National Vaccine Injury Compensation Program

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Cases before the Vaccine Court are heard in the U.S. Court of Federal Claims. United States Court of Federal Claims.JPG
Cases before the Vaccine Court are heard in the U.S. Court of Federal Claims.

The Office of Special Masters of the U.S. Court of Federal Claims, popularly known as "vaccine court", administers a no-fault system for litigating vaccine injury claims. These claims against vaccine manufacturers cannot normally be filed in state or federal civil courts, but instead must be heard in the U.S. Court of Federal Claims, sitting without a jury.

Contents

The National Vaccine Injury Compensation Program (VICP or NVICP) was established by the 1986 National Childhood Vaccine Injury Act (NCVIA), passed by the United States Congress in response to a threat to the vaccine supply due to a 1980s scare over the DPT vaccine. Despite the belief of most public health officials that claims of side effects were unfounded, large jury awards had been given to some plaintiffs, most DPT vaccine makers had ceased production, and officials feared the loss of herd immunity. [1]

Between its inception in 1986 and May 2023, it has awarded a total of $4.6 billion, with the average award amount between 2006 and 2020 being $450,000, and the award rate (which varies by vaccine) being 1.2 awards per million doses administered. The Health Resources and Services Administration reported in July 2022 that "approximately 60 percent of all compensation awarded by the VICP comes as result of a negotiated settlement between the parties in which HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury". [2] Cases are settled to minimize the risk of loss for both parties, to minimize the time and expense of litigation, and to resolve petitions quickly. [2]

National Childhood Vaccine Injury Act

The U.S. Department of Health and Human Services set up the National Vaccine Injury Compensation Program (VICP) in 1988 to compensate individuals and families of individuals injured by covered childhood vaccines. [3] The VICP was adopted in response to concerns over the pertussis portion of the DPT vaccine. [1] Several U.S. lawsuits against vaccine makers won substantial awards. Most makers ceased production, and the last remaining major manufacturer threatened to do so. [1] The VICP uses a no-fault system for resolving vaccine injury claims. [1] Compensation covers medical and legal expenses, loss of future earning capacity, and up to $250,000 for pain and suffering; a death benefit of up to $250,000 is available. If certain minimal requirements are met, legal expenses are compensated even for unsuccessful claims. [4] Since 1988, the program has been funded by an excise tax of 75 cents on every purchased dose of covered vaccine. To win an award, a claimant must have experienced an injury that is named as a vaccine injury in a table included in the law within the required time period or show a causal connection. The burden of proof is the civil law preponderance-of-the-evidence standard, in other words a showing that causation was more likely than not. Denied claims can be pursued in civil courts, though this is rare. [1]

The VICP covers all vaccines listed on the Vaccine Injury Table maintained by the Secretary of Health and Human Services; in 2007 the list included vaccines against diphtheria, tetanus, pertussis (whooping cough), measles, mumps, rubella (German measles), polio, hepatitis B, varicella (chicken pox), Haemophilus influenzae type b, rotavirus, and pneumonia. [5] From 1988 until January 8, 2008, 5,263 claims relating to autism, and 2,865 non-autism claims, were made to the VICP. Of these claims, 925 (see previous rulings), were compensated, with 1,158 non-autism and 350 autism claims dismissed, and one autism-like claim compensated; awards (including attorney's fees) totaled $847 million. [6] The VICP also applies to claims for injuries suffered before 1988; there were 4,264 of these claims of which 1,189 were compensated with awards totaling $903 million. [6] [ failed verification ] As of October 2019, $4.2 billion in compensation (not including attorneys fees and costs) has been awarded. [7]

As of December 2020, filing a claim with the Court of Federal Claims requires a $402.00 filing fee, [8] which can be waived for those unable to pay. Medical records such as prenatal, birth, pre-vaccination, vaccination, and post-vaccination records are strongly suggested, as medical review and claim processing may be delayed without them. Because this is a legal process most people use a lawyer, though this is not required. [4] By 1999 the average claim took two years to resolve, and 42% of resolved claims were awarded compensation, as compared with 23% for medical malpractice claims through the tort system. [9] There is a three-year statute of limitations for filing a claim, timed from the first manifestation of the medical problem. [10]

Autism claims

More than 5,300 petitions alleging autism caused by vaccines have been filed in the vaccine court. In 2002, the court instituted the Omnibus Autism Proceeding in which plaintiffs were allowed to proceed with the three cases they considered to be the strongest before a panel of special masters. In each of the cases, the panel found that the plaintiffs had failed to demonstrate a causal effect between the MMR vaccine and autism. [11] Following this determination, the vaccine court has routinely dismissed such suits, finding no causal effect between the MMR vaccine and autism. [12]

Many studies have failed to conclude that there is a causal link between autism spectrum disorders and vaccines, [13] and the current scientific consensus is that routine childhood vaccines are not linked to the development of autism.

Several claimants have attempted to bypass the VICP process with claims that thimerosal in vaccines had caused autism, but these were ultimately not successful. They have demanded medical monitoring for vaccinated children who do not show signs of autism and have filed class-action suits on behalf of parents. [1] In March 2006, the U.S. Fifth Circuit Court of Appeals ruled that plaintiffs suing three manufacturers of thimerosal could bypass the vaccine court and litigate in either state or federal court using the ordinary channels for recovery in tort. [14] This was the first instance where a federal appeals court has held that a suit of this nature may bypass the vaccine court. The argument was that thimerosal is a preservative, not a vaccine, so it does not fall under the provisions of the vaccine act. [15] The claims that vaccines (or thimerosal in vaccines) caused autism eventually had to be filed in the vaccine court as part of the Omnibus Autism Proceeding.[ citation needed ]

The scientific consensus, developed from substantial medical and scientific research, states that there is no evidence supporting these claims, and the rate of autism continues to climb despite elimination of thimerosal from most routine early childhood vaccines. [16] [17] [13] [18] Major scientific and medical bodies such as the Institute of Medicine [18] and World Health Organization, [19] [20] as well as governmental agencies such as the Food and Drug Administration [21] and the CDC [22] reject any role for thimerosal in autism or other neurodevelopmental disorders. [1]

Compensation awards

As of May 2023, nearly $4.6 billion in compensation and $450 million in attorneys’ fees have been awarded. [3]

The following table shows the awards by main classes of vaccines made to victims in the years 2006-2017. [23] This shows that on average 1.2 awards were made per million vaccine doses. It also shows that multiple vaccines such as MMR do not have an abnormal award rate.

DiseaseVaccinationsCompensationsComp/m vacc
Diphtheria+Tetanus+A.pertussis *503,068,1456011.2
DTaP-Hep B-IPV68,764,777420.6
HepA+HepB, HepB+HIB20,614,142211.0
Hepatitis A176,194,118550.3
Hepatitis B185,428,393810.4
HIB (Haemophilus influenzae)119,947,400120.1
HPV111,677,5521341.2
Influenza1,518,400,0002,8331.9
IPV (Inactivated poliovirus vaccine)72,962,51240.1
Measles135,66017.4
Meningococcal94,113,218430.5
MMR (Measles, mumps, rubella)101,501,7141201.2
MMR-Varicella24,798,297200.8
Mumps110,74900.0
Pneumococcal Conjugate228,588,846480.2
Rotavirus107,678,219400.4
Rubella422,54812.4
Tetanus3,836,0525213.6
Varicella116,063,014450.4
Total3,454,305,3564,1531.2

* This covers the vaccinations known by the abbreviations DT, DTaP, DTaP-HIB, DTaP-IPV, DTap-IPV-HIB, Td, Tdap

Annual awards
Fiscal year Number of awardsPetitioners’ awardAverage amount
200668$48,746,162.74$716,855.33
200782$91,449,433.89$1,115,237.00
2008141$75,716,552.06$536,996.82
2009131$74,142,490.58$565,973.21
2010173$179,387,341.30$1,036,921.05
2011251$216,319,428.47$861,830.39
2012249$163,491,998.82$656,594.37
2013375$254,666,326.70$679,110.20
2014365$202,084,196.12$553,655.33
2015508$204,137,880.22$401,846.22
2016689$230,140,251.20$334,020.68
2017706$252,245,932.78$357,288.86
2018521$199,588,007.04$383,086.39
2019653$196,217,707.64$300,486.54
2020734$186,885,677.55$254,612.64
Total5,646$2,575,219,387.11$456,113.95

Attorneys fees and costs

Self representation is permitted, although the NVICP also pays attorneys fees out of the fund, separate from any compensation given to the petitioner. [24] This is "to ensure that vaccine claimants have readily available a competent bar to prosecute their claims". [25]

