Medical Jurisprudence Commons^™

Disclosing Deviations: Using Guidelines To Nudge And Empower Physician-Patient Decision Making, Melissa Ballengee Alexander

Faculty Articles

Americans fail to receive recommended care roughly half the time, reflecting poor decision making that threatens their health. This Article offers an innovative solution: require physicians to disclose clinical practice guideline recommendations to patients during informed consent. Behavioral economics suggest that insisting physicians and patients discuss guidelines, before deviating from them, could be surprisingly effective at nudging more rational care choices. At the same time, such disclosure should also educate and empower patients, serving autonomy.

Previous scholarship on unwarranted variances in care has focused primarily on malpractice reforms, largely ignoring the role of cognitive bias and the importance of patients …

Hard Choices And Deficient Choosers, Mark Kelman

Northwestern Journal of Law & Social Policy

No abstract provided.

Stewart V Azar And The Purpose Of Medicaid: Work As A Condition Of Enrollment, Nicole Huberfeld

Faculty Scholarship

On June 29, 2018, a federal district court found that the US Department of Health and Human Services (HHS) did not properly approve Kentucky’s application for a controversial Medicaid waiver, the first to require work as a condition of eligibility.¹ Because HHS’s approval was vacated, Kentucky’s Medicaid program was required to continue as if no waiver existed, but 3 other states had already received HHS approval to proceed with work requirements. This article provides context for understanding the relevance of work requirements to implementation of Medicaid expansion under the Patient Protection and Affordable Care Act (hereinafter, Affordable Care Act), …

The Ever-Changing Landscape Of Informed Consent And Whether The Obligation To Explain A Procedure To The Patient May Be Delegated, Samuel D. Hodge, Maria Zambrano Steinhaus

Arkansas Law Review

Informed consent is an integral part of the shared decision making process and requires a patient be informed of the benefits, risks and alternatives to a medical procedure. This information, which requirement has been codified into the law and practice of every healthcare provider, helps a patient decide whether to proceed with the recommended treatment plan. Informed consent has its foundation in the ethical notion of patient autonomy and fundamental human rights. After all, it is the patient’s decision to determine what may be done to his or her body and to ascertain the risks and benefits before undertaking a …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

Challenges In Navigating Disability Discrimination And Privacy Laws In Addressing Physician Health, Rick D. Barton

Center for Health Law Policy and Bioethics

No abstract provided.

Disparities In The Use Of Prophylactic Treatments In Reproductive Health Between The Sexes: A Recommendation For The Use Of Hpv Vaccination Schemes Rather Than Surgical Interventions To Reduce Inequities And Threats To The Public's Health, Paul J. Mclaughlin

Library Faculty Publications

On the issue of prophylactic treatment of reproductive diseases, the sexes have historically been treated differently under medical ethics guidelines and the laws of the United States. Women have drawn the focus of medical and legal scrutiny on issues of prophylactic reproductive health. Women were often required to undergo quarantine and forced to recieve treatment for reproductive diseases considered dangerous to public health. Women are now afforded protections against involuntary prophylactic procedures to prevent diseases in reproductive organs. Specifically, women are provided access to vaccinations against the human papillomavirus at a higher rate than males despite the disease's ability to …

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 …

Legal Discrimination Against Organ Transplant Candidates: Medicinal Marijuana And The Double-Edged Sword, 52 Uic J. Marshall L. Rev. 859 (2019), Kyle Jorgensen

UIC Law Review

No abstract provided.

Everyone Bleeds Guilty: Blood Draws For Law Enforcement Purposes In Light Of The Hipaa Privacy Rule And Recent Supreme Court Decisions, 52 Uic J. Marshall L. Rev. 489 (2019), Bianca Valdez

UIC Law Review

Intoxicated driving claims more than 10,000 lives per year. In efforts to combat this devastating statistic, states have enacted laws that permit law enforcement officers to order warrantless blood draws from suspects of driving under the influence. In doing so, law enforcement officers seek the assistance of medical personnel to carry out the phlebotomy process. While medical personnel are obliged to assist law enforcement with their investigations, they also have an ethical duty to their patient and a legal duty to comply with the Health Insurance Portability and Accountability Act of 1996. What are the legal implications when the suspect …

Dr. Tele-Corporation: Bridging The Access-To-Care Gap, Nader Amer

Dickinson Law Review (2017-Present)

The United States is currently confronting an access-to-healthcare crisis, which rural regions are experiencing at a disproportionate rate. Many commentators have touted telemedicine as a solution for the access-to-care issue. Telemedicine uses video and telecommunication technology to allow physicians to treat patients from distant locations and thus facilitates a more equal distribution of physicians throughout the United States.

Although the telemedicine industry is quickly growing, the corporate practice of medicine doctrine impedes the industry’s expansion and consequently obstructs a viable solution to the access-to-care crisis. Generally, the corporate practice of medicine doctrine prohibits corporations and limited liability companies from employing …

Societal Pressures And Procreative Preferences For Gay Fathers Successfully Pursuing Parenthood Through Ivf And Gestational Carriers, Steven R. Lindheim Md, Jody L. Madeira, Artur Ludwin, Emily Kemmer, J. Preston Parry, Georges Sylvestre, Guido Pennings

Articles by Maurer Faculty

This retrospective study surveyed decision-making and challenges among 78 gay cisgender male couples utilizing in-vitro fertilization (IVF) and a gestational carrier. While most couples (67.1%) found the decision to actively pursue fertility treatment ‘not difficult’, 32.9% felt that it was ‘somewhat difficult’ or ‘very or extremely difficult’. Almost 30% of couples had not undertaken financial planning for treatment, which introduced delays of N2 years for 25.3% of participants. Conceiving twins was ‘important to very important’ in 52.3% of couples, and 84.2% of couples chose to transfer two embryos to ‘increase the odds’ or reach an ideal family size in a …

