Upholding Constitutional & Human Rights Law During National Emergencies

Examining Legislative Overreach with the PREP Act, the Role of the Judiciary in Protections, and Other Remediation Strategies

The Public Readiness and Emergency Preparedness (PREP) Act, enacted in 2005, (and amended 12 times as of December 2024) was designed for expedience and to shield manufacturers and distributors of medical countermeasures from liability during public health emergencies. The act grants broad immunity from liability from personal injury claims to certain entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of medical countermeasures during public health emergencies such as chemical, biological, radiological, and nuclear agents of terrorism, epidemics, and pandemics.

The Act states the following:

The declaration provides immunity from liability (except for willful misconduct) for claims:

• of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions

• determined by the Secretary to constitute a present, or credible risk of a future public health emergency

• to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures

Cases Dismissed Due to the PREP Act

The consequences of the countermeasure initiatives employed during the pandemic have illuminated significant legal and ethical concerns and challenges associated with the PREP Act, particularly regarding its impact on individual rights, accountability, and limiting access to legal recourse for individuals who suffer injuries from the use of these countermeasures.

At face value, many might presume that the liability exemption is all-encompassing and it has stood in the way of many cases as recent court cases have shown. For example, the State of Texas V. Pfizer Inc. case where the Texas State Attorney General filed suit against Pfizer for misrepresenting the effectiveness of the countermeasure product. The case was dismissed on January 1st, 2025 citing the PREP Act’s legal protections of immunity.

While the above-referenced case included allegations that could be seen as examining willful misconduct (e.g. misleading, false advertising), the dismissal was based on the legal protections afforded by the PREP Act, rather than a detailed examination of the misconduct claim. Due to this, the court justice presiding dismissed the case citing the PREP act without adjudicating on the merits of the allegations of misconduct that is added as an exception to the Act.

Constitutional Grounds That Challenge the PREP Act

Due to the broad reach of immunity in one specific clause - the Act includes a provision that no court of the United States or any state shall have subject matter jurisdiction to review actions by the HHS Secretary under the PREP Act declaration, effectively limiting judicial oversight of these declarations. This limitation on judicial review is a point of contention, as it is seen by some as circumventing the traditional balance of powers between the executive and judicial branches, as well as state sovereignty. Critics argue that such provisions undermine the judiciary’s role in checking executive actions and ensuring that they comply with the law and Constitution. Legislators passing a bill to cut out the jurisdiction of the judiciary is itself unconstitutional on several grounds.

Separation of Powers: The U.S. Constitution establishes a separation of powers among the legislative, executive, and judicial branches, as outlined in Articles I, II, and III respectively. Article III specifically vests judicial power in the courts, with Section 2 defining the types of cases to which this judicial power extends. The attempt to entirely remove judicial oversight, as could be inferred from aspects of the PREP Act, is an unconstitutional encroachment on judicial power, disrupting the balance of power established by the Constitution.

Checks and Balances: The system of checks and balances is intrinsic to the U.S. government structure, where each branch checks the others to prevent anyone from becoming too powerful. By removing judicial review over certain acts or decisions, Congress would be undermining this fundamental principle, potentially allowing for unchecked legislative or executive action.

Judicial Review: The landmark case of Marbury v. Madison (1803) established the principle of judicial review, where the courts have the authority to determine the constitutionality of laws passed by Congress. This precedent implies that the judiciary's role in interpreting the Constitution is fundamental and cannot be completely stripped by legislative action.

Seventh Amendment: Another constitutional concern is the potential violation of the Seventh Amendment, which guarantees the right to a trial by jury in civil cases. The PREP Act’s immunity provisions could be argued to infringe upon this right by limiting the ability of individuals to seek redress in court for injuries caused by covered countermeasures.

Tenth Amendment: Additionally, the Act’s provisions could be challenged based on the Tenth Amendment, which reserves powers not delegated to the federal government to the states or the people. If the PREP Act is seen as overstepping federal authority and infringing on state sovereignty, it could also be subject to constitutional scrutiny.

It is important to note that the PREP Act has been upheld in some cases, and the Supreme Court has not yet ruled on its constitutionality, but there are several historical precedents to consider in light of this Act.

