta, Janumet, Victoza and Januvia lawsuits on February 5 and 6, 2014.

The purpose of this special meeting is to invite both parties to explain the medical and scientific facts behind the complex allegations involving the effects of incretin mimetic class Type 2 diabetes drugs on the pancreas. They’ll discuss the nature of diabetes, the role of incretin-based therapies, pancreatic cancer morbidity, and data on the effects of incretin therapy.

The non-adversarial hearing will include “off the record” testimony from non-expert witnesses who will simply present their information, without cross-examinations or sworn statements. It is fairly common for judges to order science day hearings in complex pharmaceutical drug litigation proceedings.

History of incretin mimetic diabetes drugs

Incretin is a natural hormone produced by the body to prompt insulin release and lower blood sugar after a meal. Incretin mimetic drugs work by acting like the incretins in the body, causing the pancreas to release insulin as blood sugar rises and preventing the pancreas from releasing too much glucagon hormone (which encourages the release of sugar in the blood).

Byetta, a twice-daily injection, was the first drug of its class to gain FDA approval in 2005. Oral medication Januvia followed in 2007, with combination pill Janumet and daily injection Victoza introduced in 2010. Makers of the drugs say this type of diabetes drug helps keep blood sugar stabilized, without causing weight gain, hunger or low blood sugar.

Together, incretin mimetic medications account for billions in annual sales. Januvia and Janumet are the two best-selling drugs for Merck, generating $4 billion for the company last year. Novo Nordisk’s Victoza sales were up around $1.8 billion and Amylin Pharmaceuticals brought in $149 million in Byetta sales.

Januvia lawsuits and MDL

Incretin mimetic lawsuits first began to surface in March 2013 when a small, independent study found that users of these drugs had precancerous cells in the pancreas. The FDA and European drug regulators announced they would be investigating potential risks further.

As of November 2013, Janumet, Victoza, Byetta and Januvia pancreatic cancer lawsuit plaintiffs totaled 150. Proceedings have been centralized in the U.S. District Court for the Southern District of California under MDL No. 2452.

Dates for Januvia pancreatic cancer lawsuit hearings

Time is of the essence for many plaintiffs who filed Januvia lawsuits, as the five-year survival rate for pancreatic cancer ranges from 1 to 14%, depending on the stage. It is believed many of the cases will eventually become wrongful death lawsuits as the litigation wears on. Last month, the judge issued an order allowing plaintiffs to schedule early depositions if they are “reasonably near the end of life,” so their testimonies will be preserved for trial.

It could be years before the first trials, but Judge Battaglia has ordered the parties to submit a Joint Motion outlining the bellwether trial process, including proposed deadlines, by January 10th, 2014. The outcomes of the early trials could signal which direction the negotiations are likely to take – whether individual trials move forward or settlement offers are proposed.

The next status conference is scheduled for January 16, 2014.