Law Commons^™

Trust The Science But Do Your Research: A Comment On The Unfortunate Revival Of The Progressive Case For The Administrative State, Mark Tushnet

Indiana Law Journal

This Article offers a critique of one Progressive argument for the administrative state, that it would base policies on what disinterested scientific inquiries showed would best advance the public good and flexibly respond to rapidly changing technological, economic, and social conditions. The critique draws on recent scholarship in the field of Science and Technology Studies, which argues that what counts as a scientific fact is the product of complex social, political, and other processes. The critique is deployed in an analysis of the responses of the U.S. Centers for Disease Control and Food and Drug Administration to some important aspects …

Comment: On Patents And Appropriations—And Tragedies, David O. Taylor

Washington and Lee Law Review

I write to provide a few remarks concerning Sasha Hoyt’s illuminating work published in the pages of this journal. In it, Hoyt addresses the impact of the Supreme Court’s patent eligibility decisions on private investment in the development of medical diagnostic technologies. As an initial matter, I want to congratulate Hoyt for tackling an important topic. As Hoyt discusses, medical diagnostic technologies enable the diagnosis of diseases and other medical conditions such as genetic disorders, and early and accurate diagnosis may lead to early treatments and, ultimately, at least in some cases, saved lives. But the creation of medical diagnostic …

The Impact Of Uncertainty Regarding Patent Eligible Subject Matter For Investment In U.S. Medical Diagnostic Technologies, A. Sasha Hoyt

Washington and Lee Law Review

Historically, 35 U.S.C. § 101, the statute governing patent eligible subject matter, has been construed broadly—with its legislative history indicating that it should cover “anything under the sun that is made by man.” The Supreme Court crafted three exceptions to § 101: (1) abstract ideas, (2) laws of nature, and (3) natural phenomena. In recent years, the Supreme Court’s eligibility jurisprudence has further narrowed § 101 to effectively exclude meritorious medical diagnostic methods. Indeed, since the Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Federal Circuit has held every single diagnostic method claim brought before it …

Patent Eligibility And Cancer Therapy, Christopher B. Seaman

Washington and Lee Law Review

As an empirical legal scholar, I am pleased to report that Sasha Hoyt has done what very few law students—and even many law professors—could achieve. She successfully conducted a novel empirical study to assess the real-world impact of a U.S. Supreme Court decision, Mayo Collaborative Services v. Prometheus Laboratories, Inc., on venture capital (VC) investment in startups and other companies that develop medical diagnostic technology.

As Ms. Hoyt notes, patent protection is particularly important for startup companies, as it can help protect their innovations from unauthorized use, attract funding and other investments, and foster collaboration with third parties. In …

Covid-19 And Its Impact(S) On Innovation, Clark Asay, Stephanie Plamondon Bair

Utah Law Review

In previous work, we explored how certain characteristics of adversity are often more conducive to innovation than others. In this Article, prepared as part of the Lee E. Teitelbaum Utah Law Review Symposium—The Law & Ethics of Medical Research, we review some of that work and apply it specifically to the COVID-19 context. We conclude by assessing certain policy implications in light of how the COVID-19 pandemic has both spurred and hindered innovation.

Critical Reviews Of Flawed Research On Prostitution, Donna M. Hughes

Dignity: A Journal of Analysis of Exploitation and Violence

No abstract provided.

Due Process Supreme Court Appellate Division

Touro Law Review

No abstract provided.

Lessons Learned By An Interdisciplinary Research Team Evaluating Medical-Legal Partnership With The Department Of Veterans Affairs, Margaret Middleton, Jack Tsai, Robert Rosenheck

South Carolina Law Review

No abstract provided.

The Inclusion Of Pregnant Women In Clinical Research, Barbara A. Noah

Saint Louis University Journal of Health Law & Policy

In the past three decades, there has been unprecedented growth in medical research utilizing human subjects, with much promise for new treatments that extend life, improve quality of life, and prevent disease and disability. Safe prescribing of drug therapies requires that researchers design clinical trials to test products for the benefit of all persons who are likely to utilize them, not just a limited population. For this reason, it is essential that clinical trials include women, pregnant women, children, and racial minorities, as appropriate, because these populations sometimes exhibit different patterns of response or adverse reactions.

