`NO. _______
`
`In the
`Supreme Court of the United States
`
`
`
`CHILDREN’S HEALTH DEFENSE, ET AL,
`Petitioners,
`
`
`
`v.
`UNITED STATES FOOD AND DRUG
`ADMINISTRATION, ET AL.,
`Respondents.
`__________________________
`On Petition for a Writ of Certiorari to the
`United States Court of Appeals for the Fifth Circuit
`
`
`
`
`PETITION FOR A WRIT OF CERTIORARI
`
`
`
`
`
`
`
`Robert E. Barnes
` Counsel of Record
`BARNES LAW
`700 South Flower Street
`Suite 1000
`Los Angeles, CA 90017
`(310) 510-6211
`robertbarnes@barneslawllp.com
`
`
`
`
`
`
`
`
`
`
`April 22, 2024
`Counsel for Petitioners
`SUPREME COURT PRESS ♦ (888) 958-5705 ♦ BOSTON, MASSACHUSETTS
`
`
`
`i
`
`QUESTION PRESENTED
`Whether a Constitutionally cognizable case or
`controversy exists under Article III when agency action
`causes substantial resource diversion of an organi-
`zation and exposes children they represent to an
`unvetted and unsafe “vaccine”, in light of this Court’s
`conflicting injury-in-fact standards set forth in United
`States v. Students Challenging Regulatory Agency
`Procedures, 412 U.S. 669 (1973) and TransUnion LLC
`v. Ramirez, 495 U.S. 413 (2021)?
`
`
`
`
`
`
`
`
`ii
`
`PARTIES TO THE PROCEEDINGS
`
`
`Petitioners and Plaintiffs-Appellants below
`● Children’s Health Defense
`● Deborah L. Else
`● Sacha W. Cayce Dietrich
`● Aimee Villella McBride
`●
`Jonathan Shour
`● Rebecca Shour
`
`Respondents and Defendants-Appellees below
`● United States Food and Drug
`
`Administration
`● Robert M. Califf, Commissioner of the FDA
`
`
`
`
`
`
`
`
`
`iii
`
`RULE 29.6 STATEMENT
`None of the petitioners are nongovernment
`corporations. Consequently. None of the petitioners
`have a parent corporation or shares held by a publicly
`traded company.
`
`
`
`
`
`
`
`iv
`
`LIST OF PROCEEDINGS
`
`
`U.S. Court of Appeals for the Fifth Circuit
`No. 23-50167
`Children’s Health Defense, et al v. United States Food
`And Drug Administration
`Date of Final Opinion: January 23, 2024
`
`
`_________________
`
`
`U.S. District Court, Western District of Texas (Waco)
`No. 6:22-cv-00093-ADA
`Children’s Health Defense, et al v. United States Food
`And Drug Administration
`Date of Final Order: January 12, 2023
`
`
`
`
`
`
`
`
`
`v
`TABLE OF CONTENTS
`
`Page
`QUESTION PRESENTED .......................................... i
`PARTIES TO THE PROCEEDINGS ......................... ii
`RULE 29.6 STATEMENT ........................................ iii
`LIST OF PROCEEDINGS ......................................... iv
`TABLE OF AUTHORITIES .................................... viii
`OPINIONS BELOW ................................................... 1
`JURISDICTION .......................................................... 1
`CONSTITUTIONAL AND STATUTORY
`
`PROVISIONS INVOLVED .................................. 1
`STATEMENT OF THE CASE .................................... 3
`A. Proceedings In The District Court Below ....... 4
`B. Proceedings In The Court of Appeals Below ..... 5
`REASONS FOR GRANTING THE PETITION ......... 6
`I. THE INJURY-IN-FACT ELEMENT OF ARTICLE
