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James C. Fraser

Thompson Hine LLP
Washington, District of Columbia, United States

James Fraser is a Senior Counsel in the Product Liability Group at Thompson Hine LLP in Washington, D.C. and is a former Associate Chief Counsel for Litigation at the U.S. Food and Drug Administration. He has over 13 years of private practice experience defending pharmaceutical and medical device companies in product liability and mass tort litigation. This work has included briefing complex issues such as federal preemption, federal jurisdiction, admissibility of expert testimony, punitive damages, and choice of law. James is one of the only product liability defense attorneys in the United States who has worked at FDA. During his five-year stint at FDA, he 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 drugs, medical devices, and cosmetics; bringing civil enforcement actions against FDA-regulated companies for violations of the Food, Drug, and Cosmetic Act; and drafting amicus curiae and other filings advocating FDA’s positions of federal preemption and preclusion. In representing FDA, James worked closely with and provided legal advice to various organizations within the agency, such as the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH). James began his legal career in the Air Force Judge Advocate General’s (JAG) Corps, where he served as a trial prosecutor, trial defense counsel, and appellate counsel.

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