Health Law and Policy Commons^™

A Surging Drug Epidemic: Time For Congress To Enact A Mandate On Insurance Companies And Rehabilitation Facilities For Opioid And Opiate Addiction, Alanna Guy

Journal of Law and Health

This Note begins with a discussion of both the national opioid problem as well as the specific epidemic in Ohio as an example of how it has grown within all of the states. Part II discusses the differences between prescription opioids and opiates, how they can be obtained, what effects they have on the human body, and why the government has an interest in this growing problem. Next, this Note explains how and why there was an increase in access and addiction to prescription opioid pain medication. Following this explanation, the steps the government has taken to try to rectify …

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 …

Informing Consent: Medical Malpractice And The Criminalization Of Pregnancy, Laura Beth Cohen

Michigan Law Review

Since the early 1990s, jurisdictions around the country have been using civil child abuse laws to penalize women for using illicit drugs during their pregnancies. Using civil child abuse laws in this way infringes on pregnant women’s civil rights and deters them from seeking prenatal care. Child Protective Services agencies are key players in this system. Women often become entangled with the Child Protective Services system through their health care providers. Providers will drug test pregnant women without first alerting them to the potential negative consequences stemming from a positive drug test. Doing so is a breach of these providers’ …

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 …

Oral Health Convening Focusing On Children With Special Health Care Needs, Health Justice Alliance

HJA Scholarship

Barriers to good oral health care pose a significant health threat to low-income individuals and families, which in extreme cases can result in fatal consequences. Lack of good oral health may also negatively impact social function and interaction, limiting verbal and nonverbal communication, and interfering with intimacy, nutrition, and sleep. Often ignored, oral care is the most prevalent unmet health care need among children and adolescents, and tooth decay is the most chronic illness in school-age children. Within this already vulnerable group, children with special health care needs (CSHCN) are especially at risk for a variety of economic, social, environmental, …

Understanding The Sexual Assault Kit Backlog In Pennsylvania, Kallie Crawford, Lyndsie Ferrara

Graduate Student Research Symposium

According to the FBI, to date, there are more than 400,000 untested sexual assault kits nationwide. While this is a huge issue that cannot be solved overnight, continual improvements and changes are needed to reduce and hopefully eliminate the backlog.

This research examines work going on nationwide and aims to better understand the backlog issues specifically in Pennsylvania. Furthermore, the research examines a program utilized by the law enforcement community that garnered necessary resources. First, a comprehensive review of improved practices in proactive jurisdictions of Ohio, Houston, Texas, and Detroit, Michigan was conducted to identify general policies and procedures that …

2018 Legal Update: Npdb Reporting, Retaliation, Physician Well Being, And Medical Staff Litigation, Preparing For A Successful Judicial Review Hearing, Rick D. Barton, Natalie V. Mueller

Center for Health Law Policy and Bioethics

No abstract provided.

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 …

Medical Malpractice And Black-Box Medicine, W. Nicholson Price Ii

Book Chapters

The explosive proliferation of health data has combined with the rapid development of machine-learning algorithms to enable a new form of medicine: “black-box medicine.” In this phenomenon, algorithms troll through tremendous databases of health data to find patterns that can be used to guide care, whether by predicting unknown patient risks, selecting the right drug, suggesting a new use of an old drug, or triaging patients to preserve health resources. These decisions differ from previous data-based decisions because black-box medicine is, by its nature, opaque; that is, the bases for black-box decisions are unknown and unknowable.

Black-box medicine raises a …

Interpreting Canada's Medical Assistance In Dying Legislation, Jocelyn Downie, Jennifer A. Chandler

Reports & Public Policy Documents

When the Canadian medical assistance in dying (MAiD) legislation came into force in June 2016, it was widely noted that the meaning of some of its key terms and phrases was unclear. For example, questions were immediately raised about the meaning of “incurable illness, disease, or disability,” “advanced state of irreversible decline in capability,” and “natural death has become reasonably foreseeable.” Interpretation challenges are not uncommon with new legislation. However, in the context of something as significant as access to MAiD and potential criminal liability for getting the meaning of the legislation wrong, these challenges must be confronted by those …

Removing Obstacles To A Peaceful Death, Kathy L. Cerminara, Barbara A. Noah

Faculty Scholarship

We all will die, but the American health care system often impedes a peaceful death. Instead of a quiet death at home surrounded by loved ones, many of us suffer through overutilization of sometimes-toxic therapeutic interventions long past the time when those interventions do more good than harm. This article proposes revisions to health professional training and payment policy to eliminate as much as possible physical and existential suffering while progressing through the terminal phase of illness. The solution lies in seamless progression from treatment with integrated palliative care to hospice before death, but provider attitudes and payor practices must …

Access To Knowledge And The Global Abortion Policies Database, Joanna Erdman, Brooke Johnson

Articles, Book Chapters, & Popular Press

Research shows that women, healthcare providers, and even policy makers worldwide have limited or inaccurate knowledge of the abortion law and policies in their country. These knowledge gaps sometimes stem from the vague and broad terms of the law, which breed uncertainty and even conflict when unaccompanied by accessible regulation or guidelines. Inconsistency across national law and policy further impedes safe and evidence‐based practice. This lack of transparency creates a crisis of accountability. Those seeking care cannot know their legal entitlements, service providers cannot practice with legal protection, and governments can escape legal responsibility for the adverse effects of their …

Access To Knowledge And The Global Abortion Policies Database, Joanna Erdman, Brooke Johnson

Articles, Book Chapters, & Popular Press

Research shows that women, healthcare providers, and even policy makers worldwide have limited or inaccurate knowledge of the abortion law and policies in their country. These knowledge gaps sometimes stem from the vague and broad terms of the law, which breed uncertainty and even conflict when unaccompanied by accessible regulation or guidelines. Inconsistency across national law and policy further impedes safe and evidence‐based practice. This lack of transparency creates a crisis of accountability. Those seeking care cannot know their legal entitlements, service providers cannot practice with legal protection, and governments can escape legal responsibility for the adverse effects of their …

An Alternative To Medical Assistance In Dying? The Legal Status Of Voluntary Stopping Eating And Drinking (Vsed), Jocelyn Downie

Articles, Book Chapters, & Popular Press

Medical assistance in dying (MAiD) has received considerable attention from many in the field of bioethics. Philosophers, theologians, lawyers, and clinicians of all sorts have engaged with many challenging aspects of this issue. Public debate, public policy, and the law have been enhanced by the varied disciplinary analyses. With the legalization of MAiD in Canada, some attention is now being turned to issues that have historically been overshadowed by the debate about whether to permit MAiD. One such issue is voluntary stopping eating and drinking (VSED) as an alternative to MAiD. In this paper, I will apply a legal lens …

A Critique Of Canadian Jurisprudence On The Therapeutic Privilege Exception To Informed Consent, Michael Hadskis

Articles, Book Chapters, & Popular Press

The Supreme Court of Canada’s landmark decisions in Hopp v Lepp and Reibl v Hughes furnished a general analytical framework for informed consent actions that remains fully intact today. This article sets its gaze on a specific aspect of the framework, dubbed “therapeutic privilege,” that permits physicians to deviate from their general duty to disclose material, treatment-related risks to competent patients. Specifically, the privilege allows information about material risks to be withheld or generalized if physicians believe their patients are “unable to cope” with receiving such information. It is argued that the Supreme Court’s terse and vaguely-articulated exception to truth …

Dignity In Choice: A Terminally Ill Patient's Right To Choose, Cody Bauer

Mitchell Hamline Law Review

No abstract provided.

