Stay informed and subscribe. Signup

Healthcare and FDA Compliance in 2025, Part I: FDA War Stories from the Front Lines

March 11, 2025

On February 13, 2025, Gardner Law and Fredrikson co-hosted the "Healthcare and FDA Compliance in 2025" CLE program, offering hundreds of attendees valuable insights into emerging trends and regulatory challenges.

During the opening session, FDA War Stories from the Front Lines Gardner’s senior litigation attorney David Graham and Fredrikson’s Joseph Dixon shared firsthand experiences from significant healthcare and FDA litigation cases, providing practical lessons on managing regulatory risks. They provided four major lessons that you need to know in order to navigate the increasingly complex compliance landscape in 2025. Check them out below, or watch the full recording on our YouTube page. 

Key Takeaways:

FDA Compliance Experts

1. Regulatory Shifts: Federal vs. State Enforcement

  • The FDA and DOJ may scale back enforcement due to administrative changes, but state agencies are likely to increase scrutiny.
  • Multi-state enforcement coalitions are becoming more active, filling gaps left by reduced federal oversight.
  • Companies should prepare for aggressive state-level actions, which often have fewer avenues for appeal.

2. Whistleblower & False Claims Act Risks

  • Qui tam (whistleblower) lawsuits continue to rise, even in cases where the DOJ declines involvement.
  • Private funding of whistleblower cases is enabling longer, costlier litigation.
  • False Claims Act cases can result in treble damages, government contract bans, and reputational damage.

3. Preparing for Investigations

  • Companies must understand how different regulatory agencies operate and develop response strategies accordingly.
  • Document retention, compliance training, and internal audits are critical in mitigating risk.
  • Emails and internal communications should avoid hyperbolic or misleading language that could be misinterpreted in litigation.

4. The Cost of Litigation & Best Practices for Defense

  • Legal proceedings are expensive, unpredictable, and should be avoided where possible.
  • Narrowing the scope of investigations, responding strategically, and resolving issues swiftly can mitigate damage.
  • In whistleblower cases, companies must assess settlement options carefully to avoid prolonged legal battles.

During the talk, David described how to approach situations in which you or your company is handling investigations.

“Winning doesn’t look like winning—it looks like not losing a lot. It looks like protecting the company, keeping the business running, and having as little government contact as possible.”

What You Can Do

The regulatory landscape in 2025 remains uncertain, but proactive compliance measures, strategic legal defense, and maintaining awareness of evolving enforcement trends can help companies navigate the complexities of FDA and DOJ oversight. David and the rest of Gardner Law’s team are capable with providing you with timely insights on healthcare and compliance, and we are there to support you and your company by delivering expert guidance, proactive risk management strategies, and tailored legal solutions to help you stay ahead of enforcement challenges. Contact us today to ensure your organization is prepared for whatever legal hurdles lie ahead.

Resources: