National Vaccine Injury Compensation Program

From Wikipedia, the free encyclopedia
  (Redirected from Vaccine court)
Jump to navigation Jump to search
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.

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]

Many studies have failed to conclude that there is a causal link between autism spectrum disorders and vaccines,[2] and the current scientific consensus is that routine childhood vaccines do not directly cause the development of autism.

Despite this current consenus, numerous studies have concluded that there is an auto-immune component to autism-spectrum disorders, that there is a link between parents with auto-immune disorders and children with autism, and some studies have shown a link between vaccines, auto-immune responses and auto-immune disorders. Given these facts, it is far from a settled matter whether a link between vaccines and autism may exist.[3][4][5][6][7][8]

Because many people have observed a correlation between children receiving vaccines and the onset of autism symptoms, more than 5,300 parents have filed petitions at the vaccine court. However, the vaccine court has routinely dismissed such suits, failing to recognize a causal effect between the MMR vaccine and autism.[9]

National Childhood Vaccine Injury Act[edit]

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.[10] 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.[11] 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.[12] From 1988 until 8 January 2008, 5,263 claims relating to autism, and 2,865 non-autism claims, were made to the VICP. 925 of these claims, one autism-related (see previous rulings), were compensated, with 1,158 non-autism and 350 autism claims dismissed; awards (including attorney's fees) totaled $847 million.[13] 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.[13]

Filing a claim with the Court of Federal Claims requires a $250 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.[11] 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.[14] There is a three-year statute of limitations for filing a claim, timed from the first manifestation of the medical problem.[15] 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 thiomersal could bypass the vaccine court and litigate in either state or federal court using the ordinary channels for recovery in tort.[16] This is 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 thiomersal is a preservative, not a vaccine, so it does not fall under the provisions of the vaccine act.[17] 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.

Compensations[edit]

The following table shows the awards by main classes of vaccines made to victims in the years 2006-2017. [18] This shows that on average 1.2 awards were made per million applications of vaccines. It also shows that multiple vaccines such as MMR do not have an abnormal award rate.

Disease Vaccinations Compensations Comp/m vacc
Diptheria+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 (Haemophilus influenzae) 119,947,400 12 0.1
HPV 111,677,552 134 1.2
Influenza 1,518,400,000 2,833 1.9
IPV (Inactivated poliovirus vaccine) 72,962,512 4 0.1
Measles 135,660 1 7.4
Meningococcal 94,113,218 43 0.5
MMR (Measles, mumps, rubella) 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
 * This covers the vaccinations known by the abbreviations DT, DTaP, DTaP-HIB, DTaP-IPV, DTap-IPV-HIB, Td, Tdap

The amount awarded from 2006 to 2016 is shown in the table below.[18] This does not include legal and other costs.

Year No of awards Petitioners’ award Average amount
FY 2006 68 $48,746,162.74 $716,855.33
FY 2007 82 $91,449,433.89 $1,115,237.00
FY 2008 141 $75,716,552.06 $536,996.82
FY 2009 131 $74,142,490.58 $565,973.21
FY 2010 173 $179,387,341.30 $1,036,921.05
FY 2011 251 $216,319,428.47 $861,830.39
FY 2012 249 $163,491,998.82 $656,594.37
FY 2013 375 $254,666,326.70 $679,110.20
FY 2014 365 $202,084,196.12 $553,655.33
FY 2015 508 $204,137,880.22 $401,846.22
FY 2016 689 230,140,251.20 $334,020.68
Total 3,032 $1,740,282,062.10 $573,971.66

Homeland Security Act[edit]

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.[19]

Petitioner's burden of proof[edit]

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 establishing a rigorous scientific case, in the vaccine court, the burden is met with a three prong test:[20] the petitioner must present a biological theory of harm, demonstrate a logical sequence of events connecting the vaccine to the injury, and establish an appropriate time frame in which injury occurred. The petitioner must also show that there is not another biologically plausible explanation for the injury.[20]

A 2005 United States Court of Appeals for the Federal Circuit ruling[21] held that an award should be granted if a petitioner either establishes a "Table Injury" or proves "causation in fact" by proving the following 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.[22] 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.[22] 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.[22]

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.[20][23] 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.[22] 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.[20][24] 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.[20][25]

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.[26] There were six test cases in all, and the entire record of the cases is publicly available.[27] The lead petitioners, the parents of Michelle Cedillo, claimed that Michelle's autism was caused by a vaccine. Theresa and Michael Cedillo contended that thiomersal 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,"[28] 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 thiomersal-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."[29] The ruling was appealed to the U.S. Court of Appeals,[9] and upheld.

