Health Law and Policy Commons^™

Manipulating The Prescription Drug Market: Spiking Prices, Inducing Demand, And Costs To The Public, Katherine Drabiak, J.D.

DePaul Journal of Health Care Law

In 2016, Mylan made headlines when it spiked the price of its EpiPen AutoInjector by 400%, raising the price from an average of $57 to $500. Critics called the price hike “outrageous, “brutal” and “corrupt.” Public outcries fueled a demand for a Congressional investigation, and Mylan negotiated a settlement with the United States Department of Justice over alleged violations of the False Claims Act. Although competition self-corrected and similar products entered the marketplace, this case – and other similar cases involving generic drugs and insulin – highlighted the skyrocketing costs of prescription drugs in the United States. In 2019, United …

Dental Support Organizations And The Corporate Practice Of Dentistry: Will Streamlining Create Legal Violations?, Angelina Campin

DePaul Journal of Health Care Law

The increased use of technology when searching for health care providers means that consumers of dental care are more concerned with efficiency in making appointments and paying bills, immediate access to information, clear pricing, and transparency when it comes to choosing a provider and a facility to visit. Keeping up with the increased demands for efficiency and technological advances presents a challenge to sole practitioner dentists, which is the standard dental practice model. Dental support organizations (“DSOs”) have seen an increase in popularity recently, especially over the last five to ten years, in part to meet both the needs of …

Artificial Intelligence/ Machine Learning-Based Medical Devices: Regulatory And Patentability Challenges, May Lee

Penn State Journal of Law & International Affairs (2012 - Present)

No abstract provided.

The Post-Pandemic Order: A Blueprint For Balancing Health And Ip Interests In The Age Of Covid Variants, Arjun Padmanabhan, Tanner J. Wadsworth

Penn State Journal of Law & International Affairs (2012 - Present)

In December 2021, the World Health Assembly (“WHA”) convened to develop a pandemic response treaty for future pandemics. Unfortunately, as presently envisioned, the resulting pandemic response framework will suffer from many of the same inadequacies that prevented existing frameworks from responding effectively to COVID-19. The threat of new pandemics emerging in the future—and new variants developing in the present—call for a more integrated, robust, comprehensive solution.

This Article lays a blueprint for that solution: a global multilateral Council empowered to (1) investigate developing pandemics; (2) incentivize pharmaceutical companies to rapidly-produce vaccines and share them through voluntary licenses or TRIPS compulsory …

A New Architecture For Global Health Emergency Preparedness And Response—The Imperative Of Equity, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Even before COVID-19 emerged in Wuhan, China, in December 2019, the prevailing global narrative was inequity—in health, income, race, and socioeconomic status. COVID-19 amplified all these inequities. Early in the pandemic, low-income countries were left without key medical resources, such as diagnostic tests, personal protective equipment, and ventilators. By 2021, inequitable vaccine distribution captured global attention and outrage. This year, high-income countries have bought the lion’s share of Paxlovid, a highly effective antiviral treatment. Vaccine inequities remain with only 16% of people in low-income countries having received at least 1 vaccine dose vs 80% of people across high-income countries. This …

The Post-Pandemic Order: A Blueprint For Balancing Health And Ip Interests In The Age Of Covid Variants, Arjun Padmanabhan, Tanner J. Wadsworth

Student Scholarship

In December 2021, the World Health Assembly (“WHA”) convened to develop a pandemic response treaty for future pandemics. Unfortunately, as presently envisioned, the resulting pandemic response framework will suffer from many of the same inadequacies that prevented existing frameworks from responding effectively to COVID-19. The threat of new pandemics emerging in the future—and new variants developing in the present—call for a more integrated, robust, comprehensive solution.

This Article lays a blueprint for that solution: a global multilateral Council empowered to(1) investigate developing pandemics; (2) incentivize pharmaceutical companies to rapidly-produce vaccines and share them through voluntary licenses or TRIPS compulsory licensing …

From Healthcare To Hiring: Impacts Of Social And Public Policy On Disabled Veterans In The United States, Benjamin Michael Stoflet

Student Scholarship

The United States Government is struggling to fulfill commitments it has made to service members suffering from disabilities incurred during honorable service to the country. The Department of Veterans Affairs (VA) disability compensation structure, job training programs, and methods of alternative dispute resolution is a patchwork resulting from decades of legislation creating a system where veterans often become locked in a complicated and often combative process to obtain benefits they have earned. Employers, advocacy groups, academics, and federal officials agree that there are systematic issues within the VA negatively impacting disabled veterans. These include a lack of patient-centered care, divergent …