Robots Are Coming: A Discussion Of Choice-Of-Law Issues And Outcomes In Telesurgical Malpractice, Megan Cloud

Texas A&M Law Review

New technology frequently emerges that challenges the legal status quo. Early adopters must then grapple with uncertainty over how the law will apply to novel legal quandaries. There is no better example of this than in medicine; however, the health care field is notoriously risk averse. Despite this, the practice of medicine stands to gain tremendously from these technological advancements. One such advancement is the relatively new ability to perform robotic surgery in which the surgeon is remote from the patient. Widespread use of this technology would improve rural access to surgical care, as well as improve access to more …

Billion Dollar Orphans: Tension Between The Legal Intent And Social Purpose Of The Orphan Drug Act, John Sheridan

Texas A&M Law Review

This Comment examines the extent to which Congress empowered the FDA to address the increase in petitions and the general accessibility of orphan drug remedies. Specifically, this Comment seeks to understand why the FDA’s interpretation of the purpose of the ODA seems to conflict with the statutory intent as interpreted by federal courts. This Comment considers a statute’s ultimate goal or social purpose to be the purpose of the statute, whereas the express mechanisms by which Congress seeks to bring about these goals is best understood as the statute’s intent. To understand the FDA and judiciary’s differing interpretations of the …

The Opioid Crisis: The States' And Local Governments' Response To Bigpharma's Deception And Why The Supremacy Clause May Provide A Cloak For Opioid Manufacturers To Hide Behind, Tracie Childers

Barry Law Review

No abstract provided.

On The Judicialization Of Health, Ana Santos Rutschman

All Faculty Scholarship

The provision of health care has long been at the forefront of domestic and international debates, philosophical inquiries, and political agendas. A growing body of legal scholarship has added to the debate by examining the role of judicial review in the context of health-related litigation. What role, if any, should courts play in compelling the provision of health care or in furthering access to potentially life-saving medicines?

This question intersects with multiple strands of the law. For instance, it has an institutional component that interrogates the function(s) of courts within systems of checks and balances. It ties into constitutional design …

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) …

The Gender Injustice Of Abortion Laws, Joanna Erdman

Articles, Book Chapters, & Popular Press

This commentary is a response to Katarzyna Sękowska-Kozłowska’s article on the treatment of criminal abortion laws as a form of sex discrimination under international human rights law through a study of the communications, Mellet v. Ireland and Whelan v. Ireland. The commentary offers a reading of these communications, and specifically the sex discrimination analysis premised on inequalities of treatment among women, as an engagement with the structural discrimination that characterises abortion laws, and asa radical vision for gender justice under international human rights law.

Legal Considerations In Pediatric And Adolescent Obstetrics And Gynecology, Steven R. Smith

Faculty Scholarship

Providing gynecologic and obstetric care for minors raises important legal issues and it is critical that health-care providers understand those legal issues. State laws are often somewhat complicated and unsettled in the areas minors’ of consent to treatment, privacy and information, and abuse reporting requirements. State statutes commonly give minors the authority to consent to treatment for STIs, pregnancy, and contraception. There are, however, many variations among states in these areas. Most states limit the ability of minors to consent to abortion without some parental (or court) involvement. In some circumstances, a physician may provide information to parents if it …

Multiple Sclerosis Drugs Have Been Getting A Lot More Expensive, Ben Jay

Capstones

Multiple Sclerosis is a very expensive disease. According to a 2016 study in the American Journal of Managed Care, treating it can cost patients anywhere from $30,000 to $100,000 per year, which can meet or even exceed the average US household median income, depending on how severe your case is. For a disease that has no known cure, and requires frequent medical attention to manage symptoms that can completely debilitate a person if left untreated, that can mean spending $4.1 million over the course of a lifetime, according to the same study. However, in the last 20 years, that …

Legal Principles And Seminal Legal Cases In Oocyte Donation, Jody L. Madeira, Susan L. Crockin

Articles by Maurer Faculty

Oocyte donation has played an increasingly important role in assisted reproductive technologies since the early 1980s. Over the past 30 years, unique legal standards have evolved to address issues in the oocyte donation procedure itself as well as the disputes over issues, such as parentage, that inevitably arise with new technologies, particularly for individuals seeking to build nontraditional families. This essay will explore oocyte donation's legal aspects as well as seminal law concerning the procedure, including statutory law (uniform and model provisions and enacted state laws) and selected judicial opinions concerning surrogacy and parentage, testing of oocyte donors, mix-ups of …

Medical Malpractice Cuts Not The Answer, Ruqaiijah A. Yearby

All Faculty Scholarship

Tort reform--legislation that aims to reduce medical malpractice suits --will not cut medical costs and improve health care unless the government addresses the proliferation of unnecessary medical errors that victimize hundreds of thousands of patients every year.

Yearby's research considers how laws enacted to grant equal access to quality health care actually can pose barriers to the disenfranchised, and she is critical of health care reform efforts that do not address the far-reaching problem of medical errors. Finding ways to curb what she calls the "alarming rate of these medical errors," not only will reduce medical malpractice suits, but save …

Health Care Referrals Out Of The Shadows: Recognizing The Looming Threat Of The Texas Patient Solicitation Act And Other Illegal Remuneration Statutes, Trenton Brown

St. Mary's Law Journal

Abstract forthcoming

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 …

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, …