Product Crises
    Class I recalls (those involving death or serious adverse health
    • Publicity coordination
        FDA
        Media
    • Logistics
        Depth of recalls
        Ensuring the word gets out
    • Products Liability considerations
     ♦ Permanently withdrawing products from sale for safety or
    effectiveness reasons
“Systems” Crises
    Internal Investigations
    • Conducting
    • Documenting
    • Liaison with FDA and other governmental agencies
     ♦ Corrective Action Programs
    • meeting FDA requirements
    • relationship to sentencing guidelines
    • Corporate Codes of Conduct -- developing and implementation
     ♦ Criminal prosecutions
    • coordinating with key outside parties
    • maximizing corporate protections
Collateral Challenges Generated by an FDA Crisis
    ♦ SEC disclosure requirements and the investment community
    ♦ Impact on pending FDA approvals
    ♦ Shareholder concerns
    • Securities litigations
    • Derivative actions
    ♦ Qui Tam litigation
    ♦ Competitor civil suits (e.g., under RICO, Lanham Act)
    ♦ Management disruption
    ♦ Government contracting eligibility -- suspension or debarment
    ♦ Addressing possible voidable contracts (e.g., bank loans; mortgages)
    ♦ State licensing proceedings
    ♦ Contract Breach Lawsuits
    • Key customers
    • Major suppliers

To see presentations and articles on Crisis Management in the FDA
arena, just
click here ...
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Michael A. Swit