With more than 700 Byetta lawsuits, Januvia lawsuits, Janumet lawsuits, and Victoza lawsuits pending throughout the federal court system involving allegations that inadequate warnings were provided about the risk of pancreatic cancer, the drug makers have filed a motion for summary judgment, arguing that the cases should be preempted since they maintain the FDA would not have approved a label update.
Since August 2013, all product liability lawsuits filed in U.S. District Courts throughout the country involving individuals diagnosed with pancreatic cancer following use of an incretin mimetic diabetes drug have been consolidated as part of an MDL, or multidistrict litigation.
The cases are centralized before U.S. District Judge Anthony Battaglia in the Southern District of California for coordinated pretrial proceedings to reduce duplicative discovery into common issues in the cases, prevent conflicting rulings from different judges and to serve the convenience of the parties, witnesses and courts.
All of the complaints raise similar allegations that the makers of Byetta, Januvia, Janumet and Victoza, which are all part of the same class of medications, failed to adequately research the side effects of their drugs or warn users that they may face an increased risk of pancreatic cancer.
In a motion for summary judgment (PDF) filed on June 19, the makers of these medications asked Judge Battaglia to dismiss the failure to warn claims, arguing that the FDA would have rejected any pancreatic cancer warning label update proposed by the plaintiffs.
“There is such clear evidence, for FDA has taken a series of deliberate actions to acknowledge published concerns about a possible risk, to carry out a thorough study of the issue, and then to make a very public declaration of its findings and conclusion that the current labeling is adequate,” wrote defendants in the motion. “FDA has considered the very claim asserted by Plaintiffs in this litigation—namely, that the labeling for Byetta, Januvia, Janumet and Victoza should warn about a risk of pancreatic cancer. It has conducted its own comprehensive evaluation of the scientific evidence concerning pancreatic cancer. And, …FDA has explicitly rejected Plaintiffs’ scientific claim in an official statement, published in the February 2014 issue of The New England Journal of Medicine (NEJM).”
In a separate motion filed under seal the same day, plaintiffs are seeking summary judgment on the affirmative defense of pre-emption presented by the drug makers in their original answer to the complaints.
Diabetes Drug Pancreatic Cancer Concerns
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.
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.
If the claims survive the drug makers’ motion for summary judgment, it is expected that Judge Battaglia will schedule a series of early trial dates involving the different medications, 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 eventually lead to Byetta and Januvia settlement agreements if plaintiffs are successful in the test cases.