Liability-Free Products Put Our Children at Risk

OUR STAND

  • The pharmaceutical corporations that manufacture vaccines lobbied for and obtained almost complete liability protection for injury and death following administration of childhood vaccines recommended by the federal government.
  • In the US today, all 50 states mandate near liability-free vaccines with no legal recourse afforded to those who sustain injury and death.
  • The special administrative “Vaccine Court” has paid out approximately 4 billion dollars for vaccine injury and death to thousands of individuals and their families.
  • Only 1% of vaccine injuries and deaths are reported according to a Health and Human Services’ study.
  • The number of vaccines and doses on the CDC’s recommended childhood schedule tripled after the 1986 Act.
  • Rates of chronic, autoimmune, and neurodevelopmental disorders in US children more than quadrupled during the same time period.
  • The sections of the 1986 Act that shield vaccine manufacturers and health care workers from liability must be repealed to realign corporate and consumer interests and keep children safe. If vaccines are safe, there is nothing to fear. If vaccines cause harm, the opportunity for legal recourse and punitive damages creates appropriate incentives to make and administer safer vaccines.

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Stand to Shield US Children from Harm

Sign the petition to tell U.S. lawmakers that it is time to shield U.S. Children from harm and hold pharma accountable for vaccine injury and death.

The multinational pharmaceutical corporations that manufacture and distribute vaccines in the US benefit from extraordinary market access and almost complete legal protections. The federal government recommends a specific childhood vaccine schedule of over 70 doses of 16 vaccines and, guided by this schedule, all 50 states mandate vaccines for daycare and school admission. Primary care physicians administer vaccines to children according to the federal schedule as standard of care medicine, starting in hospitals on the day of birth. Health insurance plans and government entitlement programs cover the cost of vaccines.

Most notably, this streamlined and subsidized reach to 72 million American  [1] that vaccine makers enjoy is nearly liability-free. After years of industry lobbying, President Regan signed the National Childhood Vaccine Injury Act of 1986 (“1986 Act”) into law. Vaccine makers had threatened to stop manufacturing vaccines because they were tired of paying brand-damaging, multi-million dollar payments to settle lawsuits for injuries and death caused by vaccines. Following passage of the 1986 Act, if an American child is injured or dies following the proper administration of a federally-recommended childhood vaccine, the family is barred from suing either the manufacturer of the vaccine or the health care professional who administered it.[2]

In 2011, the Supreme Court upheld that parents whose children were catastrophically injured or died from vaccines could not sue for design defect liability. In other words, while the federal government acknowledges that vaccines are “unavoidably unsafe”,[3] and cause irreversible harm and death to some who receive them, the financial responsibility for the injured children’s care belongs to the parents. The sole recourse for families is the National Vaccine Injury Compensation Program (“Vaccine Court”), established as part of the 1986 Act.[4] Parents describe Vaccine Court as an unwieldy and burdensome administrative program that does not afford due process. There is no judge, jury of peers, or discovery,all important, Constitutionally-protected legal provisions. Absent very specific circumstances of injury or death following a narrowly defined set of criteria, no compensation is awarded. The no-liability childhood vaccine program is a threat to individual and public health. It further incentivizes the pharmaceutical industry to lobby for inflation of the vaccine schedule (new vaccines and extra doses of existing vaccines) without the need to invest resources into making the safest and most effective vaccines possible. Drug companies paid over 13 billion dollars between 2009 and 2014 to resolve U.S. Department of Justice allegations of fraudulent marketing practices[5]. There has been more than a three-fold increase in the number of vaccines on the US childhood vaccine schedule — representing a dramatic departure from most of our First World peers[6] — following passage of the 1986 Act.

Parents and advocates argued strongly for the 1986 Act to include language that protects a consumer’s right to sue the drug manufacturer when the Vaccine Court denied federal compensation, or the company had access to the technology to make a safer product but declined to do so.[7]  All stakeholders understood the vital role of tort liability as the pivotal assurance safeguarding the safety of American children. Parents wanted it and industry didn’t.  Industry prevailed.  The Supreme Court’s interpretation of the 1986 Act, however, closed the doors to design defect liability and left the pharmaceutical companies near liability-free access to the market of 72 million American children.[8]

Before the 1986 Act was passed, the Centers for Disease Control and Prevention’s (“CDC”) childhood vaccine schedule recommended 23 doses of vaccines between 2 months and 16 years of age,[9] with the pharmaceutical industry profiting about 750 million dollars annually.  After 30+ years of no liability, the schedule has grown to over 70 recommended doses between pregnancy and 18 years of age,[10]. The global vaccine market reached $38 billion in 2018 and is poised to exceed $70 billion by 2025, representing a robust compound annual growth rate approaching 10%.[11] The US market accounts for over ⅓ of total market share and US pharmaceutical corporations rely on a robust and growing domestic market to sell vaccines overseas. If you have children today, and choose to follow the CDC’s recommended schedule, your babies will receive more doses of vaccines by the time they are six months old than most baby boomers received by the time they went to college. Over half of these 70+ doses are given by 15 months of age.

