Sacrificing Children's Safety for Vaccine Supply: Nonexistent Safeguards for Remedying Mandatory Defectively Designed Vaccines

111 Pages Posted: 7 Dec 2013 Last revised: 14 Feb 2014

Date Written: December 5, 2013


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.

Suggested Citation

Lee, Susan, Sacrificing Children's Safety for Vaccine Supply: Nonexistent Safeguards for Remedying Mandatory Defectively Designed Vaccines (December 5, 2013). Available at SSRN: or

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