DAVID EDWARD SMITH HAS FILED A LAWSUIT IN AGAINST D.E.A., C.D.C AND DOJ ATTORNEY GENERAL FOR INTERFERENCE WITH PRESCRIPTION MEDICATIONS: AN ANALYSIS REVIEW AND PODCAST

“..Find out just what a people will submit to, and you have found out the exact amount of injustice and wrong which will be imposed upon them, and these will continue till they are resisted with either words or blows or with both. The limits of tyrants are prescribed by the endurance of those whom they oppress..” frederick douglas

reported by youarewithinthenorms.com

NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. SPIRIT OF REV. IN THE SPIRIT OF WALTER R. CLEMENT BS., MS, MBA. HARVEY JENKINS MD, PH.D., IN THE SPIRIT OF C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., EVELYN J. CLEMENT, WALTER F. WRENN III., MD., JULIE KILLINGSWORTH, RENEE BLARE, RPH, DR. TERENCE SASAKI, MD LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., RICHARD KAUL, MD., IN THE SPIRIT OF LEROY BAYLOR, JAY K. JOSHI MD., MBA,AISHA GARDNER, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS

David Edward Smith has filed a lawsuit against the United States, substituting it for the Directors of the CDC and DEA, and the Attorney General of the DOJ. 

This lawsuit, Smith v. United States, concerns claims filed by David Edward Smith, a pro se litigant, against the United States. Smith alleges negligence and unlawful interference with the practice of medicine by the Centers for Disease Control and Prevention (CDC), Drug Enforcement Administration (DEA), and Department of Justice (DOJ), as well as violations of constitutional rights and international treaties.

Smith alleges negligence and tortious interference with the practice of medicine, asserting the CDC’s 2016 opioid guidelines, DEA enforcement policies, and DOJ’s prosecution of doctors violate federal law, constitutional rights, and international treaties. 

He claims these actions have led to restricted access to pain medication, causing him bodily and economic harm. Smith requests the court review these violations and order changes to address patient harm and ensure proper medical care. 

The suit further alleges that the government’s actions have created a state-sanctioned pain patient torture program by limiting access to necessary medications based on flawed data, thus violating the Constitution. Smith seeks damages of $20,000,000.

ARGUMENT

America was envisioned as a beacon of hope, yet it has become a beacon of deception.  Our nation, entangled in its own lies and distorted beliefs, strays far from what it was meant to be. Today, artificial intelligence threatens to further erode American ideals, twisting them into instruments of oppression and exclusion. 

Larry Ellison’s ambitious vision paints a future where America is transformed into a sprawling surveillance state, driven by relentless health data mining, omnipresent drones, and an all-encompassing digital panopticon; where he advocates for all persons DNA to be captured in his data machines of loving grace.

This new “Rapture” imagines a society where personal privacy is sacrificed in the name of security and efficiency, echoing Orwellian fears of constant oversight and control.

David Edward Smith argues the CDC’s 2016 Guidelines were formulated negligently, leading to restricted access to opioid pain medications and harming patients.

He argues that the CDC acted ultra vires (beyond its legal authority) in issuing these guidelines, violating 42 U.S.C. § 1395, which prevents federal supervision over the practice of medicine.

He contends that the CDC should be held liable under Texas law, which allows suits against government officials for committing ultra vires acts. “Plaintiff contends that the publication of and continued refusal to retract or to rescind the 2016 CDC Guidelines are ultra vires acts in violation of 42 U.S.C. § 1395.”

David Edward Smith details his personal medical history, including multiple spinal surgeries and diagnoses of arachnoiditis and cauda equina syndrome.

He describes the difficulties he faced in obtaining his pain medication regimen after moving to Texas, leading to opioid withdrawal symptoms and loss of his ability to work. He blames the CDC Guidelines and DEA/DOJ enforcement policies for his inability to access adequate pain management.

Larry Ellison, channeling the utopian ambition of Andrew Ryan from BioShock, has envisioned a healthcare utopia where technology would bring eternal health and prosperity.

However, his pursuit has morphed into a nightmarish reality where data collection has become the tool of oppression rather than liberation.

Under the guise of improving healthcare, Ellison’s systems have woven a web of surveillance that has led to the United States becoming the world’s largest dystopia, with incarceration rates soaring to unprecedented heights as personal data is used not to heal but to control and punish, turning the promise of an American utopia into the reality of the world’s largest prison state.

DEA Negligence and Unlawful Tortious Interference with the Practice of Medicine in Violation of 42 U.S.C. § 1395:

David Edward Smith, accuses the DEA of ongoing negligent and unlawful enforcement of opioid dose caps and medication combination prohibitions, leading to forced tapers, sudden discontinuation, and loss of access to needed medications.

He argues this constitutes “abuse of process” by law enforcement. “Plaintiff contends that the DEA’s continued ongoing negligent and unlawful enforcement of opioid dose caps, blanket medication combination prohibitions (such as with opioids and benzodiazepines), without regard to individual patient metabolism rates, absorption rates, reactions to, or tolerance of such medications, resulting in forced-tapers, sudden discontinuation, and loss of access to opioids and to other controlled substances, has been a Proximate Cause of harm to Plaintiff and to millions** of patients.”

DEA Violations of the United Nations Single Convention on Narcotic Drugs:

David Edward Smith argues and claims the DEA’s annual cuts in opioid production and distribution violate the treaty, which mandates ensuring availability of narcotic drugs for pain relief.

“Plaintiff contends that the DEA’s annual cuts in production and distribution of opioid medications and other controlled substances violate the provisions of the Preamble of the United Nations Single Convention on Narcotic Drugs, which stipulates that: ‘Recognizing that the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering and that adequate provision must be made to ensure the availability of narcotic drugs for such purposes…'”

DOJ Tortious Interference with the Practice of Medicine in Violation of 42 U.S.C. § 1395, and in Violation of a Supreme Court Ruling:

Smith further argues and claims the Attorney General of the DOJ has allowed the DEA to arrest and prosecute doctors for treating pain without meeting the evidentiary standard set by the Supreme Court in Ruan vs. United States. This, he says, has created a climate of fear, leading to patient abandonment.

CDC, DEA, DOJ, and Congressional Acts in Violation of the 5th and 14th Amendments of the Constitution:

David Edward Smith, contends that current conditions in the U.S. amount to “STATE-SANCTIONED PAIN PATIENT TORTURE AND DEATH CAMP CONDITIONS.” He argues that restricting access to controlled substances violates patients’ rights to life, liberty, and property without due process. He claims that the laws and regulations enacted since the publication of the CDC Guidelines have almost completely denied the class of patients with disabling pain their right to life, liberty, and the pursuit of happiness, violating the 5th and 14th Amendments.

CLICK HERE OR BELOW TO HEAR THE TRUTH

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1.Lawrence Joseph Ellison is an American businessman and entrepreneur who co-founded software company Oracle Corporation. He was Oracle’s chief executive officer from 1977 to 2014 and is now its chief technology officer and executive chairman. 

2.As of January 20, 2025, he is the fourth-wealthiest person in the world, according to Bloomberg Billionaires Index, with an estimated net worth of US$188 billion, and the second-wealthiest in the world according to Forbes, with an estimated net worth of $237 billion.  Ellison is also known for his ownership of 98% of Lānaʻi, the sixth-largest island in the Hawaiian Islands.

3.Ellison, who barely completed a semester in college, envisions transforming America into a digital Rapture. Through Oracle, his tech empire, he proposes a future where AI-driven surveillance systems operate with unblinking vigilance, turning every citizen into an entry in a vast database.

4.“Citizens will be on their best behavior,” he boasts, his words echoing those of an overreaching authority rather than an innovator. Instead of fostering freedom, his vision veers toward control, a world where privacy is extinct, replaced by relentless observation. 

BACKGROUND

Plaintiff’s Personal Harm and Background:

Two distinct but related perspectives on the opioid crisis and its impact on pain patients are presented. First, a pro se litigant, David Edward Smith, is suing the U.S. government, alleging that federal agencies’ opioid policies denied him adequate pain management, violating his rights.

Secondly, the account relays the tragic story of Gretchen Lont, a chronic pain sufferer whose access to medication was restricted, culminating in a fatal health decline possibly caused by ALS, which went undiagnosed for years.

Both narratives suggest that restrictive opioid policies, purportedly aimed at combating the opioid crisis, inflict undue suffering on individuals with legitimate pain conditions.

Furthermore, the summary section argues that the DEA, CIA, and the US-backed government in Afghanistan, rather than doctors, contributed to the increase in drug traffic, and the source then concludes with a call to end the DEA harassment of doctors.

