Category: Judicial Opinions

Salus Populi: Training the Judiciary in the Social Drivers of Health

The Petrie-Flom Center Staff Leave a comment

By Elaine Marshall, Isabel Geisler, L. Virginia Martinez, Krystal Abbott, and Katherine Hazen

Social drivers of health (SDOH), sometimes known as the social determinants of health, are factors in the social environment that shape individual and population health, including poverty, racism, housing, education, and employment. When judges decide cases that impact these social factors, their rulings can have important health implications. While cases impacting the SDOH can be landmark Supreme Court cases, such as the ruling on the CDC’s eviction moratorium during the COVID-19 pandemic, judges also make decisions on a daily basis that can affect the SDOH and thereby health. Take, for example, a child welfare case out of New York, In re Brittany T, 852 N.Y.S.2d 475 (N.Y. App. Div. 2008), where the issue before the judge was whether a family willfully and without just cause violated orders meant to support their child’s health through diet and exercise. The order required the family to use all resources available to ensure the well-being of the child, enroll the child at their own cost in a local gym and attend it at least 2-3 times a week, and actively and honestly participate in a nutrition program.

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cell with pipette and needle.

Are Embryos Children? The Alabama Supreme Court Says Yes

Joelle Boxer Leave a comment

By Joelle Boxer

This month, the Alabama Supreme Court held that the term “children” in a state statute includes embryos, or “extrauterine children.”

As fertility treatments like in vitro fertilization (IVF) involve the creation of multiple embryos, not all of which are implanted, the implications of this ruling could be far-reaching. Four million births each year in the U.S. are via IVF, an important pathway to parenthood for couples with infertility, LGBTQ couples, and single parents.

This article will examine the Alabama Supreme Court’s decision in LePage v. Mobile Infirmary Clinic and its consequences for Americans building their families through fertility services.

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Birmingham, Alabama - February 8, 2020: University of Alabama at Birmingham UAB Hospital title and logo on brick facade.

The Beginning of a Bad TRIP – Alabama’s Embryonic Personhood Decision and Targeted Restrictions on IVF Provision

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By Katherine L. Kraschel

Last week, the Alabama Supreme Court called frozen embryos created via in vitro fertilization (IVF) “extrauterine children” and referred to the cryotanks where they are stored as  “cryogenic nurser(ies).” The Court sided with couples who claim the accidental destruction of frozen embryos created through IVF and cryopreserved ought to be treated equally to the death of a child. 

The case, LePage v. Center for Reproductive Medicine, involves plaintiffs seeking punitive damages from an Alabama fertility clinic for the “wrongful death” of their embryos that were destroyed when a patient in the hospital where they were stored removed them from the cryotank. While the lower Alabama Courts concluded that the cryopreserved embryos were not a person or child under the state’s law, the Alabama Supreme Court disagreed and held that the state’s Wrongful Death of a Minor Act “applies to all unborn children, regardless of their location,” and that the  plaintiff’s wrongful death claims could proceed. 

Thoughtful scholars have argued that existing state laws do not sufficiently redress mistakes and accidents that occur in the process of fertility care, pregnancy, and birth. However, the ends do not justify the means in this case; likening frozen embryos to children is not a legally sound mechanism to hold fertility clinics accountable for negligently storing embryos. It illustrates how sympathetic stories can be used to further the agendas of those who seek to equate embryos and fetuses  to “people” under the law and undercut the critical role modern fertility care plays in (re)defining the bonds that create families, and particularly, many LGBTQ+ and single parent families. 

Specifically, lawmaking in fertility care stands to fuel the movement to create fetal personhood rights and a federal abortion ban. It may also signify an inflection point in regulating assisted reproduction reminiscent of pre-Dobbs targeted restrictions on abortion provider (TRAP) laws that sought to limit abortion provision by imposing restrictions. TRAP laws’ new sibling – targeted restrictions on IVF Provision – or TRIP laws, as I call them, stand to rob patients of their ability to build their families by compelling physicians to provide less effective, more expensive care. TRIP laws will erect barriers and exacerbate long standing racial disparities in accessing fertility care, and they will disproportionately impact members of the LGBTQ+ community who wish to build families through fertility treatments.  The Alabama decision is severe, but it should serve as a warning to state legislators with a new responsibility to safeguard reproductive health care without the floor of Roe’s protections – proceed with extreme care and regard for “unintended” consequences of regulating fertility care.  Read More

wirikuta hikuri hallucinogen mexican peyote flower.

