by Illana Goldfinger, Life Sciences Practice Group Leader
Recent changes to federal vaccine guidelines are introducing new uncertainty across the insurance and liability landscape. As recommendations shift toward shared clinical decision‑making and more individualized care, long‑standing assumptions about standards of care, coverage, and risk allocation are being reevaluated. Our Life Sciences Practice Group leader, Illana Goldfinger, shares this blog that explores how evolving vaccine guidance may affect liability exposure, underwriting considerations, policy wording and claims trends—helping insurers, life sciences companies and healthcare providers better understand and prepare for the implications ahead.
Reduced routine recommendations
Health and Human Services (HHS) and the Centers for Disease Control (CDC) have downgraded broad federal recommendations for several vaccines, moving them from universal coverage to “shared clinical decision-making” or high-risk only categories (e.g., influenza, rotavirus, meningococcal, hepatitis A/B) while still requiring insurers to cover them without cost-sharing.
Implications:
- Uncertainty around standards of care: Less clear, standardized vaccination guidelines can increase disputes over what constitutes “appropriate” care or advice — a key factor in product liability and life sciences litigation.
- More individualized decisions: Shared clinical decision frameworks could shift liability disputes to whether providers appropriately informed patients, increasing claims focused on failure to warn, informed consent and medical advice quality.
Insurance implications:
- Broader coverage required under health plans may change how insurers assess risk and premiums around vaccine-related claims.
- Higher potential for allegation-driven litigation where plaintiffs argue that varying guidelines contributed to harm.
Continued liability protections under Federal emergency laws
PREP Act liability shield extended
The Public Readiness and Emergency Preparedness (PREP) Act provides broad immunity to manufacturers, distributors and administrators of vaccines designated as countermeasures, shielding them from most product liability suits unless there is willful misconduct.
Implications:
- Reduced traditional product liability risk for life sciences companies during declared emergencies because claims are routed through administrative processes or limited to willful misconduct.
- Long-term horizon for liability planning: With COVID-19 protections extended through at least 2029, insurers must account for a different risk landscape than for other biologics or non-covered vaccines.
Insurance implications:
- Lower frequency of traditional lawsuits for vaccines under PREP; claims instead go to the Countermeasures Injury Compensation Program (CICP), which insurers and policyholders must understand for risk transfer design.
- Policy wording complexity: Policies may need explicit exclusions/inclusions for PREP-covered products and related legal defenses.
Evolving legal and regulatory standards affect liability profiles
Heightened focus on informed consent and provider duties
HHS emphasis on shared clinical decision-making and parental consent bolsters the importance of documentation around clinical discussions, risk communication and consent.
Impacts:
- Increased claims alleging inadequate communication by providers or manufacturers about vaccine risks/benefits.
- Expanded legal theories: Beyond defect claims (design/manufacturing), plaintiffs may focus on failure to warn or negligent advice — especially where recommendations are less prescriptive.
Insurance implications:
- Product liability carriers may see more complex defense profiles, with mixed clinical-decision controversies.
- Life sciences policies will need to cover both traditional product risk and clinical practice-adjacent exposures.
Market and underwriting impacts
Shifting risk assessments
Life sciences underwriters and insurer actuarial teams will need to account for:
- Changing regulatory expectations for vaccine recommendations.
- Broader coverage mandates with uncertain utilization patterns.
- Diverging state and federal policy landscapes as some states may maintain previous immunization standards even as federal guidance changes.
Insurance implications:
- Rates and underwriting criteria may shift where:
- Standard of care is less uniform (higher risk of disputed causation).
- Provider obligations are more subjective (shared decisions).
- Regulatory coverage requirements directly affect claim frequency.
Potential downstream effects on claims and litigation
Clinical trial and approval changes
Emerging policies may require more stringent placebo-controlled trials for new vaccines and altered approval pathways.
Implications for life sciences insurance:
- Longer development timelines and increased trial costs can raise exposure during clinical stages — influencing clinical trial liability, E&O and D&O insurance.
- Delayed approvals could alter market timing and risk portfolios, with insurers facing shifting product launch windows.
Key insurance impacts
| Product Liability | Lower claims under PREP, but greater complexity in clinical-decision cases |
| Life Sciences Underwriting | Need to model regulatory uncertainty and varied standards of care |
| Claims Mix | Shift from manufacturing defects to claims about warnings/informed consent |
| Policy Wording | Need clearer language around coverage for vaccines amid guideline changes |
| Regulatory Risk | Increased with policy shifts, especially if trial/approval norms change |
For more information about the Bridge Specialty Group Life Sciences Practice Group, contact [email protected].
This material has been prepared for general informational purposes only, is intended to apply generally rather than to any specific company and presumes appropriate discretion will be exercised regarding any particular situation.
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