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Generally, under the National Childhood Vaccine Injury Act of 1986 (Vaccine Act), vaccine administrators and manufacturers are shielded from medical malpractice or products liability actions stemming from vaccine-related injuries and deaths. That said, as generous as these protections may be, they have boundaries, some of which are clear and others of which are unsettled. This is particularly so for in utero injuries stemming from immunization of pregnant women. The issue of whether in utero injuries are afforded such protections, vis á vis compensation by the National Vaccine Injury Compensation Program (VICP) under the Vaccine Act, has not definitively been resolved by the courts. Short of a decision by the Court of Appeals for the Federal Circuit or a statutory amendment by Congress specifically addressing this issue, the uncertainty remains.

The National Childhood Vaccine Injury Act of 1986, as amended, established the Vaccine Injury Compensation Program (VICP). The VICP went into effect on October 1, 1988 and is a Federal "no-fault" system designed to compensate individuals, or families of individuals, who have been injured by covered vaccines. From 1988 until July 2006, a total of 2531 non-autism/thimerosal and 5030 autism/thimerosal claims were made to the VICP. The compensation paid for the non-autism/thimerosal claims from 1988 until 2006 was $902,519,103.37 for 2542 awards. There was no compensation for any of the autism/thimerosal claims. On the basis of the deaths and extensive suffering to patients and families from the adverse reactions to vaccines, all physicians must provide detailed information in the Vaccine Information Statement to the patient or the parent or legal guardian of the child about the potential dangers of vaccines as well as the VICP.

Introduction.— The National Childhood Vaccine Injury Act (NCVIA) requires that physicians distribute the appropriate Vaccine Information Statements (VIS) at each immunization visit and discuss the risks/benefits of every vaccine given. In a national study, 31% of pediatricians reported not using the VIS and 56% indicated that time was a barrier to vaccine risk/benefit communication. Parents, however, indicated they want their primary providers to personally tell them about risks/benefits. Objective.— To test the feasibility of an Immunization Education Package (IEP) intervention to improve compliance with the federal mandate and to improve physician/parent vaccine risk/benefit communication. Setting.— Two multiphysician private pediatric practices in Shreveport, La. Design.— A before-after trial with comparison of 130 preintervention and 78 postintervention visits. Research assistants recorded content and duration of immunization discussions during well-baby visits during which immunizations were scheduled. Clinic staffs were masked as to variables recorded. Intervention.— The IEP was a multifaceted intervention, involving a practice-based in-service and distribution and discussion of ready-to-use materials including an exam room poster entitled "7 Questions Parents Need To Ask About Baby Shots." Results.— Patients were 90% white and 96% privately insured. Pre and post results revealed a significant increase in VIS distribution (33% vs 91%, P P P Conclusions.— This IEP was a feasible way to facilitate compliance with the NCVIA. A significant amount of additional information was provided to parents with only a slight increase in time.

With growing public fear about vaccine safety, declining vaccination rates and reports of pertussis outbreaks, this article is a thought-provoking and critical account of vaccine policymaking and vaccination law in the United States. This topic is of utmost importance to current public health policy. Vaccines are legally classified as unavoidably unsafe products, yet they are mandated for day care or school entry for all American children unless an exemption is granted. Vaccines are the only medical intervention mandated for healthy children, and each child is at risk of adverse side effects. U.S. government health officials and U.S. vaccine manufacturers endorse them as a safe and effective means of preventing infectious disease. Mounting evidence, however, suggests otherwise.This article provides a unique commentary on morality and justice in our society through the prism of the diphtheria-tetanus-pertussis vaccine. A historical account of this vaccine highlights its known dangerous propensities as an example of an unsafe vaccine and defectively designed vaccine. History demonstrates how the U.S. has lagged behind international countries on vaccine safety. Since the 1950’s U.S. government health officials were aware of this vaccine causing serious adverse reactions including death and severe neurological impairment in children. Despite this knowledge and U.S. vaccine manufacturers having the methodology and technology to develop a safer alternative feasible vaccine, it took many decades of litigation, consumer advocacy, international scientific research and congressional action to effectuate change for a safer vaccine for children.In the 1980’s, increasing lawsuits against U.S. diphtheria-tetanus-pertussis vaccine manufacturers and mounting political pressure led to a crisis. Instead of making vaccine safety a top priority by having U.S. vaccine manufacturers develop a safer alternative feasible vaccine, Congress enacted the National Childhood Vaccine Injury Act of 1986. Effectively, this legislation was a government bailout of the U.S. vaccine manufacturing industry as it gave U.S. vaccine manufacturers, physicians and health care professionals who administer vaccines substantial liability protection from vaccine injury claims. The immense liability protection granted to U.S. vaccine manufacturers is particularly troubling given its pervasive influence and significant omnipresence in vaccine policymaking. U.S. government health officials in charge of promulgating vaccine policy are often in the same circle as those who profit financially from vaccine sales. With liberal grants of waivers to numerous and substantial conflict of interests, U.S. government health officials allow the approval of unsafe vaccines on the market. As a result, this law not only insulated U.S. vaccine manufacturers from liability, but it also created perverse incentives and paved the way for potentially more unsafe vaccines to flood the market.Since 1986 rights to compensation for vaccine injuries have significantly narrowed. Through administrative and judicial interpretation, the vaccine injury compensation process has become increasingly adversarial, expensive, difficult and lengthy. In 2011, the U.S. Supreme Court ruled that U.S. vaccine manufacturers cannot be held liable for defectively designed vaccines. This decision greatly exacerbates the danger facing American schoolchildren and allows unsafe vaccines to remain on the market and bypass all current safeguards under the law.Based upon the evidence, U.S. government officials, U.S. medical organizations and individuals with substantial financial relationships with U.S. vaccine manufacturers generate propaganda to endorse the belief that vaccines are safe and effective despite knowledge they are not; use scare tactics, coercion and other deceptive means to increase vaccination rates; withhold vaccine safety information from the public; and disseminate false information about the risks of infectious disease, infectious disease outbreaks and adverse side effects following vaccination. Furthermore, there is credible evidence U.S. vaccine manufacturers exert undue influence in Congress and in other government entities to systematically restrict the rights to vaccine injury compensation while simultaneously use that influence to generate vast financial profits for themselves. Based upon the evidence, corruption, fraud and malfeasance leave little choice for parents and forces them to participate unwillingly or unknowingly in a dangerous and fraudulent financial scheme. Lastly, this compelling article provides original recommendations for Congress to rectify the grave, immediate danger in order to provide better protection and give justice to our nation’s children.

The purpose of this article is to look at the effect of the federal compensation scheme under the National Childhood Vaccine Injury Act on the people and institutions involved in the administration of vaccinations. More vaccine-injured children will probably recelve compensation than would have been true under state law, but each child will probably receive less money for damages. Manufacturers will pay excise taxes to fund the compensation scheme and receive, in return, substantial immunity from liability under state law. Although these provisions create incentives that work in opposite directions, producers likely will still have reason to improve the safety and efficacy of vaccines. The situation for those who administer vaccinations is less clear. Freeing them from the threat of litigation would leave them with little incentive to use immunizations appropriately because they do not contribute to the compensation scheme. Although Congress intended to make those who give vaccines immune from state claims, it may have failed to do so, leaving providers with their liability largely unchanged (see addendum to this article for recent congressional action). The most pervasive uncertainty is that the Act is designed to self-destruct and may soon return vaccine-injured children, manufacturers, and providers to the state of the law before Congress acted.