No medical intervention is completely risk-free. Vaccines, though they are designed to protect from disease, can cause side effects that range from mild to serious. The most common side effects of vaccination are soreness, swelling, or redness at the injection site. Some vaccines are associated with fever, rash, and achiness. Serious side effects from vaccination are rare but may include life-threatening allergic reactions, seizures, and even death.
When vaccines first began to be widely used, people who experienced serious side effects from vaccination had little recourse to compensation from manufacturers, physicians, or the government. This was particularly a problem when vaccine production techniques were in their infancy and contamination of vaccines occasionally occurred during or after manufacture. Since the passage in 1902 of the U.S. Biologics Control Act, which initiated the regulation of vaccines, such problems with negligence in manufacture have greatly declined.
As product liability law evolved during the 20th century, it eventually provided an avenue for compensation for individuals harmed by vaccines: they could sue a manufacturer for harm caused by an improperly made vaccine, or they could sue a physician for administering a vaccine when it was contraindicated. In the United States, the civil court system applies the principles of tort law to these suits.
The rest of this article addresses programs that compensate individuals for adverse clinical events that are known to be caused by properly manufactured vaccines. Because governments have an interest in maintaining public health using vaccination, many, including the U.S. government, have developed no-fault systems for compensating people who have been adversely affected by certain vaccines. These people, to some degree, have assumed the risk of adverse events on behalf of the society in which they live. Therefore, many governments have adopted the position that it is fair and reasonable to compensate those who are harmed by properly manufactured vaccines.
The Cutter Incident and Resulting Lawsuits
Individuals harmed by properly manufactured vaccines had few options for compensation before an important court case in the 1950s addressed the issue. In 1955 about 200 people were paralyzed and ten died after contracting polio from the Salk polio vaccine, certain lots of which contained viruses that had not been inactivated despite manufacturers’ adherence to federal government standards. The event came to be known as the Cutter Incident, after the manufacturer of one of the implicated vaccines. Many injured people and their families filed lawsuits against vaccine manufacturers, and most of the cases were settled out of court with monetary awards by the manufacturers. One case, Gottsdanker v. Cutter Laboratories, was heard on appeal by the California Supreme Court, and the justices upheld a jury ruling that although Cutter Laboratories was not negligent in its design or manufacture of the vaccine, the company was financially responsible for the harm the vaccine caused. It was a significant ruling, and many similar awards followed in other cases. No standards existed, however, for determining when a vaccine caused a clinical event or was simply associated temporally with it — that is, whether the event happened to occur after vaccination without a causal relationship. Juries decided these matters on a case by case basis, at times with little medical or scientific support for claims of vaccine injury causation.
DPT Lawsuits
Through the 1970s and 1980s, the number of lawsuits brought against vaccine manufacturers increased dramatically, and manufacturers made large payouts to individuals and families claiming vaccine injury, particularly from the combined diphtheria-pertussis-tetanus (DPT) immunization. In this environment of increasing litigation, mounting legal fees, and large jury rewards, many pharmaceutical companies left the vaccine business. In fact, by the end of 1984, only one U.S. company still manufactured the DPT vaccine, and other vaccines were losing manufacturers as well.
NCVIA/NVCIP
In October 1986, the U.S. Congress responded to the precarious situation in the vaccine market by passing the National Childhood Vaccine Injury Act (NCVIA). The act included several regulations related to informed consent and adverse event reporting. For example, the act required that providers administering certain vaccines provide a Vaccine Information Statement (VIS) to the vaccine recipient or a legal guardian. The VIS lists the risks and benefits of a particular vaccine. The NCVIA also established a system for reporting suspected vaccine-related adverse events. This system, the Vaccine Adverse Event Reporting System (VAERS), is described here. Additionally, the act contained provisions for a program that would fairly and efficiently compensate individuals harmed by certain vaccines that were properly manufactured. Such a system, it was hoped, would stabilize the legal environment for manufacturers, allowing them to limit their liability, better anticipate their legal costs, and reduce potential barriers to research into new vaccines.
The U.S. Department of Health and Human Services (DHHS) established this system, the National Vaccine Injury Compensation Program (NVICP), in 1988. NVICP is funded by a tax of $0.75 per vaccine dose, collected from vaccine manufacturers by the U.S. Department of the Treasury. The NVICP does not cover all vaccines; however, vaccines routinely given to children as part of the recommended immunization schedule are included, and some adult vaccines are covered as well.
Under the NVICP, those claiming a vaccine injury from a covered vaccine cannot sue a vaccine manufacturer without first filing a claim with the U.S. Court of Federal Claims. Certain medical events are presumed to be side effects of vaccination as long as no other cause is found. The claim filer is reimbursed according to a formula, provided that all the medical records meet NCVIA standards and that review by the U.S. Department of Justice determines that all legal standards have been met. If a claim is denied, or if the claim is approved and the claimant rejects the compensation, only then may the claimant file a civil lawsuit.
The National Childhood Vaccine Injury Act Reporting and Compensation Tables (VIT) list each covered vaccine, its associated adverse events, and the allowable interval from vaccination to onset of the event. The table of vaccine injuries has been formulated on the analysis of extensive data collected by the safety system, which includes reports to VAERS, prospective studies in HMOs by CDC, and studies by academic investigators. Examples of compensable injuries are intussusception within 30 days of receipt of oral, rhesus-based rotavirus vaccine, brachial neuritis within 0-28 days of receipt of tetanus toxoid containing vaccines, anaphylaxis within 0-4 hours of receipt of a variety of vaccines, and so on. The VIT is subject to review by DHHS, and vaccine injuries may be added to and removed from the tables depending on the best available evidence. Seizure disorder after DPT vaccination, which was the cause of many successful lawsuits against vaccine manufacturers before the NVICP, was removed from the list of compensable events in 1995 because of lack of evidence supporting a link. As new vaccines are added to the childhood immunization schedule, any associated adverse events are added to the VIT as well. The U.S. Department of Health and Human Services publishes the tables here.
Autism Omnibus Proceeding
Beginning around 2001, hundreds and then thousands of families began to petition NVICP claiming that their children’s autism resulted from vaccination. (See the article The History of Anti-vaccination Movements, and specifically the section “The Measles, Mumps, Rubella (MMR) Vaccine Controversy” for a discussion of the origin of these claims.) To deal with the volume of these petitions, and to address the assertion that a causal relationship existed between vaccination and autism, the NVICP established a special program in 2002 called the Omnibus Autism Proceeding, housed within the U.S. Court of Federal Claims Office of Special Masters.
The OAP consolidated many of the autism claims into three test cases that rested on different theories of causation. The first test case addressed the issue of whether the measles-mumps-rubella (MMR) vaccine alone or given along with thimerosal-containing vaccines (TCVs) is a causal factor in the development of autism. (Thimerosal is an ethylmercury compound that was a common preservative in some killed vaccines.) The second test case examined TCVs alone. The third test case was to look solely at MMR vaccines, but the case was withdrawn after parties announced that they would rely on the findings of the first test case.
A special master issued the first opinion in the OAP on theory one in 2009. The ruling found, in three test cases consolidated into theory one, that MMR vaccine was given alone or with TCVs is not a causal factor in autism. Theory two was decided in 2010, with a finding of no causal relation between TCVs and autism. Appeals by petitioners in the two test cases have been unsuccessful, and autism has not been added to the VIT for any vaccine.
Petitioners remaining in the OAP must submit new evidence or theories of causation of autism by vaccines, abide by the existing rulings as their cases are dismissed by the OAP, or exit the program to pursue other legal options. To date, no other theories of causes have been ruled upon, though petitioners are attempting to advance them.
The vaccine market has stabilized since the passage of the NCVIA and the establishment of the NVCIP. In the United States, six manufacturers supply most of the standard childhood and adult vaccines, and a handful of smaller companies and organizations supply other, less commonly used vaccines. Occasional vaccine shortages do occur (such as with influenza vaccine in 2003 through 2005) but these shortages may be due to a combination of factors without a strong connection to liability issues, such as the effect of corporate mergers, the level of government reimbursement for vaccines in the federally funded Vaccine for Children program, and regulatory issues.
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