I write to you on behalf of all my patients who will inevitably be affected by the civil complaint presented before you. My interests reside specifically in the well-being of my patients throughout the country who have filed prescriptions at Walmart, Inc. (“Walmart”) pharmacies for medications classified by the Drug Enforcement Agency (DEA) as controlled substances.
And I write to ensure that this civil action addresses the undue burdens imposed upon pharmacists and patients who are and have been disproportionately affected by the opioid epidemic – ensuring the courts recognize that law adjudicating healthcare cannot be restrictive in nature; rather, it must be affirmative in nature, maintaining a Madisonian balance between individual liberties and responsibilities, and the common good and social welfare. Or, as per the guidance of the Centers for Disease Control and Prevention (CDC), emphasize harm reduction, balancing the myriad of clinical decisions relative to the one decision that minimizes risk to the patient.
Something we experienced firsthand during the COVID-19 pandemic, when governments establish ad hoc rules and mandates purportedly in the name of public safety. A trend Supreme Court Justice Alito alluded to when he said COVID-19 restrictions highlight a disturbing trend of ‘lawmaking by executive fiat’.
But the COVID-19 pandemic simply made apparent a trend that was already present during the opioid epidemic – that government encroachment into healthcare has led to a fundamental violation of civil liberties, placing undue burdens upon select, targeted individuals – using public perception to justify unconstitutional enforcement and retroactive reinterpretation of law against select minority peoples and professions.
A premonition highlighted early in our nation’s history by French philosopher, Alexis de Tocqueville when he cautioned that America should be weary of the, ‘tyranny of the majority’. And reiterated by Ralph Waldo Emerson in his essay, Address to the Citizens of Concord (on Fugitive Slave Law). When a law restricts a perceived liberty – be it freedom, healthcare, speech – the public invariably evaluates the law relative to the natural rights it balances against.
The DEA and plaintiffs are quick to emphasize that the Controlled Substance Act (CSA), Title Code 21 is a closed system, implying the law fundamentally restricts prescribing behaviors unless certain perceived provisions are met, deeming the behavior to be medically appropriate.
This is a gross oversimplification of the harm reduction methodology advocated by the CDC and other healthcare organizations. And the difference, when applied into the context of medical jurisprudence creates a conflict between absolute restriction of a behavior versus relative restriction to a behavior.
The CSA was never intended to be a fundamentally restrictive law in the absolute sense. The law was originally interpreted as balancing the “sufferings of addiction” relative to the “cravings of an addict” – a legal interpretation that coincides more with the CDC’s approach of harm reduction than an absolute closed system as proposed by the plaintiff. The implementation of the CSA as currently construed violates the original intent of the CSA as it was written. Since restrictive laws that attempt to regulate positive rights will inevitably conflict with the Constitution.
Healthcare laws that are fundamentally restrictive are fundamentally unconstitutional because they place undue burdens on select individuals. The Declaration of Independence affirms certain ‘unalienable rights’ to all Americans, which include, ‘life, liberty and the pursuit of happiness’.
But healthcare is not a right in the absolute sense, as many legal scholars have argued, rather it is a positive right. Which means it is a right that comes with commensurate responsibilities and obligations, and the right afforded depends upon the responsibilities and obligations fulfilled. Hence healthcare law adjudicating healthcare rights should be constructed as an affirmative law, maintaining a Madisonian balance between individual liberties and common good.
Which makes the plaintiff’s emphasis on red flags as definitional of mens rea concerning. Many of the purported red flags seem more insinuations that cannot be interpreted beyond the uncertainty of reasonable doubt. And in many ways, approaching the law through the poorly defined rubric of red flags oversimplifies the complexity of medical care, and takes the act of prescribing medications out of the true context of clinical care – leading to errors of approximation and fundamentally inductive legal arguments that are probabilistic in nature and often reliant on suppressed premises.
Therefore, as you review the case before you, I humbly request that you adhere to the Constitutional principles underlying a Madisonian balance of affirmative law and analyze the CSA through the following frameworks – standardizing the medical jurisprudence.
Elemental & Essential Analysis of Law
Healthcare is unavoidably complex, and most healthcare statutes are constructed as a series of definitions, attempting to characterize these complex concepts. Which can be seen as an essential analysis of law –adjudicating criminality through the multiple attributes that define the essence of the complex concept.
But inconsistencies in how much to weigh each individual attribute within the core essence of a statute has led to legal interpretations that overweigh a limited number of individual attributes relative to the overall essence of the law – creating legal interpretations that conflate an elemental analysis of specific aspects of the law to be an essential understanding of the law in its entirety.
Flawed thinking the Roman philosopher Plutarch encapsulates in his syllogism of the lost dog searching for his master: a lost dog travels down a road he is sure his master has traveled based on sensing the master’s scent, and soon encounters a three-tiered fork in the road; the dog takes the first path but returns after losing the scent, and then takes the second path only to return again after losing the scent again; the dog then races down the third path sure that is the path the master took because he lost the scent on the first two paths, only to find his master is not on that path either.
The dog, in this syllogism, never once considers that the master is not on any of the paths. A misunderstanding that affects many prominent healthcare laws in this country. The Affordable Care Act was believed to be entirely dependent upon a tax penalty mandate, imposed upon individuals who did not obtain insurance. But the law continued to be followed even after the mandate was severed, and in certain parts of the country, a greater percentage of the population obtained insurance through ACA enabled markets after the mandate was dropped – questioning the perceived severability of the mandate relative to the overall essence of the law.
This is a critical understanding I hope you recognize when analyzing the CSA. How has overweighing or recontextualizing (ex post facto) specific aspects of the law violated the overall essence and intent of the law?
The US Court of Appeals for the Ninth Circuit and the Supreme Court have declared that the prosecution of healthcare providers under the CSA must prove that the defendant, “acted with intent to distribute the drugs and with intent to distribute them outside the course of professional practice,” suggesting that intent, or mens rea, must be established with respect to the nature of the defendant’s failure to abide by professional norms. The mens rea requirement additionally states that, “it shall be unlawful for any person knowingly … to distribute … a controlled substance … outside the course of professional practice”.
The most important words included in the mens rea requirement being ‘intent’ and ‘knowingly’. And if the mens rea standard is abandoned, the guiding compass that balances the various attributes within the essence of the statute are lost.
This point is of utmost importance. Firmly defining a standardized definition of mens rea within the clinical sphere – to truly define the phrase, “scope of medical practice” – will standardize the interpretation of criminality within the context of clinical behavior.
Otherwise you will find elemental frameworks selectively emphasizing specific actions and retroactively reinterpreting clinical behavior to be criminal – overweighing specific attributes in isolation – attempting to present an elemental analysis of law that should be essential in nature – while failing to account for the preponderance of evidence in totality. In other words, the law, when interpreted to the point of distorting the underlying clinical behavior, fails to balance the intent of the law with a consistent understanding of medically appropriate clinical behavior.
Prospective & Retroactive Understanding of Uncertainty
Clinical decision-making and behavior, as author Malcolm Gladwell describes, is “full of ambiguity and complexity”, and nearly impossible to define definitively without oversimplifying certain aspects of decisions, inevitably producing a certain vagueness in legal interpretations.
But the vagueness that may appear from simplifying patient behavior can be minimized by understanding the differences in uncertainty that arise from a clinical perspective relative to a legal perspective.
In the clinical world, you think associatively and prospectively, aggregating clinical data in real time to identify the most likely clinical scenario. In the legal world, you think linearly and retroactively, piecing together evidence after the fact to construct an argument. Information that is available after the fact is often not available in real-time.
But more importantly, what is considered important in real-time may be retroactively recontextualized to be less important afterwards. You will find many actions and behaviors characterized through the proverbial ‘should have known’ and ‘how likely it is to have known’ in the upcoming legal arguments – which are nothing more than differing perspectives in how to adjudicate uncertainty. And reflects a critical limitation in the CSA, which affects the Constitutionality of the law depending on how the law in interpreted.
The CSA fails to account for the differences in how uncertainty manifests in the clinical and legal world. When confronted with this issue in the past, previous legal interpretations opted to evaluate actions that are legally permissible or not permissible through a vaguely defined phrase, ‘bonafide medical practice’, that has not been updated in nearly a half-century. This phrase has been inconsistently applied when approximating the dynamic, prospective nature of medical uncertainty into a static, retroactive interpretation of legal uncertainty.
