Black and white photograph of the front of the Supreme Court. Pro-abortion protestors stand holding signs, one of which reads "I stand with Whole Woman's Health"

Challenging the Contours of the “Undue Burden” Standard in June Medical Services v. Gee: A Slippery Slope?

By Beatrice Brown

On October 4, the Supreme Court announced that it would hear June Medical Services v. Gee, in which a 2014 Louisiana law that requires abortion providers to have admitting privileges at a nearby hospital will be examined. The case is nearly identical to Whole Woman’s Health v. Hellerstedt, in which the Supreme Court held that a Texas law with a similar requirement for admitting privileges was unconstitutional according to the “undue burden” standard asserted in the landmark 1992 case Planned Parenthood v. Casey. According to the 5-3 ruling, such requirements for admitting privileges posed an undue burden on a woman’s constitutional right to abortion without also providing a significant health benefit to the woman.

As noted by many experts, the two cases are remarkably similar, with the key difference being the composition of the Supreme Court. In 2016, Justice Anthony Kennedy joined the four liberal judges in the majority opinion, whereas now, Justice Brett Kavanaugh will likely join the four other conservative justices. The uncertain factor, however, is that in February, Chief Justice John Roberts voted with the majority opinion to delay the Louisiana law from going into effect in light of ongoing litigation, despite voting against the majority in Whole Woman’s Health v. Hellerstedt about the constitutionality of this similar Texas law. As such, it is unclear if the Court will hold that the Louisiana law is constitutional – given that Justice Kavanaugh will likely vote for its constitutionality, the direction of the ruling hinges on whether Justice Roberts votes as he did in Whole Woman’s Health v. Hellerstedt or as he did in February. Read More

Couple sitting on a couch, leaning forward to have a serious conversation with a doctor or counselor

Genetic Testing: Is There a “Duty to Warn” At-Risk Family Members?

By Shelly Simana

Genetic information is quite distinguishable from much medical information due its familial nature and its unique ability to predict future health. The fact that genetic testing supplies comprehensive information about the genetic make-up of patients and their family members underlies the ethical and legal challenges faced by physicians and patients when deciding whether to disclose genetic information to family members. Failure to disclose information may “lead to harm, particularly when knowledge could result in avoidance, treatment, or prevention of a genetic condition or in significant changes to reproductive choices or lifestyle.” Due to the potential harm, one may ask herself if there is a legal “duty to warn” family members about the presence of defective genes, and if so, upon whom should it be imposed.

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Blurred image of a patient in critical condition in the ICU ward.

“An Act Improving Medical Decision Making:” An Argument in Favor of MA House Bill 3388 and Senate Bill 843

By Beatrice Brown

On September 10, 2019, the Joint Committee on Judiciary at the Massachusetts State House heard testimony regarding House Bill 3388 and Senate Bill 843, “An Act Improving Medical Decision Making.” The Massachusetts Medical Society (MMS) was among those testifying in favor of the act. As noted by MMS, Massachusetts is one of only five states in the U.S. that does not have a default surrogate consent statute for incapacitated patients without a health care proxy. The intent of a default surrogate consent statute is “to provide legal authority for health care decision-making through a non-judicial rule of law where no guardian or agent had been appointed.”

Without such a statute in place, this means that a patient who is incapacitated and has not declared a health care proxy must await treatment while a guardian is appointed by the courts. This may be a lengthy, time-consuming process that physically drains hospitals’ resources and emotionally drains families. By contrast, these default surrogate consent statutes establish a list of surrogates that can be appointed by physicians to make decisions in lieu of the incapacitated patient. For example, in the Massachusetts bills, the following persons are listed as candidates who may be appointed as surrogates: the person’s spouse, unless legally separated; the person’s adult child; the person’s parent; the person’s adult sibling; and any other adult who satisfies the requirement of subdivision seven of the bill which states, “The person’s surrogate shall be an adult who has exhibited special care and concern for the person, who is familiar with the person’s personal values, who is reasonably available, and who is willing to serve.” Read More

Genetic Discrimination in Education: What’s the Risk?

By Kaitlyn Dowling, based on research by the Cyberlaw Clinic at the Berkman Klein Center for Internet & Society

Illustration of a gavel made out of a DNA helixIn a new, year-long series on Bill of Health, we’ll be exploring the legal scholarship on genetic non-discrimination. We’ll talk more about GINA and state laws protecting citizens from genetic discrimination. We hope these posts help shed light on this complex and ever-more-relevant area for legal scholars, policymakers, and the public at large.

As discussed in our last post, most states regulate the use of genetic information in some way, although usually only in employment and insurance. Comparatively few states have protections against genetic discrimination in other contexts. Today, we’re exploring education protections in eight states: California, Illinois, Massachusetts, Michigan, Utah, Virginia, Washington, and West Virginia.

In comparison with other genetic non-discrimination protections, most states have not acted to implement protections in the education context. California, West Virginia, and Washington are the only states out of the eight surveyed with these types of protections.

