Ethical Dilemma with Stakeholders

As CEO, I must act decisively to protect patients while managing legal, financial, and reputational risks. Here's my 48-hour action plan:

First 24 Hours: Assessment and Immediate Actions

Hours 1-4: Crisis Team Assembly and Initial Assessment

• Convene emergency leadership team: Chief Medical Officer, General Counsel, CFO, Head of Regulatory Affairs, VP of Communications
• Direct CMO to compile all safety data and prepare patient risk assessment
• Instruct General Counsel to begin adverse event reporting to FDA immediately (we cannot wait 6 months)
• Order immediate review of all patient communications channels

Reasoning: Patient safety is paramount. Regulatory reporting timelines are for routine matters - this requires immediate disclosure under FDA regulations. Delaying would increase legal liability exponentially.

Hours 5-8: Regulatory and Medical Actions

• Contact FDA directly to report preliminary findings
• Begin drafting "Dear Healthcare Provider" letter with updated warnings
• Initiate enhanced pharmacovigilance program for current patients
• Prepare medical information hotline with trained staff

Reasoning: Proactive FDA engagement demonstrates good faith and may influence their response. We need infrastructure ready to support concerned patients and providers.

Hours 9-12: Legal and Financial Preparation

• Work with legal to draft 8-K filing for material adverse event
• CFO to model financial scenarios and prepare liquidity plans
• Begin insurance claim notifications
• Review indemnification for board members who resist disclosure

Reasoning: SEC regulations require prompt disclosure of material information. Financial preparation helps maintain operations during stock volatility.

Hours 13-16: Stakeholder Communication Planning

• Draft employee communication emphasizing our commitment to patient safety
• Prepare scripts for investor relations team
• Create FAQ for all stakeholders
• Schedule one-on-one calls with major institutional investors

Reasoning: Controlling the narrative internally prevents leaks and maintains morale. Transparency with key investors can minimize panic selling.

Hours 17-24: Board Preparation

• Draft comprehensive board presentation with three scenarios:
  1. Immediate disclosure (recommended)
  2. Delayed disclosure risks (legal, criminal, reputational)
  3. Financial mitigation strategies
• Schedule individual calls with resistant board members
• Consult external ethics advisor for independent perspective

Reasoning: Board must understand that delaying isn't an option - only how we disclose is. Individual conversations may shift resistance before group dynamics take hold.

Second 24 Hours: Execution and Communication

Hours 25-28: Final Preparations

• Finalize all communications materials
• Conduct crisis simulation with communications team
• Ensure customer service and medical information teams are fully briefed
• Confirm FDA filing is submitted

Reasoning: Practice prevents mistakes during high-pressure announcements. All teams must be aligned before external communications begin.

Hours 29-32: Board Meeting

• Present recommendation for immediate disclosure
• Emphasize director liability for knowing endangerment of patients
• Vote on disclosure plan
• If board refuses, state intention to personally ensure disclosure

Reasoning: Board must act, but CEO has independent duty to prevent harm. Personal liability attaches to anyone who knowingly allows patients to remain at risk.

Hours 33-36: Internal Communications

• All-hands employee meeting (virtual)
• Emphasize: "Patient safety is our highest value"
• Announce enhanced safety monitoring programs
• Assure employees about company stability

Reasoning: Employees will learn anyway - better from leadership first. Their confidence affects everything from retention to external communications.

Hours 37-40: Regulatory and Medical Communications

• File 8-K with SEC
• Distribute "Dear Healthcare Provider" letters electronically
• Activate patient hotline
• Issue medical community advisory through professional channels

Reasoning: Healthcare providers need information immediately to counsel patients. Multiple channels ensure rapid dissemination.

Hours 41-44: Media and Investor Relations

• Issue press release 30 minutes before market open
• Conduct investor conference call
• Key messages:
  • Patient safety is our priority
  • Proactive disclosure demonstrates integrity
  • Drug remains important treatment option with appropriate monitoring
  • Strong balance sheet can weather transition

Reasoning: Controlling timing minimizes speculation. Emphasizing proactive response may limit reputational damage.

Hours 45-48: Ongoing Management

• Monitor patient hotline volumes and concerns
• Track media coverage and social media
• Prepare for earnings call with updated messaging
• Begin planning long-term remediation strategy

Reasoning: Real-time monitoring allows rapid response to emerging issues.

Key Principles Guiding Decisions:

1. Patient safety supersedes all other concerns - 500 potential deaths over 5 years is unacceptable
2. Legal compliance is non-negotiable - Failure to disclose known risks could result in criminal charges
3. Transparency builds long-term trust - Markets punish cover-ups more than problems
4. Employee confidence is crucial - They're our ambassadors to patients and the public
5. Board resistance doesn't change CEO obligations - Personal integrity and legal duty require action

Expected Outcomes:

• Stock will likely drop 30-50% initially but may recover partially with transparent handling
• Some lawsuits are inevitable but early disclosure limits punitive damages
• FDA will likely require updated labeling but unlikely to pull drug entirely
• Company reputation can be rebuilt through ethical response
• Most importantly, patients can make informed decisions about their treatment

The alternative - waiting for more data while patients face unknown risks - is ethically indefensible and legally catastrophic. Johnson & Johnson's Tylenol response remains the gold standard: accepting short-term pain for long-term trust. That's the model we must follow.