As a result, criminality depends on whether the interpretation of the clinical behavior fits within the presumed description of medically appropriate behavior as defined by the investigating DEA officer – and if the descriptions do not match, then the law has been violated.
If a physician prescribes a controlled substance over the course of clinical care as part of a ‘bonafide medical practice’ then the prescription is valid, if not, then the law has been violated. If a patient obtains a controlled substance to relieve the ‘suffering incident to an addiction’, then the prescription is valid, but if a patient obtains it to cater to the ‘cravings of an addict’, then the law has been violated – but to describe sufferings or cravings in a patient is a matter of interpretation, that can easily change over time and easily differ depending on who is interpreting the behavior.
As a patient who fails to receive medical care can easily become an addict – just as an addict who receives proper medical care can become a patient with a substance use dependency. The very attributes that have been used to define the essence of the CSA fail to define the essence of pain management and addiction medicine – because the law fails to understand the different types of uncertainty that exist between the clinical and legal world.
When interpreting the law, establish a consistent reference standard to approach uncertainty from both perspectives, and be sure not to allow any one attribute to overwhelm the multifaceted uncertainty that will form the foundation of your jurisprudence. Create a doubt schematization framework that standardizes how uncertainty is addressed and progressively minimized from a dynamic, clinical perspective into an eventual static, legal perspective.
Failing to do so will introduce primarily inductive arguments that are more strong than valid, probabilistic in nature, and subject to change depending on whether the suppressed premise underlying the inductive argument is elucidated within the proper clinical context. You will find yourself mired in haze of doubt estimating the intent of a patient, a pharmacist, or a physician without an objective standard through which you can compare.
Establish a framework that ensures the individual actions evaluated through the lens of the law are simultaneously viewed from the perspective of clinical decision-making – weighing aspects of both types of uncertainty in your jurisprudence.
Inductive or Deductive Legal Arguments
Nearly every argument substantiating the plaintiff’s case omitted any or all underlying clinical information, including the clinical context around which the prescriptions were written. And in omitting the clinical context, the legal argument has created the insinuation that the entire act of prescribing was illegal.
But these arguments often suffer from a suppressed premise, or become invalid when additional clinical information is brought forth, and consequently rely on reinterpretations of the law to negate the need to address the suppressed premises, the clinical context.
Pain management and addiction medicine is far too complicated to fit the narrow confines of the CSA. Attempt to legislate a complex, evolving medical condition through a single act will produce, more often than not, an incomplete or more formally, an indeterminate, argument because the context of pain management and addiction medicine is more complicated than the CSA as it is currently constructed or intended, and the whole of medicine cannot be simplified into a single act of prescribing, or be defined through a limited set of interpretations. The law must appreciate the full expanse of clinical medicine – and the full context of all clinical actions – in order to fairly determine criminality in the course of patient care.
Good clinical care thrives on making optimal decisions in the face of uncertainty, as patient care changes with new information, and clinical decisions adjust with new facts.
As mentioned, an addict, through the right therapy and medication, may just as easily become a patient with an addiction, a substance use disorder, just as a patient with an addiction, through distrust and abrupt discontinuations of medications, may become an addict. What defines part of a whole changes when the whole is still developing its parts – and specific elements in a patient encounter cannot define the full essence of patient care when the care is ongoing and still developing – resulting in the tendency to create inductive arguments that are simply incomplete versions of more complete, deductive legal arguments.
The CSA hinges upon a certain intuitive obviousness in distinguishing how it should be applied, a sense of intuition Justice Oliver Wendel Holmes alluded to when he said, “even a dog distinguishes between being stumbled over and being kicked.” But excessive reliance on intuitive, non-clinical interpretations have overwhelmed the commonsense approach to law that the courts depend upon. Novel interpretations, rife with bias, stretch the meaning of the CSA beyond its original intent, and retroactively reinterpret specific clinical acts as criminal.
Interpretations that inevitably form when presented with arguments based upon red flags serving as evidence of mens rea – which are insinuations attempting to establish criminal intentions. Leading to arguments that seem to be a reaction to the devastating magnitude of the opioid epidemic on our communities – something sadly none of us appreciated at the time since we are only now learning about the systemic causes of the opioid epidemic.
