Jae Hong Lee is an attorney and a physician who has represented companies in the pharmaceutical, medical device, dietary supplement, food, and aviation industries in a broad range of matters, including product liability litigation, patent litigation, FDA regulatory issues, advertising disputes, patent prosecution and patent interference. Jae offers clients experience in medicine, law, public health, FDA regulations, quantitative methods, clinical research, basic science research, and biophysics. He earned his degrees from Johns Hopkins, the University of Pennsylvania School of Medicine, Harvard, and the University of California, Berkeley. After completing a surgical internship at Yale, Jae performed clinical research for five years at UCLA.
Jae has delivered numerous presentations at national and international meetings, most recently at the March 2014 Annual Meeting of the American College of Legal Medicine in Dallas, TX. He has published peer-reviewed articles and commentary in such journals as Neurosurgery, the Journal of Neurosurgery, the Lancet, and Pediatrics, as well as op-eds in the Baltimore Sun and Ventura County Star. Jae is a fellow of the American College of Legal Medicine, the nation's oldest organization of physician attorneys and has been "recommended" by Legal500 for pharmaceutical and medical device product liability litigation defense.
Served as national counsel for pharmaceuticals manufacturer in multiple jurisdictions around the United States; cases alleged that local anesthetic products administered through pain pumps caused glenohumeral chondrolysis. Revision of local anesthetic prescribing labels; preparation of "Dear Doctor Letters"; expert recruitment; formulation of alternative causation theories; analysis of medical records; etc.
Served as counsel for manufacturer of anticoagulants in multiple jurisdictions in cases alleging ischemic injuries from thomboembolic events. Taking and defending depositions; dissecting and dismantling opposing causation theories; formulating alternative causation theories; recruiting experts; preparing expert reports; preparing a motion for summary judgment; etc.
Served as counsel for a major beverage company facing litigation, FDA inquiries, and an Institute of Medicine investigation. Prepared a list of required expert consultants; expert recruitment; preparation of experts for an Institute of Medicine workshop; review and editing of a scientific letter responding to allegations from medical and scientific academic experts; participation in multiple teleconferences with the CEO, chief scientific officer, vice chairman of the board of trustees, and senior in-house counsel to discuss various medical, scientific, strategic, tactical, and regulatory issues; etc.
Served as counsel in patent litigation matter involving an abbreviated new drug application for a generic drug product. Recruited medical and scientific experts; prepared expert reports; prepared an expert for deposition.
Represented a major pharmaceutical company in an advertising dispute in a National Advertising Division challenge. Analyzed and critiqued clinical research studies cited in advertisements; recruited a clinical biostatistics expert; prepared a scientific affidavit for the biostatistics expert.
Represented U.S. military veterans who were test subjects in various chemical and biological warfare experiments conducted in the 1950s and 1960s in a pro bono litigation matter against various U.S. government agencies. The lawsuit sought health care services and notice for all veterans involved in these studies. Analyzed medical and scientific documents; identified required areas of expertise; recruited experts; prepared expert reports; performed and defended depositions of experts; etc.
Memberships & Affiliations
American Medical Association
American Bar Association
American College of Legal Medicine Diplomate
National Board of Medical Examiners
Awards & Distinctions
Legal500 Recommended Attorney for pharmaceutical/medical device product liability litigation defense, 2010
fellow of the American College of Legal Medicine, William M. Wiley Award for pro bono work