James C. Fraser, a former Associate Chief Counsel for Litigation at the U.S. Food and Drug Administration, has more than 16 years of experience in life sciences litigation, including FDA regulatory litigation and products liability and mass tort litigation.
In his five years at FDA, James represented the agency in civil litigation throughout the United States. This work included defending FDA against Administrative Procedure Act challenges to the agency’s decisions regarding pharmaceuticals, medical devices, and other FDA-regulated products, bringing civil enforcement actions against manufacturers of pharmaceuticals and other products for violations of the Food, Drug, and Cosmetic Act (FDCA), and drafting amicus curiae and other filings advocating FDA’s positions on federal preemption and preclusion.
In addition to his time at FDA, James has over 11 years of experience defending pharmaceutical and medical device manufacturers in products liability and mass tort litigation throughout the United States. This work has included briefing complex issues such as federal preemption, federal jurisdiction, admissibility of expert testimony under Daubert and Frye, punitive damages, and choice of law.