Vaccine court is the popular term which refers to the Office of Special Masters of the U.S. Court of Federal Claims, which 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 Court of Claims, sitting without a jury. The program 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.
Some parents of children with autism spectrum disorders have attributed the disorders' onset to vaccines, often citing the mercury-based preservative thiomersal as the cause, and some have filed suit for compensation from vaccine makers. The medical and scientific communities nearly unanimously deny a link between routine childhood vaccines and autism per se, as no evidence has been found to support this claim.
National Childhood Vaccine Injury Act
The U.S. Department of Health and Human Services set up the National Vaccine Injury Compensation Program (NVICP) 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 show a causal connection; if medical records show a child has one of several listed adverse effects soon after vaccination, the assumption is that it was caused by the vaccine. 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 (whooping cough), measles, mumps, rubella (German measles), polio, hepatitis B, varicella (chicken pox), Haemophilus influenzae type b, rotavirus, and pneumonia. 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. 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.
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. 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 are legal time limits for filing claims. As with any benefit program, eligibility requirements seem unfair to some applicants.
Several claimants have attempted to bypass the VICP process, with some successes. 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 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 (Holder v. Abbott Laboratories Inc., 444 F.3d 383). 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.
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.
A 2005 United States Court of Appeals for the Federal Circuit ruling 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:
- a medical theory causally connecting the vaccination and the injury;
- a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and
- 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. 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. 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.
In 2008 the federal government agreed to award damages to the family of Hannah Poling, a girl who developed autistic-like symptoms after receiving a series of vaccines in a single day. 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. 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. 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 conceded without proof of causation.
With the commencement of hearings in the case of Cedillo v. Secretary of Health and Human Services (Case #98-916V), the battle over vaccine injuries moved into the courts. A panel of three special masters began hearing the first cases of the historic Omnibus Autism Proceedings in June 2007. 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," 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." The ruling was appealed to the U.S. Court of Appeals, and upheld.
Petitioner’s Burden of Proof
A petitioner seeking to establish causation-in-fact must show, by a preponderance of the evidence, that but for her vaccination she would not have been injured, and that the vaccination was a substantial factor in bringing about her injury. Shyface, 165 F.3d at 1352. Mere temporal association is not sufficient to prove causation in fact; a petitioner must present a medical theory that is supported either by medical records or by the opinion of a competent physician. Grant v. Sec’y of Dep’t of Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992). Proof of actual causation must be supported by a sound and reliable “medical or scientific explanation that pertains specifically to the petitioner’s case, although the explanation need only be ‘legally probable, not medically or scientifically certain.’” Moberly, 592 F.3d at 1322 (Fed. Cir. 2010) (quoting Knudsen, 35 F.3d at 548-49); see also Grant, 956 F.2d at 1148 (medical theory must support actual cause). The preponderance of evidence standard under the Vaccine Act requires proof that a vaccine more likely than not caused the vaccinee’s injury. Althen, 418 F.3d at 1279. Causation is determined on a case-by-case basis, with “no hard and fast per se scientific or medical rules.” Knudsen, 35 F.3d at 548. On March 13, 2010, the court ruled in three test cases that thiomersal-containing vaccines do not cause autism. The test cases were among the strongest for this theory. Special Master Hastings concluded, "The overall weight of the evidence is overwhelmingly contrary to the petitioners' causation theories."
- Sugarman SD (2007). "Cases in vaccine court—legal battles over vaccines and autism". N Engl J Med 357 (13): 1275–7. doi:10.1056/NEJMp078168. PMID 17898095.
- Doja A, Roberts W (2006). "Immunizations and autism: a review of the literature". Can J Neurol Sci 33 (4): 341–6. doi:10.1017/s031716710000528x. PMID 17168158.
- 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.
- "Filing a claim with the VICP". Health Resources and Services Administration. Retrieved 2013-08-19.
- "Vaccine Injury Table". Health Resources and Services Administration. 2007. Retrieved 2008-01-22.
- "National Vaccine Injury Compensation Program statistics reports". Health Resources and Services Administration. 2008-01-08. Retrieved 2008-01-22.
- Balbier TE Jr (1999-09-28). "Statement on National Vaccine Injury Compensation Program". U.S. Department of Health and Human Services. Retrieved 2008-01-22.
- Davis WN (2006). "No longer immune". ABA J 92 (7): 19, 43.
- 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.
- "Althen v. HHS" (PDF).| This is a decision by the United States Court of Appeals for the Federal Circuit, 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)
- Offit PA (2008). "Vaccines and autism revisited—the Hannah Poling case". N Engl J Med 358 (20): 2089–91. doi:10.1056/NEJMp0802904. PMID 18480200.
- Rovner J (2008-03-07). "Case stokes debate about autism, vaccines". NPR. Retrieved 2008-03-07.
- Stobbe M, Marchione M (2008-03-07). "Analysis: vaccine-autism link unproven". Associated Press. Retrieved 2008-06-06.[dead link]
- Holtzman D (2008). "Autistic spectrum disorders and mitochondrial encephalopathies". Acta Paediatr 97 (7): 859–60. doi:10.1111/j.1651-2227.2008.00883.x. PMID 18532934.
- Honey K (2008). "Attention focuses on autism". J Clin Invest 118 (5): 1586–7. doi:10.1172/JCI35821. PMC 2336894. PMID 18451989.
- Bridges A (2007-06-12). "Children with autism get day in court". USA Today. Retrieved 2007-10-14.
- Freking K, Neergaard L (2009-02-12). "Court says vaccine not to blame for autism". Associated Press. Retrieved 2009-02-12.
- Maugh TH II, Zajac A (2010-03-13). "'Vaccines court' rejects mercury–autism link in 3 test cases". Los Angeles Times.