“Stop the Shot” Federal Case – Brief in Support of Injunction

Media Release: http://drrimatruthreports.com/?p=3617

United States District Court for the
District of Columbia

Table of Contents

Table of Contents 2

Table of Citations 3

I. Statement of the Case 5

II. Procedural History 5

IV. Jurisdiction 6

V. Ripeness 6

VI. Standing 7

VII Statement of Facts 9

VIII. Argument 16

1.The FDA did not follow its own statutory and regulatory framework in approving the vaccines.

2.The FDA’s tacit approval of squalene violates Hon. E. J. Sullivan’s unappealed 2005 Order, as to the findings which underlie the Order.

3.The FDA’s tacit approval of adulterated vaccines violates the Secretary of HHS’s duty under 42 U.S.C 300aa-27(a)(2) to make vaccines safer by using all of Secretary’s authorities to reduce the risk of adverse effects of vaccines.

4.The FDA’s action is an underlying element in New York State’s violation of Plaintiffs’ rights protected under the 14th Amendment to the United States Constitution and substantive due process.

IX. Standards for Issuance of Restraints 29

X. Request for Relief 30

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Table of Citations
Constitutional Provisions

Amendments: 1, 4, 5, 7, 14 8, 17, 28

Statutory Provisions

5 U.S.C. 701-706 9

21 U.S.C. 321 10, 33

21 U.S.C. 331 10

21 U.S.C. §351(a)(2)(B) 9, 10, 25, 26

21 U.S.C. 355 5, 8, 23, 32

21 U.S.C. § 360bbb-3 10, 25, 33

21 U.S.C. §393(b)(2) 10, 23

42 U.S.C. §300aa-27(a)(2) 17, 25, 27

42 U.S.C. §300aa-31 17

Rules of Court:

F.R.C.P 65 – Injunctions and Restraining Orders 29

Case Law:

Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 22, 32

United States v. Kirby, 7 Wall. 482 32

Lau Ow Bew v. United States, 144 U.S. 47 32

Daubert v. Merrell Dow Pharmaceuticals, Inc, 509 U.S. 579 16

Thompson v. Western States Medical Center, 535 U.S. 357 17

Doe v Rumsfeld, District Court for the District of Columbia, Civil Action No. 03-707 (EGS)
11, 20, 21, 22, 23

Abbott Laboratories v. Gardner, 387 U.S. 136 (1967) 8

Dennis Dickson, et al v. Secretary of Defense, et al., 68 F.3d 1396 (D.C.Cir. 1995) 9

Case Law Regarding the Right to Petition: 8

Eastern Railroad Presidents Conference v. Noerr Motor Freight, Inc., 365 U.S. 127 (1961)

California Motor Transport Co. v. Trucking Unlimited, 404 U.S. 508, 510 (1972

Bill Johnson’s Restaurants, Inc. v. N.L.R.B., 461 U.S. 731 (1983)

McDonald v. Smith, 472 U.S. 479 (1985)

United States v. Hylton, 710 F.2d 1106 (5th Cir. 1983)

White v. Lee, 227 F.3d 1214 (9th Cir. 2000).

United States v. Carolene Products C., 304 U.S. 144 (1938)

Regulatory Provisions

44 C.F.R. 46.101 et seq. 33

21 C.F.R. Part 210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
§ 210.2 Applicability of current good manufacturing practice regulations. 10

21 C.F.R. Part 211— CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS 21 C.F.R. § 211.1 Scope 10

21 C.F.R. §601.2(a)
§ 601.2 Applications for biologics licenses; procedures for filin. 10, 16, 26

21 C.F.R. §601.4(a)
§ 601.4 Issuance and denial of license 10, 16, 26

21 C.F.R. §610.15(a)
§ 610.15 Constituent materials 9, 10, 18

State Regulations:

Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York, Part 66, Subpart 66-3 Health Care Facility Personnel – Influenza Vaccination Requirements
30

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I. Statement of the Case

The Complaint in this matter involves the September 15, 2009 Food and Drug Administration (herein, FDA or Agency) approving the licenses for “Swine Flu” 2009-H1N1-A vaccines (herein, the Vaccines) under Title 21 of the United States Code.1 Plaintiffs seek a declaration that these Vaccine approvals are void, with injunctive relief.

II. Procedural History

This matter comes before the Court by way of a Complaint for declaratory judgment and injunctive relief arising from actions (omissions) of a Federal Agency, namely the Food and Drug Administration (herein, the Agency) and certain Federal Officials, the Defendants, pursuant to 21 U.S.C. 355. In addition, Plaintiffs are seeking a stay of the Agency’s approvals of the licenses for the Vaccines and a reversal of these approvals. The Plaintiffs seek a Temporary Restraining Order and Preliminary Injunction staying the approvals of these Vaccines until there has been adequate safety testing and a full opportunity for public hearings.

This is an emergency legal action in a matter of significant public importance. The Agency has approved the Vaccines without adequate or definitive safety testing, in clear violation of Federal Law which requires that all drugs (including the Vaccines) be proven “safe and effective” and that the benefits outweigh the risks. Without definitive safety testing, there can be no valid finding that the benefits outweigh the risks or that the Vaccines are “safe and effective” in light of the fact that most people receiving the Vaccines will already have multiple vaccines in their systems, including seasonal flu vaccines.

The Plaintiffs are several United States citizens who are in imminent peril of adverse consequences, credentialed health care professionals and citizens groups engaged in expressive association, health care civil rights activities concerning the approval of the Vaccines.