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Photograph of protestor holding a hot pink sign that reads "I Stand with Planned Parenthood"

Trump’s Title X Gag Rule: An Ethical Conundrum for Planned Parenthood

By Beatrice Brown

On August 19, Planned Parenthood announced that they would be leaving the Title X family planning program due to the Trump Administration’s new prohibition that restricts those who receive Title X funds from providing or referring patients for abortion. This restriction on Title X funding has unsurprisingly been met with a lot of criticism, namely, that it interferes with a woman’s constitutional right to abortion. This can be seen as a partial victory for those who have been attempting to defund Planned Parenthood for years, an organization that, despite others’ characterizations, is fundamentally committed to providing all women access to quality health care and is not solely an abortion provider.

As a result of this gag rule, Planned Parenthood has faced a huge ethical dilemma: Do they continue to accept Title X funding to assist low-income women with everyday health care, such as yearly routine wellness visits, or do they reject this funding and both 1) take a stand on a woman’s constitutional right to abortion and 2) continue to provide a service (or retain the right to refer patients to a service) that is crucial to women’s health? Planned Parenthood has chosen the latter, and I think that Planned Parenthood’s difficult choice is justified.

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Photograph of surrogate showing parents-to-be ultrasound pictures

What happens when assisted reproductive technology agreements break down?

By Sarah Alawi

My name is Sarah Alawi; I’m an LLM Student at Harvard Law School, from New Zealand. I am excited to contribute to the Petrie-Flom Blog as a Petrie-Flom Student Fellow. My area of interest is assisted reproductive technology (ART), although I intend to use this forum to write on a broad range of medico-legal issues in the bioethics sphere. This post introduces my specific research interest in ART disputes, and concludes with a recommendation for anyone considering ART.

ART is a growth industry and yet, despite the sophistication of new birth technologies, its use depends on functioning human relationships. Commonly, parties try to define these relationships using pre-conception ART agreements. During my fellowship at the Petrie-Flom Center, I intend to write a thesis on what should happen, in terms of the parties’ rights at law, when three common forms of ART agreements break down:

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Technical illustration of a respirator device

Why Medical Device Regulation?

By Carmel Shachar

The Petrie-Flom Center’s 2020 annual conference, Innovation and Protection: The Future of Medical Device Regulation, co-sponsored by the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law and the University of Arizona Health Law Program, was inspired by a growing sense that there is a need to reconsider our regulatory approach to medical devices as they become increasingly complex. Not only are medical devices becoming more mechanically complex, but they are also increasingly merging with digital technologies to expand capabilities.

Devices’ increasing complexity raises questions as to whether our regulatory pathways for medical devices are appropriate for ensuring safety and efficacy. The New York Times in a May 4, 2019 Editorial Opinion indicated that they believed the answer is no—that our current regulatory system, especially the 510(k) pathway and limited post-market surveillance, risk patient lives and health. The European Council is implementing new medical device regulations in May 2020 and 2022 to address similar concerns around safety and effectiveness in the EU. Both American and European regulators are struggling to find the best way to oversee the new hybrid medical devices that incorporate both hardware and software, as well as stand-alone algorithms.

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Jenn Oliva on “The Week in Health Law” Podcast

The Oklahoma opioid verdict was handed down on August 26 and, of course, there’s only one person to discuss it with, Jennifer OIiva. Professor Oliva is on the faculty at  at Seton Hall Law where she specializes in health, FDA, and evidence law. An honors graduate of Georgetown University Law Center, Professor Oliva was a Public Interest Law Scholar and served as Executive Notes & Comments Editor of The Georgetown Law Journal. After law school, Professor Oliva clerked on the 10th and 3rd Circuit court of appeals. She also served as the Deputy State Solicitor of the State of Delaware. Read her smart scholarship here.

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, Spotify, Tunein 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 and @WeekInHealthLaw.

Subscribe to TWIHL here!

Photo of a stethoscope, gavel, and book

The End of Dramatic Legal Saga: French Patient Vincent Lambert has Died

By Audrey Lebret

There are few cases as publicized in France as the story of Vincent Lambert, a patient in a vegetative state whose fate deeply divided his family. On June 28, 2019, the Cour de Cassation signed the last substantial decision of the Vincent Lambert case, after six years of proceedings. The patient died on July 11, 2019.

The facts

In 2008, Vincent Lambert was involved in a traffic accident that left him in a quadriplegic state and suffering from massive brain trauma. In 2011, a medical evaluation described his state as minimally conscious. Doctors tried to establish a code of communication to which he was never responsive. Nonetheless, doctors tracked some behaviors that they interpreted as an opposition to treatments and a refusal to live (Conseil d’Etat judgement, at 20). In 2013, his doctor initiated a procedure with the agreement of Mr. Lambert’s wife in order to interrupt the treatments. That initiated a lengthy court battle.

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human embryos under a microscope

A Lawsuit Involving an Alabama Man and a Fetus Is Particularly Threatening to Reproductive Rights

Last week Alabama passed the most restrictive abortion law in the country, criminalizing abortion of “any woman known to be pregnant,” with very limited exceptions that do not include rape or incest. But a recent case in Alabama presents an even more threatening challenge to reproductive rights.

In a new paper published in JAMA, the Journal of the American Medical Association, authors Dov FoxEli Y. Adashi, and I. Glenn Cohen, discuss a recent Alabama state court case involving a man suing an abortion clinic and the manufacturer of a pill that enabled his then-girlfriend to terminate her pregnancy at 6 weeks.

In a troubling decision, the court permitted the fetus be a co-plaintiff alongside the man in a “wrongful death” lawsuit. Read More