The National Vaccine Injury Compensation Program (VICP): What

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The National Vaccine Injury Compensation Program
(VICP)Whats 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

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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

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HRSA Americas Health Care Safety Net

• We work to
• Expand access to high-quality culturally
  sensitive health care
• Improve health outcomes among Americas minority
  communities and
• Enhance direct medical care through use of
  telehealth technology.

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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

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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

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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

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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

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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

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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

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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 (n141)
• neurologic illness 27 (central and peripheral
  nervous system)
• multi-system or chronic symptomatology 24
• musculoskeletal 14
• immune (10), endocrine (6), pulmonary (5)

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Hepatitis B Claims as of 3/31/04
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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
• FY 2001 195 19 214
• FY 2002 189 768 957
• FY 2003 154 2,435 2,589
• FY 2004 62 561 623

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Number of Post-1988 Petitions Filed as of 3/31/04
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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
• 3rd 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)

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Thimerosal Litigation (cont.)

• Civil Litigation
• gt350 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

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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

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• Geoffrey Evans, M.D.
• Medical Director,
• Division of Vaccine Injury CompensationSpecial
  Programs Bureau Health Resources and Services
  Administration5600 Fishers Lane, Room
  16C-17Rockville, MD 20857301-443-6593 or 4198
• gevans_at_hrsa.gov
• VICP Toll Free 1-800-338-2382VICP Web site
  www.hrsa.gov/osp/vicp

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