Mark Gardner, M.B.A., J.D., President

mgardner@gardner.law
‭+1 (651) 430-7150  office
‭+1 (612) 382-7584‬  mobile

Mark Gardner has provided regulatory counsel to over 300 medical technology and pharmaceutical makers across the U.S., Canada, Europe, Japan, Australia and Israel. He uses over 20 years of experience to counsel and train clients on compliance, product approvals, ad/promo review, enforcement actions, sunshine reporting, quality and regulatory matters, and privacy. Prior to practicing law he worked in commercial roles at ev3 (Medtronic), Celleration (Alliqua), and MedTox (LabCorp). He is an Adjunct Professor of Law and HLI advisory board member at Mitchell Hamline School of Law.

300+


CLIENTS COUNSELED

49


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 know what they are going through. I can relate to their business objectives and help them achieve them in a compliant fashion. This is what sets me apart from other lawyers.
– Mark Gardner, M.B.A., J.D.
Practice areas:
  • Compliance assessments, investigations and training
  • Design and implementation of compliance programs
  • Advertising and promotional review
  • Business interactions with health care professionals
  • Responding to and negotiating with the FDA and DOJ
  • Transparency reporting
  • Quality and Regulatory assessments
  • Product clinical investigation and FDA approval pathways
  • Privacy compliance
  • Responding to and negotiating with the government

Prior to practicing law Mark worked in product commercialization and development at three companies over ten years: ev3 (Medtronic), Celleration (Alliqua), 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 nearly 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)

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

Copyright Gardner Law 2019. All Rights Reserved.
Information provided on this website is not legal advice. Communications sent to or from this site do not establish an attorney-client relationship.