Should Sacred Plant Medicines Have Standing? The Original Instructions and Western Jurisprudence

The Petrie-Flom Center Staff Leave a comment

By Keith Williams and Ariel Clark

The resurgence of interest in psychedelics, or sacred plant and fungal medicines and their psychoactive constituents, has been described as a kind of “renaissance” much like the European renaissance that blossomed between the 14th – 17th centuries. The comparison is apt—for, in addition to a flowering of learning and human achievement, the psychedelic renaissance, like its namesake, is only possible because of the underlying extractivist colonial logic informing activity in this domain. We are both writing as people with ancestry from Indigenous communities, and we have a profound interest in respecting, honoring, and becoming-with our more-than-human kin. A business-as-usual approach to the so-called psychedelic renaissance will only reinforce the harmful extractivism inherent in contemporary global capitalist culture and will foreclose the kind of collective healing possible with reciprocity as an orienting principle. This post offers a brief sketch of the potential for Rights of Nature legislation to safeguard these sacred medicines by recognizing them as rights holders unto themselves and by embedding into law a relational positionality of respect and responsibility with our plant and fungal kin.

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Rows of gold post office boxes with one open mail box.

Plan to See ‘Plan C’ This Year

Joelle Boxer Leave a comment

By Joelle Boxer

Tracy Droz Tragos’ new documentary, “Plan C,” follows the work of a grassroots organization dedicated to improving access to the abortion pill by mail in the U.S., while navigating an increasingly restrictive legal landscape.

There is no better time to hear the perspectives of these patients, providers, and activists. Just last month, the U.S. Supreme Court took on a case to determine the legal status of the pill, also called mifepristone. With a decision expected in June 2024, Tragos’ film shows us what’s at stake.

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football on field

The NCAA May Pay a Healthy Sum to Student Athletes

Bobby Stroup Leave a comment

By Bobby Stroup

Right now in a Los Angeles courtroom, the fate of the NCAA hangs in the balance. Perhaps as a way to preempt the outcome, on December 6, NCAA President Charlie Baker sent a letter proposing some schools should be allowed to compensate student athletes for using their name, image and likeness (NIL). President Baker is right to try and get ahead of the student-athlete compensation issue, but NIL payments are not the only issue at play. Health care will also be a critical part of future student-athlete compensation conversations.

The NCAA describes the compensation lawsuits as beginning in 2009, yet exploring this topic reveals the debate is not so novel. The NIL terminology is newer, but limiting this to an NIL problem is overly narrow. The challenge of student-athlete compensation is a broader issue that started at the founding of the organization. This issue is rooted in more than a century of health policy, and understanding that history is essential to understanding future NCAA negotiations.

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Torso of doctor in white coat with hands displaying in between them a rendering of an antibody.

The SCOTUS Antibody Ruling Has an Uncertain Impact for Drug Makers and Patients

Timothy Bonis Leave a comment

How Amgen v. Sanofi will affect innovation and the pharmaceutical industry.

By Timothy Bonis

Millions of patients rely on monoclonal antibodies. The global market in 2022 was $210B with a compound annual growth rate of 11 percent. Monoclonal antibody patents are now some of the world’s most valuable intellectual property.

Monoclonal antibody patent law has been in turmoil for the past two decades. The Court of Appeals for the Federal Circuit (the “Federal Circuit”) has repeatedly raised the standards for antibody patents, forcing patentees to rethink how they protect their inventions. In April 2023, the increasingly stringent standards of the Federal Circuit were affirmed by the Supreme Court. In Amgen v. Sanofi, the justices unanimously upheld the invalidation of two antibody patents, potentially transforming patent law across biotech.

This post reviews the emerging post-Amgen literature, distilling the ruling’s likely impact on innovation and the pharmaceutical industry. A companion post addresses the ruling’s legal significance.

This post has three parts. Part I describes monoclonal antibodies and why Amgen is important. Parts II and III address innovation, first by discussing whether Amgen is reflective of modern antibody science and second by exploring how the ruling may affect the pharmaceutical industry.

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Judicial Court Files And Judge Gavel.

When the Law of Scientific Evidence Collides with Medical Practice

Barbara Pfeffer Billauer Leave a comment

By Barbara Pfeffer Billauer

Approaches to resolving scientific evidentiary issues continue to diverge throughout the country.[1] A prominent recent example includes the rejection of the medical diagnosis of Shaken Baby Syndrome (SBS) to reflect disparate views in the scientific, medical, and legal communities.

Under guise of making a scientific evidentiary ruling, a New Jersey court has just dismembered the medical diagnosis of SBS, with the judge disavowing the condition’s validity. The decision concerned two babies, both under one year old, who suffered devastating neurological injuries while under the care of their fathers.

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see saw with earth as fulcrum and a pile of vaccines weighing down one side with nothing on the other side.

The Case for Procurement Transparency

The Petrie-Flom Center Staff Leave a comment

By Tara Davis and Nicola Soekoe

In January 2021, the Director General of the World Health Organization (WHO) observed that the world was on the brink of a “catastrophic moral failure” if wealthier nations did not ensure the equitable distribution of COVID-19 vaccines. Global health activists and civil society organizations who worked transnationally to curtail what came to be referred to as “vaccine apartheid” faced a pharmaceutical industry that globally relied on secrecy, capital-friendly trade laws, and brute economic force to shirk considerations of human rights. In many ways, pharmaceutical companies and the states that protected them, including by failing to achieve consensus at the World Trade Organization (WTO) for a waiver of intellectual property rights with respect to vaccines, seemed impenetrable.

Unsurprisingly, given the extreme position of power from which pharmaceutical companies were negotiating contracts, there were widespread reports and allegations of inequitable contractual terms and a culture of bullying in the development of contracts. This was an issue of global concern for a long period during the pandemic. In South Africa, the Health Justice Initiative (HJI), a local advocacy organization, joined the global calls for greater procurement transparency.

However, when the South African Department of Health refused to disclose even the names of the entities with which it had entered into vaccine-related agreements, the HJI was forced to turn to the courts for relief.

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U.S. Supreme Court

Don’t Be Too Alarmed by the New SCOTUS Antibody Ruling

Timothy Bonis Leave a comment

Amgen v. Sanofi is an important case, but it won’t transform patent law on its own.

By Timothy Bonis

Last April, the Supreme Court ruled in Amgen v. Sanofi, a closely watched patent case where the justices upheld the invalidation of two monoclonal antibody patents for lack of enablement. The ruling has attracted significant interest for two reasons.

First, Amgen involved genus claims in biological and chemical fields, which some experts believe the Federal Circuit has made unduly hard to obtain. This viewpoint, most prominently expressed by Mark Lemley, Sean Seymore, and Dmitry Karshtedt in The Death of The Genus Claim (2021), informed much of the debate about Amgen, although it has been challenged by scholars like Christopher Holman.

Second, Amgen dealt with monoclonal antibody patents, which now represent some of the most valuable intellectual property. (The global market for monoclonals in 2022 was $210B.) Moreover, the scope of antibody patent claims has been narrowed markedly by heightened standards for enablement and written description introduced over the past two decades; antibody inventors once received broad protection through functional claims, but the Patent and Trademark Office (PTO) has raised its requirements, partially in response to repeated invalidations of antibody genus claims at the Federal Circuit (see Chiron v. Genentech, 2004, Centocor v. Abbott, 2011, and AbbVie v. Janssen, 2014).

The decision in Amgen continues the trend of narrowing antibody patents and the perceived trend of limiting genus claims. Thus, how impactful Amgen will be on its own remains uncertain. Does it add new constraints to the patentability of antibodies, small molecules, and chemicals, or does it merely recapitulate the Federal Circuit’s previous rulings? This post reviews that debate. Part I examines how scholars and attorneys have reacted to Amgen, focusing on whether they think the case will have a legal and practical impact. Part II synthesizes these perspectives, arguing that Amgen’s direct impact will be limited. A companion piece summarizing the ruling’s significance for the industry and innovation will follow.

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