A 2019 report by the Office of the Inspector General revealed the DEA increased production quotas for opioid medications and restricted production of medications that can help combat addictions and overdoses in the years preceding the intense scrutiny of providers. Medications like opioid overdose sprays were restricted to one or only a few suppliers until only a few years ago. The report went on to suggest the DEA had not done all it could in raising awareness concerning the addictive potential of opioids among providers and patients alike. To the contrary, the DEA actually authorized a 400% increase in oxycodone production between 2002 and 2013, and did not significantly reduce the production of oxycodone until 2017.
Another oversight report, this time evaluating the Food and Drug Administration (FDA), found similar mistakes ranging back to 2011 when the FDA implemented safety training, risk evaluation, and mitigation strategy evaluations for opioid use and abuse. But by 2013 only 14% of the goals were met, and the few physicians who participated in these programs reported, “modestly greater”, knowledge of prescribing practices. Curiously, the classes did not study overdoses, opiate related deaths, or even discuss fentanyl, which is now considered the leading opioid of abuse.
How can the Federal government decree that Walmart must bear responsibility for failing to act preemptively to address the opioid epidemic when the government itself failed to do so?
You will face a significant challenge in attempting to distinguish the political banter surrounding the opioid epidemic from the legal objectivity required to adjudicate the case properly. A standardized framework for medical jurisprudence will help establish this distinction – and will balance the elemental and essential frameworks of law and the underlying uncertainties and recognize inductive from deductive legal arguments.
And, accordingly, will account for the law of unintended consequences – the secondary and tertiary effects of legal interpretation that sway the distribution of burdens – not only from one set of individuals to another, one corporation to society as a whole, but inappropriately distribute the burden of actual risk relative to potential risk.
In law, we perceive the distribution of burdens in terms of individuals or minority populations who are disenfranchised in some capacity due to a law or the interpretation of a law. But in healthcare, the distribution of burdens must account for actual risks and potential risks that may occur when implementing a law into clinical practice – and evenly distribute the clinical burdens with the clinical risks, both actual and potential, among all patients, pharmacists, and physicians.
For example, in deciding whether a patient merits a prescription, the physician must evaluate the patient’s clinical need for the medications with the risk of abuse. That is a seemingly straightforward legal rubric – but woefully inadequate in accounting for all the clinical consequences. The physician must also evaluate whether the patient poses a potential risk of diversion – meaning the patient may not abuse the medication, but the patient may not take the necessary precautions to prevent others, family and friends, from abusing the medication.
That is a potential risk that the physician may not realistically be able to address, but a risk that physicians and pharmacists are still liable for as per recent interpretations of the CSA. As a result, physicians and pharmacists have drastically reduced the amount of opioid prescriptions in response to being additionally burdened with the added potential risk – which has been portrayed as an apparent victory in the eyes of law enforcement.
But in reducing the number of opioids prescribed, many patients with legitimate medical needs now face an unforeseen, undue burden of not being able to receive medications for their chronic medical conditions. Furthermore, numerous clinical studies have demonstrated little to no correlation in opioid abuse mortality and the total number of opioids prescribed. But for law enforcement, the potential risk of diversion supersedes the actual clinical risk to patients that comes from poor clinical care.
The pretense of mitigating a potential risk placed undue burdens upon patients, and failed to properly address all the consequences of criminalizing the opioid epidemic in such an aggressive manner, which has exacerbated poor clinical care among physicians and pharmacists too fearful to prescribe clinically necessary medications – creating undue burdens on patients with chronic medical conditions.
As a restrictive law, the CSA as applied to healthcare limits the exchange of control substances for medical purposes until certain requirements are met. A congressional declaration addressed the requirements discrepancy by stating: “many of the drugs included [as controlled substances] have useful and legitimate medical purpose and as necessary to maintain the health and general welfare of the American people”.
The CSA also clarified at the time the definition of an addict as an: “individual who habitually uses any narcotic so as to endanger the public morals, health, safety, or welfare, over so far addicted to the use of narcotic drugs as to have lost the power of self control with reference to his addiction”, and determine that, “except as authorized by this title [law], it shall be unlawful for any person knowingly or intentionally to manufacture , distribute, dispense, possess, create controlled substances in the course of professional practice”.
