Natural Solutions Foundation
The Voice of Global Health Freedom™
Blog Entry: Stop the Shot Update: http://drrimatruthreports.com/?p=3933. we publish our Memorandum in Response to the Defendants’ Motion to Dismiss below.
Civil Action No. 1:09-cv-01924 (RBW)
United States District Court for the
District of Columbia
Gary Null, rima E. Laibow, et al.,
U.S. Food and Drug Administration, et al.,
PLAINTIFFS’ RESPONDING MEMORANDUM TO
DEFENDANTS’ MOTION TO DISMISS
WITH MOTION TO AMEND COMPLAINT
Plaintiffs come before the Court responding to the Defendants’ Motion to Dismiss filed October 29, 2009 and moving before the Court to amend the Complaint filed on October 9, 2009.
Response to Motion to Dismiss
Plaintiffs address each point raised by the Defendants. The following points follow the Memorandum submitted by Defendants.
1. Plaintiffs’ Claims Should Not Be Dismissed for Lack of Jurisdiction
This Court clearly has jurisdiction to hear complaints regarding these Defendants’ approvals of vaccines. 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 Defendants, including the Agency, have engaged in final agency actions 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 applicable Statutes and Regulations, including but not limited to 21 U.S.C.A. 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 approval (of the licenses for) of the Vaccines, that is binding upon these Defendants.
Thus this Court has jurisdiction over the subject matter and over the Defendants.
2. Plaintiffs Do Not Lack Standing to Challenge FDA’s Approval of the H1N1 Vaccines
Paragraphs 8 through 11 of the Complaint set forth certain facts regarding standing and the Plaintiffs have filed, in response to the Order to Show Cause of October 23, 2009, a Memorandum in Support of Plaintiffs standing to bring this action. That Memorandum is incorporated herein as though fully set forth.
In addition to the allegations of Plaintiffs standing in the noted Complaint paragraphs, which at this juncture of the proceedings should be accepted as provable for the purposes of the motions, the Plaintiffs allege that they are in imminent peril of harm directly from the approved Vaccines, and specifically the “live virus” nasal mist vaccine which will cause its recipients to become infectious and therefore a danger to these Plaintiffs (see Complaint paragraph 23 for example). But for the Defendants’ approvals, this threat of being exposed to what the Defendants admit is a “novel influenza virus” would not exist. The Defendants have purchased and unleashed these Vaccines on to the public and these members of the public may therefore challenge the approvals.
Lujan v. Defenders of Wildlife, 504 U.S. 555, 560, 112 S. Ct. 2130, 2134 (1992) is cited by Defendants as authority Article III thus requires a party who invokes the court’s authority to “‘show that he personally has suffered some actual or threatened injury as a result of the putatively illegal conduct of the defendant,’ . . . and that the injury ‘fairly can be traced to the challenged action’ and ‘is likely to be redressed by a favorable decision.’”
If the injury has not already occurred Plaintiffs need to show a credible threat of imminent future injury. With the release of the “live virus” mist vaccine, these Plaintiffs have already been exposed to what the Defendants have termed a new pandemic virus. And if not, they will be so exposed by the actions of these Defendants. Thus they have standing to challenge that approval. Presbyterian Church (USA) v. United States, 870 F.2d 518, 528-29 (9th Cir. 1989).
To rule otherwise would put this Court in the untenable position of holding that only pharmaceutical companies have standing to challenge government drug approvals. This was never the intent of Congress in creating the comprehensive drug approval system.
Additionally, the Plaintiffs seek to amend their Complaint to include a plaintiff from New Jersey, another state that mandates the use of whatever flu vaccines the Defendants choose to approve and recommend. In the case of New Jersey, the mandate also abrogates the decision of what vaccines to include to the Federal authorities. The New Jersey mandate applies to children under five years of age attending schools. These children are especially at risk of harm from the Vaccines which the Defendants own and which they are frightening the public into using for a non-existent emergency, non-existent pandemic, knowing full-well that some children will be maimed and even killed by these dangerous and un-safety tested drugs..
