Medical Jurisprudence Commons^™

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

Familial Searching: How Implementing Minimum Safeguards Ensures Constitutionally-Permissible Use Of This Powerful Investigative Tool, Alexandra Nieto

Cardozo Law Review

This Note supports the adoption of Familial DNA Search Policies. by states that have not yet taken a position on the issue. Part I of this Note provides background on the role of Familial Searches in criminal investigations. This includes a discussion on the nature of Familial Searches, why they are useful, and the current state of the law. Part I also considers the different guidelines and protections in existing Familial Search Policies, as well as states' policies regulating their DNA databases. Part II discusses the Fourth Amendment and equal protection concerns implicated by Familial Searches and how a court …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

A Mathematical Solution To The Sine Of Madness That Is Pharmaceutical Compulsory Licensing Under The Trips Agreement And The Doha Declaration, Ashley E. Sperbeck

Marquette Intellectual Property Law Review

A viable economic solution is necessary to address the shortcomings, textual ambiguities, and deficiencies engulfing international patent protection, leading to the inability of LDCs facing public health crises or national emergencies and lacking pharmaceutical manufacturing facilities to obtain generic pharmaceuticals. This Note poses a solution to this problem via another Amendment to the TRIPS Agreement and the Doha Declaration, which provides a mathematical framework to determine when and under what circumstances a compulsory license should be granted. Furthermore, this Note contemplates establishment of a WTO subcommittee to oversee this proposed solution and to ensure compliance with this Amendment. This concrete …

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Marquette Intellectual Property Law Review

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …

The Immediacy Of Genome Editing And Mitochondrial Replacement, Raymond C. O'Brien

Scholarly Articles

After human DNA was first defined in 1953, the parallel science of assisted reproductive technology achieved a successful human birth through in vitro fertilization in 1978. Science then went on to facilitate gestational surrogacy, banking human reproductive materials, such as embryos, and greater opportunities for couples and individuals to become parents. Fertility clinics were established throughout the world to help persons and couples achieve parenthood, contributing to a steady increase in babies born through assisted reproductive means. Gradually, both federal and state laws in the United States were enacted to collect data from the fertility clinics, mandate insurance coverage of …

When Ais Outperform Doctors: Confronting The Challenges Of A Tort-Induced Over-Reliance On Machine Learning, A. Michael Froomkin, Ian Kerr, Joelle Pineau

Articles

Someday, perhaps soon, diagnostics generated by machine learning (ML) will have demonstrably better success rates than those generated by human doctors. What will the dominance of ML diagnostics mean for medical malpractice law, for the future of medical service provision, for the demand for certain kinds of doctors, and in the long run for the quality of medical diagnostics itself?

This Article argues that once ML diagnosticians, such as those based on neural networks, are shown to be superior, existing medical malpractice law will require superior ML-generated medical diagnostics as the standard of care in clinical settings. Further, unless implemented …

Developing Product Label Information To Support Evidence-Informed Use Of Vaccines In Pregnancy, Terra A. Manca, Janice E. Graham, Ève Dubé, Melissa Kervin, Eliana Castillo, Natasha S. Crowcroft, Deshayne B. Fell, Michael Hadskis, Jaelene M. Mannerfeldt, Devon Greyson, Noni E. Macdonald, Karina A. Top, On Behalf Of The Canadian Vaccine Product Monograph Working Group

Articles, Book Chapters, & Popular Press

Background: Product labelling information describing the use of vaccines in pregnancy continues to contain cautionary language even after clinical and epidemiological evidence of safety becomes available. This language raises safety concerns among healthcare providers who may hesitate to recommend vaccines during pregnancy.

Purpose: To develop clear evidence-based language about vaccine safety and effectiveness in pregnancy for inclusion in vaccine product labels.

