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First Draft: 11.14.10 – Final Draft 12.07.10

Before the
United States of America
Food and Drug Administration

PETITION
FDA Docket No. [To be Provided]
In the Matter of the 2009/2010 A-H1N1-09 “Swine Flu”
And 2010/2011 Season Influenza Vaccines

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To: Dockets Management Branch }
Food and Drug Administration
Room 1061 }
5630 Fishers Lane HFA-305
Rockville, MD 20852 }

Dated: December 17, 2010

Petition Index:
Introduction
Actions Requested
Statement of Grounds
The Park Doctrine
Disclosures Requested
Conclusion

Main Index

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Introduction
Petition Index

Pursuant to the Constitution of the United States of America, First Amendment, Right to Petition for Redress of Grievances, the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. §§ 321 et seq., the Administrative Procedure Act (APA), 5 U.S.C. § 553(e), 21 C.F.R. 10.20 and 10.30 (Citizens Petition) and, to the extent applicable, 21 C.F.R. 10.35, to amend the FDA’s rules respecting the safety, effectiveness and availability of influenza vaccines, including the 2009/2010 Swine Flu (A-H1N1-09) and the 2010/2011 Seasonal Influenza Vaccines which includes A-H1N1 viral materials (herein, the Vaccines) the undersigned Petitioners PETITION the United States, to wit:

1. This Petition is brought before the Executive Authority of the United States of America, mindful of the President’s call for transparency in government and science-based decision-making. Petition is grounded in the Constitutional Right to Petition which may not be in any way abridged by Government and therefore any regulatory requirements are subordinate to that primary source of authority for this Petition. Additionally, in so far as any of the Petitioners are protected under the RFRA, all rights are reserved under the Religious Freedom Restoration Act of 1993 (RFRA – P.L. 103-141).

The Petitioners address the formal requirements of 21 C.F.R. 10.20 – 35, Section 10.30: A. Action requested; B. Statement of Grounds; C. Environmental Impact/Exemption and D. Economic Impact.

2. Petitioners are several NonGovernmental Organizations involved in health care civil rights and several individuals who are adversely impacted, have suffered particularized harms or legal wrongs by the Department of Health and Human Services (HHS), Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) (sometimes herein, the Agencies) actions referred to in this Petition, and all persons who join in this Petition hereafter.

3. This Petition is submitted to request specific action by the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) within the scope of the mandated duties thereof, in order to exhaust administrative remedies.

4. Section 10:30 Statements

A. Actions requested:
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(1) The Petitioners request the enforcement of 21 U.S.C. 321, including Section k hereof, under the Constitutional Provision in Article II, Section 3, that the President “shall take Care that the Laws be faithfully executed…” with regard to the matters of the 2009/2010 A-H1N1-2009 Swine Flu Virus Influenza Vaccine and the 2010/2011 Seasonal Influenza Vaccines (which includes A H1N1 viral materials) and particularly the responsibility of drug company executives under the Park Doctrine for the foreseeable harms and legal wrongs arising from the Vaccines, including the miscarriages, injuries and deaths reported to the Vaccines Adverse Event Reporting System (VAERS).

(2) The Petitioners request that all approvals for the 2010/2011 Seasonal Influenza Vaccines that include the H1N1 virus be suspended forthwith, due in part to the large number of VAERS reported miscarriages, numbering at least 165 (which is to be compared to the typical number of such reports during a typical influenza season, zero to seven such reports).

(3) The Petitioners request that certain disclosure of vaccine dangers be made to the Public and that changes in public policy be made by the Agencies, as more fully set forth below in Paragraph 6 and thereafter.

(4) The Petitioners request that public hearings be held to make inquiry into the reason for the violations of the responsibility and legal charge placed upon the Agencies in order to”
a. Determine who shall be held accountable as permitted under the law in failing to perform a positive duty toward the public safety in the matter of approval of these vaccines and their purchase and dissemination,
b. Determine which administrative and regulatory procedures need to be changed, revamped, redesigned or abandoned in order to prevent this violation of the public trust from happening again
c. Determine whether conflict of interests lead to the design, purchase, approval, distribution and recommendations pertaining to these vaccines and, if so, what laws, statutes, regulation, codes of conduct or other limitations on Agency and industry personnel have been violated, if any and
d. What legal and regulatory responses, if any, should be taken to safeguard the public welfare.

(5) The Petitioners further request that all findings from these public hearings be made public in a manner that makes them easily accessible to the public, inviting the public to participate in the development of suggestions, mandates and guidelines for reform, if indicated.

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B. Statement of Grounds:
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(1) The 1976 Swine Flu Vaccine disaster resulted in hundreds of preventable deaths but none of the executives of the drug companies was punished, although the 1975 Park Doctrine* called for personal criminal responsibility.

(2) The 2009 Swine Flu Vaccine fiasco may have resulted in at least 165 (and perhaps as many as 3,000) vaccine-mediated, involuntary abortions in women who received the vaccine and whose unanticipated abortions followed shortly thereafter, as reported to VAERS, the government’s Vaccine Adverse Event Reporting System.

(3) The undersigned demand that the FDA investigate and refer to the Department of Justice all those drug and vaccine company executives who were involved in creating the un-safety tested H1N1 vaccine for an admittedly “novel” strain of the virus, providing the uninsurable and un-safety-tested drug to the public through the government Agencies herein, without ascertaining whether it would cause legal wrong or the deaths of unborn children and particularized harm, including death, to other protected persons.

(4) The undersigned further demand that all HHS, FDA and CDC officials who took part in the process whereby the government purchased, approved, recommended and distributed the deadly vaccines be suspended from their positions and be held accountable for the particularized harm and legal wrongs they have caused, without regard to any declared ‘public health emergency’, since these legal wrongs, deaths and other harms were foreseeable results of their actions and omissions.

5. The Park Doctrine:
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* United States v. Park, 421 U.S. 658 (1975) – Summary of the Supreme Court Decision:

The Act [21 U.S.C. § 331] imposes upon persons exercising authority and supervisory responsibility reposed in them by a business organization not only a positive duty to seek out and remedy violations but also, and primarily, a duty to implement measures that will insure that violations will not occur, United States v. Dotterweich, 320 US 277 (1943); in order to make food distributors “the strictest censors of their merchandise,” Smith v. California, 361 U.S. 147, 152 , the Act punishes “neglect where the law requires care, or inaction where it imposes a duty.” Morissette v. United States, 342 U.S. 246, 255 . Pp. 670-673.

21 U.S.C. § 331 – Prohibited Acts

“(k) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded.”

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C. Environmental Impact/Exemption

There is no significant environmental impact that can arise from the enforcement of 21 U.S.C. 321 against the individuals responsible for the particularized harms and legal wrongs suffered by Petitioners. The disclosures requested have no environmental impact. If any doses of vaccine are to be destroyed, this should be done in the standard manner for the disposal of any toxic medical waste, and particularly in a way in which the mercury contained in any multi-dose or other vial of the vaccine is not allowed to contaminate the environment.

D. Economic Impact

There is no significant economic impact that can arise from the enforcement of 21 U.S.C. 321 against the individuals responsible for the particularized harms and legal wrongs suffered by Petitioners, certainly since justice or the redress of grievances is intended to put the innocent victims in the position they would have been had there been no trespass.

6. Further Factual and Legal Grounds; Disclosures Required:
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(a) Petitioners petition the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to open and accept public comments and include, as part of any approval of the Vaccines, a clear requirement of strong warnings to the public, as mandated by the United States Supreme Court in another context, Thompson v. Western States Medical Center – 535 U.S. 357, 2002:

“If the First Amendment means anything, it means that regulating speech must be a last – not first – resort. … We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information… Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring each compounded drug to be labeled with a warning that the drug had not undergone FDA testing and that its risks were unknown.”

(b) The warning should therefore read: “This Vaccine has not undergone either FDA safety or efficacy testing required by law and its long and short-term risks are unknown in all age groups. The protective impact of this vaccine against seasonal influenza has not been established by significant scientific agreement. This Vaccine contains ingredients previously rejected for use in the United States and/or never evaluated by the FDA for safety or efficacy which have been shown in animal studies to cause significant adverse biological response when injected, including auto immune disease and permanent infertility.”

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(c) The Petitioners petition the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to engage in a vigorous public information campaign, interleaved with their promotion of the Vaccines, and given equal prominence in type face, media announcements, web presence and other methods of public information used to promote the Vaccines, stating that the Vaccines contain ingredients previously rejected for use in the United States and/or never evaluated by the FDA for safety or efficacy which have been shown in animal studies to cause significant adverse biological response when injected including auto immune disease and permanent infertility.

(d) The Petitioners petition the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to recommend to all implementing agencies, such as State Departments of Health, that these un-insurable, unproven and untested Vaccines not be subject to any legal mandate, whether direct or indirect, perceived or actual, requiring their use by any class of persons in order for such persons to receive government services, such as schooling or health care, or to work in particular employments, such as first responders or health care workers, or to travel or to attend any public places or for any other purpose.

(e) The Petitioners petition the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to recommend voluntary Self-Shielding at home in preference to vaccination or removal to FEMA or other relocation facilities in the event of a Declared Pandemic Emergency.

7. As an Executive Department Agency, the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) must “Take Care that the Laws be faithfully executed” (Article II, Section3, United States Constitution).

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8. This Petition is grounded in fundamental principles of inalienable right, law and equity.

9. The primary legal basis for submitting this Petition to the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) is the First Amendment to the Constitution of the United States: “Congress shall make no law…abridging… the right of the people… to petition the Government for a redress of grievances.” Additionally, the First Amendment Freedom of Speech, requiring transparency in government, as well as Fourth, Fifth, Ninth, Tenth and Fourteenth Amendments impact the arguments herein.

10. Petitioners also cite: the World Medical Association 1964 Declaration of Helsinki. See: http://www.wma.net/e/policy/b3.htm. This Declaration has the force of International Law, to which the United States is a party, and it clearly forbids experimental medication or medication without fully informed consent, as does United States law, for example, 42 U.S.C. 289(a) (a section entitled, Institutional review boards; ethics guidance program

11. The United Nations Universal Declaration of Human Rights – Article 12 – “No one shall be subjected to arbitrary interference with his privacy, family, home or correspondence, nor to attacks upon his honor and reputation. Everyone has the right to the protection of the law against such interference or attacks.” See: http://www.un.org/en/documents/udhr/ and the Geneva Conventions: Protocol Additional to the Geneva Conventions of 12 August 1949, and Relating to the Protection of Victims of Non-International Armed Conflicts (Protocol II) – Article 17.-Prohibition of forced movement of civilians:

“1. The displacement of the civilian population shall not be ordered for reasons related to the conflict unless the security of the civilians involved or imperative military reasons so demand. Should such displacements have to be carried out, all possible measures shall be taken in order that the civilian population may be received under satisfactory conditions of shelter, hygiene, health, safety and nutrition.

2. Civilians shall not be compelled to leave their own territory for reasons connected with the conflict.”

See: http://www2.ohchr.org/english/law/protocol2.htm

12. Current law and regulations provide for involuntary Provisional Quarantine, with removal, following refusal of persons to submit to vaccination with the untested, un-insurable, non-voluntary “informed consent” Vaccines. The Agency regulations should be amended to provide for voluntary Self-Shielding, Self-Quarantine and Self-Isolation as permitted alternatives.

13. Bivens v. Six Unknown-Named Agents of Fed. Bureau of Narcotics, 403 U.S. 388, 396-397, (1971); Carlson v. Green, 466 U.S. 14, 18-19 (1980). – These cases construe “42 USC § 300aa-31” with its “more likely than not” evidentiary burden and its Daubert v. Merrell Dow Pharmaceuticals, Inc, 509 U.S. 579, 113 S.Ct 2786, 2797 (1993), prohibition against expert opinion reliance upon poor quality and flawed data, the surviving good quality data shows the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) is statutorily required to reject the Vaccines approval since it “more likely than not” caused numerous neurological and immune system pandemics (e.g., autism, neurological disorders, autoimmune disorders, etc). Since the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) know of this linking data and intentionally exposed the public to these serous risks of harm, while attempting to hide/alter the data that showed the harm, the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) also violated the 14th Amendment’s “Constitutional Safety Guarantees.” Under these egregious and horrifying circumstances, both Sec. 300aa-31 and a 28 USC § 1331 “Bivens Action” would authorize injunctive relief, and where warranted, damages.

14. Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905), in which the Supreme Court of the United States, prior to the establishment of the Food, Drugs and Cosmetics Act revisions that established Federal pre-emption of drug approvals, gave deference to the Supreme Court of Massachusetts in an involuntary vaccination matter, also contains clear language authorizing Federal intervention in circumstances that are clearly present with regard to the Vaccines involved in this Petition.

