Exposing the FDA’s Vaccine Injury Cover-up: An Interview With Walter Kyle, Esq.
August 30th, 2012
Reader Views: 775
byÂ Catherine J. Frompovich
Attorney Walter Kyle of Cape Cod, Massachusetts, began representing Plaintiffs with vaccine injuries ten years before the Vaccine Injury Act began, and has argued more than forty cases before the Special Masters of the United States Court of Federal Claims [under the Vaccine Injury Compensation Act] – 42 U.S.C.A. Â§300aa, et.seq. As a result, Attorney Kyle has unique insight into the nuances of vaccine injury law.
To start our interview, may I ask how you became involved in vaccine law?
I began representation of vaccine-injured clients in Arkansas in 1977. My first case out of law school was representing a paraplegic mother who acquired paralytic polio from mutated Sabin live trivalent oral polio vaccine [TOPV] viruses shed from her three-month-old infantâs diapers. Centers for Disease control classified the woman in the âimmune deficientâ category of âvaccine associated contact casesâ from Type 2 Sabin vaccine.
Walter, you just mentioned the phrase âvaccine viruses shed.â For those who are not familiar with such terminology Iâd like to say it means certain types of vaccines contain certain viruses that are alive and once injected into [orally administered to] an individual can infect others via contact with bodily fluids, excrement, and sometimes coughing or sneezing. In your first vaccine case, the mother contracted paralytic polio from viruses âshedâ in her infantâs diapers soiled with urine and feces.Â
Walter, how did you present that case at court?
In the first case against the manufacturer, American Cyanamid, which defended based on the fact that the woman was categorized as âimmune deficientâ and implied the reaction was her fault, I countered with the position that the Type 2 vaccine caused her immune deficiency since she had never been sick in her life before contact with that vaccine. After settling that lawsuit against the manufacturer for failure to warn, I instituted a Federal Tort Claims Act (FTCA) lawsuit against HEW for regulatory violations in the license and release of OPV, in general, and the individual Lot of polio vaccine, in particular. In addition, I challenged the FDAâs intention to use Sabinâs live oral polio vaccine (OPV) for immunization of unwitting contacts of vaccine recipients as an unconstitutional invasion of their privacy (see Loge v. United States, 662 F.2d 1268 8th Cir. 1981), which evolved into civil actions of âbatteryâ against the sole manufacturer of the Sabin vaccine âAmerican Cyanamid.
Can you tell us what happened in that case?
From my perspective I gained a profound disrespect for the FDA and pro-vaccine defense experts who pretended the case could have been from wild polio in spite of the fact that most, if not all of the polio in the United States at that time, arose from parents coming into contact with the polio viruses shed in their childâs stool or saliva.
Their justification then, similar to their justification now, arose from an unwritten CDC/FDA policy to âsacrifice some for the good of the wholeâ â a comment related to me by a senior CDC physician, Dr. Michael Gregg, in a private conversation.
This explains why zero funding is available to do clinical studies of vaccine reactions in the United States.
Both of the lawsuits settled before trial. The trial judge dismissed the FTCA lawsuit and was overturned on appeal in the decision cited above.
Before you go further, can you please explain what a Vaccine Injury Table is?
According to HHS Health Resources and Services Administration, âThe Vaccine Injury Table (Table) makes it easier for some people to get compensation.â 
It makes it easier for some and impossible for others. Certain reactions within a set time period are automatically compensated. For example, the parent of a child who became paralyzed by polio within 60 days of the childâs receiving the live polio vaccine would automatically be compensated. This was the most common reaction to both live and inactivated polio vaccines.
However, a child acquiring an encephalitis where the Colburn strain of CMV (cytomegalovirus) was isolated from his brain at the age of six, would not be compensated unless his lawyer were clever enough to discover that the Colburn strain of CMV is actually simian in origin and came from the African green monkeys used to produce the live polio vaccine.
Recently Baboon endogenous retrovirus (BERV) was discovered in MMR vaccine, but no one has access to the tests to detect it in children with possible vaccine reactions. Since it is a live vaccine, one would expect the onset to occur within 3 days to three years, nor would anyone know how to correlate it to the particular Lot of vaccine given as FDA keeps such information secret.a âcommercial privilegeâ protection under FOIA.
Walter, what I find interesting about the Vaccine Injury Table is something most proponents of vaccines/vaccinations probably are not aware and it is âThe Table lists and explains injuries/conditions that are presumed to be caused by vaccines.â  So, in effect, HHS/CDC/FDA agree vaccines can cause damage. I suggest every parent becomes familiar with the Vaccine Injury Table in the link at reference .Â
The Table is per se inadequate and a mother or father should follow their gut instinct when faced with a vaccine reaction most of which are probably not on the Vaccine Injury Table. Currently there are laboratory-testing methods developed, but withheld from diagnostic use by FDA that can quickly and cheaply link reactions to vaccines. I do not feel anyone should subject their child to an immunization unless faced with an actual, not a CDC forecast, epidemic of a life-threatening pathogen. That is, until those testing procedures are made available to the general public for diagnostic evaluations of both the injured and of the vaccines which are administered.
I am not anti-vaccine but strongly oppose FDA/CDC/NIH B.S. (rhetoric and hyperbole) when it comes to evaluation of vaccine reactions. For example: Â Dr. Jonas Salk, developer of the inactivated polio vaccine (IPV) gave unchallenged testimony before the Senate Committee establishing the Vaccine Injury Table that there had been no paralytic reactions to the Salk vaccine in 450,000,000 doses resulting in a Table that provided no compensation for IPV-caused polio. The FDA stood by and said absolutely nothing, but had good reason to know Salkâs testimony was not true.Â Really!
Salk had provided expert assistance and consultation to me for 12 years while the ongoing feud between Sabin and Salk brewed over which vaccine should be used in the United States.
When the Chief Special Master appointed me to head an Attorneys Committee to investigate the possibility that Salkâs vaccine had caused hundreds of cases of polio that had never been linked to the vaccine by FDA, I truly believed that Salkâs vaccine had never caused polio except in one isolated manufacturing problem in 1955.
After the Committee investigated and discovered that not only had Salkâs IPV caused polio, it had probably started epidemics, and the famous âFrances Field Trials,â which the FDAâs predecessor touted as proving IPVâs absolute safety, were âriggedâ and probably caused as much polio as they prevented.
Walter, thatâs something that isnât well known and apparently pushed under the carpet, as they say.
Under the carpet would have been nice, HHS pushed the attorneys on my committee out the door. The Justice Department attorney began attacking members of the Committee on trivial issues, objected to our being paid promptly in all matters including other cases and ultimately all of us stopped practicing in the Vaccine Injury Compensation Program.
Walter, thank you for pointing out that important fact, something vaccine safety advocates are concerned about to this very dayâunknowns in vaccines. Itâs happened several times and constantly gets pushed under the âscientific carpetâ, it seems. Please continue.Â
By 1988, I concluded, based on evidence discovered from the OPV manufacturerâs files and FOIA litigation against the FDA, that FDA allowed release of live Sabin oral polio vaccines that also contained live simian retroviruses and/or viable genetic sequences of such retroviruses within the polio vaccine itself â a fact admitted by the Director of the Bureau of Biologics on April 15, 1980 in the Federal Register.
In 1992 a world renowned medical journal,Â The Lancet, published my paper, âSimian retroviruses, polio vaccine and origin of AIDSâ 339:600-601 (Mar. 7 1992), which linked the 1981 AIDS outbreak in the United States to the nationwide use of OPV for treatment of genital herpes in homosexual men by dermatologists. Following multiple oral doses of OPV, the viruses passed in their stools along with the then unknown simian retroviruses and herpes viruses (i.e., SIV and KSHV â Kaposiâs Sarcoma Herpes Virus â and CMV â Cytomegalovirus). Curiously, this panorama of simian herpes viruses also infected the first AIDS victims.
That article identified specific lots of contaminated OPV and suggested independent testing, which FDA refused to retest, but âpretendedâ that it had through false press releases in 1996. The FDA faced huge liability here so they spent millions sending someone to find AIDS-like virus in chimpanzees which is more genetically similar to HIV than any of the other simian viruses, problem was, the chimps would eat the same African green monkeys, the source of all SIVs, which were used in the oral polio vaccine.
Curiously, Sabinâs Type II oral polio vaccine, most frequently (of the three Types in a single dose of Sabin OPV) associated with the immune deficient category of paralytic polio was administered to and ultimately isolated from the stool of a chimpanzee.
