A Complimentary CLE event from Gardner Law 

On May 22, Gardner Law hosted the in-person and live-streamed CLE webinar, Saison-al Session: A Legal Update for FDA-Regulated Industry, at landmark beer hall and pizza restaurant Surly Brewing Co. Over the course of five gripping sessions, Gardner's attorneys presented updates and practical insights surrounding emerging enforcement trends, compliance best practices, and recent regulatory challenges impacting FDA-regulated companies. 

Amanda Johnston hopped to it with What’s Brewing in Compliance? Hot Topics and Enforcement Trends. This session covered recent Anti-Kickback Statute (AKS) and False Claims Act (FCA) cases and settlements, along with key compliance trends affecting FDA-regulated companies. Attendees also gained insights into the latest OIG Work Plan priorities and emerging healthcare compliance risks.

Next on tap was Nathan Downing's Tapping into FDA: Regulatory Hot Topics. This session provided updates on the latest with the FDA regulation. Following an engaging presentation and discussion between Nate, Rebecca Zadaka and Brynn Stanley, attendees gained insights into why and how to be proactive in crafting their regulatory approach based on an evolving regulatory and enforcement landscape.

Next, David Graham presented Pour Decisions: Lessons from Health Care Fraud & Liability Cases. This session discussed important health care fraud and product liability cases and decisions from the last year and outlined the DOJ’s and OIG’s enforcement priorities going forward. Attendees were able to draw and discuss insights into enforcement trends and priorities, risk mitigation and compliance strategies to help navigate potential legal pitfalls—all from real life cases following David's presentation.

After a brief refreshment break, Paul Rothermel cracked open his session, Hot or Cold? A Privacy Enforcement Update. Much like Minnesota temperatures in May, privacy enforcement trends are challenging to plan for. In this information-filled session, Paul broke down key privacy enforcement trends in the U.S. and abroad, including examples and relevant compliance tips. Attendees left this session with a stout awareness of enforcement priorities and how to better comply in these critical areas.

Concluding the presentation was a panel discussion led by Mark Gardner with attorneys and industry leaders, including Bryan Phillips, Sr. Vice President, General Counsel and Secretary, and Chief Compliance Officer at Inspire Medical Systems, Wendy Cusick, General Counsel and Chief Compliance Officer at CoNextions Medical, and Jonelle Burnham, VP, General Counsel and Compliance Officer at CVRx | Barostim, who discussed all the latest topics of the day.