James, a former Associate Chief Counsel for Litigation at the U.S. Food and Drug Administration, focuses his practice on FDA-related regulatory matters, litigation, and transactions. He advises and represents FDA-regulated companies on issues relating to product approvals, labeling, and current good manufacturing practice (cGMP) requirements. He also represents pharmaceutical and medical device companies in mass tort and other product liability 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 FDA-regulated products, 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 (including the Office of New Drugs and the Office of Generic Drugs); the Center for Devices and Radiological Health; the Center for Biologics Evaluation and Research; the Center for Food Safety and Applied Nutrition (including the Office of Dietary Supplement Programs and the Office of Cosmetics and Colors); the Center for Veterinary Medicine; and the Center for Tobacco Products.
James also 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 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.
Education The University of Iowa College of Law, J.D., with distinction, Iowa Law Review, associate editor; American Jurisprudence Award in Constitutional Law Michigan State University, B.A.
Bar Admissions District of Columbia Maryland
Court Admissions U.S. District Court for the District of Columbia U.S. District Court for the District of Maryland U.S. Court of Appeals for the Third Circuit U.S. Court of Appeals for the Fourth Circuit U.S. Court of Appeals for the Sixth Circuit U.S. Supreme Court