Bryan Feldhaus

About Bryan Feldhaus

I\'m an advisor, advocate and compliance leader focused on serving medical device, pharmaceutical and nutritional supplement companies.I joined DuVal & Associates, P.A. to integrate my personal interest in medical devices, biologics, and pharmaceuticals with my professional experience in legal counseling, advocacy and compliance. At DuVal, I specialize in advising medical device, pharmaceutical and nutritional supplement companies on FDA law, regulations and guidance. This includes interfacing extensively on behalf of companies with the FDA on promotional, inspectional and other enforcement matters, and providing strategic advice and advocacy on regulatory submissions and FDA appeals. I also provide legal/regulatory advice in designing and implementing sophisticated marketing programs (considering FDA’s advertising and promotional regulations, the Anti-kickback Statute, False Claims Act and the Physician Payments Sunshine Act), and conducting related sales compliance training.Finally, I counsel companies on compliance matters, conducts compliance assessments and investigations, collaborate with clients to implement compliance platforms, and provide compliance training to ensure clients understand and achieve their goals in the context of their business objectives and compliance obligations.I have previously represented clients in a variety of matters, including intellectual property litigation, corporate litigation, class action disputes, and regulatory, privacy and compliance matters. For example, I have litigated complex patent infringement actions, defended class action data privacy lawsuits, and represented professionals and companies in regulatory and compliance matters. I graduated with an LL.M. degree in Corporate Compliance and Organizational Ethics from the University of St. Thomas School of Law, which focused on the intersection of law, business, compliance and ethics, and have also obtained a Certificate in Cybersecurity and Privacy Law from Mitchell Hamline School of Law. I also enjoy being involved in the community. I have previously volunteered with the Federal Bar Association Pro Se Project, and have served on the City of Rosemount Parks and Recreation Commission, the University of St. Thomas School of Law Alumni Board, and the Rosemount Area Hockey Association.

Experience

1. President

   Duval & Associates, Pa

   Sep 2024 — Present

   I specialize in advising medical device, pharmaceutical and nutritional supplement companies on FDA law, regulations and guidance. This includes interfacing extensively on behalf of companies with the FDA on promotional, inspectional and other enforcement matters, and providing strategic advice and advocacy on regulatory submissions. I also provide legal/regulatory advice in designing and implementing sophisticated marketing programs (considering FDA’s advertising and promotional regulations, the Anti-kickback Statute, False Claims Act and the Physician Payments Sunshine Act), conducting related sales training.Finally, I counsel companies on compliance matters, conduct compliance assessments, collaborate with clients to develop compliance programs, and provide compliance training to ensure clients understand and achieve their compliance goals in the context of their business objectives.

Education

• University of St. Thomas

  Bachelor of Arts Degrees, Biology; Philosophy

  1999 — 2003

• University of St. Thomas School of Law

  Master of Laws (LL.M.) (May 2015), Corporate Compliance and Organizational Ethics

  2014 — 2015

• University of St. Thomas School of Law

  Juris Doctor, Law

  2003 — 2006

Skills

• Due Diligence
• Commercial Litigation
• Trademarks
• Corporate Compliance
• Legal Ethics
• Appellate Practice
• Copyrights
• Litigation Support
• Legal Compliance
• Corporate Law
• Risk Assessment
• Appeals
• Legal Research
• Westlaw
• Civil Litigation
• Board of Directors
• Internal Investigations
• Professional Ethics
• Project Management
• Courts
• Product Liability
• Intellectual Property
• Complex Litigation
• Mediation
• Trials
• Legal Assistance
• Arbitration
• Legal Writing
• Litigation
• Personal Injury
• Legal Issues
• Trial Practice