“It is easy, for instance, to suppose the case of an adult who is embraced by the mere words of the act, but yet to subject whom to vaccination in a particular condition of his health or body, would be cruel and inhuman in the last degree. We are not to be understood as holding that the statute was intended to be applied to such a case, or, if it was so intended, that the judiciary would not be competent to interfere and protect the health and life of the individual concerned. “All laws,” this court has said, “should receive a sensible construction. General terms should be so limited in their application as not to lead to injustice, oppression or absurd consequence. It will always, therefore, be presumed that the legislature intended exceptions to its language which would avoid results of that character. The reason of the law in such cases should prevail over its letter.” United States v. Kirby, 7 Wall. 482; Lau Ow Bew v. United States, 144 U.S. 47, 58. Until otherwise informed by the highest court of Massachusetts we are not inclined to hold that the statute establishes the absolute rule that an adult must be vaccinated if it be apparent or can be shown with reasonable certainty that he is not at the time a fit subject of vaccination or that vaccination, by reason of his then condition, would seriously impair his health or probably cause his death.”

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15. The Acts establishing the authority of the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) being herein petitioned are also a legal basis for the Petition. The Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) exist to protect the public, within the limits established by the Constitution of the United States of America. However, Article 16 of the original enabling legislation that created the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) indicates, in effect, that a primary purpose is to promote, protect and promulgate the pharmaceutical industry.

16. Petitioners note the statute in the derogation of the common law and Constitutional limitations, establishing certain limited exemptions from liability for Vaccine Injuries, 42 USC 300aa-16 (and the Vaccine Injury Compensation Program, thereunder). This law is further cited as a law that must be strictly construed in favor of patients, guardians, parents and children even if such construction is against the economic interests of the drug industry and other persons claiming exemption thereunder.

17. Petitioners note that, given the exceptional limited exemption given to both manufactures of the Vaccines and employees of the Federal Agencies and their designees which purports to eliminate the possibility of redress of grievances through the Courts by the public in the event that individuals suffer irreversible harm or death, it is especially important that careful notification and protection be offered to the public in the face of instructions or compulsions to accept the use of the Vaccines which contain ingredients previously rejected for use in the United States and/or never evaluated by the FDA for safety or efficacy which have been shown in animal studies to cause significant adverse biological response when injected.

18. The total amount that the Vaccine Injury Compensation Program has paid in compensation since its 1989 founding is in excess of $1,884,145,255.29.

See: http://www.hrsa.gov/Vaccinecompensation/statistics_report.htm

19. Basic common law principles prohibiting forced acquiescence under duress and limited or intentionally distorted information, as exemplified by the United States Supreme Court decision in the case of Thompson v Western States Medical Centers – 535 U.S. 357 (2002). The Petitioners note with concern that FDA regulation permits a choice under duress upon limited and distorted information such that those refusing the Vaccines in a Pandemic Emergency situation face incarceration/quarantine under Provisional Quarantine regulations in violation of the prohibitions mentioned above against forced acquiescence under duress and limited or intentionally distorted information. The Swine Flu National Health Emergency declared by President Obama on October 25, 2009 has not been suspended despite the fact that the World Health Organization rescinded its Level 6 Pandemic Status on XXXXX, 2010.

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20. The Statutes authorizing the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) contain general provisions that support the actions requested in this petition. Federal Law includes provisions that grant the responsible persons in the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) broad authority to promulgate rules and regulations “necessary to carry out the Act[s].”

21. The Food, Drug and Cosmetics Act (FD&C Act) Mission Statement requires that “…(B) human and veterinary drugs are safe and effective…” (21 USC §393(b)(2)). The Act had been amended repeatedly, to require that no drug be approved unless it is proven “safe and effective.”

This clear legal requirement is explained by the Agency on its web site:

“In October 1962, Congress passed the Kefauver-Harris Drug Amendments to the Federal FD&C Act. Before marketing a drug, firms now had to prove not only safety, but also provide substantial evidence of effectiveness for the product’s intended use. Temple says, “That evidence had to consist of adequate and well-controlled studies, a revolutionary requirement.”

“Also critically, the 1962 amendments required that the FDA specifically approve the marketing application before the drug could be marketed, another major change.” The Kefauver-Harris Drug Amendments also asked the Secretary to establish rules of investigation of new drugs, including a requirement for the informed consent of study subjects. The amendments also formalized good manufacturing practices, required that adverse events be reported, and transferred the regulation of prescription drug advertising from the Federal Trade Commission to the FDA.”

See: http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/PromotingSafeandEffectiveDrugsfor100Years/default.htm

22. The Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) should issue the actions requested herein as an Interim Final Rule without first completing Notice and Comment, Risk Assessment, and Cost-Benefit Analysis. Additionally, the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) should not issue the drug-industry requested vaccine approvals as an emergency matter.

23. Under ordinary circumstances, the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) must comply with procedural requirements under the Administrative Procedures Act (APA) and the specific Acts authorizing the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC), including the use of notice-and-comment rulemaking and the completion of a risk assessment and cost-benefit analysis before issuance of a new rule. However, both Acts provide for exceptions to those requirements for circumstances such as those present here (with regard to the Petitioners herein, but not with regard to the drug-industry applications), where the continuation of current policy (the emergency approval of the Vaccines) would constitute an imminent threat to public safety and any delay in the policy-making the Petitioners herein would be contrary to the public interest.

24. The Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) should only avail itself of those statutory exceptions with regard with Petitioner’s request herein and promulgate the requested policies while first providing the public with reasonable notice under these circumstances and an opportunity for comment and before completing a full risk assessment and cost-benefit analysis. The Department of Health and Human Services (HHS), the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) should first adopt the policy as an “interim-final rule,” which would become binding upon publication (or within a time certain; for example, a week after publication) and subsequently provide for public comment and complete its risk assessment and cost-benefit analysis. If such a time period is provided for public comment and the completion of risk assessment and cost-benefit analysis, the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) should make no declaration, take no action, approve no product or Vaccine related to this situation during such period.

25. The Requested Actions of Petitioners herein satisfy the “good cause” exception to the Administrative Procedure Act’s (APA) requirement for notice and comment, while the application of that exception should not apply to the Vaccine applications.

26. The Administrative Procedures Act (APA) provides that full notice-and-comment rule-making is not required when an agency “for good cause finds (and incorporates the finding and a brief statement of the reasons therefore in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. Section 553(b)(B) The good cause exception “is an important safety valve to be used where delay would do real harm.” United States Steel v EPA, 595 F.2d207, 214 (5th Cir. 1979). According to the legislative history of the provision, “impracticable” means a situation in which the due and required execution of the agency functions would be unavoidably prevented by its undertaking public rule-making proceedings.” S. Rep. No. 752, 79thCong., 1st Sess., at 16 (1945). It has been held, determining “impracticality” requires analysis in practical terms of the particular statutory-agency setting and the reasons why agency action could not await notice and comment. American Transfer & Storage Company v. ICC, 719 F. 2d 1283, 1295 (5th Cir. 1983).

27. The same urgency which motivates the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to move forward with excessive rapidly and inappropriate zeal, in the light of an alleged influenza threat (which was declared despite the mild nature of the disease) should motivate the Food and Drug Administration (FDA) and/or the Centers for Disease Control (CDC) to move forward with the measures proposed by Petitioners herein to protect both the public’s welfare and their right to fully informed consent and transparency. Inclusion of the H1N1 Swine Flu vaccine in the Seasonal Influenza shots for the 2010 flu season, in the light of a total lack of threat of either H1N1 pandemic or illness is particularly egregious and its use should be immediately halted.

28. Below are listed three of numerous instances in which courts have upheld an agency’s decision to invoke the “good cause” exception and issue a rule without providing notice and comment where a delay would threaten public safety or the environment. See: Hawaii Helicopter Operators Ass’n v. FAA, 51 F.3d 212, 24 (9th Cir. 1995) (good cause exception satisfied in view of “the threat to public safety reflected in an increasing number of helicopter accidents”); Northern Arapahoe Tribe v. Hodel, 808 F.2d741, 750-52 (10th Cir. 1987) (good cause exception satisfied in view of urgent need for hunting regulations where herds were threatened with extinction); Northwest Airlines v. Goldschmidt, 645 F2d 1309, 1321 (8th Cir. 1981) (good cause exception satisfied in view of urgent need to allocate landing slots at major airport).

29. The rationale underlying those decisions is that compliance with time-consuming procedural requirements would “do real harm” by delaying implementation of urgently needed policies to safeguard public health. Swine Flu causes a disease of low virulence and pathogenicity so that the need for current Agency displays of overwhelming haste in their approval is not present, but the Vaccines contain never-before-approved, but previously rejected, adjuvants and known toxins so that the need for caution in their approval is very much present. Clearly, the exigent circumstances necessary to satisfy the Administrative Procedures Act’s (APA’s) good cause exception are present with regard to Petitioner’s concerns as set forth in the Factual Basis for Relief. They are not present with regard to the Vaccine approval applications. On the contrary, such approval would harm the public health.