This document provides a detailed review of David Edward Smith’s “Petition for Review of Federal Tort Claims Act Claims, and for Review of Constitutional Rights Violations and International Treaty Violations.” Smith, acting as a pro se litigant, is suing the United States government, specifically naming the Director of the CDC, the Administrator of the DEA, and the Attorney General of the DOJ.

Smith details his personal medical history, including multiple spinal surgeries and diagnoses of arachnoiditis and cauda equina syndrome. He describes the difficulties he faced in obtaining his pain medication regimen after moving to Texas, leading to opioid withdrawal symptoms and loss of his ability to work. He blames the CDC Guidelines and DEA/DOJ enforcement policies for his inability to access adequate pain management.

Lack of adequate pain management leads to various negative consequences, such as broken families, job losses, and even suicide. Despite the prevalence of chronic pain, there’s a shortage of pain specialists and documented undertreatment in various healthcare settings, exacerbating the problem. 

He alleges negligence and tortious interference by these agencies in managing the “opioid crisis,” leading to the denial of adequate pain management for himself and millions of others.

Smith argues that the actions of these agencies have violated the FTCA, Constitutional rights (5th and 14th Amendments), and international treaties, specifically the United Nations Single Convention on Narcotic Drugs.

He seeks judicial review and relief to restore access to controlled substances for legitimate medical use and to end what he describes as “STATE-SANCTIONED STRUCTURES WHICH TORTURE PAIN PATIENTS AND RESULTS IN NEEDLESS DEATH.”

What follows below is a hard read. It was shared with me by “Maria” one of Gretchen’s few surviving friends. I have edited slightly for precision. And I have probed social media deeply enough to believe that Gretchen Lont was a real person, not a created meme.

What is truly horrifying about this story is that millions of chronic pain patients face similar conditions because of the fraud and misdirection of US healthcare agencies that have destroyed the practice of pain medicine. Gretchen’s story, was related to us from Dr. Richard Lawhern by way of her friend Maria as the first-person narrative who wrote this discussion behalf of her dearest friends, Gretchen Lont, a fellow pain warrior whose spirit I cherished deeply.

I made a promise to her: to ensure her pain story is told. Her last hope was that by sharing her experience, we might alleviate the needless suffering of others grappling with untreated or undertreated pain. We call ourselves pain warriors, having fought tirelessly since 2016 for the rights of those struggling with painful conditions to receive adequate pain treatment.

According to the NIH oand CDC, nearly 21% of the U.S. population—51.6 million adults—suffer from chronic pain, surpassing the combined numbers of those afflicted by heart disease, diabetes, and cancer.

DISCUSSION

Before her disability, Gretchen lived life vibrantly. She adored her three sons—Zach, Jordan, and Nathan—and cherished every moment with her family, including her father John, her sisters Stacy and Kristen and brother Michael. She worked tirelessly to provide for her children and always carved out time for joy and laughter. To live life to the fullest.

Gretchen embodied the belief that giving is a greater blessing than receiving. Her generosity knew no bounds, and her radiant smile could light up any room. With a feisty spirit, she was a fierce protector of her loved ones. She found solace in crafting—painting and making jewelry—each piece a testament to her incredible talent.

Animals had a special place in her heart; her social media was filled with adorable animal pictures. She often fed the squirrels and birds in her yard and she adopted a special needs cat named Cleo saying, “We’re two damaged bodies just trying to survive, and we’ll do it together.”

Gretchen’s journey into pain began with an accident at an upscale restaurant in Tacoma. A spill that had gone uncleaned caused her to slip and fall, resulting in a severe back injury which later required surgery. This injury ushered in years of excruciating pain, followed by joint pain, more surgeries and a possible diagnosis of Rheumatoid Arthritis at the age of 57.

Desperate for relief, Gretchen explored every alternative treatment available, yet none eased her suffering. Living with chronic pain is akin to living with a chronic illness; you feel invisible. On the outside, you might appear fine, but inside, your body is screaming in agony.

Eventually, she found a compassionate pain management doctor who, for many years, treated her as an individual. With the help of opioids, she managed to regain a semblance of her life—spending time with family, painting and crafting, celebrating holidays, and enjoying the beauty of nature. Her passion for art blossomed, allowing her to create stunning jewelry and amazing paintings.

Sadly, her doctor, after years of facing scrutiny from medical agencies (though she never lost her cases), decided to retire, joining many physicians who chose to close their doors due to the hostile environment surrounding pain management. In June 2021, she gave her patients a year’s notice in the hopes it would be enough time to find new care.

Unfortunately, Washington proved to be a wasteland for chronic pain patients; most physicians are unwilling to take on patients who are on opioid therapy, and those who will often refuse to continue the opioids and force patients to try previously failed methods.

Gretchen’s only option was to pursue invasive surgery for a pain pump. To qualify, she needed to undergo extensive psychological and physical evaluations, which she passed.

However, she was then told she had to reduce her opioid dosage by 75%. This drastic cut left her bedridden, trapped in a cycle of agonizing pain. After months of suffering, the pain specialist told her that her insurance, Medicaid, would not cover the cost of the pain pump or surgery.

In desperation, she asked if her opioid dosage could be increased to a dose that would provide some relief from the agonising pain. Unfortunately, she only received a minimal increase leaving Gretchen to continue suffering in unbearable agony.

On October 3, 2023, Gretchen felt a deep despair settle over her. Bedridden and in relentless pain, she questioned why a person should be forced to suffer this way.

There was always a battle to fight, trying to find a doctor willing to provide adequate pain treatment, dealing with pharmacists who were choosing whether or not to fill a valid prescription for pain medication and insurance companies not covering prescribed pain treatment. She felt like a burden, unable to spend time with her family or do any of the things that brought pleasure in life.

The pain specialist seemed indifferent to her deteriorating condition. She made the heartbreaking decision to take all her medications in an attempt to end her suffering. Fear gripped her, and she confided in her son, who immediately called 911. Resuscitated through CPR, the ER team noted that this tragic episode could have been avoided had her pain been managed appropriately. They had seen this happen many times. Gretchen was discharged with the recommendation to consult her pain specialist about increasing her medication.

The following day, during a virtual visit, her pain specialist expressed sympathy and promised to improve her pain management. Yet, hope quickly faded when, the next day, at an in person meeting, he declined to increase her dosage, and Gretchen continued her downward spiral.

A friend referred her to a new doctor who specialized in both primary care and pain management. This physician was willing to help but insisted on a cautious approach. They tried various medications, which provided minimal relief, but Gretchen’s health continued to decline.

diagnosed with ALS also known as Lou Gehrigs disease

The years of untreated pain had caused irreparable damage. She had been losing 5-8 pounds weekly, struggled with swallowing, and faced increasingly severe breathing difficulties. She was a mere shadow of the vibrant person she had been two years prior.

By late December 2024, Gretchen’s breathing worsened, leading her doctor to recommend a visit to the UW Emergency Room for treatment of suspected pneumonia and to obtain a neurology consult.

Ultimately, alongside pneumonia, Gretchen was diagnosed with ALS also known as Lou Gehrigs disease. The suffering she had endured for so many years, stemmed from this undiagnosed, incurable, and painful disease.

Admitted to the hospital on January 1, 2025, Gretchen was discharged to home hospice on January 17. Just an hour after returning home, she suffered a coughing fit and an anxiety attack, necessitating another trip to the Emergency Room at a local hospital.

Unfortunately, she soon became unresponsive. She remained in this state for approximately 24 hours, surrounded by her loved ones, until she finally stopped breathing on Sunday, January 19th.

“She has her Angel Wings now, flying free from pain—a bright light in our lives whose flame will never be extinguished” 

summary

As in previous presentations this article more than clearly demonstrates that our work in youarewithinthenorms.com has been absolutely correct;

“that Medical professionals in the US, (with ongoing concerns about the supply chain and the need for further international cooperation,) were never the causative factor of the so-called opioid crisis, and they knew it…as these medical providers were just easier enforcement targets.”  

Immediately after the US invasion, the DEA/CIA teamed up with many of the same Narco-Warlords who had been involved in the drug trade before 2001 as part of the Northern Alliance. The US-backed government then legalized poppy cultivation. Within a year, heroin production returned to pre-Taliban levels, and Afghanistan became the world’s largest producer, supplying 1,000 metric tons of pure heroin each year for two decades – double the global demand.

Following the US withdrawal from Afghanistan and the Taliban’s return to power, poppy cultivation in Helmand Province has reportedly dropped by 99%. This dramatic decrease is a repeat of a similar eradication effort by the Taliban in 2001 before the US invasion. 

