Pharmaceutical

Makers of generic Reglan hoping federal law preempts lower court’s ruling

Reglan 435x303 Makers of generic Reglan hoping federal law preempts lower courts rulingDrug companies Pliva Inc., Actavis Elizabeth LLC, and Teva Pharmaceuticals USA Inc., hope the New Jersey Appellate Division will find that federal law overrides a lower court’s ruling that consumers can sue makers of generic versions of the heartburn drug Reglan (metoclopramide) who they claim failed to update their labels to include new warnings on the brand name drug’s label.

Reglan, known generically as metoclopramide, is used to treat gastric esophageal reflux disease (GERD). It is also used to treat nausea and vomiting, and heartburn caused by a stomach problem known as gastroparesis in diabetic patients.

The issue stems from a new warning the Food and Drug Administration (FDA) approved for Reglan in July 2004 advising that the drug not be taken for more than 12 weeks because of an increased risk of a movement disorder known as tardive dyskinesia.

Makers of generic versions of drugs are required to have the same labels as their brand name equivalent and to make changes in a timely manner when the brand name drug’s label is updated. Plaintiffs have accused generic drug manufacturers of not changing their labels in a timely enough manner thus failing to adequately warn consumers of the tardive dyskinesia risks with metoclopramide.

The generic drug makers are arguing that the responsibility is to ensure their labeling matches a brand name product is exclusively a federal issue. However, the plaintiffs say they aren’t looking to enforce federal sameness requirements as part of a traditional failure-to-warn case.

Source: Law360