IV. Jurisdiction

This Court has jurisdiction over this action pursuant to 28 U.S.C. § 1331 (federal question) and 28 U.S.C. § 1361 (mandamus). The relief requested is authorized pursuant to 28 U.S.C. § 1651 (all writs act); 28 U.S.C. § 2201 (declaratory relief); and 28 U.S.C. § 2202 (further relief). Plaintiffs have a right to bring this action pursuant to the Administrative Procedures Act because the Agency has engaged in final agency action presenting an actual controversy for which these Plaintiffs are entitled to relief. Venue is proper in this district pursuant to 28 U.S.C. § 1391(e) because this is a civil action in which at least one of the defendants is an officer of the United States that resides in this judicial district or an agency of the United States that resides in this judicial district. The Agency approve the licenses or amended licenses for the Vaccines on September 15, 2009 (with planned availability to the public on or about the first week of October 2009). Plaintiffs allege this arbitrary and capricious approval was done without adequately considering the risks and benefits of the Vaccines. Plaintiffs allegations are based upon the considered opinion of experts in the fields of medicine, wellness and immunology.

V. Ripeness

With the licensing of the Vaccines on September 15, 2009, the controversy over their approval as a “change of strain” vaccine without definitive safety testing, rather than as a “novel virus” vaccine requiring full safety testing, became ripe for judicial review. Since one of the Vaccines approved (and the first one that the government, which has purchased an owns all these Vaccines, is making available to the public) is a “live virus” nasal mist vaccine, made with a virus declared by both the government and the World Health Organization, (W.H.O.) to be a “novel virus” with pandemic potential, this particular Vaccine poses an immediate risk of irreparable harm. The determination by the Agency to proceed with approving the Vaccines as a “change of strain,” in light of the Agency’s inconsistent prior determination that the 2009-H1N1-A virus is a “novel” virus with pandemic potential, is arbitrary and capricious and is neither supported by the scientific evidence nor transparent. With the threat that the Vaccines will be available to the public on or before October 15, 2009 and several States1 now mandating their use, the matter is of immediate public concern.

For example, based upon Federal government “recommendations” the State of New Jersey has mandated flu vaccines for all school children; the State of California has mandated the Vaccines for certain people and the State of New York has mandated all influenza vaccines for nearly all health care workers with patient contact, including the Vaccines subject to the Complaint, which will be supplied by the Defendant Department in the next few days. This matter is ripe for adjudication.

VI. Standing

The Plaintiffs are all nongovernmental organizations and United States Citizens who are members of the organizations and the general public. The allegations of the Complaint set forth the specific State regulations which are dependent upon the issuing of the Federal licenses for the Vaccines herein that will subject the individual Plaintiffs to imminent peril of irreparable harm, loss of livelihood, liberty, property and other protected rights.

These individuals stand in imminent peril of loss of livelihood or licensure, or public benefits such as public school attendance, as set forth in the Certifications submitted with the Complaint. Based upon the licensing of the Vaccines, these Plaintiffs are in imminent peril of being coerced, mandated or required to receive the Vaccines against their will and without fully informed, voluntary consent.

Federal law has long recognized the First Amendment Right of the People to Petition government for redress of grievances. See: Eastern Railroad Presidents Conference v. Noerr Motor Freight, Inc., 365; U.S. 127 (1961); California Motor Transport Co. v. Trucking Unlimited; 404 U.S. 508, 510 (1972)(“Certainly, the right to petition extends to all departments of the Government”); Bill Johnson’s Restaurants, Inc. v. N.L.R.B., 461 U.S. 731 (1983); McDonald v. Smith, 472 U.S. 479 (1985); United States v. Hylton, 710 F.2d 1106 (5th Cir. 1983) (filing lawsuit is a petition for redress); and White v. Lee, 227 F.3d 1214 (9th Cir. 2000).

This Court is empowered to act expeditiously when individuals are suffering a legal wrong because of Agency action (or failure to act), or adversely affected or aggrieved by the Agency within the meaning of a relevant statute, such as 21 U.S.C. 355, thereby entitling them to judicial review thereof. See 5 U.S.C.A 702. The Court has thus been presented with, and it should decide, a relevant question of law and statutory provision. Id. at 706. Based on this authority, it can “hold unlawful and set aside agency action … found to be – (A) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law; … (C) in excess of statutory jurisdiction, authority, or limitations, or short of statutory right; (D) without observance of procedure required by law; … or (F) unwarranted by the facts to the extent that the facts are subject to trial de novo by the reviewing court.” Id. The APA erects a “presumption of judicial review” at the behest of those adversely affected by agency action. Abbott Laboratories v. Gardner, 387 U.S. 136 (1967); Dennis Dickson, et al v. Secretary of Defense, et al., 68 F.3d 1396 (D.C.Cir. 1995). The only statutory exceptions to this rule are if a statute “preclude[s] judicial review” or if “agency action is committed to agency discretion by law.” See §§ 701(a)(1),(2). Here, no statute precludes judicial review. The licensing of Vaccines is not discretionary if the requirements of law are met in the Biologic Licensing Application (BLA). Nor does any exception of the APA apply thereby permitting judicial review.

VII Statement of Facts

1. (A) Without taking into account serious objections raised by many citizens, Defendant FDA approved four (4) A/H1N1 Vaccines on September 15, 2009 (with planned availability to the public on or about the first week of October 2009) without adequately considering the risks and benefits of the Vaccines. In addition, Defendant Secretary has listed these vaccines as covered items under the PREP Act because of a “ possible health emergency (possible pandemic influenza)” permitting Defendant FDA to issue an “Emergency Use Authorization” (EUA) order under which unapproved vaccines may not only be administered in a mass vaccination program but also uncontrolled vaccine manufacture may be conducted in a manner that fails to provide any assurance that these on-site admixed Vaccines will be safe to administer at the locations (90,000 sites) at which these unapproved vaccines may be manufactured, mixed, prepared and administered. The federal government owns all of the Vaccines to be provided to the public, including the Plaintiffs herein.