3. Plaintiffs Face Threat of Imminent Injury
Dr. Rrima E. Laibow MD, a Plaintiff herein and New York licensed physician, filed a Second Declaration simultaneously with Plaintiffs’ Memorandum on Standing. In that certification she set forth some of the threats of imminent injury facing the Plaintiffs. Others of these are documented in the Complaint and proposed Amendment to Complaint. The new Plaintiff, Dawne Vrabel, on her own behalf and that of her minor children, filed a similar Declaration alleging such harm. At this stage in the proceedings, such allegations give rise to the presumption that the threat of imminent injury is justiciable.
4. Plaintiffs’ Alleged Injuries That Are Fairly Traceable to FDA’s Vaccine Approvals
The case before this court is not a typical challenge to FDA approval of drugs. These particular drugs were purchased by the Defendants, are their property, were then, Plaintiffs allege, unlawfully approved, recommended and provided to the public. If someone is injured by these uninsurable, unsafety-tested drugs, that injury is clearly traceable to the actions of these Defendants. But for the purchase, approval, recommendation and distribution by these Defendants these Plaintiffs could be neither mandated to receive the vaccines nor, even absent the mandate, would they be exposed to the “live virus” mist vaccine thus exposing them to what the Defendants call a novel pandemic virus.
5. Plaintiffs’ Claims About Adjuvanted Vaccines Are Ripe
The Defendants quibble regarding the ripeness of the adjuvanted vaccine issue; but, the very vaccines that were approved contain Aluminum, an adjuvant. The fifth vaccine that was purchased by the government but not approved on September 15, 2009 is adjuvanted and about to be provided under an EUA. This Court has the power to pierce the veil of obscuration which the Defendants seek to throw over their actions, take account of the plans for the dangerous admixing of adjuvants and vaccines at 90,000 uncontrollable sites, as alleged in the Complaint with direct citations to the Defendants’ public announcements, and exercise the Court’s equitable powers to prevent the imminent peril. This Court does not have to wait until dozens, or hundreds, of people have died before hearing this petition for redress of grievances.
6. Plaintiffs Are Entitled to Preliminary Injunctive Relief
If the Defendants actions are about to trigger a danger pandemic with the use of perhaps even more dangerous Vaccines, as the Plaintiffs allege, then there is simply no redress after the fact that would make these Plaintiffs whole. The only redress that matters would be a strong Preliminary Injunction protecting against the head-long rush to distribute the Defendants’ Vaccines without adequate, definitive safety testing and full disclosures of the risks.
7. Plaintiffs Have a Reasonable Likelihood of Success on the Merits
Plaintiffs allege very specific violations of the approval process which, if proven (and at this stage in the proceedings ought to be taken as proven) show that the approvals are fatally flawed under Berkovitz v US, 486 US 531 (1988), where 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). Furthermore the Defendants have a clear, non-discretionary mandate under 42 U.S.C.A. §300aa-27(a)(2) to assure “safer” vaccines.
8. FDA’s Scientific and Regulatory Determinations, Particularly as to the Approval of Drugs and Vaccines, Are Due Substantial Deference Only when Supported by Nonbiased Scientific Evidence
Daubert v. Merrell Dow Pharmaceuticals, Inc, 509 U.S. 579, 113 S.Ct. 2786, 2797 (1993) expresses a clear 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.
9. FDA Did Not Follow the Appropriate Statutory and Regulatory Framework in Approving the Vaccines
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.
The FDA failed to follow its own regulations with regard to the approval of the Vaccines, including specifically: a) Section 351(a)(2)(B) that the manufacturer must “assure that such drug meets the requirements of this chapter as to safety…”, b) the provisions of 21 CFR § 601.2(a),(2), and c) the provisions of 42 U.S.C.A. §300aa-27(a)(2) that mandate that the Defendant Secretary assure “safer” vaccines by reducing the risks of adverse reactions to said vaccines.
With regard to Section 601.2 of Title 21 of the Code of Federal Regulations, 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 required in the manufacturer’s Biologic License Application (BLA) (21 CFR § 601.2(a)) before the FDA can legally approve a vaccine (21 CFR § 601.4(a)).
10. FDA Approved Adjuvanted Vaccines
The Defendants’ claim that adjuvanted vaccines have not been approved is disingenuous at best. The vaccines approved contain Aluminum, which is an adjuvant, according to the Declarations of Plaintiffs’ experts. Additionally, the Defendants have purchased about $484,000,000 worth of the adjuvant Squalene , with a declared intent to use this unapproved drug under a EUA. See paragraphs 17 and 18 of the Complaint.
11. FDA Has Placed Plaintiffs in Imminent Peril of an EUA for the H1N1 Vaccines
As alleged in the Complaint, for the reasons cited in point 10 above, the Plaintiffs are in imminent peril of being exposed to vaccines owned by the Defendants that cannot be approved under the usual procedures and will therefore be distributed under an EUA. When the EUA is issued there may be no legal recourse, thus, the Plaintiffs now stand in imminent peril of harm and the Court needs to act now, not at some future time when, as it were, “the horse is already out of the barn…”
12. Plaintiffs Can Enforce 42 U.S.C. § 300aa-27(a) or 21 U.S.C. § 351(a) Against the Defendants
Plaintiffs assert in good faith they have standing to challenge the unlawful approval of the Vaccines. As part of that challenge the Plaintiffs have an enforceable interested in opposing the Defendants failure to abide by the provisions of law governing the approval of drugs. Plaintiffs respectfully disagree with Defendant’s assertions regarding the cited statutes and urge the Court to accept the Plaintiffs’ position argued in Plaintiffs’ previous memoranda. Congress did not intend Section 300aa-27(a) to be a meaningless enactment; it meant to direct the Executive in executing the law and is quite clear with regard to the duty of Defendant Secretary.
13. Plaintiffs’ Constitutional Arguments Are Not Frivolous
The Plaintiffs have, integrated into the arguments, cited provisions of the Constitution of the United States, which is the supreme law of the land. Only lawless agencies that wrongly believe there are no limits on their authority whenever they choose to declare emergencies, even in the face of no significant scientific agreement that there is an emergency, consider the Constitution frivolous. These Plaintiffs have correctly asserted their First Amendment right to associate together, as member or supporters of the two Foundations which are also Plaintiffs here, to seek redress of grievances. Further, Plaintiffs have asserted important Constitutional Issues under the 14th Amendment and otherwise which are justiciable in this Court. The Foundation Plaintiffs have as their missions educating the public and decision makers regarding health matters and therefore seek injunctive relief requiring this Defendants make only truthful and not misleading statements regarding the Vaccines which these Defendants own and are distributing.
14. Plaintiffs Have Demonstrated Irreparable Harm and the Balance of Hardships Weighs Strongly in Favor of Injunctive Relief
The Plaintiffs and their experts assert that the course the Defendants have decided to take with the $6.4 billion worth of unsafety-tested 2009-H1N1-A Vaccines they purchased and then approved is a dangerous course that can lead to a pandemic where one does not in actuality already exist and that can lead to large numbers of serious adverse reactions, including permanent injury and death, as happened in 1976 with the first Swine Flu Vaccine program of these Defendants. After the pandemic is triggered; after the adverse reactions are flooding the hospitals, it will be too late to protect these Plaintiffs. In balancing the hardships and weighing the nature of the potential harm, at this stage in the proceeding, the Court should give all due weight to the allegation of the Plaintiffs and permit this matter to move forward.
15. Plaintiffs Will Suffer Irreparable Harm Absent Preliminary Relief
The Defendants have already begun to distribute their dangerous, un-safety tested drugs. The disinformation campaign by these Defendants continues to alarm the public and give rise to a dangerous level of panic. At this time the Court must act to stop the headlong rush to potential disaster. Only by granted a carefully crafted Preliminary Injunction, along the lines urged in the Memorandum on Standing heretofore submitted can the Plaintiffs be protected from the continuing unlawful acts of the Defendants.
16. The Entry of Injunctive Relief Would Not Substantially Harm Others and Would Not be Contrary to the Public Interest
For all of the reasons set forth in the Complaint, Memorandum in Support of Injunctive Relief, Memorandum in Support of Standing and the Declarations of the Parties and experts, Plaintiffs assert that reasonably crafted injunctive relief will further important public interests, rather than, as the Defendants urge, “be contrary” to the public interest, while protecting the public from erroneous agency decisions, which have the potential to create a repeat of the 1976 Swine Flu Vaccine fiasco, that left hundreds dead and thousands maimed, for a disease which, like the 2009-H1N1-A virus, was no actual threat to public health. In 1976 the courts appear to have failed to intervene in time to, in the words of Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905), prevent approvals of vaccines that “would seriously impair… health or probably cause… death…”
November 2, 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