This suggests that the US-backed government was at least tacitly supporting opium production. The current situation allows for a clearer view of who was truly responsible for the drug production during the 20 years of US presence, revealing that it was not the Taliban.

CONCLUSION

Americans are sick of the DEA, especially since their intrusion into the medical profession.  Free Doctor Joseph Parker and Doctor Merideth Norris. Stop the harassment of Doctor Mark Ibsenand reinstate Doctors Norman Clement and Neil Anand their DEA licenses. We patients have had all we can take from our government.  Stop using patients as targets.   

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Briefing Document:

“THE PAIN LAWSUIT 2-1-2025.pdf”

Date: October 26, 2023

Subject:

Analysis of David Edward Smith’s Petition for Review of Federal Tort Claims Act (FTCA) Claims

Author: [David Edward Smith, pro se.]

Executive Summary:

This document provides a detailed review of David Edward Smith’s “Petition for Review of Federal Tort Claims Act Claims, and for Review of Constitutional Rights Violations and International Treaty Violations.” Smith, acting as a pro se litigant, is suing the United States government, specifically naming the Director of the CDC, the Administrator of the DEA, and the Attorney General of the DOJ.

He alleges negligence and tortious interference by these agencies in managing the “opioid crisis,” leading to the denial of adequate pain management for himself and millions of others. Smith argues that the actions of these agencies have violated the FTCA, Constitutional rights (5th and 14th Amendments), and international treaties, specifically the United Nations Single Convention on Narcotic Drugs.

He seeks judicial review and relief to restore access to controlled substances for legitimate medical use and to end what he describes as “STATE-SANCTIONED STRUCTURES WHICH TORTURE PAIN PATIENTS AND RESULTS IN NEEDLESS DEATH.”

I. Parties Involved:

• Plaintiff: David Edward Smith (Pro Se Litigant)
• Defendant: United States (substituted for individual defendants). Specifically:
• Mandy K. Cohen, Director, Centers for Disease Control and Prevention (CDC)
• Anne Milgram, Administrator, Drug Enforcement Administration (DEA)
• Merrick B. Garland, Attorney General, United States Department of Justice (DOJ)

II. Jurisdictional Basis:

Smith asserts jurisdiction based on the following:

• 28 U.S.C. § 1346(b): Federal Tort Claims Act (FTCA) – For money damages due to negligent or wrongful acts of government employees. He argues the U.S., if a private person, would be liable under similar circumstances.
• 28 U.S.C. § 2680(a): Challenges the applicability of the exception that exempts claims based on acts/omissions of government employees exercising due care in executing statutes/regulations.
• 28 U.S.C. § 2680(h): FTCA exception for intentional torts (assault, battery, etc.). However, Smith invokes the “law enforcement proviso,” arguing the actions of the DEA and DOJ constitute “abuse of process” by law enforcement officers.
• 28 U.S.C. § 1331: Federal Question Jurisdiction – To rule on Constitutional questions (5th and 14th Amendments) raised.
• 28 U.S.C. § 1331: To rule on questions raised by the Plaintiff regarding whether the actions taken by the United States government are in violation of international treaties to which the United States is a signatory.
• Corner Post v. Board of Governors of the Federal Reserve System: SCOTUS ruling on statute of limitations, arguing Proximate Causes of action of Plaintiff’s harms can be ruled upon even though the harms occurred more than 6 years following the publication of the CDC Guidelines.

III. Claims and Allegations:

Smith presents five core claims:

1. CDC Liability for Negligence and Tortious Interference with the Practice of Medicine in Violation of 42 U.S.C. § 1395: He argues the CDC’s 2016 Guidelines were formulated negligently, leading to restricted access to opioid pain medications and harming patients. He argues that the CDC acted ultra vires (beyond its legal authority) in issuing these guidelines, violating 42 U.S.C. § 1395, which prevents federal supervision over the practice of medicine. He contends that the CDC should be held liable under Texas law, which allows suits against government officials for committing ultra vires acts. “Plaintiff contends that the publication of and continued refusal to retract or to rescind the 2016 CDC Guidelines are ultra vires acts in violation of 42 U.S.C. § 1395.”
2. DEA Negligence and Unlawful Tortious Interference with the Practice of Medicine in Violation of 42 U.S.C. § 1395: He accuses the DEA of ongoing negligent and unlawful enforcement of opioid dose caps and medication combination prohibitions, leading to forced tapers, sudden discontinuation, and loss of access to needed medications. He argues this constitutes “abuse of process” by law enforcement. “Plaintiff contends that the DEA’s continued ongoing negligent and unlawful enforcement of opioid dose caps, blanket medication combination prohibitions (such as with opioids and benzodiazepines), without regard to individual patient metabolism rates, absorption rates, reactions to, or tolerance of such medications, resulting in forced-tapers, sudden discontinuation, and loss of access to opioids and to other controlled substances, has been a Proximate Cause of harm to Plaintiff and to millions** of patients.”

