Ethical Dilemma with Stakeholders

This response outlines a comprehensive plan to address the situation in the next 48 hours, considering legal liability, ethical obligations, financial implications, PR strategy, patient safety, employee morale, and regulatory relationships.

Hours 1-2: Assemble Key Team and Assess Situation

• Gather immediate team: General Counsel, Head of Regulatory Affairs, Head of Medical Affairs, and Head of Communications.
• Review all available data on the rare but serious side effect (liver failure).
• Confirm the accuracy of the 1 in 8,000 patient risk over 5 years.

Hours 3-6: Legal and Regulatory Strategy

• Discuss with General Counsel the legal obligations for reporting adverse effects, potential liabilities, and the regulatory pathway.
• Confirm that early disclosure may mitigate long-term legal risks by demonstrating transparency and proactive management.
• Explore options for expedited reporting with regulatory bodies.

Hours 7-12: Develop Communication Plan

• Work with the Head of Communications to draft a statement that conveys the company's commitment to patient safety and transparency.
• Prepare for various scenarios: immediate disclosure, delayed disclosure, and different levels of regulatory and public reaction.

Hours 13-18: Board Preparation

• Prepare a concise, data-driven presentation for the board meeting in 48 hours.
• Emphasize patient safety, ethical considerations, and potential long-term benefits of transparency.
• Anticipate and prepare responses to questions about financial implications, regulatory strategy, and mitigation plans.

Hours 19-24: Internal Communication and Preparation

• Brief senior management on the situation, proposed actions, and communication plan.
• Ensure all team members understand the importance of confidentiality during this period.

Hours 25-30: Engage Regulatory Authorities Discreetly

• Use regulatory relationships to discreetly inform authorities of the potential issue and seek guidance on next steps.

Hours 31-36: Finalize Disclosure Plan

• Based on regulatory feedback, finalize the plan for disclosure, including timing and content.
• Prepare for immediate disclosure to patients and healthcare providers.

Hours 37-42: Earnings Call Strategy

• Prepare for the earnings call in 72 hours, focusing on transparency about the situation and steps being taken.

Hours 43-48: Board Meeting and Decision

• Present findings and proposed actions to the board.
• Emphasize ethical obligations, patient safety, and long-term reputational benefits of transparency.
• Make a decisive recommendation for immediate disclosure and regulatory reporting.

By following this plan, the company can ensure transparency, prioritize patient safety, and mitigate long-term legal and financial risks.