I believe an honest evaluation of the science would place AIDS under the vaccine injury table, and what a massive expense that would be.
So Congressional oversight of the issue may be hard to acquire, but should be sought, all parents should ask for is âthe whole truth,â the portions of truth FDA releases often times mislead.
Although I have not actively practiced law for several years, I have followed the scientific developments in the vaccine injury debate. Furthermore, I feel it is possible to eliminate the Vaccine Injury Table and simultaneously streamline the onerous litigation process HHS has devolved for vaccine injury cases, but only if the FDA provides:
- Vaccine injury claimants have access to the deep sequencing technology and microbial detection arrays capable of identifying every known and sequenced virus, pathogen, fungus and parasite that might be associated with the onset of illnesses following vaccinations, and
- similar sequencing data on every lot of vaccine distributed in the United States for comparison of illnesses following immunization with pathogens present in the vaccines and the medium (substrate) used to generate the vaccine, or;
- for recombinant DNA vaccines (rDNA), studies on the viability, propensities, and evolutionary tendencies of the genetic vaccine agent when introduced into an appropriate species or cell line free of any other portions of the original putative agent toward which the vaccine is targeted.
Walter! That would be an answer to a lot of prayers, Iâd venture to say. What has happened recently?
The latest vaccine saga began on May 7, 2010 in Gaithersburg, Maryland, when the Vaccine and Related Biological Products Advisory Committee (VRBPAC) met to review the finding that 200,000 copies of a pig virus were found in each dose of the rotavirus vaccine. An independent laboratory with access to Lawrence Livermoreâs Microbial Detection Array, (LLMDA), screened some off-the-shelf vaccines for all known and sequenced viruses and the findings were published in Virology on March 10, 2010. Test results on the polio vaccines were apparently withheld, possibly for unwanted results consistent with comments that I made at the meeting. (Transcript p221).
That modus operandi is getting to sound a little familiar, Iâd say. Go on, please.
In that meeting Dr. Holly Franz, developer of the array patented by Lawrence Livermore Labs stated Transcript p330) that over 2 million known pathogens could be detected with this 2×3 inch glass slide that cost about $400.00 and that it could detect mitochondrial DNA changes before any vaccine reaction occurred. The chips were developed, promoted and patented with claims of usefulness in diagnosis of the cause of illnesses.
Walter, thatâs exactly what vaccine safety advocatesâespecially Iâhave been suggesting, asking for, and promoting with regard to mitochondrial DNA. Sorry to interrupt, but that is amazing.Â
The FDA âfix,â unfortunately, was in place at the time of the meeting and the Committee discussion at the end of the day foreshadowed what FDA planned for this revolutionary diagnostic tool. VRBPAC members voiced concern that someone might use the LLMDA on other vaccines or products and newly detected agents would appear that VRBPAC could not explain. The unspoken fear, in my opinion, was that vaccine reactions could now be scientifically correlated to agents in the vaccines, and no longer defended with argument and innuendo which formed FDAâs historical basis for publicly assuring vaccine safety.
Walter, if such technology is availableâand its invention may have been funded by taxpayersâ dollarsâwhat kind of conspiracy or collusion is going on that prevents the public and their physicians and pediatricians from having access, especially now that the CDCâs VAERS reporting system shows serious numbers of adverse events. Oh my goodnessâCongress ought to get involved and mandate FDA release LLMDA to professional and health consumersâ access. Please continue.Â
The meeting itself appeared to be a âred-herringâ approach to quell public outcry over a non-required vaccine, which contained a contaminant that had been in the vaccine for 15 years and could have been detected by PCR (polymerase chain reaction). FDA members on VRBPAC assured the public that no reactions had been associated with the pig viruses in the vaccine during those fifteen years.
That, Catherine, was the FDA at its Orwellian best â its orchestration glibly implied that testing for pig viruses was routinely performed in diagnosis of a potential reactants unusual symptoms. The FDA failed to disclose how many, if any, physicians had ordered PCRs for these pig viruses in the past fifteen years. Why would they? Chances are high that no testing was ever done, which is probably why the FDA âspunâ this lack of data into âproof of safetyâ â and allowed the continued distribution of the vaccine.
Walter, that makes me want to cry for all those who received that vaccine over fifteen years. Thatâs perfect proof to quell those who say vaccine safety advocates are conspiracy theorists and donât know what they talk about or science. What you just said should be considered âhigh crimes and misdemeanors,â I think. Please continue.
This scenario is consistent with the FDAâs findings in 1970 that 100% of the Sabin Oral Polio vaccine was contaminated with simian herpes viruses and FDA permitted it without ever notifying physicians of potential adverse effects or even its presence in the vaccine. The same can be seen in 1975 when FDA lab workers found simian retroviruses contaminating OPV, and it was allowed to continue by the Bureau of Biologics (BoB). A year after asserting the vaccine, the regulations did not bar the release of OPV contaminated with simian retroviruses, the Director of BoB became the Senior Vice President of Scientific Affairs at American Cyanamid â the only company producing OPV in the United States at that time.
Walter, what does that tell you? Someoneâs fanny ought to be sitting in a jail cell, I say. What do you suggest?
That the Chairman of the American of the American Academy of Pediatrics, Dr. Sam Katz, should be in jail with them. I say this based on the internal memorandums at Lederle, which indicate they obtained his support to block regulations that would have required Lederle to remove the simian herpes viruses from their vaccine after it was discovered in 1971 that 100% of the OPV carried African green monkey cytomegalovirus within the vaccine. I say this without regard to his giving me one of the highest accolades a vaccine injury attorney could receive when he shouted at me (after Congressman Burtonâs hearing on the Hep B vaccine) â âYou are a despicable attorney.â
Katz co-authored the FDA treatise on polio vaccines in 1980 that asserted the regulations did not prohibit release of oral polio vaccines containing simian retroviruses, which included Simian immunodeficiency viruses from rhesus monkeys, African green monkeys and chimpanzees that could be passed by the vaccine.
People should question why VRBPAC did not address the baboon (BERV) and human endogenous retrovirus (HERV-k) found in MMR vaccine, reported in Virology in the same article that identified the pig viruses. Could it have been the potential damage to the FDAâs Omnibus Litigation on autism pending before the Supreme Court?
Ahhhhhh! Something smells a little fishy, Iâd say.
I feel, that at the very minimum, FDA should have revealed the scientific developments, available to the FDA, which should have been used to screen all 5,000 litigants, instead of basing their defense on the testimony of an expert for Claimants whom they vilified. That was argument and innuendo, not scienceâŠand certainly not within the spirit of the legislation intended to assist vaccine-injured claimants in a simple and hassle-free recovery.
Walter, does Congress know about that? If not, why not? I sure hope there can be a congressional investigation into vaccines, and Iâd love for you ask that dynamite question.Â Go on, please.
I doubt that anyone in Congress fully appreciates the plethora of âpoliticalâ scientists who occupy the upper level positions at FDA and NIH and who have the capability of not funding projects that would scientifically analyze vaccine reactions. We have seen that failure to follow up from the outset when SV-40 viruses contaminated the initial Salk vaccines, to the 1971 discovery of simian herpes viruses contaminating OPV â which all seemed, curiously enough, to all appear in the initial epidemic of AIDS â to the current comments on RUOâs and IUOâs where the College of American Pathologists and American Society of Microbiology subtly âbought inâ to the FDAâs concern about using the LLMDA testing to screen vaccine victims for reactions.
After the VRBPAC meeting, Lawrence Livermore Labs stopped looking for âcommercial partnersâ to develop new uses for the technology â for example using it to test vaccine injured claimants for diagnostic purposes, and FDA threatened to revoke the license of any lab that used the technology for diagnostic purposes and proposed regulations which limited the use to research and investigational use only. For more information, Google RUO and IUO and the attempt to regulate the chip under the âmedical devicesâ regulations.
Walter, what you say above is nothing short of collusion and/or conspiracy on the part of FDA to keep health science from healthcare consumers whom FDA is supposed to be protecting.Â
How down right damning of FDA!
I feel the actions of the Secretary of HHS, in denying Claimants access to the latest scientific methodology to present their claims violates Claimantsâ rights to both substantive and procedural due process as guaranteed by the Constitution of the United States and the Vaccine Compensation Act. This is not saying that the Vaccine Compensation Act, itself, is unconstitutional, but that Claimantsâ rights to recover compensation under the Act are compromised by the bar set up by the FDA, which should be considered a violation of the Secretaryâs statutory and Constitutional powers. Unlike a claim under the Federal Tort Claims Act (FTCA) that can be barred by the âdiscretionary functionâ exemption, the Secretaryâs power to administer the Act arises from the statute, which was intended by Congress to streamline recovery for people injured by vaccines.
The Secretary, in withholding access to the latest science from Claimants, their attorneys and experts, violates the Claimantsâ rights to substantive and procedural due process, especially where the Off-table injured, are denied the ability to adequately present and argue their case. Intentionally withholding scientific developments from vaccine Claimants whose right of recovery is dictated by Judges appointed by the Secretary, in a Court controlled by the Secretary might best be moved to Australia where kangaroos are an indigenous species.
Walter, thank you so much for saying that. Thatâs the legal crux of the entire vaccine issue, I think. So?
Under the Act, as presently interpreted by the Supreme Court, claimants are barred from challenging the relative safety of one vaccine, compared to the safety of another vaccine, in suits against vaccine manufacturers. The definition of âsafetyâ of a vaccine depends on the HHS Secretaryâs discretionary decision to not clinically investigate reactions to any given vaccine. The Secretary routinely chooses to not investigate the safety of vaccines where adverse reactions are reported and this discretionary decision may not be challenged under the FTCA.
But I do not believe Congress intended to grant the Secretary, nor does the Secretary have the discretionary authority to block a Claimantâs access to the latest scientific technology in order to prove a claim, where the science may be the only possible means for direct proof and Claimantâs Constitutional right to a âredress of grievancesâ and access to state courts has been limited by the Vaccine Act.
How outrageous! And innocent infants, toddlers, teenagers, and adults suffer!
Donât forget the taxpayers. Access to the science should streamline and make the claims process less confrontational and more succinctâŠeliminating fees for experts and lawyers and saving moneyâŠalthough it could open the door to more claims, it could also close the door on othersâŠbut at least it can now provide answers to parents with doubts. If vaccines are so safe as the proponents claim, there should be no objecting to implementing and analyzing information gleaned from these advances in meta-genomics and high through-put sequencing. Most suspect their concerns are that the vaccines are not as safe as âadvertised.â
However, where the vaccine is improperly made in violation of specific regulations, the discretionary function exception does not apply under the FTCA.
Under the Vaccine Compensation Act, Congress clearly intended that people injured by vaccines should recover damages by merely proving that a vaccine caused the injury without needing to show the warnings given were inadequate or that the vaccine was improperly made. All that needs to be proven is that the vaccine caused the injury.
Congress also intended that recovery be quick and non-confrontational.
Now wait a minute, Walter. Talk to any parent whoâs tried to get a vaccine claim filed. Continue.
Neither of which has been followed since the early days of the Vaccine Compensation Program and the âdeck,â unfortunately, has been stacked against Claimantâs recovery.
You said it!
In Loge v. United States my proposed action against the HHS Secretary under the jurisdiction of a âConstitutional Tort Claimâ for an invasion of the motherâs right to privacy for being exposed to and immunized with a untested and unsafe âshedâ polio virus vaccine pursuant to a government program to immunize people without their knowledge, or consent, and against their free will was rejected by the Eighth Circuit Court of Appeals.
I was later informed, however, that the FDA was very concerned about this approach, which followed the logic found in Bivens v. Six Unknown and Unidentified Federal Narcotics Agents. Loge was allowed to proceed under the claim that the original vaccine, itself, failed to pass mandatory safety regulations and ultimately settled.
May I ask a ballpark figure, or canât that award be disclosed?
The amount is immaterial. There is not enough money to compensate a mother for the loss of her legs when her first and, as a consequence, only infant is three months old.
I suggest that any childhood immunization is a per se invasion of the recipients privacy since the child cannot provide meaningful consent. Hence the Secretaryâs action to block access to technology [LLMDA] that could both predict reactions before they occur or prove causation when they occur is a violation of the childâs right to privacy and the basis for a Constitutional Tort Claim against the Secretary of HHS.