Legal Precedents and Interpretations:

• Ex Parte McCardle (1868): This case is often cited in discussions about Congress's power over judicial jurisdiction. Here, the Supreme Court held that Congress could restrict the Court's appellate jurisdiction, but this was under the Exceptions Clause of Article III, Section 2, which allows Congress to make exceptions to the Supreme Court's appellate jurisdiction. However, this case does not support entirely eliminating judicial review over all matters, especially those involving constitutional rights.

• Jurisdiction Stripping: While Congress has the authority to define the jurisdiction of lower federal courts and make exceptions to the Supreme Court's appellate jurisdiction, there's a debate about how far this can go without infringing on constitutional rights. Scholars like Henry M. Hart Jr. have argued that Congress cannot remove judicial review over constitutional issues entirely because it would defeat the purpose of the judiciary in safeguarding constitutional rights.

• Constitutional Protections: Specific constitutional provisions like the Due Process Clauses of the Fifth and Fourteenth Amendments imply that individuals have a right to judicial review to protect their rights. Completely barring judicial review would arguably violate these protections.

Judicial and Legislative Oversight

Legislators cannot remove Judicial review as they are separate powers. Such a move can be interpreted as “Legislative Overreach.”

• Checks and Balances: The judiciary is meant to check legislative overreach, ensuring laws are constitutional. If a law like the PREP Act is seen to violate fundamental rights or ethical standards, courts should theoretically address this proactively or through cases that question the law's application.

• Constitutional Review: Courts have the authority to review laws for constitutionality under Article III of the U.S. Constitution. This means that even without specific cases, courts can address constitutional questions if they arise in litigation or through judicial activism.

• Judicial Activism: Judges can use their prerogative to question laws on constitutional grounds, particularly in areas where there's evident public harm¹ or ethical issues at stake.

Judicial oversight can give Congress specific legal guidelines that would necessitate amending the act to address specific areas where constitutional law and the Bill of Rights cannot be abridged concerning emergency countermeasures.

Practical and Ethical Considerations

While Congress has some authority to regulate the jurisdiction of the federal judiciary, entirely cutting out judicial review should be seen as unconstitutional because it has undermined the separation of powers, the system of checks and balances, and the judiciary's role in upholding the Constitution. Legal scholars and various judicial opinions over time have suggested that there are constitutional limits to how much Congress can restrict judicial review, particularly when fundamental rights and constitutional interpretation are at stake.

The Right to Due Process

The U.S. Constitution's Fifth and Fourteenth Amendments ensure that individuals are not deprived of "life, liberty, or property" without due process of law.

1. Violation of Due Process - Judicial Oversight: The PREP Act's provision that explicitly bars judicial review (42 U.S. Code § 247d–6d(b)(7)) violates the constitutional right to due process. Renowned legal scholar and professor at George Washington University Law School, Jonathan Turley, has consistently emphasized that the judiciary's role in checking executive and legislative overreach is fundamental to due process, and scholars at the Hoover Institution say the same.

2. Practical and Ethical Considerations: The PREP act's framework has enabled the administration of health interventions without full disclosure to the public, which is seen as an ethical violation and potentially a human rights issue under international treaties like the International Covenant on Civil and Political Rights (ICCPR) and the Convention Against Torture, and other Cruel, Inhuman, or Degrading Treatment or Punishment (CAT) - both ratified and subject to the Supremacy Clause.

   1. Potential for Abuse: Without judicial review, there's a heightened risk of abuse of power, where laws could be passed or actions taken that might otherwise be deemed unconstitutional or harmful to individual rights.

   2. Accountability and Transparency: Removing judicial oversight has led to unchecked governmental actions, reducing accountability and transparency, which are essential for maintaining public trust and ensuring that government actions align with our constitutional Bill of Rights.

   3. Lack of Informed Consent:

      Mary Holland, legal scholar and professor at New York University School of Law, has critiqued how the PREP Act allows for the deployment of medical countermeasures without traditional informed consent processes. This is particularly concerning in the context of EUAs, where the urgency of the situation is claimed as the right to bypass individual consent rights.²

   4. Bodily Autonomy and Sovereignty:

      Bodily Autonomy: lawyers like Robert F. Kennedy Jr. argue that the PREP Act's liability protections and the ability to mandate treatments infringe on personal sovereignty and the right to refuse medical treatment, which is fundamental to bodily autonomy.³

      Sovereignty: The broad powers given to the Secretary of HHS under the PREP Act can be seen as an overreach into personal health decisions, challenging the notion of individual sovereignty over one's body.

   

The Consequences of the PREP Act

These arguments and resources underline the tension between emergency health responses and the foundational legal and ethical principles of the U.S. Constitution, highlighting the urgent need for legislative reassessment of the PREP Act. Even without considering the Constitutional legality of the act, the cases that were dismissed due to the act, and the current legal challenges related to the act, we must also consider the extent and scope of damages endured by the populace with substandard tracking, and care or compensation given to the injured and bereaved.

Injuries and Harms Reported

VAERS (Vaccine Adverse Event Reporting System)⁴:

• Commonly Reported Injuries and Harms:

  • Cardiovascular: Heart attacks (18,504 reported by Feb 3, 2023), myocarditis, and pericarditis.

  • Neurological: Seizures (348 pages of reports), paralysis (60 pages), and stroke (with a notable increase post-2020).

  • Death: Over 34,270 deaths were reported by February 2023, with specific scrutiny on the correlation with vaccinations.

  • Other Serious Conditions: Blindness (126 pages), thrombosis (368 pages), respiratory issues like pulmonary fibrosis.

  • Disability: 63,097 reports of individuals becoming permanently disabled.

• Concerns with VAERS:

  • Underreporting: There's evidence suggesting that less than 1% of vaccine adverse events are reported to VAERS.⁵

  • Data Handling: Issues with data processing and public transparency, where updates to reports aren't always reflected in the public database.⁶

V-Safe Data⁷:

• Medical Care: Approximately 7.7% of all registered V-Safe users (10,108,273) reported needing medical care post-vaccination.

• Serious Harms: While V-Safe collects data on health impacts, much of it is relegated to free-text fields, potentially hiding the severity or frequency of adverse events from public view.

• Discontinuation: V-Safe has reportedly stopped accepting new reports of vaccine injuries, moving users to VAERS, which raises concerns about ongoing safety monitoring.

• Issues with V-Safe:

  • Limited Public Data: Unlike VAERS, V-Safe data isn't made public in raw form but through studies or reports by the CDC, potentially reducing transparency.

  • Design Flaws: The system's design, including the use of free-text fields, might limit the ability to quantify or recognize patterns of adverse events effectively.

Note: This data represents real human experiences, not just numbers, highlighting the need for Accountability and Transparency.

Failure to Provide Financial Support to the Injured

After the passage of the National Childhood Vaccine Injury Act, or NCVIA in 1986, injury claims were transferred to the government to shield the Pharmaceutical industry from losses due to injury lawsuits. However, with the passage of the PREP act in 2005, for pandemics, the Countermeasures Injury Compensation Program (CICP) was created specifically for those injured from the emergency countermeasures. Only, the CICP system has proven to be wholly inadequate, with limited staff support to process claims in a timely fashion for victims dealing with piling debt for medical care bills dealing with severe, or debilitating injuries. Despite over 13,000 claims filed, it was reported that only three percent of claims have been awarded. Articles cite these statistics stating that only 3% were “eligible” suggesting 97% are not. Yet, of those 3% deemed, “eligible”, far less than 3% were awarded specifically for COVID-19 countermeasures, with other amounts awarded to those injured by flu vaccines, and other pharmaceutical products.⁸

Considering the profits gained by the industry that benefitted from government contracts complete with injury liability shields, paired with an obvious lack of support for the injured, is it ethical to mandate the products with blanket immunity while also failing to provide adequate support to the adversely affected? To allow such a flagrant disregard for the dignity of those who suffered as a result of the pandemic response is unconscionable, morally reprehensible, and a complete miscarriage of justice so long as Justices continue to ignore the plight of the injured citing the PREP Act as the reason to dismiss their legal cases.

The Pandemic Response Raises Valid Ethical Concerns

By presenting the injury data alone, even without the underreporting factor, there is enough evidence of harm to prove the necessity of revising legal frameworks like the PREP Act to incorporate greater accountability and transparency, ensuring public health measures are both effective and ethically sound. The PREP Act's application during the SARS-CoV-2 response bypassed traditional informed consent procedures, which is also ethically problematic. The ethical issues around informed consent, especially in light of these reported harms, underscore the need for systems that ensure individuals are fully aware of potential risks, particularly when legal protections prevent recourse for adverse outcomes.

There's a significant ethical issue with transparency when public health actions are taken with little oversight or public knowledge, especially if those actions could involve harm. The lack of clear, public access to comprehensive data from both systems means there's less scrutiny over the actions of those deploying countermeasures. This opacity can lead to distrust and questions about the actual safety of the products marketed and disseminated as a part of emergency authorizations.

The sheer number of reported serious injuries and deaths, even if not causally linked, highlights the need for a system where accountability can be pursued. With legal immunity for injury under the PREP Act, there's a significant barrier to holding manufacturers or administrators accountable for injuries that might stem from negligence or malfeasance if their crimes have been purposefully hidden through the lack of transparency. This concern is echoed in discussions by Aaron Siri and J.B. Handley, who argue for accountability mechanisms.⁹

Regardless of how much liability shielding for injuries the courts interpret by the Act, the lack of transparency exhibited during the pandemic is apparent. A transparent reporting system would not only help in identifying true safety signals but also in reassuring the public about the safety of public health measures, thus balancing emergency response with ethical medical practice.

Direct Challenges to the Immunity Clause of the PREP Act

The PREP Act provides immunity from liability for claims of loss caused by, arising out of, relating to, or resulting from the administration or use of covered countermeasures during a declared public health emergency. This immunity is broad but there is a specific legal nuance - the act includes an exception for "willful misconduct.”

Regardless of the arguments on the constitutionality of the Act itself, the key aspect to consider concerning the Public Readiness and Emergency Preparedness (PREP) Act’s immunity provisions is that it excludes claims of willful misconduct from protection. According to the Act, immunity does not cover actions that result in death or serious physical injury due to willful misconduct. This means that if an individual or entity is accused of such misconduct, they can still face legal liability. Willful misconduct is defined as an act or omission that is taken intentionally to achieve a wrongful purpose, knowingly without legal or factual justification, and in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit. In legal contexts, it often involves a deliberate violation of rules, a disregard of standards of behavior that people rightfully expect, or negligence that manifests culpability, wrongful intent, evil design, or an intentional and substantial disregard of the people’s interests or the health industries’ duties and obligations.

Preparing cases to address all areas of misconduct may give legal standing to those injured by the misconduct, despite the broad scope of liability limitations of the act. Here’s where we tread into the grey area of the Act’s liability shield.

Gross Negligence, Malfeasance, Nonfeasance, Fraud, and Profiteering: The act's structure encourages profiteering, especially in scenarios where emergency health measures lead to lucrative contracts for pharmaceuticals under less scrutiny. The dangers of not checking administrative or executive power under the guise of emergencies are precisely because the PREP Act can be misused by vested interests to manufacture emergencies to then profit from the contracts granted under blanket immunity. Those with financial interests can and will abuse this avenue to maximize profits at the expense of public health and safety. This is a dangerous precedent that necessitates both transparency and accountability to ensure such probabilities of profit interests at the expense of the public good and common welfare are entirely negated, and harms as a result of negligence, malfeasance, nonfeasance, and fraud are properly mitigated and remediated.

Federal Enforcement Actions: The PREP Act immunity does not extend to federal enforcement actions either, whether they are civil, criminal, or administrative. Under the Office of the Inspector General (OIG), civil penalties, injunctions, criminal prosecution, or seizures can be implemented, depending on the nature of the violation and the agency involved. This means that if a federal agency (OIG) brings an enforcement action against a covered person, agency, corporation, or organization, the PREP Act immunity does not protect against such actions.

Exclusion of Equitable Relief Claims: The immunity also does not cover claims for equitable relief under federal law. Equitable relief typically refers to remedies that are not monetary, such as injunctions or other forms of court orders. With that context in mind, those in the legal profession do have the leverage to seek injunctions to mitigate harm.

Future Actions to Remedy Emergency Health Failures

Given the recent experiences with emergency health measures, there's an increasing call for reevaluation or amendment of the PREP Act to ensure it respects constitutional rights and ethical standards.

The public's experience with the deployment of EUAs for treatments mislabeled as vaccines, alongside concerns about transparency and consent, might fuel more direct legal challenges.

Legal Challenges and Legislative Amendments:

Legal scholars and activists must argue for:

• Constitutional Violations:

  • Due Process: Section 42 U.S. Code § 247d–6d(b)(7) infringes on the right to due process by preventing judicial review, especially when new evidence of harm or misconduct emerges.

  • Separation of Powers: This provision could be seen as Congress or the executive branch unconstitutionally limiting the judiciary's role.

  • Equal Protection: If protections are seen to systematically benefit certain parties (like pharmaceutical companies) without equal accountability, this might raise equal protection issues.

  • Infringement on Bodily Autonomy: Mandates under the PREP Act could be challenged under privacy and personal liberty rights.

  • First and Seventh Amendment Issues: Claims related to the freedom to refuse medical treatment without facing repercussions or the right to sue for damages could be brought to court.

• Other Legal Strategies:

  • Lawsuits: Individuals or groups could sue, arguing for a reinterpretation or strike-down of this provision based on new evidence of misuse during the pandemic.

  • Recourse for the Injured: Even with the PREP Act, lawsuits can sometimes find other avenues or focus on preemption issues, or state consumer protection laws.

  • Amicus Briefs: Legal scholars, organizations concerned with civil liberties, or those representing victims could file briefs supporting such challenges.¹⁰

The Legal and Legislative Initiatives Have Just Begun

Attorney Jeff Childers, known for his involvement in various legal battles concerning health mandates and rights, has filed a lawsuit challenging the constitutionality of the PREP Act. The Moms for America v. Becerra case was filed in Federal Court in Florida on June 26, 2024.

The lawsuit primarily argues that the PREP Act violates constitutional rights by providing immunity from liability for those involved in deploying countermeasures, which Childers claims infringes on the Seventh Amendment right to a jury trial and the due process clauses of the Fifth and Fourteenth Amendments. It also questions the lack of judicial review, arguing it undermines the separation of powers.

As court cases can take years, we will have to pay attention to the developments of this case. The best-case scenario would be a new legal precedent set to address the constitutionality of the act. ICAN has also filed a lawsuit to strike down unconstitutional provisions.¹¹ Other lawyers can and should bring cases like these to court in their jurisdictions as well to improve the likelihood of justices adjudicating in favor of remediation.

Legislative Amendments or New Legislation: Congress could repeal or make further amendments to the act:

• Limit or Clarify: Define more explicitly the conditions under which protections can be extended, ensuring they align with current public health needs rather than extending protections indefinitely for past emergency events.

  • Limiting Immunity: Narrow the scope of liability immunity to only those actions that are genuinely necessary and devoid of negligence or fraud, with clear accountability pathways.

• Reinstating Judicial Review: Amendments could include provisions to allow judicial review of decisions made under the PREP Act to ensure they align with constitutional protections.

• Oversight and Sunset Clauses: Introduce oversight committees, mandatory reporting, or sunset clauses for emergency declarations to prevent indefinite or excessive use of emergency powers. Include provisions that require periodic review or automatic expiration of such protections.

• Transparency and Accountability: Mandate transparency in the deployment and outcomes of countermeasures, along with mechanisms for accountability.

• Informed Consent: Require explicit mechanisms for informed consent even in emergencies, ensuring transparency in the deployment of countermeasures. This is explored in the Pharmaceutical Accountability and Transparency Act, proposed on Policies for the People.¹²

Challenges/Solutions to Legislative Change:

While there are clear challenges, the system, although exhibiting behaviors evidently in favor of corporate rights over individual rights, isn't necessarily "doomed." Public pressure, legal challenges, and shifts in political power can lead to change. The challenge with Legislative changes requires overcoming significant lobbying from pharmaceutical interests. Many legislators have financial ties to pharmaceutical companies, which can influence legislation. However, exact numbers are not publicly detailed but can be inferred from lobbying disclosures and financial disclosures of legislators.

