Natural Solutions Foundation

United States District Court for the District of Columbia
Civil Action No. 1:09-cv-01924 (RBW)

Gary Null, Rima E. Laibow, et al.,
Plaintiffs,

v.

U.S. Food and Drug Administration, et al.,
Defendants.

PLAINTIFFS’ MEMORANDUM
In Support of Standing to Bring Action
ON COMPLAINT FOR INJUNCTIVE RELIEF

Introduction

The Plaintiffs submit this Brief in Support of Standing, in response to the Court’s Order to Show Cause of October 27, 2009. Plaintiffs also submit a further Declaration of Rima E. Laibow, MD, a Plaintiff in this action, providing further factual data and professional opinion in support thereof.

In this Brief, we also address the significant issue of what Remedies would be appropriate if the Plaintiffs prevail in this matter. This Court is not being asked to merely interpose itself between the Plaintiffs and Federal authority, but to fashion Remedies that will advance influenza health care in the United States and reduce adverse events, including neurological damage and death from current influenza care under the direct control of the Defendants. One of Plaintiffs’ goals, as expressed in the Complaint and other papers submitted, is to obtain a Permanent Injunction protecting important interests of the Plaintiffs and all Americans. That injunction should permit the Defendants to continue their mass vaccination program only upon definitive safety testing and full disclosure of all risks.

Plaintiffs also seek, in part, interim and permanent Remedies fashioned under the logic of Thompson v. Western States Medical Center (535 U.S. 357, 2002). This First Amendment case concerns a clause in the Food, Drug and Cosmetics Act that allows pharmacists to “compound” medications for specific prescriptions without safety testing, but forbids pharmacists from advertising the specific compounds they make. The Supreme Court held that the restriction on Commercial Speech was unconstitutional, stating, “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.” Thus, one of the Remedies Plaintiffs seek is that proper warnings be given with regard to the H1N1 Vaccines that they had not been specifically safety tested. Further Remedies include proper warnings concerning other influenza vaccines stating that the drugs have not been shown to be effective in preventing influenza and that they carry significant risks.

Plaintiffs further seek a Mandate from this Court that the Defendants shall cease to recommend that any particular group or person receive the Vaccines, or state, imply or suggest that the Vaccines are either safe, or effective or “safe and effective”. As Dr. Laibow’s Declaration shows, there is no significant scientific agreement that any influenza vaccine prevents or reduces the likelihood of influenza incidence in individuals, epidemics or pandemics. Indeed, the use of live virus mist vaccines may very well have already increased the incidence of the disease and, according to the manufacturer, is actually expected to induce it. The use of killed virus vaccines has not been shown to reduce the incidence of the disease and may enhance its development while presenting risk to the individual of serious adverse events following its use.

As the CBS news study referenced in the Declaration shows, nearly 90% of alleged “Swine Flu” cases cannot be demonstrated to be caused by, or associated with, the A1N1 Swine Flu virus and are, in fact, something else. The NIH media release of October 21, 2009, also referenced therein, shows that influenza vaccines have a range of what appear to be immune system responses in up to 36% of the test subjects; it is noted that placebo effects are often in that range. In the absence of formaldehyde, Thimerosal, aluminum, Gentamicin, Polysorbate 80, Squalene, foreign proteins, adventitious viruses, malignancy-causing and otherwise, and other vaccine ingredients and contaminants, this immune system response is not known to be associated with any protective benefit since the immune response that occurs following vaccination is substantively different from that which occurs when a virus is encountered by the immune system from natural contact.

The Defendants are bound by the Data Quality Act1 to produce and disseminate only truthful information to the people of the United States. They have woefully failed in that duty and are thereby harming these Plaintiffs. The Court should therefore act with judicious restraint to fashion a temporary and, we trust, ultimately a permanent injunction that requires only truthful and not misleading public health care advice and information from these Defendants. Given that the recommendations of the Centers for Disease Control’s Advisory Committer on Immunization Practices is viewed as scientifically valid enough to become State and other mandates, this is of grave significance in the public health policy and impact of recommendations based on possibly flawed information and interpretation.