Homeland Security Act

The Homeland Security Act of 2002 provides another exception to the exclusive jurisdiction of the vaccine court. If smallpox vaccine were to be widely administered by public health authorities in response to a terrorist or other biological warfare attack, persons administering or producing the vaccine would be deemed federal employees and claims would be subject to the Federal Tort Claims Act, in which case claimants would sue the U.S. Government in the U.S. district courts, and would have the burden of proving the defendants' negligence, a much more difficult standard. [26]

Petitioner's burden of proof

Notably, the Health Resources and Services Administration reported in July 2022 that "approximately 60 percent of all compensation awarded by the VICP comes as result of a negotiated settlement between the parties in which HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury". [2] Cases are settled to minimize the risk of loss for both parties, to minimize the time and expense of litigation, and to resolve petitions quickly. [2]

Of the remaining cases, in the vaccine court, as in civil tort cases, the burden of proof is a preponderance of evidence, but while in tort cases this is met by expert testimony based on epidemiology or rigorous scientific studies showing both general and specific causation, in the vaccine court, the burden is met with a three prong test established in Althen, [27] a 2005 United States Court of Appeals for the Federal Circuit ruling. [28] Althen held that an award should be granted if a petitioner either establishes a "Tabled Injury" or proves "causation in fact" by proving three prongs:

  1. a medical theory causally connecting the vaccination and the injury;
  2. a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and
  3. a showing of a proximate temporal relationship between vaccination and injury.

This ruling held that tetanus vaccine caused a particular case of optic neuritis, even though no scientific evidence supported the petitioner's claim. [29] Other rulings have allowed petitioners to gain awards for claims that the MMR vaccine causes fibromyalgia, that the Hib vaccine causes transverse myelitis, and that the hepatitis B vaccine causes Guillain–Barré syndrome, chronic demyelinating polyneuropathy, and multiple sclerosis. [29] In the most extreme of these cases, a 2006 petitioner successfully claimed that a hepatitis B vaccine caused her multiple sclerosis despite several studies showing that the vaccine neither causes nor worsens the disease, and despite a conclusion by the Institute of Medicine that evidence favors rejection of a causal relationship. [29]

In 2008, the federal government settled a case brought to the vaccine court by the family of Hannah Poling, a girl who developed autistic-like symptoms after receiving a series of vaccines in a single day. [30] [31] The vaccines given were DTaP, Hib, MMR, varicella, and inactivated polio. Poling was diagnosed months later with encephalopathy (brain disease) caused by a mitochondrial enzyme deficit, a mitochondrial disorder; it is not unusual for children with such deficits to develop neurologic signs between their first and second years. [29] There is little scientific research in the area: no scientific studies show whether childhood vaccines can cause or contribute to mitochondrial disease, and there is no scientific evidence that vaccinations damage the brains of children with mitochondrial disorders. [30] [32] Although many parents view this ruling as confirming that vaccines cause regressive autism, most children with autism do not seem to have mitochondrial disorders, and the case was settled without proof of causation. [30] [33]

With the commencement of hearings in the case of Cedillo v. Secretary of Health and Human Services (Case #98-916V), the argument over whether autism is a vaccine injury moved into the vaccine court. A panel of three special masters began hearing the first cases of the historic Omnibus Autism Proceedings in June 2007. [34] There were six test cases in all, and the entire record of the cases is publicly available. [35] The lead petitioners, the parents of Michelle Cedillo, claimed that Michelle's autism was caused by a vaccine. Theresa and Michael Cedillo contended that thimerosal seriously weakened Michelle's immune system and prevented her body from clearing the measles virus after her vaccination at the age of fifteen months. At the outset Special Master George Hastings, Jr. said "Clearly the story of Michelle's life is a tragic one," [36] while pledging to listen carefully to the evidence. On February 12, 2009, the court ruled in three test cases that the combination of the MMR vaccine and thimerosal-containing vaccines were not to blame for autism. Hastings concluded in his decision, "Unfortunately, the Cedillos have been misled by physicians who are guilty, in my view, of gross medical misjudgment." [37] The ruling was appealed to the U.S. Court of Appeals, [12] and upheld.

