Event Recap: A Discussion on Litigation & Government Strategy

Government scrutiny often begins as a manageable regulatory issue. It can become more serious when a company fails to respond, loses credibility, or treats an agency interaction as routine business correspondence.

In the first session of Gardner Law’s 10-year anniversary program, Marking 10 Years: Past, Present, & Future Perspectives in FDA Law, Amanda Johnston moderated a discussion with David Graham and Vivian Egbu on how FDA-regulated companies should think about litigation risk, government investigations, recalls, warning letters, and agency escalation.

FDA Enforcement Is Law Enforcement

A central theme of the discussion was that FDA enforcement is law enforcement. FDA, USDA, state agencies, DOJ, OIG, CMS, and other government actors have different tools and mandates, but their core incentives often remain consistent. They are focused on protecting patients and consumers, addressing fraud, protecting the government purse, and preserving the integrity of regulated markets.

“FDA enforcement and USDA enforcement are law enforcement. If an agency tells you to do something different, you need a good reason not to do that.”
David Graham, Senior Counsel

For companies in FDA-regulated industries, agency engagement works best when the response is prompt, well supported, and calibrated to the risk at issue. A company that disputes an agency conclusion should be prepared to explain its position through the record while maintaining credibility with the regulator.

What Drives Escalation

The panel identified several recurring drivers of escalation, including patient harm, public health risk, evidence of fraud, false statements, repeat observations, weak remediation, and lack of cooperation. A Form FDA 483, warning letter, recall discussion, document request, or employee complaint can become a larger government matter when the company response appears incomplete, delayed, or unsupported.

“Even if the amount is small, if many patients were harmed or the issue raises a public safety concern, the government may still pursue the case.”
Vivian Egbu, Associate Attorney

The panel also addressed warning letters and agency follow-up. A company may have grounds to challenge an agency position, clarify the evidence, or negotiate the appropriate corrective path. Ignoring the agency is different. It can increase scrutiny and narrow the company’s ability to control the next steps.

“Anytime FDA is coming to you with a concern, it is wise to respond. They are not going to go away, and the issue can escalate.”
Amanda Johnston, Partner

Early Mistakes Can Shape the Entire Matter

The panel emphasized that companies can create unnecessary risk in the earliest days of an inquiry. Common mistakes include not having a response plan, failing to train employees on how to respond to government contacts, allowing speculation to spread internally, treating document requests or interviews as routine, and failing to involve appropriate counsel early enough.

The speakers also discussed meeting recordings, transcripts, chat logs, and AI note-taking tools. These materials may be discoverable if they are not privileged. Even where privilege may apply, companies can create avoidable disputes by allowing automated tools to record sensitive legal, regulatory, or quality discussions.

Practical Takeaways for FDA-Regulated Companies

A disciplined response is a credibility-building exercise. The goals are to understand the issue, preserve the record, communicate accurately, protect the company’s rights, and resolve the matter before it becomes harder to manage. 

• Have a response plan for inspections, warning letters, document requests, interviews, recalls, whistleblower allegations, and cross-agency inquiries.
• Train employees on how to respond when government personnel ask questions outside ordinary inspection channels.
• Control internal communications without suppressing facts or discouraging legitimate reporting.
• Address whistleblower concerns seriously and avoid retaliation or dismissive treatment.
• Use recording, transcription, and AI note-taking tools carefully in sensitive legal, compliance, and quality discussions.

Watch the Discussion and Contact Gardner Law

Watch the session recording above and download the slides for more detail. If your organization is responding to FDA enforcement activity, government scrutiny, a warning letter, recall issue, whistleblower concern, or litigation risk, contact Gardner Law for assistance in evaluating the issue and developing a practical response strategy.