Transcript Childhood Vaccinations – Legal Issues and Legal Solutions December 14, 2009 at 12:00 noon Central Primary Sponsor: ABA Health Law Section Public Health & Policy.

Childhood Vaccinations –
Legal Issues and Legal Solutions
December 14, 2009 at 12:00 noon Central
Primary Sponsor:
ABA Health Law Section Public Health &
Policy Interest Group
Supporters:
American Public Health Association
And
Immunization Alliance
Panel
•
•
•
•
•
Jane Seward, MBBS, MPH, Acting Deputy Director, National Center for
Immunization and Respiratory Diseases, CDC, Atlanta, GA 30333
James G Hodge, Jr, JD, LL.M, Lincoln Professor of Health Law and Ethics and
Fellow, Center for the Study of Law, Science, & Technology, ASU Sandra Day
O’Connor College of Law, Senior Scholar, Centers for Law and the Public’s Health: A
Collaborative at Johns Hopkins & Georgetown Universities, Tempe, AZ
Paul Offit, MD, Chief - Division of Infectious Diseases and Director - Vaccine
Education Center, Children’s Hospital of Philadelphia; Maurice R Hilleman Professor
of Vaccinology and Professor of Pediatrics, U Penn SOM, Philadelphia, PA
Alexandra M. Stewart, JD, Asst Research Professor, Department of Health Policy,
School of Public Health and Health Services, George Washington University,
Washington, DC
Moderator: Howard H Kaufman, MD, JD, MPH, FACS, Voluntary Professor, Dept
of Epidemiology and Public Health, University of Miami School of Medicine, Boca
Raton, FL
2
Teleconference Outline
•
Introduction by Moderator: Howard H Kaufman, MD, JD, MPH, FACS
•
“Prevention of Vaccine Preventable Diseases in the United States:
Successes and Challenges” by Jane Seward, MBBS, MPH, Pgs. 4-34
•
“State School Vaccination Laws: Requirements and Challenges,”
by James G Hodge, Jr, JD, LL.M, Pgs. 35-36
•
“The Disproved Myth that Vaccination Causes Autism” by Paul Offit, MD, Pgs. 37-38
•
“Vaccine Injury Compensation Program,” by Alexandra M. Stewart, JD, Pgs. 39-58
•
Questions and Answers
•
Conclusion
3
Prevention of Vaccine Preventable
Diseases in the United States:
Successes and Challenges
American Board Association
Public Health Interest Group: Health Law
Section Teleconference December 14th 2009
Jane Seward, MBBS, MPH
Centers for Disease Control and Prevention
404-639-8688
[email protected]
About Jane Seward
• Dr. Seward obtained her medical degree from the University of
Western Australia, her clinical training in Pediatrics and infectious
diseases at Tulane University and obtained her Masters Degree in
Public Health in Epidemiology from Emory University. Her public
health career has spanned both domestic and international arenas in the
fields of Maternal and Child Health, Birth Defects, Nutrition, and
Immunizations. Since joining CDC in 1996, she has worked in or had
responsibility for United States vaccination programs for polio, measles,
mumps, rubella, varicella and herpes zoster, and has collaborated on
other domestic and international vaccine programs including influenza,
rotavirus and neonatal tetanus. She is an internationally recognized
varicella and immunization expert and she lead the public health
response in the United States to a large mumps outbreak in 2006. She
is currently acting deputy director in the National Center for
Immunizations and Respiratory Diseases, Centers for Disease Control
and Prevention.
5
Outline
• Experience with control of vaccine
preventable diseases in the U.S.
– Disease burden in absence of vaccination
– Achievements and Challenges
• Trends in vaccine coverage, exemption
and attitudes to vaccination
• Conclusions
6
Disease Burden Before
Vaccination
7
Poliomyelitis
• > 21,000 reported
paralytic polio cases in
1952
• 1879 deaths annually
1951-1954
Measles
•
•
•
•
3-4 million cases
4,000 encephalitis cases
48,000 hospitalizations
450 deaths
8
Haemophilus influenzae Type B
• Leading cause bacterial
meningitis < 5 years
• 20,000 cases invasive Hib
disease (1/200 children per year)
Streptococcus pneumoniae
• In children < 5 years:
– Major cause of pneumonia,
bacterial meningitis, sepsis
– Estimated 16,069 cases
invasive pneumococcal disease
per year
Courtesy, American Academy of Pediatrics
9
Immunization Successes
In the U.S., selected as one of 10 great public health
achievements of the 20th Century†
•
•
•
•
•
Smallpox eradication (globally)
Polio elimination
Measles elimination
Rubella elimination
Declines in morbidity and mortality for all VPDs
† CDC , MMWR 1999;48:241-243
10
Comparison of 20th Century Annual Morbidity and Current
Morbidity: Vaccine-Preventable Diseases
Disease
20th Century
Annual Morbidity†
2008
Reported Cases † †
Percent
Decrease
Smallpox
29,005
0
100%
Diphtheria
21,053
0
100%
Measles
530,217
140
> 99%
Mumps
162,344
454
> 99%
Pertussis
200,752
13,278
93%
Polio (paralytic)
16,316
0
100%
Rubella
47,745
16
> 99%
Congenital Rubella Syndrome
152
0
100%
Tetanus
580
19
97%
20,000
193*
99%
Haemophilus influenzae
†Source:
JAMA. 2007;298(18):2155-2163
CDC. MMWR August 14, 2009/58(31);856-869. (Final 2008 NNDSS data)
* 30 type b and 163 unknown (< 5 years of age)
† † Source:
11
Impact of Newer Vaccines
• Conjugate pneumococcal vaccine for
children
• Rotavirus (gastroenteritis) vaccine
12
Invasive Pneumococcal Disease among
Children <5 Years, ABCs, 1998-2008
Cases per 100,000
120
100
2008 vs. baseline
80
All Serotypes: -79%
60
40
20
PCV7 Types: -99%
PCV7
introduction
0
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
Year
13
Moore, IDSA 2009
13
Rates of IPD Caused by PCV7 Serotypes among
Adults >18 years-old, ABCs 1998-2008
60
Cases per 100,000
2008 vs. baseline
50
65+: -93%
40
50-64: -90%
PCV7
introduction
30
20
18-49: -92%
10
65+ yrs
50-64 yrs
0
18-49 yrs
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
Year
Moore, IDSA 2009
14
Estimated IPD Cases Prevented
All ages, US, 2001-2007
Age <5
Age =>5
40,000
Cases prevented
35,000
30,000
25,000
20,000
15,000
10,000
5,000
210,000 cases & 14,000 deaths prevented
0
2001
2002
2003
2004
2005
2006
2007
Year
Pilishvili, JID 2010, In press.
15
Decrease in Number of Positive Rotavirus Tests,
US Laboratory Surveillance, 2000-2008
Total N Tests
900
Total N Positive
RotaTeq introduced
800
700
600
500
400
300
200
100
0
2000
2001
2002
2003
2004
2005
2006
2007
2008
16
Achievements: High Vaccine Coverage
Rates Among Preschool-Aged Children
Percent
100
80
2010 Target
DTP / DTaP(3+)†
Hep B
(3+)
PCV 7
(3+)
60
MMR(1+)
Polio (3+)
40
20
Hib (3+)
Varicella (1+)
0
1967 1970 1973 1976 1979 1982 1985 1988 1991 1994 1997 2000 2003 2006
† DTP(3+) is not a Healthy People 2010 objective. DTaP(4) is used to assess Healthy People 2010 objectives.
Note: Children in the USIS and NHIS were 24-35 months of age. Children in the NIS were 19-35 months of age.
Source: USIS (1967-1985), NHIS (1991-1993) CDC, NCHS, and NIS (1994-2006), CDC, NIP and NCHS;
No data from 1986-1990 due to cancellation of USIS because of budget reductions.
17
Strategies for Achieving and Maintaining
High Vaccine Coverage, U.S.
• Vaccine policy and schedule
• Eliminate cost barriers (Federal and state
programs)
• On time vaccination (reminder, recall)
• Child care and school requirements
• Strong parent/provider relationship
• Vaccine risk communication
18
Challenges with Successful
Vaccine Programs
• Success may lead to complacency
– Disease uncommon or rare
– Lower level of knowledge about health burden from
vaccine preventable diseases before use of vaccines
• Changing context vaccine safety
–
–
–
–
–
Cultural changes re parenting
Informational available 24/7, internet
Distrust government, big pharmaceutical companies
States allowing personal belief exemptions
Health care system doesn’t allow time for
communication and relationship building
19
Vaccination and Society
Decision to vaccinate
Decision to not vaccinate
• Individual benefit
• Increased risk disease
for the individual
• Increased risk of
disease for members of
their community
• Wider community
benefit through herd
immunity
– Measles
– Pertussis
Salmon et al. JAMA 1999, Feiken et al, JAMA 2000, Omer et al., JAMA, 2006
20
Exemption to School Immunization
Laws
( 28)
( 2)
( 20)
21
Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health, updated June 11, 2009
Nonmedical Exemptions for States With Religious
Exemptions and With Personal Belief Exemptions -1991 –
2007*
Personal Belief Exemptions Permitted
Exemption Rate
Only Religious Exemptions Permitted
*Updated data courtesy of S Omer
Omer et al., JAMA, 2006
22
WA State Counties’ School Entry Exemption Rates
2006-2007
Omer et al., New Eng Journal of Medicine, 2009
23
Measles Outbreaks in Pockets of
Unvaccinated School-aged Children, 2008
• San Diego: 12 cases in children 10
months – 9 years; all unvaccinated, 9
due to personal belief exemptions
(PBEs), 3 < 12 months. Source was 7
year old unvaccinated boy who
returned from travel to Switzerland
• Washington State: 19 cases including 16
school-aged children (11/16 were being
home-schooled); all unvaccinated due
to PBEs. Possible outbreak source was
a Japanese traveler who had attended a
youth conference in Washington State
• Illinois: 30 cases including 25 schoolaged children (all were homeschooled);
all unvaccinated due to PBE. Likely
source was an unvaccinated adolescent
traveler returning home from Italy
24
25
140 cases
25 importations
D5
D4
D4
D4
H1
D5
D4
Measles Importations, U.S. 2008
26
Invasive Haemophilus influenzae Type B Disease in
5 young children, Minnesota, 2008
27
Investigation of Hib Cases, Minnesota, 2008
• Parents resided in 5 counties, no relationship between the cases
• Three patients were unvaccinated because of parent deferral or refusal
• One child was subsequently diagnosed with hypogammaglobulimemia
28
Parents Concerns
• It is painful for children to
get so many shots during
one doctors visit (48%)
• Ingredients in vaccines are
unsafe (34%)
• Children get too many
vaccines in first 2 years
(33%)
• Vaccines are not tested
enough for safety (32%)
• Vaccines may cause
developmental disabilities
e.g. autism (33%)
Source: Healthstyles, 2008
29
30
What Does the Science Show?
Vaccines, MMR vaccine and Thimerosal
• Ecologic studies: autism does not go down
when thimerosal is removed from childhood
vaccines
– US starting in 1999 – 2001
• Epidemiologic studies: well-designed studies
demonstrate no association between thimerosal
or MMR vaccine exposure from vaccines and
autism
• IOM report: no causal association
31
Omnibus Autism Proceedings
• Created by the National Vaccine Injury Compensation program to handle
the volume of claims (> 5,500) that vaccines cause autism
• 3 theories with 3 test cases each heard by Special Masters
• Theory 1: MMR vaccine and thimerosal containing vaccines cause autism
– Court of Federal Appeals decision Feb 12th 2009 “The MMR vaccine, in
combination with thimerosal-containing vaccines, do not cause or contribute to
autism”
– “In this case, the evidence advanced by the petitioners has fallen far short of
demonstrating such a link”
• Theory 2: Thimerosal-containing vaccines alone can cause autism
– Cases heard, court decision pending
• Theory 3: MMR vaccine alone can cause autism was voluntarily dismissed
by the Petitioners Steering Committee in 2008
http://www.hrsa.gov/vaccinecompensation/omnibusproceeding.htm
32
Summary
• U.S. has achieved great success with its national
immunization program
• For each birth cohort vaccinated* and followed through
adulthood
–
–
–
–
33,000 lives saved
14 million infections prevented
$10.5 billion savings from health care perspective
$42 billion savings from societal perspective
• Unvaccinated persons are at risk of acquiring vaccine
preventable diseases
• Global society and easy transmission of vaccine
preventable diseases
• Achieving and maintaining high population immunity
through vaccination is essential to prevention
of vaccine preventable diseases
*Based on vaccines against diphtheria, pertussis, tetanus, measles, mumps, rubella,
polio, Hib, varicella, hepatitis B
F Zhou, Arch Pediatr Adolesc Med 2005
33
Acknowledgements
• Staff in state, city and local health departments
• Staff from National Center for Immunization
and Respiratory Diseases
–
–
–
–
–
Division Viral Diseases
Division Bacterial Diseases
Global Immunization Division
Immunization Services Division
Office of Communications
• Dr. Saad Omer, Emory University
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State School Vaccination Laws:
Requirements and Challenges
James G. Hodge, Jr, JD, LL.M
James G Hodge, Jr, JD, LL.M, Lincoln Professor of Health Law and
Ethics and Fellow, Center for the Study of Law, Science, & Technology,
ASU Sandra Day O’Connor College of Law, Senior Scholar, Centers
for Law and the Public’s Health: A Collaborative at Johns Hopkins &
Georgetown Universities, Tempe, AZ
[email protected]
480/727-8576
There are no slides for this presentation.
35
About James Hodge
•
•
Lincoln Professor of Health Law and Ethics
Faculty Fellow, Center for the Study of Law, Science, & Technology
•
Through scholarly and applied work, James Hodge delves into multiple areas of public health law, global health law,
ethics, and human rights. Professor Hodge teaches Health Law, Ethics, and Policy, Public Health Law and Ethics, and
Global Health Law and Policy at the College of Law.
•
Professor Hodge, the recipient of the 2006 Henrik L. Blum Award for Excellence in Health Policy from the American
Public Health Association, has drafted (with others) several public health law reform initiatives, including the Model
State Public Health Information Privacy Act, the Model State Emergency Health Powers Act, the Turning Point Model
State Public Health Act, and the Uniform Emergency Volunteer Health Practitioners Act. His diverse, funded projects
include work on emergency legal preparedness; the legal framework underlying the use of volunteer health
professionals during emergencies; the compilation, study and analysis of state genetics laws and policies as part of a
multi-year NIH-funded project; historical and legal bases underlying school vaccination programs; international
tobacco policy for the World Health Organization; legal and ethical distinctions between public health practice and
research; legal underpinnings of partner notification and expedited partner therapies; and public health law case studies
in multiple states. He is a national expert on public health information privacy law and policy, having advised numerous
federal, state, and local governments on these issues.
•
Before joining the College of Law faculty in 2009, Professor Hodge was a Professor at the Johns Hopkins Bloomberg
School of Public Health, an Adjunct Professor of Law at Georgetown University Law Center, and a Core Faculty
member of the Johns Hopkins Berman Institute of Bioethics. He is a Senior Scholar at the Centers for Law and the
Public’s Health: A Collaborative at Johns Hopkins and Georgetown Universities, President of the Public Health Law
Association, and Vice-Chair of the ABA Public Health Interest Group.
36
“The disproved myth that
vaccination causes autism.”
Paul Offit, MD
Division of Infectious Diseases and Director - Vaccine Education Center,
Children’s Hospital of Philadelphia; Maurice R Hilleman Professor
of Vaccinology and Professor of Pediatrics, U Penn SOM,
Philadelphia, PA
[email protected]
There are no slides for this presentation.
37
About Paul Offit
•
Paul A. Offit, MD is the Chief of the Division of Infectious Diseases and the Director of the Vaccine
Education Center at the Children’s Hospital of Philadelphia. In addition, Dr. Offit is the Maurice R.
Hilleman Professor of Vaccinology and a Professor of Pediatrics at the University of Pennsylvania
School of Medicine. He is a recipient of many awards including the J. Edmund Bradley Prize for
Excellence in Pediatrics from the University of Maryland Medical School, the Young Investigator
Award in Vaccine Development from the Infectious Disease Society of America, and a Research
Career Development Award from the National Institutes of Health. Dr. Offit has published more than
130 papers in medical and scientific journals in the areas of rotavirus-specific immune responses and
vaccine safety. He is also the co-inventor of the rotavirus vaccine, RotaTeq, recommended for
universal use in infants by the CDC; for this achievement Dr. Offit received the Gold Medal from the
Children’s Hospital of Philadelphia, the Jonas Salk Medal from the Association for Infection Control
and Epidemiology, the Luigi Mastroianni Clinical Innovator and the William Osler Patient Oriented
Research Awards from the University of Pennsylvania School of Medicine, and the Charles Mérieux
Award for Achievement in Vaccinology and Immunology from the National Foundation for
Infectious Diseases. Dr Offit was a member of the Advisory Committee on Immunization Practices to
the Centers for Disease Control and Prevention, is a founding advisory board member of the Autism
Science Foundation, and is the author of five books titled Vaccines: What You Should Know (Wiley,
2003, 3rd Edition), Breaking the Antibiotic Habit (Wiley, 1999), The Cutter Incident: How America’s First
Polio Vaccine Led to Today’s Growing Vaccine Crisis (Yale University Press, 2005), Vaccinated: One Man’s
Quest to Defeat the World’s Deadliest Diseases (HarperCollins, 2007), and Autism’s False Prophets: Bad
Science, Risky Medicine, and the Search for a Cure (Columbia University Press, 2008).
38
Vaccine Injury Compensation
Program
Alexandra M. Stewart, JD
Department of Health Policy
School of Public Health and Health Services
George Washington University
Washington, DC
39
About Alexandra M. Stewart
•
•
•
Professor Stewart’s area of expertise is U.S. vaccine policy. She has conducted research
related to the intersection of immunization law and policy, and how law can support
public health goals regarding vaccination for all populations in the United States.
She directed The Epidemiology of U.S. Immunization Law, a CDC-funded initiative. The
Project released a series of analyses that examined immunization coverage and access
issues for the following areas: 1) how state private health insurance laws address coverage
of immunizations, 2) Medicaid coverage of immunizations for non-institutionalized
adults, 3) coverage of adult and childhood immunizations under the Federal Employee
Health Benefit Program, 4) immunization requirements for staff and residents of longterm care facilities under state laws/regulations, and 5) whether state laws governing
medical and health providers support vaccine delivery through the use of standing orders.
Most recently, her work has focused on the Vaccine Injury Compensation Program and
the Omnibus Autism Proceedings, and the impact of the HPV vaccine on U.S. vaccine
policy and law.
Professor Stewart has drafted model statutes addressing 1) state private insurance law for
immunization coverage, 2) establishment of state immunization registries, 3) data sharing
among immunization registries, and 4) establishment of perinatal and infant hepatitis B
testing and vaccination programs.
40
Introduction
• Before a vaccine was developed, Pertussis (whooping cough) caused 1000s
of child deaths annually
• Post-vaccine, 99% reduction in # of cases per 100,000
• 1978: First action filed in state court claiming injury from DTP vaccine
• By 1985: 219 claims filed against DTP vaccine manufacturers
• Vaccine cost rose from $.11 in 1984 to $11.40 in 1986
• Vaccine manufacturers left the market:
•
•
•
Supply shortages
decreased access to immunization
threatened vaccine coverage rates
41
The National Childhood Vaccine Injury Act of 1986
Created the Vaccine Injury Compensation Program (VICP) also
known as the “Vaccine Court” to:
•
Ensure an adequate supply of vaccines
•
Increase immunization rates
•
Maintain vaccine research and development
•
Stabilize vaccine costs
•
Establish and maintain an accessible, efficient forum for
individuals found to be injured by certain vaccines
•
Provide liability protection to industry and providers
42
National Vaccine Injury Compensation Program
• Became operational October, 1988
• Persons who believe they have been injured by a vaccine must
file a claim with the Vaccine Court before approaching state
court
• Claims are heard by judges called Special Masters
• A no-fault alternative to the tort system
• Less adversarial than traditional tort system
43
The National Vaccine Injury Compensation Trust Fund
The VICP is supported by:
• $.75 excise tax levied on each dose of vaccine for each
disease prevented in the dose
• Balance as of 01/31/07: $2.5 billion
44
Persons Eligible to File a Claim
• Individuals who received covered vaccine while in the U.S.
• Recipient’s parents or legal guardian
• Deceased recipient’s legal representative
• If recipient was outside of the U.S.
• Must be U.S. citizen employed by the U.S. government, or
dependent of U.S. citizen
• Must have received a vaccine manufactured in the U.S.
