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Contact Information

ralph.hall@FaegreBD.com2200 Wells Fargo Center
90 S. Seventh Street
Minneapolis, Minnesota 55402-3901
T: +1 612 766 8766
C: +1 651 261 3467
F: +1 612 766 1600

Education

University of Michigan Law School
J.D., cum laude (1977)
Indiana University, Bloomington
A.B., magna cum laude (1974)

Bar Admissions

Indiana Minnesota

Ralph F. Hall

Counsel

Ralph Hall has extensive experience in the areas of FDA, health care law and corporate compliance, including the application of those regulatory systems to the medical device industry. He has expertise in the design and implementation of regulatory compliance programs and with FDA enforcement actions. Ralph also has experience in developing and implementing cross disciplinary corporate legal strategies, corporate law department organization and management, and general corporate counseling.

Prior to rejoining Faegre Baker Daniels, Ralph was with Guidant Corporation where he served as Senior Vice President and Deputy General Counsel – Litigation and Compliance. Also at Guidant, he was Special Counsel to the Board of Director's Compliance Committee and the corporation's Compliance Office. Earlier, Ralph was General Counsel of Guidant's Cardiac Rhythm Management Group — a billion dollar plus business. Before joining Guidant, Ralph was with Eli Lilly and Company where he served in a number of legal roles, including chief environmental counsel.

Ralph also serves as a Professor of Practice at the University of Minnesota Law School where he teaches courses in FDA law, corporate compliance and negotiation. Ralph has written extensively on FDA and compliance matters, as well as spoken frequently at legal seminars on a variety of subjects.

Congressional Testimony

  • House Energy and Commerce Committee — Subcommittee on Health, February 2012
  • Senate Health, Education, Labor and Pension Committee — November 2011
  • Senate Special Committee on Aging — April 2011
  • House Energy and Commerce Committee — Subcommittee on Health, February 2011

Faculty Positions

  • University of Minnesota Law School — Professor of Practice, 2004-present, and Adjunct Professor, 2000-03
  • Indiana University Robert H. McKinney School of Law, Indianapolis — Adjunct Professor, 1988-92, and Visiting Professor, 2009

Professional Associations

  • American Bar Association
  • Minnesota State Bar Association
  • Food and Drug Law Institute — National Board of Directors, 2007-11
  • Nanotechnology Consortium — Working group of consortium studying regulatory oversight models for nanotechnology in life sciences, environment, FDA, workplace exposure, agriculture and other areas pursuant to a National Science Foundation Grant
  • Institute for Engineering in Medicine (IEM) — Interdisciplinary research organization strengthening collaborative efforts between the disciplines of engineering and biomedicine at the University of Minnesota and fostering collaborations with the medical device industry

Civic Activities

  • MR3 Medical, LLC — CEO

Presentations

  • Doing Business in Med Tech: FDA and CDRH in 2014
    BioBusiness Alliance of Minnesota, Minneapolis, February 2014
  • Top Cases of 2012 and 2013: The Changing Legal Environment
    Panelist, Food and Drug Law Institute (FDLI) Advertising & Promotion Conference, Washington, D.C., September 2013
  • Caronia, First Amendment and FDA Regulation
    Plenary Session, Food and Drug Law Institute Annual Meeting, Washington, D.C., April 2013
  • The Sunshine Act Final Rule
    Life Science Alley, Minneapolis, March 2013
  • Corporate Compliance Programs — What Does the Data Show?
    Indiana University McKinney School of Law, Indianapolis, September 2012
  • Update and Key Issues Involving 510(k) Reform Efforts
    Panelist, Food and Drug Law Institute (FDLI) Annual Conference, Washington, D.C., April 2011
  • Improving the 510(k) Process: Lessons Learned From Recent Benchmarking Studies
    Panelist, OneMed Forum, San Francisco, January 2011
  • Assessment of Medical Device Recalls, Reasons and Implications
    IOM 510(k) Study Committee, June 2010
  • 510(k) Under Assault
    Indiana University Emerging Technologies Center, Indianapolis, June 2010
  • 510(k) Under Assault
    Co-presenter with Vincent Ventimiglia, LifeScience Alley, Washington, D.C., May 2010
  • Ethical and Legal Issues in Nanotechnology
    Co-presenter, University of Notre Dame Symposium, March 2010
  • Reducing Risk of Major Government Enforcement
    Co-presenter with Erin Reilly Lewis, ePharmaceuticals Webinar, August 2008
  • Nanotechnology Law, Regulation & Policy Conference
    Co-chair, Food and Drug Law Institute, Washington, D.C., February 2008
  • National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials
    Presenter, American Conference Institute, New York City, February 2008
  • Understanding U.S. FDA Law
    Chinese FDA Delegation, University of Minnesota, November 2007
  • Case Study: Incidental Findings in Clinical Trials Research — Legal Regulatory and Ethical Concerns
    National Conference on Managing Legal Risks in Structuring and Conducting Clinical Trials, Boston, September 2007
  • The Three Faces of Post Market Surveillance
    Life Science Alley Trade Association, St. Louis Park, Minnesota, June 2007

