Ethical Dilemma with Stakeholders

This is a high-stakes ethical, legal, and business crisis requiring immediate, strategic, and transparent leadership. As CEO, my ultimate responsibilities are to protect patients, preserve trust, comply with legal and regulatory obligations, and ensure long-term viability of the company—even if it causes short-term financial pain.

The 48-hour window before the board meeting is critical for fact-finding, internal alignment, and preparation. Here's an hour-by-hour action plan with rationale.

🕒 HOUR-BY-HOUR ACTION PLAN (FIRST 48 HOURS)

⏰ HOUR 1–2: Immediate Executive Gathering (Emergency Meeting)

• Participants: CEO (me), Chief Medical Officer (CMO), Chief Legal Officer (CLO), Chief Compliance Officer (CCO), Chief Risk Officer (CRO), Head of R&D, Head of Regulatory Affairs, Chief Communications Officer (CCO), CFO.
• Objective: Confirm and understand the scientific findings, legal implications, and regulatory obligations.
• Tasks:
  • Verify data integrity (replication, methodology, sample size, statistical significance).
  • Legal and compliance teams present regulatory obligations and timeline.
  • Initial patient risk assessment.
• Rationale: Establish a unified, accurate understanding of the issue. This sets the foundation for all decisions.

⏰ HOUR 3–4: Convene Internal Scientific Review Board and External Experts

• Form a cross-functional working group of internal scientists and 2–3 independent external medical experts in hepatology/pharmacovigilance.
• Objective: Validate findings, assess risk magnitude, and explore mitigation (e.g., screening protocols).
• Rationale: External validation strengthens credibility and helps mitigate legal risk if accused of hiding internal-only data.

⏰ HOUR 5–6: Legal & Regulatory Strategy Session

• CLO, CCO, and Head of Regulatory Affairs lead.
• Tasks:
  • Map out formal regulatory reporting obligations (e.g., FDA, EMA, Health Canada).
  • Prepare draft of a pre-emptive voluntary disclosure (before formal 6-month timeline).
  • Assess litigation exposure and outline risk mitigation (e.g., patient alerts, label updates).
• Rationale: Proactive regulatory engagement is ethically sound and helps protect from future enforcement penalties.

⏰ HOUR 7–8: Preliminary Communication Strategy Session

• Led by Chief Communications Officer.
• Participants: Legal, Medical Affairs, Investor Relations.
• Outline:
  • Internal communication to employees.
  • External plan: physicians, pharmacists, patients, investors, media.
  • Draft Q&A for earnings call.
  • Prepare holding statements and FAQs.
• Rationale: Transparency builds trust; lack of control over the message leads to reputational damage.

⏰ HOUR 9–10: Drafting Initial Disclosure & Risk Mitigation Steps

• Medical Affairs drafts a proposed “Dear Healthcare Provider” letter.
• Regulatory Affairs begins drafting a voluntary safety communication for FDA submission.
• Legal reviews all drafts.
• Rationale: Shows good faith and protects patients via early awareness.

⏰ HOUR 11–12: CEO One-on-One Calls with Key Board Members

• Call each board member individually (especially the three urging delay).
• Share validated findings and outline ethical, legal, and financial risks of delaying disclosure.
• Emphasize: “Protecting patients and credibility now protects shareholder value long term.”
• Rationale: Builds consensus and reduces boardroom surprises.

⏰ HOUR 13–14: CEO Call with FDA Liaison (Off the Record)

• Inform FDA liaison confidentially of early findings, intent to disclose, and desire to collaborate on mitigation.
• Rationale: Builds trust with regulators, may soften future enforcement, shows proactivity.

⏰ HOUR 15–16: CEO Internal Message to Employees

• Company-wide message acknowledging the finding, committing to patient safety, and promising transparency.
• Live Q&A for leadership team in next 24 hours.
• Rationale: Retains morale and trust; rumors can destroy culture.

⏰ HOUR 17–20: Scenario Planning with Finance, Legal, and IR

• Model financial impacts:
  • Revenue loss from label change or patient drop-off.
  • Legal exposure (class actions, settlements).
  • Stock price decline and activist investor risk.
• CFO and Investor Relations prepare messaging for earnings call.
• Rationale: Prepares leadership to communicate confidently and mitigate panic.

⏰ HOUR 21–24: Prep for Board Meeting

• Assemble full briefing book:
  • Scientific findings
  • Legal obligations and options
  • Financial modeling
  • PR strategy
  • Proposed actions and timeline
• Finalize CEO’s presentation and recommendation: “Voluntary early disclosure with mitigation plan.”
• Rationale: Board must be fully informed and aligned before public disclosure.

⏰ HOUR 25–30: External Legal and PR Counsel Consultations

• Retain external crisis communications agency.
• Consult external legal counsel on disclosure risk and SEC exposure.
• Rationale: Objective outside perspective strengthens decisions and protects legally.

⏰ HOUR 31–36: Finalize Materials for Board Meeting

• Update based on external counsel feedback.
• CEO rehearses key messaging.
• Ensure alignment across all executives.
• Rationale: Cohesive story and plan increases board confidence and consensus.

⏰ HOUR 37–40: CEO Reaches Out to Key Institutional Investors (Confidential)

• Under NDA (if appropriate), alert top 3–5 investors of upcoming disclosure and rationale.
• Rationale: Pre-empts panic selling, positions decision as long-term value protection.

⏰ HOUR 41–44: Chief Medical Officer Prepares Physician & Patient Outreach Plan

• Webinars for physicians
• Dedicated hotline for patients
• Updated safety information portal
• Rationale: Support network reduces confusion and protects patients.

⏰ HOUR 45–48: Final Touches & Board Meeting Prep

• Dry-run of board presentation.
• Align messaging between CEO, CMO, CLO, and CFO.
• Final check on legal and regulatory documents for readiness to submit next day.
• Rationale: Professional, well-prepared presentation ensures board support.

📌 KEY DECISION FOR BOARD MEETING

• Recommend immediate voluntary disclosure to regulators and physicians.
• Launch patient safety program (e.g., liver monitoring guidelines).
• Initiate label update process.
• Begin investor & public disclosure immediately following board approval.

🧭 RATIONALE BEHIND OVERALL STRATEGY

• Ethical: Patients deserve to know risks affecting their health. Transparency upholds duty of care.
• Legal: Early disclosure reduces penalties, shows good faith, and limits liability.
• Reputational: Short-term hit is better than long-term erosion of trust.
• Financial: While stock may drop now, credibility preserved with regulators/investors ensures long-term viability.
• Employee Morale: Transparency retains purpose-driven culture and talent.

📞 EARNINGS CALL (HOUR 72)

• CEO opens with transparency: “We’ve identified a rare but serious adverse effect. We’re taking immediate action in full alignment with our values.”
• CFO explains financial impact estimates.
• CMO discusses patient safety measures.
• IR handles Q&A with prepared, honest answers.

Conclusion

This hour-by-hour plan embraces transparency, scientific rigor, legal prudence, and ethical leadership. The long-term health of the company depends on doing the right thing now. Waiting for more data—given known risk to patients—is not only unethical, it's reckless.