Breaking the Ice: FDA-focused firm leader sees benefits in AI

Written by Todd Nelson // November 14, 2024 

[This article was originally published on minnlawyer.com.]

Artificial intelligence already is positively affecting health, according to Mark Gardner, managing partner of Gardner Law, which represents clients subject to Food and Drug Administration regulations.

“Overall, AI is making us all safer and healthier by putting tools in the hands of providers that make them more effective at keeping us all healthy,” Gardner said.

AI, for example, can review images much faster and more effectively than a radiologist, Gardner said, “which is important when the work involves reviewing thousands of images to find a blood clot in the brain.”

Gardner, who founded his Stillwater-based firm in 2016, has 25-plus years of experience in FDA-regulated industries. Eight of the firm’s other attorneys have in-house experience, while another is a career FDA litigator. The firm also has three non-attorney specialists: a former FDA compliance officer, a cybersecurity technician, and a pharmaceutical labeling specialist.

Gardner Law focuses on litigation and compliance, regulatory and privacy matters. Clients, all regulated by the FDA, include companies that manufacture medical devices, drugs, foods and cosmetics.

Name: Mark Gardner

Title: Managing partner, Gardner Law

Education: B.S., economics and finance, University of Wisconsin-La Crosse; MBA, University of St. Thomas’ Opus College of Business; J.D., Hamline University School of Law

Q: Best way to start a conversation with you?

A: I’m Gen-X, so I feel like a tweener with all the communication methods. I’m a sucker for the old-school phone call or meeting over lunch. Short answer: email, phone, text, carrier pigeon.

Q: Why law school?

A: My first academic touch with the law was an undergraduate business law class. It was fascinating to see disputes resolved quickly and effectively by the legal system. In business school, I really got the itch after taking two business law classes. My professor and another student encouraged me to apply for law school. The real attraction was the idea of helping speed commerce through effective counsel. Working with business leaders on ideas that can help to change the world for the better. I wanted to establish a firm that gets at the core of the human experience — health. Without it, we have nothing.

Q: What are you reading?

A: Albert Einstein’s biography by Walter Issacson, “Einstein: His Life and Universe.”

Q: Pet peeve?

A: Inefficiency. My father instilled an anti-waste characteristic in me. Finish your meal. Turn off the lights. Don’t waste anything.

Q: Best part of your work?

A: Helping our clients achieve their goals. We’ve helped clients on the ropes get through to the FDA and get their products on the market. We’ve helped clients get out of hot water with the government and get their businesses back on line. Mentoring our incredibly bright team of attorneys.

Q: Most challenging?

A: The stress of being responsible for hundreds of clients and 13 employees. This pressure is something that also drives me. We have an amazing team that I know I can rely upon. We help one another, so it’s by no means doing all the rowing alone. But as the captain, I have to constantly look at the horizon for opportunities and threats.

Q: Favorite activity away from work?

A: Alpine skiing. It’s what I imagine flying feels like. I’ll teach anyone how to ski if they reach out to me. We can meet at Afton Alps, which is a mile from our house.

Q: Where would you take someone visiting your hometown?

A: Grandad’s Bluff in La Crosse, Wisconsin. From there, you can see the entire city and decide where to go next.

Q: Legal figure you admire?

A: John Marshall, known as the father of the Supreme Court. He established federalism, which is credited by some as the reason our diverse states and views as a nation have survived, and thrived, as a republic.

Q: Misconception about your work?

A: Most people think I’m a patent attorney. There are no books or movies about regulatory lawyers that I know of. Most Americans don’t know that 20% of the U.S. economy is regulated by the FDA.

Q: Favorite book, movie or TV show about lawyers?

A: The “Godfather.” The role of Tom Hagen, Don Corleone’s consigliere, which means counselor or adviser in Italian, fascinated me. It was interesting that someone like Don Corleone would listen to his lawyer.