FDA Policy/General

Controlling FDA Expert Opinion in Court

Three Kaye Scholer attorneys say that FDA regulatory experts often testify in court cases and can serve a valuable purpose in helping juries understand regulations and how companies interact with the agency. Writing in an online post, the three say that sometimes parties, often plaintiffs, try to use regulatory experts for “purposes that invade the province of the judge and the jury.”

The attorneys write that legally impermissible or problematic subjects for such witnesses include a party’s knowledge, motive, intent, or state of mind; whether a company complied with FDA regulations; whether a company complied with state tort or products liability law; or simply providing a narrative of facts.

The post reviews the general evidentiary rule covering the inadmissibility of expert opinion interpreting and applying the applicable law and regulations, and the ways in which some narrow FDA regulatory expert testimony may be allowed.

“The proposed testimony and reports of such experts must be examined with great scrutiny and a keen eye,” the attorneys conclude. “By identifying and challenging inappropriate opinions, parties may be able to exclude expert opinions either in part or entirely. When appropriately cabined, FDA regulatory expert opinions are manageable and can frequently be rebutted with competing expert testimony.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome