Law Commons^™

Patients, Corporate Attorneys, And Moral Obligations, Ioan-Radu Motoarcă

St. Mary's Journal on Legal Malpractice & Ethics

There are two main questions that any account of corporate lawyers’ moral obligations needs to answer: (1) Do corporate lawyers have moral obligations to third parties? and (2) In cases of conflict between obligations to the corporation and obligations to third parties, which should prevail? This Article offers answers to these questions in the context of lawyers working in medical corporations. I argue that lawyers do have moral obligations to third parties, and that in cases where patients’ rights are being violated by a medical company, patients’ rights should prevail. Consequently, attorney–client confidentiality rules should be relaxed to allow for …

When Desperate Patients Go To Court For Unproven Treatments - The Battle For Hospital Independence, Christopher Robertson, Margaret Houtz

Faculty Scholarship

As the Covid-19 pandemic wears on, patients have asked courts to compel hospitals to administer unproven therapies, with mixed legal results. Although talk radio hosts, politicians, and social media users have promoted various treatment approaches, they have given particular attention to ivermectin. The Food and Drug Administration (FDA) has approved ivermectin for use in humans for treating onchocerciasis (river blindness), intestinal strongyloidiasis, certain other parasitic worms, head lice, and skin conditions such as rosacea. Although this approval facilitates legal offlabel use for prophylaxis against or treatment of other conditions, both the FDA and the Centers for Disease Control and Prevention …

The Grass Is Greener Somewhere: Protecting Privacy Rights Of Medical Cannabis Patients In The Workplace, Benjamin West

Chicago-Kent Law Review

No abstract provided.

Protecting Patients From Physicians Who Inflict Harm: New Legal Resources For State Medical Boards, Elizabeth Pendo, Tristan Mcintosh, Heidi A. Walsh, Kari Baldwin, James M. Dubois

Saint Louis University Journal of Health Law & Policy

State medical boards (SMBs) protect the public by ensuring that physicians uphold appropriate standards of care and ethical practice. Despite this clear purpose, egregious types of wrongdoing by physicians are alarmingly frequent, harmful, and under-reported. Even when egregious wrongdoing is reported to SMBs, it is unclear why SMBs sometimes fail to promptly remove seriously offending physicians from practice. Legal and policy tools that are targeted, well-informed, and actionable are urgently needed to help SMBs more effectively protect patients from egregious wrongdoing by physicians.

Past reviews of SMB performance have identified features of SMBs associated with higher rates of severe disciplinary …

Medical Violence, Obstetric Racism, And The Limits Of Informed Consent For Black Women, Colleen Campbell

Michigan Journal of Race and Law

This Essay critically examines how medicine actively engages in the reproductive subordination of Black women. In obstetrics, particularly, Black women must contend with both gender and race subordination. Early American gynecology treated Black women as expendable clinical material for its institutional needs. This medical violence was animated by biological racism and the legal and economic exigencies of the antebellum era. Medical racism continues to animate Black women’s navigation of and their dehumanization within obstetrics. Today, the racial disparities in cesarean sections illustrate that Black women are simultaneously overmedicalized and medically neglected—an extension of historical medical practices rooted in the logic …

The Pharma Perspective: The Double-Edged Sword Of Direct-To-Consumer Advertising, Ela H. Yalcin

Health Law Outlook

No abstract provided.

Teaching Criminal Law: Integrating Professional Responsibility, Robert Batey

University of Denver Criminal Law Review

No abstract provided.

21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen

University of Michigan Journal of Law Reform

The 21st Century Cures Act introduced innovative changes to the Food and Drug Administration’s regulatory processes. In an effort to address the slow, costly, and burdensome approval process for high-risk devices, the Cures Act modernized clinical trial data by allowing reviewers to determine whether devices merit expedited review and to consider post-market surveillance data in the premarket approval process. These changes will get life-saving devices to the people who need them faster than ever before. But the tradeoff is a greater risk of injury to the patient. The 2008 Supreme Court decision Riegel v. Medtronic, Inc., held that any …

Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox

Michigan Telecommunications & Technology Law Review

Biologic drugs offer major advancements over small-molecule drugs when it comes to treating serious diseases. Biosimilars, which mimic innovative biologic drugs, have the potential to further revolutionize the practice of medicine. States now have decades of experience regulating the substitution of generic, small-molecule drugs for their brand-name equivalents. But the complexities of biologic drugs and biosimilars force states to confront novel scientific and legal issues. Many states have begun tackling those issues by passing laws that regulate when pharmacists may substitute biosimilars for their corresponding biologic drugs. Other states have yet to do so. This Note surveys five provisions common …

Regulating Black-Box Medicine, W. Nicholson Price Ii

Michigan Law Review

Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process of care, and increase efficiency. Those algorithms, however, vary widely in quality. Some are accurate and powerful, while others may be riddled with errors or based on faulty science. When an opaque algorithm recommends an insulin dose to a diabetic patient, how do we know that dose is correct? Patients, providers, and insurers face substantial difficulties in identifying high-quality algorithms; they …

Reviewer's Note, Vincent J. Palusci, Frank E. Vandervort

Reviews

Review of Child Abuse & the Law by Jennifer N Fishe and Frederick L. Moffat III.

A False Sense Of Safety: How The Drug Quality And Security Act Fails To Protect Patients From Harm, Tyler Dinkelaker

Saint Louis University Journal of Health Law & Policy

For many years, the art of pharmaceutical compounding in the United States has been largely an overlooked and under regulated industry providing millions of patients each year with customized medications. Only after piecemeal enforcement resulted in hundreds of injuries and deaths in an event known as the New England Compounding Center Tragedy, did legislators and regulatory agencies refocus attention on current regulations in pharmaceutical compounding. Congress passed the Drug Quality and Security Act providing clarification for state and federal agencies as to their specific regulatory authority and responsibility to ensure patient safety in pharmaceutical compounding. However, the Drug Quality and …

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.

Progress In The Fight Against Multidrug Resistant Bacteria?: A Review Of Fda-Approved Antibiotics 2010-2015, Kevin Outterson

Faculty Scholarship

A weak antibiotic pipeline and the increase in drug-resistant pathogens have led to calls for more new antibiotics. Eight new antibiotics were approved by the U.S. Food and Drug Administration (FDA) between January 2010 and December 2015: ceftaroline, fidaxomicin, bedaquiline, dalbavancin, tedizolid, oritavancin, ceftolozane-tazobactam, and ceftazidime-avibactam. This study evaluates the development course and pivotal trials of these antibiotics for their innovativeness, development process, documented patient outcomes, and cost. Data sources were FDA approval packages and databases (January 2010 to December 2015); the Red Book (Truven Health Analytics); Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (FDA); and supplementary information …

Community Emergency Medicine: Benefits And Challenges Of Screening For Elder Abuse In The Emergency Department Of A Developing Country, Muhammad Akbar Baig, Asad Mian, Erfaan Hussain, Shahan Waheed

Department of Emergency Medicine

No abstract provided.

A Defense Of Physicians’ Gatekeeping Role: Balancing Patients’ Needs With Society’S Interests, Jessica Mantel

Pepperdine Law Review

Although scholars and policymakers increasingly accept the need to ration health care, physicians doing so at the bedside remains controversial. Underling this debate is how to characterize the duty of care physicians owe their individual patients. Ethically, physicians are under strict fiduciary obligations that require them to give primacy to individual patients' best interests. However, new health care delivery models that hold providers financially accountable for health care costs assign to physicians a gatekeeping role, with physicians obliged to balance individual patients' needs with the competing societal goal of controlling costs. This Article explains that the choice between the traditional …

Wollschlaeger, A Patient’S Right To Privacy, And A Renewed Focus On Mental Health Treatment, Chad A. Pasternack

University of Miami Business Law Review

In response to doctors pushing gun control agendas on patients, Florida enacted the Firearm Owners Privacy Act. The law, upheld by the Eleventh Circuit in Wollschlaeger v. Governor of Florida, protects patients from intrusive lines of inquiry unrelated to their treatment and from discrimination due to firearm ownership. While patients in Florida benefit greatly from the Firearm Owners Privacy Act, this note argues for more specific language in the law, which would parallel language in the Florida Mental Health Act (“Baker Act”). The proposed changes would limit inquiries into firearm ownership to instances where there is a substantial likelihood …

Piercing The Veil: The Limits Of Brain Death As A Legal Fiction, Seema K. Shah

University of Michigan Journal of Law Reform

Brain death is different from the traditional, biological conception of death. Although there is no possibility of a meaningful recovery, considerable scientific evidence shows that neurological and other functions persist in patients accurately diagnosed as brain dead. Elsewhere with others, I have argued that brain death should be understood as an unacknowledged status legal fiction. A legal fiction arises when the law treats something as true, though it is known to be false or not known to be true, for a particular legal purpose (like the fiction that corporations are persons). Moving towards greater transparency, it is legally and ethically …