(B) Upon information and belief, most if not all of the inactivated-influenza Vaccines will be or become unapproved vaccines when the adjuvants, lacking proof of safety to the standard required in 21 CFR Sec. 610.15(a), will be admixed with the “approved” Vaccines at the 90,000 sites outside of all semblance of manufacture under current good manufacturing practice (CGMP) and, thereby, be not only adulterated drugs under 21 U.S.C. Sec. 351(a)(2)(B) but also unapproved drugs, with no assurance of safety, uniformity, or absence of contamination.

2. 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’.” The provisions of 21 U.S.C. 355 provide for the approval process.

This clear legal requirement is further 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.”2

3. The applicable Statutes and Regulations, including but not limited to 21 U.S.C. 321, 331, 351(a)(2)(B), 355, 360bbb-3, 393(b)(2), and 21 C.F.R. Part 210, 210.2, Part 211, 211.1, Part 601, 601.2(a), 601.4(a) and 610.15(a) establish a comprehensive regulatory system for the licensing of the Vaccines, binding upon the government and the vaccine companies.

4. The Defendants have arbitrarily and capriciously failed to follow the statutes and regulations, thereby issuing invalid licenses for the Vaccines. The Defendants have failed to obtain from the purported licensees all of the applicable proofs of safety and efficacy to the Agency in the manufacturer’s Biologic License Application (BLA) (21 CFR § 601.2(a)) before the Agency can legally approve a vaccine (21 CFR § 601.4(a)).

5. If the H1N1 “Swine Flu” vaccination results are similar to the 1976 “Swine Flu” vaccination panic, hundreds, if not thousands, may die (more than are alleged to have died from the 2009 “Swine Flu”) and hundreds of thousands or more may be injured. If the Vaccines, with their MF59 proprietary version of squalene and other toxic adjuvants, are as deadly as the experimental squalene Anthrax Vaccine (“Vaccine A”) mandated for United States soldiers during the First Gulf War, hundreds of thousands will be hospitalized due to vaccine adverse reactions with tragic consequences to them and enormous preventable financial burdens on the healthcare system. The Novartis adjuvanted vaccine under consideration by the Agency has a concentration of squalene one million times greater than that present in the experimental squalene Anthrax Vaccine. Squalene has never been approved for use in any drug in the United States and Vaccine A was permitted under the now otherwise moot April 5, 2005 Order issued by Judge Emmet G. Sullivan in the matter of Doe v Rumsfeld, District Court for the District of Columbia, Civil Action No. 03-707 only on a “voluntary” basis and then with fully informed consent on the part of the recipients. Judge Sullivan’s findings of fact, including that squalene is an unapproved drug, was not appealed by the government and the government is therefore bound by that decision.

6. The Agency has, through its public pronouncements and the approvals of licenses granted on September 15, 2009, determined that the Vaccines will not be treated as “new drugs” requiring safety testing, but rather as “change of strain” drugs not requiring full safety testing. This is true although all of the authorities in government and independent organizations, and indeed, the Agency itself, shows that there is significant scientific agreement that the 2009-H1N1-A virus as a “novel” virus and the manufacture of this vaccine is covered by recent patents obtained by Baxter International, Novartis and others in 2007 and 2008. The public record shows:

(a) “Norman Baylor, PhD, director of FDA’s Office of Vaccines Research and Review, explained the FDA’s probable decision to go ahead with the simplified approval process, rather than a lengthy new drug application process. “We have decades of experience with H1N1, that’s why we feel we can do this with a strain-change,” said Dr. Baylor.”3

The last time there was a “Swine Flu” vaccine, in 1976, the only time in the “decades” alleged by Dr. Baylor for which there was a “Swine Flu” vaccine, the vaccine killed hundreds and maimed thousands in a well-known historical fiasco that forced the Agency to abandon the use of the vaccine after ten weeks of availability to the public. How can the Agency therefore now claim such scientifically valid fore-knowledge of safety for the Vaccines at issue here that safety testing should not be required?4

(b) “Q. Will vaccine be adjuvanted?
A. It is unlikely H1N1 vaccine will be adjuvanted. Definitive information will be available once clinical trial data are available.

Q. If vaccine is adjuvanted, how will it be formulated?
A. Formulation will vary by provider. For Novartis, vaccine may be preformulated with adjuvant. For CSL, GSK and Sanofi Pasteur, mixing of vaccine and adjuvant at the site of administration will be necessary. Specific information on storage requirements and procedures for mixing vaccine and adjuvant will be provided by CDC. Medimmune vaccine will not be adjuvanted.

Q. Will the vaccine be administered under EUA (Emergency Use Authorization)?
A. EUA will not be used for unadjuvanted vaccine if FDA licenses the vaccine under the current BLA (Biologics License Application) as a strain change.”

http://www.cdc.gov/h1n1flu/vaccination/statelocal/qa.htm

(c) “There’s a chance the early data will show the vaccine is ineffective at stimulating an immune response. If that’s the case, the FDA might have to issue an “emergency use authorization” for an oil-in-water adjuvant that
sparks a stronger reaction in the immune system, but causes more side effects.”5

Two companies, GlaxoSmithKline and Novartis, applied for approval for vaccines that contain oil and water adjuvants. The NIH is also conducting a dose response trial of an adjuvant-enhanced vaccine and has announced that early results suggest that a single dose of adjuvanted vaccine may be “sufficient.” The Defendant Department or Agency has purchased nearly a half billion dollars worth of a squalene adjuvants.6

“There are currently no licensed influenza vaccines that contain an adjuvant, and Dr. Baylor said he couldn’t recall a time when the FDA issued an emergency use authorization for a vaccine.

The panel’s consumer representative said if the FDA does issue an emergency use authorization for a adjuvanted vaccine, she would prefer as little adjuvant as possible to avoid side effects…

What do these numbers mean? Protection of humans against seasonal influenza is generally believed to require a HI titer of 1:40 or more. Therefore when MF59 adjuvant is used in mice, one immunization is sufficient to confer protection against disease. Without adjuvant, two doses are required for protection.

Trials are ongoing in adults to determine the immunogenicity of 2009 H1N1 vaccines with and without adjuvant.”7

7. A major question in this case is whether 2009-H1N1-A is, as the Defendants have repeatedly said, a “novel” virus with pandemic potential, or is merely a “change of strain” for which no safety testing is allegedly needed? Based on the significant scientific agreement that the virus is “novel” that question must be answered that the virus is novel and full safety testing is required. The Agency cannot, acting within the strictures of the case law requirement(s), credibly act based on scientific evidence, and then have the question answered both ways.

8. Additionally, the Agency acknowledges the danger of side effects from this untested, unapproved adjuvant, yet has approved it for use in light of an alleged pandemic from a virus which has so far shown itself to be not a significant threat. Even if the 2009-H1N1-A virus did pose such a threat, according to Defendant Sibelius’ aforesaid testimony before Congress, no evidence of a significant mutation toward increased disease-causing capacity exists. Even if this virus did pose such a threat, the known dangers of squalene adjuvants, used in laboratories as “Freund’s Adjuvant” to cause massive auto immune disease, paralyze and create disorders in animals, appears unjustified to the Plaintiffs, and our physician expert, Dr. Laibow states so in her Certification in support of this application. The Agency has not substantiated the need for such Draconian immunology.

9. The immunological expert Dr Schon states in the Expert’s Certification, Exhibit A that it is not proper science to treat a novel virus vaccine which is produced by a method that may or may not heretofore have been used to produce flu vaccines as a mere “change of strain” and that the Vaccines herein should therefore have been subjected to full safety testing as unapproved new drugs. This reasonable, professional opinion conforms to basic legal and medical ethics principles while any contrary opinion produced by Defendants will be unreasonable, unscientific and violate both the letter and the spirit of the applicable law.

10. In his Certification in support of the application, Dr. Paul King, PhD, an expert in drug approval procedures, outlines in detail the regulatory and statutory failings of the Agency action with respect to Thimerosal-containing formulations and the live-virus 2009-H1N1-A vaccine manufactured by MedImmune.

11. (A) When announcing the licensing of the Vaccines, Respondent Sebelius testified before Congress that all the Vaccines would be owned by the government and distributed through a single contract distributor to approximately 90,000 locations, including schools, hospitals and other places of public accommodation. If the “live virus” nasal mist Vaccine, which the manufacturer publicly admits will cause a case of the flu, is released to the public, this act will trigger the very pandemic the government claims it wishes to avoid. Further, Defendants have indicated that if the use of an adjuvanted vaccine is made “necessarey” by a pandemic, the vaccine and adjuvant will be “mixed” at the sites of the inoculations. Thus, upon information and belief, an unapproved squalene laced adjuvant will be mixed in non-sterile circumstances, across the entire country, leading to further injuries and ensuring the deadly results of a pandemic induced by the arbitrary and capricious decisions of the Defendants, decisions that are not based on science or testing.

(B) Moreover, with respect to said mixing, the manufacture of new drugs totally is outside of the federal and state laws designed to ensure that said drugs are safe and uncontaminated. Finally, if the mixing of the vaccine and the adjuvant is to be permitted to occur multiple times at 90,000 locations, the end result will be hundreds of thousands of different new drug formulation lots with no assurance that any two will be the same, or proof that each of the hundreds of thousands of mixed product lots is uncontaminated, properly mixed, and sufficiently safe, or means to keep track of which exact mixed lot each inoculee received or, since no explicit provision is required for a retention sample from each mixed lot, no means to access the cause of any adverse reaction that may occur.

VIII. Argument

1. The FDA did not follow its own statutory and regulatory framework in approving the vaccines.

The Congress of the United States has charged the Secretary of Health and Human Services, who is ultimately accountable, and the U.S. Food and Drug Administration (FDA), which has been delegated as the Agency actively engaged in the review and approval of drugs, with the responsibility for the licensing of safe and effective drugs (including the Vaccines) which the manufacturers have proven safety in a manner that complies with all safety regulations and other requirements where the established benefits of the drugs outweigh the risks. This comprehensive system of drug approval is detailed in Title 21 of the United States Code and in Regulations made pursuant thereto.
In this context, Plaintiffs cite cases imposing strict standards on government action when dealing with new drugs. First, the manufacturers have an absolute non-dischargeable duty to provide proof of the safety of any new drug to the applicable standards as well as to provide proof of effectiveness to the standards established. For vaccines, the manufacturers must submit all of the applicable proofs of safety and efficacy to the Agency in the manufacturer’s Biologic License Application (BLA) (21 CFR § 601.2(a). Only after the vaccine manufacturer has submitted all of the required documents can the Agency begin its review of approval (21 CFR § 601.4(a).

Then, after confirming that all of the required proof of safety and efficacy have been submitted, the Agency must engage in a scientific balancing of risks and benefits based on the submitted proofs of safety and efficacy and other factors, before approving the candidate vaccine. Legal actions lie when these standards are ignored. Daubert v. Merrell Dow Pharmaceuticals, Inc, 509 U.S. 579, 113 S.Ct. 2786, 2797 (1993) expresses 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 pandemic consequences of pandemic magnitude (e.g., devastating, profound and pervasive 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 28 USC § 1331 would authorize injunctive relief, and where warranted, damages. In the matter before this Court, Plaintiffs seek injunctive relief.

In Thompson v. Western States Medical Center, 535 U.S. 357 (2002) the Supreme Court held that people have the right to truthful and not misleading information about health care matters, even if the information might lead people to act in ways not recommended by the government:

“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.”

As shown by the comments of Agency representatives in the Statement of Facts and in the attachments to this Application, government’s decision to “recommend” these Vaccines and the underlying the Agency decision to treat the vaccine as a “change of strain” rather than a “novel virus” are contrary to the Agency’s own position as to the “novel” nature of 2009-H1N1-A, arbitrary and capricious, and not supported by substantial evidence in the administrative record.

Of further concern is whether these Vaccines may contain “adjuvants” – substances added to the Vaccines to reduce the amount of viral material used, or to force an immune system response. For an adjuvant to be used, the vaccine manufacturer must, among other things, prove/establish/show that the adjuvant meets the current good manufacturing practice (CGMP) minimum for adjuvants set forth in 21 CFR § 610.15(a) which, in part states:

“(a) Ingredients, preservatives, diluents, adjuvants. All ingredients used in a licensed product, and any diluent provided as an aid in the administration of the product, shall meet generally accepted standards of purity and quality. Any preservative used shall be sufficiently nontoxic so that the amount present in the recommended dose of the product will not be toxic to the recipient, and in the combination used it shall not denature the specific substances in the product to result in a decrease below the minimum acceptable potency within the dating period when stored at the recommended temperature. Products in multiple-dose containers shall contain a preservative, except that a preservative need not be added to Yellow Fever Vaccine; Poliovirus Vaccine Live Oral; viral vaccines labeled for use with the jet injector; dried vaccines when the accompanying diluent contains a preservative; or to an Allergenic Product in 50 percent or more volume in volume (v/v) glycerin. An adjuvant shall not be introduced into a product unless there is satisfactory evidence that it does not affect adversely the safety or potency of the product. …”. [Emphasis added.]

Thus, before an adjuvant can be legally added to a vaccine formulation, the adjuvant must be proven not to adversely affect the safety of the vaccine or the “potency” of the vaccine. Since no published studies have established that the proposed adjuvanted A/H1N1 vaccines have even the same safety as the unadjuvanted vaccines for all of the possible “mixed” vaccines and the historical record seems to indicate that oil-based adjuvants, like those being proposed, cause adverse reactions in some of those inoculated with vaccines containing them, this requirement would seem to preclude the government from permitting the “mixing” of an unapproved adjuvant with an existing approved vaccine formulation because doing so would render the approved product an adulterated drug.

Thus, the use of adjuvants would require separate approval as each is a different drug, and FDA has not followed its own process for approval, including determining that the vaccine manufacturers had proven: a) the oil-based adjuvants being proposed would produce adjuvant-added vaccines that no less safe than the no-adjuvant basis vaccine, and b) the oil-based adjuvants do not adversely affect the “potency” of the vaccine. Then, based on the proofs submitted by the manufacturer of each proposed adjuvant-added vaccine, the Agency can then determine that these adjuvant-added vaccines are “safe and effective” and that the benefits of their use outweigh the risks. As shown in the Certification of Ralph Fucetola JD, the Plaintiffs efforts to determine what adjuvants are being used has been “stonewalled” by the Agency and by the major supplier of such drugs. The responsible Cabinet Officer overseeing the Agency, Secretary of Health and Human Services, Kathleen Sebelius’ testimony to Congress on the licensing of the Vaccines is ambiguous as to whether the Vaccines made available to the public will have adjuvants.8 This Defendant admitted that the Agency’s scientists “don’t want us to go down that road.” Nonetheless the Defendant continue to keep this option available because they know the government does not own enough vaccine to provide same to the entire population (its stated goal) without the use of dangerous adjuvants.

Plaintiffs ask the Court to take judicial notice that this is a matter of significant public health interest, based on (a) the 1976 “Swine Flu” vaccine disaster, (b) the adulteration, earlier this year, of certain annual flu vaccines with live pandemic viruses (the Baxter vaccine incident referenced in some of the Certifications) and (c) the existence of the National Vaccine Injury Compensation Program (NVICP), which replaced vaccine injured persons’ right to sue for damages, in limited cases, with compensation paid for by a special tax, not on the vaccine producers, but on those who voluntarily or otherwise buy vaccines; that program has paid out about two billion dollars since its inception a decade after the 1976 “Swine Flu” vaccine incident.9 These events show that the attempt by the Agency to short-cut the vaccine approval process is a real threat to public health and safety and an imminent threat to the individual Plaintiffs herein.

Further, the lack of transparency regarding the contents of the various Vaccines licensed and the questionable nature of approval process can be considered an effort to avoid judicial review. The lack of transparency about the contents and testing of the drug violates FDA’s obligations to the public and calls out for judicial review.

2. The FDA’s tacit approval of squalene violates Hon. E. J. Sullivan’s unappealed 2005 Order, as to the findings which underlie the Order.

In 2003 an anonymous active duty member of the United States armed forces filed a complaint in the District of Columbia District Court. The matter is entitled Doe v Rumsfeld, District Court for the District of Columbia, Civil Action No. 03-707 (EGS). After a full preliminary injunction hearing Judge Emmet G. Sullivan enjoined the use by the military of “Vaccine A” – the alleged anthrax vaccine, which had not been approved as a new drug and which contained an unapproved drug substance, squalene. The Court acted after the evidence showed the clear and present danger to the health and lives of the members of the armed forces. Some time after the Order was issued, Congress passed the Project Bioshield Act of 2005 and the government issued an “Emergency Use Authorization” (EUA) which resulted in the District Court modifying its Order with the fully informed consent of the parties, allowing the use of the vaccine under conditions of fully informed consent and voluntary agreement to be vaccinated. The Judge specifically indicated that his finding that squalene was not approved for human use in the United States was not disturbed, that he was not passing on the legality or the merits of the EUA and that any such vaccine use must be “voluntary” (the Judge underlined the word “voluntary” and stipulated that the Court was to receive regular monthly reports that the use was in fact voluntary. While the injunctive provisions of the Order may now be moot, the government never appealed those factual and legal determinations of the Court and are bound thereby.

