AstraZeneca indicates that after settling dozens of cases earlier this year, it continues to face more than 400 Byetta lawsuits involving allegations that former users of the diabetes drug developed pancreatic cancer, thyroid cancer or pancreatitis.
In a second quarter financial report (PDF) issued last week, AstraZeneca disclosed that Byetta settlement agreements have been reached to resolve at least 84 claims pending in California state court, including one case that was scheduled for trial to begin in February 2014.
Other than the resolved cases, the drug maker notes that about 409 lawsuits over Byetta side effects remain in various state and federal courts nationwide.
Neither the terms of the settlement agreements or the nature of injuries involved in the claims were disclosed by the drug maker.
Many of the remaining cases involve allegations that plaintiffs developed pancreatic cancer from Byetta. All of those lawsuits pending in the federal court system are currently consolidated as part of a multidistrict litigation (MDL), which is centralized before U.S. District Judge Anthony Battaglia in the Southern District of California to reduce duplicative discovery, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.
The MDL not only includes cases involving Byetta, but also consists of Januvia lawsuits, Janumet lawsuits and Victoza lawsuits where plaintiffs allege they developed pancreatic cancer after taking those similar diabetes medications.
According to the latest case list (PDF) released by the U.S. Judicial Panel on Multidistrict Litigation, more than 460 cases are currently pending in the MDL involving the various different diabetes drugs that are all part of a class of medications known as incretin mimetics.
As part of the coordinated pretrial proceedings before Judge Battaglia, it is expected that a series of early trial dates will be scheduled in the MDL involving each of the different medications, to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. While the outcomes are not binding in other cases, it may help the parties reach additional agreements to settle Byetta and Januvia cases.
Byetta Cancer Risk
Byetta, Januvia, Janumet and Victoza are all part of the same 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.
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. Bydureon is an extended-release version of Byetta. Victoza (liraglutide) is a similar injectable diabetes drug introduced by Novo Nordisk in 2010 as a longer-acting daily injection.
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.
It has previously been estimated that about 55 Byetta thyroid cancer lawsuits are also pending against AstraZeneca, which are excluded from the MDL proceedings. The plaintiffs in those cases allege that the Byetta warning label should mention the potential risk of thyroid cancer, which has been added to the label for Victoza.