Case 1:21-cv-01782 Document 1 Filed 07/02/21 Page 1 of 30
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`THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF COLUMBIA
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`CASE NO. ___________
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`VERIFIED COMPLAINT FOR
`DECLARATORY AND INJUNCTIVE
`RELIEF
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`JOSHUA A. MAZER, individually and on
`behalf of his minor child
`c/o SIRI & GLIMSTAD LLP
`200 Park Avenue, 17th Floor
`New York, New York 10166
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`
`Plaintiff,
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`-against-
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`THE DISTRICT OF COLUMBIA
`DEPARTMENT OF HEALTH
`899 North Capitol Street, NE
`Washington, DC 20002
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`AND
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`LAQUANDRA S. NESBITT, in her official
`capacity as Director of the District of Columbia
`Department of Health
`899 North Capitol Street, NE
`Washington, DC 20002
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`AND
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`MURIEL BOWSER, in her official capacity as
`Mayor of the District of Columbia
`John A. Wilson Building
`1350 Pennsylvania Avenue, NW
`Washington, DC 20004
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`Defendants.
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`Plaintiff, JOSHUA A. MAZER (“Plaintiff”) for his complaint, against THE DISTRICT
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`OF COLUMBIA DEPARTMENT OF HEATH, LAQUANDRA S. NESBITT, and MURIEL
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`BOWSWER, by and through his attorneys, alleges as follows:
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`1
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`Case 1:21-cv-01782 Document 1 Filed 07/02/21 Page 2 of 30
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`INTRODUCTION
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`1.
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`On March 16, 2021, the “Minor Consent for Vaccinations Amendment Act of
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`2020” (“2020 DC Law”)1 that had been passed in 2020 by the D.C. Council, codified at subsection
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`600.9 of title 22-B § 600 of the Code of D.C. Municipal Regulations, became effective in the
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`District of Columbia. This law permits a child, 11 years of age or older, to receive vaccinations
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`without their parent’s consent or knowledge.
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`2.
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` The 2020 DC Law, in fact, creates an entire structure by which the health care
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`provider, insurance company, school, and health department all engage in an elaborate and
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`deceitful scheme, including lying to the parents, to hide from those parents the fact that their child
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`was vaccinated without parental notification, control, or consent, and all without any finding that
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`a parent is unfit.
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`3.
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`A child does not have to be a resident of the District of Columbia in order to take
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`advantage of the 2020 DC Law. Any child only has to seek a vaccination from a medical provider
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`located in the District of Columbia.
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`4.
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`The 2020 DC Law runs contrary to, and is preempted by, long-established federal
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`requirements for obtaining informed consent for childhood vaccinations established by Congress
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`more than thirty-five years ago in the National Childhood Vaccine Injury Act of 1986 (the “1986
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`Federal Act”) (42 U.S.C. §§ 300aa-1 through 300aa-34) which creates a detailed federal statutory
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`scheme for childhood vaccines, including granting pharmaceutical companies immunity for
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`injuries caused by childhood vaccines and counterbalancing that by adding safety related
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`requirements for administering childhood vaccines.
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`1 https://code.dccouncil.us/dc/council/laws/23-193.html.
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`2
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`5.
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`Among the safety requirements mandated by Congress in the 1986 Federal Act is
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`the prerequisite that a health care provider who intends to administer a childhood vaccine must
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`provide to the parent2 a vaccine information statement (“VIS”) prepared by the United States
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`Department of Health and Human Services (“HHS”) prior to administering the vaccine. The VIS
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`provides the parent with critical information regarding the vaccine, including information about
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`the importance of the vaccine, information regarding the risks inherent in the vaccine, and advice
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`to parents on when a child should not receive the vaccine. It also advises the parent to inform the
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`doctor if the child has any of the listed risk conditions. It further informs the parent of the limited
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`methods for seeking redress in the event the child is injured by the vaccine (i.e., through the
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`Vaccine Injury Compensation Program).
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`6.
