Vaccine court
Encyclopedia
Strict liability
In law, strict liability is a standard for liability which may exist in either a criminal or civil context. A rule specifying strict liability makes a person legally responsible for the damage and loss caused by his or her acts and omissions regardless of culpability...
for litigating vaccine injury
Vaccine injury
A vaccine injury is an injury caused by vaccination.Allegations of vaccine injuries in recent decades have appeared in litigation in the United States. Some families have won substantial awards from sympathetic juries, even though most public health officials believed that the claims of injuries...
claims. These claims against vaccine
Vaccine
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins...
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
National Childhood Vaccine Injury Act
The National Childhood Vaccine Injury Act of 1986 was enacted in the United States to reduce the potential financial liability of vaccine makers due to vaccine injury claims. The legislation was aimed at ensuring a stable market supply, and to provide cost-effective arbitration for vaccine...
(NCVIA), passed by the United States Congress
United States Congress
The United States Congress is the bicameral legislature of the federal government of the United States, consisting of the Senate and the House of Representatives. The Congress meets in the United States Capitol in Washington, D.C....
in response to a threat to the vaccine supply due to a 1980s scare over the DPT vaccine
DPT vaccine
DPT refers to a class of combination vaccines against three infectious diseases in humans: diphtheria, pertussis and tetanus...
. 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
Herd immunity
Herd immunity describes a form of immunity that occurs when the vaccination of a significant portion of a population provides a measure of protection for individuals who have not developed immunity...
.
Some parents of children with autism spectrum disorders have attributed the disorders' onset to vaccines
MMR vaccine controversy
The MMR vaccine controversy was a case of scientific misconduct which triggered a health scare. It followed the publication in 1998 of a paper in the medical journal The Lancet which presented apparent evidence that autism spectrum disorders could be caused by the MMR vaccine, an immunization...
, often citing the mercury-based preservative thiomersal
Thiomersal
Thiomersal , and commonly known in the US as thimerosal, is an organomercury compound. This compound is a well established antiseptic and antifungal agent....
as the cause, and have demanded compensation from vaccine makers. However, the mainstream medical and scientific communities have consistently found no link
MMR vaccine controversy
The MMR vaccine controversy was a case of scientific misconduct which triggered a health scare. It followed the publication in 1998 of a paper in the medical journal The Lancet which presented apparent evidence that autism spectrum disorders could be caused by the MMR vaccine, an immunization...
between routine childhood vaccines
Vaccination schedule
A vaccination schedule is a series of vaccinations, including the timing of all doses, which may be either recommended or compulsory, depending on the country of residence....
and autism
Autism
Autism is a disorder of neural development characterized by impaired social interaction and communication, and by restricted and repetitive behavior. These signs all begin before a child is three years old. Autism affects information processing in the brain by altering how nerve cells and their...
.
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 a scare over the pertussis portion of the DPT vaccine. These claims were later generally discredited, but some 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 also 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
Diphtheria
Diphtheria is an upper respiratory tract illness caused by Corynebacterium diphtheriae, a facultative anaerobic, Gram-positive bacterium. It is characterized by sore throat, low fever, and an adherent membrane on the tonsils, pharynx, and/or nasal cavity...
, tetanus
Tetanus
Tetanus is a medical condition characterized by a prolonged contraction of skeletal muscle fibers. The primary symptoms are caused by tetanospasmin, a neurotoxin produced by the Gram-positive, rod-shaped, obligate anaerobic bacterium Clostridium tetani...
, pertussis
Pertussis
Pertussis, also known as whooping cough , is a highly contagious bacterial disease caused by Bordetella pertussis. Symptoms are initially mild, and then develop into severe coughing fits, which produce the namesake high-pitched "whoop" sound in infected babies and children when they inhale air...
(whooping cough), measles
Measles
Measles, also known as rubeola or morbilli, is an infection of the respiratory system caused by a virus, specifically a paramyxovirus of the genus Morbillivirus. Morbilliviruses, like other paramyxoviruses, are enveloped, single-stranded, negative-sense RNA viruses...
, mumps
Mumps
Mumps is a viral disease of the human species, caused by the mumps virus. Before the development of vaccination and the introduction of a vaccine, it was a common childhood disease worldwide...
, rubella
Rubella
Rubella, commonly known as German measles, is a disease caused by the rubella virus. The name "rubella" is derived from the Latin, meaning little red. Rubella is also known as German measles because the disease was first described by German physicians in the mid-eighteenth century. This disease is...
(German measles), polio, hepatitis B, varicella (chicken pox), Haemophilus influenzae type b, rotavirus
Rotavirus
Rotavirus is the most common cause of severe diarrhoea among infants and young children, and is one of several viruses that cause infections often called stomach flu, despite having no relation to influenza. It is a genus of double-stranded RNA virus in the family Reoviridae. By the age of five,...
, and pneumonia
Pneumonia
Pneumonia is an inflammatory condition of the lung—especially affecting the microscopic air sacs —associated with fever, chest symptoms, and a lack of air space on a chest X-ray. Pneumonia is typically caused by an infection but there are a number of other causes...
. From 1988 until 2008-01-08, 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
Medical malpractice
Medical malpractice is professional negligence by act or omission by a health care provider in which the treatment provided falls below the accepted standard of practice in the medical community and causes injury or death to the patient, with most cases involving medical error. Standards and...
claims through the tort
Tort
A tort, in common law jurisdictions, is a wrong that involves a breach of a civil duty owed to someone else. It is differentiated from a crime, which involves a breach of a duty owed to society in general...
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 so far. 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
Thiomersal
Thiomersal , and commonly known in the US as thimerosal, is an organomercury compound. This compound is a well established antiseptic and antifungal agent....
could bypass the vaccine court and litigate in either state or federal court utilizing the ordinary channels for recovery in tort
Tort
A tort, in common law jurisdictions, is a wrong that involves a breach of a civil duty owed to someone else. It is differentiated from a crime, which involves a breach of a duty owed to society in general...
(Holder v. Abbott Laboratories
Abbott Laboratories
Abbott Laboratories is an American-based global, diversified pharmaceuticals and health care products company. It has 90,000 employees and operates in over 130 countries. The company headquarters are in Abbott Park, North Chicago, Illinois. The company was founded by Chicago physician, Dr....
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 ActHomeland Security Act
The Homeland Security Act of 2002, , 116 Stat. 2135 was introduced in the aftermath of the September 11 attacks and subsequent mailings of anthrax spores. The HSA was cosponsored by 118 members of Congress. It was signed into law by President George W...
of 2002 provides another exception to the exclusive jurisdiction of the vaccine court. If smallpox
Smallpox
Smallpox was an infectious disease unique to humans, caused by either of two virus variants, Variola major and Variola minor. The disease is also known by the Latin names Variola or Variola vera, which is a derivative of the Latin varius, meaning "spotted", or varus, meaning "pimple"...
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
Federal Tort Claims Act
The Federal Tort Claims Act or "FTCA", , is a statute enacted by the United States Congress in 1948. "Federal Tort Claims Act" was also previously the official short title passed by the Seventy-ninth Congress on August 2, 1946 as Title IV of the Legislative Reorganization Act, 60 Stat...
, 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.
Previous rulings
A 2005 United States Court of Appeals for the Federal CircuitUnited States Court of Appeals for the Federal Circuit
-Vacancies and pending nominations:-List of former judges:-Chief judges:Notwithstanding the foregoing, when the court was initially created, Congress had to resolve which chief judge of the predecessor courts would become the first chief judge...
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
Tetanus
Tetanus is a medical condition characterized by a prolonged contraction of skeletal muscle fibers. The primary symptoms are caused by tetanospasmin, a neurotoxin produced by the Gram-positive, rod-shaped, obligate anaerobic bacterium Clostridium tetani...
vaccine caused a particular case of optic neuritis
Optic neuritis
Optic neuritis is the inflammation of the optic nerve that may cause a complete or partial loss of vision.-Causes:The optic nerve comprises axons that emerge from the retina of the eye and carry visual information to the primary visual nuclei, most of which is relayed to the occipital cortex of the...
even though no scientific evidence supported the petitioner's claim. Other rulings have allowed petitioners to gain awards for claims that the MMR vaccine
MMR vaccine
The MMR vaccine is an immunization shot against measles, mumps, and rubella . It was first developed by Maurice Hilleman while at Merck in the late 1960s....
causes fibromyalgia
Fibromyalgia
Fibromyalgia is a medical disorder characterized by chronic widespread pain and allodynia, a heightened and painful response to pressure. It is an example of a diagnosis of exclusion...
