Medical Jurisprudence Commons^™

Mdl Revolution, Elizabeth Chamblee Burch, Abbe Gluck

Scholarly Works

Over the past 50 years, multidistrict litigation (MDL) has quietly revolutionized civil procedure. MDLs include the largest tort cases in U.S. history, but without the authority of the class-action rule, MDL judges—who formally have only pretrial jurisdiction over individual cases—have resorted to extraordinary procedural exceptionalism to settle cases on a national scale. Substantive state laws, personal jurisdiction, transparency, impartiality, reviewability, federalism, and adequate representation must all yield if doing so fulfills that one goal.

Somehow, until now, this has remained below the surface to everyone but MDL insiders. Thanks to the sprawling MDL over the opioid crisis—and unprecedented opposition to …

Factors Affecting Access To Administrative Health Data For Research In Canada: A Study Protocol, Cynthia Kendell, Adrian Levy, Geoff Porter, Elaine Gibson, Robin Urquhart

Articles, Book Chapters, & Popular Press

In Canada, most provinces have established administrative health data repositories to facilitate access to these data for research. Anecdotally, researchers have described delays and substantial inter-provincial variations in the timeliness of data access approvals and receipt of data. Currently, the reasons for these delays and variations in timeliness are not well understood. This paper provides a study protocol for (1) identifying the factors affecting access to administrative health data for research within select Canadian provinces, and (2) comparing factors across provinces to assess whether and how they contribute to inter-provincial variations in access to administrative health data for research.

Transparency Of Regulatory Data Across The European Medicines Agency, Health Canada, And Us Food And Drug Administration, Alexander C. Egilman, Amy Kapczynski, Margaret E. Mccarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach, Joseph S. Ross

Articles, Book Chapters, & Popular Press

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

Exploring The Food And Drug Administration’S Review And Approval Of Entresto (Sacubitril/Valsartan), Ashley Eadie, Keith Brunt, Matthew Herder

Articles, Book Chapters, & Popular Press

Federal regulatory agencies such as the United States Food and Drug Administration review pharmacological evidence to ensure the safety and efficacy of new and repurposed pharmaceuticals prior to market approval. The discussions, disagreements and procedural decisions contained within such reviews offer unique insight into a pharmaceutical's strengths, weaknesses and opportunities, yet are often overlooked as a significant source of pharmacological information for research and development. To highlight the value of such resources, we present a case study on Entresto, a first-in-class angiotensin receptor-neprilysin inhibitor for the treatment of heart failure with reduced ejection fraction, and explore the regulatory rationale underlying …

In The Name Of Public Health: Misoprostol And The New Criminalization Of Abortion In Brazil, Mariana Prandini Assis, Joanna Erdman

Articles, Book Chapters, & Popular Press

This article explores the criminal regulation of misoprostol as a controlled drug in Brazil as a new form of abortion criminalization. A qualitative analysis of Brazilian case law shows how the courts use a public health rhetoric of unsafe abortion to criminalize the distribution of misoprostol in the informal sector. Rather than an invention of the local bench, this judicial rhetoric reflects global public health discourse and policy on unsafe abortion and the double life of misoprostol as both an essential medicine and a controlled drug. In contrast to previous studies, the article shows that abortion criminalization is not the …

Attitudes Toward Withholding Antibiotics From People With Dementia Lacking Decisional Capacity: Findings From A Survey Of Canadian Stakeholders, Gina Bravo, Lieve Van Den Block, Jocelyn Downie, Marcel Arcand, Lise Trottier

Articles, Book Chapters, & Popular Press

Background

Healthcare professionals and surrogate decision-makers often face the difficult decision of whether to initiate or withhold antibiotics from people with dementia who have developed a life-threatening infection after losing decisional capacity.

Methods

We conducted a vignette-based survey among 1050 Quebec stakeholders (senior citizens, family caregivers, nurses and physicians; response rate 49.4%) to (1) assess their attitudes toward withholding antibiotics from people with dementia lacking decisional capacity; (2) compare attitudes between dementia stages and stakeholder groups; and (3) investigate other correlates of attitudes, including support for continuous deep sedation (CDS) and medical assistance in dying (MAID). The vignettes feature a …

Social Determinants Of Health And Slippery Slopes In Assisted Dying Debates: Lessons From Canada, Jocelyn Downie, Udo Schuklenk

Articles, Book Chapters, & Popular Press

The question of whether problems with the social determinants of health that might impact decision-making justify denying eligibility for assisted dying has recently come to the fore in debates about the legalization of assisted dying. For example, it was central to critiques of the 2021 amendments made to Canada’s assisted dying law. The question of whether changes to a country’s assisted dying legislation lead to descents down slippery slopes has also come to the fore—as it does any time a jurisdiction changes its laws. We explore these two questions through the lens of Canada’s experience both to inform Canada’s ongoing …

Optimizing The Data Available Via Health Canada's Clinical Information Portal, Alexander C. Egilman, Joseph S. Ross, Matthew Herder

Articles, Book Chapters, & Popular Press

Through its Public Release of Clinical Information initiative, Health Canada has provided public access to a vast repository of data that have been submitted to support market authorization of drugs and medical devices. Health Canada has released data from more than 160 submissions for drugs, biologics, vaccines and medical devices. The regulator is currently in its third year of a 4-year phase-in schedule to release clinical data proactively from submissions for all new active substances, new clinical indications, generic drugs and higher-risk devices that are approved, withdrawn or rejected. Substantial clinical data submitted by the industry sponsor of the application, …

Does The Law Require Reinterpretation And Return Of Revised Genomic Results?, Ellen W. Clayton, Wendy K. Chung, Gary E. Marchant, Jessica L. Roberts

Vanderbilt Law School Faculty Publications

Knowledge about the clinical implications of individual genetic variants, genes, and genomics is growing rapidly. As a result, interpretations that were made at one time may later turn out to be incorrect. Awareness of these changes in results can occur in two ways. In the first case, the laboratory initially identified and reported a variant, assigning it some level of disease causation ranging from pathogenic to uncertain significance to benign. Subsequently acquired knowledge then reveals that the variant that was reported is now understood to have a different interpretation, most frequently more benign. In the second case, the laboratory may …

Isscr Guidelines For The Transfer Of Human Pluripotent Stem Cells, Ellen W. Clayton, I Hyun, Et. Al.

Vanderbilt Law School Faculty Publications

The newly revised 2021 ISSCR Guidelines for Stem Cell Research and Clinical Translation includes scientific and ethical guidance for the transfer of human pluripotent stem cells and their direct derivatives into animal models. In this white paper, the ISSCR subcommittee that drafted these guidelines for research involving the use of nonhuman embryos and postnatal animals explains and summarizes their recommendations.

The newly revised ISSCR Guidelines for Stem Cell Research and Clinical Translation includes scientific and ethical guidance for the transfer of human pluripotent stem cells and their direct derivatives into animal models (ISSCR, 2021). We are the members of the …

Protecting Research Data Of Publicly Revealing Participants, Ellen Clayton, B. A. Malin, Kyle J. Mckibbin

Vanderbilt Law School Faculty Publications

Biomedical researchers collect large amounts of personal data about individuals, which are frequently shared with repositories and an array of users. Typically, research data holders implement measures to protect participants’ identities and unique attributes from unauthorized disclosure. These measures, however, can be less effective if people disclose their participation in a research study, which they may do for many reasons. Even so, the people who provide these data for research often understandably expect that their privacy will be protected. We discuss the particular challenges posed by self-disclosure and identify various steps that researchers should take to protect data in these …

The Illusion Of Victory: Access To Abortion After June Medical Services, Brittany L. Raposa

Roger Williams University Law Review

No abstract provided.

