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Prior to joining the firm in 2000, Mr. Fleder served as the Director of the Department of Justice's Office of Consumer Litigation between 1985 and 1992, after serving in various other capacities in that office since 1973. He also served a stint as a Special Assistant United States Attorney in Baltimore. As Director of the Office of Consumer Litigation, he directed enforcement cases in federal court for the U.S. Food and Drug Administration, Federal Trade Commission and Consumer Product Safety Commission. While in the government, Mr. Fleder was co-lead counsel in the highly-publicized trials held in Brooklyn, New York, in which two executives of the Beech-Nut Nutrition Corporation were convicted of multiple felonies for defrauding the public into buying adulterated apple juice. Mr. Fleder specializes in litigation and internal investigations concerning clients involved in criminal, civil, and regulatory matters relating to FDA, the FTC, and the CPSC. Mr. Fleder received his B.A. in 1969 from Franklin & Marshall College, and his J.D. in 1972 from New York University. He is admitted to practice in the District of Columbia and numerous federal courts, including the United States Supreme Court.
Articles / Publications
Advertising and Promotion: FDA Is Not the Only Cop on the Beat,
August 2010
Whistleblowers: Treat Them With Kid Gloves,
July 2010
The Lanham Act: Another Vehicle to Enforce the Food, Drug, and Cosmetic Act?,
April 2010
But My Lawyer Told Me It Was Okay,
January/February 2010
The Park Criminal Liability Doctrine: Is it Dead or is it Awakening?,
September/October 2009
Search Warrants - What Happens When the FDA Storm Arrives,
May/June 2009
The Curious Case of the Prosecution of Lawyer Paul Kellogg,
March/April 2009
Imported Products - FDA Is Not Fooling Around,
January 2009
A Bad Fit: Qui Tam Actions and Off-Label Use Allegations,
November 2008
Cosmetics Product Enforcement - Not an Oxymoron,
September 2008
Checking the Box Can Get You in the Hot Seat,
August 2008
FDA Moves Against Marketed Unapproved Human Drugs,
May/June 2008
Playing "Hard Ball" With FDA Might Lead to Criminal Prosecution,
April 2008
FDAAA Enforcement Summary,
February 2008
The Pursuit of Civil Money Penalties - An Important Weapon in FDA's Enforcement Arsenal,
December 2007
The OxyContin Case - Something for Everyone,
September 2007
Thinking of Marketing a Weight-Loss or Diet Product?,
July 2007
Who Decides A Company's Fate in FDA Enforcement Matters?,
May 2007
Are Food and Drug Lawyers 'Real' Lawyers?,
April 2007
Corporate Compliance Officer - Gatekeeper or Jailbird,
January 2007
Justice Department Alters Its Policies for Prosecuting Business Organizations,
December 2006
Product liability drug case not preempted by FDC Act,
March 3, 2006
FDA Issues Long-Awaited Prescription Drug Labeling Regulations,
January 26, 2006
Responding to FDA Form 483 and FDA Warning Letters,
January 18, 2006
Government Investigations: Responding to Requests for Information Including E-Discovery,
September 2005
Current Good Manufacturing Practices, and FDA Enforcement Actions and Inspections,
July 2004
Enforcement and Litigation Conference: Actions Against Competitors,
September 23, 2003
Avoid FDA Problems: Implementing a Corporate Compliance Program,
June 5, 2003
Can FDA Seek Restitution or Disgorgement?,
2003
First Amendment Implications of Labeling and Advertising Restrictions,
June 22, 2002
What You Say May Be Used Against You,
May/June 2002
How FDA's New Labeling Rule Could Preempt State Law
Criminal Prosecutions Initiated for the FDA,
April 2001
A Voluntary Disclosure Programs for FDA - The Time has Come,
1999
The History, Provisions and Implementation of the Generic Drug Enforcement Act of 1992,
1994
The Role of the Department of Justice in Enforcement Matters Relating to the Food and Drug Administration,
1991
FDA's Right to Get Disgorgement Is Threatened
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