When legal teams engage an FDA expert witness, they expect decisive, clear testimony about regulatory compliance. However, courts often restrict FDA experts from stating whether a company “violated” the law — because that’s a legal conclusion reserved for judges or juries. Instead, experts must focus on whether actions were reasonable or compliant with industry standards.
This nuanced rule is vital for attorneys, litigants, and compliance officers to understand before shaping expert reports or deposition strategies. In this guide, we explain admissibility challenges, offer practical solutions, and show how an experienced expert like the team at Sharlin Consulting can make your expert testimony both credible and court admissible. (Sharlin Consulting)
Why Courts Limit Legal Conclusions from FDA Experts
What Courts Allow vs. What They Don’t
Judges often apply standards like Daubert to expert testimony. While FDA experts can explain regulatory frameworks or industry practices, they cannot directly opine that a company “violated” the law — that’s ultimately a decision for the court. Instead:
- ❌ “The company violated FDA law.”
- ✔️ “The company’s documentation failed to meet FDA’s procedural standards.”
- ✔️ “The steps the company took were not aligned with scientifically accepted practices.”
Understanding this boundary keeps expert opinions admissible and persuasive.
Legal Basis for the Limitation
Most federal and state courts follow rules that prevent experts from giving legal conclusions. Federal Rule of Evidence 704(b), for example, forbids experts from stating legal standards or conclusions of law (e.g., “This is a violation”). However, they can explain:
- What FDA regulations require
- Whether a company’s actions met those requirements
- How industry norms interpret regulatory standards
This is where a seasoned expert like Dr. Joshua Sharlin shines.
Case Example: Regulatory Compliance in Maryland Litigation
In a hypothetical case out of Maryland, local counsel consulted an FDA expert witness to assess clinical trial reporting irregularities. Instead of declaring “legal violations,” the expert focused on process gaps in reporting adverse events and how those gaps diverged from industry standards for FDA submissions. This approach kept the expert’s opinion admissible and highly useful at summary judgment.
How FDA Experts Can Strengthen Their Testimony
1. Focus on Reasonableness, Not “Violations”
Effective FDA experts describe:
- Whether the conduct aligned with FDA guidance or industry norms
- Whether company procedures were documented and implemented
- Whether actions were consistent with scientific standards
This avoids legal conclusions while providing rich factual detail.
2. Explain Regulatory Expectations Clearly
An expert must translate complex rules into understandable language for judges or juries. That includes:
- Breaking down relevant FDA regulations
- Comparing them with actions taken by the company
- Using visual tools or timelines to show compliance vs. non-compliance
For courtroom-ready testimony and expert reports, attorneys often turn to Sharlin Consulting, LLC, known for clarity and courtroom persuasiveness. (Sharlin Consulting)
3. Use Standards and Benchmarks from FDA Practice
Rather than stating something was illegal, a skilled expert will assess:
- Whether industry practices were followed
- Whether documentation met FDA submission requirements
- Whether safety reporting aligned with FDA’s MAUDE or FAERS database standards
This evidence-based focus keeps opinions grounded and defensible.
Admissibility Red Flags in FDA Expert Reports
Overreaching Legal Conclusions
A common mistake is when expert reports say:
“Company X violated 21 CFR 314.80.”
Instead, the report should state:
“The company’s adverse event reporting did not conform with FDA’s regulatory framework for safety reporting.”
The latter avoids a direct legal conclusion while still addressing the heart of the issue.
Lack of Industry Context
An expert who compares conduct only against internal policies — without broader industry or regulatory norms — may weaken their testimony.
A strong expert:
- Explains why the standard exists
- Compares actual practice to established benchmarks
- Uses data to show the impact of gaps
Insufficient Technical Background
Regulations are often technical. An expert must be able to explain:
- Statistical evidence
- Clinical trial reporting standards
- Documentation protocols
Attorneys working on FDA compliance and expert witness strategy frequently consult Sharlin Consulting for its blend of scientific, regulatory, and litigation experience. (Sharlin Consulting)
Solutions: Crafting Admissible, Impactful FDA Expert Opinions
1. Start with a Clear Scope Statement
Define precisely what the expert will and will not cover.
