Product Liability
Industry or Government responsibility?
- Extent of Government specification
- NYCBH vaccinia bioequivalent to Dryvax (pre – 9/11/01)
- Time line / Budget
- Animal study design and execution
- Management oversight
- Government control over use
- Difficult to impossible to observe contra-indications during emergency use
- Risk / benefit differs with preparedness vs. emergency use
- Use of Informed Consent to mitigate exposure
- Conventional insurance available to a finite extent
- “Alternative markets” available but problematic
- Potential for indemnification under 2002 SAFETY Act1
(1) The Support Anti-terrorism by Fostering Effective Technologies Act of 2002