Transparency Of Regulatory Data Across The European Medicines Agency, Health Canada, And Us Food And Drug Administration, Alexander C. Egilman, Amy Kapczynski, Margaret E. Mccarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach, Joseph S. Ross

Faculty Scholarship

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

Courts Beyond Judging, Michael C. Pollack

Articles

Across all fifty states, a woefully understudied institution of government is responsible for a broad range of administrative, legislative, law enforcement, and judicial functions. That important institution is the state courts. While the literature has examined the federal courts and federal judges from innumerable angles, study of the state courts as institutions of state government — and not merely as sources of doctrine and resolvers of disputes — has languished. This Article remedies that oversight by drawing attention for the first time to the wide array of roles state courts serve, and by evaluating the suitability of both the allocation …

Re-Reading Chevron, Thomas W. Merrill

Faculty Scholarship

Though increasingly disfavored by the Supreme Court, Chevron remains central to administrative law doctrine. This Article suggests a way for the Court to reformulate the Chevron doctrine without overruling the Chevron decision. Through careful attention to the language of Chevron itself, the Court can honor the decision’s underlying value of harnessing comparative institutional advantage in judicial review, while setting aside a highly selective reading that unduly narrows judicial review. This re-reading would put the Chevron doctrine – and with it, an entire branch of administrative law – on firmer footing.

Adolescent Medical Decisionmaking Rights: Reconciling Medicine And Law, Doriane Lambelet Coleman, Philip M. Rosoff

Faculty Scholarship

Dennis Lindberg came into his aunt’s care when he was in the 4th grade because his parents struggled with drug addiction and could not provide for him. At thirteen, he was baptized in his aunt’s faith as a Jehovah’s Witness. Just days after he turned fourteen, on November 6, he was diagnosed with acute lymphoblastic leukemia.

The prognosis was that Dennis had a 75% chance of cure with standard oncology treatment. Consistent with the requirements of his new faith, however, Dennis told his doctors, “I do not want to be treated if the requirement is that I would have to …

The Stellenbosch Consensus On Legal National Responses To Public Health Risks: Clarifying Article 43 Of The International Health Regulations, Roojin Habibi, Steven J. Hoffman, Gian Luca Burci, Thana Cristina De Campos, Danwood Chirwa, Margherita Cinà, Stéphanie Dagron, Mark Eccleston-Turner, Lisa Forman, Lawrence O. Gostin, Benjamin Mason Meier, Stefania Negri, Gorik Ooms, Sharifah Sekalala, Allyn Taylor, Alicia Ely Yamin

Georgetown Law Faculty Publications and Other Works

The International Health Regulations (IHR), of which the World Health Organization is custodian, govern how countries collectively promote global health security, including prevention, detection, and response to global health emergencies such as the ongoing COVID-19 pandemic. Countries are permitted to exercise their sovereignty in taking additional health measures to respond to such emergencies if these measures adhere to Article 43 of this legally binding instrument. Overbroad measures taken during recent public health emergencies of international concern, however, reveal that the provision remains inadequately understood. A shared understanding of the measures legally permitted by Article 43 is a necessary step in …

The Stellenbosch Consensus On The International Legal Obligation To Collaborate And Assist In Addressing Pandemics: Clarifying Article 44 Of The International Health Regulations, Margherita Cinà, Steven J. Hoffman, Gian Luca Burci, Thana Cristina De Campos, Danwood Chirwa, Stéphanie Dagron, Mark Eccleston-Turner, Lisa Forman, Lawrence O. Gostin, Roojin Habibi, Benjamin Mason Meier, Stefania Negri, Gorik Ooms, Sharifah Sekalala, Allyn Taylor, Alicia Ely Yamin

Georgetown Law Faculty Publications and Other Works

The International Health Regulations (IHR), of which the World Health Organization is custodian, govern how countries collectively promote global health security, including prevention, detection, and response to potential global health emergencies such as the ongoing covid-19 pandemic. While Article 44 of this binding legal instrument requires countries to collaborate and assist each other in meeting their respective obligations, recent events demonstrate that the precise nature and scope of these legal obligations are ill-understood. A shared understanding of the level and type of collaboration legally required by the IHR is a necessary step in ensuring these obligations can be acted upon …