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`The passage and implementation of the 2020 D.C. Law violates the 1986 Federal
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`Act because it improperly calls for the alteration of the VIS documents themselves and completely
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`does away with the requirement at the VIS be given to the child’s parents. The D.C. Council is
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`not permitted to override the will of Congress; therefore the 2020 D.C. Law cannot be
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`implemented.
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`7.
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`Plaintiff Joshua A. Mazer is the parent and legal guardian of a minor child, who
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`will be referred to herein as Jane Doe or J.D.,3 who just turned 16 years old.
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`8.
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`9.
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`Plaintiff and J.D. reside in the State of Maryland.
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`Despite J.D. being a resident of another State, she was able to travel to the District
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`of Columbia without her parents and request that she be administered a vaccination, without her
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`parents’ knowledge or consent, pursuant to the provisions of the 2020 D.C. Law.
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`2 Hereinafter, “parent” shall mean biological parent, legal parent, or guardian.
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`3 The initials “J.D.” stand for Jane Doe and are used for the purposes of the anonymity of Plaintiff’s
`minor child.
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`3
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`Case 1:21-cv-01782 Document 1 Filed 07/02/21 Page 4 of 30
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`JURISDICTION AND VENUE
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`This Court has subject-matter jurisdiction over this action under 28 U.S.C. §§ 1331
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`10.
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`and 1343(a). This Court is authorized to issue the non-monetary relief sought herein pursuant to
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`the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
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`11.
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`Venue is proper in this judicial district under 28 U.S.C. § 1391(e) because
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`Defendants reside in this judicial district and a substantial part of the events or omissions giving
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`rise to this action occurred in this judicial district.
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`PARTIES
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`Plaintiff Joshua A. Mazer is an individual and is the parent and guardian of the
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`12.
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`minor child discussed herein, Jane Doe.
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`13.
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`Defendant Muriel Bowser is the Mayor of the District of Columbia, and in her
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`capacity as Mayor, Muriel Bowser is responsible for “the proper execution of all laws relating to
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`the District.” D.C. Code § 1-204.22. Defendant Muriel Bowser does see that the laws of the
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`District of Columbia are executed, including the 2020 DC Law.
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`14.
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`Defendant Laquandra S. Nesbitt, M.D., M.P.H., is the Director of the District of
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`Columbia Department of Health and is responsible for enforcement of all laws and regulations
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`relating to public health and vital statistics. D.C. Code § 7-101. Defendant Laquandra S. Nesbitt
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`does see that the laws of the District of Columbia are executed, including the 2020 DC Law.
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`15.
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`The District of Columbia Department of Public Health is a department within the
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`Executive Branch of the Government of the District of Columbia and is responsible for the
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`planning, development, and implementation of the delivery of health care services for the District
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`of Columbia. D.C. Code § 7-151, including, without limitation, implementation and enforcement
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`of the 2020 DC Law.
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`4
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`Case 1:21-cv-01782 Document 1 Filed 07/02/21 Page 5 of 30
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`FACTS
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`A. The National Childhood Vaccine Injury Act of 1986 and its Requirement to Provide
`a “Vaccine Information Statement” as the Basis for Informed Consent
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`
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`16.
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`In 1986, to address the problem of the high costs of liability for pharmaceutical
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`companies for vaccine injuries, Congress passed H.R. 5546, the National Childhood Vaccine
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`Injury Act.
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`17.
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`Unlike nearly every other company selling a consumer product, pharmaceutical
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`companies are not liable for injuries caused by their vaccines. The 1986 Federal Act (42 U.S.C.
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`§§ 300aa-1 through 300aa-34) grants pharmaceutical companies immunity from financial liability
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`for injuries caused by their vaccine products and instead places the responsibility for vaccine safety
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`in the hands of the Secretary of Health and Human Services (the “Secretary”). Recognizing that
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`by providing such immunity it eliminated an important incentive for pharmaceutical companies to
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`assure the safety of their vaccine products, Congress created various safeguards regarding the use
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`of vaccines. Among these safeguards is the requirement that every parent of a minor child receive
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`a VIS prior to the minor child being vaccinated to ensure the parent receives critical information
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`regarding this medical procedure, including information to help determine whether their child
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`should not receive the vaccine.