`III STANDING IS UNSETTLED BY DECISIONS
`OF THIS COURT. ................................................. 7
`A. One Line of Decisions Holds That
`
`Standing Exists So Long as an
`
`“Identifiable Trifle” of Injury Is
`
`Suffered by The Plaintiff. ........................... 8
`B. A Separate Line of Decisions Holds
`
`That Standing Cannot Exist Unless
`
`“Materialized” Risk of Future Harm Is
`
`Suffered by The Plaintiff. ......................... 11
`
`
`
`vi
`TABLE OF CONTENTS – Continued
`
`Page
`II. THIS COURT SHOULD SETTLE THE TWO
`CONFLICTING INJURY-IN-FACT STANDARDS TO
`PRESERVE UNIFORMITY OF COURT DECISIONS
`OVER THIS IMPORTANT PUBLIC AND
`CONSTITUTIONAL ISSUE. .................................. 12
`
`III. THIS COURT SHOULD ALSO RESOLVE THE
`UNSETTLED ISSUE OF WHEN AN ORGANIZATION
`HAS STANDING TO SUE WHERE ITS RESOURCES
`ARE DIVERTED BY AGENCY ACTION. ................ 14
`CONCLUSION .......................................................... 15
`
`
`
`
`
`
`
`vii
`TABLE OF CONTENTS – Continued
`
`Page
`
`
`
`
`
`APPENDIX TABLE OF CONTENTS
`
`OPINIONS AND ORDERS
`
`Opinion, U.S. Court of Appeals for the
`
`Fifth Circuit (January 23, 2024) ........................ 1a
`Order Granting Defendants’ Motion to Dismiss,
` U.S. District Court for the Western District of
`
`Texas, Waco Division (January 12, 2023) ....... 15a
`
`OTHER DOCUMENTS
`First Amended Complaint
`
`(January 12, 2023) ............................................ 35a
`
`
`
`
`
`
`
`
`
`
`viii
`TABLE OF AUTHORITIES
`
`Page
`
`TABLE OF AUTHORITIES
`
`CASES
`Abigail Alliance for Better Access to
`Developmental Drugs v. Eschenbach,
`469 F.3d 129 (D.C. Cir. 2006) ........................... 14
`Allen v. Wright,
`468 U.S. 737 (1984) ............................................. 7
`Am. Acad. of Pediatrics v. FDA,
`379 F.Supp.3d 461 (D. Md. 2019) ..................... 14
`Bowman v. Wilson,
`672 F.2d 1145 (3rd Cir. 1982) ........................... 10
`Buck v. Bell,
`274 U.S. 200 (1927) ............................................. 7
`Clapper v. Amnesty International USA,
`568 U.S. 398 (2013) ........................................... 11
`Cottrell v. Alcon Laboratories,
`874 F.3d 154 (3rd Cir. 2017) ............................. 10
`Cutler v. Kennedy,
`475 F.Supp. 838 (D.D.C. 1979) ......................... 10
`El Rescate Legal Services, Inc. v. Executive
`Office of Immigration Review,
`959 F.2d 742 (9th Cir. 1991) ............................. 14
`Hooker v. Weathers,
`990 F.2d 913 (6th Cir. 1993) ............................. 14
`In re Paoli R.R. Yard PCB Litig.,
`916 F.2d 829 (3rd Cir. 1990) ............................... 9
`Massachusetts v. United States Dept. HHS,
`923 F.3d 209 (1st Cir. 2019) .............................. 10
`
`
`
`ix
`TABLE OF AUTHORITIES – Continued
`Page
`
`Natural Resources Defense Council v. U.S.
`E.P.A., 735 F.3d 873 (9th Cir. 2013) ................... 9
`Natural Resources Defense Council, Inc.
`v. SEC, 606 F.2d 1031 (D.C.Cir.1979) .............. 14
`Natural Resources Defense Council, Inc.