Commentary On Emerson V. Magendantz, Lucinda M. Finley

Contributions to Books

Published as Chapter 13 of Feminist Judgments: Rewritten Tort Opinions, Martha Chamallas & Lucinda M. Finley, eds. (Cambridge University Press 2020). Emerson v. Magendantz assesses how to measure harm when people get pregnant after a negligently performed sterilization, or have disabled children after genetic counseling or prenatal testing misdiagnosed the risk. The court permitted parents to recover child-rearing costs only for disabled children, reasoning that the emotional benefits of a healthy child invariably outweigh its economic burdens. Critiquing this reasoning as a double insult to the disabled and to the importance of reproductive autonomy, the feminist rewritten opinion uses the …

Feigned Consensus: Usurping The Law In Shaken Baby Syndrome/Abusive Head Trauma Prosecutions, Keith A. Findley, D. Michael Risinger, Patrick D. Barnes, Julie A. Mack, David A. Moran, Barry C. Scheck, Thomas L. Bohan

Articles

Few medico-legal matters have generated as much controversy--both in the medical literature and in the courtroom--as Shaken Baby Syndrome (SBS), now known more broadly as Abusive Head Trauma (AHT). The controversies are of enormous significance in the law because child abuse pediatricians claim, on the basis of a few non-specific medical findings supported by a weak and methodologically flawed research base, to be able to “diagnose” child abuse, and thereby to provide all of the evidence necessary to satisfy all of the legal elements for criminal prosecution (or removal of children from their parents). It is a matter, therefore, in …

Evidence Supporting The Value Of Surgical Procedures: Can We Do Better?, Jonathan J. Darrow, Christopher Robertson, Willard S. Kasoff

Faculty Scholarship

There is an acknowledged need for higher-quality evidence to quantify the benefit of surgical procedures, yet not enough has been done to improve the evidence base. This lack of evidence can prevent fully informed decision-making, lead to unnecessary or even harmful treatment, and contribute to wasteful expenditures of scare health care resources. Barriers to evidence generation include not only the long-recognized technical difficulties and ethical challenges of conducting randomized surgical trials, but also legal challenges that limit incentives to conduct surgical research as well as market-based challenges that make it difficult for those funding surgical research to recoup investment costs. …

International Law And The Legalization Of Abortion In Northern Ireland, Emily Uterhark

Journal of Law and Health

On July 24, 2019, the Parliament of the United Kingdom passed an act that included an amendment requiring Northern Ireland to implement recommendations from the Committee on the Elimination on Discrimination Against Women. The amendment required Northern Ireland to repeal the 1861 abortion act and requires the decriminalization of abortion. The law went into effect on October 22, 2019, since the Northern Ireland power-sharing government (Stormont) did not reconvene before October 21, 2019. Since the law did go into effect, it gave women the right to obtain abortions under the CEDAW recommendations; however, when the Northern Irish government (Stormont) reconvenes, …

Hacking Hipaa: "Best Practices" For Avoiding Oversight In The Sale Of Your Identifiable Medical Information, Riyad A. Omar

Journal of Law and Health

In light of the confusion invited by applying the label "de-identified" to information that can be used to identify patients, it is paramount that regulators, compliance professionals, patient advocates and the general public understand the significant differences between the standards applied by HIPAA and those applied by permissive "de-identification guidelines." This Article discusses those differences in detail. The discussion proceeds in four Parts. Part II (HIPAA’s Heartbeat: Why HIPAA Protects Identifiable Patient Information) examines Congress’s motivations for defining individually identifiable health information broadly, which included to stop the harms patients endured prior to 1996 arising from the commercial sale of …

The Public Health Demand For Revoking Non-Medical Exemptions To Compulsory Vaccination Statutes, Emma Tomsick

