Mark Gardner, M.B.A., J.D., Directing Attorney
Mark Gardner, MBA, JD, Directing Attorney, Gardner Law, has worked in FDA-regulated industry since 1999. He advises companies on a wide variety of topics including health care compliance, advertising and promotion review, FDA -regulatory, -quality, and -clinical matters, privacy, transparency reporting, and enforcement. He has been “seconded” to manufacturers such as Bayer Healthcare and Johnson & Johnson. Previously he worked in commercial roles, including product management, at ev3 (Medtronic), Celleration, and MedTox Laboratories (Labcorp).
Mark is an Adjunct Professor of Law at Mitchell Hamline School of Law where he teaches Drug & Device Law, sits on the Health Law Institute Advisory Board, and serves as a judge and coach for student competitions.
He has written and lectured extensively on a variety of topics relating to anti-fraud, FDA, transparency, and enforcement matters. Mark sits on the Section Council for the MSBA Food, Drug and Device Law Section. He previously served as Chair, Vice Chair and Secretary for the Section. Mark also sits on the FDLI Advertising and Promotion of Medical Products Conference Planning Committee. He previously served as Chair for the Medical Alley Regulatory Special Interest Group.
750
Clients Counseled
54
Ski Areas Visited

Executives today face a more rigorous and demanding regulatory environment than those that preceded them. My clients appreciate my prior industry experience and how I apply it in my practice. Since I’ve walked in the shoes of my clients, I understand the complex challenges they face.
– MARK GARDNER, M.B.A., J.D.
Practice Areas:
- Health care compliance
- Advertising and promotion review
- FDA -regulatory, -quality, and -clinical matters
- Privacy
- Transparency reporting
- Enforcement
Prior to practicing law Mark worked in product commercialization and development at three companies over ten years: ev3 (Medtronic), Celleration, and MedTox Laboratories (LabCorp).
- Adjunct Professor of FDA law at Mitchell Hamline School of Law
- Board member of Mitchell Hamline School of Law Health Law Institute Advisory Board
- Health Law Regulatory Compliance Competition Coach at Mitchell Hamline School of Law
- Former chair of Minnesota State Bar Association Food, Drug, and Device Law Section
- Former chair of Medical Alley Regulatory Special Interest Group
- Member of American Bar Association
- Member of Minnesota State Bar Association Food, Drug and Device Law Section and Health Law Section
- Member of Medical Alley
- Member of competitive alpine ski racing teams
Mark has been invited to speak publicly on various regulatory topics 100+ times in his career. He has authored articles about FDA, federal fraud and abuse, and disclosure laws and regulations. He is quoted by the press regarding issues that impact pharmaceuticals and medical technologies.
- Juris Doctor, Mitchell Hamline School of Law (St. Paul, Minnesota)
- Master of Business Administration, major: Venture Management, University of St. Thomas Opus College of Business (St. Paul, Minnesota)
- Bachelor of Science, double major, Finance and Economics, University of Wisconsin-La Crosse (La Crosse, Wisconsin)
- Minnesota
- U.S. District Court, District of Minnesota
Mark counsels pharmaceutical and medical technology companies of all sizes on various matters including:
- Contract general counsel, compliance counsel, and/or compliance officer
- Designing, developing, deploying, and monitoring compliance programs for manufacturers
- Performing routine compliance audits for manufacturers
- Drafting regulatory assessments of compliance with FDA and FTC regulations, Anti-Kickback Statute, False Claims Act, Stark Law, Sunshine Act, HIPAA, the Foreign Corrupt Practices Act, and other laws
- Conducting due diligence for buyers and sellers
- Serving as a reviewer for Medical, Legal, and Regulatory (MLR) review of product labeling and advertising
- Investigate alleged employee misconduct—bribing customers
- Perform board-directed audit of combination product manufacturer to investigate whether large sales force was promoting off-label and/or providing inappropriate reimbursement advice
- Investigate alleged employee misconduct for misappropriation of drug samples
- Performing a compliance audit of a speaker bureau for a pharmaceutical manufacturer
- Providing regulatory support to a major pharmaceutical company responding to subpoena in a qui tam (whistleblower) case
- Evaluating grant requests
- Establishing off-label dissemination policies and procedures for pharmaceutical and medical device manufacturers
- Evaluating reimbursement tools and support programs, a.k.a., “hubs” and patient assistance programs
- Performing compliance training for staff of all shapes and sizes
- National Sales Meeting training
- Facilitating the Open Payments (Physician Payments Sunshine Act) reporting process
- Providing legal support for various feasibility, IDE, and post-approval trials
- Performing FDA regulatory classification assessments
- Drafting, and responding to, competitive trade complaints
- Resolving Warning Letters, Import Alerts, and CFG holds for international and domestic medical device manufacturers
- Negotiated Consent Decrees with DOJ/FDA
- Respond to Consent Decree directed towards a manufacturer for alleged CGMP violations. Consent Decree eventually rescinded
- Performing FDA-directed “Expert Reviews” for manufacturers required by Consent Decree
- Successfully petitioned for relief from Consent Decree
- Resolving FDA and U.S. Customs and Border Protection Seizure action directed at manufacturers
- Drafting regulatory assessments for HCT/P manufacturers to determine whether their products are exempt from premarket review
- Reviewing and drafting contracts
- Performing privacy reviews
- Acting as an expert witness in a trial on behalf of a manufacturer