Articles

  • Op-Ed: What Do “The Hunger Games” and 510(k) Have in Common? More Than You’d Think.

    Published on April 29, 2013
    Authored by Mark DuVal
    Categorized as FDA News

    Op-Ed: What Do “The Hunger Games” and 510(k) Have in Common? More Than You’d Think.

    MDDI Device Talk Blog

    Posted: April 29, 2013

    Like the tributes thrust into the Hunger Games arena, medical device manufacturers want a fair shot at surviving the everchanging FDA 510(k) pathway.

    The FDA 510(k) program is beautiful and practical in its simplicity, and yet sophisticated in its ability to accommodate complexity and flexibility. It is as maligned as it is revered. But describing the nuanced process in detail is far too complex, as it requires an admixture of macro and micro politics, political philosophy being subtly carried out, and regulatory and administrative law, medicine, and science.
    By putting it into a caricature using the pop culture phenomenon The Hunger Games, however, I have tried to provide an amusing analogy to demonstrate what it’s like to take a client through the surprise-filled arena we call the 510(k) program as well as some tips on how to make it out alive.

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

    Published on January 18, 2011
    Authored by Mark DuVal
    Categorized as 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
    Authored by Mark DuVal
    Categorized as 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
    Authored by Mark DuVal
    Categorized as 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.”

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