Cruel Dilemmas In Contemporary Fertility Care: Problematizing America's Failure To Assure Access To Fertility Preservation For Trans Youth, Anna Reed

Michigan Journal of Gender & Law

Transgender youth are increasingly able to access gender-affirming healthcare. Because gender-affirming care such as hormone therapy is clinically shown to reduce gender dysphoria and ease physical and social transition, every major U.S. medical association recognizes that gender-affirming healthcare is medically necessary for the treatment of dysphoria. However, an important dimension of gender-affirming care remains under-insured and overpriced: fertility preservation (FP). Several studies indicate that hormone therapies and certain gender-affirming surgeries can have negative, long-term impacts on future fertility. Although these impacts can be mitigated through approved FP methods such as sperm cryopreservation and oocyte cryopreservation, such methods are rarely affordable …

Pregnant Transgender People: What To Expect From The Court Of Justice Of The European Union's Jurisprudence On Pregnancy Discrimination, Hannah Van Dijcke

Michigan Journal of Gender & Law

Pregnant transgender people’s experiences vary: they may identify as male or non-binary and may seek gender-affirming medical care to different degrees. This variety in gender identities and bodies puts additional pressure on CJEU’s pregnancy discrimination case law—a case law that is, as this Article argues, already flawed. Building on a critique of the CJEU’s decision in Dekker, this Article discusses three alternative approaches to addressing pregnancy discrimination in EU law. The first two approaches are different ways of construing pregnancy discrimination as sex discrimination. First, the Article discusses a gender-stereotyping approach to direct sex discrimination, and, second, an indirect sex …

Cost-Effectiveness Comes To America: The Promise And Perils Of Cost-Effective Analysis In Medication Coverage Decisions, Carl Coleman

Georgia State University Law Review

In an effort to control rising drug costs, some health insurers have begun experimenting with methods to link decisions about coverage to the value added by medicines, including through the use of formal cost-effectiveness analysis (CEA). Increased interest in subjecting new drugs to rigorous economic analysis is a welcome development, as it offers the potential to minimize wasteful spending on drugs whose high prices are not justified by evidence of additional benefits produced. At the same time, CEA raises significant ethical issues, particularly when payers use it to limit access to drugs deemed to provide insufficient value for money. For …

Does Size Matter? Nanoscale Particle Size As An Indicator Of Inherency In Nanopharmaceutical Patent Validity, Kirsten Fehlan

Georgia State University Law Review

Scientific and technological advances in nanopharmaceuticals bring the doctrine of inherent obviousness to a head. On the one hand, nanotechnology promises to offer novel ways to target and treat traditionally incurable diseases by operating at a scale that is comparable to the scales that most biological systems use. On the other hand, nanotechnology inventions that result in improved pharmacokinetic properties are susceptible to validity challenges based on inherent obviousness.

Inherency and obviousness are two independently recognized and well-understood principles in United States patent law. Inherency refers to a claimed limitation or feature that is either necessarily present in, or the …

Statement From Columbia Law School’S Center For Gender And Sexuality Law On The Supreme Court Decision Overruling The Constitutional Right To Abortion, Center For Gender And Sexuality Law

Center for Gender & Sexuality Law

The Supreme Court opinion in Dobbs v. Jackson Women’s Health Organization signals a major break with at least three generations of constitutional law. This opinion eliminates not only constitutional protections for abortion, but well-settled legal principles on which fundamental rights have rested for over 60 years. “Within a 24-hour period the Supreme Court ruled on the one hand that abortion rights are a local issue to be decided by each state independently, while on the other, states are barred from making local decisions about how to regulate guns,” said Katherine Franke, James L. Dohr Professor of Law and Director of …

404 Provider Not Found: Contributions And Solutions To Inadequate Provider Networks For Behavioral Health Care, Travis Williams

Georgia State University Law Review

Despite the efforts of policymakers, access to in-network behavioral health care services has continued to lag relative to other types of health care. Many psychiatrists, for example, do not accept insurance, limiting access to their services to only those individuals who can afford to pay out of pocket. Several factors contribute to insurance networks’ paucity of behavioral health care providers, including low insurance reimbursement for behavioral health care services, inadequate regulation and enforcement, provider shortages, and a lack of access to telehealth services. To maximize the utility of existing regulatory structures, states should take an outcome-oriented enforcement approach that principally …

The Mda Public Education Campaign: An X-Ray View, James Pond, Matt Maguy

The Journal of the Michigan Dental Association

The MDA Public Education Campaign has achieved significant engagement, surpassing previous milestones in video views and Find-a-Dentist searches. The article delves into the campaign's success, emphasizing its educational focus and strategic use of digital platforms. It explores the campaign's structure, target audience, and the integration of the Find-a-Dentist tool. With a shift from traditional TV commercials to digital advertising, the campaign's adaptability and real-time metrics are highlighted. The piece concludes by providing insights into the campaign's funding, oversight, and the content of the 2022 initiatives.