Utilizing Adr As A Vehicle For Effective Communication And Success Of Payment In Urgent Care, Stephanie R. Goldberg

Cardozo Journal of Conflict Resolution

Section II of this Note provides background on urgent care and ADR. Section III will elaborate on current payment procedures and explain some of the pitfalls that create a need for a supplementary payment solution. Section IV lays out a four-step plan incorporating a logical progression of ADR techniques that would enable quality of care and ease and success of financial arrangements, and vastly improved patient-provider relations. The feasibility of this plan will be demonstrated through application of its steps to hypothetical examples, representative of various realistic patient experiences, in Section V. This plan is intended to aid the millions …

The Failure Of “Sorry”: An Empirical Evaluation Of Apology Laws, Health Care, And Medical Malpractice, Benjamin J. Mcmichael

Lewis & Clark Law Review

As part of the effort to contain the size and frequency of medical malpractice claims, many states have adopted apology laws. These laws make apologies from physicians to patients inadmissible in any subsequent court proceedings. The basic rationale behind apology laws is that meritless malpractice claims are less likely to be filed when a physician can apologize to his or her patient without risking those statements being used in court. Through the use of a unique dataset, this Article corrects several misunderstandings concerning this new generation of tort reform.

First, it shows that while apology laws may reduce the frequency …

Cancer's Ip, Jacob S. Sherkow

Articles & Chapters

The state of publicly funded science is in peril. Instead, new biomedical research efforts — in particular, the recent funding of a “Cancer Moonshot” — have focused on employing public-private partnerships, joint ventures between private industry and public agencies, as being more politically palatable. Yet, public-private partnerships like the Cancer Moonshot center on the production of public goods: scientific information. Using private incentives in this context presents numerous puzzles for both intellectual property law and information policy. This Article examines whether—and to what extent — intellectual property and information policy can be appropriately tailored to the goals of public-private partnerships. …

Depression: The Often Overlooked Sequela Of Head Trauma, Samuel D. Hodge Jr., Jack E. Hubbard

Cleveland State Law Review

Depression is a common sequela of head trauma. Approximately half of all individuals with a cranial injury will experience depression within the first year, regardless of the severity of the injury. The ailment is characterized clinically as a mood disorder, often associated with intense feelings of sadness. However, depression is more complex than mood disorders, as many mental and bodily complaints—such as insomnia, fatigue, anxiety, appetite changes, aches and pains, and lack of interest in previously enjoyable activities—are associated with depression. These intense feelings, particularly when combined with despair and hopelessness, can lead to suicide, a dreaded potential complication of …

Hiv And The Ada: What Is A Direct Threat?, Dawn-Marie Harmon

Maine Law Review

Anne, a surgical technician at a local hospital, recently learned that she was HIV-positive. She works in the emergency room and, as a part of her job, she hands surgical instruments to doctors performing emergency surgery. It is a fast paced and unpredictable environment. Her hands often come in contact with sharp instruments. Although Anne has never put her hands into a patient's body cavity, there is a remote possibility that she may need to do so in the future. There is always a possibility, however small, that she will cut herself and come into blood-to-blood contact with a doctor …

A Deliberate Departure: Making Physician-Assisted Suicide Comfortable For Vulnerable Patients, Browne Lewis

Arkansas Law Review

On an episode of Marvel’s Jessica Jones, Kilgrave uses his mind control powers to get Jack Denton to give him both of his kidneys. After he loses his kidneys, Denton goes on dialysis and has a stroke. Therefore, when private investigator Jessica Jones tracks down Denton, she discovers that he is wheelchair-bound and unable to speak. Denton goes to great lengths to write a note asking Jones to kill him. This fictionalized story may be the reality for some people. Everyone wants to live a happy life and to have a good death. Some people have the privilege of dying …

Confronting The Ghost: Legal Strategies To Oust Medical Ghostwriters, Deanna Minasi

Fordham Law Review

Articles published in medical journals contribute significantly to public health by disseminating medical information to physicians, thereby influencing prescribing practices. However, the information guiding treatment decisions becomes distorted by selective publishing and medical ghostwriting, which negatively affects overall patient care. Although there is general consensus in the medical community that these practices of publication bias represent a moral failing, the issue is rarely framed as a wrong that necessitates legal consequences. This Note takes the stance that medical ghostwriting constitutes an act prohibited under the Racketeer Influenced and Corrupt Organizations Act (RICO) and argues that physicians fraudulently named as authors …