Long-Term Financial Burden Of Breast Cancer: Experiences Of A Diverse Cohort Of Survivors Identified Through Population-Based Registries, Reshma Jagsi, John A.E. Pottow, Kent A. Griffith, Cathy Bradley, Ann S. Hamilton, John Graff Rutgers University, Steven J. Katz, Sarah T. Hawley

Articles

Purpose: To evaluate the financial experiences of a racially and ethnically diverse cohort of long-term breast cancer survivors (17% African American, 40% Latina) identified through population-based registries. Methods: Longitudinal study of women diagnosed with nonmetastatic breast cancer in 2005 to 2007 and reported to the SEER registries of metropolitan Los Angeles and Detroit. We surveyed 3,133 women approximately 9 months after diagnosis and 4 years later. Multivariable models evaluated correlates of self-reported decline in financial status attributed to breast cancer and of experiencing at least one type of privation (economically motivated treatment nonadherence and broader hardships related to medical expenses). …

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

Faculty Scholarship

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 …

Reverse Payment Agreements: Why A “Quick Look” Properly Protects Patents And Patients, Natalie Stoltz

Saint Louis University Law Journal

No abstract provided.

Nudging The Fda, W. Nicholson Price Ii, I. Glenn Cohen

Law Faculty Scholarship

[Excerpt] "The FDA’s regulation of drugs is frequently the subject of policy debate, with arguments falling into two camps. On the one hand, a libertarian view of patients and the health care system holds high the value of consumer choice. Patients should get all the information and the drugs they want; the FDA should do what it can to enforce some basic standards but should otherwise get out of the way. On the other hand, a paternalist view values the FDA’s role as an expert agency standing between patients and a set of potentially dangerous drugs and potentially unscrupulous or …

Managed Care Grievance Procedures: The Dilemma And The Cure , Joyce Krutick Craig

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Special Populations: Mobilization For Change

Touro Law Review

This Article is based on a transcript of a break-out discussion which took place at An Obvious Truth: Creating an Action Blueprint for a Civil Right to Counsel in New York State, held at Touro Law Center, Central Islip, New York, in March 2008. The discussion was moderated by Karen L. Nicolson, Michael Williams, and Toby Golick.

This Article assesses the needs of various special populations and the possible strategies and solutions to create change through enacting a civil right to counsel. The Article is intended to capture information and viewpoints of the people who participated in the break-out discussion …

The Responsible Patient: The Senior's Obligation To Conserve Medical Resources, Jeffrey B. Hammond

Marquette Elder's Advisor

No abstract provided.

Can Consumers Control Health-Care Costs?, Mark A. Hall, Carl E. Schneider

Articles

The ultimate aim of health care policy is good care at good prices. Managed care failed to achieve this goal through influencing providers, so health policy has turned to the only market-based option left: treating patients like consumers. Health insurance and tax policy now pressure patients to spend their own money when they select health plans, providers, and treatments. Expecting patients to choose what they need at the price they want, consumerists believe that market competition will constrain costs while optimizing quality. This classic form of consumerism is today’s health policy watchword. This article evaluates consumerism and the regulatory mechanism …

Paying For Terminal Illness

Marquette Elder's Advisor

The need for public assistance for terminal care has moved death itself from a private family matter to the public professional sphere. Congress intended Medicare hospice coverage to be comprehensive, but its eligibility rules and per diem limits deprive some patients of needed care. This article examines these limits and the alternative models for care of the dying.

The Elderly And September 11, 2001, Joseph A. Liberman Iii

Marquette Elder's Advisor

No abstract provided.

Baby Steps: The Changing Relationship Between Michigan Obstetricians And Certified Professional Midwives, Deborah M. Fisch

Marquette Elder's Advisor

The possible enactment of licensure for Certified Professional Midwives (CPMs) by the state of Michigan provides an opportunity to reexamine the CPM-obstetrician (OB) relationship that has grown up under CPMs' unlicensed state of practice. This article examines the legal and institutional factors that shape the CPM-OB relationship in Michigan, with comparisons to two other neighboring states, Indiana and Wisconsin, as well as to a more distant example, the Netherlands. Four potential relationships are identified and explored: Exclusion, Coexistence, Subordination and Cooperation. Other factors that may shape the relationship are also studied, such as medical malpractice liability, liability …

Revitalizing Informed Consent And Protecting Patient Autonomy: An Appeal To Abandon Objective Causation, Evelyn Tenenbaum

Oklahoma Law Review

No abstract provided.