`v. U.S. Food and Drug Admin.,
`710 F.3d 71 (2nd Cir. 2013) ................................ 9
`Public Citizen v. Foreman,
`631 F.2d 969 (D.C.Cir.1980) ............................. 14
`Sutton v. St. Jude Medical S.C., Inc.,
`419 F.3d 568 (6th Cir. 2005) ............................... 9
`TransUnion LLC v. Ramirez,
`495 U.S. 413 (2021) .................................. i, 11, 13
`United States v. Students Challenging
`Regulatory Agency Procedures,
`412 U.S. 669 (1973) .................... i, 8, 9, 10, 11, 13
`Whitmore v. Aransas,
`495 U.S. 149 (1990) ........................................... 11
`
`CONSTITUTIONAL PROVISIONS
`U.S. Const. art. III, § 2 ...................... i, 1, 5, 6, 7, 8, 12
`
`
`
`x
`TABLE OF AUTHORITIES – Continued
`Page
`
`STATUTES
`5 U.S.C. § 553(e) ..................................................... 2, 4
`5 U.S.C. § 706 .......................................................... 2, 4
`28 U.S.C. § 1254(1) ..................................................... 1
`
`JUDICIAL RULES
`Sup. Ct. R. 10(c) .......................................................... 6
`
`
`
`
`
`
`
`1
`
`
`
`OPINIONS BELOW
`The Opinion of the United States Court of Appeals
`for the Fifth Circuit (“Court of Appeals” or “Fifth
`Circuit”), dated January 12, 2023 is included in the
`Appendix (“App.”) App.1a-14a. The Order of Dismissal
`of the U.S. District Court, Western District of Texas
`at Waco (the “District Court”) is included at App.15a-
`34a. These opinions and orders were not designated
`for publications.
`
`
`
`JURISDICTION
`The Court of Appeals entered its Opinion on
`January 23, 2024. App.1a-14a. This Court has jurisdic-
`tion under 28 U.S.C. § 1254(1).
`
`
`
`CONSTITUTIONAL AND
`STATUTORY PROVISIONS INVOLVED
`U.S. Const. art. III, § 2
`The judicial Power shall extend to all Cases, in
`Law and Equity, arising under this Constitution,
`the Laws of the United States, and Treaties made,
`or which shall be made, under their Authority;—
`to all Cases affecting Ambassadors, other public
`Ministers and Consuls;—to all Cases of admiralty
`and maritime Jurisdiction;—to Controversies to
`which the United States shall be a Party;—to
`
`
`
`2
`
`Controversies between two or more States;—
`between a State and Citizens of another State,—
`between Citizens of different States,—between
`Citizens of the same State claiming Lands under
`Grants of different States, and between a State,
`or the Citizens thereof, and foreign States,
`Citizens or Subjects . . .
`5 U.S.C. § 553(e)
`Each agency shall give an interested person the
`right to petition for the issuance, amendment, or
`repeal of a rule.
`5 U.S.C. § 706
`To the extent necessary to decision and when
`presented, the reviewing court shall decide all
`relevant questions of law, interpret constitutional
`and statutory provisions, and determine the
`meaning or applicability of the terms of an agency
`action. The reviewing court shall—
`(1) compel agency action unlawfully withheld or
`unreasonably delayed; and
`(2) hold unlawful and set aside agency action,
`findings, and conclusions found to be—
`(A) arbitrary, capricious, an abuse of dis-
`cretion, or otherwise not in accordance
`with law;
`(B) contrary to constitutional right, power,
`privilege, or immunity;
`(C) in excess of statutory jurisdiction,
`authority, or limitations, or short of
`statutory right;
`
`
`
`3
`
`(D) without observance of procedure required
`by law;
`(E) unsupported by substantial evidence in a
`case subject to sections 556 and 557 of this
`title or otherwise reviewed on the record of
`an agency hearing provided by statute; or
`(F) unwarranted by the facts to the extent that
`the facts are subject to trial de novo by the
`reviewing court.
`In making the foregoing determinations, the court
`shall review the whole record or those parts of it
`cited by a party, and due account shall be taken
`of the rule of prejudicial error.
`
`
`
`STATEMENT OF THE CASE
`Petitioner Children’s Health Defense (“CHD”) is
`a nonprofit “organization that has tasked itself with
`protecting and promoting the health and wellbeing of
`children.” App.3a. The remaining petitioners are
`parents of children whose ages range from 2 months
`to 13 years old. App.38a-39a. (hereinafter along with
`CHD collectively “Petitioners”). Respondents are the
`Food & Drug Administration an agency within the
`U.S. Department of Health and Human Services
`(hereinafter the “FDA”), and its Commissioner, Robert
`M. Califf. App.2a.
`On April 1, 2020, the Secretary of the U.S. Health
`and Human Services determined that circumstances
`surrounding the COVID-19 outbreak justified “the
`authorization of emergency use of drugs and biological
`
`
`
`4
`
`products.” App.2a. In December 2020, the FDA issued
`two emergency use authorizations (“EUAs”) for admin-
`istering COVID-19 vaccines to people over age 16.
`App.2a-3a. From May 2021 through to June 2022, the
`FDA expanded those EUAs to authorize vaccinations
`to children from 17 years down to 6 months old. App.3a.
`In May 2021, petitioner CHD filed a citizen petition
`with the FDA (the “Citizen Petition”), demanding
`FDA to revoke the existing EUAs, because the COVID-
`19 vaccines authorized by them were ineffective and
`lacked proper vetting. App.3a. The Citizen Petition
`requested that FDA stay its issuance of EUAs until
`proper scientific and administrative procedures had
`been followed first. App.3a. On August 23, 2021, FDA
`responded to the Citizen Petition with a denial of the
`relief requested therein. App.3a.
`A. Proceedings In The District Court Below
`Following the FDA’s denial of the Citizen Petition,
`Petitioners filed a civil action against FDA on January
`24, 2022. On July 1, 2022, Petitioners filed a First
`Amended Complaint (the “Amended Complaint”),
`alleging two causes of action, the first under the
`Administrative Procedures Act codified in 5 U.S.C.
`§§ 553(e) and 706(2) (the “APA”), and the second for
`declaratory relief. App.108a-118a. The Amended Com-
`plaint alleged that FDA violated the APA by failing to
`grant citizen redress and judicial review of the EUAs
`prior to unleashing improperly vetted vaccinations upon
`children nationwide, and further that FDA’s inadequate
`assessment of the adverse effects of the vaccines
`authorized by the EUAs posed a substantial risk of
`harm and even death to children who received them.
`App.36a-38a, App.41a-43a, App.46a-54a. and App.89a-
`97a.; App.3a-4a and 6a. The Amended Complaint further
`
`
`
`5
`
`alleged that FDA affirmatively misrepresented the
`safety, and omitted to disclose the risks and dangers,
`of the COVID-19 vaccines authorized by the EUAs.
`App.64a-68a. Finally, the Amended Complaint alleged
`that the EUAs issued by the FDA, combined with the
`FDA’s aforementioned misrepresentations and omis-
`sions regarding the subject vaccines, had the effect
`of spawning tremendous public and social pressure
`on parents and their children to get vaccinated, even
`leading to vaccinations absent parental consent. App.
`67a-68a; App.3a-4a.
`On January 12, 2023, the District Court granted
`Respondents’ motion to dismiss the Amended Complaint
`with prejudice for lack of subject-matter jurisdiction,
`finding that Petitioners lacked Article III standing
`to bring their claims against FDA (the “Order of
`Dismissal”). App.15a-34a.
`B. Proceedings in the Court of Appeals Below
`On March 3, 2023, Petitioners filed a timely
`Notice of Appeal, seeking review by the Fifth Circuit
`Court of Appeals (the “Fifth Circuit”) of the District
`Court’s Order of Dismissal.
`On January 23, 2023, the Fifth Circuit entered its
`unpublished opinion affirming the District Court’s
`Order of Dismissal (the “Fifth Circuit Opinion”).
`App.1a-14a. The basis for the Fifth Circuit’s affirmance
`of the District Court’s Order of Dismissal, was that
`Petitioners’ pleadings failed to sufficiently allege the
`injury-in-fact element of associational Article III
`standing. App.6a-12a. On February 14, 2024, the Fifth
`Circuit issued a Judgment as the mandate in the matter.
`
`
`
`6
`
`
`
`REASONS FOR GRANTING THE PETITION
`Review on writ of certiorari may be granted for
`compelling reasons, which include that a “United
`States court of appeals has decided an important
`question of federal law that has not been, but should
`be, settled by this Court, . . . ”. Rule 10(c)1. This case
`asks a question this Court’s own Justices recently
`asked at oral argument: who can sue the FDA when
`the FDA violates the law, misrepresents the safety
`and efficacy of a drug, and endangers the public?2 The
`lower courts answered: no one can. Is that the law?
`To the ordinary person, this matter is a “case or
`controversy” within the plain language and original
`intent of Article III of the United States Constitution.
`Yet the lower courts determined that a federal agency
`lying to the public in a manner costing the petitioner
`substantial resources and endangering the lives of
`toddlers wasn’t a “case or controversy” at all in the
`language of the law. The law may have its linguistic
`roots in Latin, but that makes our own Constitutional
`words written in a language foreign to our founders.
`The lower courts have stretched the doctrine of
`standing to justify abdication of judicial obligation,
`
`1 “Rule” refers herein to the Rules of the Supreme Court of the
`United States.
`2 U.S. Food and Drug Administration, et al., v. Alliance For
`Hippocratic Medicine, et al.; Docket No. 23-235: “Is there anybody
`who can sue and get a judicial ruling on whether what FDA did
`was lawful? And maybe what they did was perfectly lawful, but
`shouldn’t somebody be able to challenge that in court?” Justice
`Alito asked the government’s lawyer at oral argument.
`
`
`
`7
`
`excusing emergency exceptions to our Constitutional
`liberties for rogue, wayward, conflicted administrative
`agencies, at the expense of our most vulnerable popula-
`tion: toddler, foster children, and children in institutional
`care. The last time this Court tolerated such conduct?
`A case called Buck v. Bell, 274 U.S. 200 (1927). Is
`that ignominious, infamous tradition what this Court
`wants to return to?
`It is time for this Court to clarify the meaning of
`Article III in a manner that gives meaningful predict-
`ability and consistent Constitutional conformity for all.
`A standard currently missing from the conflicting and
`confusing lower court decisions across the Circuits
`concerning this most critical and foundational question:
`who has access to the judicial branch of government
`to petition for redress of grievances?.
`I. THE INJURY-IN-FACT ELEMENT OF ARTICLE III
`STANDING IS UNSETTLED BY DECISIONS OF THIS
`COURT.
`Forty years ago in one of its most seminal
`decisions on Article III standing, Allen v. Wright, 468
`U.S. 737, 751 (1984), this Court held that the injury-in-
`fact element of Constitutional Article III jurisdictional
`standing requires the courts to draw a line between
`injuries that confer standing because they are “distinct
`and palpable”, and those which it characterized as
`“abstract”, “conjectural”, or “hypothetical”. This Court
`in Allen stated that the absence of precise and mech-
`anical rules “ . . . hardly leaves courts at sea in applying
`the law of standing.” (Id., at 751). Yet, the underlying
`case that gave rise to this Petition reveals that the
`District and Circuit Courts indeed remain very much
`“at sea” in regards to whether plaintiffs that suffer
`
`
`
`8
`
`a risk of future harm arising from the actions of a
`defendant, have Article III standing.
`Clarity by this Court over this most important
`principle and its ramifications for separation of
`powers is thus crucial at this juncture. This Petition
`grants this Court the opportunity to do just that.
`A. One Line of Decisions Holds That Standing
`Exists So Long as an “Identifiable Trifle” of
`Injury Is Suffered by The Plaintiff.
`On one end of the spectrum regarding standing is
`the case of United States v. Students Challenging
`Regulatory Agency Procedures, 412 U.S. 669 (1973)
`(“SCRAP”).
`In SCRAP, this Court rejected an argument that
`standing should be accorded only to persons
`“significantly” affected by agency action. Instead, this
`Court ruled that the plaintiffs in SCRAP sufficiently
`alleged standing by contending that a rail freight
`surcharge could discourage use of recyclable goods,
`encourage greater use of virgin materials, and thus
`impair the future pleasures of outdoor activities that
`comprised the injury to the plaintiffs in that case. In
`determining that the SCRAP plaintiffs’ aesthetic-based
`injury comprised standing, this Court held: “‘an iden-
`tifiable trifle is enough for standing to fight out a
`question of principle; the trifle is the basis for standing
`and the principle supplies the motivation’ [citation
`omitted].” Id., at 689, fn. 14. The SCRAP decision
`still remains as authority by this Court supporting
`that injury-in-fact may be found despite the plaintiff
`not suffering any present or even imminent injury.
`
`
`
`9
`
`Recent Circuit Court decisions in other Circuits
`remain faithful to that very “identifiable trifle” standard
`set forth in SCRAP.
`In Natural Resources Defense Council, Inc. v. U.S.
`Food and Drug Admin., 710 F.3d 71 (2nd Cir. 2013),
`the Second Circuit found standing where the plaintiffs’
`claim was that the FDA failed to appropriately deter-
`mine whether a substance contained in antibacterial
`soap called triclosan should be approved for use by the
`public, despite the uncertainty of risk of injury to a
`person’s thyroid or liver. Id., at 84 [rejecting the govern-
`ment’s contention that the absence of “quantitative
`evidence of the ‘precise risk’” was necessary to show
`standing].
`Similarly, in In re Paoli R.R. Yard PCB Litig.,
`916 F.2d 829, 850 (3rd Cir. 1990), the Third Circuit
`held that: “ . . . courts have begun to recognize claims
`like medical monitoring, which can allow plaintiffs some
`relief even absent present manifestations of physical
`injury” and that “in the toxic tort context, courts have
`allowed plaintiffs to recover for emotional distress
`suffered because of the fear of contracting a toxic
`exposure disease.”
`The Sixth Circuit followed suit. In Sutton v. St.
`Jude Medical S.C., Inc., 419 F.3d 568 (6th Cir. 2005),
`plaintiffs had standing to bring claims against the
`defendant hospital arising from exposure to an increased
`risk of future harm arising from a defective device that
`was implanted into their body, despite no symptoms
`arising from the subject devices being exhibited.
`The Ninth Circuit followed suit as well. In
`Natural Resources Defense Council v. U.S. E.P.A.,
`735 F.3d 873, 878-879 (9th Cir. 2013), the Circuit
`
`
`
`10
`
`found standing where an environmental organization
`challenged conditional registration of a pesticide that
`would be used on many forms of manufactures textiles,
`on the grounds the parents could not control the risk
`that their children would be exposed to the pesticide
`in various ways.
`Decisions in the D.C. Circuit did so as well.
`Cutler v. Kennedy, 475 F.Supp. 838, 848 (D.D.C. 1979)
`[consumers can bring suit against the FDA when the
`agency has “increased the risk that they will purchase
`and consume unsafe or ineffective drugs. . . . [the] risk
`and deprivation itself constitutes a distinct and palp-
`able injury . . . ”].
`As did the Third Circuit in Cottrell v. Alcon
`Laboratories, 874 F.3d 154 (3rd Cir. 2017) (“Cottrell”).
`In Cottrell, the plaintiffs brought claims against the
`manufacturers of an allegedly defective eye medication.
`In holding that those plaintiffs had standing pursuant
`to this Court’s “identifiable trifle” standard the Third
`Circuit held:
`“The injury-in-fact requirements is ‘very
`generous’ to claimants, demanding only that
`the claimant ‘allege[] some specific, ‘identifi-
`able trifle’ of injury.” (citing Bowman v.
`Wilson, 672 F.2d 1145, 1151 (3rd Cir. 1982)
`(quoting SCRAP, 412 U.S. at 686-90 n. 14).
`It ‘is not Mount Everest.’ (citing Danvers
`Motor Co., Inc. v. Ford Motor Co., 432 F.3d
`286, 288 (3rd Cir. 2005)).”
`Cottrell, supra, 874 F.3d at 162-163.
`Finally, in Massachusetts v. United States Dept.
`HHS, 923 F.3d 209, 222 (1st Cir. 2019), the First Circuit
`held: “[i]t is bedrock proposition that a relatively small
`
`
`
`11
`
`economic loss – even an ‘identifiable trifle’ – is enough
`to confer standing.” (citing among other authority,
`SCRAP, supra, 412 U.S. at 690 n. 14).
`B. A Separate Line of Decisions Holds That
`Standing Cannot Exist Unless “Material-
`ized” Risk of Future Harm Is Suffered by
`The Plaintiff.
`On the other end of the spectrum, is the case of
`Clapper v. Amnesty International USA, 568 U.S. 398
`(2013) (“Clapper”). In that case, this Court held that:
`“‘allegations of possible future injury are not sufficient’
`(quoting Whitmore v. Aransas, 495 U.S. 149, 158
`(1990)).” (emphasis original). Indeed, Clapper was both
`cited and heavily relied upon by the Fifth Circuit below
`in affirming the District Court’s Order of Dismissal of
`Petitioner’s claims for lack of standing. App.6a-7a, and
`11a.
`Similarly, in another case relied upon by the Fifth
`Circuit below to affirm dismissal of Petitioners’ claims,
`this Court’s recent decision in TransUnion LLC v. Ramirez,
`495 U.S. 413, 437-438 (2021) (“TransUnion”) held that
`the plaintiffs in that case failed to show injury-in-fact
`because “plaintiffs did not demonstrate that the risk
`of future harm materialized” and such risk was “too
`speculative”. Compare Fifth Circuit’s Opinion affirming
`Order of Dismissal, at App.8a-11a.
`The Fifth Circuit thus diverted from the First
`Circuit, the Second Circuit, the Third Circuit, the Sixth
`Circuit, the Ninth Circuit, and the Tenth Circuit–
`reflecting a divide found in this Court’s own conflicting
`directions on the fundamental question of: who can
`petition the judicial branch for redress?
`
`
`
`12
`
`II. THIS COURT SHOULD SETTLE THE TWO
`CONFLICTING INJURY-IN-FACT STANDARDS TO
`PRESERVE UNIFORMITY OF COURT DECISIONS
`OVER THIS IMPORTANT PUBLIC AND CONSTI-
`TUTIONAL ISSUE.
`We face an unparalleled moment in the history of
`public health: the race to rush a vaccine authorization
`and approval without robust debate or meaningful
`citizen participation. Forced vaccination onto unwilling
`citizens without strict safety safeguards, with no
`manufacturer liability, using experimental technology
`to combat a novel virus from a viral family with no
`history of vaccine success.
`The FDA misled caretakers and guardians of
`children as young as six months old into believing that
`what they are receiving is a biologically licensed, fully
`vetted and completely approved vaccine, when such a
`product was not even available. Despite the overwhelm-
`ing evidence to the contrary, the FDA continuously
`misrepresented the biologic as a “safe,” “effective,”
`“vaccine,” when it is neither safe nor effective, nor even
`a vaccine under the colloquial and common definition
`of a vaccine – to actually prevent infection and trans-
`mission.
`If Petitioners cannot sue, who can? As Justices of
`this court effectively asked at recent oral argument, can
`no one sue the FDA? Is that what Article III means?
`If that is the law, then Article III is empty and the
`judicial branch legally impotent from rogue agencies
`exercising extraordinary emergency powers at the
`direct expense of the people they were obligated to
`protect. If CHD, drained of resources fighting the lies
`of the FDA to protect children, have no right of redress
`
`
`
`13
`
`from the judicial branch, then the FDA is both above
`the law and beyond the Constitution.
`The basis for Constitutional standing is a simple
`one: a “case or controversy.” If those subject to forced
`vaccines, and an organization whose mission it is to
`protect our country’s most vulnerable groups against
`medical harm, cannot be said to have a “case and
`controversy” against the government agency tasked
`with maintaining transparency and honesty in pharma-
`ceutical labeling, then there is no plaintiff who could.
`As discussed above, the District and Circuit Courts
`lack uniformity of decisions from this Court in deter-
`mining whether standing arising from the plaintiff’s
`exposure to risk of future harm requires an “identifiable
`trifle” (SCRAP, supra, 412 U.S. at 690 n. 14), or “mate-
`rialized” “future harm” (TransUnion, supra, 495 U.S.
`at 437-438).
`The Fifth Circuit below went with the far more
`exacting standard set forth in TransUnion, essen-
`tially ignoring the deferential standard set forth in
`SCRAP. It is imperative for this Court to clarify which
`standard applies, in order for uniformity of decisions
`over this most important issue of separation of powers
`to exist going forward.
`Ultimately, the FDA asks this Court to declare
`itself powerless, the judiciary empty of remedy, the
`balance of powers imperfectly imbalanced, and the
`Constitutional check on executive power mute. That
`is not the law, and this Court should say so.
`
`
`
`14
`
`III. THIS COURT SHOULD ALSO RESOLVE THE
`UNSETTLED ISSUE OF WHEN AN ORGANIZATION
`HAS STANDING TO SUE WHERE ITS RESOURCES
`ARE DIVERTED BY AGENCY ACTION.
`The Fifth Circuit also diverted from sister Circuits
`on the question of organizational standing. Unlike the
`decision below, decisions of sister Circuit Courts affirm
`an organization’s standing under Article III, where
`its pre-litigation efforts to evaluate and challenge
`government acts result in a drain on the organization’s
`resources. See e.g., Abigail Alliance for Better Access
`to Developmental Drugs v. Eschenbach, 469 F.3d 129
`(D.C. Cir. 2006); Hooker v. Weathers, 990 F.2d 913,
`915 (6th Cir. 1993); El Rescate Legal Services, Inc. v.
`Executive Office of Immigration Review, 959 F.2d 742,
`748 (9th Cir. 1991); Public Citizen v. Foreman, 631
`F.2d 969, fn. 12 (D.C.Cir.1980); Natural Resources
`Defense Council, Inc. v. SEC, 606 F.2d 1031 (D.C. Cir.
`1979); Am. Acad. of Pediatrics v. FDA, 379 F.Supp.3d
`461 (D. Md. 2019).
`For example, the DC Circuit Court found an
`organization need not show an “overly burdensome”
`injury to satisfy standing. Public Citizen v. Foreman,
`631 F.2d 969, fn. 12 (D.C. Cir. 1980) (“Public Citizen”).
`In Public Citizen, the court held that a nonprofit public
`interest group and two of its members had standing
`against the government to seek a declaratory judgment
`that nitrates used in curing bacon are an “unsafe” food
`additive under the Federal Food, Drug, and Cosmetic
`Act. The Court found that because nitrite-free bacon
`“was not readily available at a reasonable price”,
`plaintiffs sustained an injury, even though they could
`abstain from eating bacon or purchase the more
`
`
`
`15
`
`expensive nitrite-free bacon and the injury was not
`“overly burdensome.” Id. at fn. 12.
`The Fifth Circuit diverted from these sister Circuits,
`requiring a direct, immediate, intended injury beyond
`foreseeable resource diversion, that reflects a continued
`confusion in this critical area of law governing judicial
`access. For that reason as well, this Petition should be
`granted by this Court in order to clarify this unsettled
`area of the law of organizational standing.
`
`
`
`CONCLUSION
`For the reasons set forth above, this petition for a
`writ of certiorari should be granted.
`
`
`Respectfully submitted,
`
`Robert E. Barnes
` Counsel of Record
`BARNES LAW
`700 South Flower Street
`Suite 1000
`Los Angeles, CA 90017
`(310) 510-6211
`robertbarnes@barneslawllp.com
`
`Counsel for Petitioners
`
`
`April 22, 2024
`
`
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