Point One: As a Consequence of the Actions of Defendants, the State of New York Continues to Put the Plaintiffs in Imminent Peril of Mandated Vaccinations

While the media reports that the New York emergency flu vaccine mandate, which includes the H1N1 vaccines as a consequence of their approval by the Defendants herein, is being suspended due to lack of enough vaccines at this moment to cover all half million New York health care workers, the actual position of the State is that it reserves the right to re-impose the mandate at any moment.
As Richard F. Daines, M.D., Commissioner of Health of New York stated:

“The current emergency regulation mandating influenza vaccinations for health care workers will expire on November 11, 2009, and a second emergency regulation would not have the desired effect during the current H1N1 influenza season or the expected seasonal outbreaks expected later this year and in early 2010. Therefore, no new emergency regulations will be promulgated. Instead, the DOH is advancing a permanent regulation requiring health care personnel in these settings to be vaccinated.”

Regarding the underlying fact pattern in this matter, the State is going to be advancing a permanent regulation requiring health care personnel in these settings to be vaccinated in the State of New York with all vaccines approved and recommended by the Defendants; therefore, it is not, as the Court suggests, “unclear at this juncture” that the Plaintiffs may be subjected to potential harm. Rather, a supposed emergency measure is about to be implemented on a standing basis which provides for ongoing harm.
Rather, the Plaintiffs would suffer harm if either vaccinated against their will or if forced to refuse to submit to a mandatory vaccination policy upon which their employment hinges in order to exercise their personal and private judgment based on religion, health or conscience. 

After all, the New York DOH is advancing a permanent regulation requiring health care personnel in these settings to be vaccinated.  Here, with the Court acknowledging that a question still remains as to whether the Plaintiffs’ employers, regardless of the outcome of that hearing, might impose mandatory vaccination upon their employees — the issue is not that employers might impose — the issue is WHEN will they impose such mandatory vaccination with the DOH waiting in the wings to simply enforce the “National Recommendations” of the Defendants.

The veil between Federal power and State action is very thin, if existent at all, in such circumstances. In any event, these Defendants, having proclaimed a Pandemic and a National Emergency, should not be permitted by the Court to hide behind local and state action when it is the independent determinations of these Defendants that, for all practical matters, settles what un-insurable influenza vaccines will be both mandatory or released into public commerce.

Point Two: Knowing Violation of Approval Statutes by Permitting Live-Virus or Otherwise Ineffective Vaccines Lead to Harm to the Plaintiffs, Whether the Vaccines are Mandated or Voluntary, or Taken by Third Parties, thereby Infecting Plaintiffs

Approving the amendments to the licenses for the four Vaccines and now adding a 5th untested, Squalene-adjuvanted vaccine (the second Squalene-adjuvanted vaccine approved in this instance, Novartis’ vaccine being the first since it was included in the group of 4 vaccines approved on September 15, 2009), without the Defendants having first obtained from the purported licensees all of the applicable proofs of safety and efficacy in the manufacturer’s Biologic License Application (BLA) (21 CFR § 601.2(a)), before the Agency could have legally approved a vaccine (21 CFR § 601.4(a)) was a knowing violation of the statute.

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 arise 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 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, and being in imminent peril of irreparable harm, whether mandated to take the vaccines or not, have standing to seek the same from this honorable court. Nasal mist vaccines provide a continuing contagion for those who have not been exposed to the vaccine, which places unvaccinated persons at potential serious risk. Since the nasal mist vaccines cause both shedding of infectious viruses in the absence of disease in the vaccinated person and shedding in the presence of the disease which the nasal is, according to its manufacturer, designed to produce, whether people volunteer for the nasal mist vaccine, or are given the vaccine on a mandated basis or refuse the vaccine, they will be exposed to a novel virus that the WHO, FDA and the President of these United States have declared to be of nearly inestimable harm to humans. Further, those who do not take the vaccine are being exposed against their will by their own government to a virus, which that government believes could kill them.

In Berkovitz v US, 486 US 531 (1988), the Supreme Court held the government liable for approving the distribution of a live-virus polio vaccine lot 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, giving rise to an action challenging the approvals; in such an action, any person who might be harmed by the release of the drug into interstate commerce has standing to complain to the federal courts. Anyone, including each Plaintiff herein, who stands in imminent peril of harm from such live-virus vaccines has standing to complain to this court about the harm that may be unleashed against them as a result of the approval of the vaccines herein. Vaccines that do not contain the live, bioengineered, cold-adapted virus are still fully capable of causing serious neurological and other side effects, which qualify as adverse events according to the Defendant’s own published definitions of such adverse events.