The Secretaryâs actions in blocking use or this technology for diagnostic purposes violates the rights of Claimants under the Vaccine Injury Act to their rights of procedural and substantive due process and effectively eliminates their Constitutional right to âredress of grievancesâ and access to the state courts.
Pardon me for interrupting you, Walter, but I need to applaud that statement.
We now know that many vaccines carry previously unidentified agents (i.e. simian herpes viruses and immunodeficiency viruses (OPV/IPV), Baboon endogenous retrovirus (BERV) and human endogenous retrovirus k (HERV-k) in MMR vaccines and those are the tip of the iceberg.
Walter, MMR has been suspect for a long time in parentsâ minds. Parents have stated that when a child receives the MMR vaccine, thatâs when the problems begin.
As a class, infants and children forced to receive immunizations under the FDA threat of withholding education to States that do not exercise their âpolice powersâ to require immunizations for school entry, are the most vulnerable, innocent, and unprotected group in our society. As a group they are also our nationâs greatest assets.
Whereâs the problem, as you assess it?
At VRBPAC the government abdicated all control and oversight of vaccine substrates to the pharmaceutical manufacturers in an apparent attempt to side step liability for any future contaminants that might travel within vaccines.
Unless Congress requires that all vaccines distributed in the United States be screened using the latest scientific technology available and making that information public record, more chicanery from manufacturerâs such as Merck, which recently was exposed as falsifying efficacy data in a whistleblowerâs lawsuit [[Civil Action No.10-4374, U.S. District Court for the Eastern District of Pennsylvania filed August 27, 2010] is certain to occur âŠand efficacy is one baby-step away from safety.
So, what does that portend for the future of vaccinations?
With such information public record, or at a minimum available to any claimant alleging injury following immunization, and any claimant having access to the latest scientific methodology to assess their claims, is the only way to assure a safe vaccine program and the only way to justify mass immunizations of our children.
Having these tools available should streamline the vaccine claims process and ultimately, obviate protracted litigation. If vaccines are so safe, as proclaimed by the FDA, it would eliminate recovery by Claimants who do not suffer from vaccine derived injuries.
Where the FDA has abdicated substantial authority to vaccine manufacturers on substrates, and claimants lack access to such knowledge and information as a result of FDAâs actions, it is only fair that this technology be made available to all Claimants and all physicians investigating the etiology of any disease or malady suffered by children who have been immunized or in close contact with other immunized children.
Finally, I suggest that authority over the nationâs vaccine program be removed from the Secretary of HHS and be given to a new Cabinet level appointment who is independent of pharmaceutical company influence or control.
Walter, this has been a most amazing interview, for which I thank you. Iâm certain our readersâ minds will be blown. However, more than anything, I truly hope and pray some members of Congress read this and take the necessary actions to correct and neutralize the apparent conspiracy involving vaccines in federal government agencies. Again, thank you!Â
A note to Readers:Â
Please send a copy of this article to your U.S. Senators and Congressmen and women in Washington, DC. Furthermore, I request that you ask every person running for elected office the following question:
Would you support the movement to force the FDA to make the latest scientific tests available to the public for evaluation of vaccines sold in the USA, and allow parents who suspect their child had a vaccine reaction to have open access to the diagnostic technology LLMDA for diagnostic purposes?â
Letâs make FDA accountable to those whom it is supposed to protect, not Big Pharma.
Catherine J Frompovich (website) is a retired natural nutritionist who earned advanced degrees in Nutrition and Holistic Health Sciences, Certification in Orthomolecular Theory and Practice plus Paralegal Studies.
Her work has been published in national and airline magazines since the early 1980s. Catherine authored numerous books on health issues along with co-authoring papers and monographs with physicians, nurses, and holistic healthcare professionals. She has been a consumer healthcare researcher 35 years and counting.
Catherineâs latest book,Â A Cancer Answer, Holistic BREAST Cancer Management, A Guide to Effective & Non-Toxic Treatments, is available on Amazon.com and as a Kindle eBook.
Two of Catherineâs more recent books on Amazon.com areÂ Our Chemical Lives And The Hijacking Of Our DNA,Â A Probe Into Whatâs Probably Making Us SickÂ (2009) andÂ Lord, How Can I Make It Through Grieving My Loss, An Inspirational Guide Through the Grieving ProcessÂ (2008).
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