Pill pack.

Fortifying the US Pharmaceutical Supply Chain

By Laura Karas

The COVID-19 pandemic triggered supply chain disruption across the globe. The United States, in particular, is susceptible to interruptions in the supply chain for pharmaceutical drugs because many of the raw materials, active pharmaceutical ingredients, and manufacturing processes needed to produce domestically marketed prescription drugs have been outsourced beyond U.S. borders.

Is it time to bring some of these processes back to our shores? This post will demystify the pharmaceutical supply chain and explore some key considerations as we head toward 2021.

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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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Man in hospital.

Following the Yellow Brick Road Toward Hospital Price Transparency

By Laura Karas

The Center for Medicare and Medicaid Services (CMS) scored a victory on the price transparency front in June of this year with the D.C. Circuit decision in American Hospital Association v. Azar, No. 1:19-cv-03619-CJN.

The CMS final rule at issue in the suit requires price transparency for hospital items and services. The legal victory will begin to remedy the information asymmetry that has kept patients in the dark about hospital prices for far too long.

As the final rule states, its aim is to empower patients to become “active consumers” of health care “so that they can lead the drive towards value.” The rule is part of a federal effort to improve the ability of patients to make informed choices based on price and gain leverage to negotiate unreasonable hospital charges.

The American Hospital Association, the Association of American Medical Colleges, and several other groups brought suit to contest the CMS final rule mandating that hospitals make public and update annually certain “standard charges” for hospital “items and services.”

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Kirkland, WA / USA - circa March 2020: Street view of the Life Care Center of Kirkland building, ground zero of the coronavirus outbreak in Kirkland.

Why We Must Hold Nursing Homes Legally Accountable for COVID-19 Outbreaks

By Laura Karas

Immunity from liability disincentivizes nursing homes from expending the time, money, effort, and resources needed to keep residents safe.

The COVID-19 pandemic has highlighted the stakes of the issue: granting legal immunity to nursing homes for COVID-related care is tantamount to leaving our most vulnerable out on the street corner.

According to data from the Center for Medicare and Medicaid Services, there have been over 216,000 confirmed COVID-19 cases and over 53,000 COVID-19 deaths among nursing home residents.  These figures are likely underestimates, as nursing homes have had to adjust to federal reporting guidelines.  Recent data indicate that deaths in nursing homes are on the rise in states with COVID-19 resurgences.

Kimberly Hall North in Windsor, Connecticut, was one of many nursing homes ravaged by COVID-19.  Reports in June of this year cited 47 deaths among its 138 residents, a death toll exceeding one-third of the nursing home’s resident population.

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