HP&M Presents the Evolution of FDA and the Park Doctrine

September 21, 2010

Join Hyman, Phelps & McNamara, P.C. attorneys on October 8, 12:00 p.m. – 1:30 p.m. for a free webinar on a very important, timely topic.  You can register for the free webinar here.  (Please register by September 29th.)

In criminal prosecutions of corporate executives, ignorance of the law and the facts is often no defense.  FDA’s application of the Park Doctrine has taken different forms in the decades since its inception.  In the 1960’s through 1980’s, FDA frequently prosecuted company officials without any allegation that the defendant intended to violate the law. However, FDA has rarely brought these cases since that time.  Recently, FDA announced it will resuscitate the so-called Park Doctrine under which FDA, through the U.S. Department of Justice (“DOJ”), can criminally prosecute food, drug, medical device, and cosmetic company executives and other employees when their company has allegedly violated the Federal Food, Drug, and Cosmetic Act, even though the government can’t prove the employee knew about or approved the alleged conduct.
The webinar will feature attorneys from Hyman, Phelps & McNamara, P.C. with decades of experience in FDA’s application of the Park Doctrine. You will hear from FDA’s Chief Counsel from the 1980’s when many of these cases were initiated and from DOJ officials who pursued such prosecutions. They will:

  • Share their insights of the doctrine from their government days;
  • Make predictions as to the type of cases they believe are most likely to lead to a prosecution under the doctrine;
  • Provide tips on how companies and their executives can minimize their risk of being subject to one of these criminal prosecutions;
  • Discuss potential career-ending consequences of misdemeanor convictions; and
  • Answer participants' questions submitted during or before the webinar.

Your presenters:

John Fleder specializes in litigation and internal investigations in criminal, civil, and regulatory matters relating to FDA, the FTC, and the CPSC. 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 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 FDA, FTC and CPSC.  See Mr. Fleder’s recent article on the Park Doctrine here.

Doug Farquhar works primarily on civil and criminal litigation, arbitration, and enforcement issues. He has handled a variety of consent decrees, criminal investigations, civil seizures, injunction actions (both those brought by FDA and those brought against FDA), difficult FDA inspections, lawsuits against competitors of clients, and criminal prosecutions and appeals. From 1990 to 1997, Mr. Farquhar served as an Assistant U.S. Attorney in the District of Maryland.

Tom Scarlett has practiced food and drug law for more than 40 years.  In 1971, he joined the Office of the General Counsel of the Department of Health and Human Services (then HEW) as a staff attorney in the Social and Rehabilitation Services Division. Two years later, he became a trial attorney in the FDA Chief Counsel's Office in HHS, where he served until 1979, concluding as Deputy Chief Counsel for Regulations and Hearings.  After practicing with Morgan, Lewis & Bockius from 1979 to 1981, he was appointed Chief Counsel of FDA, a position he held until 1989, when he became a Director at Hyman, Phelps & McNamara, P.C.  He now serves as Senior Counsel to the firm.

Categories: Enforcement |  Miscellaneous