Excluding Or Limiting FDA Regulatory Expert Opinion

Introduction

It has become increasingly commonplace in pharmaceutical or medical device product liability litigation—particularly large, centralized mass tort litigations involving hundreds or thousands of plaintiffs—for both plaintiffs and defendants to offer competing FDA regulatory experts. As with all other expert testimony, FDA regulatory experts are permitted to the extent that their scientific, technical, or other specialized knowledge assists the trier of fact to understand the evidence or to determine a fact in issue.

Although FDA regulatory experts are routinely offered and permitted to testify in such cases, there are grounds for opposing such proffered opinions, in whole or in part, particularly if the expert overreaches. In general, such experts are permitted to testify (if qualified) about the FDA regulatory framework, the contents of FDA regulations, and perhaps the defendant company's interactions with the FDA. Experts cross the line, and are vulnerable to being excluded when they overreach by offering legal conclusions, advocacy-based narratives of facts, or opinions about the state of mind or intent of the agency or of the defendant in a given case.

This article discusses the issues regarding admissibility of regulatory expert opinion and bases for excluding or limiting such opinion.

General Evidentiary Rule: Expert Opinion Interpreting and Applying Domestic Law or FDA Regulations Is Inadmissible

It is a fundamental evidentiary rule that expert testimony on the meaning and applicability of law is inadmissible because it usurps the role of the judge. In a trial setting, the judge alone instructs the jury as to what the law is and what the legal standards applicable to the case are. As the DC Circuit held: "Each courtroom comes equipped with a 'legal expert,' called a judge, and it is his or her province alone to instruct the jury on the relevant legal standards." Burkhart v. WMATA, 112 F.3d 1207, 1213 (D.C. Cir. 1997). FDA regulatory experts are not permitted to testify about domestic law, i.e., the law that governs the case in which they are testifying (such as state tort law or strict products liability law) and may be precluded from offering interpretations of FDA regulations.

Courts have precluded experts, including FDA regulatory experts, from offering opinions about the standards that apply to the case and whether the defendant pharmaceutical or device manufacturer violated duties of care under applicable domestic law (such as expert opinion that a pharmaceutical manufacturer failed to fulfill its duty to warn under state law). The court in In re: Initial Public Offering Securities Litigation summarized the general rule that expert opinion on domestic law is inadmissible: "The rule prohibiting experts from providing their legal opinions...