Services -- Crisis Management

Product Crises

   ♦  Class I recalls (those involving death or serious adverse health consequences)
      • Publicity coordination
          ○ FDA
          ○ Media
      • Logistics
          ○ Depth of recalls
          ○ Ensuring recall communicated
      •  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
       • 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
    ♦  False Claims Act/Whistleblower (Qui Tam) lawsuits
    ♦  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
        • manufacturing
        • formularies
    ♦  Contract Breach Lawsuits
        • Key customers
        • Major suppliers

To see presentations and articles on Crisis Management in the FDA arena, ...