Supreme Court - Bill of Health

New York, USA, November 2021: Pfizer Covid-19 Paxlovid treatment box isolated on a white background.

How to Fairly Allocate Scarce COVID-19 Therapies

January 31, 2022January 30, 2022 Govind Persad Leave a comment

By Govind Persad, Monica Peek, and Seema Shah

Vaccines are no longer our only medical intervention for preventing severe COVID-19. Over the past few months, we have seen the arrival and wider availability of treatments such as monoclonal antibodies (mAbs), and more recently, of novel oral antiviral drugs like Paxlovid and molnupiravir.

The recent Delta and Omicron surges have made these therapies scarce. The Delta variant led the federal government to resume control over mAb supply and promulgate allocation guidelines. The Omicron variant exacerbated scarcity because only one of the currently available mAbs, sotrovimab, appears to be effective against it. While Paxlovid and molnupiravir are effective against Omicron, both will likely be in short supply for many months. Paxlovid is currently constrained by a lengthy manufacturing process. Molnupiravir — which is substantially less effective — is contraindicated for use in patients under 18 and not recommended for use during pregnancy.

To allocate COVID-19 vaccines, the CDC’s Advisory Committee on Immunization Practices, the National Academies of Sciences, Engineering and Medicine (NASEM), and the World Health Organization (WHO) identified ethical goals for prioritization, such as maximizing benefit and minimizing harm, mitigating health inequities, and reciprocity. These committees, particularly the NASEM and WHO committees, included ethics experts as well as experts in social science, biology, and medicine. Current federal guidelines for therapy allocation, in contrast, do not identify ethical objectives or involve ethics expertise.

In an open-access Viewpoint in Clinical Infectious Diseases, we identify ethical goals for the allocation of scarce therapies. We argue that the same ethical goals identified for vaccine allocation–in particular maximizing benefit, minimizing harm, and mitigating health inequities — are also relevant for therapy allocation. Because many people have now taken steps to mitigate pandemic scarcity, for instance by protecting themselves through vaccination, we argue that reciprocity is also relevant.

The Supreme Court’s Rulings on COVID-19 Vaccine Mandates, Explained

January 18, 2022January 18, 2022 Kaitlynn Milvert Leave a comment

By Kaitlynn Milvert

In a pair of rulings issued January 13, the Supreme Court put on hold the federal vaccine-or-test requirements for large employers, but allowed federal vaccination requirements for health care workers to take effect while they are litigated in the lower federal courts.

The Court decisions each addressed questions of whether federal agencies — the Occupational Safety and Health Administration (OSHA) and the Centers for Medicare and Medicaid Services (CMS) — have authority to set these vaccination-related requirements.

In doing so, the Court drew new and unprecedented lines between the kinds of risks that agencies operating outside of the health care context — such as OSHA — have power to address through federal regulations. The Court’s decisions on these issues are likely to loom large in future litigation as federal vaccine requirements continue to be litigated in the lower courts.

The Beginning of the End of Federalism

January 10, 2022May 6, 2022 Jennifer S. Bard Leave a comment

By Jennifer Bard

Friday’s emergency hearing by the Supreme Court regarding the Occupational Safety and Health Administration’s (OSHA) vaccine-or-test mandate was extraordinary both in that it happened at all and what took place.

The hearing came in a response to a petition by a coalition of states and the National Federation of Independent Business (NFIB) to halt an Emergency Temporary Standard (ETS) issued by OSHA mandating that all employers with over 100 employees “establish minimum vaccination standards” including “vaccination verification, face covering, and testing requirements.”

That the Court heard the case on an emergency basis signaled their concern that OSHA, in issuing the ETS, was overreaching its authority, as they ruled the Centers for Disease Control and Prevention had done in issuing an eviction moratorium.

But what made the colloquies particularly unsettling is that the ETS was carefully crafted to be, as Professors Larry Gostin and Dorit Rubinstein Reiss explain lucidly, well within contemporary standards for an exercise of federal power affecting a health matter usually within the jurisdiction of a state. It applies only to employers already obligated to follow OSHA workplace standards and fell far short of a vaccine mandate. Moreover, however severe the risk of COVID when this was drafted six months ago, the risk from the Omicron variant is many times greater.

Yet the sympathetic ear given by the majority of the Justices to the arguments made by the lawyers seeking a stay made it possible to wonder if the whole thing was happening in either one of DC or the MCU’s multiverse. This is because the questioning, directly and by implication, calls into doubt what past Courts have identified as the framework of federalism — a nickname for the Constitution’s balancing of a strong federal government against the rights of individual states. We cannot know the extent to which the Justices will adopt any of the arguments offered them for limiting federal agency power, but from this hearing we can anticipate substantial strengthening of an individual state’s ability to resist federal regulation.

Major Questions about Vaccine Mandates, the Supreme Court, and the Major Questions Doctrine

January 5, 2022January 5, 2022 wparmet Leave a comment

By Wendy Parmet and Dorit Reiss

This Friday, the Supreme Court will hear arguments about two federal vaccine mandates: the Centers for Medicare and Medicaid Services’ (CMS) mandate for health care workers, and the Occupational Safety and Health Administration’s (OSHA) vaccine-or-test mandate for employers with over 100 workers. In each case, a key question will be whether the Court should apply the so-called “major questions doctrine.” The Court’s adoption of this approach in the mandate cases would not only remove an important tool for combating the pandemic; it also would severely limit the federal government’s capacity to address many other health threats, while expanding the Court’s ability to substitute its judgment for Congress’.