Journal of Law and Health

In 2019, the United States saw the single largest outbreak of measles in recent history. The measles crisis has prompted state legislative bodies to face a seemingly impossible dilemma: eliminate both religious and philosophical exemptions to mandatory school vaccination statutes or sit by idly and allow measles to continue to run its course. As of June 2019, five states have neither religious nor philosophical exemptions to their mandatory vaccination statutes. This Note argues that states should remove all religious and philosophical exemptions to compulsory vaccination statutes. The 2019 measles outbreak demonstrates that the anti-vaccination movement poses a legitimate risk to …

Should A Physician Apologize For A Medical Mistake? – The Controversy Over The Effectiveness Of Apology Law Statutes, Samuel D. Hodge, Jr.

Cleveland State Law Review

There are two approaches that health care providers can pursue in handling a medical error. Is it better for a physician not to admit a mistake and aggressively defend the claim or apologize and try to amicably resolve the matter? There has been a growing movement for physicians to offer words of sympathy or to apologize for a medical mistake as a way of minimizing the impact of a medical error and reducing the chances of a malpractice claim. There are a number of benefits to this approach but critics maintain that an apology is a useless gesture with an …

The Great Coronavirus Pandemic Of 2020—7 Critical Lessons, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The world is experiencing a once-in-a-lifetime pandemic, causing untold human suffering and death, unraveling of social relationships, and robbing individuals of livelihoods and countries of prosperity. The coronavirus pandemic has strained health systems, revealed unconscionable inequalities, and upended international institutions. Here are 7 critical lessons.

Medical Disputes And Conflicting Values: Is There A “Right To Die” Later?, Janet L. Dolgin

BYU Law Review

No abstract provided.

Tuberculosis, Human Rights, And Law Reform: Addressing The Lack Of Progress In The Global Tuberculosis Response, Matthew M. Kavanagh, Lawrence O. Gostin, John Stephens

Georgetown Law Faculty Publications and Other Works

In 2018, the United Nations General Assembly convened the first-ever high-level meeting (HLM) on tuberculosis (TB). Since that time news on the world’s most lethal infectious disease is not good—the 2019 WHO TB report shows 1.2 million people died from TB, a number that has fallen just 11% since 2015, less than one-third of the way towards the End TB Strategy milestone of a 35% reduction (to about 850 million deaths) by 2020. The same number of people, 10.0 million, are estimated to have fallen ill with TB in 2018 as in 2017. The stubborn persistence of TB is attributable …

Material Lives: Amending The False Claims Act To Restore Qui Tam Medicaid Enforcement And Protect Our Most Vulnerable Communities, C. Deen

Washington and Lee Journal of Civil Rights and Social Justice

In 2016, the Supreme Court granted cert. in Universal Health Services, Inc. v United States ex rel. Escobar to resolve a circuit split on implied certification under the False Claims Act. The Court’s opinion also addressed the issue of materiality under the False Claims Act. The “rigorous standard” expounded by the Court raised the standard of materiality beyond simple contractual or regulatory noncompliance. This heightened standard represents a significant departure from previous jurisprudence. Moreover, the heightened standard frustrates the repeatedly expressed will of Congress to empower qui tam whistleblowers to prosecute fraud perpetrated on the government. The primary focus of …

Kicked Out, Kicked Again: The Discharge Review Boards’ Illiberal Application Of Liberal Consideration For Veterans With Post-Traumatic Stress Disorder, Jessica Lynn Wherry

Georgetown Law Faculty Publications and Other Works

In recent years, the Department of Defense (DoD) has responded to the growing awareness of mental health issues for military servicemembers during and after service. This Article focuses on veterans who have already been discharged from service, and specifically those who have been discharged under other-than-honorable conditions for misconduct that is likely the result of a mental health condition, including post-traumatic stress disorder (PTSD), traumatic brain injury, sexual assault, or sexual harassment. Thousands of former servicemembers have been kicked out of the military for misconduct rather than treated for mental health conditions they experienced due to their military service. When …