Published Articles

  • The New Regulator? The Rise of IMDRF
    BioFutures, official magazine of the Indiana Health Industry Forum and Indiana Medical Device Manufacturers Council, March 2014
  • CDRH in 2014: Five Things to Watch
    Indiana Medical Device Manufacturers Council Update, 2014
  • Rethinking Lohr: Eoes "SE" Mean Safe and Effective, Substantially Equivalent or Both
    Co-author with Michelle Mercer, Minnesota Journal of Law, Science and Technology, Vol. 13-2, 2012
  • A Failure to Comply: An Initial Assessment of Gaps in IOM's Medical Device Study Committee
    Co-author with Eva Stensvad, Minnesota Journal of Law, Science & Technology, Vol. 12, Issue 2, 2011
  • Matrixx Catches a Cold: Linking FDA and SEC Obligations
    Co-author with David Worrell, Financial Fraud Law Report, Vol. 3, Issue 6, June 2011
  • Two Tracks, One Train? CMS and FDA Cooperation
    Co-author with Vincent Ventimiglia and Elizabeth Spurgin, Law360, Portfolio Media, Inc., September 23, 2010
  • When You Have a Hammer Everything Looks Like a Nail: Misapplication of the False Claims Act to Off-Label Promotion
    Co-author with Robert J. Berlin, Food and Drug Law Journal, Vol. 61, No. 4
  • Inconsistent Government Policies: Why FDA Off-Label Regulation Cannot Survive First Amendment Review Under Greater New Orleans
    Co-author with Elizabeth S. Sobotka, Food and Drug Law Journal, Volume 62, No. 1
  • Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of FDA and Implications for Nanobiotechnology
    Co-authored with Paradise, Tisdale and Kokkuli, 37 Journal of Law, Medicine and Ethics 598, 2009
  • Nanotechnology and FDA — Regulated Products: The Essential Guide
    Author of two chapters (Book published by Food and Drug Law Institute), 2009
  • FDA Enforcement Heating Up
    Co-author with Erin Reilly Lewis, Law360, November 20, 2009
  • Punishing Corporate Crime: Legal Penalties for Criminal and Regulatory Violations
    Co-author with James T. O'Reilly, James Patrick Hanlon, Steven L. Jackson and Erin Reilly Lewis, Oxford University Press, August 2009
  • Rethinking How to Respond to Government Investigations
    Co-author with J.P. Hanlon and Erin Reilly Lewis, Update Magazine, Food and Drug Law Institute, Issue 6, November/December 2008
  • Developing Oversight Frameworks for Nanotechnology
    Co-author, Minnesota Journal of Law, Science and Technology, Volume 9, Issue 1, Winter 2008
  • Does the Constitution Provide a Right of Access to Experimental Drugs?
    Journal of Nursing Law, Volume 11, No. 1
  • Weaning FDA, Congress and Industry From Users Fees
    Co-author with Robert J. Berlin, Update Magazine, Food and Drug Law Institute, 2007
  • The Next Enforcement Target: Your Company's Compliance Office
    Update Magazine, Food and Drug Law Institute, 2006
  • Access to Experimental Drugs: A New Constitutional Right?
    Co-author with Colleen M. Roberts, Update Magazine, Food and Drug Law Institute, 2006