Methods: We conducted a three-stage consensus-methods project with stakeholders, including: healthcare providers, vaccine regulators, industry representatives, and experts in public health, communication, law, ethics, and social sciences. Using qualitative and quantitative methods, we held a nominal group technique (NGT) …

Halted Innovation: The Expansion Of Federal Jurisdiction Over Medicine And The Human Body, Myrisha S. Lewis

Faculty Publications

Modern medical innovations are blurring the line between medical practice and medical devices and drugs. Historically, many techniques have been developed in medicine, without any interference from the federal government, as medical practice is (and has historically been) an area of state jurisdiction. Over the past two decades, however, the U.S. Food and Drug Administration (FDA) has been exerting jurisdiction over the human body and the practice of medicine by targeting new medical techniques for oversight and subjecting the continued use of those treatments to onerous and legally questionable regulatory requirements that hinder the use of those treatments in practice. …

Crispr/Cas-9 Technologies: A Call For A New Form Of Tort, Kendall Lovell

San Diego International Law Journal

Once relegated to the domains of science fiction, modern day scientists and researchers are poised on the precipice of making genome editing clinically available. Once introduced into a clinical setting the effects of an off-target mutation or germline edit will remain largely unknown until health issues arise later in life or in the following generation. The novelty of the injuries that will arise require a system that is able to balance the interests of physicians with single and multi-generational plaintiffs, while providing a realistic framework for courts to follow. This comment offers a brand-new context that accounts for these needs …

Reforming Regenerative Medicine Regulation, Sarah Duranske

Georgia State University Law Review

Regenerative medicine is defined as the branch of medicine that develops methods to regrow, repair, or replace damaged or diseased cells or tissues. It includes a variety of approaches, such as transplanting cells to promote healing, editing genes in cells to attack cancer, and even building organs from biological materials. Regulating regenerative medicine therapies is no easy task. Finding a balance between competing interests–enabling timely access for needy patients while simultaneously ensuring a positive benefit/risk profile and promoting the development of beneficial innovations–is hard enough at any given point in time. But add in constantly advancing scientific knowledge and increasing …

How Subterranean Regulation Hinders Innovation In Assisted Reproductive Technology, Myrisha S. Lewis

Cardozo Law Review

Most scholars believe assisted reproductive technology is subject only to minimal regulation, especially by the federal government. This belief I contend, is wrong. In this Article, I examine agency documents, statements by officials, and letters that the U.S. Food and Drug Administration (FDA) has sent to physicians and researchers over the past fifteen years to reveal an overlooked regulatory program. The FDA has been targeting new forms of assisted reproductive technology that involve small genetic modifications (advanced assisted reproductive technologies or AARTs) through regulatory actions that receive little public, media, or scholarly attention. I term this method of regulation "subterranean …

Noa V. Doa: Increasing Medical Diagnostic Patentability After Mayo, Karen Mckenzie

Marquette Intellectual Property Law Review

The medical diagnostics market is expected to reach 65 billion by 2018. In March 2012, in Mayo Collborative Services v. Prometheus Labs, Inc. , ("Mayo") the U.S. Supreme held that the Mayo Clinic (the "Clinic") had not infringed on Prometheus Labs’ (“Prometheus”) diagnostic patent because the Prometheus patent involved ineligible subject matter, and was therefore invalid. Section 101 of the Patent Act defines eligible subject matter an “any new and useful process, machine, manufacture, or composition of matter” as patentable subject matter. Courts have held that Section 101 contains an implicit exception, making laws of nature, natural phenomena, and abstract …

Use Of Mediation To Recover Rights To Our Genes, Rachel Albert

Pepperdine Dispute Resolution Law Journal

No abstract provided.

Germ-Line Gene Editing And Congressional Reaction In Context: Learning From Almost 50 Years Of Congressional Reactions To Biomedical Breakthroughs, Russell A. Spivak, J.D., I. Glenn Cohen, J.D., Eli Y. Adashi, M.D., M.S.

Journal of Law and Health

On December 18, 2015, President Obama signed into law a policy rider forestalling the therapeutic modification of the human germ line. The rider, motivated by the science’s potential unethical ends, is only the most recent instance in which the legislature cut short the ongoing national conversation on the acceptability of a developing science. This essay offers historical perspective on what bills were proposed and passed surrounding four other then-developing scientific breakthroughs—Recombinant DNA, in vitro fertilization, Cloning, Stem Cells—to better analyze how Congress is, and should, regulate this exciting and promising science.

