`
`Case 1:21-cv-00212-DCN Document 1 Filed 05/14/21 Page 1 of 27
`
`
`
`Mauricio Cardona, ISB #10748
`Davillier Law Group
`414 CHURCH ST Suite 308
`Sandpoint, ID 83864-1347
`208-920-6140
`Email: mcardona@davillierlawgroup.com
`
`Attorney for Plaintiff
`
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF IDAHO
`
`
`Case No. _________________
`
`COMPLAINT FOR DECLARATORY
`AND INJUNCTIVE RELIEF
`DEMAND FOR JURY TRIAL
`
`
`
`
`HEALTH FREEDOM DEFENSE FUND,
`INC., RYAN BLASER, on his own behalf and
`as natural guardian for and on behalf of his
`minor children, K.B.B. and K.S.B.,
`MICHELLE SANDOZ, on her own behalf and
`as natural guardian for and on behalf of her
`minor children, R.S. and E.S., BARBARA
`MERCER, an individual, EMILY
`
`KNOWLES, on her own behalf and as natural
`
`guardian for and on behalf of her minor
`
`children, A.G.K. and A.T.K., and KENDALL
`
`NELSON, an individual,
`
`
`
`
`vs.
`
`CITY OF HAILEY, IDAHO, a municipal
`
`corporation, and MARTHA BURKE, in her
`official capacity as the Mayor of the City of
`
`Hailey, as well as in her personal capacity for
`purposes of Section 1983 claims asserted
`
`herein.
`
`Plaintiffs,
`
`Defendants.
`
`
`
`
`
`
`
`
`
`Complaint for Declaratory and Injunctive Relief
`
`
`
`
`1
`
`

`

`
`
`Case 1:21-cv-00212-DCN Document 1 Filed 05/14/21 Page 2 of 27
`
`
`
`I draw sweet air, Deeply and long, As pure as prayer, As sweet as song, Where lilies glow,
`
`And roses wreath, Heart-joy I know, Is just to breathe.
`
`Breath is Enough.
`
`
`
`Plaintiffs, HEALTH FREEDOM DEFENSE FUND, INC. (“HFDF”), RYAN BLASER
`
`and his minor children, K.B.B. and K.S.B., MICHELLE SANDOZ and her minor children, R.S.
`
`and E.S., BARBARA MERCER, EMILY KNOWLES and her minor children, A.K. and A.K.,
`
`and KENDALL NELSON, by and through their undersigned counsel, sue Defendants, the CITY
`
`OF HAILEY and MARTHA BURKE in her official capacity as the Mayor of the City of Hailey,
`
`as well as in her personal capacity for the Section 1983 claims asserted herein, and allege as
`
`follows:
`
`PRELIMINARY STATEMENT
`
`1.
`
`Plaintiffs challenge Public Health Emergency Order No. 2021-03 adopted by
`
`Defendant City of Hailey on May 11, 2021 (the “Mask Mandate”), a true and correct copy of which
`
`is attached hereto as Exhibit A. The Mask Mandate requires that every person in any indoor public
`
`place in the City of Hailey completely cover their nose and mouth with a face covering.1 The wearing
`
`of ‘face coverings”2 is purportedly required for a medical purpose, i.e., to “slow the community
`
`
`1 Public Health Emergency Orders were authorized pursuant to Hailey Ordinance No. 1277, enacted on February 8,
`2020, which provides that such orders shall have a duration of no more than 90 days, which may be extended upon
`approval by the City Council. The Mask Mandate was originally instituted pursuant to City of Hailey Public Health
`Emergency Order No. 2020-05, which took effect on July 1, 2020. The Mask Mandate was subsequently renewed or
`amended via Emergency Order Nos. 2020-06, 2020-07, 2020-08, 2021-01, and 2021-02. The current iteration, Order
`No. 2021-03, withdraws the requirement of wearing masks in outdoor public spaces, but maintains the requirement for
`indoor public spaces.
`2 The FDA defines face masks as a device and includes face coverings as a subset. See Exhibit B, FDA April 24, 2020
`letter to Manufacturers of Face Masks; Health Care Personnel; Hospital Purchasing Departments and Distributors; and
`Any Other Stakeholders. (“A face mask is a device, with or without a face shield, that covers the user’s nose and mouth
`and may or may not meet fluid barrier or filtration efficiency levels. It includes cloth face coverings as a subset. It may
`be for single or multiple uses, and if for multiple uses it may be laundered or cleaned. There are many products
`marketed in the United States as “face masks” that offer a range of protection against potential health hazards. Face
`masks are regulated by FDA when they meet the definition of a “device” under section 201(h) of the Act. Generally,
`Complaint for Declaratory and Injunctive Relief
`
`2
`
`
`

