Congress passed the National Vaccine Injury Act (NVIA) of 1986, which granted immunity to the pharmaceutical companies for injuries caused by the vaccines they manufactured. As explained by the U.S. Supreme Court in Bruesewitz v. Wyeth 1, the reason for that protection is that Congress deemed vaccines to be unavoidably unsafe, 2 thus no manufacturer would make a vaccine if they had to suffer the liability for injuries they would unavoidably cause. 3
Mary S. Holland explains the issue: “The success of the national vaccine program has come at a cost. Some children are permanently disabled or die from their vaccine exposures. … Between 1980 and 1986, people who claimed vaccine injury brought over three billion dollars of damages claims to U.S. civil courts against vaccine manufacturers.” 4
In response to the litigation that held them accountable for the injuries caused by their vaccines, the vaccine manufacturers lobbied Congress, and in 1986 they were able to get the NVIA law passed. That law had the effect of protecting them from civil liability for injuries caused by vaccines that they manufactured.
The underlying legal reasoning of Congress for the 1986 NVIA law was a concept borrowed from the Restatement of Torts law that vaccines were “unavoidably unsafe.” Holland explains that “[t]he Restatement describes all vaccines as ‘unavoidably unsafe’ products and implicitly recommended that manufacturers not be liable for injuries if doctors administered them properly.” 5
The NVIA set up a system of government compensation for vaccine injuries that has in practice served more to prevent compensation than anything else. Robert F. Kennedy explains:
Parents, legal guardians and legal representatives can file on behalf of children, disabled adults, and individuals who are deceased. According to the vaccine-injured and their loved ones, the program has failed miserably as a litigious, broken system where the injured are up against a government vaccine program, government owned vaccine patents, government health officials who administer the program and government paid attorneys from the Department of Justice. There is no judge, no jury of your peers and no discovery. Claimants feel the system is set up for their claims to fail. 6
The U.S. Supreme Court in Bruesewitz, supra, ruled that language in the statute categorically preempts even design defect claims against vaccine manufacturers. Holland explains that U.S. Supreme Court ruling “removed incentives for pharmaceutical corporations to conduct the extensive research and development necessary to ensure that FDA-approved vaccines remain as safe and effective as possible after licensure. FDA approval alone has not been a sufficient guarantee of drug safety, owing in part to the FDA’s limited authority to compel further safety research after final approval.” 7
Holland reveals the real-world consequences of the NIVA for vaccine recipients:
[Gayle] DeLong showed that the proportion of people that reported a serious complication from a vaccine after [enactment of the NVIA in] 1986 is more than double the proportion of people who experienced a serious complication from a disease before a vaccine for it was available. The difference is statistically significant and is likely greater because of underreporting.
DeLong’s analysis suggests that the Vaccine Act “gave firms greater incentives to capture the regulator: If consumers cannot sue firms for product liability, the only barrier to sales is regulatory approval.” 8
The NVIA protects vaccine makers from liability for “unavoidable” injuries caused by vaccines. The NVIA states in pertinent part:
No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings. 9
In order to make sure the immunity from liability pill goes down easier for the public, the NVIA mandated that the Secretary of HHS “promote the development of childhood vaccines that result in fewer and less serious adverse reactions than those vaccines [presently] on the market.” 10
That requirement was supposed to be performed by a task force made up of the “Director of the National Institutes of Health [NIH], the Commissioner of the Food and Drug Administration [FDA], and the Director of the Centers for Disease Control [CDC].” 11
The NVIA statute required that “within 2 years after December 22, 1987, and periodically thereafter, the Secretary [of HHS] shall prepare and transmit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report describing the actions taken pursuant to subsection (a) during the preceding 2-year period.” 12
The NIH, FDA, and CDC scoundrels thumbed their noses at Congress. They violated the law by not filing the required reports with the U.S. Congress. Why did they not file the required reports? The only logical reason is that they did not meet as required, and they did not “promote the development of childhood vaccines that result in fewer and less serious adverse reactions than those vaccines [presently] on the market” 13 as required by the statute.
That is clear evidence that the component agencies of HHS (CDC, NIH, and FDA) have no interest in the development of safe vaccines for children.
Robert F. Kennedy Jr. discovered the scofflaws at HHS when he filed a Freedom of Information Act request with HHS requesting the reports prepared and transmitted to Congress as required by the NVIA. HHS refused to comply with the request. He sued HHS. 14 After being served with the lawsuit, HHS admitted that they never filed any required reports with Congress. 15 That means that the component agencies of HHS (CDC, NIH, and FDA) never formed the required task force and made no effort to see that vaccines were made safer.