On March 13, 2010, the court ruled in three test cases that thimerosal-containing vaccines do not cause autism. Special Master Hastings concluded, "The overall weight of the evidence is overwhelmingly contrary to the petitioners' causation theories." [12]

See also

Related Research Articles

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Vaccination is the administration of a vaccine to help the immune system develop immunity from a disease. Vaccines contain a microorganism or virus in a weakened, live or killed state, or proteins or toxins from the organism. In stimulating the body's adaptive immunity, they help prevent sickness from an infectious disease. When a sufficiently large percentage of a population has been vaccinated, herd immunity results. Herd immunity protects those who may be immunocompromised and cannot get a vaccine because even a weakened version would harm them. The effectiveness of vaccination has been widely studied and verified. Vaccination is the most effective method of preventing infectious diseases; widespread immunity due to vaccination is largely responsible for the worldwide eradication of smallpox and the elimination of diseases such as polio and tetanus from much of the world. However, some diseases, such as measles outbreaks in America, have seen rising cases due to relatively low vaccination rates in the 2010s – attributed, in part, to vaccine hesitancy. According to the World Health Organization, vaccination prevents 3.5–5 million deaths per year.

<span class="mw-page-title-main">Thiomersal</span> Organomercury antiseptic and antifungal agent

Thiomersal (INN), or thimerosal, also sold under the name merthiolate is an organomercury compound. It is a well-established antiseptic and antifungal agent.

<span class="mw-page-title-main">Vaccine hesitancy</span> Reluctance or refusal to be vaccinated or have ones children vaccinated

Vaccine hesitancy is a delay in acceptance, or refusal, of vaccines despite the availability of vaccine services and supporting evidence. The term covers refusals to vaccinate, delaying vaccines, accepting vaccines but remaining uncertain about their use, or using certain vaccines but not others. Although adverse effects associated with vaccines are occasionally observed, the scientific consensus that vaccines are generally safe and effective is overwhelming. Vaccine hesitancy often results in disease outbreaks and deaths from vaccine-preventable diseases. Therefore, the World Health Organization characterizes vaccine hesitancy as one of the top ten global health threats.

<span class="mw-page-title-main">Bernard Rimland</span> American psychologist (1928–2006)

Bernard Rimland was an American research psychologist, writer, lecturer, and influential person in the field of developmental disorders. Rimland's first book, Infantile Autism, sparked by the birth of a son who had autism, was instrumental in changing attitudes toward the disorder. Rimland founded and directed two advocacy groups: the Autism Society of America (ASA) and the Autism Research Institute. He promoted several since disproven theories about the causes and treatment of autism, including vaccine denial, facilitated communication, chelation therapy, and false claims of a link between secretin and autism. He also supported the ethically controversial practice of using aversives on autistic children.

<span class="mw-page-title-main">National Childhood Vaccine Injury Act</span> US law

The National Childhood Vaccine Injury Act (NCVIA) of 1986 was signed into law by United States President Ronald Reagan as part of a larger health bill on November 14, 1986. NCVIA's purpose was to eliminate the potential financial liability of vaccine manufacturers due to vaccine injury claims to ensure a stable market supply of vaccines, and to provide cost-effective arbitration for vaccine injury claims. Under the NCVIA, the National Vaccine Injury Compensation Program (NVICP) was created to provide a federal no-fault system for compensating vaccine-related injuries or death by establishing a claim procedure involving the United States Court of Federal Claims and special masters.

Concerns about thiomersal and vaccines are commonly expressed by anti-vaccine activists. Claims relating to the safety of thiomersal, a mercury-based preservative used in vaccines, are refuted, but still subject to fearmongering, notably claims it could cause neurological disorders such as autism, leading to its removal from most vaccines in the US childhood schedule. This had no effect on the rates of diagnosis of pervasive developmental defects, including autism. Extensive scientific research shows no credible evidence linking thiomersal to such conditions.

A vaccine adverse event (VAE), sometimes referred to as a vaccine injury, is an adverse event believed to have been caused by vaccination. The World Health Organization (WHO) refers to Adverse Events Following Immunization (AEFI).

The Omnibus Autism Proceeding was a set of six test cases heard by Special Masters of the United States Court of Federal Claims to examine claims of a causal link between vaccines and autism.

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<i>Cedillo v. Secretary of Health and Human Services</i> Legal case in US Court of Federal Claims, decided in 2009

Michelle Cedillo v. Secretary of Health and Human Services, also known as Cedillo, was a court case involving the family of Michelle Cedillo, an autistic girl whose parents sued the United States government because they believed that her autism was caused by her receipt of both the measles-mumps-and-rubella vaccine and thimerosal-containing vaccines. The case was a part of the Omnibus Autism Proceeding, where petitioners were required to present three test cases for each proposed mechanism by which vaccines had, according to them, caused their children's autism; Cedillo was the first such case for the MMR-and-thimerosal hypothesis.

