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
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