To date, the Vaccine Court has paid out approximately $4 billion in compensation for harm and death caused by vaccines,[12] representing an estimated one percent of the actual damages.[13]  The Vaccine Court is an obligatory administrative program (in lieu of legal recourse) to give families an avenue for potential compensation and a level of justice for government-mandated vaccinations. The existence of the Vaccine Court, however, does not justify the indemnification of the pharmaceutical industry nor is it adequate protection for the health of our children and future generations.  During the same time period, following the dramatic increase in the number of vaccines and doses on the CDC’s recommended childhood schedule, the rates of chronic, autoimmune, and neurodevelopmental disorders in US children more than quadrupled.[14][15]

American parents must make it a top priority to see certain sections of the 1986 Act repealed so that pharmaceutical companies can be held accountable for the safety of their products. Vaccine hesitancy is one of the top health concerns facing not just the citizens of America but of the world, according to organizations such as the World Health Organization, Center for Disease Control, the National Health Institute, the Institute of Medicine and U.S. Congress.[16]  Leaders of these organizations are looking for solutions to vaccine hesitancy by enforcing stricter vaccine mandates and the eroding of constitutional rights such as parental choice and religious freedoms.  Will American parents tolerate the violation of human rights?  Citizens are rising up and asking the hard questions about vaccine safety. We have lived the ramifications of the liability protections implemented as part of the 1986 Act. It’s now time to shield US children.  Let’s keep vaccine manufacturers honest and our children safe.

Tell the President of the United States and Congress that vaccine hesitancy will continue to grow so long as there is no incentive for vaccine manufacturers to make the safest product possible.  We uphold the preservation of human rights, legal due process, and alignment of interests through free market forces, especially when it comes to products mandated for American children.

Sign the petition and share it with your friends today to stand for the health of our children and future generations!


[1] “Trends in the Number of Children in the United States.” https://www.childtrends.org/indicators/number-of-children

[2]  42 U.S.C. § 300aa-22(b)(1); Bruesewitz v. Wyeth, LLC, 131 S. Ct. 1068, 1082 (2011).

[3] 42 U.S.C. § 300aa-22.

[4] “About the National Vaccine Injury Compensation Program,” https://www.hrsa.gov/vaccine-compen- sation/about/index.html.

[5] “Big Pharma’s Big Fines,” https://projects.propublica.org/graphics/bigpharma

[6] “Vaccination Schedule Recommended by the Japan Pediatric Society,” https://www.jpeds.or.jp/uploads/files/20180801_JPS%20Schedule%20English.pdf (Japan recommends 34 routine, childhood vaccines) (August 1, 2018).

[7] National Childhood Vaccine Injury Act of 1986 (PL99-660).

[8] See Breusewitz, 131 S. Ct. at 1082.

[9] https://www.cdc.gov/vaccines/schedules/images/schedule1983s.jpg

[10] https://www.cdc.gov/vaccines/schedules/downloads/past/2018-child.pdf

[11] “Vaccines Market worth over $70bn by 2025: Global Market Insights, Inc.,” https://www.globenewswire.com/news-release/2019/03/07/1749613/0/en/Vaccines-Market-worth-over-70bn-by-2025-Global-Market-Insights-Inc.html (accessed August 18, 2019).

 [12] “Vaccine injury compensation data,” https://www.hrsa.gov/vaccine-compensation/data/index.html (“Total compensation paid over the life of the program is approximately $4.2 billion.”).

[13] Health and Human Services engaged Harvard to do a study on reports of vaccine injuries in the U.S.  Harvard found that less than 1% of all injury and death from vaccinations are reported.  In 2016 alone, there were 59,117 injuries reported through VAERS with 432 reported deaths. Ross L, Klompas M. Electronic Support for Public Health—Vaccine Adverse Event Reporting System (ESP:VAERS). Rockville, MD: The Agency for Healthcare Research and Quality (AHRQ), Grant Final Report, R18 HS 017045.

[14] Bethel et. al, 2011, A National and State Profile of Leading Health Problems and Health Care Quality for US Children: Key Insurance Disparities and Across-State Variations, Academic Pediatrics; “CDC’s Work on Developmental Disabilities,” https://www.cdc.gov/ncbddd/developmentaldisabilities/about.html (April 21, 2017).

[15] McDonald and Paul, Environ. Sci. Technol. “Timing of Increased Autisitic Disorder Cumulative Incidence,” Vol. 44, 2112-2118 (2010).

[16] “Ten Threats to Global Health in 2019,” https://www.who.int/emergencies/ten-threats-to-global-health-in-2019 (2019).