`

`
`
`Case 1:21-cv-00212-DCN Document 1 Filed 05/14/21 Page 3 of 27
`
`spread and protect the health, safety, and welfare of individuals living, working and visiting the City
`
`of Hailey” from the virus known as SARS-CoV-2, which has been determined to cause the ailment
`
`known as COVID-19. The Mask Mandate also provides for an advertising and public awareness
`
`campaign to promote the use of masks to prevent the spread of COVID-19. The Mask Mandate must
`
`be struck down because:
`
`a. The Mask Mandate is preempted under the Supremacy Clause by the federal law
`
`under which the Food and Drug Administration (“FDA”) issued the Emergency
`
`Use Authorization (“EUA”) for mask use, which requires that use of masks must
`
`be optional to the user because the normal testing, evaluation, and approval
`
`process for use of such masks has been bypassed by the FDA due to an emergency;
`
`b. The Mask Mandate’s public awareness campaign is preempted under the
`
`Supremacy Clause because it violates the scope of the emergency use
`
`authorization for masks issued by the FDA, which provides that it is misleading
`
`to “state or imply that the product is intended for antimicrobial or antiviral
`
`protection or related uses or is for use such as infection prevention or reduction”;
`
`c. The Mask Mandate implements a mandatory human experiment under which
`
`residents of and visitors to Hailey are forced to use a medical device when the
`
`medical impact on adults and children (including physical and psychological short
`
`and long-term side-effects) of such use has not been tested, evaluated, and
`
`approved by the FDA under normal procedures and is therefore unknown
`
`(experimental), and thus violates international law, federal law, and Idaho law;
`
`d. The Mask Mandate violates Plaintiffs’ fundamental human rights deeply rooted
`
`in American history and traditions, including the right to breathe unencumbered,
`
`
`face masks fall within this definition when they are intended for a medical purpose. Face masks are regulated under 21
`CFR 878.4040 as Class I 510(k)-exempt devices (non-surgical masks.”) emphasis added.
`Complaint for Declaratory and Injunctive Relief
`
`
`
`3
`
`

`

`
`
`Case 1:21-cv-00212-DCN Document 1 Filed 05/14/21 Page 4 of 27
`
`the right to breathe fresh air, the right to self-determination in medical care, and
`
`the parental right to determine a child’s health care matters; it is not narrowly
`
`tailored to achieve a compelling state interest; and therefore violates the due
`
`process clause of the Fourteenth Amendment to the Constitution; and
`
`e. The Mask Mandate has been placed in force and enforced by the Defendants
`
`herein operating under color of law who have deprived Plaintiffs of rights,
`
`privileges and immunities secured by the Constitution and laws of the United
`
`States, as noted above.
`
`INTRODUCTION
`
`2.
`
`None of the currently available face coverings for COVID-19 has received final
`
`approval from the FDA. Rather, such face coverings are unapproved products that have been
`
`authorized for emergency use under an Emergency Use Authorization (“EUA”). A true and correct
`
`copy of the EUA authorizing the use of masks during the current emergency (the “Mask EUA”) is
`
`attached hereto as Exhibit B.
`
`3.
`
`The statute granting the FDA the power to authorize a medical product for emergency
`
`use requires, inter alia, that the person being administered the unapproved product be advised of his
`
`or her right to refuse administration of the product. See 21 U.S.C. §360bbb-3(e)(1)(A) (“Section
`
`360bbb-3”).
`
`4.
`
`The FDA has taken the position that the terms and conditions of the Mask EUA
`
`preempts state and local laws that would impose obligations that are inconsistent with those terms
`
`and conditions. See Exhibit C, Emergency Use Authorization of Medical Products and Related
`
`Authorities: Guidance for Industry and Other Stakeholders at 39-40.3
`
`
`3 “FDA believes that the terms and conditions of an EUA issued under section 564 preempt state or local law, both
`legislative requirements and common-law duties, that impose different or additional requirements on the medical
`product for which the EUA was issued in the context of the emergency declared under section 564… To the extent state
`or local law may impose requirements different from or in addition to those imposed by the EUA for a particular
`Complaint for Declaratory and Injunctive Relief
`
`
`
`4
`
`

