Pharmacovigilance and signal detection expert

Expert class library · Mass tort and product liability · Plaintiff side

Analyzes adverse event reports and company safety practices to say when a drug or device maker knew or should have known of a safety signal and whether it responded reasonably. Courts generally admit disproportionality analyses and opinions on the reasonableness of a company's safety monitoring from qualified witnesses, but bar them from turning signal data into medical causation opinions or reading internal documents to the jury as narrative.

What this expert is retained to answer

• What database did the witness analyze, for what period, and what comparator drugs or products were used?
• How did the analysis handle reporting driven by publicity or litigation, and confounders such as age, sex or underlying disease?
• Is the witness offering a signal or notice opinion, or is the opinion being used to prove that the product causes the injury?
• What regulatory or industry standard does the witness use to judge whether the company's safety monitoring was reasonable?
• Does the testimony analyze the company's safety documents, or merely recite them?

Methods

• FAERS and MAUDE data mining
• Disproportionality analysis (PRR, ROR)
• Company safety database review
• Signal evaluation timeline
• Comparison with FDA pharmacovigilance guidance

How the testimony is attacked

• Signal data offered as causation. Defendants argue that adverse event reports generate hypotheses and cannot prove causation. In In re Abilify the court allowed a biostatistician's FAERS disproportionality analyses but barred him from giving a medical causation opinion because he was not a physician or pharmacologist.
• Flawed comparator and no adjustment for confounders. Challengers show that a disproportionality analysis compared the product with all other drugs without restricting by age or sex. In the 2018 Mirena ruling the court excluded a drug safety witness who relied on a disproportionality analysis its own author had repudiated for exactly those flaws.
• Weight of the evidence built on case reports. Opponents attack opinions that stack spontaneous reports and case studies without a sound method. The 2018 Mirena ruling held a weight of the evidence approach unreliable where it ignored alternative explanations and rested on isolated case reports.
• Narrative recitation of company documents. Courts bar pharmacovigilance witnesses from simply reading internal documents to the jury. In In re Mirena IUD the court allowed opinions on the reasonableness of the company's adverse event monitoring but barred copied narrative and speculation about motives.
• Statistically insignificant trends. Defendants attack reliance on findings that do not reach statistical significance. In In re Abilify the court excluded the witness's characterization of five statistically insignificant clinical trial results as a concerning trend, while admitting his significant FAERS findings.
• Qualifications for adverse event analysis. Proponents answer that questions about how a qualified witness drew inferences from adverse event reports go to weight. In In re Mirena IUD the court refused to exclude a former FDA medical officer's reliance on adverse event reports to show the company's knowledge, leaving the issue to cross-examination.

What the public record shows

A deliberately narrow CourtListener search, (FAERS OR "adverse event reports" OR pharmacovigilance OR disproportionality) AND expert AND (Daubert OR "Rule 702"), returned 356 opinions filed since 2015, as of October 3, 2026; broader searches return more. Three that show how courts handle this class of testimony:

Each case links to the free opinion text on CourtListener.

Under amended Rule 702

Since December 1, 2023, Rule 702 says expressly that the party offering an expert must show the court it is more likely than not that the testimony meets each requirement: that it rests on sufficient facts or data, uses reliable methods, and reflects a reliable application of those methods to the case. Questions about the basis of an opinion are no longer automatically matters of weight for the jury. For how the circuits have applied the amendment, see the Rule 702 tracker, which follows each court of appeals; for what that means for preparing or attacking this class of expert, see the guide on amended Rule 702.

Related classes

• FDA regulatory expert
• General-causation epidemiologist
• Biostatistician (meta-analysis)

Guides

• Amended Rule 702 After Nearly Three Years: What Courts Exclude

Simulating this class on a matter

Supreme Mind simulates a class of expert, never a named individual, on your fact pattern and returns the likely opinion, the ranked cross-examination weaknesses, the Rule 702 attack surface and what it means for settlement. Read how it works, or book a demo.

Last reviewed October 3, 2026. How this page is built: rulings are found by searching court opinions on CourtListener, and each one is read in the opinion before it is summarised here; outcomes are labelled by what the court did with the expert's testimony. No individual expert is named. This page summarises public decisions for orientation and is not legal advice; read the opinion before relying on any ruling.