Brief of the Nat’l Ass’n of Counties, the Cnty. Executives of Am., the Nat’l League of Cities, the U.S. Conf. of Mayors, and the Int’l Mun. Lawyers Ass’n as Amici Curiae Supporting Appellees Urging Affirmance
Robert Nealon
Anne Davis
J. Carl Cecere
SimpleOriginal

Summary

Amici for cities and counties urge affirmance, stressing pharmacies fueled the opioid crisis by ignoring diversion duties. With local governments bearing huge costs, accountability and abatement are vital to protect public health.

2023 | Federal Juristiction

Brief of the Nat’l Ass’n of Counties, the Cnty. Executives of Am., the Nat’l League of Cities, the U.S. Conf. of Mayors, and the Int’l Mun. Lawyers Ass’n as Amici Curiae Supporting Appellees Urging Affirmance

Keywords Opioid crisis; drug overdose deaths; opioids; pharmacies; prescription drugs; addiction; fentanyl; public health; suspicious prescriptions; pharmaceutical industry

INTRODUCTION AND SUMMARY OF ARGUMENT

The opioid crisis represents one of the greatest threats to public health in our lifetime, with profound consequences for the communities Amici serve. From 2010 to 2015, over 63% of the 52,404 drug overdose deaths recorded by the Centers for Disease Control and Prevention (CDC) involved an opioid. And the death toll has only risen from there. In 2021, 107,000 people died from drug overdoses—two-thirds involving opioids. Even now, 114 people in the United States lose their lives every day in opioid-related fatalities, making drug overdose driven by opioids the leading cause of death for people younger than 50, killing more Americans than heart disease, cancer, and automobile accidents.

The problem is even worse than this tragic death toll suggests. One Ohio public-health nurse described her Ohio county as “awash in pain pills.” And the same could be said of virtually every county, city, and town in the United States. The past two decades have seen dramatic nationwide increases in opioid addiction rates, opioid-related traffic accidents, opioid-related admissions to substance abuse facilities, opioid-related emergency room visits, opioid-related hospital admissions, and the occurrence of entirely new diseases in newborns created by their mothers’ opioid addictions.

Amici have witnessed these tragedies first-hand. They have borne witness as the scourge of opioids has killed their residents, torn apart their families, and ravaged their communities. Amici have also been forced to bear much of the epidemic’s staggering expense, from the hard costs of administering services to a populace overwhelmed by opioid addiction, to more intangible costs like loss of human capital caused by employees so traumatized from their day-to-day jobs that they suffer depression, risk of suicide, and post-traumatic stress disorder.

Unlike other public health crises of the recent past—including the influenza pandemic of the late 1910s, the spread of the human immunodeficiency virus (HIV) of the 1980s and 1990s, or the ongoing COVID pandemic of the past few years—the opioid crisis is not the result of some new pathogen of indeterminate origin. We know exactly when, where, and how the crisis began: “in doctor’s offices and hospitals,” with doctors prescribing too many pills in the prescription drug trade.13 From there, the crisis blossomed to include physician over-access, pill mills, and diversion, and soon came to encompass illegal opioids like heroin and fentanyl. But it all started with the prescription drug trade and spread through the active involvement of the pharmaceutical industry.

The nation’s drug pharmacies—represented here by the industry’s most prominent pharmacy chains—played a key role in that spread. They failed to comply with their legally imposed duties as handlers of Schedule II prescription drugs to investigate suspicious prescriptions and resolve any red flags in a manner that could have halted the opioid epidemic. Instead, the dispensers chose to overlook troublesome prescriptions, if not facilitate them, in order to sell more pills. Those retail-level failures were central to the opioid epidemic’s rise, and any effort to halt the crisis runs through the pharmacies, because their unsurpassed knowledge of physician prescribing practices and patient behavior at the end the prescription opioid supply chain gives them an irreplaceable ability to halt the suspicious transactions that lead to opioid abuse.

Yet in this case, the Pharmacy Defendants would have the Court turn a blind eye to their refusal to block suspicious opioid prescriptions and sales. Adopting their position would absolve the pharmacies of their responsibility for creating an opioid epidemic that costs this country over $78 billion a year, much of which is born by Amici and their members. And it would so constrict pharmacies’ duties to identify and halt suspicious drug transactions that they would be required to do virtually nothing to stop diversion of opioids, leaving them with no appreciable role in preventing the further spread of the crisis, much less helping to reverse it. The pharmacies should not get the last word on their role in fueling the opioid epidemic or their responsibility for stopping it. This Court should therefore reject their arguments and affirm the decision below.

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Introduction and Summary of Argument

The opioid crisis represents a significant public health challenge, with profound consequences for communities. Between 2010 and 2015, over 63% of the 52,404 drug overdose deaths recorded by the Centers for Disease Control and Prevention (CDC) involved an opioid. Fatalities have continued to rise, with 107,000 people dying from drug overdoses in 2021, two-thirds of which were opioid-related. Presently, 114 individuals in the United States lose their lives daily to opioid-related causes, establishing opioid-driven drug overdose as a leading cause of death for individuals under 50, exceeding heart disease, cancer, and automobile accidents.

The problem's scope extends beyond the tragic death toll. The past two decades have seen substantial nationwide increases in opioid addiction rates, opioid-related traffic accidents, admissions to substance use facilities, emergency room visits, hospital admissions, and new medical conditions in newborns resulting from maternal opioid addiction. Communities have directly experienced these tragedies, observing the impact on their residents, families, and local structures. They have also absorbed significant financial burdens, including the direct costs of providing services to populations affected by opioid addiction and intangible costs, such as the loss of human capital stemming from employee trauma.

Unlike other recent public health crises, such as the influenza pandemic of the 1910s, the human immunodeficiency virus (HIV) epidemic of the 1980s and 1990s, or the ongoing COVID-19 pandemic, the origin of the opioid crisis is well-documented. It began with the over-prescription of pills in doctors' offices and hospitals, expanding to include issues like physician over-access, "pill mills," and diversion. This eventually encompassed illegal opioids such as heroin and fentanyl, but the crisis originated within the prescription drug trade and was facilitated by the pharmaceutical industry.

National drug pharmacies, represented by prominent industry chains, played a central role in the crisis's spread. These entities failed to fulfill their legally mandated duties as handlers of Schedule II prescription drugs. Specifically, they did not adequately investigate suspicious prescriptions or resolve identified red flags, actions that could have potentially halted the opioid epidemic. Instead, dispensers often overlooked or facilitated problematic prescriptions to increase sales. These retail-level failures were crucial to the opioid epidemic's escalation. Efforts to mitigate the crisis necessitate engaging pharmacies, as their comprehensive understanding of physician prescribing practices and patient behavior at the end of the supply chain provides a unique capacity to interrupt suspicious transactions that lead to opioid abuse.

The Pharmacy Defendants, however, seek to disregard their refusal to block suspicious opioid prescriptions and sales. Adopting their position would absolve these pharmacies of responsibility for contributing to an opioid epidemic that costs the country over $78 billion annually, a substantial portion of which is borne by communities and their members. Furthermore, it would severely restrict pharmacies' obligations to identify and halt suspicious drug transactions, effectively minimizing their role in preventing the further spread of the crisis or assisting in its reversal. Therefore, their arguments should be rejected, and the decision below affirmed.

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INTRODUCTION AND SUMMARY OF ARGUMENT

The opioid crisis represents a significant threat to public health. From 2010 to 2015, over 63% of drug overdose deaths involved an opioid. The death toll continued to rise, with 107,000 people dying from drug overdoses in 2021, two-thirds of which were opioid-related. Currently, 114 people in the United States die each day from opioid-related causes, making drug overdose a leading cause of death for individuals under 50. Beyond these tragic deaths, communities across the United States have seen dramatic increases in opioid addiction rates, related traffic accidents, and admissions to substance use facilities and emergency rooms. New diseases in newborns resulting from mothers’ opioid addictions have also emerged.

Local communities and public health organizations have witnessed these tragedies firsthand. The spread of opioids has devastated residents, families, and communities. These entities have also been forced to bear a substantial portion of the epidemic's cost. This includes the direct expenses of providing services to a population overwhelmed by opioid addiction, as well as less tangible costs. For example, employees traumatized by their daily work may suffer from depression, an increased risk of suicide, and post-traumatic stress disorder.

Unlike other recent public health crises, such as past pandemics, the opioid crisis did not arise from an unknown pathogen. Its origins are well-documented, beginning in healthcare settings with doctors prescribing an excessive number of pills. From this initial stage, the crisis expanded to include widespread physician over-access, illegal "pill mills," and the diversion of prescription drugs. This eventually led to the proliferation of illegal opioids like heroin and fentanyl, but the crisis fundamentally started with the prescription drug trade and the active involvement of the pharmaceutical industry.

Major pharmacy chains played a crucial role in the epidemic's spread. They failed to comply with their legal obligations as handlers of Schedule II prescription drugs. This required them to investigate suspicious prescriptions and resolve any red flags that could have prevented the opioid epidemic. Instead, these dispensers often overlooked or even facilitated problematic prescriptions, prioritizing sales over public safety. These failures at the retail level were central to the opioid epidemic's growth.

Any effective strategy to halt the crisis must involve these pharmacies. Their extensive knowledge of physician prescribing patterns and patient behavior at the end of the prescription opioid supply chain provides them with a unique and irreplaceable ability to identify and stop suspicious transactions that lead to opioid abuse. Allowing pharmacies to disregard their responsibility for blocking suspicious opioid prescriptions and sales would effectively absolve them of their role in creating an epidemic that costs the country over $78 billion annually. Furthermore, it would severely limit their duties to identify and stop suspicious drug transactions, leaving them with little to no responsibility for preventing the crisis from worsening or helping to reverse its effects.