On March 13, 2010, the court ruled in three test cases that thiomersal-containing vaccines do not cause autism. Special Master Hastings concluded, "The overall weight of the evidence is overwhelmingly contrary to the petitioners' causation theories."[9]

References[edit]

  1. ^ a b c d e f Sugarman, Stephen D. (27 September 2007). "Cases in Vaccine Court — Legal Battles over Vaccines and Autism". New England Journal of Medicine. 357 (13): 1275–1277. doi:10.1056/NEJMp078168. PMID 17898095.
  2. ^ Doja, Asif; Roberts, Wendy (2 December 2014). "Immunizations and Autism: A Review of the Literature". Canadian Journal of Neurological Sciences. 33 (4): 341–346. doi:10.1017/s031716710000528x. PMID 17168158.
  3. ^ Vadalà, Maria; Poddighe, Dimitri; Laurino, Carmen; Palmieri, Beniamino (20 July 2017). "Vaccination and autoimmune diseases: is prevention of adverse health effects on the horizon?". EPMA Journal. 8 (3): 295–311. doi:10.1007/s13167-017-0101-y. PMC 5607155. PMID 29021840.
  4. ^ Keil, Alexander; Daniels, Julie L.; Forssen, Ulla; Hultman, Christina; Cnattingius, Sven; Söderberg, Karin C.; Feychting, Maria; Sparen, Par (November 2010). "Parental Autoimmune Diseases Associated With Autism Spectrum Disorders in Offspring". Epidemiology. 21 (6): 805–808. doi:10.1097/EDE.0b013e3181f26e3f. PMC 3115699. PMID 20798635.
  5. ^ Brimberg, L; Sadiq, A; Gregersen, P K; Diamond, B (20 August 2013). "Brain-reactive IgG correlates with autoimmunity in mothers of a child with an autism spectrum disorder". Molecular Psychiatry. 18 (11): 1171–1177. doi:10.1038/mp.2013.101. PMID 23958959.
  6. ^ Edmiston, Elizabeth; Ashwood, Paul; Van de Water, Judy (March 2017). "Autoimmunity, Autoantibodies, and Autism Spectrum Disorder". Biological Psychiatry. 81 (5): 383–390. doi:10.1016/j.biopsych.2016.08.031. PMC 5373490. PMID 28340985.
  7. ^ Yan, Jun (21 August 2009). "Relationship Found Between Autism and Autoimmune Disorders". Psychiatric News. 44 (16): 25. doi:10.1176/pn.44.16.0025a.
  8. ^ Brimberg, L; Sadiq, A; Gregersen, P K; Diamond, B (20 August 2013). "Brain-reactive IgG correlates with autoimmunity in mothers of a child with an autism spectrum disorder". Molecular Psychiatry. 18 (11): 1171–1177. doi:10.1038/mp.2013.101. PMID 23958959. Lay summaryScienceDaily (August 29, 2013).
  9. ^ a b c Maugh TH II, Zajac A (2010-03-13). "'Vaccines court' rejects mercury–autism link in 3 test cases". Los Angeles Times. Retrieved 2019-01-16.
  10. ^ Edlich RF; Olson DM; Olson BM; et al. (2007). "Update on the National Vaccine Injury Compensation Program". J Emerg Med. 33 (2): 199–211. doi:10.1016/j.jemermed.2007.01.001. PMID 17692778.
  11. ^ a b "Filing a claim with the VICP". Health Resources and Services Administration. Retrieved 2013-08-19.
  12. ^ "Vaccine Injury Table". Health Resources and Services Administration. 2007. Retrieved 2008-01-22.
  13. ^ a b "National Vaccine Injury Compensation Program statistics reports". Health Resources and Services Administration. 2008-01-08. Archived from the original on September 23, 2001. Retrieved 2008-01-22.[failed verification]
  14. ^ Balbier TE Jr (1999-09-28). "Statement on National Vaccine Injury Compensation Program". U.S. Department of Health and Human Services. Archived from the original on July 22, 2001. Retrieved 2008-01-22.
  15. ^ "Who Can File". www.hrsa.gov. Last Reviewed: February 2016: U.S. Department of Health and Human Services Health Resources and Services Administration. Retrieved 12 October 2016.
  16. ^ Holder v. Abbott Laboratories Inc., 444 F.3d 383
  17. ^ Davis WN (2006). "No longer immune". ABA Journal. 92 (7): 19, 43.
  18. ^ a b "Data and Statistics" (PDF). Health Resources & Services Administration. Retrieved 18 February 2019.
  19. ^ Pear R (2002-12-14). "Threats and responses: legal risks; for victims of vaccine, winning case will be hard". New York Times. Retrieved 2008-01-22.
  20. ^ a b c d e 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.
  21. ^ 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)
  22. ^ a b c d Offit, Paul A. (15 May 2008). "Vaccines and Autism Revisited — The Hannah Poling Case". New England Journal of Medicine. 358 (20): 2089–2091. doi:10.1056/NEJMp0802904. PMID 18480200.
  23. ^ Rovner J (2008-03-07). "Case stokes debate about autism, vaccines". NPR. Retrieved 2008-03-07.
  24. ^ 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.
  25. ^ Honey, Karen (1 May 2008). "Attention focuses on autism". Journal of Clinical Investigation. 118 (5): 1586–1587. doi:10.1172/JCI35821. PMC 2336894. PMID 18451989.
  26. ^ Kirkland, Anna (13 March 2012). "Credibility battles in the autism litigation". Social Studies of Science. 42 (2): 237–261. doi:10.1177/0306312711435832. PMID 22848999.
  27. ^ Omnibus Autism Proceeding, US Court of Federal Claims, http://www.uscfc.uscourts.gov/omnibus-autism-proceeding, visited October 12, 2016.
  28. ^ Bridges A (2007-06-12). "Children with autism get day in court". USA Today. Retrieved 2007-10-14.
  29. ^ Freking K, Neergaard L (2009-02-12). "Court says vaccine not to blame for autism". Associated Press. Retrieved 2009-02-12.

External links[edit]