Hundreds of plaintiffs in California will be able to pursue pancreatic cancer lawsuits involving Byetta and other incretin mimetics, after they successfully appealed a trial court’s decision dismissing their claims.
The ruling affects more than 300 cases centralized before a single judge in Los Angeles Superior Court, all of which were filed on behalf of individuals who were diagnosed with pancreatic cancer after being prescribed Byetta, Victoza, Januvia, or Janumet to treat Type 2 diabetes.
Plaintiffs’ claim the drugs’ manufacturers failed to warn that incretin memetics increased the risk for pancreatic cancer. While the U.S. Food & Drug Administration (FDA) did not initially require such warnings when it approved the medications, plaintiffs contend that their labels should have been updated to reflect subsequent scientific evidence of a causal link between incretin mimetics and pancreatic cancer.
Defendants had moved for dismissal on the basis of preemption, asserting that undisputed evidence showed the FDA would not have permitted a label warning for pancreatic cancer. The trial court agreed and awarded defendants summary judgment in November 2015.
In reversing that decision on November 6th, the California Court of Appeal, 2nd Circuit, found that the trial court had erred in refusing to consider new scientific evidence that wasn’t evaluated by the FDA when the agency initially approved the drugs’ label warnings.
The decision echoes the findings of the U.S. Court of Appeals for the 9th Circuit, which recently reinstated hundreds of additional incretin mimetics claims that had been dismissed by the U.S. District Court, Southern District of California, on similar grounds.
Incretin mimetics lower blood sugar levels in people with Type 2 diabetes by mimicking the action of incretin hormones, which are produced by the gut to stimulate the release of insulin in response to a meal.
The U.S. Food & Drug Administration (FDA) approved Byetta in April 2005. Since then, more than a dozen incretin mimetic drugs have brought to market, including:
In 2013, studies published in JAMA Internal Medicine and Diabetes suggested that people taking incretin mimetics faced an increased risk for pancreatitis and pancreatic cancer. A Drug Safety Communication published by the FDA that year warned of a possible association between incretin mimetic diabetes drugs and pancreatitis, as well as pre-cancerous changes to pancreatic tissue.
An additional study published in 2016 contradicted earlier pancreatic cancer finding. However, doctors were cautioned to continue monitoring incretin mimetic patients for signs of the disease.