1. The Legal and Policy Implications of Reinstituting Smallpox Vaccinations

2. LSU Progam in Law, Science, and Public Health2 Edward P. Richards Director, Program in Law, Science, and Public Health Harvey A. Peltier Professor of Law Paul M. Hebert Law Center Louisiana State University Baton Rouge, LA 70803-1000 richards@lsu.edu http://biotech.law.lsu.edu

3. LSU Progam in Law, Science, and Public Health3 Legal Regulation of Vaccines State Regulation of Variolation Boston Smallpox Epidemic 1721 Coton Mather Advocated Variolation for the 1 st Time in the US “Vaccine Agents” in Early 1800s Assured Proper Preparation of Cowpox Vaccine Raised Money to Support Vaccination

4. LSU Progam in Law, Science, and Public Health4 Vaccine Agent Legislation 2 Stat. 806 (1813) “...to preserve the genuine vaccine matter, and to furnish the same to any citizen of the United States, whenever it may be applied for, through the medium of the postoffice...” Repealed in 1822 after an Alleged Vaccine Related Outbreak of Smallpox Left to States Until 1902

5. LSU Progam in Law, Science, and Public Health5 FDA Regulation Vaccines Must Be Safe and Effective to be Approved for General Use Smallpox is an Investigational New Drug – IND Allows Control of Distribution Raises Difficult Consent Issues Can a New Vaccine be Shown to be Effective?

6. LSU Progam in Law, Science, and Public Health6 Liability for Primary Vaccine Injuries Informed Consent Was the Patient Warned of the Risk? Is it 1/1,000,000 or 1/10 for the Immunosuppressed? Negligent Screening Is it reasonable to rely on self-screening when the clinical trials demanded medical testing?

7. LSU Progam in Law, Science, and Public Health7 Liability for Secondary Spread Spread to Family Members Is a Warning to the Vacc7inee Enough? Should there be Investigation? Spread to Patients by Health Care Providers Should Vaccinated Persons be in the Workplace? Should Patients be Warned?

8. LSU Progam in Law, Science, and Public Health8 Employment Discrimination Issues What Happens When Health Care Providers and Others Refuse Vaccination? What if they Cannot be Immunized? Must they be Removed from Emergency Preparedness Teams? What about Other Workplace Sanctions?

9. LSU Progam in Law, Science, and Public Health9 Vaccine Manufacturer Liability Products Liability Informed Consent These Can be Sheltered under Various Federal Laws

10. LSU Progam in Law, Science, and Public Health10 Mass Vaccination Programs Federal Policy No Mandatory Vaccinations Vaccinate Every Exposed Person, Regardless of Contra-indications Exposed Persons Should be Quarantined No One in Quarantine unless Immunized What Happens to Unimmunized, Exposed Persons? Immunosuppressed Persons who Do Not Develop Immune even if Vaccinated?

11. LSU Progam in Law, Science, and Public Health11 Homeland Security Act Solution "For purposes of this section, and subject to other provisions of this subsection, a covered person shall be deemed to be an employee of the Public Health Service with respect to liability arising out of administration of a covered countermeasure against smallpox to an individual during the effective period of a declaration by the Secretary under paragraph (2)(A)."

12. LSU Progam in Law, Science, and Public Health12 FTCA Act Immunity FTCA Claims Allows Medical Malpractice Does not Allow Products Liability Does not Allow Punitive Damages Procedure Must File Administrative Claim First May Then Sue if Claim is Not Resolved

13. LSU Progam in Law, Science, and Public Health13 Discretionary Authority Varig Airlines, 467 U.S. 797 (1984). FAA Could Spot Check Airplanes Berkovitz by Berkovitz v. U.S., 486 U.S. 531 (1988) FDA is Liable if it does not Follow its Own Rules in Approving Batches of Vaccine Key – is the Agency Making a Policy Choice?

14. LSU Progam in Law, Science, and Public Health14 Atomic Fallout Cases Government liability cannot logically be predicated on the failure of test-site personnel to go beyond what the operational plans specifically required them to do. If, as the plaintiffs maintain, the AEC delegated "unfettered authority" to a Test Manager and his subordinates to implement public safety programs, this simply compels the conclusion that those officers exercised considerable discretion. Their actions, accordingly, also fall within the discretionary function exception. It is irrelevant to the discretion issue whether the AEC or its employees were negligent in failing to adequately protect the public. Allen v. United States, 816 F.2d 1417 (10th Cir. 1987)

15. LSU Progam in Law, Science, and Public Health15 What Triggers This? Secretary of HHS Must Make a Declaration Must Specify the Covered Actions Immunity Only Extends to Covered Use of Vaccine Does Not Apply to Unauthorized Use or Blackmarket Includes People and Institutions

16. LSU Progam in Law, Science, and Public Health16 What is Excluded? Probably Worker’s Comp Not a Liability Claim If Included, then the Injured Worker has no Compensation Black-market and Direct Inoculation

17. LSU Progam in Law, Science, and Public Health17 What About Covered Injuries? If the Government is Careful in Establishing Policies, then there is no Liability Private Insurers Might Decline Because this is Related to Military Defense What Are Alternatives? Swine Flu Model National Childhood Vaccine Injury Compensation Act Model