1. National Vaccine Injury Compensation Program Geoffrey Evans, MD Department of Health and Human Services Health Resources and Services Administration Director, Division of Vaccine Injury Compensation

2. American Medical News (4/1/08) Vaccine Court's Ruling Adds to Confusion over Autism Link “….special vaccine court's decision to pay for the care of a young girl injured by vaccines. The court ruled last fall that …..underlying mitochondrial disorder was aggravated by the shots … resulted in brain dysfunction and 'features of autism spectrum disorder.'..." Vaccine Court's Ruling Adds to Confusion over Autism Link

3. NY TIMES EDITORIAL (2/12/09) Vaccines Exonerated on Autism A special federal vaccine court issued three devastating verdicts on Thursday that should help demolish lingering fears that childhood vaccines can and have caused autism. The verdicts won’t satisfy die-hard adherents of the theory that the medical establishment is recklessly harming their children. But the vast majority of parents ought to accept the verdicts as persuasive evidence that no child need forgo vaccinations against dangerous diseases out of fear that the vaccines might cause autism.

4. 1980’s Background Events Media reports of alleged DTP-related injury and death Dramatic increase in DTP lawsuits Exponential price increases Withdrawal of most vaccine companies DTP supply shortages/rationing (1984) Demand for national solution

5. National Childhood Vaccine Injury Act of 1986 Ensure an adequate supply of vaccines Stabilize vaccine costs Establish an accessible and efficient “no-fault” compensation system –Table of compensable injuries – Rules of evidence, discovery and other legal procedures relaxed to accelerate process – No age restrictions on who may file – Must file first with the federal system – Must reject judgment to sue vaccine company and/or healthcare provider

6. Federal Role National Vaccine Injury Compensation Program (VICP) Department of Health and Human Services (HHS) –HRSA administers program (claims review/payments to petitioners and attorneys) Department of Justice –represents HHS in court US. Court of Federal Claims –decides who will be paid (special masters) entitlement and damages

7. “Covered” Vaccines Diphtheria, tetanus, pertussis (DTaP, DTP, DTP-Hib, DT, Td, and TT) Measles, mumps and rubella (MMR, MR, M, R) Polio (IPV and OPV) Haemophilus influenzae type b (Hib) Hepatitis B (HBV) Varicella (VZV) Rotavirus (RV) Pneumococcal conjugate Hepatitis A (December 1, 2004) Influenza vaccine (July 1, 2005) Meningococcal (February 1, 2007) Human papillomavirus (February 1, 2007)

8. Entitlement Determination To be compensated, one must demonstrate one of the following: – proof of a Vaccine Injury Table condition – proof of causation – proof of significant aggravation Standard of proof (civil standard) -- preponderance of evidence (more likely than not) Effects of injury must: –last greater than 6 months, or –have resulted in inpatient hospitalization AND surgical intervention

9. Process Claims (“petitions”) filed by or on behalf of the individual thought to be injured by VICP-covered vaccine –Filing deadlines (following onset of injury) INJURIES-- 3 years DEATHS-- 2 years (or within 4 years of injury leading to a death) Supporting documents: – medical records, affidavits, expert witness reports HRSA medical staff review and recommendation on entitlement sent to DOJ DOJ legal review and creates report with final recommendation on entitlement (Rule 4 Report)

10. Process Recommendation +/- entitlement sent to court by DOJ –for entitlement (concession) usually leads to compensation –against entitlement may result in a hearing before SM parents, expert medical witnesses Court issues final decision/judgment Special master’s decision may be appealed to –A judge of the Court –U.S. Court of Appeals for the Federal Circuit (is binding) –U.S. Supreme Court

11. Awards Awards/attorneys’fees/costs from VICP Trust Fund –excise tax of 75 cents on each “dose” (disease prevented) Trust Fund balance is > $3.0 billion Injury--usually initial lump sum and annuity –pain and suffering (non-economic) capped at $250K –unlimited lost wages/attorneys fees/costs Death--lump sum limited to $250,000 Attorneys’ fees--paid if claim brought on a “good faith and reasonable basis” regardless of entitlement outcome

12. VICP x 20 Years Phase I, II, III –I: Adjudications under the original VIT (88-94) “pre-88 claims (75% DTP) IOM reports (DTP, rubella, MMR, Hib, HBV, polio) –II: Adjudications under evolving VIT’s (95-01) Modifications to Table based on IOM reports New vaccines added with few, if any conditions –III: Non-autism/autism (02-08)

13. VICP Claims: Fast Facts Nearly 13,000 claims filed Overall awards > $1.8 billion Compensated Claims: FY’s 2004-2008 –HHS Concessions: 18% –Court (special master) Decisions: 23% –Settlements: 60% –Awards to individuals averaged $1,022,699 –Single largest award to date approximately $13 mil.

14. History: MMR/Thimerosal Litigation In 2001, parents began filing petitions, alleging autism, or neurodevelopmental disorders similar to autism, may be caused by: –MMR vaccine; –by the “thimerosal” ingredient previously contained in certain other vaccines; or –by some combination of these two alleged effects In July 2002, Court ordered Omnibus Autism Proceeding (OAP) –Short form petitions (no medical records necessary) –2-phase process (discovery and hearings)

15. Omnibus Autism Proceeding 3 general theories of causation –Theory #1 (combined) and 3 test cases heard June, October, November 2007 –Theory #2 (thimerosal only) and 3 test cases heard May/July 2008 –Theory #3 (MMR only): MMR-only (Theory 1) No new evidence to be introduced –Decisions: Theories 1 & 3: February 12, 2009 Appeals pending Decisions in Theory 2 test cases expected late 2009.

16. Challenges Table-based to non-Table process –“Initial” Table (1986)—7 vac./12 conditions Table claims predominate –Current Table (2009)—16 vac./13 conditions Causation-in-fact claims predominate –Federal Circuit Court of Appeals decisions OAP Claims –>95% filed as short form petitions without medical records or HHS (HRSA) medical reviews –Court-ordered jurisdictional reviews underway

17. VICP Outcome Measures Compensation –awards made to > 2,200 families/ individuals Process improvements –no fault, limited discovery, short, informal hearings, use of annuities, trust, and guardianships to ensure stream of benefits Marketplace stabilization –Supply shortages resolved, high immunization rates, new products being licensed, pricing stability Decreased civil litigation –DTP/DTaP claims were at pre-litigation crisis levels –similar for providers and for other vaccines

18. Non-autism DTP/DTaP Lawsuits Filed Against U.S. Companies

19. Future Directions Expanding VICP coverage –Adult vaccines pneumococcal polysacharide/ herpes zoster –Travelers vaccines –Vaccines in R & D for maternal imm. group B strep/cytomegalovirus (CMV) Congressional attention –Tort reform measures—liability protections –Standard of causation –Others (statute of limitations, death benefits, etc.)

20. Contact Information Geoffrey Evans, MD Director, Division of Vaccine Injury Compensation 301-443-6593 gevans@hrsa.gov www.hrsa.gov/vaccinecompensation 1-(800)-338-2382