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Childhood Vaccinations – Legal Issues and Legal Solutions December 14, 2009 at 12:00 noon Central

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.

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Childhood Vaccinations – Legal Issues and Legal Solutions December 14, 2009 at 12:00 noon Central

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  1. Childhood Vaccinations – Legal Issues and Legal SolutionsDecember 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

  2. 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

  3. 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

  4. Prevention of Vaccine Preventable Diseases in the United States: Successes and Challenges American Board AssociationPublic Health Interest Group: Health Law Section Teleconference December 14th 2009 Jane Seward, MBBS, MPH Centers for Disease Control and Prevention 404-639-8688 jseward@cdc.gov

  5. 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.

  6. 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

  7. Disease Burden Before Vaccination

  8. 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

  9. Leading cause bacterial meningitis < 5 years 20,000 cases invasive Hib disease (1/200 children per year) Haemophilus influenzae Type B 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

  10. 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

  11. Comparison of 20th Century Annual Morbidity and Current Morbidity: Vaccine-Preventable Diseases †Source: JAMA. 2007;298(18):2155-2163 † †Source: CDC. MMWR August 14, 2009/58(31);856-869. (Final 2008 NNDSS data) * 30 type b and 163 unknown (< 5 years of age)

  12. Impact of Newer Vaccines • Conjugate pneumococcal vaccine for children • Rotavirus (gastroenteritis) vaccine

  13. Invasive Pneumococcal Disease among Children <5 Years, ABCs, 1998-2008 PCV7 intro-duction 2008 vs. baseline All Serotypes: -79% PCV7 Types: -99% 13 Moore, IDSA 2009

  14. Rates of IPD Caused by PCV7 Serotypes among Adults >18 years-old, ABCs 1998-2008 2008 vs. baseline 65+: -93% 50-64: -90% 18-49: -92% PCV7 intro-duction 65+ yrs 50-64 yrs 18-49 yrs Moore, IDSA 2009

  15. Estimated IPD Cases Prevented All ages, US, 2001-2007 210,000 cases & 14,000 deaths prevented Pilishvili, JID 2010, In press.

  16. Decrease in Number of Positive Rotavirus Tests, US Laboratory Surveillance, 2000-2008 RotaTeq introduced

  17. Achievements: High Vaccine Coverage Rates Among Preschool-Aged Children 2010 Target DTP / DTaP(3+)† HepB (3+) PCV 7 (3+) MMR(1+) Polio (3+) Hib (3+) Varicella (1+) †DTP(3+) is not a Healthy People 2010objective. 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.

  18. 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

  19. 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

  20. Decision to vaccinate Individual benefit Wider community benefit through herd immunity Decision to not vaccinate Increased risk disease for the individual Increased risk of disease for members of their community Measles Pertussis Vaccination and Society Salmon et al. JAMA 1999, Feiken et al, JAMA 2000, Omer et al., JAMA, 2006

  21. Exemption to School Immunization Laws ( 28) ( 2) ( 20) Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health, updated June 11, 2009

  22. Nonmedical Exemptions for States With Religious Exemptions and With Personal Belief Exemptions -1991 – 2007* Only Religious Exemptions Permitted Personal Belief Exemptions Permitted Exemption Rate *Updated data courtesy of S Omer Omer et al., JAMA, 2006

  23. WA State Counties’ School Entry Exemption Rates2006-2007 Omer et al., New Eng Journal of Medicine, 2009

  24. 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 school-aged children (all were homeschooled); all unvaccinated due to PBE. Likely source was an unvaccinated adolescent traveler returning home from Italy Measles Outbreaks in Pockets of Unvaccinated School-aged Children, 2008

  25. Measles Importations, U.S. 2008 140 cases 25 importations D5 D4 D4 D4 H1 D5

  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. 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

  30. 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

  31. 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

  32. 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

  33. 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 James.Hodge.1@asu.edu 480/727-8576 There are no slides for this presentation.

  34. 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.

  35. “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 OFFIT@email.chop.edu There are no slides for this presentation.

  36. 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).

  37. Vaccine Injury Compensation Program Alexandra M. Stewart, JD Department of Health Policy School of Public Health and Health Services George Washington University Washington, DC

  38. 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 long-term 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.

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. 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

  45. 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

  46. The Vaccine Court Recognizes Two Types of Claims • VACCINE INJURY TABLE • Known ADVERSE EVENT + outlined TIME INTERVAL = presumed vaccine injury • 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

  47. 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

  48. 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 Awarded to petitioners • 67,699,584.42 Awarded to attorneys for compensated claims • 42,812,879.94 Awarded to attorneys for dismissed claims • __________________________________________________________________________________________________________________________________ • $1,913,708,809.71 Total outlay

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