Bioprospecting Legislation In The United States: What We Are Doing, What We Are Not Doing, And What Should We Do Next, Emily J. Stolfer

Cleveland State Law Review

Bioprospecting is a growing worldwide effort to protect knowledge and the environment. With its potential economic benefit and technological advancements, bioprospecting will continue to grow as the world advances. Other nations have begun to protect the information available and continue to develop legislation. However, the United States has been hesitant to ratify international treaties or implement its own legislation. This Note examines both domestic and international efforts to protect both indigenous people and the environment. It analyzes the legislation the United States currently has in place but also examines where the United States is lacking. Regarding the United States’ failure …

Charting The Contours Of Copyright Regime Optimized For Engineered Genetic Code, Christopher M. Holman

Faculty Works

There is a growing disconnect between the traditional patent-centric approach to protecting biotechnological innovation and the emerging intellectual property imperatives of “synthetic biology,” a promising new manifestation of biotechnology that enables the design and construction of artificial biological pathways, organisms or devices, as well as the redesign of existing natural biological systems. As explained in previous articles, one way to deal with this disconnect would be to expand the scope of copyrightable subject matter to encompass engineered genetic sequences, much in the way that copyright was expanded in the 1970s and 1980s to include computer programs. The present article expands …

Fda’S Efforts To Tame The 'Wild West' Of Regenerative Medicine, Christopher M. Holman

Faculty Works

Stem cell-based regenerative therapies hold the potential to address a host of health concerns, particularly congenital, age-related, and trauma-induced injuries, and diseases involving organ and tissue degeneration, conditions that have proven refractory to conventional drug-based approaches. For the time being, however, there is little in the way of solid evidence supporting the safety and efficacy of most cell-based therapeutic approaches (with the notable exception of hematopoietic stem cells used to treat diseases of the blood and immune system). This Holman Report begins with an overview of the current uncertain regulatory status of regenerative medicine in the U.S., including several draft …

Key Challenges In Bringing Crispr-Mediated Somatic Cell Therapy Into The Clinic, Jacob S. Sherkow

Other Publications

Genome editing using clustered regularly interspersed short palindromic repeats (CRISPR) and CRISPR-associated proteins offers the potential to facilitate safe and effective treatment of genetic diseases refractory to other types of intervention. Here, we identify some of the major challenges for clinicians, regulators, and human research ethics committees in the clinical translation of CRISPR-mediated somatic cell therapy.

Patent Law's Reproducibility Paradox, Jacob S. Sherkow

Articles & Chapters

Clinical research faces a reproducibility crisis. Many recent clinical and preclinical studies appear to be irreproducible; their results cannot be verified by outside researchers. This is problematic for not only scientific reasons but legal ones: patents grounded in irreproducible research appear to fail their constitutional bargain of property rights in exchange for working disclosures of inventions. The culprit is likely patent law’s doctrine of enablement. Although the doctrine requires patents to enable others to make and use their claimed inventions, current difficulties in applying the doctrine mitigate or even actively dissuade reproducible data in patents. This Article assesses the difficulties …

Quintavalle: The Quandary In Bioethics, Lisa Cherkassky

Journal of Law and Health

The case of R. (Quintavalle) v. Human Fertilisation Embryology Authority (and Secretary of State for Health) presents a handful of legal problems. The biggest legal query to arise from the case is the inevitable harvest of babies, toddlers and very young children for their bone marrow. This article unpacks the judicial story behind Quintavalle to reveal how the strict provisions of the Human Fertilisation and Embryology Act 1990 - namely ‘suitable condition’ under schedule 2 paragraph 1(1)(a) and ‘treatment services’ and ‘assisting’ under section 2(1) - were widely misinterpreted to introduce the social selection of embryos into law. The legal …

Technological Opacity, Predictability, And Self-Driving Cars, Harry Surden, Mary-Anne Williams

Cardozo Law Review

Autonomous or "self-driving" cars are vehicles that drive themselves without human supervision or input. Because of safety benefits that they are expected to bring, autonomous vehicles are likely to become more common. Notably, for the first time, people will share a physical environment with computer-controlled machines that can both direct their own activities and that have considerable range of movement. This represents a distinct change from our current context. Today people share physical spaces either with machines that have free range of movement, but are controlled by people (e.g. automobiles) or with machines that are controlled by computers, but highly …

Decline Of Dosage Regimen Patents In Light Of Emerging Next-Generation Dna Sequencing Technology And Possible Strategic Responses, Na An

Minnesota Journal of Law, Science & Technology

No abstract provided.