Yes, The Mda Stands For Something, Michael G. Maihofer Dds

The Journal of the Michigan Dental Association

In the President's address, Dr. Maihofer responds to concerns about the MDA's relevance, outlining four key points that emphasize its commitment to ethical dentistry, continuous education, advocacy, and adapting to changing professional needs. He highlights the MDA's role in opposing dental therapy, advocating for tax repeals, and promoting diversity, equity, and inclusion. Dr. Maihofer encourages member participation, emphasizing the collective strength of the MDA community. The address expresses gratitude to various contributors, including predecessor Dr. Steve Meraw, President-elect Dr. Vince Benivegna, the Board of Trustees, MDA staff, volunteers, and his wife, Denise.

Dentistry And The Law: Purchase Price Allocation When Selling Your Practice, Dan Schulte Jd

The Journal of the Michigan Dental Association

This Dentistry & the Law column advises a dentist on the importance of carefully considering the purchase price allocation when selling a dental practice. While the initial letter of intent may contain such terms, the author emphasizes that they are not binding, and negotiations on the purchase agreement will determine the final allocation. The article highlights the significance of tax implications for both the seller and the buyer, urging involvement of an attorney and accountant in the process. The Internal Revenue Code's requirements for purchase price allocation and potential tension in negotiations are discussed, emphasizing the need for informed decision-making.

Staff Matters: More Tips For Hiring And Developing A Great Staff, Jodi Schafer Sphr, Shrm-Scp

The Journal of the Michigan Dental Association

Addressing the challenge of hiring staff in the current job market, this Staff Matters column provides insights for dental practices. With a focus on creating an attractive work culture, the article suggests developing partnerships with educational institutions and emphasizes the importance of continuous learning opportunities. The author encourages practices to define key skills, establish clear expectations, and implement training processes for effective communication, conflict resolution, and teamwork. Emphasizing the role of ongoing coaching and mentoring, the column outlines the necessity of investing in training and development to build a skilled and cohesive dental team.

J Mich Dent Assoc June 2022

The Journal of the Michigan Dental Association

Monthly, The Journal of the Michigan Dental Association brings news, information, and feature articles to our state's oral health community and the MDA's 6,200+ members. No publication reaches more Michigan dentists!

In this June 2022 issue, the reader will find the following original content:

• A cover feature on the MDA Public Education Campaign
• A 10-Minute EBD, "Are Neoplasms a Risk for Peri-Implantitis?"
• A feature on "The President’s Address to the House of Delegates"
• News you need: an Editorial, a Headquarters Report, Facts about MDA Peer Review, and regular department articles, Dentistry and the Law, Staff Matters, Advocacy, and component news …

At Long Last, Who Member States Agree To Fix Its Financing Problem, Alexandra Finch, Kevin A. Klock, Eric A. Friedman, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Those who deeply care about improving the health and well-being of all people no matter their personal circumstances have long argued that sustainably financing the World Health Organization is a cornerstone imperative—and for good reason. WHO is the only institution with the mandate and legitimacy to sit at the center of the global health architecture and bring together all stakeholders to coordinate and execute all-of-humanity approaches. Now after decades of inaction, WHO's member states have agreed to substantially improve the agency’s financing model, giving it greater flexibility and enhanced capacity to fulfill its mandate as the world’s health champion. What …

America’S Constant Crisis Of Care: The Case For Passing A National Direct Care Ratio For Nursing Homes, Marissa Espinoza

Journal of Law and Policy

For decades, the conditions in America’s nursing homes have been the subject of bombshell media reporting, governmental investigations, and public outrage. Longstanding issues—such as chronic staffing shortages and inadequate infection control measures—were laid bare as the COVID-19 pandemic tore through nursing homes, exposing society’s most vulnerable populations—the elderly and the sick—to appalling living conditions. