Ethical Dilemma with Stakeholders

48-HOUR CRISIS PLAYBOOK
(All times are “CEO clock”; every action is logged, time-stamped, and preserved on the company’s litigation-hold server.)

DAY 0 – T+0 h (Today, the moment the internal memo lands on your desk)

00:00 – 00:30 TRIAGE & LEGAL PRIVILEGE

• Convene the “Red Notebook” team (you, General Counsel, Chief Medical Officer, Head of R&D, Head of Pharmacovigilance, outside counsel, compliance officer).
• Declare the meeting attorney-client privilege; open a separate secure Slack/Teams channel labeled “Project Nightingale—Privileged.”
• Issue litigation-hold notice to every employee who has ever touched the drug (auto-archive emails, lab books, WhatsApp, Signal, etc.).
  Reason: Establishes control of narrative, preserves privilege, reduces downstream spoliation risk.

00:30 – 01:30 PATIENT SAFETY FIRST—STOP THE BLEEDING

• Order immediate cross-check of worldwide safety database: every reported hepatic event, every ALT >3× ULN.
• Freeze all promotional material; pull next week’s DTC ad buys (saves $4 M and shows good faith).
• Instruct global medical affairs to draft “Dear HCP” letter template (not released yet—just drafted).
  Reason: Regulators and juries punish companies that keep selling while they “think about it.”

01:30 – 02:30 ONE-PAGE FACT SHEET

• CMO creates a single living document: incidence estimate, biological plausibility, confounders, comparators (competitor labels, NSAIDs, acetaminophen).
• No adjectives like “rare” or “low”; only numbers and 95 % CIs.
  Reason: Boards and investors freeze without a clear, numbers-only sheet; prevents anecdotal drift.

02:30 – 03:00 SEC DISCLOSURE DRY RUN

• Call outside securities counsel (Skadden or equivalent).
• Run 4-factor materiality test (probability × magnitude). 1/8,000 × 5 yrs × 4 M patients ≈ 500 avoidable liver-failure cases; lifetime cost per case ≈ $3 M → $1.5 B exposure.
• Conclusion: disclosure is mandatory under Item 303 (MD&A) and Reg FD; silence = securities fraud.
  Reason: Personal criminal liability for CEO if you knowingly omit material information.

03:00 – 04:00 BOARD PRE-READ PACKET (privileged)

• Send encrypted folder: fact sheet, legal memo, stock-drop model (base case –40 %, worst –60 %), remediation cost, timeline options.
• Schedule 7 a.m. tomorrow emergency session (Zoom with video recording).
  Reason: Directors must have overnight to absorb; prevents “I didn’t understand” defense later.

04:00 – 05:00 SPECIAL COMMITTEE FORMATION

• Ask the three “wait-for-more-data” directors to recuse themselves from vote; form Independent Safety & Ethics Sub-committee (only outside directors with no pharma ties).
• Offer them separate counsel (Paul Weiss) paid by company—clears conflict.
  Reason: Shows fiduciary neutrality; protects D&O insurance.

05:00 – 06:00 EMPLOYEE & CULTURE HOLD

• Record 3-min CEO webcam video (internal only): “We discovered a potential signal; patient safety is our North Star; more tomorrow.”
• Disable comments to avoid Slack rumor spiral.
  Reason: Morale collapses faster than stock if staff feel blindsided.

06:00 – 07:00 REGULATORY PRE-NOTICE

• Phone FDA’s Director of ODE-I (your drug’s division) and EMA’s PRAC chair.
• Give “heads-up, we have a hepatic signal, formal submission within 72 h.”
• Follow up with email to create paper trail.
  Reason: Voluntary early disclosure converts you from “target” to “partner” in every future negotiation.

07:00 – 08:00 INSIDER-TRADING LOCK-UP

• Expand blackout list to all VPs and above, plus anyone on Red Notebook team.
• Freeze 10b5-1 plans; instruct brokers.
  Reason: Prevents SEC claim you let insiders trade on material non-public info.

08:00 – 09:00 FAMILY & PERSONAL

• Call spouse, family office: no stock transactions, no leaks.
• Schedule 30-min with executive coach tomorrow 6 a.m. for sanity check.
  Reason: You cannot afford personal distractions or appearance of self-dealing.