In this case, at least one of the approved vaccines contains live viruses, and by the admission of the applicant on its own web site provides alleged immunity by giving the recipient a case of the flu. According to Plaintiffs’ experts, as alleged in the Complaint, persons receiving the live-virus nasal-mist vaccine will be infectious for some period of time and may, during that time, infect anyone of the Plaintiffs, unknowingly. The other three vaccines, perhaps to a lesser extent, can also indirectly create recipients who can spread the disease. Even if there is no mandate requiring any of the Plaintiffs to receive any of the approved vaccines, nonetheless, they may be harmed by the government-owned, approved vaccines being released into commerce and the environment and thus infecting them. The list of persons who should not be vaccinated with the live-virus nasal mist and who should not come in contact with people who have been vaccinated with it is extensive and runs to up to 1/3 of the population. Yet avoidance of those who are shedding the virus, and thus avoidance of the virus is, for all practical purposes, impossible, no matter how significant the health risks may be to the exposed non-vaccinated person.

Point Three: Federal Government Ownership of the Vaccines, Control of Release, Distribution and Rules of Use Gives Rise to the Imminent Peril of Harm Faced by Plaintiffs, Without Regard to Mandates

The United States, through its Defendant agencies, owns all of the “Swine Flu” Vaccines challenged in this matter. This ownership is no simple matter to be dismissed as inconsequential. The Defendants, or some of them, spent at least $6.4 billion of taxpayers funds to purchase all of the A/H1N1 Vaccine supplies of five applicants (although the Defendants’ only initially approved four of the Vaccines, because, Defendant Sebelius testified before a Congressional committee on September 15, 2009, the Defendant FDA’s own scientists, in effect, objected to the adjuvanted versions of the vaccines. The fifth vaccine was approved 6 weeks later.) According to a July 13, 2009 media release from Defendant Sebelius’ Department, the government also purchased $484 million of Squalene from two of the applicant companies.

Even the Defendant Secretary’s September 15, 2009 testimony appears inaccurate. Though Secretary Sebelius claimed that no adjuvanted vaccine had been approved, at least two of the approved vaccines contain aluminum, which is an adjuvant, and clearly highly neurotoxic. The purpose of the aluminum, as alleged in the Complaint, is to act as an adjuvant, affecting the immune system response.

Thus, the government first purchased the vaccines and adjuvants and then approved all of them either on September 15, 2009 or subsequently. The President’s October 23, 2009 National Emergency Declaration paved the way for the fifth, adjuvanted vaccine, to have been authorized under an Emergency Use Authorization without approval under the law. Despite the claim that the 2009-H1N1-A Swine Flu virus is novel, and despite the fact that several of the approved vaccines used novel methods and possibly cell-culture techniques in their manufacture, these very same vaccines were not safety-tested under a potentially dangerous theory that vaccines to a novel 2009-H1N1-A virus were merely “change of strain” vaccines. How can the Defendants know that a novel virus in “the same old vaccines” made in novel ways will react the same way? Where is the Precautionary Principle that is supposed to underlie Public Health decisions?

Therefore, the government, which owns the vaccines, is seeking to ignore or suspend its own safety rules for the distribution and administration of the vaccines it owns and approves. It cannot exculpate itself from responsibility for its potentially dangerous property that the Defendants choose to release into commerce, as the sole source of supply. A product which can be released into commerce only if lawfully licensed is a product that anyone who may be harmed by it, in commerce, such as these Plaintiffs have alleged in their Complaint that they will be harmed by the live-virus vaccines, has standing to challenge.
According to the GAO Report of October 26, 2009:

“With respect to the 2009 influenza pandemic, and pursuant to the [April 25, 2009] public health emergency, the Public Health Emergency Fund is available (but currently unfunded…) and certain Emergency Use Authorizations [EUAs] have been granted by FDA… However, the Secretary’s waiver and modification authority has not been activated because there is no concurrent presidential declaration under either the Stafford Act or the National Emergencies Act.”

In the event of such declaration (as has occurred since the writing of the report), the GAO continues:

“A presidential declaration under the Stafford Act triggers federal emergency authorities that are independent of the Secretary’s public health emergency authorities… A …declaration… authorizes… federal agencies to support state and local emergency assistance activities; coordinate… relief provided by federal and non-federal organizations; provide technical… [and] emergency assistance… assist… in the distribution of medicine…”2

Point Four: Where Harm is Alleged from Defendants’ Actions in Approving and Recommending Vaccines, Whether Mandated or Voluntary, the Courts Must Acknowledge Standing

Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905) – though erroneously sometimes still cited as authority for mandatory vaccinations, Plaintiffs understand this U.S. Supreme Court decision is rather more nuanced and announces a clear role for Federal Courts 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:

“…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.”

While Jacobson did not prevail in the Supreme Court, it is to be noted that he never alleged harm or peril of harm; he only alleged that the mandating of the vaccination was ultra vires the state’s authority and the $5.00 fine imposed was unconstitutional. Jacobson never was actually forced to be vaccinated and history shows us that the $5.00 fine was vacated.

Furthermore, the case was decided before the comprehensive pre-emption of drug approval that is now embodied in the statutory material discussed above with regard to the Defendants’ failure to abide by existing legal requirements. The argument for Federal court action in the face of a potential for the vaccines to “seriously impair” health — even for those who never receive or who are mandated to receive the vaccines, is far stronger now that it might have been a hundred years ago, before the meta-studies and other experience that shows the potential harm that wide-spread vaccination must cause. Congress adopted the National Vaccine Injury Compensation Program (42 U.S.C. § 300aa-10 et seq.) precisely because vaccines do cause harm and are uninsurable. The legal maxim, “No harm without a remedy” applies here and the Supreme Court in Jacobson instructs this honorable court that it is not to be understood to be holding “that the judiciary would not be competent to interfere and protect the health and life of the individual concerned.”

Approval of any drug (including a vaccine) by Federal Authority is now a necessary prerequisite for that drug to be lawfully available to the public in commerce. Such approval is a necessary prerequisite for any state mandate for the forced use of any such drug. Without the Defendant FDA’s approval, the mandate is meaningless. Without the Defendant HHS Secretary’s “recommendation” (through the Advisory Committee on Immunization Practices and other communication systems by the Centers for Disease Control within HHS) the specific mandates in both New Jersey [still in effect] and New York [perhaps only temporarily suspended] would not cover any of the Influenza Vaccines since both mandates abrogate to Federal authority the choice of what vaccines will be mandated.

Conclusion

As a result of the actions of the Defendants, five approved vaccines (two with the adjuvant aluminum and one with the adjuvant Squalene) and, through the imminent issuing of an EUA, the fifth Squalene-adjuvanted vaccine, all property of the Defendants, are being or are about to be shipped in interstate commerce, where they can be admixed with the purchased, heretofore unapproved injectable Squalene, to inconsistent and potentially very high levels (in 90,000 non-pharmaceutical facilities), and thus very high levels of dangerous molecules such as Squalene can be delivered across state lines by the Defendants’ contract supplier to recipients, including potentially these Plaintiffs, who will assume that the vaccines are safe and well tested because that is what is required by United States statutes and regulations.

Therefore the Defendants actions (failing to approve the vaccines lawfully, owning the vaccines, and recommending them) are necessary prerequisites to the exposure of the Plaintiffs to imminent peril of irreparable harm whether the vaccines are mandated for Plaintiffs consequent to the approving or recommending actions of Defendants, or merely therefore available in commerce where they may infect the Plaintiffs due to the intentional introduction of live viruses into the Plaintiffs’ environment. In either event, the Plaintiffs face harm and this honorable Court is empowered to hear their petition for redress.

Plaintiffs ask this honorable Court to fashion both temporary and permanent restraints on government action, and on these Defendants, that will vindicate important public health needs, while allowing Plaintiffs to continue to contest the validity of the panic, rush-to-market approvals of these vaccines.

All too often drugs approved by these Defendants have proven to be so unsafe as to have to be withdrawn from the market. A declared pandemic public health national emergency is far too serious to allow that dangerous and poor “business as usual” practice to prevail. Studies published in leading medical journals like the Journal of the American Medical Association show that properly used pharmaceuticals approved by these Defendants are a major cause of death in the United States.

The People seek change in the way things have been done, where the potential results are so risky and where the benefit to the public health so uncertain and no longer supported by significant scientific agreement.

Dated: October 29, 2009

James S. Turner, Esq.
Swankin & Turner
Attorneys for Plaintiffs
1400 16th Street, NW, Suite 101
Washington, DC 20036
(202) 462-8800 Fax: (202) 265-6564
DC Bar #082479

Leslie Fourton, 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
DC Bar #452324

On the Brief:
Ralph Fucetola JD