1. DEA Violations of the United Nations Single Convention on Narcotic Drugs: He claims the DEA’s annual cuts in opioid production and distribution violate the treaty, which mandates ensuring availability of narcotic drugs for pain relief. “Plaintiff contends that the DEA’s annual cuts in production and distribution of opioid medications and other controlled substances violate the provisions of the Preamble of the United Nations Single Convention on Narcotic Drugs, which stipulates that: ‘Recognizing that the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering and that adequate provision must be made to ensure the availability of narcotic drugs for such purposes…'”
2. DOJ Tortious Interference with the Practice of Medicine in Violation of 42 U.S.C. § 1395, and in Violation of a Supreme Court Ruling: Smith claims the Attorney General of the DOJ has allowed the DEA to arrest and prosecute doctors for treating pain without meeting the evidentiary standard set by the Supreme Court in Ruan vs. United States. This, he says, has created a climate of fear, leading to patient abandonment.
3. CDC, DEA, DOJ, and Congressional Acts in Violation of the 5th and 14th Amendments of the Constitution: Smith contends that current conditions in the U.S. amount to “STATE-SANCTIONED PAIN PATIENT TORTURE AND DEATH CAMP CONDITIONS.” He argues that restricting access to controlled substances violates patients’ rights to life, liberty, and property without due process. He claims that the laws and regulations enacted since the publication of the CDC Guidelines have almost completely denied the class of patients with disabling pain their right to life, liberty, and the pursuit of happiness, violating the 5th and 14th Amendments.

IV. Plaintiff’s Personal Harm and Background:

Smith details his personal medical history, including multiple spinal surgeries and diagnoses of arachnoiditis and cauda equina syndrome. He describes the difficulties he faced in obtaining his pain medication regimen after moving to Texas, leading to opioid withdrawal symptoms and loss of his ability to work. He blames the CDC Guidelines and DEA/DOJ enforcement policies for his inability to access adequate pain management.

V. Arguments and Evidence:

Smith presents a range of arguments and supporting evidence, including:

• Criticism of the CDC Guidelines: He asserts the guidelines are based on flawed data and misrepresentations, particularly regarding the risk of addiction and overdose from prescribed opioids. He references experts who challenge the validity of the MME (morphine milligram equivalent) chart and the way “opioid use disorder” (OUD) is being diagnosed.
• Criticism of the DEA and DOJ: He cites the Libby Report and Doctors of Courage to support his claims of DEA abuses in prosecuting doctors for prescribing pain medication. He argues that the DEA continues to enforce dose caps and medication combination prohibitions despite evidence of their harmful effects on patients.
• Focus on the “Law Enforcement Proviso” of the FTCA: He argues the actions of the DEA and DOJ constitute “abuse of process,” negating the qualified discretionary immunity defense typically available under the FTCA.
• Reference to International Treaties: He argues that restricting access to opioid pain medication violates the United Nations Single Convention on Narcotic Drugs and potentially the Nuremberg Code.
• Concerns about Patient Data Privacy: He raises concerns about unbridled access to patient data through Prescription Drug Monitoring Programs (PDMPs), arguing it violates HIPAA.

VI. Relief Sought:

Smith seeks a wide range of relief, including:

• Judicial review of the Constitutional and international treaty violations.
• Nullification of federal laws, rules, and regulations that restrict access to controlled substances for legitimate medical use.
• Orders for the Attorney General, DOJ, and DEA to cease unjust arrests and prosecutions of doctors.
• Orders for the DEA to stop the forfeiture of assets prior to a conviction.
• Orders for the CDC to immediately fund and staff the “Opioid Rapid Response Program.”
• Restrictions on law enforcement access to patient data in PDMPs without a warrant.
• A ruling on the international treaty violations of both the United Nations Single Narcotics Treaty and the Nuremberg Code.

