• Concerns heighten over the prospect of ‘responsible corporate officer’ prosecutions against drug and device manufacturers

    • Published on: January 18, 2011
    • Category: FDA News

    Concerns heighten over the prospect of ‘responsible corporate  officer’ prosecutions against drug and device manufacturers

    Westlaw article by Kim M. Schmid, Esq., and Molly J. Given, Esq., Bowman & Brooke, and Mark DuVal, J.D., and Mark Gardner J.D. DuVal & Associates

    JANUARY 18, 2011-VOLUME 17, ISSUE 24

    The recent announcement that the Department of Justice, Health and Human Services’ Office of Inspector General, and the Food and Drug Administration plan to aggressively pursue individual criminal charges against executives for illegal offlabel marketing deservedly caused a stir in the drug and medical device manufacturing community.

    High-ranking employees of pharmaceutical and medical device manufacturers are taking notice as they analyze the prospect of facing a personal criminal investigation under the “responsible corporate officer” doctrine of the Food, Drug and Cosmetic Act.  However, the concern over the government’s stated intent to use the RCO doctrine has implications greater than personal criminal liability because it may also provide fuel to the plaintiffs’ product liability tort bar.

    The results for manufacturers should government agencies forge ahead with these aggressive RCO prosecutions could be farreaching, affecting not only manufacturers and their executives and managers, but also medical industry insurers, shareholders and, ultimately, the health care consumer.

    This article outlines the contemplated enforcement actions and explores the impact that RCO prosecutions and convictions may have in the world of product liability lawsuits involving pharmaceuticals and medical devices.  Industry must anticipate the likely increase in RCO prosecutions and plan accordingly.


  • The Prosecutorial Prism: Are We All Felons?

    • Published on: March 1, 2005
    • Category: FDA News

    Update March/April 2005

    I appreciate this opportunity to comment on the role the First Amendment has—or, more accurately, has not—played in Department of Justice (DOJ) prosecutions undertaken in recent years. This commentary will focus on DOJ cases involving off-label uses of medical products, allegations of False Claims Act violations, DOJ’s announcement that it has over 500 drugs under investigation,1 and DOJ’s continued threats to prosecute more medical device companies.

    Prosecutors have a problem when they begin to look at everyone as a criminal. Industry has a problem when management turns a blind eye to programs and /or payments that might be illegal or fails to put into place effective compliance programs. Prosecutors look at the world through a prism partially of their own making and partially constructed from the bad actors they encounter. Industry must acknowledge that the vision of corporate managers can be clouded by the pressures of pleasing executive management and shareholders who want them to get the most out of their corporate assets. As such, companies must be diligent in policing themselves.

    This commentary, however, focuses on prosecutors and the recent prosecutions in the pharmaceutical and medical device sectors. There are four issues that need to be discussed “straight-up” with prosecutors and that may add an industry viewpoint not covered in the WLF correspondence above.

  • Justice Contacts the WLF

    • Published on: March 1, 2005
    • Category: FDA News

    Update March/April 2005


    This article is comprised of three parts: a letter from the Department of Justice (DOJ) to the Washington Legal Foundation (WLF), WLF’s letter in response, and an author’s commentary in reaction to both. The letters are reprinted here from text provided to Update by the WLF legal department.

    Justice Contacts the WLF

    [The following October 5, 2004 letter was addressed to Mr. David Price, Senior Vice President, Legal Affairs, WLF.]

    Dear Mr. Price: I am writing in response to your letters of April 16, 2004 and June 15, 2004, on behalf of the [WLF], in which you express concern about the [DOJ’s] criminal and civil investigations of the promotion by pharmaceutical companies of “off-label” uses of their products.

    In your April 16 letter, you write that WLF is “concerned about recent press reports indicating that various United States Attorneys’ offices are conducting civil and criminal investigations of major pharmaceutical companies based, in part, on truthful and non-misleading speech about their products.”

  • Off-Label Dissemination: What the Constitution Giveth, Are the OIG and DOJ Taking Away?

    • Published on: January 1, 2004
    • Category: FDA News

    Although this may be an unusual format for expressing legal and political views, it seems appropriate to address this communiqué—call it an open letter—to each of you in a public forum. This "letter" is not intended to be a law review-like dissertation; rather it is an honest and candid assessment of where industry feels it is today, given your recent prosecutions in, among others, the TAP, AstraZeneca, Abbott, Schering-Plough, and Guidant cases.1

    While we do not condone some of the activity cited in those cases, some of the legal theories espoused trouble industry because they seem to have an intended application far beyond those cases. It as if the Office of Inspector General (OIG) and the Department of Justice (DOJ) are expressing politically their institutional distaste both for off-label prescribing and for the otherwise constitutionally-protected activity of off-label dissemination as contemplated by Judge Lamberth in the Washington Legal Foundation (WLF) case.2

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