T+9–12 h SLEEP (non-negotiable, 6 h max)

DAY 1 – T+12 h

06:00 – 06:30 MINDSET RESET

• 10-min meditation, 20-min treadmill.
• Re-read company values statement; decide you will disclose even if board votes no (resignation letter drafted but not dated).
  Reason: Clarity under oath later—“I was ready to resign.”

07:00 – 09:00 BOARD EMERGENCY SESSION
Agenda (pre-circulated):

1. CMO presents data (15 min).
2. GC presents legal duties (10 min).
3. CFO presents financial scenarios (10 min).
4. Independent counsel presents personal liability to directors (10 min).
5. CEO proposal (below).
   Vote:
   A. Authorize immediate FDA/EMA filing within 48 h.
   B. Authorize “Dear HCP” letter and patient alert within 72 h.
   C. Authorize Q2 earnings pre-release with disclosure of signal and $1.5 B contingent-liability reserve.
   D. Suspend share-repurchase program.
   E. Create $500 M patient-compensation fund (no-fault, non-admission).
   Outcome: 7–3 vote in favor; dissenters noted in minutes.
   Reason: Minutes will be Exhibit 1 in any shareholder suit; show reasonableness and due care.

09:00 – 09:30 D&O INSURANCE TRIGGER

• Notify carrier of potential claims; open claim file.
• Request advance of defense costs.
  Reason: Preserves coverage; carrier cannot later deny for late notice.

09:30 – 10:30 RESET EARNINGS CALL

• Cancel existing call; reschedule for T+96 h (gives 24 h extra to refine messaging).
• Draft 8-K with new earnings date + short paragraph on safety signal.
• File immediately.
  Reason: Markets hate uncertainty more than bad news; shows control.

10:30 – 12:00 SCIENTIFIC DEEP DIVE

• Convene external hepatic experts (via CRO) for blinded data review.
• Charter: validate 1/8,000 estimate within 2 weeks.
  Reason: Speeds label update and regains scientific credibility.

12:00 – 13:00 PATIENT-ADVOCACY TOUCHPOINT

• Call heads of American Liver Foundation, National Pain Advocacy Center.
• Offer joint webinar within 7 days.
  Reason: Turns potential enemies into allies; juries notice.

13:00 – 14:00 COMMUNICATIONS WAR ROOM

• Hire external crisis firm (Teneo or Kekst CNC).
• Prepare 3 buckets of messaging: patients, HCPs, investors.
• Pre-draft Q&A with no “we take seriously” clichés; every answer includes next action.
  Reason: Speed beats perfection; silence vacuum will be filled by plaintiffs’ bar.

14:00 – 15:00 EMPLOYEE ALL-HANDS PREP

• HR builds FAQ for line managers.
• Schedule global town hall T+48 h (after regulatory filing).
  Reason: Field reps will get questions first; arm them.

15:00 – 16:00 SUPPLY-CHAIN & INTERNATIONAL

• Check inventory: 6-month stock on hand.
• Instruct affiliates to prepare local language “Dear HCP” letters; do NOT ship until central go-signal.
  Reason: Prevents accidental off-label panic or runs on pharmacy shelves.

16:00 – 17:00 CREDIT-FACILITY COVENANTS

• Call lead bank (JPM).
• Walk through $1.5 B reserve; confirm no EBITDA covenant breach.
• Ask for waiver letter anyway.
  Reason: Keeps access to $3 B revolver if stock tanks.

17:00 – 18:00 LAWYER HAND-OFF

• Turn over Red Notebook to outside counsel; internal team now on “implementation” only.
• Privilege log started.
  Reason: Minimizes in-house fingerprints on strategy docs.

T+18–20 h FAMILY DINNER & SLEEP (protected time)

DAY 2 – T+24 h to T+48 h

06:00 – 08:00 REGULATORY FILING DRAFT

• Complete expedited safety report (FDA Form 3500A, EMA EVCT).
• Include proposed label change: black-box warning, mandatory baseline LFTs, monthly monitoring.
• Send to FDA/EMA at 08:00 EST.
  Reason: Meets 15-day “unexpected serious” clock; starts official review timer.

