John R. Fleder
John R. Fleder represents companies and individuals facing civil and/or criminal actions by the government on issues related to FDA, the FTC, the CPSC, and other federal agencies. He has more than 40 years experience, including almost 20 years personally prosecuting or supervising criminal and civil cases on behalf of these agencies, as well as later representing industry in private practice in those same types of actions. As a result, he provides insightful counsel and strategic guidance on regulatory matters, potential and actual litigation, and internal investigations concerning matters involving a number of federal agencies.
Mr. Fleder also represents clients who want to challenge FDA and other agencies in court. In these instances, he advises clients on strategies that range from seeking to avoid the need to bring suit against the government to personally litigating cases that are brought against the government. Mr. Fleder represents clients that intervene in cases where companies wish to support FDA's position in court. In his prior government service, Mr. Fleder represented federal agencies, including FDA, the FTC, and the CPSC, in lawsuits filed in federal district courts, and courts of appeals involving challenges to their programs and actions. He also spent many years supervising other government attorneys in those same actions. Mr. Fleder's experience interacting and litigating with FDA and other federal agencies spans diverse product areas.
Mr. Fleder is a prolific writer and speaker on FDA and the FTC, as well as numerous other enforcement issues. He recently participated in HPM webinars on the Park criminal liability doctrine and the Caronia off-label marketing case, which each drew an audience of more than 300 people. An article he co-authored in 2005 with Richard M. Cooper: "Responding to a Form 483 or Warning Letter: A Practical Guide," continues to be widely referenced for its insight on responses to FDA warning letters and Form 483s. His 2007 FDLI article, "Who Decides Your Fate in FDA Enforcement Matters?" is probably the first and only publication that publicly identifies the various offices that are involved in decisions by FDA to bring enforcement actions.
Prior to joining the firm in 2000, Mr. Fleder served as the Director of the Department of Justice's Office of Consumer Litigation (now called the Consumer Protection Branch), from 1985 to 1992, after having served in various other capacities in that office since 1973. As Director of the Office of Consumer Litigation, Mr. Fleder directed enforcement cases in federal courts across the country for FDA, the FTC and the CPSC. He also served as a Special Assistant U.S. Attorney in Baltimore, Maryland.
• Recently convinced the Justice Department and FDA not to bring a proposed injunction case against a corporate client.
• Recently represented a food company in a case involving allegations of violations of the FDCA; he persuaded the court to deny FDA most of the relief FDA had sought.
• Successfully sued USDA, overturning a major ruling that USDA had promulgated; the court later awarded his client its attorney fees from the government.
• Convinced prosecutors not to initiate criminal charges against clients.
• Negotiated numerous settlements with the DOJ, FDA, the FTC, and other agencies.
• Conducted and defended depositions, and participated in numerous hearings and trials.
• Successfully prosecuted a criminal contempt case in a trial that was conducted by a federal court of appeals.
• Conducted internal investigations of corporate clients facing government investigations.
• Co-lead counsel of highly publicized trials in which two executives of the Beech-Nut Nutrition Corporation were convicted of multiple felonies for defrauding the public into buying adulterated apple juice.
Awards & Recognition
• DC Super Lawyer, Food & Drug, 2014-2015
Articles / Publications
see more articles
• Garbage Runs, Fake Identities, and Surprise Home Visits - Strategies to Deal With FDA's Nontraditional Investigative Tools,
June 20, 2012
• Knocking On Your Front Door: Government Visits To Employees' Homes,
August 19, 2011
• Must FDA Treat Similarly-Situated Competitors the Same Way?,
• The Evolution and Resurgence of Strict Liability Criminal Prosecutions Under the Park Doctrine,
October 8, 2010
• Advertising and Promotion: FDA Is Not the Only Cop on the Beat,
see more speaking engagements
• DIA'S Marketing Pharmaceuticals 2016 Conference, Session 1: Ad-Promo Litigation: Amarin and Beyond, March 2-4, 2016
• Advertising and Promotion of Medical Devices Conference, November 18-19, 2014
• FDLI: Enforcement Litigation and Compliance Conference, Panel moderator for the session on "Responding to FDA Enforcement Actions - Advanced Applications", December 10 - 11, 2013
• Advertising and Promotion fo Medical Devices Workshop, The Federal Trade Commission and the Regulation of Medical Devices, November 13- 14, 2013
• Real-World Implications of United States v. Caronia, January 31, 2013
see more blog entries
• The Biggest Park Doctrine Ruling in Over 40 Years?,
July 6, 2016
• Second Circuit Affirms Dismissal of Off-Label Promotion Case That was Brought under the False Claims Act, Relying on Caronia,
May 24, 2016
• Yates' Update on Yates Memo,
May 16, 2016
• Amarin Announces a Proposed Settlement of its First Amendment Lawsuit Against FDA: Coming Full Circle in a New Era of the Regulation of Off-label Prom,
March 8, 2016
• The Perils of Being a Store Clerk in an FDA-Regulated World,
January 28, 2016