Refusing To Treat Noncompliant Patients Is Bad Medicine, Jessica Mantel

Cardozo Law Review

Government health programs and private payors have adopted various reforms that fundamentally transform the physician-patient relationship. Public reporting on how well physicians perform on various quality and cost metrics, as well as payment reforms that link physicians' reimbursements to their performance on these metrics, incentivize physicians to improve the quality and efficiency of care they provide to patients. Less appreciated, however, is that these reforms also create strong incentives for physicians to reject patients who do not abide by their physician's medical opinion, including recommendations that the patient adopt healthier behaviors. These noncompliant patients increasingly willfind themselves rejected by physicians, …

Tort Reform Through The Back Door: A Critique Of Law And Apologies, Yonathan A. Arbel, Kaplan, Yotam Kaplan, Yotam

Articles

In this Article, we show how the biggest tort reform of the last decade was passed through the back door with the blessing of its staunchest opponents. We argue that the widely-endorsed "apology law" reform-a change in the national legal landscape that privileged apologies-is, in fact, a mechanism of tort reform, used to limit victims' recovery and shield injurers from liability. While legal scholars overlooked this effect, commercial interests seized the opportunity and are in the process of transforming state and federal law with the unwitting support of the public.

Distinctive Factors Affecting The Legal Context Of End-Of-Life Medical Care For Older Persons, Marshall B. Kapp

Georgia State University Law Review

Current legal regulation of medical care for individuals approaching the end of life in the United States is predicated essentially on a factual model emanating from a series of high-profile judicial opinions concerning the rights of adults who become either permanently unconscious or are clearly going to die soon with or without aggressive attempts of curative therapy.

The need for a flexible, adaptable approach to medically treating people approaching the end of their lives, and a similar openness to possible modification of the legal framework within which treatment choices are made and implemented, are particularly important when older individuals are …

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.

The Doctor Requirement: Griswold, Privacy, And At-Home Reproductive Care, Yvonne F. Lindgren

Faculty Works

Supreme Court privacy jurisprudence has traditionally offered greater protection to activities when exercised within the home. This is true in common law as well as across a broad range of constitutional claims. For example, common law privacy identifies the home as a location of solitude and repose, often conceptualized as the “right to be let alone.” Speech, or the right to be free of unwanted messages, is enhanced when the claimant is within the confines of her or his home. Fourth Amendment protections against search and seizure and the notion of the reasonable expectation of privacy are enhanced when the …

Analysis Of The Proposed Tpp-Related Patent Linkage System In Taiwan, Ping-Hsun Chen

Journal of Law and Health

The Trans-Pacific Partnership (TPP) Agreement mandates member states to implement a patent linkage system vested in Article 18.53. To successfully join the TPP Agreement, Taiwan has begun the legislation of a patent linkage system by proposing an amendment for the Pharmaceutical Affairs Act. Article 18.53 requires a member either to adopt a notification mechanism under Paragraph 1 or to stay the issuance of marketing approval under Paragraph 2. But, Taiwan’s proposal includes both measures. Taiwan’s patent linkage system allows a pioneer drug company to register patents claiming (a) a material, (b) a combination or formula, or (c) pharmaceutical use. The …

Trading Safety For Innovation And Access: An Empirical Evaluation Of The Fda’S Premarket Approval Process, George Horvath

BYU Law Review

Congress created the premarket approval process (PMA) to provide a rigorous safety evaluation of high-risk medical devices before they may be sold on the U.S. market. Evaluating a PMA application requires the Food and Drug Administration (FDA) to conduct a lengthy, complex, and costly assessment of the extensive data a manufacturer must submit. But other policy concerns, notably a fear of hampering innovation and a desire to assure timely access to new technologies, have led Congress to relax some of the rigorous data requirements the PMA process imposes on manufacturers. Congress mandates that the FDA employ the “least burdensome” approach …