Background
Among the several different types of therapies indicated for treating type 2 diabetes are increatin mimetics. The medications approved by the FDA that fall into this class of drugs are:
- Byetta (exenatide)
- Bydureon (exenatide)
- Januvia (sitagliptin)
- Janumet (sitagliptin)
- Victoza (liraglutide)
Previous scientific studies suggested that these incretin-based diabetes drugs may carry an increased risk of developing pancreatic cancer, but the FDA has not added any such warnings to the drug labels.
Previous Lawsuits
In 2015, Judge Anthony Battaglia in the Southern District of California effectively shut down all federal court lawsuits alleging that Byetta, Januvia, Victoza, and the other drugs in this class caused pancreatic cancer in the patients who used them. Over 700 of these cases were filed, and consolidated into the Incretin Mimetics Products Liability Litigation MDL.
The plaintiffs in these federal court cases argued that drug manufacturers knew of the risks of developing pancreatic cancer, yet failed to warn doctors and patients.
However, the federal judge ruled that there was sufficient evidence to establish that any requests to add pancreatic cancer warnings to the drug labels would not have been approved by the FDA. He based his decision on the fact that the FDA concluded that “a causal association between the drugs and pancreatic cancer is indeterminate,” which “falls below the science-based regulatory standards that govern what must be included in product labeling.”
A Second Chance?
On December 6, 2017, a federal appeals court issued an opinion that reverses the judge’s 2015 ruling. This is significant because it reinstates all of the lawsuits that were previously tossed out.
This decision was made on the basis that the plaintiffs’ attorneys were not given access to requested documents, nor were they allowed to present “newly discovered evidence” concerning animal studies and clinical trials at the time of the original trial.
While this is certainly good news for the plaintiffs, the cases will be tried by the same judge that originally tossed them out. While the attorneys for the plaintiffs will be allowed to collect and present additional information, they still run into the issue of whether that information would have caused the FDA to require a label change for Byetta, Bydureon, Januvia, Janumet, and Victoza.
We will continue to monitor the legal news pertaining to Byetta, Bydureon, Januvia, Janumet, and Victoza and the upcoming new trials, and report on significant developments. In the meantime, we encourage you to visit our website and complete a free case evaluation if you or someone you know has been diagnosed with pancreatic cancer after using one of these incretin-based diabetes drugs.
Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
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