Open Amicus Brief as PDF

Introduction and Summary of Argument

The opioid crisis is one of the most significant public health threats in modern times, with serious effects on communities across the country. Between 2010 and 2015, over 63% of the 52,404 drug overdose deaths recorded by the Centers for Disease Control and Prevention (CDC) involved an opioid. The number of deaths has continued to rise, with 107,000 people dying from drug overdoses in 2021, two-thirds of which involved opioids. Currently, 114 people in the United States die every day from opioid-related causes. This makes opioid-driven drug overdose the leading cause of death for people under 50, surpassing heart disease, cancer, and car accidents. The problem extends beyond deaths, with many communities facing widespread addiction, increased traffic accidents, more admissions to substance use centers, and a rise in emergency room visits and hospital stays. New diseases in newborns, caused by their mothers' opioid addictions, have also become more common.

Groups affected by the crisis have seen these tragedies firsthand. They have witnessed opioids killing residents, breaking apart families, and damaging communities. These groups have also had to bear much of the crisis's enormous financial burden. This includes direct costs for providing services to a population overwhelmed by opioid addiction, as well as less obvious costs. For example, employees become so traumatized by their daily work that they suffer from depression, face suicide risks, and develop post-traumatic stress disorder.

Unlike other recent public health crises, such as the influenza pandemic of the 1910s, HIV in the 1980s and 1990s, or the ongoing COVID pandemic, the origin of the opioid crisis is well-known. It began in doctors' offices and hospitals, with doctors prescribing too many pills. From there, the crisis grew to include doctors over-prescribing medications, illegal "pill mills," and the diversion of drugs for non-medical use. It later expanded to include illegal opioids like heroin and fentanyl. However, the crisis primarily started with prescription drug practices and spread with the active involvement of the pharmaceutical industry.

The nation's pharmacies, including some of the largest chains, played a key role in the spread of opioids. They failed to meet their legal responsibilities as businesses handling controlled prescription drugs. These duties required them to investigate suspicious prescriptions and address any warning signs that could have stopped the opioid epidemic. Instead, the pharmacies often overlooked problematic prescriptions, or even helped facilitate them, in order to sell more pills. These failures at the retail level were central to the rise of the opioid epidemic. Any effort to stop the crisis must involve pharmacies because their extensive knowledge of how doctors prescribe and how patients behave at the end of the prescription drug supply chain gives them a unique ability to stop suspicious transactions that lead to opioid abuse.

Despite their role, the Pharmacy Defendants want the Court to ignore their refusal to block suspicious opioid prescriptions and sales. If their position were accepted, it would release pharmacies from their responsibility for creating an opioid epidemic that costs the country over $78 billion each year, much of which is paid by affected communities and their members. It would also limit pharmacies' responsibilities to identify and stop suspicious drug transactions so much that they would do almost nothing to prevent opioid diversion. This would leave them with no significant role in preventing the crisis from spreading further or helping to reverse it. The pharmacies should not have the final say on their part in fueling the opioid epidemic or their duty to stop it. Therefore, this Court should reject their arguments and uphold the previous decision.

Open Amicus Brief as PDF

Introduction and Summary of Argument

The opioid crisis is a very serious health problem for many people. Many people have died from drug overdoses, and most of these deaths involved opioids. The number of deaths has grown much higher over the years. Opioids now cause more deaths for people under 50 than heart disease, cancer, or car accidents. The problem is also bigger than just the number of deaths. Many towns and cities have too many pain pills. More people are becoming addicted to opioids, and there are more related car accidents, hospital visits, and health problems for babies born to mothers who used opioids.

Local groups have seen these terrible problems firsthand. Opioids have killed people, broken families, and hurt whole communities. These groups also had to pay a lot of money to help people and deal with the crisis. Workers helping others were often very stressed and sad from their jobs because of what they saw.

This health crisis is different from others like the flu or COVID-19 because people know exactly how it started. It began when doctors in hospitals and clinics gave out too many pain pills. The problem then grew to include places that gave out many pills easily, and later, illegal drugs like heroin. But the drug companies and the selling of prescription pills were where it all began.

Drug stores (pharmacies) played a key role in making the problem worse. They did not follow rules to check if prescriptions were suspicious. Instead, they often ignored problems to sell more pills. These actions by pharmacies were a major reason the opioid crisis became so bad. Pharmacies have important information about what doctors prescribe and how patients get drugs. They could have stopped suspicious sales that led to drug abuse.

The drug stores being sued want the court to ignore their part in the crisis. If the court agrees with them, the pharmacies would not be held responsible for the opioid problem. This problem costs the country over $78 billion each year. It would also mean pharmacies would have almost no duty to stop suspicious drug sales, keeping them from helping to stop the crisis. The court should not agree with the drug stores and should stand by the earlier ruling.

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Footnotes and Citation

Cite

Brief of the Nat’l Ass’n of Counties, the Cnty. Executives of Am., the Nat’l League of Cities, the U.S. Conf. of Mayors, and the Int’l Mun. Lawyers Ass’n as Amici Curiae Supporting Appellees Urging Affirmance, In re Nat’l Prescription Opiate Litig., 82 F.4th 455 (6th Cir. 2023) (Nos. 22-3750/3751/3753/3841/3843/3844)

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