Although not fully defined or delineated, the major questions doctrine bars administrative agencies from using broad grants of statutory authorities in new and “major” ways. A type of clear statement rule, it requires courts to presume that in the absence of specific Congressional authorization, agencies lack the power to issue new regulations that could be seen as “major.”

In theory, the rule allows courts to avoid federalism and separation of powers concerns. In practice, it empowers courts to resurrect long-discarded approaches to federalism and separation of powers without saying so. It also enables courts to disregard explicit grants of statutory authority (so much for textualism!).

(Institute for the feeble-minded, Lincoln, Ill. / Library of Congress)

Brittney Poolaw and the Long Tradition of State-Sponsored Control of Women and Their Fertility

October 26, 2021October 26, 2021 Lauren Breslow Leave a comment

By Lauren Breslow

On October 5, 2021, a 20-year-old Native American woman, Brittney Poolaw, was convicted by an Oklahoma jury of manslaughter for the death of her 17-week-old, non-viable fetus.

Her conviction stands as a modern recapitulation of the historical violations that women, especially Black and Brown women, have endured regarding their fertility.

Activists and concerned residents of New York City gathered at Union Square to demand Free, Safe and Legal Abortion on Sept 12, 2021.

Health Justice Meets Reproductive Justice

September 28, 2021September 28, 2021 The Petrie-Flom Center Staff Leave a comment

By Rachel Rebouché

Over the past few weeks, the headlines have been dominated by the implementation of a Texas “heartbeat” law. The law, which prohibits abortions after detection of fetal cardiac activity, “shall be enforced exclusively through . . . private civil actions” and “no enforcement may be undertaken by an officer of the state or local government.” For that reason, the Fifth Circuit, and then the Supreme Court, declined to enjoin the law’s application because, in part, no one had yet to enforce it. The Court did not opine on the law’s constitutionality, even though the statute directly contradicts precedent protecting abortion rights before viability. Indeed, as the DOJ argued in its recent lawsuit against Texas, the state designed the law specifically to circumvent judicial review.

What does Texas’s abortion ban have to do with health justice? The answer may not seem obvious because of how the debate over Texas’s law has been framed. Commentary has focused on whether or not litigants have standing to challenge the law or whether the federal government could successfully intervene to stop enforcement of the law. And these are important questions, especially for the providers and those “aiding and abetting” them, who are subject to the lawsuits of private citizens suing for $10,000 per procedure in violation of the law.

The costs of this law, however, could far exceed these potential damages. A health justice perspective highlights those costs and how lack of access to abortion entrenches economic and racial inequality.

Abortion rights protest following the Supreme Court decision for Whole Women's Health in 2016

Beyond Abortion: The Far-Reaching Implications of SB 8’s Enforcement Mechanism

September 28, 2021September 28, 2021 czhang Leave a comment

By Cathy Zhang

The United States Supreme Court’s refusal to block Texas’s SB 8 abortion restriction earlier this month foreshadowed an uncertain future for abortion jurisprudence and put reproductive rights at the center of national discourse.

But abortion is not the only right at stake: the novel enforcement mechanism behind SB 8 may soon appear in a wide range of legislation, making it more difficult to challenge unconstitutional laws.

How Social Movements Have Facilitated Access to Abortion During the Pandemic

August 31, 2021August 30, 2021 The Petrie-Flom Center Staff Leave a comment

By Rachel Rebouché

Before the end of 2021, the U.S. Food and Drug Administration (FDA) will reconsider its restrictions on medication abortion. The FDA’s decision could make a critical difference to the availability of medication abortion, especially if the Supreme Court abandons or continues to erode constitutional abortion rights.

Under that scenario of hostile judicial precedents, a broad movement for abortion access — including providers, researchers, advocates, and lawyers — will be immensely important to securing the availability of remote, early abortion care.

COVID-19 and the New Reproductive Justice Movement

July 27, 2021July 26, 2021 The Petrie-Flom Center Staff Leave a comment

By Mary Ziegler

The COVID-19 pandemic has transformed advocacy for reproductive rights and reproductive justice in what previously had been called an endless, unchanging, and intractable abortion conflict.

The pandemic — and the stay-at-home orders it required — finally shifted the movement’s focus to abortion access, rather than abortion rights, as exemplified by its emphasis on medication and telehealth abortion.

The Patent Trial and Appeal Board Again Survives Supreme Court Review

June 23, 2021June 22, 2021 The Petrie-Flom Center Staff Leave a comment

By Gregory Curfman

For the generic drug and biosimilar industries, the Supreme Court’s recent decision in United States v. Arthrex, Inc. comes as a relief.

In his opinion, Chief Justice John Roberts allowed the Patent Trial and Appeal Board (PTAB) to survive and to continue to provide an alternative route for generic drugs and biosimilars to gain early market entry.

Patients, who may rely heavily on these less costly alternatives for their prescription drugs, will also benefit significantly from the Court’s decision in this case.

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