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`18.
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`In 1986, there were just two vaccines the Centers for Disease Control and
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`Prevention (“CDC”) recommended injecting into children, DTP and MMR, and due to crippling
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`financial liability from injuries caused by these vaccines, only one manufacturer remained for each
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`vaccine. As explained by the United States Supreme Court, “by the mid-1980’s … the remaining
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`manufacturer [of DTP] estimated that its potential tort liability exceeded its annual sales by a factor
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`of 200.” Bruesewitz v. Wyeth LLC, 562 U.S. 223, 227 (2011). Hence, as explained by the Institute
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`of Medicine, by 1986 the “litigation costs associated with claims of damage from vaccines had
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`5
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`Case 1:21-cv-01782 Document 1 Filed 07/02/21 Page 6 of 30
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`forced several companies to … stop producing already licensed vaccines” and the remaining
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`pharmaceutical companies producing vaccines threatened to withdraw from the vaccine market.
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`IOM, Adverse Events Associated with Childhood Vaccines, (1994) at 2.
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`19.
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`Instead of allowing market forces to drive pharmaceutical companies to develop
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`safer vaccines – as occurs with drugs and almost all other consumer products – Congress passed
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`the 1986 Federal Act, which virtually eliminated economic liability for pharmaceutical companies
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`for injuries caused by their vaccine products. See 42 U.S.C. § 300aa-11 (“No person may bring a
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`civil action for damages in an amount greater than $1,000 or in an unspecified amount against a
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`vaccine administrator or manufacturer in a State or Federal court for damages arising from a
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`vaccine-related injury or death.”); Bruesewitz v. Wyeth LLC, 562 U.S. at 223 (“we hold that the
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`National Childhood Vaccine Injury Act preempts all design-defect claims against vaccine
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`manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine
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`side effects”).
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`20.
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`Since 1986, the CDC’s childhood vaccine schedule has grown from injecting just
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`2 vaccines to the current 14 vaccines (HepB, DTaP, Hib, PCV13, IPV, IIV, MMR, VAR, HepA,
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`Tdap, HPV, MenACWY, MenB, and PPSV23) and soon the CDC will likely add the COVID-19
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`vaccine. During that time, with a liability-free, captive market of millions of children required to
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`receive these vaccines by law, vaccine sales have similarly grown from a market worth just a few
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`hundred million dollars around 1986 to a market worth over $37 billion in 2020.4
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`21.
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`By granting pharmaceutical companies financial immunity for injuries, Congress
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`sought to improve vaccine safety by including in the 1986 Federal Act a subsection entitled
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`4 See https://www.ncbi.nlm.nih.gov/books/NBK216815/; see also https://tinyurl.com/3x3k977r.
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`6
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`“Assuring A Safer Childhood Vaccination Program In The United States” codified at 42 U.S.C.
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`§§ 300aa-25 – 300aa-28.
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`22.
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`That sub-section provides, among other things, that the Secretary shall create a
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`Vaccine Information Statement for each childhood vaccine that is to be provided to the parent of
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`the child receiving the vaccine. See 42 U.S.C. § 300aa-26(a). (The Secretary is required to
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`“develop and disseminate vaccine information materials for distribution by health care providers
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`to the legal representatives of any child or to any other individual receiving a vaccine set forth in
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`the Vaccine Injury Table.”)
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`23.
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`The content of each VIS must include information about the benefits and risks of
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`the vaccine, information about the National Vaccine Injury Compensation Program, and other
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`relevant information as determined by the Secretary. See 42 U.S.C. § 300aa-26(c) (“The
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`information in such materials shall be based on available data and information, shall be presented
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`in understandable terms and shall include – (1) a concise description of the benefits of the vaccine,
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`(2) a concise description of the risks associated with the vaccine, (3) a statement of the availability
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`of the National Vaccine Injury Compensation Program, and (4) such other relevant information as
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`may be determined by the Secretary.”)
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`24.
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`In response, the Secretary has developed a VIS for each vaccine on the CDC’s
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`childhood vaccination schedule.
