Jae Hong Lee

Of Counsel
San Francisco,  CA  U.S.A.

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Experience & Credentials

Practice Areas

  • Commercial & Business Litigation
  • Product Liability
  • Pharmaceuticals & Medical Devices
  • Intellectual Property
Contact InfoTelephone: 415.625.9259
Fax: 415.434.1370
University Johns Hopkins University, B.A., departmental honors in Biophysics, 1987; University of Pennsylvania School of Medicine, M.D., 1993 National Institute of Mental Health/Measey Foundation Training Grant in Behavioral Neuroscience; American Heart Association Medical Student Research Fellowship; Harvard University, M.P.H., 2001
Law SchoolUniversity of California, Berkeley, School of Law, J.D., 2005; Fellow, Berkeley Center for Law & Technology; fellow, Grace C. Barbee Fellowship in Law and Medicine; annual review adviser, article editor, Berkeley Technology Law Journal; communications director, Biotechnology Law Society
Admitted2006, California; U. S. District Court, Southern, Central, Northern and Eastern Districts of California

Memberships & Affiliations

American Medical Association
American Bar Association
American College of Legal Medicine Diplomate
National Board of Medical Examiners


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 nations oldest organization of physician attorneys and has been recommended by Legal500 for pharmaceutical and medical device product liability litigation defense.

Awards & Distinctions

Selected for inclusion in Rising Stars for Northern California Super Lawyers, 2015
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


FDA Approves Biosimilar Agent Zarxio: Dawn of a New Era in Pharmaceutical Therapy and Product Liability Law

Biosimilars: A New Era in Product Liability Law

March 13, 2015

The FDA has approved the first biosimilar agent under abbreviated procedures outlined in the Biologics Price Competition and Innovation Act of 2009. The approval heralds a new era of less-expensive biologics, a class of therapeutic agents that are among the most expensive in the U.S. market, and foreshadows a new era in product liability law, as plaintiffs' attorneys are likely to exploit the unique statutory and regulatory status of biosimilar agents in pursuing product liability claims against manufacturers.

Concussion Litigation: The Next Frontier

Concussion Litigation: The Next Frontier

March 13, 2015

Organized sports at every level face significant challenges by play-related brain injuries resulting in increased litigation and unanticipated financial exposure for youth, collegiate and semi-professional sports organizations alike.


Preparing for a Multiple Front War: Managing Litigation and Simultaneous Government Investigations


April 29, 2015

Client webinar

Changes to 510(k) Regulatory Process and Laboratory-developed Tests

Speaking Engagements

October 23-24, 2014

Navigators Advisory Council Meeting

The FDA's New Regulatory Scheme for Laboratory-developed Tests (LDT): Potential Regulatory and Litigation Impact

Speaking Engagements

October 16-17, 2014

Navigators Advisory Council Meeting

Reported CasesRepresentative Matters: 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.

Documents by this lawyer on Martindale.com

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Concussion Litigation: The Next Frontier
Anthony B. Corleto,Jae Hong Lee, March 31, 2015
By now everyone has heard about the widely reported concussion lawsuits - former professional players suing because they claim to suffer from a form of brain injury, chronic traumatic encephalopathy (CTE), linked to repetitive head trauma. The condition has afflicted athletes across the spectrum of...

FDA Approves Biosimilar Agent Zarxio: Dawn of a New Era in Pharmaceutical Therapy and Product Liability Law
Amy L. Baker,Genese K. Dopson,Jae Hong Lee, March 31, 2015
The FDA's approval on March 6, 2015, of Sandoz's Zarxio (filgrastim-sndz) is a momentous occasion for pharmaceutical therapy and product liability law in the United States. Catching up with Europe (where Sandoz's identical Zarzio has been marketed since 2009), Zarxio is the first...
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Office Information

Jae Hong Lee

525 Market Street, 17th Floor
San FranciscoCA 94105-2725


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