A three-judge panel has found that failure-to-warn claims against makers of generic versions of the heartburn drug Reglan could move forward because the companies failed to update their warning labels when the brand name product’s label was changed to include new side effect warnings.
The ruling affects a large number of the roughly 650 lawsuits consolidated in Middlesex County, where they were transferred from Atlantic County last month.
The panel of judges wrestled with the 2011 ruling in Pliva v. Mensing that state tort claims against makers of generic drugs alleging inadequate warnings should be overridden by federal law, which dictates the language on drug safety labels. However, this would be the case only if generic drug makers had the same labels as the brand name drug. The judges refused to dismiss the claims against the generic makers of Reglan because when the brand name manufacturer updated Reglan’s safety label, the generic companies did not follow suit until much later.
Reglan, known generically as metoclopramide, was approved by the Food and Drug Administration (FDA) in 1980 to treat gastro-esophageal reflux disease, or GERD, and was originally sold by Wyeth. Generic versions of the drug hit the market beginning in 1985.
When Reglan was first approved, its label stated that long-term use of the drug “has not been evaluated and cannot be recommended.” In 1985, the branded drug’s label was updated to include a warning for tardive dyskinesia, a serious movement disorder. In July 2004, a boldfaced statement was added to warn against use longer than 12 weeks. In February 2009, that warning was made into a boxed warning, the most serious type the FDA can give. Lawsuits began to mount against Wyeth and generic manufacturers.
The judges panel found that the plaintiffs’ claims against generic manufacturers was based on the defendants failing to provide adequate warnings about the risk of tardive dyskinesia with long-term use, and that these manufacturers had a duty under federal law to adopt the changes of the brand name product.
Source: NJ Law Journal