and the recipient must return to the U.S. within 6 months
post vaccination
45
Accessing the Vaccine Court
In Order to File a Claim the Injury Must:
•
Last more than 6 months post vaccination
•
Require a hospital stay AND surgery, or
•
Result in death
• FILING FEE: $250, may be waived by Special Master
• Legal counsel not required
• Legal fees are routinely awarded regardless of the outcome of
the claim
46
Accessing the Vaccine Court
Filing Deadlines
• INJURY: within 3 years after the first symptom of the
vaccine injury
• DEATH: within 2 years of the death & 4 years after the start
of the first symptoms of the injury from which the death
occurred
47
The Vaccine Court Recognizes Two Types of Claims
1. VACCINE INJURY TABLE
•
Known ADVERSE EVENT + outlined TIME INTERVAL = presumed
vaccine injury
TETANUS TOXOOID-CONTAINING VACCINES: (DTaP, Tdap, DTP-Hib, DT, Td, TT)
1. Anaphylaxis or anaphylactic shock
2. Brachial neuritis
3. Any acute complication or sequela of above events
1. 0 – 4 hours
2. 2 – 28 days
3. Not applicable
2. NON-TABLE INJURY
•
Petitioner must prove that the vaccine caused the injury using the
Preponderance of the Evidence Standard:
•
PERMISSIBLE PROOF: Not governed by evidentiary rules applicable
in federal district court, and can include:
• Expert medical opinion
• Medical records
• Circumstantial evidence
• Widely accepted, unproven scientific theories
48
Awards
DEATH AWARD
• Maximum = $250,000 + attorneys’ fees
INJURY AWARD
• No Limit = Past/future non-reimbursable medical cost & related
expenses (must be reasonable)
And
• Maximum = $250,000 Actual and Projected PAIN, SUFFERING &
EMOTIONAL DISTRESS
49
Awards
• FY1988 - FY2010: 13,198 petitions filed
• FY1989 - FY2010: 7,334 adjudications (average 2-3 year post filing)
• FY1989 - FY2010: 2,376 claims compensated
*********************************************************
TOTAL AWARDS FY 1989 – FY2010:
$1,803,196,345.35
67,699,584.42
42,812,879.94
Awarded to petitioners
Awarded to attorneys for compensated claims
Awarded to attorneys for dismissed claims
__________________________________________________________________________________________________________________________________
$1,913,708,809.71
Total outlay
50
Autism and the Vaccine Court
FY 1999:
First autism claim filed
FY 2000 – 2010:
5,610 autism claims filed
DISMISSED:
588 autism claims
COMPENSATED: 0 autism claims
51
Omnibus Autism Proceeding
• Established July, 2002
• Consolidated 5,300 pending autism claims
• Claims based on 2 different theories of causation:
1. MMR vaccine COMBINED WITH thimerosal containing vaccines
can cause autism spectrum disorder
2. Thimerosal containing vaccines ALONE can cause autism spectrum
disorder
• All cases will be heard individually
52
Omnibus Autism Proceeding
THEORY 1
• MMR vaccine COMBINED WITH thimerosal containing
vaccines can cause autism spectrum disorder
• 3 test cases regarding Theory 1:
• Cedillo v. Secretary of HHS
• Hazlehurst v. Secretary of HHS
• Snyder v. Secretary of HHS
53
Omnibus Autism Proceeding
THEORY 2
• Thimerosal containing vaccines ALONE can cause autism
spectrum disorder
• 3 test cases regarding Theory 2:
• King v. Secretary of HHS
• Mead v. Secretary of HHS
• Dwyer v. Secretary of HHS
• Special Masters will issue rulings as soon as possible
54
Omnibus Autism Proceedings:
Theory 1 Test Case Decisions - February 2009
“[T]he petitioners in this litigation have been the victims of bad science,
conducted to support litigation rather than to advance medical and
scientific understanding of autism spectrum disorder.” Snyder
Petitioners Claims Dismissed:
Failed to Satisfy Preponderance of the Evidence Standard:
•
•
•
•
•
Unproven theories
Inadequate expert witness testimony
Cause of autism is unknown
Current credible theories suggest other causes of autism
Lack of any accepted studies to support association between MMR
vaccine and autism
55
Omnibus Autism Proceedings:
Theory 1 Test Case Decisions – Appellate Activity
3 Petitioners Appeal to U.S. Court of Federal Claims
Summer 2009, Special Masters’ Decision was affirmed:
• Under applicable review standards of the Vaccine Act, the
Special Master’s decision is “rational and reasonable in all
respects and is in accordance with law.”
56
Omnibus Autism Proceedings:
Theory 1 Test Case Decisions – Appellate Activity
1 Petitioner filed a notice of appeal to the U.S. Court of
Appeals for the Federal Circuit (September 2009)
• If Special Masters decision is upheld, petitioners may:
1. Request Supreme Court review
or
2. Discontinue the appeals,
permit the case to go to judgment,
reject the judgment, and
file a civil action in state court
57
Omnibus Autism Proceedings: Implications
• The VICP preserves the vaccine supply, promotes R & D,
protects manufacturers from unsubstantiated claims,
recognizes and compensates persons who have been injured
by vaccines.
• The vaccine court is capable of addressing the autism claims,
no matter how numerous.
• Without credible proof, the vaccine court cannot hold
vaccines responsible for autism.
58
Resources
For more information about the ABA Health Law Section,
please visit www.abanet.org/health or contact Simeon
Carson at 312-988-5824 or [email protected]
59