Topic Archives: Drug & Medical Device

Pharma

Federal Preemption Claims:
Clear Evidence and an Unclear Standard

Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. The court found that the FDA’s rejection of additional warnings and consistent approval of labeling contrary to plaintiff’s demands constituted “clear evidence” of a conflict between federal and state law, and therefore served as grounds for preemption. ...›

New Settlement Highlights FDA’s Diminishing Power Over Off-Label Promotion

In a surprising turn of events, Pacira Pharmaceuticals, Inc. and the Food and Drug Administration (FDA) announced that they have settled their dispute regarding the off-label promotion of Exparel, one of Pacira’s anesthetic drugs. This settlement represents the latest marker of the FDA’s diminishing power to regulate off-label promotion. ...›