Mark Gardner
Founder and Managing Partner

mgardner@gardner.law
O: 651.430.7150
M: 612.382.7584

Mark advises medtech, pharma, biotech, food, and life sciences companies on high-stakes FDA and healthcare, compliance, and enforcement matters. He spent a decade in commercial roles before practicing FDA and healthcare law and is often brought in by executive teams and in-house counsel to solve regulatory problems without slowing the business.

Mark’s practice reflects how his career developed. He started in sales and product management before practicing FDA and healthcare law, including working inside companies through secondments. That experience still shapes how he works. Legal and regulatory issues do not arise in a vacuum. They affect product launches, transactions, growth strategy, and day-to-day decisions under pressure.

He is often a lawyer to lawyers, working alongside in-house legal and regulatory teams to help them see around corners in the intersection of FDA, CMS, enforcement risk, and business demands. Gardner Law is built to dovetail with internal teams, not slow them down or restate the law.

Clients bring Mark into matters that are high stakes, operationally messy, or difficult to solve from a purely technical legal perspective. His work includes FDA submission strategy, warning letters, consent decrees, recalls, internal investigations, compliance audits and remediation, sunshine (Open Payments), privacy, and regulatory diligence in significant transactions.

A significant portion of Mark’s practice focuses on interactions with healthcare providers, including compliance with the Anti-Kickback Statute, False Claims Act, Stark Law, and the Foreign Corrupt Practices Act, as well as AdvaMed and PhRMA codes. He regularly advises on structuring arrangements, conducting audits, and applying OIG guidance, including pursuing advisory opinions where appropriate.

Mark holds an M.B.A. and is known for translating regulatory risk into practical decisions for management and boards, particularly where compliance, commercialization, governance, and regulatory strategy overlap.

Focus Areas

FDA regulatory strategy, including submission strategy and lifecycle counseling
Enforcement response (FDA, DOJ, CMS, and OIG)
Sales and marketing compliance, including market access, medical affairs, and R&D activities
Compliance with healthcare provider interactions (AKS, FCA, Stark, FCPA, AdvaMed, PhRMA, OIG guidance, Sunshine Act, and state and municipal analogs)
Compliance program design, audits, and remediation
Regulatory and compliance diligence in transactions
Privacy and HIPAA compliance

Representative Experience

Negotiated and remediated FDA consent decrees involving dietary supplement companies and executives
Led court-ordered expert review and helped vacate an injunction for a probiotic manufacturer
Testified as an expert witness in a food industry trial
Conducted regulatory, compliance, and privacy diligence for a medical device acquisition exceeding $1B
Led board-directed compliance audit and enterprise remediation for a pharmaceutical company
Served in compliance leadership roles and secondments as in-house counsel and compliance officer for drug and device manufacturers, including Fortune 500 companies
Advised on sunshine (Open Payments) and global transparency compliance, including end-to-end reporting
Audited reimbursement support and patient services programs for multinational device companies
Conducted HIPAA compliance audits for healthcare and DME companies
Negotiated clinical trial agreements for hundreds of studies on behalf of sponsors
Resolved FDA enforcement matters including 483s, warning letters, recalls, import holds, seizures, injunctions, and certificate denials
Served on advertising, promotional, and scientific/medical review committees as legal and regulatory reviewer

Differentiators

10 years in commercial roles before practicing law
FDA and healthcare attorney with in-company secondment experience
Deep experience advising on healthcare provider interactions and enforcement risk (AKS, FCA, Stark, FCPA, OIG)
Regularly handles matters involving FDA, DOJ, CMS, and OIG
Works directly with in-house legal and regulatory teams, boards, and executives
Focused on solving regulatory problems without disrupting business operations

Thought Leadership, Teaching, & Ventures

Adjunct Professor, University of Minnesota Law School
Adjunct Professor, Mitchell Hamline School of Law
Senior Lecturer, Carlson School of Management
Founder, Chrysalis Incubator (FDA-focused medtech incubator working with inventors and early-stage teams)
Co-Founder, JDL Access (medtech market access solutions)
Founder, Stillwater MedTech Consulting (quality and operations advisory)
Founder and GP, Bear Woods (healthcare-focused angel investment)
Mark writes and speaks regularly on FDA, healthcare, compliance, and commercialization issues and mentors students, founders, and early-stage professionals.

Education

J.D., Mitchell Hamline School of Law
M.B.A., University of St. Thomas, Venture Management
B.S., Economics and Finance, University of Wisconsin–La Crosse

Admissions & Affiliations

Minnesota
U.S. District Court, District of Minnesota
Co-Chair, FDLI Advertising and Promotion Conference (2023); long-time member of the FDLI Advertising and Promotion Conference Planning Committee
Past Council Member and officer roles, including Chair, MSBA Food, Drug and Device Law Section
Current Council Member, MSBA Health Law Section
Member, Medical Alley; past chair of regulatory special interest group

Personal

Mark is an avid skier who has skied 68 areas across five continents, eight countries, and numerous U.S. states. He is an active masters alpine ski racer in slalom, giant slalom, and super G. He also enjoys mountain bike racing and golfing, especially the friendly competition he shares with his father, brother, and son.

Mark GardnerFounder and Managing Partner