30. Vaccinations cause well-known and foreseeable harm. Autism, neurological damage, Guillian Barré syndrome, post vaccination Encephalitis, asthma, coma, juvenile ALS, adult ALS, oil-in-water adjuvant-induced poly arthritis, dermatitis, fibromyalgia, fatigue, malaise, death and other known consequences of vaccine injury are generally not reversible and the present danger from the Vaccines to children and adults is so great that the “good cause” exception referenced above is well warranted in this case. Consumers are being defrauded while children and others are being irreversibly damaged. Once a child collapses into autism or juvenile ALS, post vaccine poly arthritis, for example, there is a virtually irreversible path which the child and family follow, often leading to eventual institutionalization. These are, in most cases, preventable tragedies. The probable harm is immediate and irreparable.

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Conclusion
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31. In order to redress the perceived harm, there are several procedural matters that should be addressed by Agency Rule or Court interpretation. These are the need for:

(1) Clear and prominent Warnings as specified elsewhere herein,
(2) Due-process compliant procedures for opting out of involuntary vaccinations,
(3) Sound information to support informed consent if the vaccination is truly voluntary, and
(4) Due-process compliant procedures required to involuntarily isolate or quarantine any person who refuses to take an involuntary vaccine,
(5) Agency and congressional hearings into
1. the causes of behavioral and neurological vaccine damage and the repair of such damage
2. The cause and conduct of these approvals any conflicts of interest or other improprieties, if any,
3. The persons responsible for these improprieties, if any.

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32. Medical ethics, United States law regarding medical experimentation and treatment, and international legal standards require nothing less. These international legal standards are among the international standards the Agency pledged to harmonize to in a notice published in the Federal Register of October 11, 1995 (60 FR 53078), “FDA articulated its policy regarding the development and use of standards with respect to the harmonization of various national and international regulatory requirements and guidelines…”

See: http://www.cfsan.fda.gov/~lrd/fr970707.html

33. The Vaccines are advertised to the Public as “safe and effective” and as “approved” and “recommended” by the Agencies. This is false and misleading. The most complete and recent review of the literatures shows no proof of safety or efficacy. See: Geier DA, King PG, Geier MR. Influenza Vaccine: Review of effectiveness of the U.S. immunization program and policy considerations. J American Physicians and Surgeons 2006 Fall; 11(3): 69-74.

34. The A-H1N1 “Swine Flu” 2009/2010 vaccination deadly results are similar to the 1976 “Swine Flu” vaccination panic results: hundreds of unborn children and others have died (more than are alleged to have died from the 2009 “Swine Flu”) and hundreds of thousands or more will be injured. Other countries, including Finland and Australia, after purchasing and recommending the same vaccines, noted with alarm the increase in neurological disorders including narcolepsy and convulsions. Their response was to ban the vaccines, noting that they were not necessary since the risk of the vaccine outweigned the risk of seasonal or H1N1 influenza. The United States can do no less for its citizens.

35. Since the 2010/2011 Vaccines contain the A-H1N1 strain, hundreds if not thousands of more deaths, including preventable miscarriages, will occur. These deaths are a foreseeable result of the Agencies’ policies and of the failure of the company executives to obey the law requiring that vaccines be safe and effective. Since vaccines have not been shown to be either safe or effective with significant scientific agreement, the Vaccines are misbranded.

36. Therefore, the Petitioners petition the Agencies to fully enforce 21 U.S.C. 321 and hold those company executives and Agency employees responsible for these foreseeable deaths; for the particularized harms and legal wrongs they have and are imposing upon Petitioners and others similarly situated.

37. The Petitioners reserve all Rights including any Right any Petitioner may have to petition the other co-equal branches of the Federal Government, the Congress and the United States Courts, for redress of grievances, particularized harm or legal wrong in any case or controversy for which any may have standing.

Wherefore the undersigned certifies that to the best of his knowledge and belief the factual statements made herein are true, complete and not intentionally misleading.

The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the Petitioner which are unfavorable to the petition.

December 17, 2010

By:
Ralph Fucetola JD – ralph.fucetola@usa.net
www.HealthFreedomPortal.org
Natural Solutions Foundation Trustee, on behalf of all Petitioners

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