National Childhood Vaccine Injury Act

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The National Childhood Vaccine Injury Act (NCVIA) of 1986 (42 U.S.C. §§ 300aa-1 to 300aa-34) was signed into law by President Ronald Reagan on Nov 14, 1986, 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 injury claims. Under the NCVIA, the National Vaccine Injury Compensation Program (NVICP) was created to provide a federal no-fault system for compensating vaccine-related injuries or death by establishing a claim procedure involving the United States Court of Federal Claims and special masters.

Contents

Background

In the 1970s and 1980s, a controversy erupted related to the question of whether the whole-cell pertussis component caused permanent brain injury in rare cases, called pertussis vaccine encephalopathy.[1] No studies showed a causal connection, and later studies showed no connection of any type between the DPT vaccine and permanent brain injury. The alleged vaccine-induced brain damage proved to be an unrelated condition, infantile epilepsy.[2] In 1990, the Journal of the American Medical Association called the connection a “myth” and “nonsense”.[3] However, before that point, criticism of the studies showing no connection and a few well-publicized anecdotal reports of permanent disability that were blamed on the DPT vaccine gave rise to 1970s anti-DPT movements.[4][5] In the United States, low profit margins and an increase in vaccine-related lawsuits led many manufacturers to stop producing the DPT vaccine by the early 1980s.[1] By 1985, vaccine manufacturers had difficulty obtaining liability insurance. The price of DPT vaccine skyrocketed, leading providers to curtail purchases, limiting availability. Only one manufacturer remained in the US by the end of 1985. To correct the situation, Congress in 1986 passed the National Childhood Vaccine Injury Act (NCVIA), which established a federal no-fault system to compensate victims of injury caused by mandated vaccines.[6]

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National Vaccine Injury Compensation Program

Vaccines save lives by preventing disease.

Most people who get vaccines have no serious problems. Vaccines, like any medicines, can cause side effects, but most are very rare and very mild. Some health problems that follow vaccinations are not caused by vaccines.

In very rare cases, a vaccine can cause a serious problem, such as a severe allergic reaction.  In these instances, the National Vaccine Injury Compensation Program (VICP) may provide financial compensation to individuals who file a petition and are found to have been injured by a VICP-covered vaccine.  Even in cases in which such a finding is not made, petitioners may receive compensation through a settlement.

How It Works

The National Vaccine Injury Compensation Program is a no-fault alternative to the traditional legal system for resolving vaccine injury petitions.

It was created in the 1980s, after lawsuits against vaccine companies and health care providers threatened to cause vaccine shortages and reduce U.S. vaccination rates, which could have caused a resurgence of vaccine preventable diseases.

Any individual, of any age, who received a covered vaccine and believes he or she was injured as a result, can file a petition. Parents, legal guardians and legal representatives can file on behalf of children, disabled adults, and individuals who are deceased.

The process is as follows:

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The National Childhood Vaccine Injury Act of 1986

NVIC’s co-founders worked with Congress on the National Childhood Vaccine Injury Act of 1986 (42 U.S.C. §§ 300aa-1 to 300aa-34). This historic law acknowledged that vaccine injuries and deaths are real and that the vaccine injured and their families should be financially supported and that vaccine safety protections were needed in the mass vaccination system. The law set up a federal vaccine injury compensation program as well as included legal requirements for vaccine providers to:

  • give parents vaccine benefit and risk information before their children are vaccinated;
  • keep written records of vaccine manufacturer names and lot numbers for each vaccination given;
  • enter serious health problems following vaccination into a child’s permanent medical record; and
  • report serious health problems following vaccination to the federal Vaccine Adverse Events Reporting System (VAERS)

The law preserved the right for vaccine injured persons to bring a lawsuit in the court system if federal compensation is denied or is not sufficient. By 2012, the U.S. Court of Claims had awarded over $3 billion dollars to vaccine victims for their catastrophic vaccine injuries, although two out of three applicants have been denied compensation. Below are links to the National Vaccine Injury Act of 1986 broken down into specific sections, as listed by the US Government Publishing Office. The law may also be viewed in its entirety on the US House of Representatives Office of the Law and Revision Council here.

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Vaccine Injury Compensation Programs

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 from 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 reaction, seizure, 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 declined greatly.

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.

This 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 by means of 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 event 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 virus that had not been inactivated in spite of 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/NCVIP

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 a number of 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.

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