1. National Vaccine Injury Compensation Program HRSA The National Vaccine Injury Compensation Program (VICP): What’s New? National Immunization Conference May 14, 2004 Geoffrey Evans, M.D. U.S. Department of Health and Human Services Health Resources and Services Administration Special Programs Bureau

2. National Vaccine Injury Compensation Program HRSA Purpose of the VICP To ensure individuals thought injured by routine childhood vaccines are provided with fair and efficient compensation To ensure a stable vaccine supply by limiting liability for manufacturers and administrators

3. National Vaccine Injury Compensation Program HRSA HRSA: America’s Health Care Safety Net We work to: Expand access to high-quality culturally sensitive health care; Improve health outcomes among America’s minority communities; and Enhance direct medical care through use of telehealth technology.

4. National Vaccine Injury Compensation Program HRSA Vaccine Injury Compensation Trust Fund Derives from excise tax of $.75 on each dose of covered vaccine purchased Examples: – DTaP Vaccine -- $2.25 – IPV -- $.75 Provides payment of awards Current balance is $2 billion

5. National Vaccine Injury Compensation Program HRSA Vaccines Covered Vaccines recommended by CDC for routine administration to children: Diphtheria, tetanus, pertussis (DTP, DTaP, DT, TT, or Td) Measles, mumps, rubella (MMR or any components) Polio (OPV or IPV) Hepatitis B Haemophilus influenza type b (Hib) Varicella (chicken pox) Rotavirus Pneumococcal conjugate

6. National Vaccine Injury Compensation Program HRSA Vaccine Injury Table Lists specific injuries and the time frames that they must occur Legal mechanism for defining complex medical conditions Allows legal “presumption of causation” Provides compensation unless alternative cause unrelated to vaccine

7. National Vaccine Injury Compensation Program HRSA Adding New Vaccines Must be recommended by CDC for routine administration to children Excise tax must be enacted by Congress Rulemaking process – Consult with the Advisory Commission on Childhood Vaccines (ACCV) – publication of Notice of Proposed Rulemaking in the Federal Register – 180-day public comment period and a public hearing – publication of final rule in Federal Register 8 years retroactive coverage from effective date of excise tax with 2 years to file

8. National Vaccine Injury Compensation Program HRSA Adding Hepatitis A Vaccine Licensed in 1996 CDC publishes modified general use recommendation in October 1999 Applies to those states with 2x national average of disease incidence Bills introduced adding excise tax – Senate passed S. 1072 in 2004 ACCV resolution to cover Hepatitis A

9. National Vaccine Injury Compensation Program HRSA Adding Influenza Vaccines Publication of “routine use” recommendation by CDC Consultation with ACCV regarding proposed rulemaking Publication of notice by Secretary, HHS Enactment of excise tax for “trivalent influenza vaccines” – Senate passed S. 1072 in 2004 Publication of final rule – effective date of coverage based on excise tax

10. National Vaccine Injury Compensation Program HRSA Hepatitis B Claims FY 1997-2004 – 483 claims Large percentage filed just prior to August 1999 deadline Court planning omnibus hearings based on 10 diagnostic categories Few claims have been adjudicated Medical records review (n=141) – neurologic illness 27% (central and peripheral nervous system) – multi-system or chronic symptomatology 24% – musculoskeletal 14% – immune (10%), endocrine (6%), pulmonary (5%)

11. National Vaccine Injury Compensation Program HRSA Hepatitis B Claims as of 3/31/04

12. National Vaccine Injury Compensation Program HRSA Number of Post-1988 Petitions Filed as of 3/31/04 Average number of petitions filed during FY 1988-2000  125 Number of petitions filed for FY 2001 – 2004 Non-Autism/thimerosal Autism/thimerosal Total zFY 2001195 19214 zFY 2002189768957 zFY 2003154 2,435 2,589 zFY 2004 62561 623

13. National Vaccine Injury Compensation Program HRSA Number of Post-1988 Petitions Filed as of 3/31/04

14. National Vaccine Injury Compensation Program HRSA Thimerosal Litigation New trend in civil litigation beginning 2001 Plaintiff arguments for not filing with VICP – not suing for “vaccine-related” injuries since VICP excludes injuries from any “adulterant” or “contaminant” in vaccines – 3 rd party (derivative) claims not covered by VICP – seeking damages for less than $1,000 Types of civil lawsuits – traditional tort claim alleging specific child injured – “derivative” claims by parent, legal guardian or spouse – “medical monitoring” class action suits (future injury)

15. National Vaccine Injury Compensation Program HRSA Thimerosal Litigation (cont.) Civil Litigation >350 individual lawsuits for injured – vaccine manufacturer and administrator (physician) – most dismissed on finding vaccine is not “adulterant” – variable decisions regarding other civil actions – derivative claims allowed to continue depending on state law no rulings on merits of causation – first individual lawsuits expected to go to trial 2005 Class action (medical monitoring) lawsuits are being dismissed

16. National Vaccine Injury Compensation Program HRSA Thimerosal Litigation (cont.) VICP Litigation Increase in VICP filings starting FY 2001 3,800 claims filed as of March 2004 Omnibus Autism Proceeding – allege autism or developmental disorders caused by thimerosal- containing or MMR vaccines – 2-year schedule adopted (discovery, evidentiary hearing, decision) – conclusions reached, and then applied to individual claims – unique short-form petitions with little/no medical records – petitioners can opt in or opt out of proceeding or leave after 240- day deadline and seek remedies in tort system

17. National Vaccine Injury Compensation Program HRSA Geoffrey Evans, M.D. Medical Director, Division of Vaccine Injury Compensation Special Programs Bureau Health Resources and Services Administration 5600 Fishers Lane, Room 16C-17 Rockville, MD 20857 301-443-6593 or 4198 gevans@hrsa.gov VICP Toll Free: 1-800-338-2382 VICP Web site: www.hrsa.gov/osp/vicpwww.hrsa.gov/osp/vicp

18. National Vaccine Injury Compensation Program HRSA