VII. Key Themes and Implications:

• The central argument of the lawsuit revolves around the Plaintiff’s assertion that the government’s response to the opioid crisis has gone too far, harming legitimate pain patients by restricting access to needed medications.
• The lawsuit challenges the validity of the CDC Guidelines and the DEA/DOJ enforcement policies, arguing that they are based on flawed data and have led to unintended consequences.
• The use of the “law enforcement proviso” of the FTCA is a key legal strategy to overcome the qualified discretionary immunity defense.
• The lawsuit raises important ethical and legal questions about the balance between preventing opioid abuse and ensuring access to pain relief for patients with chronic conditions.
• The Plaintiff is acting as a pro se litigant, which may present challenges in navigating the complexities of the legal system.

Navigating “The Pain Lawsuit”: A Study Guide

Quiz

Answer the following questions in 2-3 sentences each, based on the provided document.

1. What is the legal basis for the Plaintiff’s claim that the CDC’s guidelines are unlawful?
2. According to the Plaintiff, how does the DEA violate the United Nations Single Convention on Narcotic Drugs?
3. What evidentiary standard does the Plaintiff argue the DOJ must meet before prosecuting doctors for prescribing controlled substances?
4. What is the “law enforcement proviso” and how does the Plaintiff use it to support their claims?
5. What specific harms did the Plaintiff allegedly suffer due to the actions of the defendants?
6. What does the Plaintiff mean by “STATE-SANCTIONED PAIN PATIENT TORTURE AND DEATH”?
7. How does the Plaintiff’s medical history relate to the lawsuit?
8. What does the Plaintiff say about the use of rapid urine tests by doctors?
9. What is the difference between “dependence” and “addiction” as described by the Plaintiff?
10. According to the Plaintiff, how has the HHS redefined “opioid use disorder”?

Quiz Answer Key

1. The Plaintiff argues the CDC’s guidelines are unlawful because they are ultra vires acts, exceeding the agency’s authority and violating 42 U.S.C. § 1395, which prohibits federal interference in the practice of medicine. The Plaintiff claims that the government employee’s actions would be liable under similar circumstances, and thus the United States would be substituted as the responsible party.
2. The Plaintiff contends the DEA violates the United Nations Single Convention on Narcotic Drugs by implementing annual cuts in the production and distribution of opioid medications, leading to inadequate supplies for legitimate medical use and pain relief. This allegedly contradicts the treaty’s requirement to ensure the availability of narcotic drugs for medical purposes.
3. The Plaintiff asserts that the DOJ must meet the evidentiary standard set forth by the Supreme Court in Ruan vs. United States before prosecuting doctors for prescribing controlled substances. This standard requires proving that the doctor acted outside the usual course of professional practice, with no legitimate medical purpose.
4. The “law enforcement proviso” is an exception to the Federal Tort Claims Act (FTCA) that allows claims against law enforcement officers for certain intentional torts like assault, battery, false arrest, and abuse of process. The Plaintiff uses it to argue that the DEA and DOJ’s actions fall under this exception, negating the Qualified Discretionary Immunity defense.
5. The Plaintiff allegedly suffered bodily harm, economic harm (including bankruptcy), and harms caused by the international crimes of “torture, cruel, inhuman and degrading treatment or punishment”. These harms stemmed from denial of pain medication, forced tapers, withdrawal symptoms, and inability to work.
6. By “STATE-SANCTIONED PAIN PATIENT TORTURE AND DEATH,” the Plaintiff refers to the conditions created by the government’s policies, including restrictions on opioid prescriptions, aggressive prosecution of doctors, and data mining. These conditions, according to the Plaintiff, result in the suffering, inadequate treatment, and deaths of chronic pain patients.
7. The Plaintiff’s medical history includes scoliosis with spinal fusion, arachnoiditis, and cauda equina syndrome, all causing chronic pain. This history is relevant because it establishes the Plaintiff’s need for pain management and provides context for the alleged harm caused by restricted access to medication.
8. The Plaintiff claims that rapid urine tests are unreliable and produce high rates of false positives. The Plaintiff alleges that they are not reliable enough to use as a basis for dismissing a patient from care or for denying prescriptions.
9. According to the document, “dependence” is a purely physiological response to prolonged opioid use at doses strong enough to build tolerance, while “addiction” is a very rare and unpredictable outcome of prescribing. The plaintiff cited an American Medical Association estimate that 3-19% of people who take prescription pain medications develop an addiction to them.
10. According to the Plaintiff, the HHS redefined “opioid use disorder (OUD) to include patients responsibly taking their prescribed meds”. In 2021, HHS changed the NSDUH’s methods.

