Out of your jurisdiction: why FDA recalls and courts do not mix.

• Author: Benedict, Mollie F.

International Association of Defense Counsel Committee members prepare newsletters on a monthly basis that contain a wide range of practical and helpful material. This section of the Defense Counsel Journal is dedicated to interesting topics covered in recent newsletters so that other readers can benefit from committee specific articles.

This article originally appeared in the August 2011 Drug, Device and Biotechnology Committee Newsletter.

A lesser known but equally helpful cousin of federal preemption, the doctrine of primary jurisdiction allows courts to avoid consideration of complex legal issues involving a regulatory agency's particular expertise. (1) Courts can defer the case until the agency with "primary jurisdiction" over an issue has had an opportunity to consider the dispute. (2) In recent years, courts have put this established doctrine to a new use in cases involving the recall of medical devices and pharmaceutical medications by manufacturers regulated by the U.S. Food and Drug Administration.

Though the FDA has federal regulatory authority over the conduct of product recalls, plaintiffs commencing litigation immediately after such recalls have, in recent cases, attempted to influence the course of the recalls themselves. Fortunately for consumers and manufacturers, courts are declining to interfere with an FDA-approved recall strategy. In addition to other arguments on preemption and judicial abstention, defendants should employ the primary jurisdiction doctrine to convince courts not to interrupt an FDA-approved recall when aggressive plaintiffs (and their law firms) seek to secure a litigation advantage by impeding or altering product recalls under the banner of consumer safety or evidence spoliation.

The History and Policy of the Primary Jurisdiction Doctrine

First recognized in the 1940s, the primary jurisdiction doctrine generally allows courts to defer to a federal agency's specialized knowledge, expertise, and central position within a regulatory regime in resolving issues arising under the applicable federal law. (3) Primary jurisdiction applies where a plaintiff seeks to enforce a legal claim that requires the resolution of issues within the "special competence" of a regulatory agency; "in such a case the judicial process is suspended pending referral of such issues to the administrative body for its views." (4)

Pharmaceutical and Medical Device Recalls Are within the FDA's Authority and Expertise

Congress empowered the FDA to oversee recalls of prescription medications and medical devices under the Food, Drug & Cosmetic Act (FDCA). (5) The FDA has long exercised extensive and predominant regulatory authority to monitor product recalls and assesses the adequacy of a firm's recall efforts through a comprehensive set of regulations that establish specific recall procedures. (6)

Under these regulations, the FDA exercises authority over the details of the recall based on its expertise. For example, the FDA evaluates the extent of the health hazard to at-risk populations presented by the recalled product, and its conclusion must be "supported as completely as possible by scientific documentation." (7) The regulations specify the factors that firms must consider when developing their recall strategies, including the "depth" of the recall, meaning the "level in the distribution chain to which the recall is to extend," depending on "the product's degree of hazard and extent of distribution." (8) The FDA reviews the adequacy of a firm's proposed recall strategy and communications and recommends changes as appropriate. (9) If the FDA is not satisfied with a pharmaceutical or device manufacturer's compliance with recall laws and regulations, it can--and does--seek enforcement of the FDCA in the courts. (10)

Courts Are Wielding the Doctrine of Primary Jurisdiction to Deny Plaintiff Requests for Injunctive Relief Regarding Recalls of FDA-Regulated Products

Given this expertise and federal authority to supervise recalls, courts may defer to the primary jurisdiction of the FDA in matters where its specialized expertise in science and medicine...