Excluding Or Limiting FDA Regulatory Expert Opinion

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