Legal Services Relating to Crisis Management in the FDA Arena

FDACounsel.com -- Legal Services -- for the life of a Life Sciences company

CRISIS MANAGEMENT SERVICES

Product Crises
   ♦ Class I recalls (those involving death or serious adverse health consequences)
      • 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
   ♦ 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
       •manufacturing
       •formularies
   ♦ Contract Breach Lawsuits
       • Key customers
       • Major suppliers

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