The Treatment For Malpractice – Physician, Enhance Thyself: The Impact Of Neuroenhancements For Medical Malpractice, Harvey L. Fiser

Pace Law Review

This article will introduce some of the issues and offer some possible guidelines which may eventually guide cases of medical malpractice and medical care in the face of neurointerventions. First, I will briefly address the standard of care in medical malpractice cases in general. Second, I will discuss some of the existing and potential physical and neurological enhancements available for physicians. Finally, I will explore how these neurointerventions could alter the standards for medical malpractice for both the enhanced doctors and the entire medical profession.

Health Information And Data Security Safeguards, 32 J. Marshall J. Info. Tech. & Privacy L. 133 (2016), Jane Kim, David Zakson

UIC John Marshall Journal of Information Technology & Privacy Law

The healthcare industry possesses information coveted by cyber criminals. Unfortunately, healthcare providers are also among the most vulnerable and unprepared to deal with cyber attacks. The Introduction sets the background of this paper with cyber security statistics of the healthcare sector. Part A of this paper will discuss how new Russian law impacts global data security. Part B takes a broad look at data security safeguards. Part C focuses on U.S. attempts at safeguarding data through NIST and its Presidential Policy Directive. In Part D, the paper explores in greater detail causes that precipitate security breaches and specific security defenses …

The Patenting Of Gene Based Diagnostic Assays In A Post Mayo And Myriad World, 16 J. Marshall Rev. Intell. Prop. L. 1 (2016), Michael Sanzo

UIC Review of Intellectual Property Law

Recent advances in biotechnology have given researchers the ability to comprehensively examine the genetic basis of disease in unprecedented ways and will undoubtedly result in many new and valuable gene based diagnostic assays in the near future. These advances came during a period of roughly thirty years during which the patent eligibility of such assays was essentially unquestioned. Then, beginning in 2010, the Supreme Court embarked on a series of decisions that will, in almost all cases, preclude the patenting of diagnostic assays that rely on genetic mutations or gene expression patterns. This article suggests that reason that the issue …

Can Dna Be Speech?, Jorge R. Roig

Scholarly Works

DNA is generally regarded as the basic building block of life itself. In the most fundamental sense, DNA is nothing more than a chemical compound, albeit a very complex and peculiar one. DNA is an information-carrying molecule. The specific sequence of base pairs contained in a DNA molecule carries with it genetic information, and encodes for the creation of particular proteins. When taken as a whole, the DNA contained in a single human cell is a complete blueprint and instruction manual for the creation of that human being. In this article we discuss myriad current and developing ways in which …

Describing Drugs: A Response To Professors Allison And Ouellette, Jacob S. Sherkow

Articles & Chapters

Profs. Allison and Ouellette’s Article, How Courts Adjudicate Patent Definiteness and Disclosure, 65 Duke L.J.609 (2015), on courts’ adjudication of certain patent disputes presents some surprising data: pharmaceutical patents litigated to judgment fare substantially worse on written-description analyses if they are not part of traditional pioneer-generic litigation. This Response engages in several hypotheses for this disparity and examines the cases that make up Allison and Ouellette’s dataset. An analysis of these cases finds that the disparity can be best explained by technological and judicial idiosyncrasies in each case, rather than larger differences among pharmaceutical patent cases. This finding contextualizes …

Can Dna Be Speech?, Jorge R. Roig

Cardozo Arts & Entertainment Law Journal

DNA is generally regarded as the basic building block of life itself. In the most fundamental sense, DNA is nothing more than a chemical compound, albeit a very complex and peculiar one. DNA is an information-carrying molecule. The specific sequence of base pairs contained in a DNA molecule carries with it genetic information and encodes for the creation of particular proteins. When taken as a whole, the DNA contained in a single human cell is a complete blueprint and instruction manual for the creation of that human being.

This Article discusses a myriad of current and developing ways in which …

Technology, Gender And Fashion, Jeanne L. Schroeder

Cardozo Arts & Entertainment Law Journal

No abstract provided.