`

`
`
`Case 1:21-cv-00212-DCN Document 1 Filed 05/14/21 Page 5 of 27
`
`5.
`
`The Mask EUA specifies that “emergency use of face masks must be consistent with,
`
`and may not exceed, the terms of this letter…”. See Exhibit B. Further, the Mask EUA states that
`
`the product must not be:
`
`“labeled in such a manner that would misrepresent the product’s intended use; for
`example, the labeling must not state or imply that the product is intended for
`antimicrobial or antiviral protection or related uses or is for use such as infection
`prevention or reduction”.
`
`
`6.
`
`Defendant City of Hailey’s promotional campaign therefore exceeds the terms of the
`
`EUA and misleads the public because it promotes the use of masks as preventing or reducing
`
`infection from SARS-CoV-2. It therefore not only misleads the public, but conflicts with the EUA
`
`and is preempted under the Supremacy Clause.
`
`7.
`
`It is by now well-settled that medical experiments, better known in modern parlance
`
`as clinical research, may not be performed on human subjects without the express consent of the
`
`individual. This human right against human experimentation has its roots in the Nuremberg Code of
`
`1947, has been ratified by the 1964 Declaration of Helsinki, the United States Code of Federal
`
`Regulations, the law of Idaho, and indeed is so universally recognized across the globe that it
`
`constitutes a jus cogens norm under international law. In short, forced human experiments are
`
`universally recognized as against the law. Such globally recognized international standards are
`
`binding upon the United States and, when violated, create a cause of action enforceable by citizens
`
`of the United States damaged thereby.
`
`8.
`
`Masks are traditionally worn by healthcare workers, who are trained in their use, and
`
`only for short periods of time.
`
`
`medical product within the scope of the declared emergency or threat of emergency (e.g., requirements on prescribing,
`dispensing, administering, or labeling of the medical product), such law “stands as an obstacle to the accomplishment
`and execution of the full purposes and objectives of Congress,” and “conflicts with the exercise of Federal authority
`under [§ 564].””
`Complaint for Declaratory and Injunctive Relief
`
`
`5
`
`
`
`

`

`
`
`Case 1:21-cv-00212-DCN Document 1 Filed 05/14/21 Page 6 of 27
`
`9.
`
`The short and long-term medical impact and psychological side-effects to children
`
`and adults from being forced to consistently wear masks, especially for hours on end while at school
`
`or work, have not been studied. Indeed, the evidence is that wearing masks for extended periods of
`
`time is harmful, and that this harm is in no way counterbalanced by any benefit.
`
`10.
`
`The Mask Mandate thus constitutes a grand medical experiment and forcing every
`
`person in a public place in Hailey to wear a face covering constitutes a violation of international law,
`
`federal law, and Idaho law, all of which prohibit human experiments absent informed consent.
`
`11.
`
`Even if the Mask Mandate does not constitute a mandatory human experiment, the
`
`Mask Mandate (a) violates Plaintiffs’ fundamental human rights deeply rooted in American history
`
`and traditions (such as the right to breath fresh air, the right of self-determination in health care, and
`
`the right of parents to determine the health care of their children), (b) is not narrowly tailored to
`
`achieve a compelling state interest, and (c) therefore violates the due process clause of the Fourteenth
`
`Amendment to the Constitution. Indeed, the Mask Mandate serves no state interest at all (let alone a
`
`compelling one) in that it cannot, even according to the FDA, be said to reduce or prevent the spread
`
`of COVID-19.
`
`12.
`
`There is no “pandemic exception” to the Constitution or any of the law relied upon by
`
`Plaintiffs. Plaintiffs therefore ask that the Court intervene to protect their rights.
`
`PARTIES
`
`13.
`
`Plaintiff HFDF (hereinafter, “Plaintiff HFDF”), is a not-for-profit public benefit
`
`Wyoming corporation with its headquarters in Sandpoint, Idaho. HFDF is a member organization
`
`that seeks to advocate and educate the public on the topics of medical choice, bodily autonomy,
`
`and self-determination, and that opposes laws and regulations that force individuals to submit to
`
`the administration of medical products, procedures, and devices against their will.
`
`14.
`
`Several of Plaintiff HFDF’s members reside in Blaine County, Idaho, and are
`
`Complaint for Declaratory and Injunctive Relief
`
`
`
`
`6
`
`

`

`
`
`Case 1:21-cv-00212-DCN Document 1 Filed 05/14/21 Page 7 of 27
`
`directly affected by the Mask Mandate, as more fully set out in Declarations 1 through 3 attached
`
`hereto and made a part hereof as Composite Exhibit D. Plaintiff HFDF’s members therefore
`
`would have standing in their own right to bring the causes of action asserted by Plaintiff HFDF.
`
`As well, the interests at stake in this case are germane to Plaintiff HFDF’s purpose, and neither the
`
`claims asserted nor the relief requested by Plaintiff HFDF require the individual participation of
`
`Plaintiff HFDF’s members. Plaintiff HFDF therefore has standing to bring this case, which
`
`presents a justiciable issue for the Court.
`
`15.
`
`Plaintiff Ryan Blaser is a resident of the age of majority of the State of Idaho
`
`domiciled in the City of Hailey. Mr. Blaser is of sound mind and has the capacity to bring this
`
`lawsuit. Mr. Blaser is the father and natural guardian of three minor children, including K.B.B.
`
`and K.S.B. Mr. Blaser is subject to the Mask Mandate, and, although Mr. Blaser objects to the
`
`Mask Mandate, he routinely wears a mask as required by the Mask Mandate, but does so against
`
`his will, and explicitly does not consent to the wearing of a face covering as required by the Mask
`
`Mandate. Moreover, Mr. Blaser disagrees with any requirement that K.B.B. and K.S.B. be
`
`required to wear a face covering as required by the Mask Mandate, does not consent to same on
`
`behalf of K.B.B. and K.S.B., and asserts his parental rights to determine whether or not K.B.B.
`
`and K.S.B. should wear a face covering. Mr. Blaser therefore has standing to bring this case, on
`
`his own behalf and on behalf of K.B.B. and K.S.B., which presents a justiciable issue for the
`
`Court.
`
`16.
`
`Plaintiff Michelle Sandoz is a resident of the age of majority of the State of Idaho
`
`who is domiciled in and owns a business in Hailey. Ms. Sandoz is of sound mind and has the
`
`capacity to bring this lawsuit. Ms. Sandoz is the mother and natural guardian of two minor
`
`children, R.S. and E.S., both of whom live and go to school in Hailey. Ms. Sandoz, R.S., and E.S.
`
`are subject to the Mask Mandate. Although Ms. Sandoz objects to the Mask Mandate, she
`
`Complaint for Declaratory and Injunctive Relief
`
`
`
`
`7
`
`

`

`
`
`Case 1:21-cv-00212-DCN Document 1 Filed 05/14/21 Page 8 of 27
`
`routinely wears a mask as required by the Mask Mandate, but does so against her will, and
`
`explicitly does not consent to the wearing of a face covering as required by the Mask Mandate.
`
`Moreover, Ms. Sandoz disagrees with any requirement that her children be required to wear a face
`
`covering as required by the Mask Mandate, does not consent to same on behalf of R.S. and E.S.,
`
`and asserts her parental rights to determine whether or not her children should wear a face
`
`covering. Ms. Sandoz therefore has standing to bring this case, on her own behalf and on behalf
`
`of R.S. and E.S., which presents a justiciable issue for the Court.
`
`17.
`
`Plaintiff Barbara Mercer is a resident of the age of majority of the State of Idaho
`
`who is domiciled in Blaine County, Idaho and owns a business in the City of Hailey. Ms. Mercer
`
`is of sound mind and has the capacity to bring this lawsuit. Ms. Mercer is subject to the Mask
`
`Mandate, and, although Ms. Mercer objects to the Mask Mandate, she routinely wears a mask as
`
`required by the Mask Mandate, but does so against her will, and explicitly does not consent to the
`
`wearing of a face covering as required by the Mask Mandate. Ms. Mercer therefore has standing
`
`to bring this case, which presents a justiciable issue for the Court.
`
`18.
`
`Plaintiff Emily Knowles is a resident of the age of majority of the State of Idaho
`
`who is domiciled in the City of Hailey, Idaho. Ms. Knowles is the mother and natural guardian of
`
`two minor children, A.G.K. and A.T.K. Ms. Knowles, A.G.K., and A.T.K. are subject to the
`
`Mask Mandate, and, although Ms. Knowles objects to the Mask Mandate, she routinely wears a
`
`mask as required by the Mask Mandate, but does so against her will, and explicitly does not
`
`consent to the wearing of a face covering as required by the Mask Mandate. Moreover, Ms.
`
`Knowles disagrees with any requirement that A.G.K. and A.T.K. be required to wear a face
`
`covering as required by the Mask Mandate, does not consent to same on behalf of her children,
`
`and asserts her parental rights to determine whether or not her children should wear a face
`
`covering. Ms. Knowles therefore has standing to bring this case, on her own behalf and on behalf
`
`Complaint for Declaratory and Injunctive Relief
`
`
`
`
`8
`
`

`

`
`
`Case 1:21-cv-00212-DCN Document 1 Filed 05/14/21 Page 9 of 27
`
`of A.G.K. and A.T.K., which presents a justiciable issue for the Court.
`
`19.
`
`Plaintiff Kendall Nelson is a resident of the age of majority of the State of Idaho
`
`who is domiciled in Ketchum, Idaho, and frequently shops and visits public places and businesses
`
`in the City of Hailey. Ms. Nelson is subject to the Mask Mandate, and, although Ms. Nelson
`
`objects to the Mask Mandate, she routinely wears a mask as required by the Mask Mandate, but
`
`does so against her will, and explicitly does not consent to the wearing of a face covering as
`
`required by the Mask Mandate. Ms. Nelson therefore has standing to bring this case, which
`
`presents a justiciable issue for the Court.
`
`20.
`
`Plaintiffs Blaser and K.B.B. and K.S.B., Sandoz and R.S. and E.S., Mercer,
`
`Knowles and A.G.K. and A.T.K., and Nelson are referred to herein as the “Individual Plaintiffs”.
`
`21.
`
`Allegations regarding “Plaintiffs” hereinbelow shall be deemed to include the
`
`Individual Plaintiffs and Plaintiff HFDF.
`
`22.
`
`Defendant, City of Hailey, is a municipal corporation that has enacted laws that
`
`deprive and infringe, or threaten to deprive and infringe, Plaintiffs of certain rights, privileges, and
`
`immunities under the laws and Constitution of the United States, under the laws and Constitution
`
`of the State of Idaho, and under international law so widely adopted and accepted as to establish
`
`jus cogens. The City of Hailey is therefore a person under 42 U.S.C. § 1983. See Monell v. Dep’t
`
`of Soc. Servs., 436 U.S. 658 (1978).
`
`23.
`
`Defendant, Martha Burke, is the Mayor of the City of Hailey and ultimately
`
`charged with enforcing all City of Hailey ordinances, including those complained of herein, and
`
`personally signed the Mask Mandate into law. Ms. Burke is being sued in her official capacity as
`
`the Mayor of the City of Hailey well as in her personal capacity.
`
`JURISDICTION AND VENUE
`
`24.
`
`This Court has jurisdiction to hear all federal claims asserted in this case under 28
`
`Complaint for Declaratory and Injunctive Relief
`
`
`
`
`9
`
`

`

`
`
`Case 1:21-cv-00212-DCN Document 1 Filed 05/14/21 Page 10 of 27
`
`U.S.C. § 1331, which confers original jurisdiction on federal district courts to hear suits arising
`
`under the laws and Constitution of the United States; the Supremacy Clause of the Constitution of
`
`the United States, which allows federal district courts to hear suits alleging preemption of state
`
`and local laws by the Constitution and federal laws made in pursuance thereof; and 42 U.S.C. §
`
`1983 and 28 U.S.C. § 1343 in relation to Defendants’ deprivation and infringement under color of
`
`law of the Individual Plaintiffs’ rights, privileges, and immunities secured by the United States
`
`Constitution and laws, as detailed further herein.
`
`25.
`
`This Court has jurisdiction over the claims asserting violations of the laws and
`
`Constitution of the State of Idaho through its supplemental jurisdiction under 28 U.S.C. § 1367(a),
`
`as those claims are so closely related to the Plaintiffs’ federal question and Section 1983 claims
`
`that they form part of the same case or controversy under Article III of the United States
`
`Constitution.
`
`26.
`
`This Court has the authority to award the requested declaratory relief under 28
`
`U.S.C. § 2201; the requested injunctive relief under 28 U.S.C. § 1343(a); and attorneys’ fees and
`
`costs under 42 U.S.C. § 1988.
`
`27.
`
`The United States District Court for The District of Idaho is the appropriate venue
`
`for this action pursuant to 28 U.S.C. § 1391(b)(1) and (2) because it is the District in which
`
`Defendants reside, and/or have deprived the Individual Plaintiffs of the rights and liberties under
`
`the laws and Constitution of the United States, and have violated the laws and Constitution of the
`
`State of Idaho, all as is further alleged herein. It is also the District in which a substantial part of
`
`the events giving rise to Plaintiffs’ claims have occurred and continue to occur.
`
`FACTUAL BACKGROUND
`
`The Universal Prohibition on Human Experimentation Without Consent.
`
`28.
`
`Among the horrors that emerged from the rubble of World War II were stories of
`
`Complaint for Declaratory and Injunctive Relief
`
`
`
`
`10
`
`

`

`
`
`Case 1:21-cv-00212-DCN Document 1 Filed 05/14/21 Page 11 of 27
`
`barbaric medical experiments performed on unwilling victims of Nazi Germany’s concentration
`
`camps.
`
`29.
`
`On August 8, 1945, the prevailing Allies established an International Military
`
`Tribunal (the “IMT”). Under the aegis of the IMT, the law authorized the creation of U.S. military
`
`tribunals for the trial of “lower-level” war criminals, such as doctors accused of conducting
`
`medical experiments without the subjects’ consent.4
`
`30.
`
`A U.S. military tribunal subsequently found 15 doctors guilty of conducting
`
`nonconsensual experiments, which included the testing of drugs for immunization against malaria,
`
`epidemic jaundice, smallpox, and cholera.
`
`“In every single instance appearing in the record,”
`
`the tribunal concluded, “subjects were used who did not consent to the experiments. . . .” The
`
`tribunal sentenced seven of the doctors to death, and the remaining eight to life in prison.
`
`31.
`
`As part of its final judgment, the tribunal promulgated the Nuremberg Code on
`
`Permissible Medical Experiments. Point One of the Nuremberg Code states: “The voluntary
`
`consent of the human subject is absolutely essential.”
`
`32.
`
`This standard has since been repeatedly ratified and adopted around the globe, in
`
`laws, treaties, regulations, and ethical guidelines for medical research. For example, in 1964, the
`
`World Medical Association adopted the Declaration of Helsinki, which provides that human
`
`subjects “must be volunteers and informed participants in the research project.” Declaration of
`
`Helsinki at Art. 20.
`
`33.
`
`Although themselves non-binding, the principles underlying the Declaration of
`
`Helsinki and the Nuremberg Code have been incorporated into international conventions, as well
`
`as the laws and regulations of countries around the world, including the United States of America.
`
`
`4 Sources for the historical facts set forth herein can be found in Abdullahi v. Pfizer, Inc., 562 F.3d 163 (2d Cir. 2009),
`which explains in detail the history and reasons why the prohibition against nonconsensual human experimentation
`should be regarded as a jus cogens norm.
`Complaint for Declaratory and Injunctive Relief
`
`
`11
`
`
`
`

`

`
`
`Case 1:21-cv-00212-DCN Document 1 Filed 05/14/21 Page 12 of 27
`
`34.
`
`The International Covenant on Civil and Political Rights of the United Nations,
`
`which went into effect in 1976, provides in Article I that “[a]ll peoples have the right of self
`
`determination” and in Article 7 that “no one shall be subjected without his free consent to medical
`
`or scientific experimentation.”
`
`35.
`
`The informed consent principles of the Declaration of Helsinki were also
`
`incorporated by a 2001 Directive passed by the European Parliament and the Council of the
`
`European Union.
`
`36.
`
`In addition, 35 members of the Council of Europe have signed the Convention on
`
`Human Rights and Biomedicine, which provides that informed consent is required for a subject’s
`
`involvement in medical research.
`
`37.
`
`In 2005, the General Conference of UNESCO adopted the Universal Declaration
`
`on Bioethics and Human Rights, requiring free and informed consent for participation in medical
`
`research-oriented treatments.
`
`38.
`
`On December 1, 2020, the High Court of Justice, Queen’s Bench Division,
`
`Administrative Court in the United Kingdom concluded that minors lack the ability to give
`
`informed consent to the administration of puberty blockers to treat gender dysphoria because the
`
`procedure remains experimental.5
`
`39.
`
`40.
`
`These principles have been adopted by statutes and regulations in the United States.
`
`In 1979, the Department of Health, Education and Welfare issued the Belmont
`
`Report, which addressed the issue of informed consent in the human experimentation setting. The
`
`Report identified respect for self-determination by “autonomous persons” as the first of three
`
`“basic ethical principles” which “demands that subjects enter into the research voluntarily and
`
`
`5 See Bell v. The Tavistock and Portman NHS Foundation Trust, Case No. CO/60/2020, [2020] EWHC 3274
`Wales) https://www.judiciary.uk/wp-content/uploads/2020/12/Bell-v-Tavistock-
`(Admin) (Engl. &
`Judgment.pdf. (Last viewed on 5/14/21)
`
`Complaint for Declaratory and Injunctive Relief
`
`
`
`
`12
`
`

`

`
`
`Case 1:21-cv-00212-DCN Document 1 Filed 05/14/21 Page 13 of 27
`
`with adequate information.”
`
`41.
`
`Ultimately, the principles of the Belmont Report, which itself was guided by the
`
`Nuremberg Code and the Declaration of Helsinki, were adopted by the FDA in its regulations
`
`requiring the informed consent of human subjects for medical research. See 21 C.F.R. § 50.20.6
`
`42.
`
`The Department of Health and Human Services has similarly adopted this standard
`
`in its regulations governing grants for medical research. See 45 C.F.R. § 46.116. The United States
`
`clearly regards itself as bound by the provisions of the Nuremberg Code and the Declaration of
`
`Helsinki.
`
`The State of Idaho has adopted the principle of informed consent for all medical
`43.
`treatment. See I.C. § 39-4501 (requiring informed consent for medical treatment).
`For these and other reasons, the prohibition against nonconsensual human
`44.
`
`experimentation must be regarded not only as established by U.S. law and regulations, but also as
`
`so broadly recognized by all nations as to constitute a jus cogens norm under international law.
`
`The Use of Face Coverings by the General Population is Experimental, and the Mask
`Mandate is a Forced Human Experiment.
`
`45.
`
`Prior to the COVID-19 pandemic, the only time masks were prescribed for use in
`
`public spaces in the United States was during the 1918 flu pandemic. Even then, they were only
`
`mandated in certain cities for a matter of a few weeks – certainly not for months on end. Studies
`
`of mask use in 1918 have concluded either that they were useless against the flu or that their
`
`efficacy was, at best, inconclusive.
`
`46.
`
`Accordingly, the scientific literature regarding the short-term and long-term
`
`
`6 The exceptions to this standard are extremely narrow, and require certification by a researcher and an independent
`physician that, for example, “[t]he human subject is confronted with a life-threatening situation necessitating the use of
`the test article”; informed consent cannot be obtained from the subject; time does not permit obtaining informed
`consent from the subject’s legal representative; and “there is available no alternative method of approved or generally
`recognized therapy that provides an equal or greater likelihood of saving the life of the subject.” 21 C.F.R. § 50.23. See
`also 21 C.F.R. § 50.24 (providing a similarly narrow exception to informed consent requirements for emergency
`research).
`Complaint for Declaratory and Injunctive Relief
`
`
`13
`
`
`
`

`

`
`
`Case 1:21-cv-00212-DCN Document 1 Filed 05/14/21 Page 14 of 27
`
`medical and psychological impact of wearing face masks as a general practice throughout the day
`
`by children and adults is sparse. General scientific consensus on the short-term and long-term
`
`medical and psychological impact on children and adults of wearing face masks as a general
`
`practice throughout the day simply does not exist.
`
`47. According to the National Institute of Health, “clinical research is medical research
`
`involving people.” “Clinical trials are research studies performed in people that are aimed at
`
`evaluating a medical, surgical, or behavioral intervention. They are the primary way that
`
`researchers find out if a new treatment, like a new drug or diet or medical device (for example, a
`
`pacemaker) is safe and effective in people.”7 According to Merriam Webster, an experiment is to
`
`“try out a new procedure, idea, or activity.”8
`
`48.
`
`Plaintiffs allege, and will show at the trial of this matter, that the Mask Mandate
`
`is in fact a medical experiment being forced on unwilling participants. The Mask Mandate
`
`meets the definition of an experiment in that it is a new procedure, idea or activity. It also
`
`meets the definition of a clinical trial in that it the result of the Mask Mandate will be to
`
`determine whether a medical device, the face covering, is safe for people for extended use,
`
`because at this time that issue is unknown.
`
`49. As a factual matter, the Mask Mandate is a human experiment forced on the
`
`citizens and visitors to the City of Hailey, including Plaintiffs.
`
`Masks Have No Benefit in Reducing or Preventing Infection From SARS-CoV-2.
`
`The FDA and Scholarly Studies Establish Masks Have No Benefit.
`
`50.
`
`The FDA has determined that the efficacy of face coverings for reducing or
`
`preventing infection from SARS-CoV-2 has not been established, and that it would be
`
`
`7 U.S. Department of Human Services, National Institute on Aging, What Are Clinical Trials and Studies?,
`https://www.nia.nih.gov/health/what-are- clinical-trials-and-studies Last viewed on May 14, 2021
`8 Experiment, Merriam-Webster.com Dictionary, Merriam-Webster, https://www.merriam-
`webster.com/dictionary/experiment. Last viewed on May 14, 2021
`Complaint for Declaratory and Injunctive Relief
`
`
`
`14
`
`

`

`
`
`Case 1:21-cv-00212-DCN Document 1 Filed 05/14/21 Page 15 of 27
`
`misleading to state that they are effective in preventing or reducing such infection.
`
`51.
`
`In the EUA authorizing general emergency use of face masks, Exhibit B hereto,
`
`the FDA stated that it would “would misrepresent the product’s intended use” to state that it “is
`
`for use such as infection prevention or reduction”.
`
`52.
`
`Similarly, in its Enforcement Policy for Face Masks and Respirators During the
`
`Coronavirus Disease (COVID-19) Public Health Emergency (Revised),9 the FDA stated in three
`
`instances that face masks are not intended to reduce or prevent infection:
`
`The product is not intended for any use that would create an undue risk in light of
`the public health emergency, for example the labeling does not include uses for
`antimicrobial or antiviral protection or related uses or uses for infection
`prevention or reduction or related uses and does not include particulate filtration
`claims. Id. at 7, repeated twice on page 8.
`
`53.
`
`The first and only randomized controlled trial evaluating the impact of mask-
`
`wearing on the spread of SARS-CoV-2 in six thousand individuals concluded that masks were
`
`ineffective in reducing or preventing infection from SARS-CoV-2.10
`
`54. A study published in the Emerging Infectious Disea