The solution is the restoration of a Free Press to raise public awareness. Using Substack, X, Rumble, and other alternative networks that allow public discourse, instead of using platforms like Facebook, Instagram, and YouTube (which have been actively censoring Americans on the front lines of the health freedom movement), is helping American citizens research and work on issues around accountability and transparency, as well as the necessary reforms required to address the failures of government to serve and protect their citizens from overreach. Increased media coverage and public campaigns can also influence legislative actions that can resolve standing issues.

Public outcry and evidence of harm have already shifted the political landscape with a majority of Americans voting for what they hope is a different Administration. While we expect the new administration will rectify the previous administration's failures, it is always important for citizens to engage in their civic duty to demand public servants listen to their constituency, not just deep-pocket donors. Until the republic also stands United to Protect and Defend our Constitution and hold elected officials accountable for violating the values inherent in our American DNA, we will continue to witness efforts of many within our systems of governance to systematically erode it. The just and moral cause to uphold and protect our Bill of Rights, and honor human rights law, is a principle All Americans must remain ever vigilant in protecting regardless of whether we are in times of peace, or in times of emergency.

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Additional Resources:

1. Totality of Evidence: Adverse Events following COVID-19 injections: https://totalityofevidence.com/adverse-events-following-covid-19-injections

2. Mary Holland, "Legally Poisoned: How the Law Puts Us at Risk from Toxicants," Harvard Environmental Law Review; "The PREP Act: A Threat to Medical Freedom," The Hill; "The Unchecked Power of Emergency Health Laws," Children's Health Defense Blog.

3. Robert F. Kennedy Jr.: His advocacy for children injured through Children's Health Defense has involved critiquing laws like the PREP Act, focusing on the loss of individual rights, the lack of informed consent, and the implications of liability immunity. "The Assault on Informed Consent," discusses the erosion of consent rights in health emergencies; "Unpacking the PREP Act and Public Health Overreach," The Joe Rogan Experience.

4. https://vaers.hhs.gov/data.html

5. OpenVAERS: What is underreporting and why it matters? | https://www.openvaers.com/faq/what-is-underreporting-and-why-it-matters

6. OpenVAERS: Confirmation Comes That Indeed There Are Two Sets of Books | https://www.openvaers.com/faq/confirmation-comes-that-indeed-there-are-two-sets-of-books

7. Informed Consent Action Network V-SAFE Data | https://icandecide.org/v-safe-data/

8. “Review of US vaccine injury reimbursement program shows less than 3% of claims eligible for compensation” CIDRAP - Center for Infectious Disease Research & Policy
Research and Innovation Office, University of Minnesota, Minneapolis, MN https://www.cidrap.umn.edu/covid-19/review-us-vaccine-injury-reimbursement-program-shows-less-3-claims-eligible-compensation

9. Aaron Siri: Known for challenging vaccine mandates and related laws, Siri has commented on how laws like the PREP Act could facilitate mandates without adequate accountability or transparency, particularly concerning EUAs. Siri has made many appearances in media interviews where he focuses on the lack of accountability for pharmaceutical companies under PREP. https://www.sirillp.com/aaron-siri/

10. America’s Front Line Doctors (AFLDS) Files Amici Curiae Brief in Kennedy v. Biden | https://americasfrontlinedoctors.org/about-us/press-releases/aflds-files-amici-curiae-brief-in-kennedy-v-biden

11. https://thehighwire.com/ark-videos/ican-funds-major-lawsuit-targeting-prep-act-immunity/

12. Policies for the People: Comprehensive Pharmaceutical Accountability and Transparency Act (PATA) | https://forum.policiesforpeople.com/t/comprehensive-pharmaceutical-accountability-and-transparency-act-pata/19626 |

Note: this article was 70% human with 30% AI assistance or LLM support.