ShieldCoverage engineered for molecules that heal or harm in the same dosage.
Shield wraps pharmaceutical manufacturers, clinical trial sponsors, and specialty distributors in layered liability coverage — from Phase III exposure to first commercial batch.
$2.4B
Annual recall losses
1 in 5
Trials face litigation
7.2 yrs
Avg claim lifecycle
Average product liability settlement for a single adverse event filing
One adverse event filing can consume a decade of operating margin.
Mid-cap pharma companies face average settlements of $38M per adverse event — before legal fees, remediation costs, or brand rehabilitation. Shield's product liability layer is structured to absorb the full claim lifecycle, not just the initial filing.
Coverage Response
- →Adverse event defense costs and indemnity
- →Recall and remediation expense coverage
- →Third-party distribution chain liability
- →Reputational harm and market withdrawal costs
Phase III clinical trials faces at least one litigation event before NDA submission
Phase III is where molecules become liabilities before they become therapies.
IRB deviations, informed consent failures, and serious adverse events during trials generate litigation that can outlast the drug's commercial life. Trial sponsors need coverage that mirrors the complexity of the protocol — not a general liability policy with a pharma endorsement.
Trial Coverage Layers
- →Participant injury and wrongful death defense
- →Protocol deviation regulatory exposure
- →Sponsor indemnification for CRO failures
- →Emergency compassionate use liability
Average lifecycle from first claim filing to final resolution in pharmaceutical liability
Your coverage needs to hold its structure for seven years, not seven months.
Pharmaceutical claims don't resolve on the timeline of standard commercial policies. Multi-year defense costs, expert witness fees, and multi-jurisdiction filings require coverage with long-tail durability — and a carrier with the capitalization to match.
Long-Tail Coverage Features
- →Extended reporting periods up to 10 years
- →Defense cost coverage without eroding limits
- →Multi-jurisdiction coordination for global trials
- →Continuous coverage through corporate restructuring
Every layer of pharmaceutical risk, precisely underwritten.
Coverage structures calibrated to molecule class, trial phase, and regulatory jurisdiction — not off-the-shelf policies.
1 in 5
trials faces litigation
Clinical Trial Liability
Coverage engineered for investigational drug adverse events, protocol deviations, and IRB compliance failures across all trial phases.
$38M
avg settlement
Product Liability
First-party and third-party coverage for recalled batches, contamination events, and supply chain interruption claims.
+34%
warning letters YoY
Regulatory Defense
Legal defense costs and civil penalties arising from warning letters, consent decrees, and import alerts.
$2.4B
annual recall losses
Distribution & Logistics
Temperature excursion losses, cargo damage, and specialty biologics spoilage across the entire distribution network.
7.2 yrs
avg claim lifecycle
Executive Exposure
D&O coverage for securities claims arising from clinical setbacks, safety disclosures, and FDA enforcement actions.
of mid-cap pharma companies are underinsured against Phase III adverse events
Your balance sheet deserves coverage written for your molecule, not the industry average.
A 12-minute guided assessment maps your trial phase, revenue band, and pipeline stage to the precise coverage architecture your risk profile demands.
$4.8B
Coverage capacity deployed
340+
Pharma clients covered
96%
Claims resolved within 18 months