Susan E. Van Gelder

All articles by Susan E. Van Gelder


A Rock and a Hard Place: Court Rejects Drug Manufacturer’s Defense that Changes to the Label Required FDA Approval and Were Preempted

This week, a Florida federal court denied a drug manufacturer’s motion in limine to preclude a plaintiff’s alternative warning theory on the basis that any changes to the label required FDA approval and were preempted. Dopson-Trout v. Novartis Pharma. Corp., 2013 U.S. Dist. LEXIS 135834 (M.D.Fla. Sept. 23, 2013). During her treatment for breast cancer that had metastasized to her bones, the plaintiff was infused with Aredia and then Zometa. She then had her tooth extracted, after which she began experiencing jaw pain caused…