Essay Questions

Consider these questions and develop well-reasoned arguments supported by evidence from the document.

1. Analyze the Plaintiff’s use of legal precedent (e.g., court cases, statutes) to support their claims. How effective is this strategy, and what are its potential weaknesses?
2. Discuss the ethical implications of the government’s approach to the opioid crisis, as presented in the Plaintiff’s arguments. Is the government prioritizing public safety at the expense of individual rights and well-being?
3. Evaluate the Plaintiff’s argument that the government’s actions constitute a violation of international treaties. What evidence is presented to support this claim, and how compelling is it?
4. Critically assess the Plaintiff’s claims regarding the CDC’s guidelines and their impact on medical practice. To what extent are these guidelines responsible for the alleged harms suffered by pain patients?
5. Explore the concept of “Qualified Discretionary Immunity” and its role in this case. Should government officials be shielded from liability for their actions in this context, and what are the potential consequences of such protection?

Glossary of Key Terms

• Pro Se Litigant: A person who represents themselves in court without an attorney.
• Federal Tort Claims Act (FTCA): A federal statute that allows private parties to sue the United States in federal court for certain torts committed by federal employees.
• Jurisdiction: The power of a court to hear and decide a case.
• Venue: The proper location for a trial or hearing.
• Tort: A civil wrong that causes someone else to suffer loss or harm resulting in legal liability for the person who commits the tortious act.
• Negligence: Failure to exercise the care that a reasonably prudent person would exercise in similar circumstances.
• Proximate Cause: A cause that directly produces an event and without which the event would not have occurred.
• Abuse of Process: The improper use of a legal procedure for an ulterior motive.
• Qualified Discretionary Immunity: A legal doctrine that protects government officials from liability for discretionary actions taken within the scope of their employment.
• Ultra Vires: An action taken by a government official or entity that exceeds their legal authority.
• Tortious Interference: Wrongfully interfering with another’s contractual or business relationships.
• Morphine Milligram Equivalent (MME): A standard measurement of opioid dosage, used to compare the potency of different opioid medications.
• CYP 450 Genetic Pleomorphism: Genetic variations in the CYP450 enzyme system, which affects how individuals metabolize drugs, including opioids.
• Opioid Use Disorder (OUD): A problematic pattern of opioid use leading to clinically significant impairment or distress.
• Forced Taper: Rapidly reducing or discontinuing opioid medication, often against a patient’s will or without proper medical supervision.
• Constructive Denial: Under the FTCA, if a federal agency does not make a final disposition of a claim within six months after it is filed, the claimant may deem the claim to be denied.
• United Nations Single Convention on Narcotic Drugs: An international treaty that aims to control and regulate the production, distribution, and use of narcotic drugs.
• Nuremberg Code: A set of ethical research principles for human experimentation set as a result of the Nuremberg trials at the end of the Second World War.
• Harrington Rod: A stainless steel surgical device used to treat scoliosis by stabilizing the spine.
• Arachnoiditis: A painful condition caused by inflammation of the arachnoid, one of the membranes that surround and protect the brain and spinal cord.
• Cauda Equina Syndrome: A serious condition that occurs when the nerve roots of the cauda equina are compressed, disrupting motor and sensory function to the legs and bladder.
• HIPAA (Health Insurance Portability and Accountability Act): A U.S. law designed to provide privacy standards to protect patients’ medical records and other health information provided to health plans, doctors, hospitals and other health care providers.
• PDMP (Prescription Drug Monitoring Program): A state-run electronic database that tracks the prescribing and dispensing of controlled substances.
• Ruan vs. United States: A SCOTUS case which addressed what the government must prove to convict a doctor of illegally prescribing controlled substances.

VIII. Conclusion:

David Edward Smith’s petition represents a significant challenge to the government’s approach to the opioid crisis. The lawsuit raises complex legal and ethical issues that will require careful consideration by the court. Success for the Plaintiff would have far reaching implications for pain management policy and the legal liability of government agencies.