United States District Court for the
District of Columbia
Civil Action No. 1:09-cv-01924 (RBW)
Gary Null, Rima Laibow et al.,
U.S. Food and Drug Administration, et al.,
PLAINTIFFS’ MOTION FOR INJUNCTIVE RELIEF
Pursuant to Rule 65 of the Federal Rules of Civil Procedure, the Plaintiffs, through undersigned counsel, hereby move this United States District Court for the District of Columbia to issue a preliminary injunction, or, if no preliminary injunction hearing can be held on or before the 21st day of October 2009, a temporary restraining order pending such hearing requiring the Defendants in their official capacities or as agents of the United States to withdraw or suspend the four 2009-H1N1-A Influenza Vaccine license modification approvals of September 15, 2009, whereby the Defendants approved certain vaccines which have been or will be purchased by Federal government agencies for distribution to the public, including the individual Plaintiffs herein, who stand in imminent peril of irreparable harm, having been mandated by regulation to receive the vaccines upon Defendants’ approval, or suffer penalties imposed by regulation, upon the facts set forth in the Complaint and supporting Certifications herein and for the reasons set forth in the Brief in Support of the Motion for Preliminary Injunction. See Exhibit “A” attached to this motion and incorporated herein by this reference.
Plaintiffs further request, pursuant to Local Rule 65.1(d) a preliminary injunction hearing within twenty days of the filing of this motion because of the emergent nature of the probable harm. As more fully set forth in the moving papers, based on the best information currently available to Plaintiffs, Plaintiffs believe that a hearing will be required on or before October 21, 2009 in order to avoid imminent irreparable injury to Plaintiffs threatened by the Defendants actions complained of in this action.
The reasons supporting this motion, and the facts that particularly justify immediate judicial action to preserve valuable rights, as set forth below, are more fully developed in the accompanying Plaintiffs’ Brief in Support of Motion for Preliminary Injunction, Complaint and Certifications in support thereof.
1. The Defendants’ decision to issue the aforesaid licenses, modified licenses or approvals is arbitrary, capricious and contrary to law, and there is a substantial likelihood that Plaintiffs will succeed on the merits of this action. Specifically, the approvals violate the Food, Drug and Cosmetics Act (FDCA) and other statutes cited in Plaintiffs’ Brief, the Defendant Agencies’ implementing regulations and the Administrative Procedures Act show the following.
2. There is significant scientific agreement among independent scientists that the foreseeable risk of a vaccine’s potential to cause harm cannot be determined without adequate testing and that this is especially true regarding the 2009-H1N1-A Virus which has been arbitrarily and capriciously declared to be in a state of pandemic emergency. Further, Defendants have published a plan on their web sites to adulterate the approved vaccines with an unapproved “oil in water” adjuvant (squalene, a squalene derivative, and/or a squalene/GP120 mixture along with other as yet undisclosed and unlabeled components).
3. The U.S. Food and Drug Administration (FDA) has never heretofore approved these “oil in water” adjuvant components for inclusion in vaccines licensed for general human use in the United States and, indeed, Defendant Sebelius testified before a Congressional committee on September 15, 2009 that the Defendant Agency’s own scientists do not want “to go down that road.” Nonetheless, the Defendants have purchased over $484 million dollars worth of squalene and adjuvant and have a published plan to adulterate the approved vaccines with it. Moreover, the majority of the doses of these novel “Swine Flu” A/HINl influenza vaccines contain other toxins such as mercury (in the form of Thimerosal) and may also, based on some news releases, include nanoparticles also never approved for human use.
4. There is significant scientific agreement that there has been either inadequate or no definitive safety testing of the vaccines and those components of the vaccines that are highly toxic and require specific toxicity testing to prove their safety for use in a vaccine, such as Thimerosal when used as a preservative, and the “oil in water” adjuvants for which independent toxicological safety testing to established standards is required by law – (21 CFR § 6l0.15(a).
5. Based on the low level of danger of the novel 2009-H1N1-A “Swine Flu” virus that has been observed so far and the probable high level of risk from the unapproved adjuvant squalene and the certainty of the presence of another highly toxic ingredient, Thimerosal, it is likely that the purported benefits cannot outweigh the foreseeable risks.
6. At least one of the approved vaccines is a “cold adapted” (genetically modified), live A/H1N1 virus, flu vaccine. This category of vaccine is more dangerous than other kinds. This is the first of the four vaccines the government is providing to the public.
7. Inoculation with any live-virus vaccine is, in and of itself, clearly associated with higher levels of mortality and morbidity (as well as with risks for secondary transmission and disease spread) than injections of the other types of vaccines (e.g., inactivated-virus, bacterial component, and viral component), even absent. squalene and other toxic adjuvants and preservatives.
8. In addition, there is concern that no large-scale review of post-vaccination effectiveness has, to date, demonstrated that any influenza vaccines are effective in preventing those inoculated with them from contracting influenza. One of these large-scale review studies was co-authored by Plaintiffs’ expert, Dr. Paul G. King, PhD, analytical chemist and is the only 20-plus-year study (1979 -2001) of in-use effectiveness of influenza vaccination in the U.S. The record shows that strain mismatch, strain mutation, the large number of influenza strains circulating at low levels, other circulating viral disease organisms (e.g., cold viruses), the complex factors affecting transmission and infection, and the, at best, incomplete immunity conferred all contribute to the reality that influenza vaccines have not been found to be in-use effective in preventing influenza-related infection in either the inoculated population or the non-inoculated population.
9. A comparison of the under 600 deaths in the United States that have been attributed to A/H1N1, compared to the CDC’s estimate of an annual 36,000 seasonal influenza-related deaths in the United States and the lack of any reported significant increase in influenza.
10. At least two of the approved vaccines in question may include added “oil in water” adjuvants including squalene, which has never been approved for drug use in humans in the United States. Historically, squalene is used in laboratories as “Freund’s Adjuvant” to cause massive autoimmune disease, and/or paralyze and kill animals. Based on squalene’s proven ability to induce autoimmune disease in all animals exposed to it at low levels by injection and squalene having been implicated as a factor in the harm caused to U.S. anthrax-vaccinated soldiers where squalene was present in some formulations that were not FDA-approved, there is no ethical medical reason to permit the use of squalene-containing vaccine injections with any human subject.
11. The FDA knows full well that the “Pandemic Influenza” Vaccines, containing mercury and/or other problematic components (to which the autoimmune toxin squalene may be added), do not work and are less than safe. In fact, the government has acknowledged that the vaccines, before the addition of squalene and other adjuvants, may well maim and kill 30,000 or more Americans, mainly, according to their statements, children and pregnant women!
12. The Defendants say that these vaccines will be accepted if they create some level of antibodies (which “may be associated with” protection, but which may not be so associated) in 4 out of 10 recipients with at least 70 percent of those 4 (4 x 0.7 = 2.8 people per 10!) achieving an antibody level that is believed (but there is no certainty in this belief) to provide a protection to those who are subsequently exposed to the novel influenza virus.
13. Even accepting the unproven hypothesis of “herd immunity” or, more accurately, “herd protection”, an immune response in 28% of the “herd” does not quality for herd protection by a factor of 3 since herd protection is general1y considered to have been achieved if at least 85% of the herd is assured of being protected, not the absurd 28% acceptable to the FDA in this instance. This means that an acceptable vaccine candidate would provide possible “protection” for 28% of vaccine recipients or less than 3 out of 10 recipients; moreover the FDA’s acceptance “standard” drops to 18% efficacy for those over 65 years of age (60% of 30%).
14. Now add to that the fact that public records show that the “Pandemic Influenza” vaccine formulations that include added squalene may contain a million times more of the damaging lipid squalene than the source of Gulf War Syndrome, Vaccine A, and you have a nightmare scenario which simply must not be allowed to take place.
15. Finally, inoculation with the live viruses in the “nasal mist vaccine”, which is to be the first one released for use, will convert all those inoculated into shedders of a live novel A/H1N1 virus that may infect others.
16. Absent a preliminary injunction or temporary restraining order, the public health will suffer as untold numbers of the patients and/or health care clients of the Plaintiffs will be exposed to dangerous vaccine toxins and similar trespasses leading to a significant risk of medication errors and patient harm. There is no valid pandemic emergency, declared or otherwise, that would justify the Defendants decision or that would justify judicial inaction in the face of what the Supreme Court in Jacobson v Massachusetts, 197 U.S. 11 (1905) that the judiciary is “competent to interfere and protect the health and life of the individual concerned. ” The harm which Plaintiffs will suffer is further irreparable since money damages may not be had against the Defendants (having protected themselves from any liability through a claimed “Pandemic Emergency Declaration” of April 25, 2009).
17. The issuance of an injunction will not substantially injure Defendants, since, among other considerations, Defendant Agencies have the statutory duty to protect the public from drugs which have not been properly safety tested, as more fully set forth in Dr. Paul King’s Certification.
18. Lastly, it is in the public interest to issue an injunction because the Defendants’ decision places the public health at risk and places these Plaintiffs personally at risk of adverse consequences as a direct result of that decision. The courts must be especially vigilant to prevent the Defendants from repeating the same mistake their predecessors made with the 1976 Swine Flu Vaccination, which cost hundreds of lives and left thousands maimed for life.
19. As attested in the accompanying Certificate of Counsel pursuant to Local Rule 65.1(a), Counsel for Plaintiffs has informed the Department of Justice of the United States of America, 950 Pennsylvania Avenue, NW – Washington, DC 20530-0001 of Plaintiffs’ intention to seek a temporary restraining order in the alternative in this matter and the time of the making of this application and has provided said counsel with copies of Plaintiffs’ Complaint for Declaratory, Injunctive or other relief, this motion and all supporting Certification and papers, including the accompanying proposed order.
20. The facts in this case make an expedited preliminary injunction hearing essential due to the imminent spread of the 2009-H1N1-A “pandemic influenza” virus by the licensed vaccinations, and specifically the “live virus” nasal mist vaccine, the first of the four approved vaccines being distributed under the control of the government to the public, as more fully explained in the moving papers. Accordingly, Plaintiffs seek a hearing on Plaintiffs motion on or before October 21, 2009, concerning a preliminary injunction requiring Defendants to withdraw or suspend its approval of the four vaccines approved on September 15, 2009.
21. If the motion for preliminary injunction cannot be heard and adjudicated on or before October 30, 2009, Plaintiffs respectfully request a temporary restraining order not to exceed the period allowed by Federal Rule of Civil Procedure 65(b)(2), requiring Defendants to withdraw or suspend its decision approving the vaccines, or, requiring that all such vaccines be given only to persons who have been fully and truthfully informed of all the risks associated with these vaccines and who, after having been fully and truthfully informed of aforesaid risks, have given their fully informed voluntary written consent for the administration of these vaccines to themselves or their children or others for whom they are responsible.
Dated: October 14, 2009
Media Release and Health Freedom Action Item: