Ethical Dilemma with Stakeholders

Hour-by-Hour Action Plan

Key Priorities: Patient safety, regulatory compliance, ethical transparency, financial stability, and stakeholder trust.

---

First 24 Hours: Crisis Assessment & Preparation

Hour 0–2 (Immediate Response):

• Convene a cross-functional crisis team (Chief Medical Officer, General Counsel, Chief Compliance Officer, CFO, Head of Communications, Head of Regulatory Affairs).
  • Reasoning: Ensure alignment on facts, risks, and strategy. Legal and compliance teams will outline reporting obligations; medical team will validate the risk severity.
• Lock down internal communications to prevent leaks.
  • Reasoning: Avoid premature market panic or misinformation.

Hour 3–5:

• Engage external independent experts (e.g., hepatologists, pharmacovigilance specialists) to validate the findings.
  • Reasoning: Independent verification strengthens credibility and informs regulatory/legal strategy.
• Draft preliminary regulatory filings (e.g., FDA Adverse Event Reporting System) with legal oversight.
  • Reasoning: Accelerate the 6-month timeline by pre-preparing documentation.

Hour 6–8:

• Scenario-planning with CFO and Investor Relations:
  • Model financial impacts of disclosure (e.g., stock drop, litigation costs).
  • Prepare messaging for earnings call that balances transparency with reassurance (e.g., highlighting other pipeline assets).
  • Reasoning: Mitigate investor panic while upholding ethical obligations.

Hour 9–12:

• Develop patient safety action plan:
  • Immediate update to drug labeling and prescriber warnings via “Dear Healthcare Provider” letters.
  • Launch a patient notification system (e.g., pharmacy alerts, website updates).
  • Reasoning: Proactive risk mitigation reduces liability and demonstrates ethical responsibility.

Hour 13–18:

• PR/Comms Strategy Session:
  • Draft press releases, FAQs, and internal talking points.
  • Emphasize patient safety, transparency, and commitment to solutions.
  • Reasoning: Controlled messaging prevents speculation and maintains trust.

Hour 19–24:

• Pre-Board Meeting Briefings:
  • Share crisis team findings and recommendations with key board members individually.
  • Advocate for immediate disclosure, emphasizing long-term reputational/legal risks of delay.
  • Reasoning: Pre-meeting alignment reduces boardroom conflict and ensures unified messaging.

---

Next 24 Hours: Execution & Communication

Hour 25–30:

• Board Meeting:
  • Present validated data, external expert opinions, and recommended actions.
  • Overrule “wait for data” push by framing delay as existential risk (legal, regulatory, reputational).
  • Vote to approve immediate disclosure and patient safety measures.
  • Reasoning: Ethical leadership requires prioritizing patient welfare over short-term financial concerns.

Hour 31–36:

• Regulatory Submission:
  • File preliminary reports with regulators (FDA, EMA, etc.), flagging urgency.
  • Request expedited review given public health implications.
  • Reasoning: Demonstrates compliance and builds regulatory goodwill.

Hour 37–42:

• Internal Communications:
  • Host all-hands meeting to inform employees, emphasizing company values and patient-first ethos.
  • Reasoning: Maintain morale and prevent internal dissent/leaks.

Hour 43–48:

• Public Disclosure & Earnings Call Prep:
  • Issue press release and host media briefing:
    • Acknowledge the issue, apologize, detail patient safety steps.
    • Highlight ongoing research and support for affected patients.
  • Finalize earnings call script:
    • Briefly address the issue but focus on financial resilience (e.g., cash reserves, diversified portfolio).
  • Reasoning: Transparent public communication limits reputational damage; earnings call reassures investors.

---

Critical Decisions & Rationale

1. Immediate Disclosure Over Delay:

   • Why: Waiting risks regulatory penalties, catastrophic lawsuits, and irreparable trust loss. A 40% stock drop is reversible; bankruptcy from litigation is not.

2. Patient Safety First:

   • Why: Proactive warnings and provider alerts reduce harm and liability. Ethically, patients deserve informed consent.

3. Earnings Call Strategy:

   • Why: Acknowledge the issue without oversharing unvalidated data. Reaffirm financial stability to prevent panic selling.

4. Board Management:

   • Why: Pre-meeting lobbying ensures alignment. CEOs must lead, not defer to short-term board pressures.

---

Post-48-Hour Next Steps

• 72 Hours (Earnings Call): Stick to pre-approved messaging; defer detailed questions to pending investigations.
• Week 1: Launch patient support programs (e.g., liver monitoring subsidies).
• Month 1: Begin settlement negotiations for potential litigation and explore insurance coverage.

Final Note: This approach balances ethical rigor with strategic pragmatism, safeguarding lives while preserving the company’s viability. Transparency is the only sustainable path forward.