A federal judge denied plaintiffs’ motion to gather drug companies’ analysis of pancreatic cancer cases among users of their type 2 diabetes drugs; however, his decision is still pending regarding plaintiffs’ request to gather adverse event reports involving those drugs submitted to the U.S. Food and Drug Administration (FDA).
U.S. District Judge Anthony Battaglia is presiding over a multidistrict litigation (MDL) involving about 460 plaintiffs who allege they developed pancreatic cancer after taking one of four drugs in a class of type 2 diabetes drugs known as incretin mimetics.
The lawsuits name Amylin Pharmaceuticals and Eli Lilly & Co., for the drug Byetta; Merck Sharp & Dohme Corp., for the drugs Januvia and Janumet; and Novo Nordisk Inc., for its drug Victoza.
Plaintiffs already have adverse event reports collected by the FDA, but the group is asking the judge to compel the drug makers to produce underlying medical records of patients used to compile those reports. The drug makers are fighting that request, saying that the adverse event reports cannot establish general causation and the source files are “even less meaningful.”
Recent studies have linked incretin mimetics – in particular Byetta and Januvia – to an increased risk of acute pancreatitis, a painful inflammation of the pancreas. The condition increases the risk for pancreatic cancer, to which the drugs also were linked.
The FDA has conducted a safety review of the drugs. Meanwhile, more people are joining the multidistrict litigation, claiming they were not adequately warned of the risk of pancreatic cancer or other pancreatic conditions associated with the drugs.
Source: National Law Journal