Pill bottles.

During the COVID-19 Pandemic, the Opioid Epidemic Continues

By Laura Karas

“The boy’s first outcry was a rueful laugh,

As he swung toward them holding up the hand

Half in appeal, but half as if to keep

The life from spilling. Then the boy saw all—

Since he was old enough to know, big boy

Doing a man’s work, though a child at heart—

He saw all spoiled. . . .

He lay and puffed his lips out with his breath.

And then—the watcher at his pulse took fright.

No one believed. They listened at his heart.

Little—less—nothing!—and that ended it.

No more to build on there. And they, since they

Were not the one dead, turned to their affairs.”

This except from Robert Frost’s 1916 poem “Out, Out—,” which portrays the sudden death of a young boy after a woodcutting accident and the onlookers’ casual acceptance of his tragic death, is particularly apropos today, more than one hundred years later, in an America that looks very different than that of Frost’s time. Between the opioid crisis and the COVID-19 pandemic, America now suffers from a surplus of needless, untimely deaths.

Just as the protagonist of Frost’s poem became the casualty of a tragic accident, so too do the many victims of the opioid epidemic become casualties in a losing battle — lives “spoiled” by substance use disorder and cut short by tragic overdose. In this post I explore the status of the opioid epidemic in light of the COVID-19 pandemic and ongoing initiatives to address opioid use disorder (OUD).

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Map of United States made up of pills.

The Opioid Multidistrict Litigation, Federal Rule 23, and the Negotiation Class

By Laura Karas

A recent Sixth Circuit decision dashed hopes of a faster resolution to the federal opioid multidistrict litigation (MDL).

The MDL (In re National Prescription Opiate Litigation, Docket No. 1:17-md-02804) consolidated many thousands of suits against opioid makers and distributors.

Thus far, action in the MDL has presaged the enormity of corporate responsibility for the opioid crisis. Roughly one year ago, the first bellwether trial in the MDL, involving two Ohio counties, was averted due to a last-minute settlement by Teva Pharmaceuticals and the “Big Three” drug distributors (AmerisourceBergen, Cardinal Health, and McKesson). A $465 million verdict last year against Johnson & Johnson “abated” one year’s worth of damage to the state of Oklahoma from the opioid crisis, which was held to be a public nuisance under Oklahoma law. And another bellwether trial involving pharmacy chains including Walgreens and CVS is scheduled to take place next year, despite the pharmacy chains’ strong pushback.

As part of the MDL, the U.S. District Court for the Northern District of Ohio had certified a new kind of class, distinct from a litigation or settlement class — a “negotiation class” of cities and counties throughout the United States — under Federal Rule of Civil Procedure 23, the Federal Rule that governs class actions.

But on September 24, a decision by the U.S. Court of Appeals for the Sixth Circuit reversed this decision.

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Large pile of amber prescription pill bottles

A Look at Florida’s Decade-Long Effort to Curb the Opioid Epidemic

By Jessica Lam and Megan Bershefsky

Over the years, Florida, an early hotspot in the opioid epidemic, has implemented a series of legal and regulatory responses that have been met with both success and continued challenges.

Since 2016 — about 25 years into an opioid crisis that began in the 1990s — more than half of the country has passed laws to limit either the number of days or the amount of opioids that can be prescribed. Florida is on the leading edge of both the epidemic and efforts to use law to combat its effects, passing its first laws before many other states.

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Suboxone.

Obstacles and Advances to Accessing Medication for Opioid Use Disorder

By Marissa Schwartz

Medication for Opioid Use Disorder (MOUD), sometimes referred to as Medication-Assisted Treatment (MAT), is a life-saving, evidence-based treatment method considered the gold standard for addressing opioid use disorders. Unfortunately, however, there are a number of barriers — both legal and cultural — that prevent some patients from accessing the treatment they need.

MOUD combines the use of prescription medications (like buprenorphine, methadone, and naltrexone) with counseling and behavioral therapies to provide comprehensive treatment in an inpatient or outpatient setting.

Due to stigma toward MOUD from patients and providers, as well as an overall lack of providers certified to dispense MOUD, there are currently more prescribing rules in the U.S. for the drugs used in MOUD, like buprenorphine, than for opioids. Major legal barriers include provider limits on the number of patients to whom they can offer MOUD, restrictions on which facilities can provide in-patient MOUD treatment, and insurance pre-authorization requirements.

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Large pile of amber prescription pill bottles

How Policy Surveillance Might Help to Counter the Opioid Epidemic

By Erin Napoleon

In 2017, more than 47,000 people had died of an opioid overdose, and 2 million people were dependent on opioids. This astonishing number is attributable in part to the lack of federal and state legislation to curb the over-prescription of opioids.