, that the Hib vaccine
Hib vaccine
Haemophilus influenzae type B vaccine is a conjugate vaccine developed for the prevention of invasive disease caused by Haemophilus influenzae type b bacteria. The Centers for Disease Control and Prevention has recommended the use of the Hib vaccine. Due to routine use of the Hib vaccine in...
causes transverse myelitis
Transverse myelitis
Transverse myelitis is a neurological disorder caused by an inflammatory process of the spinal cord, and can cause axonal demyelination. The name is derived from Greek referring to the "spinal cord", and the suffix -itis, which denotes inflammation...
, and that the hepatitis B vaccine
Hepatitis B vaccine
Hepatitis B vaccine is a vaccine developed for the prevention of hepatitis B virus infection. The vaccine contains one of the viral envelope proteins, hepatitis B surface antigen . It is produced by yeast cells, into which the genetic code for HBsAg has been inserted...
causes Guillain–Barré syndrome, chronic demyelinating polyneuropathy, and multiple sclerosis
Multiple sclerosis
Multiple sclerosis is an inflammatory disease in which the fatty myelin sheaths around the axons of the brain and spinal cord are damaged, leading to demyelination and scarring as well as a broad spectrum of signs and symptoms...
. 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
Institute of Medicine
The Institute of Medicine is a not-for-profit, non-governmental American organization founded in 1970, under the congressional charter of the National Academy of Sciences...
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
Hib vaccine
Haemophilus influenzae type B vaccine is a conjugate vaccine developed for the prevention of invasive disease caused by Haemophilus influenzae type b bacteria. The Centers for Disease Control and Prevention has recommended the use of the Hib vaccine. Due to routine use of the Hib vaccine in...
, MMR
MMR vaccine
The MMR vaccine is an immunization shot against measles, mumps, and rubella . It was first developed by Maurice Hilleman while at Merck in the late 1960s....
, varicella
Varicella vaccine
The varicella vaccine is a live virus that protects against the viral disease commonly known as chickenpox caused by Varicella Zoster Virus . Varicella vaccine is marketed as Varivax in the U.S. by Merck...
, and inactivated polio. Poling was diagnosed months later with encephalopathy
Encephalopathy
Encephalopathy means disorder or disease of the brain. In modern usage, encephalopathy does not refer to a single disease, but rather to a syndrome of global brain dysfunction; this syndrome can be caused by many different illnesses.-Terminology:...
(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
Thiomersal
Thiomersal , and commonly known in the US as thimerosal, is an organomercury compound. This compound is a well established antiseptic and antifungal agent....
seriously weakened Michelle's immune system
Immune system
An immune system is a system of biological structures and processes within an organism that protects against disease by identifying and killing pathogens and tumor cells. It detects a wide variety of agents, from viruses to parasitic worms, and needs to distinguish them from the organism's own...
and prevented her body from clearing the measles
Measles
Measles, also known as rubeola or morbilli, is an infection of the respiratory system caused by a virus, specifically a paramyxovirus of the genus Morbillivirus. Morbilliviruses, like other paramyxoviruses, are enveloped, single-stranded, negative-sense RNA viruses...
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 has been appealed to the U.S. Court of Appeals.
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."
Current proceedings
Currently, nearly 5,000 families are attempting to demonstrate that vaccines can cause autismAutism
Autism is a disorder of neural development characterized by impaired social interaction and communication, and by restricted and repetitive behavior. These signs all begin before a child is three years old. Autism affects information processing in the brain by altering how nerve cells and their...
, despite the medical and scientific consensus that there is no evidence that autism is caused by vaccines or any preservative or additive ever used in vaccines.