The CDC, NIH, and FDA never met to develop a plan for safe vaccines for children. Why? Because CDC, NIH, and FDA know that the pharmaceutical companies have no interest making vaccines safe for children! Vaccines are unavoidably unsafe and the vaccine makers like it that way. Pharmaceutical companies get rich when people are made sick. It is a racket where they cause injury via their vaccines and then make the patent medicines to address the symptoms of the injuries they have caused. There was a fly in their ointment, and that was civil liability for the injuries they caused. The immunity granted by the NVIA solved that problem. Since the NVIA, the pharmaceutical companies have been off to the races creating one ineffective and unsafe vaccine after another.
As explained by Texans for Vaccine Choice, “[t]he [NVIA] removed all liability from vaccine manufacturers when their products injure or kill. Realizing that removing consumer accountability would eliminate any motivation for manufacturers to ensure their products are as safe and effective as they can possibly be, the Mandate for Safer Childhood Vaccines clause was added to the the Act as a check-and-balance.” But we now know that there is no check-and-balance. Robert F. Kennedy Jr. explains:
This speaks volumes to the lack of seriousness by which vaccine safety is treated at HHS and heightens the concern that HHS doesn’t have a clue as to the actual safety profile of the now 29 doses, and growing, of vaccines given by one year of age. 16
The CDC, when asked, was unable to provide any evidence that any childhood vaccine has ever been tested for safety using a placebo control. Indeed, Robert F. Kennedy Jr. points out that “not one of the 72 vaccines on the schedule mandated for our children, have been tested with a placebo.” There is a reason. No vaccine could ever survive being tested for safety and effectiveness against a placebo. The pharmaceutical companies know that their vaccines are not only ineffective, they are injurious. Research has shown that childhood vaccines cause injuries. 17 And that is by design. A design for which the U.S. Supreme Court has ruled the drug companies have immunity from civil liability.
The CDC, NIH, and FDA know it is a fool’s errand to try to convince the drug companies to manufacture something safe when to do so would undermine the drug companies’ pecuniary interests. The surreptitious goal of the drug companies is to make people sick through vaccines. That is why the CDC, NIH, and FDA had nothing to report to Congress regarding their efforts to develop vaccines with “fewer and less serious adverse reactions.” The goal of the vaccine makers is to cause injury. The pharmaceutical companies, CDC, NIH, and FDA all know that vaccines will unavoidably cause injuries. They have no interest in mitigating the damage caused by vaccines because those injuries make the pharmaceutical companies rich through the patent medicines they sell to address the injuries caused by the vaccines.
For example, on December 13, 2021, Pfizer announced:
Pfizer will acquire Arena, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases. Under the terms of the agreement, Pfizer will acquire all the outstanding shares of Arena for $100 per share in an all-cash transaction for a total equity value of approximately $6.7 billion. The boards of directors of both companies have unanimously approved the transaction. 18
Pfizer is acquiring a company that makes drugs that treat the very immuno-inflammatory injuries caused by Pfizer’s COVID-19 vaccine. Arena has drugs in the pipeline to treat cardio inflammatory diseases like myocarditis; the Pfizer COVID-19 vaccine has become notorious for causing myocarditis. 19 Also notable is Arena’s development of a drug (Termanogrel) to address microvascular obstructions, which several doctors have identified as the root cause of many illnesses resulting from Pfizer’s COVID-19 vaccine. 20 For example, Dr. Charles Hoffe, MD — who practices in British Columbia, Canada — explained in very simple terms how the mRNA COVID vaccines create the spike proteins which cause widespread microscopic blood clotting that will eventually kill many people within three years of taking the shots. 21 Pfizer now wants to get in on the action of offering overpriced patent medicines to give to desperate patients suffering from the deadly side-effects of their vaccine. How much more Machiavelian can you get?
Please be mindful that the COIVD-19 vaccine manufacturers are also protected from civil liability. The COVID-19 vaccines will be subjected to the even more exacting standards and limited compensation of the Public Readiness and Emergency Preparedness Act (PREP Act), which authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to injured parties. A notable limitation under the CICP is that an injured party will be subjected to the statute of limitations that forecloses all legal actions not filed within one year of vaccination. 22 That is compared with the statute of limitations for an approved vaccine under the National Vaccine Injury Act (NVIA) of 3 years from the occurrence of the first symptom of injury from the vaccine. 23
Experts specializing in vaccine injury cases say that the bar for obtaining compensation is very high under the PREP Act. 24 Over the last ten years, 94% of injured patients who filed claims under the PREP Act received no compensation. 25 In reference to the virtually insurmountable hurdles erected under the CICP, Renée Gentry, director of the Vaccine Injury Litigation Clinic at the George Washington University Law School, said COVID-19 vaccine claimants have two rights: “You have the right to file,” she said. “And you have the right to lose.” 26 Altom Maglio, whose 22 lawyer law firm, Maglio Christopher & Toale, specializes in vaccine injury cases, says that you’re out of luck if you’ve suffered an injury related to any of the COVID-19 vaccines in receiving any compensation for your injury. 27 That all is not intended to suggest that the NVIA is fair. The NVIA has its own problems. Two out of three claims filed under the NVIA are denied. 28
A “declared public health emergency” as described in the PREP Act is the legal landscape under which the COVID-19 vaccine is being developed. Under the PREP Act, there is a moral hazard where manufactures of the COVID-19 vaccines will be protected from any liability for injuries caused by their COVID-19 vaccines. They have no financial incentive to make a vaccine that is safe or effective. They can sit back and count their billions in profits as they injure the public with impunity. The demand for the product is guaranteed by a marketplace that is rigged by the U.S. and state governments, which will pay for the vaccine and then mandate that the public consume that vaccine. The attitude of the vaccine manufacturers toward the consumer who is injured is “oh well, too bad, so sad, it sucks to be you.”
“For the love of money is the root of all evil: which while some coveted after, they have erred from the faith, and pierced themselves through with many sorrows.” 1 Timothy 6:10.
1 562 U.S. 223 (2011), https://www.supremecourt.gov/opinions/10pdf/09-152.pdf.
2 42 U.S.C. § 300aa–22, https://www.law.cornell.edu/uscode/text/42/300aa-22.
3 National Vaccine Injury Compensation Program, Children’s Health Defense, https://childrenshealthdefense.org/national-vaccine-injury-compensation-program/ (last visited on January 6, 2021).
4 Mary S. Holland, Liability for Vaccine Injury: The United States, the European Union, and the Developing World, Emory Law Journal, Vol 67, 2018, https://scholarlycommons.law.emory.edu/elj/vol67/iss3/3/.
5 Mary S. Holland, Liability for Vaccine Injury: The United States, the European Union, and the Developing World, Emory Law Journal, Vol 67, 2018, https://scholarlycommons.law.emory.edu/elj/vol67/iss3/3/.
6 National Vaccine Injury Compensation Program, Children’s Health Defense, https://childrenshealthdefense.org/national-vaccine-injury-compensation-program/ (last visited on January 6, 2021).
7 Mary S. Holland, Liability for Vaccine Injury: The United States, the European Union, and the Developing World, Emory Law Journal, Vol 67, 2018, https://scholarlycommons.law.emory.edu/elj/vol67/iss3/3/.
8 Mary S. Holland, Liability for Vaccine Injury: The United States, the European Union, and the Developing World, Emory Law Journal, Vol 67, 2018, https://scholarlycommons.law.emory.edu/elj/vol67/iss3/3/. Quoting Gayle DeLong, Is “Delitigation” Associated with a Change in Product Safety? The Case of Vaccines, Rev. Ind. Org. (June 14, 2017).
9 42 U.S.C. § 300aa–22, https://www.law.cornell.edu/uscode/text/42/300aa-22.
10 42 U.S.C. § 300aa–27, https://www.law.cornell.edu/uscode/text/42/300aa-27.
11 42 U.S.C. § 300aa–27.
12 42 U.S.C. § 300aa–27.
13 42 U.S.C. § 300aa–27.
14 RFK, Jr. Proves HHS is in Violation of the “Mandate for Safer Childhood Vaccines” as Stipulated in the Vaccine Injury Compensation Act, Children’s Health Defense, September 13, 2018, https://childrenshealthdefense.org/child-health-topics/federal-failures/rfk-jr-proves-hhs-is-in-violation-of-the-mandate-for-safer-childhood-vaccines-as-stipulated-in-the-vaccine-injury-compensation-act/. ICAN v. HHS, Complaint for Declaratory and Injunctive Relief, April 12, 2018, https://childrenshealthdefense.org/wp-content/uploads/rfk-complaint-against-united-states-department-of-health-and-human-services.pdf. See also ICAN & RFK, Jr. Call Out DHHS for Vaccine Safety Violations, Texans for Vaccine Choice, July 18, 2018, https://texansforvaccinechoice.com/ican-rfk-jr-call-out-dhhs-for-vaccine-safety-violations/.
15 ICAN v. HHS, Stipulation, July 9, 2018, https://childrenshealthdefense.org/wp-content/uploads/rfk-hhs-stipulated-order-july-2018.pdf.
16 RFK, Jr. Proves HHS is in Violation of the “Mandate for Safer Childhood Vaccines” as Stipulated in the Vaccine Injury Compensation Act, Children’s Health Defense, September 13, 2018, https://childrenshealthdefense.org/child-health-topics/federal-failures/rfk-jr-proves-hhs-is-in-violation-of-the-mandate-for-safer-childhood-vaccines-as-stipulated-in-the-vaccine-injury-compensation-act/.
17 Edward Hendrie, Study Shows That Vaccinated Children Are Significantly Less Healthy Than Unvaccinated Children, December 20, 2020, https://greatmountainpublishing.com/2020/12/20/study-shows-that-vaccinated-children-are-significantly-less-healthy-than-unvaccinated-children/. Edward Hendrie, Vaccines Increase Mortality of Infants, August 17, 2020, https://greatmountainpublishing.com/2020/08/17/vaccines-increase-mortality-of-children/. Edward Hendrie, Vaccines Cause Autism and Allergies, August 5, 2020, https://greatmountainpublishing.com/2020/08/05/vaccines-cause-autism-and-allergies/.
18 Pfizer to Acquire Arena Pharmaceuticals, December 13, 2021, https://www.pfizer.com/news/press-release/press-release-detail/pfizer-acquire-arena-pharmaceuticals.
19 Edward Hendrie, Follow the SILENCE: Paper Proving That COVID-19 Vaccines Cause Myocarditis Is Removed From Publication Without Explanation, October 31, 2021, https://greatmountainpublishing.com/2021/10/31/follow-the-silence-paper-proving-that-covid-19-vaccines-cause-myocarditis-is-removed-from-publication-without-explanation/. See also Edward Hendrie, The FDA and Pfizer Concealed Evidence That COVID-19 Vaccines Will Cause Myocarditis in Children, November 7, 2021, https://greatmountainpublishing.com/2021/11/07/the-fda-and-pfizer-concealed-evidence-that-covid-19-vaccines-will-cause-myocarditis-in-children/.
20 Pfizer buys immuno-inflammatory firm Arena Pharmaceuticals for $6.7b, December 13, 2021, Outsourcing-Pharma, https://www.outsourcing-pharma.com/Article/2021/12/13/Pfizer-buys-immuno-inflammatory-firm-Arena-for-6.7b.
21 Edward Hendrie, Doctor Finds That His Patients Have Permanent Organ Damage from Blood Clots Caused by COVID-19 Vaccines, Great Mountain Publishing, October 23, 2021, https://greatmountainpublishing.com/2021/10/23/doctor-finds-that-his-patients-have-permanent-organ-damage-from-blood-clots-caused-by-covid-19-vaccines/, quoting CFT Team, Doctor Warns How COVID mRNA ‘Vaccines’ Will Cause Delayed Strokes & Heart Attacks — ‘The Worst Is Yet To Come’, July 14, 2021, https://christiansfortruth.com/doctor-warns-how-covid-mrna-vaccines-will-soon-cause-strokes-heart-attacks-the-worst-is-yet-to-come/.
22 Countermeasures Injury Compensation Program, Request for Benefits Form Instructions, OMB Control No. 0915-0334, Expiration Date: 3/31/2023, https://www.hrsa.gov/sites/default/files/hrsa/cicp/cicp-request-form-instructions.pdf.
23 42 U.S. C. § 300aa–16.
24 McKenzie Sigalos, You Can’t Sue Pfizer or Moderna If You Have Severe Covid Vaccine Side Effects. The Government Likely Won’t Compensate You for Damages Either, CNBC, December 17, 2020, https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-compensation-lawsuit.html.
25 McKenzie Sigalos, You Can’t Sue Pfizer or Moderna If You Have Severe Covid Vaccine Side Effects. The Government Likely Won’t Compensate You for Damages Either, CNBC, December 17, 2020, https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-compensation-lawsuit.html.
26 Megan Redshaw, Injured by a COVID Vaccine? Want Financial Compensation? Too Bad, Says Injury Compensation Law Firm, The Defender, July 1, 2021, https://childrenshealthdefense.org/defender/covid-vaccine-injury-no-compensation-program/.
27 Megan Redshaw, Injured by a COVID Vaccine? Want Financial Compensation? Too Bad, Says Injury Compensation Law Firm, The Defender, July 1, 2021, https://childrenshealthdefense.org/defender/covid-vaccine-injury-no-compensation-program/.
28 Vaccine Injury Fund: Lessons From a Vaccine Lawyer-“Covered” Vaccines in the Court (and the DtaP), Widman Law Firm, https://www.widmanlawfirm.com/vaccine-injury-fund-lessons-from-a-vaccine-lawyer-covered-vaccin.html (last visited on August 28, 2021).
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