Three Journal Articles Cited in Court Case
Three articles from the Food & Drug Law Journal were recently cited in the court case of U.S. v. Lane Labs-USA, Inc. The U.S. Court of Appeals for the Third Circuit in Philadelphia ruled that FDA can exercise its enforcement powers by seeking and obtaining a restitution award against a dietary supplement manufacturer.
The first article, entitled "Can FDA Seek Restitution or Disgorgement?" (Volume 58, Issue 2, Food & Drug Law Journal, 2003), examines the asserted legal underpinnings for FDA's invocation of this powerful enforcement tool, as well as the arguments against the use of restitution and disgorgement. Co-authors Jeffrey N. Gibbs and John R. Fleder explain how FDA's use of restitution and disgorgement is unsupported by statutory authority, case law, and fundamental canons of statutory construction.
The second article, entitled "The Authority of a Court to Order Disgorgement for Violations of the Current Good Manufacturing Practices Requirement of the Federal Food, Drug, and Cosmetic Act" (Volume 58, Issue 2, Food & Drug Law Journal, 2003), is co-authored by Erika King and Elizabeth M. Walsh. It responds to an article, published in the Food and Drug Law Journal in 2000, in which the FDA's Deputy Chief Counsel for Litigation presented a legal justification for the disgorgement award included in the agency's 1999 consent decree with Abbott Laboratories.
The third article, entitled "Anchors Away: The Food and Drug Administration's Use of Disgorgement Abandons Legal Moorings" (Volume 59, Issue 1, Food & Drug Law Journal, 2004), addresses the fundamental elements of the equitable remedy of disgorgement and demonstrates that FDA's recent actions depart significantly from the historic precedents. Co-authored by William W. Vodra and Arthur N. Levine, this article recommends that FDA take affirmative actions to ensure that this enforcement tool is not improperly used in the future.
FDLI is honored to have the articles cited in such an important case and congratulates these co-authors for their achievements.