Yet these explanations created the opposite effect by introducing terms subject to widely disparate interpretations – how can you prove someone is “knowingly and intentionally” prescribing medications to an addict, who is not just an addict, but an addict who has lost self-control because of his or her addiction, and has become a public danger? – and how can you balance the threatened harm to patients by not prescribing medically necessary medications with the speculative harm to society by prescribing medications that may be diverted?
Rather than address this fundamental issue directly, the courts added more verbiage as guidelines for future rulings: “a physician is restricted to dispensing or prescribing drugs in the bonafide treatment of a patient’s disease, including a modern amount of drugs to a known addict in a good faith attempt to treat the addiction or to relieve conditions or suffering incident to addiction. Under the guise of treatment a physician cannot sell drugs to a dealer nor distribute drugs intended to cater to the cravings of an addict”.
And upon request for further clarification, the courts again side stepped the core issue and simply stated: “what constitutes bonafide medical practice should be determined upon consideration of all the evidence and attending circumstances”.
Therefore, I humbly request that you standardize a framework for medical jurisprudence and analyze actual and potential clinical risk and the distributions of clinical burdens through multiple layers of consequences – the most immediate, apparent consequences, and the unintended, insidious consequences that have proven to be just as considerable.
Expound upon the medical jurisprudence will help align the intent of the law with the implementation of the law.
The simplest, most consistent manner to address the myriad of consequences is by stress-testing the aforementioned frameworks by actively simulating patient decision-making – implementing principles of game theory to assess the Constitutionality of a proposed legal interpretation within a range of predefined clinical scenarios.
In game theory, individuals make choices based upon the nature of the game being played. In zero sum games, individuals have opposing interests, and in non-zero sum games, individuals have some interests in common and some not – what is called mixed motives. When individuals agree on a plan of action, the game is called cooperative, and when individuals cannot agree, the game is called noncooperative. The behavior of the players, and the decisions made, are influenced by the nature of the game.
The most common introductory example of game theory is the prisoner’s dilemma, a noncooperative game in which two men are imprisoned in separate jail cells, and told that if neither confesses, both will receive a mild sentence; but if one confesses and one does not, the one who confesses will be freed while the other will receive a severe sentence; but if both confess, they both will receive a moderate sentence.
Ideally neither should confess, but by pursuing their own interests, both prisoners confess and receive moderate sentences. The example summarizes the conflict between the interests of individuals and what is in the best interest of the group. A dilemma pharmacists face when evaluating whether to fill a prescription for an individual patient in light of the looming criminality healthcare providers now face during the opioid epidemic.
And a dilemma directly applicable to how Constitutionally appropriate interpretations of the CSA must balance individual patient rights and liberties with the perceived common good.
Healthcare is a non-zero sum game with varying degrees of cooperation and noncooperation. To determine whether a specific action or decision constitutes criminal behavior, define the behavior within the context of a non-zero sum game, and ascertain whether clinically appropriate behavior would have been cooperative or noncooperative in that scenario. Study the behavioral tendencies of physicians, pharmacists, and patients within this context, and in response to one another, to ascertain whether true criminal intent, mens rea, influences the behavior in question.
As you review the evidence presented in the case, you will find my words prescient and an indispensable guide in your jurisprudence – and you will have to decide whether healthcare is a right, and if you believe it is a right, then you are likely to agree that it is a positive right – implying that the interactions, decisions, and behaviors of patients, physicians, and pharmacists must be evaluated against a reference standard that adjudicates individual actions within a broader, clinical context.
A Madisonian balance equating rights and liberties afforded with civic duties and responsibilities fulfilled.
It is my sincere hope that you see the passion and dedication I have for my patients through the words I have written. The opioid epidemic has taken countless lives and affected innumerable Americans, both directly and indirectly – but through the collective pain, I have gained wisdom, which I have shared in hopes that you are now able to recognize, and can now deliberate upon the full clinical impact of the case before you.
I now leave you with the lasting words of Swiss moralist Henri-Frédéric Amiel, “in health there is freedom – health is the first of all liberties.” And if we are to, at last, solve the opioid epidemic in the communities, we must first resolve the opioid epidemic in the court of law.
IHME model extends to November 01, 2021 – predicts Fall upswing in mortality
Mortality expected to increase 3x from current levels.
Increase in excess deaths attributed to spread of Delta variant.