Drug Makers Score Big Victory in Failure-to-Warn Drug Labeling Case

On Monday, drug makers scored a big victory in multidistrict litigation that accused the drug makers of failing to warn patients that taking certain Type 2 diabetes drugs they produced could lead to pancreatic cancer. A California federal judge granted summary judgment in the drugmakers’ favor, holding that if the companies had proposed a label that had warned patients about the potential pancreatic disease risks, the FDA would have rejected those proposals.

In his order, U.S. District Judge Anthony J. Battaglia noted that the “evidence establishes the FDA has reviewed the risk specific to plaintiffs’ claims and, after considering the totality of available scientific data, concluded a warning or other reference to that risk is unsubstantiated.” Judge Battaglia also held that the FDA’s finding on the matter preempts state law failure-to-warn claims.

The multidistrict litigation, which was combined in August 2013, targets a class of Type 2 diabetes drugs known as incretin mimetics. In early 2013, researchers suggested that use of these drugs may lead to an increase of pancreatitis and precancerous cells. However, in a February 2014 report, the FDA found no concrete evidence that the drugs are connected to the pancreas problems. In his summary judgment order,

The drugs include Janumet and Januvia, produced by Merck; Byetta, developed by Amylin and sold in collaboration with Eli Lilly; and Victoza, made by Novo Nordisk.

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