National Vaccine Injury Compensation Program
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.
The National Vaccine Injury Compensation Program was established by the 1986 National Childhood Vaccine Injury Act, 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.
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 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 caused the alleged injury". 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.
National Childhood Vaccine Injury Act
The U.S. Department of Health and Human Services set up the National Vaccine Injury Compensation Program in 1988 to compensate individuals and families of individuals injured by covered childhood vaccines. The VICP was adopted in response to concerns over the pertussis portion of the DPT vaccine. Several U.S. lawsuits against vaccine makers won substantial awards. Most makers ceased production, and the last remaining major manufacturer threatened to do so. The VICP uses a no-fault system for resolving vaccine injury claims. 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. 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.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, measles, mumps, rubella, polio, hepatitis B, varicella, Haemophilus influenzae type b, rotavirus, and pneumonia. 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, were compensated, with 1,158 non-autism and 350 autism claims dismissed, and one autism-like claim compensated; awards totaled $847 million. 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. As of October 2019, $4.2 billion in compensation has been awarded.
, filing a claim with the Court of Federal Claims requires a $405 filing fee, 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. 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. There is a three-year statute of limitations for filing a claim, timed from the first manifestation of the medical problem.
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. Following this determination, the vaccine court has routinely dismissed such suits, finding no causal effect between the MMR vaccine and autism.Many studies have failed to conclude that there is a causal link between autism spectrum disorders and vaccines, 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. In March 2006, the U.S. Fifth Circuit Court of Appeals ruled that because the NVICP only protected vaccine manufacturers from liability, and thimerosal was not itself a vaccine, 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. 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. The claims that vaccines caused autism eventually had to be filed in the vaccine court as part of the Omnibus Autism Proceeding.
The scientific consensus, developed from substantial medical and scientific research, states that there is no evidence supporting these claims, and the rate of autism diagnoses continues to climb despite elimination of thimerosal from most routine early childhood vaccines. Major scientific and medical bodies such as the Institute of Medicine and World Health Organization, as well as governmental agencies such as the Food and Drug Administration and the CDC reject any role for thimerosal in autism or other neurodevelopmental disorders.
Compensation awards
As of May 2023, nearly $4.6 billion in compensation and $450 million in attorneys’ fees have been awarded.The following table shows the awards by main classes of vaccines made to victims in the years 2006-2017.
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.
| Disease | Vaccinations | Compensations | Comp/m vacc |
| Diphtheria+Tetanus+A.pertussis * | 503,068,145 | 601 | 1.2 |
| DTaP-Hep B-IPV | 68,764,777 | 42 | 0.6 |
| HepA+HepB, HepB+HIB | 20,614,142 | 21 | 1.0 |
| Hepatitis A | 176,194,118 | 55 | 0.3 |
| Hepatitis B | 185,428,393 | 81 | 0.4 |
| HIB | 119,947,400 | 12 | 0.1 |
| HPV | 111,677,552 | 134 | 1.2 |
| Influenza | 1,518,400,000 | 2,833 | 1.9 |
| IPV | 72,962,512 | 4 | 0.1 |
| Measles | 135,660 | 1 | 7.4 |
| Meningococcal | 94,113,218 | 43 | 0.5 |
| MMR | 101,501,714 | 120 | 1.2 |
| MMR-Varicella | 24,798,297 | 20 | 0.8 |
| Mumps | 110,749 | 0 | 0.0 |
| Pneumococcal Conjugate | 228,588,846 | 48 | 0.2 |
| Rotavirus | 107,678,219 | 40 | 0.4 |
| Rubella | 422,548 | 1 | 2.4 |
| Tetanus | 3,836,052 | 52 | 13.6 |
| Varicella | 116,063,014 | 45 | 0.4 |
| Total | 3,454,305,356 | 4,153 | 1.2 |
| Fiscal year | Number of awards | Petitioners’ award | Average amount |
| 2006 | 68 | $48,746,162.74 | $716,855.33 |
| 2007 | 82 | $91,449,433.89 | $1,115,237.00 |
| 2008 | 141 | $75,716,552.06 | $536,996.82 |
| 2009 | 131 | $74,142,490.58 | $565,973.21 |
| 2010 | 173 | $179,387,341.30 | $1,036,921.05 |
| 2011 | 251 | $216,319,428.47 | $861,830.39 |
| 2012 | 249 | $163,491,998.82 | $656,594.37 |
| 2013 | 375 | $254,666,326.70 | $679,110.20 |
| 2014 | 365 | $202,084,196.12 | $553,655.33 |
| 2015 | 508 | $204,137,880.22 | $401,846.22 |
| 2016 | 689 | $230,140,251.20 | $334,020.68 |
| 2017 | 706 | $252,245,932.78 | $357,288.86 |
| 2018 | 521 | $199,588,007.04 | $383,086.39 |
| 2019 | 653 | $196,217,707.64 | $300,486.54 |
| 2020 | 734 | $186,885,677.55 | $254,612.64 |
| Total | 5,646 | $2,575,219,387.11 | $456,113.95 |