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Ralph F. Hall

Professor of Practice

Ralph F. Hall

N219 Mondale Hall
229–19th Ave. South
Minneapolis, MN 55455

612-625-6487

hallx171@umn.edu

Indiana University, B.A.
University of Michigan, J.D.

Professor Ralph F. Hall is a professor of practice at the Law School and is Of Counsel to the law firm of Faegre Baker Daniels where he counsels clients in the area of drug and medical device regulation and corporate compliance matters. He also serves as CEO of MR3 Medical LLC, a start-up medical device company. He is a frequent speaker on FDA regulatory issues and compliance matters and has testified a number of times before Congressional committees.

Prior to his association with the University of Minnesota Law School, Professor Hall served in various capacities with Guidant Corporation including Senior Vice President and Deputy General Counsel—Litigation and Compliance and General Counsel of the Cardiac Rhythm Management group. During this time, Professor Hall also served as Special Counsel to the Guidant Board of Directors Compliance Committee and as Counsel to the Guidant Chief Compliance Officer. Prior to joining Guidant, he was with Eli Lilly, including serving as the head of Lilly's worldwide environmental law group.

Professor Hall received his B.A. from Indiana University in 1974 and his J.D. from the University of Michigan where he was a Weymouth Kirkland Scholar. Professor Hall's interests include FDA regulation, corporate compliance and governance, negotiations and the interface between corporate practice and the academic world.

PUBLICATIONS

Book Chapters

Corporate Integrity Agreements, in James T. O'Reilly et al., Punishing Corporate Crime: Legal Penalties for Criminal and Regulatory Violations 97 (Oxford University Press, 2009)

Deferred Prosecution and Non-Prosecution Agreements, in James T. O'Reilly et al., Punishing Corporate Crime: Legal Penalties for Criminal and Regulatory Violations 119 (Oxford University Press, 2009)

Understanding and Complying with Compliance Agreements, in James T. O'Reilly et al., Punishing Corporate Crime: Legal Penalties for Criminal and Regulatory Violations 155 (Oxford University Press, 2009)

Remedies of Disgorgement and Restitution, in James T. O'Reilly et al., Punishing Corporate Crime: Legal Penalties for Criminal and Regulatory Violations 181 (Oxford University Press, 2009)

FDA Regulation of Drugs, in Nanotechnology & FDA-Regulated Products: The Essential Guide 43 (Food and Drug Law Institute, 2009)

FDA Regulation of Medical Devices, in Nanotechnology & FDA-Regulated Products: The Essential Guide 75 (Food and Drug Law Institute, 2009)

Journal Articles

Rethinking Lohr: Does"SE" Mean Safe and Effective, Substantially Equivalent, or Both?, 13 Minnesota Journal of Law, Science & Technology 737 (2012) (with Michelle Mercer)

Enforcing the Rights of Human Sources to Informed Consent and Disclosures of Incidental Findings from Biobanks and Researchers: State Mechanisms in Light of Broad Regulatory Failure, 13 Minnesota Journal of Law, Science & Technology 575 (2012) (with Leili Fatehi)

Left to Their Own Devices: IOM's Medical Device Committee's Failure to Comply, 13 Minnesota Journal of Law, Science & Technology 75 (2012) (with Eva Stensvad)

Recommendations for Nanomedicine Human Subjects Research Oversight: An Evolutionary Approach for an Emerging Field, 40 Journal of Law, Medicine and Ethics 716 (2012) (with Susan M. Wolf & others)

A Failure to Comply: An Initial Assessment of Gaps in IOM's Medical Device Study Committee, 12 Minnesota Journal of Law, Science & Technology 731 (2011) (with Eva Stensvad)

Recommendations for Oversight of Nanobiotechnology: Dynamic Oversight for Complex and Convergent Technology, 13 Journal of Nanoparticle Research 1345-1371 (2011) (with Gurumurthy Ramachandran, Susan M. Wolf, Jordan Paradise, Jennifer Kuzma, Efrosini Kokkoli & Leili Fatehi)

Right Question, Wrong Answer: A Response to Professor Epstein and the "Permititis" Challenge, 94 Minnesota Law Review Headnotes 50 (2010)

Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of the FDA and Implications for Nanobiotechnology, 37 Journal of Law, Medicine & Ethics 598 (2009) (with Jordan Paradise, Alison W. Tisdale & Efrosini Kokkoli)

Developing Oversight Frameworks for Nanobiotechnology, 9 Minnesota Journal of Law, Science & Technology 399 (2008) (with Jordan Paradise, Susan M. Wolf, Gurumurthy Ramachandran, Efrosini Kokkoli & Jennifer Kuzma)

Leaving No Child Behind? Abigail Alliance, Pediatric Products and Off-label Use, 8 Houston Journal of Health Law & Policy 271 (2008) (with Tracy A. Braun)

Does the Constitution Provide a Right of Access to Experimental Drugs?, 11 Journal of Nursing Law 210 (2007)

Inconsistent Government Policies: Why FDA Off-Label Regulation Cannot Survive First Amendment Review under Greater New Orleans, 62 Food and Drug Law Journal 263 (2007) (with Elizabeth S. Sobotka)

The Risk of Risk Reduction: Can Postmarket Surveillance Pose More Risk than Benefit?, 62 Food and Drug Law Journal 473 (2007)

When You Have a Hammer Everything Looks Like a Nail: Misapplication of the False Claims Act to Off-Label Promotion, 61 Food and Drug Law Journal 653 (2006) (with Robert J. Berlin)

A Proposed Solution to the Notification Problem, 7 Minnesota Journal of Law, Science & Technology 189 (2005)

To Recall or Not to Recall, That Is the Question: The Current Controversy over Medical Device Recalls, 7 Minnesota Journal of Law, Science & Technology 161 (2005)

Other Publications

The Decline of the DPA: What Has Happened and Why, Update 50 (Issue 2, Mar./Apr. 2009) (with Timothy Schmidt)

Weaning FDA, Congress and Industry from User Fees, Update (Issue 3, May/June 2007) (with Robert J. Berlin)

The Next Enforcement Target: Your Company's Compliance Office, Update 30 (Issue 6, Nov./Dec. 2006)

Access to Experimental Drugs, A New Constitutional Right?, Update 11 (Issue 5, Sept./Oct. 2006) (with Colleen M. Roberts)

"Off-label" Speech: Uncertainty Reigns for Device and Drug Makers, 20 Legal Backgrounder (Washington Legal Foundation) (Dec. 2, 2005)

COURSES

Food and Drug Law
Corporate Compliance
Negotiations