Consumer Adverse Drug Event Group-Complaint Tool

FDA 46 novel approvals 2025; post-approval adverse event reporting famously under-reported. Individual patients have near-zero enforcement power when reporting solo.

Patient posts to Reddit/Facebook, calls pharma 1-800, rarely files MedWatch. Isolated anecdotes, regulators see only pharma-filtered reports.

Verb Transplant: 'class action' from civil litigation → adverse drug event regulatory petition. Not suing pharma but forming a structured regulatory petition cohort — 500-patient cohort with identical structured adverse event profiles triggers FDA signal.

FDA MedWatch (individual), FDA FAERS (aggregator not patient-facing), RxISK (educational, some self-report), MedShadow Foundation (advocacy). Nobody runs patient-owned petition layer producing regulator-ready filings.

Concern: PI firm capture risk. Personal injury firms could fund/capture the cohort, push toward mass-tort plaintiff pipeline, destroy regulator trust.

Mitigation: 501(c)(3)-governed data layer or LLC with nonprofit governance. PI firms pay for access but don't control. Revised conviction 50% after mitigation.

Borderline survived at 50% with founding-choice mitigation explicit.

TEMPLATE GATE: shares structural template 'patient-owned permissioned data layer + inquiring-party-pays' with Thread 8. Thread 8 is stronger (cleaner adoption barrier pass, no PI-firm capture risk, established advocacy distribution, novel enabling tech). Kill-the-weaker per Pass 2 protocol.