Hurair Vasken Aposhian was a Ph.D. toxicologist and an emeritus professor of molecular and cell biology at the University of Arizona, a post he held beginning in 1975. He is also a former professor of pharmacology at the medical school at said university. He received his bachelor's degree in chemistry, at Brown University, 1948. He received a master's degree and a PhD in physiological chemistry at the University of Rochester, where he published some scientific studies about the synthesis of isoalloxazine ring-containing compounds. He did a postdoctoral with Nobel Laureate Arthur Kornberg in the department of biochemistry at Stanford University School of Medicine. He has done sabbatical scholar-in-residence at MIT and at the University of California at San Diego. He is best known for his pioneering work on Succimer and Unithiol in the treatment of arsenic, mercury, lead and other heavy metals leading to FDA approval of succimer in childhood lead poisoning at levels over 40 ug/dl. Previous posts he had held include at Vanderbilt, Tufts University, and the University of Maryland. His views about mercury in vaccines and in dental amalgams go against the consensus of the medical community and are controversial.

Frank DeStefano FACPM is a medical epidemiologist and researcher at the Centers for Disease Control and Prevention, where he is director of the Immunization Safety Office.

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The Lancet MMR autism fraud centered on the publication in February 1998 of a fraudulent research paper titled "Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children" in the Lancet. The paper, authored by now discredited and deregistered Andrew Wakefield, and twelve coauthors, falsely claimed causative links between the measles, mumps, and rubella (MMR) vaccine and colitis and between colitis and autism. The fraud involved data selection, data manipulation, and two undisclosed conflicts of interest. It was exposed in a lengthy Sunday Times investigation by reporter Brian Deer, resulting in the paper's retraction in February 2010 and Wakefield being struck off the UK medical register three months later. Wakefield reportedly stood to earn up to US$43 million per year selling diagnostic kits for a non-existent syndrome he claimed to have discovered. He also held a patent to a rival vaccine at the time, and he had been employed by a lawyer representing parents in lawsuits against vaccine producers.

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JABS is a British pressure group launched in Wigan in January 1994. Beginning as a support group for the parents of children they claim became ill after the MMR vaccine, the group is currently against all forms of vaccination.

References

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  8. ↑ "Updated Fee Schedule". United States Court of Federal Claims. Retrieved January 28, 2022.
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  15. ↑ Davis WN (2006). "No longer immune". ABA Journal. 92 (7): 19, 43.
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  19. ↑ World Health Organization (2006). "Thiomersal and vaccines: questions and answers". Archived from the original on October 12, 2003. Retrieved May 19, 2009.
  20. ↑ WHO. "Statement on thiomersal". www.who.int. Archived from the original on October 29, 2012. Retrieved April 3, 2018.
  21. ↑ "Thimerosal in vaccines". Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. June 3, 2008. Retrieved July 25, 2008.
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  28. ↑ Althen v. Secretary of Health and Human Services(Fed. Cir.July 29, 2005), Text . This decision, which is binding upon the United States Court of Federal Claims, clarified the standing for proving "causation in fact" absent a "Table Injury" under 42 U.S.C. 300aa-11(c)(1)(C)
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  30. 1 2 3 Keelan, J; Wilson, K (November 2011). "Balancing vaccine science and national policy objectives: lessons from the National Vaccine Injury Compensation Program Omnibus Autism Proceedings". American Journal of Public Health. 101 (11): 2016–21. doi:10.2105/ajph.2011.300198. PMC   3222385 . PMID   21940934.
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  32. ↑ Holtzman, David (July 2008). "Autistic spectrum disorders and mitochondrial encephalopathies". Acta Paediatrica. 97 (7): 859–860. doi:10.1111/j.1651-2227.2008.00883.x. PMID   18532934. S2CID   46213238.
  33. ↑ Honey, Karen (May 1, 2008). "Attention focuses on autism". Journal of Clinical Investigation. 118 (5): 1586–1587. doi:10.1172/JCI35821. PMC   2336894 . PMID   18451989.
  34. ↑ Kirkland, Anna (March 13, 2012). "Credibility battles in the autism litigation". Social Studies of Science. 42 (2): 237–261. doi:10.1177/0306312711435832. PMID   22848999. S2CID   1798838.
  35. ↑ "Omnibus Autism Proceeding". US Court of Federal Claims. Retrieved October 12, 2016.
  36. ↑ Bridges A (June 12, 2007). "Children with autism get day in court". USA Today. Retrieved October 14, 2007.
  37. ↑ Freking K, Neergaard L (February 12, 2009). "Court says vaccine not to blame for autism". Associated Press. Retrieved February 12, 2009.
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