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`25.
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`Federal law is unequivocal that the health care provider who administers the
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`vaccine must provide the VIS to the parent before administering the vaccine to any child. As
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`provided in 42 U.S.C. § 300aa-26(d):
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`each health care provider who administers a vaccine set forth in the
`Vaccine Injury Table shall provide to the legal representatives of
`any child or to any other individual to whom such provider intends
`to administer such vaccine a copy of the [VIS] … supplemented with
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`7
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`visual presentations or oral explanations, in appropriate cases. Such
`materials shall be provided prior to the administration of such
`vaccine.
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`26.
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`For the purposes of this section: “The term ‘legal representative’ means a parent or
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`an individual who qualifies as a legal guardian under State law.” 42 U.S.C. § 300aa-33. Thus,
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`under federal law, a medical practitioner must provide the VIS, along with any appropriate
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`supplemental explanations, to the legal guardian of a child prior to injecting the child with a
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`vaccine.
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`27.
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`By statute, the content of each VIS must include information about the benefits and
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`risks of the vaccine, information about the National Vaccine Injury Compensation Program
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`(“VICP”), and other relevant information as determined by the Secretary. See 42 U.S.C. § 300aa-
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`26(c).
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`28.
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`Plaintiff’s daughter, J.D., suffered a severe reaction to a tetanus, diphtheria, and
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`pertussis-containing vaccine when she was five years of age. Immediately after these vaccinations,
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`J.D., required urgent medical treatment, including a multi-day oral steroid pack to reduce the
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`swelling and inflammation and to assist with the severe pain she was experiencing.
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`29.
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`The current VIS for the vaccine J.D. received when she was five years old clearly
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`tells a parent to “[t]ell your vaccine provider if the person getting the vaccine … had an allergic
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`reaction after a previous dose of any vaccine that protects against tetanus, diphtheria, or
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`pertussis … or had severe pain or swelling after a previous dose of any vaccine that protects
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`against tetanus or diphtheria.” (emphasis in original.) These are the precise reactions that J.D.
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`suffered after her receipt of this vaccine at five years of age and the VIS informs a parent to make
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`sure to inform any medical provider seeking to administer this vaccine about this prior reaction.
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`8
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`30.
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`In another section of the 1986 Federal Act, Congress mandated that any claims for
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`injuries from a childhood vaccine must be made to the VICP, which is part of the United States
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`Court of Federal Claims. In the VICP, the Secretary, as the respondent, is legally obligated to
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`defend against any claim of injury and is represented by the formidable resources of the U.S.
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`Department of Justice which vigorously defends against any claim that a vaccine has caused an
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`injury.
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` See, e.g., https://www.congress.gov/106/crpt/hrpt977/CRPT-106hrpt977.pdf (“DOJ
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`attorneys make full use of the apparently limitless resources available to them,” “pursued aggressive
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`defenses in compensation cases,” “establish[ed] a cadre of attorneys specializing in vaccine injury”
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`and “an expert witness program to challenge claims.”); 42 U.S.C. § 300aa-12 (“In all proceedings
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`brought by the filing of a petition [in the VICP] the Secretary shall be named as the respondent.”).
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`31.
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`Each VIS typically has seven sections, which provide important and potentially
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`life-saving information for the parent to consider prior to vaccinating their child.
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`32.
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`The first section entitled “Why get vaccinated?” provides important information
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`regarding the benefit of receiving the vaccine. Vaccines are considered a crowning achievement
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`of medical science. Their benefits are widely regarded. But not all individuals are aware of their
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`promoted benefits. Providing a VIS to the parent assists in informing the parent of these benefits.
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`33.
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`The second section explains who should receive the vaccine and when. The third
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`section makes clear that a parent must “[t]ell your vaccine provider if the person getting the
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`vaccine” meets one of the listed criteria so that the health care provider will know not to give a
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`vaccine. For example, the VIS for the Tdap vaccine informs the parent to tell the doctor if the
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`child has had:
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`• “an allergic reaction after a previous dose,”
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`• “a coma, decreased level of consciousness, or prolonged seizures within 7 days
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`after a previous dose,”
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`• “seizures or another nervous system problem [at any time],”
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`• “Guillain-Barré Syndrome [at any time],” or
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`• “severe pain or swelling after a previous dose of any vaccine.”
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`34.
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`Tdap is a pertussis, diphtheria, and tetanus-containing vaccine that is approved for
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`adults and children seven years of age and older, and one dose is recommended by the CDC to be
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`given during the pre-teen or teenage years. The only other doses of a pertussis, diphtheria, and
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`tetanus containing-vaccine would have been given at 2 months, 4 months, 6 months, 16 months,
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`and 4 years of age. Hence, a pre-teen or teenage child would likely not know if he or she
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`experienced any of the above conditions from a prior dose of the vaccine. This is why it is so
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`important for the parent to receive the VIS prior to vaccination. Section four of the VIS details
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`the risks of a vaccine reaction. Section five advises what to do if a serious problem arises from
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`the vaccination. Section six explains the existence of the VICP program to compensate people
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`injured by the vaccine. The VIS references the VICP to ensure that parents are aware of the
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`program and that timely filing a claim in this program is critical. A child cannot file a claim – it
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`must be filed by the child’s parent– and there is no tolling of claims during the period an individual
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`is a minor. 42 U.S. Code § 300aa-16. Hence, even assuming that the child (i) did not suffer an
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`injury that impacted his or her judgment, (ii) is aware of the VICP, (iii) is capable of filing a claim
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`and wants to file a claim, and (iv) has the wherewithal to hire an attorney, the child still cannot file
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`a claim without his or her parent’s participation.
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`B. Vaccinations Are Capable of Causing Harm
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`35.
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`The vast majority of health professionals believe the benefits of vaccination far
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`exceed the risks of receiving a vaccine. But there are still risks. Indeed, despite the fact that a
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`petitioner must prove causation for nearly all claims of injury,5 the VICP has awarded
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`compensation for the following injuries from the Tdap, HPV, IIV, and MenACWY vaccines, the
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`four vaccines typically given to teenagers (the “Teenage Vaccines”):
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`abscess, acute disseminated encephalomyelitis (ADEM), acute liver
`failure,
`adhesive
`capsulitis,
`aggravation
`of
`pre-existing
`encephalopathy, agoraphobia, anaphylactic shock, anaphylaxis,
`angioedema, antisynthetase
`syndrome, angiomatoid
`fibrous
`histiocytoma, aplastic anemia, anxiety, aplastic anemia, arm injury,
`arthritis, ataxia, atypical fibromyalgia, autism, autoimmune hep type
`2, autoimmune encephalitis, autoimmune hemolytic anemia,
`autoimmune
`limbic
`encephalitis,
`autoimmune meningitis,
`autoimmune neuroretinitis, behavioral issues, bell's palsy, benign
`tumor, bilateral peripheral neuropathy, bilateral shoulder pain,
`bilateral symmetric diaphragmatic palsy, blindness, blood clots,
`bowel obstruction, brachial neuritis, brachial plexopathy, brachial
`plexus, neuritis, cardiac injury, celiac disease, cellulitis, central
`nervous system demyelinating disorder, cerebellitis, cerebral
`vasculitis, cerebellar ataxia, cerebrovascular accident, chest pain,
`choreiform, movement disorder, chronic
`fatigue, chronic
`gastrointestinal issues, chronic arthritis, chronic fatigue syndrome,
`chronic
`headache,
`chronic
`inflammatory
`demyelinating
`polyneuropthay (CIDP), chronic pain, chronic urticaria, complex
`regional pain syndrome, demyelinating disease of central nervous
`system,
`conversion
`disorder,
`demyelinating
`polyradiculoneuropathy, death, deltoid bursitis, demyelinating
`
`
`5 This was not what Congress intended in passing the 1986 Federal Act. Instead, the 1986 Federal
`Act created a Vaccine Injury Table (the “Table”) which was intended to permit the Vaccine Court
`to quickly compensate certain common vaccine injuries. 42 U.S.C. § 300aa-12. If the child suffered
`an injury on the Table, the burden shifted to HHS to prove the vaccine did not cause the injury. 42
`U.S.C. § 300aa-13. After passage of the 1986 Federal Act, almost 90% of claims were Table claims
`and quickly settled. Stevens v. Secretary of HHS, No. 99-594V (Office of Special Masters 2001).
`However, in 1995 and 1997, HHS amended the Table such that 98% of claims became off-Table.
`http://www.gao.gov/assets/670/667136.pdf. As a result, injured children must now almost always
`prove “causation” – the biological mechanism by which the vaccine injured the child.
`https://www.ncbi.nlm.nih.gov/nlmcatalog/101633437 (“Persons alleging a condition not included in
`the table … must prove that the vaccine was the cause.”).
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`11
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`Case 1:21-cv-01782 Document 1 Filed 07/02/21 Page 12 of 30
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`condition, demyelinating sensorimotor polyneuropathy, dermatitis,
`dermatomyositis, diverticulitis, dravet syndrome, developmental
`delay, devic’s disease, eczema, elevated intraocular pressure,
`encephalititis, encephalopathy, epilepsy, epstein barr virus,
`erythema multiforme major, evan’s syndrome, exacerbation of
`existing cardiomyopathy, expressive language delay, fainting
`injuries, fatigue, febrile seizure, fibromyalgia, fibrosis, frozen
`shoulder, gastrointestinal symptoms, gastrointestinal
`issues,
`gastroparesis, GM1 gangliosidosis, guillain-barre syndrome (GBS),
`glomerulonephritis,
`hashimoto’s
`thyroiditis,
`headaches,
`hemophagocytic lymphohistiocytosis (HLH), heel pain, henoch-
`schonlein purpura (HSP), hernia, hip impingement syndrome,
`hodgkin's
`lymphoma,
`hypereosinophilia,
`hypersensitivity,
`hyperthyroidism, hypotensive-hyporesponsive
`shock collapse
`(HHE), hypoproteinemia, hypotonia,
`immobile flaccid
`legs,
`immune issues, idiopathic intracranial hypertension, immune
`thrombocytopenia purpa, impingement syndrome, increased risk of
`cancer, infantile spasms, inflammatory arthritis, inflammatory
`brachial plexopathy, inflammatory neuropathy, intractable epilepsy,
`joint pain, juvenile dermatomyositis, joint stiffness, juvenile
`idiopathic arthritis, juvenile rheumatoid arthritis (JRA), kawasaki
`disease, keloid scarring, labrum tear, leukocytoclastic vasculitis
`(LCV),
`leukodystrophy,
`leukoencephalopathy,
`latent herpes
`simplex virus infection, lichen planus, lipomas, long thoracic nerve
`palsy, lupus (SLE), lymphangitis, lymphomatoid granulomatosis,
`macrophagic myofasciitis, meningoencephalitis, metal toxicity,
`mixed connective tissue disease (MCTD), monoplegia, motor tics,
`multi organ failure, multiple sclerosis, muscle spasms, muscle
`weakness, myalgias, myelitis, necrotizing pancreatitis, nerve
`damage, neurological
`injury, neuromyelitis optica
`(NMO),
`neuropathic arm pain, neuropathy, nodular fasciitis, opsoclonus-
`myoclonus syndrome (OMS), ocular visual disturbance, optic
`neuritis, panic, pancreatitis, polyarthralgia pain syndrome,
`polyarthritis, overlap syndrome, panuveitis, panniculitis, parsonage
`turner syndrome, pemphigus vulgaris, peripheral neuropathy,
`permanent spastic tetraparesis, persistent headaches, polyarthralgia,
`polyneuropathy,
`post-vaccine
`encephalopathy,
`progressive
`encephalopathy, psoriatic arthritis, pulmonary edema, pyoderma
`gangrenosum, radial nerve damage, rash, reactivation of herpes
`simplex virus, reactive inflammatory arthritis, reflex sympathetic
`dystrophy, residual seizure disorder (RSD), retinal vasculitis, retro
`seizures, rhabdomyolysis, rheumatoid arthritis, rheumatologic
`injuries, scaring, scn1a, seizures, seizure disorder, sensory
`neuropathy, sensory polyneuropathy, serum sickness, SIDS,
`significant aggravation of pre-existing neurodevelopmental
`disorder, sirva, small fiber neuropathy, shoulder pain, skin
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`12
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`Case 1:21-cv-01782 Document 1 Filed 07/02/21 Page 13 of 30
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`disfigurement, spinal accessory neuropathy, splenic rupture,
`sjogren’s syndrome, snapping hip syndrome, strep infection, stroke,
`suprascapular neuropathy, sweets syndrome, syncopal seizure,
`syncope, synovitis, systemic juvenile idiopathic arthritis, tendonitis,
`tendinopathy,
`topical epidermal necrolysis,
`toxic epidermal
`necrolysis (TEN), toxic shock syndrome, transverse myelitis (TM),
`thrombocytopenic purpa,
`tics,
`tremors,
`trigeminal neuralgia,
`ulcerative colitis, urticaria, undifferentiated connective tissue
`disease (UCTD), ulceration, ulnar neuropathy, urinary incontinence,
`urticarial angioedema, uveitis, vasculitis, vasovagal syncope,
`vertigo, vestibular neuronitis6
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`Also, federal law requires that the pharmaceutical company selling the vaccine list
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`36.
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`on the package insert for each vaccine “only those adverse events for which there is some basis to
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`believe there is a causal relationship between the drug and the occurrence of the adverse event.”
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`21 C.F.R. § 201.57 (emphasis added.) The package inserts for the four Teenage Vaccines list the
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`following adverse events their manufacturers have a basis to believe have a causal relationship
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`with the vaccines:
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`abnormal gait, acute disseminated encephalomyelitis, anaphylactic
`and anaphylactoid reactions, angioedema, arthralgia, arthritis,
`asthenia, autoimmune diseases including autoimmune hemolytic
`anemia, back pain, Bell’s Palsy, bronchospasm, cellulitis, chest
`pain, chills, convulsions (with and without fever)(including febrile
`seizures), death, deep venous thrombosis, diarrhea, difficulty
`breathing, dizziness, drowsiness, dysphagia, dysphonia, dyspnea,
`encephalitis, encephalopathy, eosinophilic meningitis, epistaxis,
`erythema,
`exacerbation
`of
`symptoms
`of mitochondrial
`encephalomyopathy
`(Leigh syndrome), exanthem, extensive
`swelling of the injected limb, eye pain, facial edema, facial palsy,
`facial or cranial nerve paralysis, flushing, generalized skin reactions,
`Guillain-Barré
`syndrome,
`Henoch-Schönlein
`purpura,
`hypersensitivity,
`hypoesthesia,
`hypokinesia,
`hypotension,
`idiopathic
`thrombocytopenic purpura,
`influenza-like
`illness,
`injected limb mobility decreased, injection site bruising, injection
`site ecchymosis, injection site erythema, injection site induration,
`injection site inflammation, injection site mass, injection site
`nodule, injection site pruritus, injection site rash, injection site
`reaction, injection site sterile abscess, injection site warmth,
`
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`6 See, e.g., https://uscfc.uscourts.gov/aggregator/sources/7.
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`13
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`

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`Case 1:21-cv-01782 Document 1 Filed 07/02/21 Page 14 of 30
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`insomnia, irritability, large injection site swelling, laryngitis, limb
`paralysis, loss of appetite, loss of consciousness, lymphadenitis,
`lymphadenopathy, malaise, meningitis, motor neuron disease,
`muscle weakness, musculoskeletal pain and pain in the extremity,
`myalgia, myocarditis, nausea, neck pain, neuralgia, neuritis,
`neuropathy, pallor, pancreatitis, paralysis, paresthesia, pericarditis,
`photophobia, presyncope, pruritus, pulmonary embolus, pyrexia,
`rash, rhinitis, serum sickness, somnolence, sweating, syncope,
`throat tightness, thrombocytopenia, transverse myelitis, tremor,
`upper airway swelling, urticaria, vaccine-associated encephalitis,
`vasculitis which may be associated with transient renal involvement,
`vasovagal syncope, vomiting, wheezing7
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`37. While medical science has not yet established the rate at which most of the above
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`injuries occur, the potential rate may be gleaned from the Vaccine Adverse Events Reporting
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`System (“VAERS”), a passive reporting system operated by the CDC and FDA which receives a
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`vast majority of its reports from health care professionals or pharmaceutical companies. See
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`https://stacks.cdc.gov/view/cdc/36403. In the last ten years, for the four Teenage Vaccines,
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`VAERS has received, in total, reports of 1,999 deaths, 6,091 permanent disabilities, and 18,773
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`hospitalizations. An HHS-funded, three-year study by Harvard Medical School researchers
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`explained that “fewer than 1% of vaccine adverse events are reported.” In fact, recent peer
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`reviewed reports have affirmed that VAERS captures far less than 1% of adverse events.8
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`7 See Section 6.2 of the Package Insert for each of the four vaccines available at
`https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states.
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`8 According to the CDC, “Anaphylaxis after COVID-19 vaccination … occurred in approximately
`2 to 5 people per million vaccinated in the United States based on events reported to VAERS.” In
`contrast, a recent study at Mass General Brigham that assessed anaphylaxis in a clinical setting
`after the administration of COVID-19 vaccines found “severe reactions consistent with
`anaphylaxis occurred at a rate of 2.47 per 10,000 vaccinations.” This is equivalent to 50 times to
`120 times more cases than what are reported to VAERS for a condition that occurs almost
`immediately after vaccination and which vaccine providers are repeatedly advised to report.
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`Similarly, the CDC expected that 11,440 deaths from long term care facilities (“LTCF”) would
`be reported to VAERS given the number of deaths that would naturally occur during the period
`directly after COVID-19 vaccination in these facilities. Instead, VAERS only received 129 reports
`of deaths following COVID-19 vaccination in LTCF (or 1.1%) for a condition, death, that is easy
`to identify and which the FDA and CDC have repeatedly reiterated must by law be reported to
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`
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`14
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`Case 1:21-cv-01782 Document 1 Filed 07/02/21 Page 15 of 30
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`38.
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`Thus, while most health care professionals assert that the benefits of vaccines likely
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`outweigh the risks, the risks are real and must be taken into consideration. This is why the VIS is
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`so important in educating parents regarding the vaccines their child is taking, and in ensuring that
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`if the child has a reaction the parent has some means to draw a connection between the vaccination
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`and the adverse reaction.
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`C. The 2020 D.C. Law, the “Minor Consent for Vaccinations Amendment Act of 2020”
`violates Federal law
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`
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`39.
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`On March 16, 2021, the 2020 DC Law that had been passed in 2020 by the D.C.
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`Council, became effective in the District of Columbia. This law permits a child, 11 years of age or
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`older, to receive vaccinations without their parent’s consent or knowledge.
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`40.
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`The D.C. Council enacted the 2020 DC Law in December 2020 by adding a new
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`subsection 600.9 to 22-B DCMR § 600. Section “a” of this new subsection states:
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`A minor, 11 years of age or older, may consent to receive a vaccine if the
`minor is capable of meeting the informed consent standard, the vaccine is
`recommended by the United States Advisory Committee on Immunization
`Practices (“ACIP”), and will be provided in accordance with ACIP’s
`recommended immunization schedule. Id.
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`
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`41.
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` Section “b” then provides an amorphous standard for when a minor “is capable of
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`meeting the informed consent standard[.]” Id. It simply says that the minor will meet the standard
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`if he or she “is able to comprehend the need for, the nature of, and any significant risks ordinarily
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`inherent in the medical care.” Id. That section provides no objective measures and leaves the
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`VAERS. See, e.g., Fact Sheet for Healthcare Providers Administering Vaccine for each of the
`three authorized vaccines.
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`If anaphylaxis and death are being underreported, it is not surprising th