Opioids first entered the US market in the late 1990s. Pharmaceutical companies’ assured physicians that opioids were less addictive than morphine and posed less dangerous side effects, and doctors began prescribing the pills at unprecedented rates.

Understanding how the dearth of federal and state legislation, coupled with prescribing patterns based on race and socioeconomic status, influence the over-prescription of opioids can potentially lead to new and innovative ways of solving the opioid epidemic that continuously threatens the United States.

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The Week in Health Law podcast logo twihl.com

TWIHL 212: Substance Use Privacy Before and After CARES

By Nicolas Terry

In this episode, I welcome back Kirk Nahra, a partner and Co-Chair of the Cybersecurity and Privacy Practice at Wilmer Hale in DC. He has been a leading authority on privacy and cybersecurity matters for more than two decades. Mr. Nahra counsels clients across industries, from Fortune 500 companies to startups, on implementing the requirements of privacy and data security laws across the country and internationally.

And, after all this time, finally I welcome Melissa Goldstein, Associate Professor in the Department of Health Policy and Management at the Milken Institute School of Public Health at the George Washington University, where she teaches courses in bioethics (including genomics, reproductive ethics, end-of-life, and research ethics issues), health information technology policy, and public health law and conducts research on health information privacy and the legal and policy aspects of health information technology. Our excuse for getting together is that we recently co-authored a piece on the Health Affairs blog titled COVID-19: Substance Use Disorder, Privacy, And The CARES Act.

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, SpotifyTunein or Podbean.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find me on Twitter @nicolasterry or @WeekInHealthLaw.

hospital equipment, including heart rate monitor and oxygen monitor functioning at bedside.

Why COVID-19 is a Chronic Health Concern for the US

By Daniel Aaron

The U.S. government has ratified a record-breaking $2 trillion stimulus package just as it has soared past 100,000 coronavirus cases and 1,500 deaths (as of March 27). The U.S. now has the most cases of any country—this despite undercounting due to continuing problems in testing Americans on account of various scientific and policy failures.

Coronavirus has scared Americans. Public health officials and physicians are urging people to stay at home because this disease kills. Many have invoked the language of war, implying a temporary battle against a foreign foe. This framing, though it may galvanize quick support, disregards our own systematic policy failures to prevent, test, and trace coronavirus, and the more general need to solve important policy problems.

Coronavirus is an acute problem at the individual level, but nationally it represents a chronic concern. No doubt, developing innovative ways to increase the number of ventilators, recruit health care workers, and improve hospital capacity will save lives in the short-term — despite mixed messages from the federal government. But a long-term perspective is needed to address the serious problems underlying our country’s systemic failures across public health.

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pill bottle - buprenorphine / naloxone

Protecting the Vulnerable Substance Use Disorder Population During COVID-19

By Brandon George and Nicolas P. Terry

Introduction

Earlier this month, Dr. Nora Volkow, director of the National Institute on Drug Abuse identified those with substance use disorder (SUD) as a particularly vulnerable population during the COVID-19 pandemic. She highlighted the negative effects of opioid or methamphetamine use on respiratory and pulmonary health in addition to the disproportionate number of those with SUD who are homeless or incarcerated.

We detail the additional challenges faced by the SUD population and, specifically, the opioid use disorder (OUD) sub-group at this time, identify positive ameliorative steps taken by federal, state, and local governments, and recommend additional steps.

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a pill in place of a model globe

When it comes to opioids, it’s all about turf.

By Stephen Wood

When it comes to selling opioids, turf matters. Access to customers and geography play a role in the day to day sales of opioids. This often means selling in areas where there is a wanting and willing customer base with funds to spare. It also means picking a spot, a corner, where enforcement is low or where corruption can overcome most legal problems. The delivery can’t be too conspicuous. It needs to be hidden from plain sight, done in the shadows or alleyways where no one is looking. It’s a craft and when done right can lead to fistfuls of cash in the hands of the distributor, the dealer.

This may sound like a street-level drug deal, but it isn’t. It’s the tactic many American pharmaceutical companies are taking in response to increased regulation on prescription opioids. Like the stealth and shadowy moves of a street-level dealer, American pharmaceutical companies have moved their turf to new, mostly naïve markets to sell their wares. They have done this to escape the federal regulations that have limited their market; a response to the opioid crisis that has seen hundreds of thousands of lives affected by substance use disorder or lost to overdose.

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close up of an open book

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of December. The selections feature topics ranging from potential Medicare savings on inhaler prescriptions through use of negotiated prices and a defined formulary, to evaluation of the REMS for extended-release/long-acting opioids, to the costs of medication non-adherence in adults with atherosclerotic cardiovascular disease in the US. A full posting of abstracts/summaries of these articles may be found on our website. Read More