Insights & Articles
Plain-language explainers on the statistics that decide medical-device, pharmaceutical, and clinical-trial litigation, written by Lei Li, Ph.D. These articles are for general education only. They are not advice for any particular matter and do not represent the views of the FDA.
Relative Risk Greater Than Two and Specific Causation in Toxic Tort Cases
Why courts often treat a relative risk above 2.0 as the threshold for the doubling-of-risk argument, and what that statistic can and cannot say about specific causation.
Read articleDaubert and Statistical Evidence: What Attorneys Should Know
How courts evaluate the reliability of statistical methods and expert opinions under the Daubert framework.
Coming soonStatistical Significance, P-Values, and Confidence Intervals in Litigation
What these core measures actually mean, and the common ways they are misread in the courtroom.
Coming soonNumber Needed to Harm and Interpreting Adverse-Event Rates
Translating adverse-event incidence into measures that attorneys, judges, and juries can reason about.
Coming soonHow Meta-Analysis Is Used (and Misused) in Product Liability Litigation
Pooling studies can strengthen or distort an inference. A look at heterogeneity, study selection, and publication bias.
Coming soon510(k) vs. PMA: The Statistical Evidence Behind FDA Device Clearance
How the evidentiary and statistical expectations differ across FDA device pathways, and why it matters in disputes.
Coming soonReal-World Evidence (RWE) in FDA Submissions and Litigation
Where real-world data fits in regulatory decision-making, and the methods used to address confounding.
Coming soonCritiquing and Rebutting an Opposing Statistical Expert
A framework for examining the assumptions, methods, and data underlying an opposing expert's analysis.
Coming soonSurvival Analysis and Time-to-Event Data in Clinical Trial Disputes
How time-to-event methods work and the interpretation questions they raise in clinical-trial litigation.
Coming soonNew articles are published periodically. Check back for additional explainers on statistical evidence in litigation.
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Independent statistical review, expert reports, and consulting for medical-device, pharmaceutical, and clinical-trial litigation. Available to plaintiff and defense counsel, subject to a conflicts-of-interest check.