Despite some significant progress …

Dual Use Research Policy Implementation, Carole R. Baskin, Todd J. Richardson

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Life Sciences Dual Use Research Of Concern, Public Health And Safety, And The Doctrine Of Unconstitutional Conditions, Vickie J. Williams

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Regulating Dual Use Research To Promote Public Trust: A Reply To Dr. Franz, Robert Gatter

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Data, Policies And Conflicts Of Interest In Research, Jeremy Sugarman

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Apologies In The Healthcare System: From Clinical Medicine To Public Health, Michal Alberstein, Nadav Davidovitch

Law and Contemporary Problems

Alberstein and Davidovitch explore the role of apologies in healthcare systems from a broader perspective. The significance of apology in terms of social solidarity is addressed and the ways in which each apology situation entails a clash between cultural identities are demonstrated. The debate on apology is explored by presenting a public health perspective of apologies following collective traumatic events such as the application of sterilization laws or flawed human experimentations in various settings.

Beyond Bidil: The Expanding Embrace Of Race In Biomedical Research And Product Development, Jonathan Kahn

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Pharmacogenomics And The Genetic Information Nondiscrimination Act Of 2008: Legislation Limitations And Its Impact On Pgx Research And Clinical Opportunity, Amanda Tessmer

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Regulation Of Research With Children: The Evolution From Exclusion To Inclusion, Duane Alexander

Journal of Health Care Law and Policy

No abstract provided.

Whose Duty Is It Anyway?: The Kennedy Krieger Opinion And Its Implications For Public Health Research, Diane E. Hoffmann, Karen H. Rothenberg

Journal of Health Care Law and Policy

No abstract provided.

Comments On The Second Report Of The Maryland Attorney General's Research Working Group, Franklin G. Miller

Journal of Health Care Law and Policy

No abstract provided.

The National Bioethics Advisory Commission: Bridging The Gaps In Human Subjects Research Protection, James F. Childress

Journal of Health Care Law and Policy

No abstract provided.

Issues Raised By Research Using Persons Suffering From Dementia Who Have Impaired Decisional Capacity, Peter V. Rabins

Journal of Health Care Law and Policy

No abstract provided.

Regulating Research With Vulnerable Populations: Litigation Gone Awry, John M. Oldham, Stephan Haimowitz, Susan J. Delano

Journal of Health Care Law and Policy

No abstract provided.

Proxy Consent To Participation Of The Decisionally Impaired In Medical Research-Maryland's Policy Initiative, Diane E. Hoffmann, Jack Schwartz

Journal of Health Care Law and Policy

No abstract provided.

Regulation Of Research On The Decisionally Impaired: History And Gaps In The Current Regulatory System, Jonathan D. Moreno

Journal of Health Care Law and Policy

No abstract provided.

Protecting Vulnerable Research Subjects: Practical Realities Of Institutional Review Board Review And Approval, Alison Wichman

Journal of Health Care Law and Policy

No abstract provided.

In Harm's Way: Research Subjects Who Are Decisionally Impaired, Clarence J. Sundram

Journal of Health Care Law and Policy

No abstract provided.

The Elderly Questionably Competent Client Dilemma: Determining Competency And Dealing With The Incompetent Client, Marilyn Levitt

Journal of Health Care Law and Policy

No abstract provided.

Achieving Proper Balance In Research With Decisionally-Incapacitated Subjects: Nami's Perspectives On The Working Group's Proposal, Laurie M. Flynn, Ronald S. Honberg

Journal of Health Care Law and Policy

No abstract provided.

Assessment Of Capacity To Give Consent To Research Participation: State-Of-The-Art And Beyond, Evan G. Derenzo, Robert R. Conley, Raymond Love

Journal of Health Care Law and Policy

No abstract provided.

Book Review, Allan M. Wheatcraft

RISK: Health, Safety & Environment (1990-2002)

Review of the following book: SHELDON KRIMSKY, BIOTECHNICS AND SOCIETY: THE RISE OF INDUSTRIAL GENETICS. (Praeger 1991) [280 pp.] Bibliography, figures, index, list of acronyms used, tables. LC: 90-23214, ISBN: 0-275-93860-3. [Paper $17.95. P.O.B. 5007, Westport CT 06881.]