Out of Your Jurisdiction: Why FDA Recalls and Courts Do Not Mix

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 Defense Counsel Journal is dedicated to interesting topics covered recent newsletters so that other readers can benefit from committee specific articles. This article originally appeared August 2011 Drug, Device and Biotechnology Committee Newsletter. A lesser known but equally helpful cousin of federal preemption, doctrine of allows courts to avoid consideration of complex legal issues involving a regulatory agency's particular expertise. (1) Courts can defer case until agency with primary jurisdiction over an issue has had an opportunity to consider dispute. (2) In recent years, courts have put this established doctrine to a new use cases involving recall of medical devices and pharmaceutical medications by manufacturers regulated by U.S. Food and Drug Administration. Though FDA has federal regulatory authority over conduct of product recalls, plaintiffs commencing litigation immediately after such recalls have, recent cases, attempted to influence course of 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 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 banner of consumer safety or evidence spoliation. The History and Policy of Primary Jurisdiction Doctrine First recognized 1940s, doctrine generally allows courts to defer to a federal agency's specialized knowledge, expertise, and central position within a regulatory regime resolving issues arising under applicable federal law. (3) Primary applies where a plaintiff seeks to enforce a legal claim that requires resolution of issues within special competence of a regulatory agency; in such a case judicial process is suspended pending referral of such issues to administrative body for its views. (4) Pharmaceutical and Medical Device Recalls Are within FDA's Authority and Expertise Congress empowered FDA to oversee recalls of prescription medications and medical devices under Food, Drug & Cosmetic Act (FDCA). (5) The FDA has long exercised extensive and predominant regulatory authority to monitor product recalls and assesses adequacy of a firm's recall efforts through a comprehensive set of regulations that establish specific recall procedures. (6) Under these regulations, FDA exercises authority over details of recall based on its expertise. For example, FDA evaluates extent of health hazard to at-risk populations presented by recalled product, and its conclusion must be supported as completely as possible by scientific documentation. (7) The regulations specify factors that firms must consider when developing their recall strategies, including depth of recall, meaning level distribution chain to which recall is to extend, depending on the product's degree of hazard and extent of distribution. (8) The FDA reviews adequacy of a firm's proposed recall strategy and communications and recommends changes as appropriate. (9) If FDA is not satisfied with a pharmaceutical or device manufacturer's compliance with recall laws and regulations, it can--and does--seek enforcement of FDCA courts. (10) Courts Are Wielding 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 of FDA matters where its specialized expertise science and medicine justifies deferral to its judgment enforcing its regulatory authority. …