1. Compensation and Liability for Vaccines The Special Case of Vaccines for Bioterrorism Agents Edward P. Richards Director, Program in Law, Science, and Public Health Harvey A. Peltier Professor of Law LSU Law Center Baton Rouge, LA 70803-1000 richards@lsu.edu http://biotech.law.lsu.edu

2. There is Nothing New Under the Sun Vaccines for bioterrorism agents pose the extreme cases of vaccine law and policy Consent versus Mandated Vaccinations Liability Compensation Market issues for one-shot preventive measures These are still controversial for routine vaccines

3. Special Problems for Bioterrorism Agents No effectiveness data What if it does not work? Limited clinical data because you will not use them until there is a emergency Emergency use means poor screening and follow-up Emergency use means a psychologically loaded environment which is very conducive to epidemic hysterical illness Timeframe – we are using 30 year old smallpox vaccine - liability can be a time bomb

4. Why Worry about Liability for Vaccine Manufacturers?

5. Will They Make the Vaccine without Liability Protections? Polio – 1950s and 1960s Swine Flu – 1970s Childhood Immunizations – 1980s Bioterrorism Agents – 2000s Liability is at an all time high Why might it not matter to a manufacturer?

6. What if They Will Make the Vaccine without Liability Protections? If the manufacturer will make it without protection, are there other reasons to provide protection?

7. Is Liability the Basis for Compensation? What if there is not enough insurance to pay the claims? What if the manufacturer declares bankruptcy or uses other legal strategies to dodge the liability?

8. Will Liability Undermine Epidemiology? The real secret of effect personal injury law Get clients to friendly doctors for primary treatment Then all the medical records support your claim An issue in Swine Flu The legal system will compensate people without regard to scientific evidence

9. What about Health Care Providers? They must have protection or they will not give vaccinations It must be complete and not dependent on their medical malpractice insurance

10. Separate Liability from Compensation If you have a compensation system, fund it separately from liability determinations The federal government can seek indemnification based on liability if liability is seen as an important market discipline

11. There is only one effective mechanism to provide complete protection Substitute the federal government for the defendant Swine flu Smallpox (Sec 304) Federal Community Health Centers Most all federal employees This does not prevent the federal government from seeking contribution or indemnification from the manufacturer for bad acts

12. Compromise Solutions Federal indemnification You have to deal with the litigation Gives a judge the chance to find a reason why the feds do not have to indemnify you Safety Act Depends on the secretary’s certification Could be attacked in court Allows litigation, which creates chances for the judges to undermine the protections

13. The Role of Compensation

14. Why do People Take Vaccines? People take vaccines when are more frightened of the disease than of the vaccine People make other people take vaccines when they are more worried about their spreading disease than they are worried about other people’s choices The purpose of education is to make them more frightened of the disease than the vaccine

15. Is compensation just a bribe to make the vaccine more attractive? Smallpox compensation program: (C) who has volunteered and been selected to be a member of a smallpox emergency response plan described in subparagraph (B) prior to the time at which the Secretary publicly announces that an active case of smallpox has been identified either within or outside of the United States;

16. Who Should You Bribe? Who really cared about compensation? Hospitals and employers Not addressed by the smallpox comp program All benefits are secondary to worker’s comp and insurance benefits No reimbursement for the benefits costs and other costs to the hospital 304 Fails this test

17. What about the Individuals? Does compensation really make you more likely to take what you see as a dangerous vaccine? Does a compensation system increase the fear of vaccinations? Public acceptance of vaccines has not increased after National Childhood Vaccine Injury Compensation Act

18. What Should a Compensation Program Look Like? Administrative review Based on an injury table Funded by federal funds not tied to the vaccines All cases reviewed by independent medical examiner, including physical exam in cases based on physical diagnosis Realistic compensation levels Reimbursement of third party expenses