The FDA’s tacit approval of the adjuvant squalene in some or all of the Vaccines subject to this Petition for Review violates the unappealed 2005 Order in several respects. In the first place, squalene remains an unapproved drug material. No EUA has been issued with regard to the Vaccines’ ingredients. The HHS Secretary’s testimony before Congress on September 15, 2009 indicates that the Agency is unsure if squalene will be included. This is very strange, since the licensing of a drug presupposes that the government will at least know what substances will be in the drug. The Court should take judicial notice of the nearly half billion dollars the government has spent this year to purchase an apparently squalene-based adjuvant, MF-59. The licensing of at least one Vaccine with “live viruses” of the declared pandemic 2009-H1N1-A poses a similar threat to the public as the squalene adulterated “Vaccine A” posed to the military in the Doe vs Rumsfeld case. Until the government is able to specify what drugs it has approved and how it can authorize the release of 2009-H1N1-A virus into the environment, to be used on the public in a “live virus” vaccine, no license should be permitted to be effective by this Court.

The Court is asked to start with the case often cited as the “lead case” in vaccination matters, Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905). While Plaintiffs believe this case is erroneously still cited as authority for mandatory vaccinations, the case is rather more nuanced and announces compelling authority for Federal Court intervention in vaccination matters. While giving due deference to the State authorities, the Supreme Court reserved for the Federal Courts the right to intervene in matters where health and life may be at stake.

Plaintiffs are not here arguing for or against mandatory vaccination, per se, Plaintiffs do raise an issue which could only be raised after the Jacobson decision. At the time of the Jacobson decision, there was no general Federal law requiring Agency approval of new drugs (including vaccines). Today there is such law, and the Agency, by determining to approve the Vaccines without adequate or definitive safety testing, is openly violating the law requiring all new drugs to be proven both “safe and effective” before they are approved for use by the public. Even if such approval were to be permitted under an Emergency Use Authorization (EUA), which has not yet been issued, any vaccination under such EUA usage must be strictly voluntary under the rationale of the case of Doe v Rumsfeld, United States District Court for the District of Columbia, Civil Action No. 03-707 (EGS).

It is simple logic that adequate safety testing is required to prove safety. Vaccines are clearly included in the larger class of “drugs” in the regulations and statutes which obtain here. The “risk – benefit” analysis required by Federal Law before the approval of a drug is impossible without both proof of safety and evidence of the risks. This is especially so as the Vaccines may contain known toxins, including squalene, which have never been approved for addition to any drug in the United States, and may also include nano particles also never approved for human use. The Agency has stated in various contexts that the safety testing for these novel Vaccines under consideration will be completed in July, 2010 although it also had stated on July 23, 2009 that all novel Vaccines under consideration would be approved in time for administration in the early fall of 2009, prior to the completion of any safety tests. Respondent Sebelius made that decision clear to the House of Representatives in her testimony. Thus the government predetermined to license the Vaccines, safety testing or none, and thereby exposes the arbitrary nature of the truncated approval process to which these Vaccines were subject.

It is settled law that the Agency may only approve drugs that are “safe and effective” — (21 USC §393(b)(2) — and for which the “benefits” outweigh the “risks.” All of this is admitted by the Agency in its public pronouncements and on its web site. Section 355 of Title 21 provides for the procedures required to approve a new drug. Dr. King discusses this procedure in detail in his Certification.

Nonetheless, the Agency capriciously and arbitrarily ignored these legal requirements in its head-long rush to approve the H1N1 Vaccines without adequate or any safety testing. The “dosage” testing now being conducted is with versions of the Vaccines that do not contain some or all of the dangerous adjuvants that very well may be present in some or all versions offered to the public. See the health care professionals’ Certifications submitted herewith.

While the ordinary legal requirements discussed are settled law, the provisions of recently enacted “emergency” laws have not been subject to significant judicial review. For example, Judge Sullivan stated in the Order in Doe v Rumsfeld that he was not deciding on the legality or the merits of the EUA in that matter. The challenge to the Agency brought by way of the instant action is a matter of first impression regarding the application of such “emergency” provisions to the alleged “pandemic emergency” which was declared in the United States on April 26, 2009, less than 2 weeks after the first alleged death, on April 14, 2009, from a viral infection officially defined as a “totally novel H1N1 virus” whose characteristics, lethality, transmissibility and impact could not therefore be known if the virus were, in fact, novel; see the Determination and Declarations Regarding Emergency Use published on August 4, 2009 in Volume 74 of the Federal Register at page 38628-38630.10

In the event the Agency ultimately asserts that it may approve the Vaccines herein for civilian use without adequate safety testing due to an Emergency Use Authorization (EUA), the Plaintiffs challenge both the lawfulness and the merits of such EUA for a mild form of the flu which, according to the Agency and its international cohorts in the World Health Organization, has little or no potential for serious harm to the vast majority of Americans despite dire warnings in the press and elsewhere. Estimates of seriousness and dispersion of the virus are being offered by the Agency and others in the absence of reliable typing and documented data to verify that alleged victims have the virus in their systems or that it has caused any serious issues. Such lack of clarity and certainty certainly does not justify vaccination with untested materials to the prudent man, or to the individual Plaintiffs herein.

The Certifications of the health care professionals submitted with this application show that the novel “Swine Flu” virus is not in a pandemic state nor is it particularly dangerous. A comparison of the under 600 deaths in the United States that may be attributed to this virus, compared to the annual 36,000 seasonal influenza-related deaths reported by the Agency in the United States, shows that no reasonable finder of fact could conclude that there is any “emergency” for which an EUA can be lawfully issued. This Court is not bound to accept unreasonable Agency determinations of the existence of an “emergency” under 21 U.S.C. § 360bbb-3 that are not based on science and are so devoid of rationality as to be suspect in their intentions. CDC and Agency pronouncements, along with those of the World Health Organization, in fact characterize the disease allegedly caused by the novel virus as minor, requiring no medical intervention and no more serious than the seasonal flu and very likely less serious than that disease. Thus there is no justification for any EUA or rush to approve without definitive safety testing.

3. The FDA’s tacit approval of adulterated vaccines violates the Secretary of HHS’s duty under 42 U.S.C 300aa-27(a)(2) to make vaccines safer by using all of Secretary’s authorities to reduce the risk of adverse effects of vaccines.

The licensed vaccines include, among other adulterants and contaminants under 21 U.S.C. 351 substances such as the allegedly dangerous live pandemic flu virus 2009-H1N1-A, Thimerosal (mercury), and the unapproved adjuvant, MF59 (which is believed to contain squalene). Paragraph (a) of Section 351 provides:

Sec. 351. Adulterated drugs and devices
A drug or device shall be deemed to be adulterated –
(a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture
(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or
(2) (A) if it has been prepared , packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or
(B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess; …” [Emphasis added.]

Thus, under Section 351(a)(2)(B), the manufacturer must “assure that such drug meets the requirements of this chapter [CHAPTER 9 – FEDERAL FOOD, DRUG, AND COSMETIC ACT] as to safety…” The provisions of 21 CFR 601.2(a)11 require the manufacturer to, among other requirements, “submit data derived from nonclinical laboratory and clinical studies which demonstrate [prove] that the manufactured product meets prescribed requirements of safety, purity, and potency”. Further 21 CFR § 601.2(a) also states:

“An application for a biologics license shall not be considered as filed until all pertinent information and data have been received by the Food and Drug Administration.”

Further, 21 CFR § 601.4(a) states, in part:

“(a) A biologics license shall be issued upon a determination by the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research that the establishment(s) and the product meet the applicable requirements established in this chapter.”

and, therefore, requires the Agency not to issue a “biologics license” and approve a vaccine or other biological product until all of the “the applicable requirements established in this chapter” are met.

In the case of Berkovitz v US, 486 US 531 (1988), the Supreme Court held the government liable for licensing a live-virus polio vaccine without first receiving the required safety data since the government had no discretion to issue a license under such circumstances, and doing so would violate a specific statutory and regulatory directives (pages 540 – 545). The same failure has occurred in the licensing of the Vaccines at consideration here.

Furthermore the Defendants have a clear, non-discretionary mandate under 42 U.S.C. §300aa-27(a)(2) to assure “safer” vaccines. The Section states in part:

Sec. 300aa-27. Mandate for safer childhood vaccines
(a) General Rule. …In the administration of this part and other pertinent laws under the jurisdiction of the Secretary, the Secretary shall – (1) promote the development of childhood vaccines that result in fewer and less serious adverse reactions than those vaccines on the market on December 22, 1987, and promote the refinement of such vaccines, and (2) make or assure improvements in, and otherwise use the authorities of the Secretary with respect to, the licensing, manufacturing, processing, testing, labeling, warning, use instructions, distribution, storage, administration, field surveillance, adverse reaction reporting, and recall of reactogenic lots or batches, of vaccines, and research on vaccines, in order to reduce the risks of adverse reactions to vaccines. [Emphasis added]

The Plaintiffs urge the Court to consider how the Vaccines licensed herein are made “safer” for children (or for anyone else, though it is children who will be among the first victims of these products) if they contain the putrefied or decomposed materials, including “live” 2009-H1N1-A viruses that have been declared to be novel and pandemic, and laced with contaminants of the various sorts that the expert Certifications attached hereto reveal.

4. The FDA’s action is a violation of rights protected under the 14th Amendment to the United States Constitution and substantive due process.

The facts alleged by the Plaintiffs in the Complaint and in the Certifications of the various individual Plaintiffs which are made a part of the Complaint by reference, show that the United States citizens who are Plaintiffs herein are being subjected to numerous violations of their rights and interests protected by the United States Constitution. These rights include the rights to liberty and property protected by the 14th Amendment, which under the New York regulation is taken without due process, their 4th and 5th Amendment rights to privacy and the control of their own health care choices, their 7th Amendment right to a jury trial in the event they suffer damages as a result of the approved, licensed, recommended and mandated Vaccinations owned by the Defendant Department or as may be further mandated under the Project Bioshield Act or other Federal emergency enactment or EUA.

Americans as United States citizens have a substantive due process right in health, safety and employment (and access to schooling to prepare for employment and to obtain and maintain the licensing or other credentials needed for those purposes). The violation of the proper approval and licensing process, and the evident lack of transparency, rises to level of substantive due process violation. This Court is empowered to engage in an analysis of such violations and consider them in decreeing a proper remedy.
United States v. Carolene Products C., 304 U.S. 144 (1938) gave deference to presumptively constitutional enactments of Congress and subjected governmental actions in the economic realm to a less strict “rational basis” analysis such that, when such action is supported by substantial public-health evidence, it would be held to be not arbitrary or irrational. When it is not supported by such substantial evidence, as in this case, where there is no definitive safety evidence and the Defendants have failed to specify the ingredients or take into account the significant scientific agreement as to the novel nature of the virus, the government action cannot pass the “rational basis” test and thus violates substantive due process.

IX. Standards for Issuance of Restraints

In cases where there is imminent, foreseeable, immediate and irreparable harm, the Federal Rules of Civil Procedure provide for the authority of the Court to issue Temporary Restraints, Preliminary and Permanent Injunctions. This is covered under Rule 65, Injunctions and Restraining Order.
The Rule provides in part:

“Temporary Restraining Order.

(1) Issuing Without Notice.

