Litigation Support Services
Independent statistical expert-witness and consulting support for medical-device, pharmaceutical, and clinical-trial disputes — from early case assessment through expert reports and, where retained to do so, trial testimony. Dr. Li accepts engagements for both plaintiff and defense, each subject to a conflicts-of-interest check.
Consulting and testifying roles
Counsel can retain Dr. Li in a non-testifying advisory capacity, as a disclosed testifying expert, or move from one to the other as a matter develops.
Non-testifying advisory support
Behind-the-scenes statistical analysis and strategy to help counsel understand the numbers and shape the case.
- Early case assessment and evaluation of statistical strengths and weaknesses
- Methodology review of studies, analyses, and submissions at issue
- Identifying flaws, assumptions, and limitations in an opposing party's analysis
- FDA regulatory and evidence-strategy review, including 505(b)(2)-pathway considerations
Disclosed testifying expert
Independent opinions documented and defended on the record. Dr. Li is available for and welcomes testifying engagements.
- Expert reports under the applicable rules of procedure
- Declarations and affidavits
- Rebuttal of opposing statistical experts
- Daubert and admissibility support
- Deposition and trial testimony
What Dr. Li can do
Drawing on regulatory review experience at FDA/CDRH and biostatistics roles in cardiovascular devices and vaccine development, Dr. Li offers a focused set of statistical services for litigation.
Statistical methodology review
Independent assessment of study design, analysis methods, assumptions, and conclusions in the data at issue.
Adverse-event & incidence analysis
Evaluation of adverse-event and incidence rate calculations, denominators, and comparative methodology.
FDA regulatory & clearance opinion
Statistical perspective on PMA, De Novo, 510(k), IDE, and real-world-evidence considerations from a former CDRH reviewer.
Rebuttal reports
Critical response to opposing statistical experts, identifying methodological errors and overstated conclusions.
Daubert & admissibility support
Analysis supporting or challenging the reliability and fit of statistical evidence and expert methodology.
Expert reports, declarations & affidavits
Written opinions prepared to the standards applicable to the forum and stage of the matter.
Deposition & trial testimony
Available to present and defend statistical opinions at deposition and at trial when retained to testify.
Early case assessment
Threshold review of the statistical issues so counsel can gauge exposure and direction before committing resources.
Pharmaceutical evidence & regulatory strategy review
Assessment of evidence-generation strategy, clinical and biomarker evidence gaps, and FDA pathway considerations.
Plain-language explanation & demonstratives
Clear, accurate translation of statistical concepts for judges and juries, including supporting demonstratives.
How Dr. Li approaches an engagement
Dr. Li accepts engagements from both plaintiff and defense. Every prospective engagement begins with a conflicts-of-interest check before any work is undertaken. His opinions are independent and methodology-driven: they follow the data and the applicable statistical standards rather than the position of the retaining party.
Prior experience does not predict or guarantee any particular outcome. Each matter is assessed on its own facts, data, and record.
How an engagement starts
- Initial confidential discussion of the matter and the statistical questions involved
- Conflicts-of-interest check
- Written engagement agreement defining scope, role, and terms
- Analysis and deliverables begin once the engagement is confirmed
No duty of confidentiality arises until an engagement is confirmed in writing. Please do not send privileged or confidential information before the engagement is in place.
Discuss a matter with Dr. Li
Tell us about the statistical issues in your case. Initial discussions are confidential, and every engagement is subject to a conflicts-of-interest check.