David Graham
Senior Counsel
O: 651.393.6487
M: 612.499.4149
David Graham advises FDA-regulated companies, food manufacturers, medical device companies, pharmaceutical companies, healthcare providers, and related businesses in litigation, enforcement, and regulatory matters where business operations and legal exposure converge. Clients bring him into matters involving FDA, USDA, state agency, DOJ, FTC/NAD, and False Claims Act risk, particularly when a regulatory problem could become a contested dispute.
David’s practice reflects decades of work at the intersection of food and drug regulation, product liability, health care disputes, and complex commercial litigation. He has represented manufacturers, distributors, laboratories, providers, and regulated product companies in matters involving labeling, safety, recalls, off-label marketing, billing, medical necessity, and post-market product claims.
He works with clients to connect regulatory strategy with litigation posture. That includes helping executives, in-house counsel, regulatory teams, and business leaders evaluate what happened, assess exposure, manage communications with government authorities, and take corrective action without creating unnecessary downstream risk.
Clients bring David into matters that require careful judgment under pressure, including internal investigations, government inquiries, FDA and state agency interactions, food safety and labeling disputes, product liability litigation, and False Claims Act matters. His work often requires translating dense regulatory and factual records into a practical path forward.
David’s teaching, writing, and bar leadership reinforce the same practical focus he brings to client work. He helps clients understand not only what the law requires, but how enforcement theories, litigation dynamics, and business realities interact when regulated products are under scrutiny.
Focus Areas
- FDA enforcement response and regulatory counseling
- Food labeling, safety, and post-market disputes
- Medical device and pharmaceutical product liability litigation
- False Claims Act, Medicare billing, and health care fraud matters
- Cannabis and CBD regulation in food and medicine
- Recall strategy, corrective actions, and internal investigations
- FTC/NAD, advertising, and performance claims disputes
- Commercial litigation involving regulated product companies
Representative Experience
- Defended a national fast-food chain against local and county food regulations.
- Represented a juice manufacturer and distributor in a labeling class action in federal court.
- Represented a food testing lab in a DOJ investigation of a listeria outbreak.
- Defended a food manufacturer against Proposition 65 claims.
- Represented a food packaging company in an FTC/NAD performance claims dispute.
- Represented a medical device manufacturer in a government investigation regarding off-label marketing.
- Defended an artificial heart valve manufacturer in product liability lawsuits.
- Represented a penile implant company in nationwide injury lawsuits.
- Defended a diabetes monitor manufacturer in product liability cases.
- Defended a pharmaceutical company in mass litigation involving an erectile dysfunction drug.
- Represented an antibiotics manufacturer in product liability litigation.
- Represented a hormone replacement therapy manufacturer in mass litigation.
- Represented a medical device manufacturer in a government investigation of alleged false claims related to silicone use.
- Defended a provider in a False Claims Act case regarding Medicare billing.
- Represented a provider in a False Claims Act case regarding the medical necessity of services.
Differentiators
- Brings a litigation perspective to FDA regulatory, enforcement, food safety, labeling, and post-market risk matters.
- Has represented food, medical device, pharmaceutical, laboratory, provider, and regulated product companies in disputes involving federal and state authorities.
- Draws on extensive teaching and writing experience in FDA, food law, False Claims Act, and product liability issues.
- Has handled matters involving FDA, USDA, DOJ, FTC/NAD, state agencies, and courts.
- Combines regulatory analysis with practical judgment about evidence, documentation, litigation exposure, and business disruption.
Thought Leadership, Teaching, & Ventures
- FDA and Food Law Professor, Mitchell Hamline University School of Law.
- Adjunct Professor, University of Minnesota Law School, Food, Drug and Device Law.
- Guest lecturer on the False Claims Act, University of Minnesota Law School, 2008 to 2013.
- Founding Chair, Mitchell Hamline School of Law Food Law Center Advisory Board.
- Past Chair, Minnesota State Bar Association Food, Drug and Device Law Section.
- Author of articles on food labeling, FDA authority, consumer fraud theories, preemption, the learned intermediary doctrine, clinical trials, and product liability.
Education
- J.D., Hamline University School of Law (St. Paul, MN)
- B.A., Political Science & Religion, St. Olaf College (Northfield, MN)
- Post-graduate study of Religion, Vanderbilt University (Nashville, TN)
Admissions & Affiliations
- Minnesota
- U.S. District Court, District of Minnesota
- Federal district court pro hac vice admissions in Arkansas, the Western District of Washington, and the Southern District of Illinois
- U.S. Court of Appeals for the Federal Circuit
- U.S. Court of Appeals for the Eighth Circuit
- U.S. Supreme Court
- American Bar Association
- Minnesota State Bar Association, Health Care and Food, Drug and Device Law Sections
- Mitchell Hamline School of Law Food Law Center Advisory Board, Founding Chair
- Volunteer Lawyers Network, Benefactor Board Co-Chair
Honors & Awards
- Recipient of an AV Preeminent Rating by Martindale- Hubbell
Personal
Outside his client work, David has devoted substantial time to pro bono and community service, including asylum, housing, education, equity stripping, and death penalty matters, as well as board and development work with Mitchell Hamline Law School Alumni Association, the Arthritis Foundation, SteppingStone Theatre, and Volunteer Lawyers Network.