08:00 – 09:00 “DEAR HCP” LETTER APPROVED

• Final sign-off by GC and outside counsel.
• Upload to Medscape, NEJM Knowledge+, company portal.
• Push through EMR vendors (Epic, Cerner) as clinical decision support alert.
  Reason: Reaches 80 % of prescribers within 24 h.

09:00 – 10:00 PATIENT PORTAL & CALL CENTER

• Post plain-language alert on branded website.
• Activate 200-seat call-center overflow (contract with Sykes).
• Script: clear, no jargon, free re-test offer.
  Reason: Reduces adverse-event reporting burden on FDA; shows proactive care.

10:00 – 11:00 COMPENSATION FUND TERMS

• Publish simple criteria: diagnosis of drug-related acute liver failure, no-fault, independent claims administrator, payments start in 30 days.
• Cap fund at $500 M; excess stays on balance sheet.
  Reason: Signals empathy without unlimited liability; accelerates settlements.

11:00 – 12:00 BOARD FOLLOW-UP EMAIL

• Confirm all actions taken; attach executed filings and press-release draft.
• Reiterate that any director wanting to resign may do so; none do.
  Reason: Locks in board unanimity going forward.

12:00 – 13:00 INVESTOR RELATIONS DRAFT

• Pre-wire top 20 shareholders (BlackRock, Vanguard, Wellington) with 15-min call slots.
• Message: “We found it, we owned it, we fixed it, we funded it.”
  Reason: Reduces surprise selling; stabilizes stock.

13:00 – 14:00 MEDIA EMBARGO LIFT

• Release full press kit at 14:00 EST (FDA receipt confirmed).
• CEO quote: “We are acting with urgency and transparency because patients deserve nothing less.”
  Reason: Own the 24-hour news cycle; prevents leak-driven hysteria.

14:00 – 15:00 EMPLOYEE TOWN HALL (pre-recorded)

• CEO, CMO, CHRO speak for 20 min; 10 min live Q&A via Slido (moderated).
• Give talking points to field reps: “Show the letter, offer the test, call medical info.”
  Reason: Aligns 8,000 employees behind single narrative.

15:00 – 16:00 SOCIAL LISTENING DASHBOARD

• Deploy Talkwalker & Synthesio keywords: “liver,” “[drug name],” “class action.”
• Escalate threshold: >100 mentions/hour with negative sentiment >60 %.
  Reason: Early flare detection for further PR or legal response.

16:00 – 17:00 CLINICAL-TRIAL PAUSE REVIEW

• Decide whether to halt ongoing post-market OLE study (answer: yes, until new monitoring in place).
• Send notice to IRBs and investigators within 2 h.
  Reason: Protects trial subjects; avoids additional FDA sanctions.

17:00 – 18:00 PERSONAL LIABILITY CHECK

• Meet with personal counsel (Williams & Connolly) for 30 min.
• Review D&O indemnification, advancement, and personal umbrella policy.
  Reason: You cannot lead if you are distracted by personal survival.

18:00 – 19:00 FINAL SIGN-OFF

• GC certifies all regulatory clocks met.
• CFO signs 8-K and earnings pre-release.
• You sign CEO certification under SOX §302.
  File 8-K at 19:00 EST.
  Reason: Meets SEC requirement; puts market on notice before next day’s trading.

19:00 – 20:00 DEBRIEF WITH CHAIRMAN

• Agree on talking points for tomorrow’s sell-side analyst calls.
• Confirm you remain CEO with unanimous support.
  Reason: Public display of unity reduces activist risk.

T+48 h MISSION ACCOMPLISHED
You have:

1. Filed with regulators worldwide.
2. Warned physicians and patients.
3. Reserved $1.5 B and funded $500 M no-fault program.
4. Pre-announced material financial impact.
5. Preserved privilege and D&O coverage.
6. Protected employees and culture.

Next 24 h: attend rescheduled earnings call, answer every question with the same three numbers: incidence, action taken, money reserved.

You will still lose 30–40 % of market cap, but you will keep your license to operate, your personal freedom, and—most importantly—prevent hundreds of liver failures.