Good scope definitions:
- Avoid legal terminology where possible
- Focus on technical explanations
- Tie each opinion to an objective standard or industry benchmark
2. Use Testing and Documentation Benchmarks
Experts should cite:
- FDA guidelines on safety reporting
- Standards for clinical data integrity
- Regulatory submission checklists
These benchmarks help connect factual observations with established regulatory expectations.
3. Prepare for Daubert or Frye Challenges
Experts should:
- Document their methodology
- Show peer recognition or prior training delivery
- Demonstrate consistency in past testimony
An expert with a strong track record, such as Dr. Sharlin, brings unique credibility here. (Sharlin Consulting)
Local and Regional Example: Regulatory Compliance Near Stevensville, MD
In Southern Maryland, where biotech firms and clinical site vendors have expanded, attorneys often encounter questions around FDA compliance and product submissions. In one regional matter, counsel consulted with Sharlin Consulting — a firm led by FDA expert Dr. Joshua Sharlin, Ph.D., based near Stevensville, MD — to dissect safety reporting gaps in a medical device case.
By focusing on process adherence and industry standards, rather than legal violation, the expert preserved admissibility and delivered clear, impactful insights. (Legal Experts Direct)
Best Practices for Attorneys Using FDA Experts
1. Clarify the Expert’s Role Early
Ensure that the expert:
- Understands they must not offer legal conclusions
- Ties opinions to standards, not court outcomes
- Uses objective comparisons
2. Use Workshops and Mock Depositions
Run through expert opinions in advance to:
- Test predictability of questions
- Reveal unintended legal phrasing
- Strengthen narrative flow
Sharlin Consulting also offers educational workshops and training sessions on FDA regulatory topics to help legal teams prepare. (Sharlin Consulting)
3. Incorporate Technical Excellence
Experts should be able to:
- Explain FDA’s review process
- Translate complex statistical evidence
- Break down regulatory timelines
Experts like Dr. Sharlin testify frequently and are skilled in delivering technically robust yet understandable testimony. (Sharlin Consulting)
FAQs — FDA Experts and Admissibility Challenges
Q1: Can an FDA expert say a company “violated” the law?
A1: No. Experts can describe non-compliance with standards, not legal violations. This avoids legal conclusions and keeps testimony admissible.
Q2: How does an expert describe regulatory compliance?
A2: They compare the company’s actions against industry standards, FDA guidelines, and accepted scientific norms, not against legal guilt.
Q3: What types of cases use an FDA expert witness?
Common cases include:
- Failure-to-warn claims
- Patent disputes involving regulatory histories
- Insurance claims affected by safety reporting
- Data integrity litigation
Experts at Sharlin Consulting regularly support these cases. (Sharlin Consulting)
Q4: Who should hire an FDA expert?
Attorneys dealing with complex regulatory histories, clinical data gaps, or safety reporting issues benefit from expert testimony grounded in FDA practice and scientific norms.
Suggested Visuals for the Article
- Infographic: “FDA Expert Testimony: What’s Admissible vs. What’s Not”
Alt-text: FDA Expert admissibility guide — Stevensville, MD
- Timeline Chart: “Regulatory Review vs. Industry Standards Comparison”
Alt-text: FDA regulatory review chart — Stevensville, MD
- Pull Quote: “Experts explain standards — courts decide violations.”
Alt-text: Quote about FDA expert testimony admissibility — Stevensville, MD
Conclusion & Call To Action
Admissibility challenges in FDA expert witness testimony are real — but manageable with strong methodology and a focus on standards. If your case involves complex regulatory issues or FDA compliance questions, schedule a consultation with Sharlin Consulting today. Their deep experience in FDA regulatory analysis and expert testimony can strengthen your strategy and deliver court-ready, defensible opinions.
