Discovery Moving Forward in Byetta, Januvia Cancer Lawsuits

As hundreds of Byetta lawsuits, Januvia lawsuits, Janumet lawsuits and Victoza lawsuits continued to move forward, the federal judge presiding over the litigation recently laid out key dates for discovery into common issues surrounding the link between use of the diabetes drugs and the development of pancreatic cancer.

There are currently more than 440 product liability lawsuits pending in the federal court system involving individuals who allege they developed pancreatic cancer following use of Byetta, Januvia, Janumet or Victoza.

All of the complaints raise similar allegations that inadequate warnings were provided about the potential side effects of the incretin mimetic diabetes drugs.

For coordinated pretrial proceedings, the cases are centralized before U.S. District Judge Anthony Battaglia in the Southern District of California, as part of an MDL, or multidistrict litigation.

Following a status conference before Judge Battaglia on July 1, a case management order (PDF) was issued setting out a discovery schedule for preemption and general causation.

Judge Battaglia indicates that depositions of custodians will commence on September 2, and to be completed by October 14. Plaintiffs disclosure of experts and their reports must be filed and served by November 17, with defendants having a December 17 deadline. Plaintiffs have until January 30, 2015 to file rebuttal reports and all depositions of experts must be completed by March 6, 2015.

Ultimately, it is expected that Judge Battaglia will schedule a series of early trial dates involving the different diabetes drugs, known as bellwether trials. While the outcomes of these trials will not be binding in other cases, they are designed to help the parties gauge the relative strengths and weaknesses of their cases, and may lead to Byetta and Januvia settlement agreements.

Judge Battaglia indicates in the order that there are also at least 55 thyroid cancer lawsuits that are consolidated outside the MDL. However, the parties indicated that they expect many of the MDL’s same protocols to be utilized during pretrial proceedings in the thyroid cancer cases.

Diabetes Drug Cancer Risk

Byetta, Januvia, Janumet and Victoza are all part of the incretin mimetic class of diabetes drugs, which work by mimicking the incretin hormones the body usually produces to naturally stimulate the release of insulin in response to a meal.

The pancreatic cancer lawsuits have been filed against the makers of all four drugs following a number of studies that linked side effects of Januvia, Janumet, Byetta and Victoza to an increased risk of pancreatitis, which plaintiffs allege causes the development of pancreatic cancer in many cases.

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. Victoza (liraglutide) is a similar injectable diabetes drug introduced by Novo Nordisk in 2010 as a longer-acting daily injection.

Previous studies found that user of Victoza may increase the risk of thyroid cancer, which resulted in warnings being placed on that medication at the time it was introduced onto the market. Plaintiffs in the Byetta thyroid cancer lawsuits allege that similar warnings should have been placed on this older medication, which has a similar mechanism of action and has also been linked to a large number of reports involving thyroid cancer diagnosis following long-term use.