The court may issue a temporary restraining order without written or oral notice to the adverse party or its attorney only if:

(A) specific facts in an affidavit or a verified complaint clearly show that immediate and irreparable injury, loss, or damage will result to the movant before the adverse party can be heard in opposition; and
(B) the movant’s attorney certifies in writing any efforts made to give notice and the reasons why it should not be required.

(2) Contents; Expiration.

Every temporary restraining order issued without notice must state the date and hour it was issued; describe the injury and state why it is irreparable; state why the order was issued without notice; and be promptly filed in the clerk’s office and entered in the record. The order expires at the time after entry — not to exceed 10 days — that the court sets, unless before that time the court, for good cause, extends it for a like period or the adverse party consents to a longer extension. The reasons for an extension must be entered in the record.”

The Plaintiffs herein urge the Court to consider that the imminent imposition of the mandatory or voluntary use of the Vaccines without adequate or any safety testing will place the Plaintiffs in foreseeable, immediate and irreparable risk of harm that cannot be prevented other than by injunctive relief by this Court. See Plaintiff Certifications. Various Plaintiffs are subject to mandatory vaccination with the Vaccines objected to herein under the amendment to Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York, Part 66, as Subpart 66-3 Health Care Facility Personnel – Influenza Vaccination Requirements which became effective August 13, 2009. As set forth in the Complaint, the state mandate in this Regulation, (“Such influenza vaccination(s) must be in accordance with the national recommendations in effect at the time of the vaccination(s)…”) is subject to the Defendants’ approval and recommendation of specific Vaccines. Therefore, the licensing of these Vaccines is the mandating of their use, at least by the covered healthcare workers, but not by all persons who come into contact with patients. This effect is invidiously capricious and arbitrary and is a direct result of the approval of the licenses complained of herein.

X. Request for Relief

The Plaintiffs seek (1) the reversal of the licenses granted and (2) immediate injunctive relief covering the following areas:

a. An order that the Agency reveal the full and complete contents of the Vaccines; the role presence and dosage/concentration of any adjuvants, including, but not limited to such as squalene, MF59, GP120, and aluminum; the role, dosage/concentration of any alleged “preservatives,” such as mercury; all minor, adventitious, residue, preparation remnants, accidental and minor components; and the full and complete details of any clinical trials, whether for dosage, immunogenicity, clinical response or any other purpose; and

b. An injunction staying the licenses until all safety testing requirements for new drugs are satisfactorily completed and a clear determination can be made that the Vaccines are safe and effective in a manner that complies with all applicable established legal standards for safety and effectiveness; all significant risks to those vaccinated that may occur with a frequency of 1 in a million or greater have been identified; these significant risks do not outweigh the putative benefits of the vaccines to those who are vaccinated and subsequently exposed to an influenza strain covered by the vaccines; and the “Swine Flu” influenza vaccination program is at least societally cost effective when all of the costs of the vaccination program, including the costs of all the identified adverse reactions at the rates identified, the percentage of influenza cases that are actually 2009-H1N1-A, and the most probable number of cases of influenza for the 2009 – 2010 flu season are appropriately included in the cost-effectiveness estimates; and

c. An order that the approval of the licenses for the A/H1N1 vaccines are contingent upon clear restrictions mandating complete disclosure of the risks and their severity and most probable rates, the obtaining of written informed consent and that these A/H1N1 vaccines may only be given to those giving voluntary, informed consent for themselves or, in the case of minors, their children or wards without coercion or risk of loss of schooling, livelihood, licensure or other public good.

Plaintiffs return to the findings of the Supreme Court of the United States in the early case of Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905), in which the Court (prior to the enactment of the Food, Drugs and Cosmetics Act revisions that established a degree of Federal preemption of drug approvals) gave deference to the Supreme Court of Massachusetts in an involuntary vaccination matter. This case contains clear language authorizing Federal Court intervention in circumstances that are clearly present with regard to the Vaccines involved in this application for preliminary relief:

“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.”

In the matter before this Court today, that is precisely the case: the Agency has licensed Vaccines without adequate or definitive safety testing which could thereby “…seriously impair … health or probably cause … death.”

Since the Agency has determined, contrary to significant scientific agreement and the provisions of Law, including 21 U.S.C. 355, to falsely treat the novel 2009-H1N1-A virus and the Vaccines alleged to confer immunity against it as a mere “change of strain” for which the Agency asserts no definitive safety testing is required, this Court should consider any use of the Vaccines challenged herein as experimental.

There is clear Law in the United States regarding experimental medicine, which is codified in 44 C.F.R. 46.101 et seq. and which requires very strict protections of the subjects of such experiments. Essentially, such unapproved, experimental drugs may only be used with fully informed, voluntary consent. In the matter before this court, no such fully informed, voluntary consent is currently possible since the risks are unknown.

Wherefore the Plaintiffs herein petition this Honorable Court for the issuance of an Order to Show Cause with a Temporary Restraining Order and an immediate opportunity to be heard on an application for a Preliminary Injunction, binding upon the Secretary of Health and Human Services and the Commissioner of the Food and Drug Administration, and all subordinate agents and agencies thereof, temporarily restraining the Secretary, the Commissioner et al., until further Order of the Court, staying the licenses issued under 21 U.S.C. 321, under 21 U.S.C. § 360bbb-3 (Emergency Use Authorization) or otherwise issued for any “Swine Flu” 2009-H1N1-A Vaccine, as more fully set forth in the form of an Order to Show Cause with Restraints attached hereto.

Leslie Fourton JD, Esq.
c/o Swankin and Turner
Attorneys for Plaintiffs
1400 16th Street, NW, Suite 101
Washington, DC 20036
(202) 462-8800 Fax: (202) 265-6564
Assisting On the Brief:

James Turner JD
Larry Becraft JD
Alan G. Phillips JD
Ralph Fucetola JD

Media Release: http://drrimatruthreports.com/?p=3617

“Stop the Shot” Federal Case – Brief in Support of Injunction

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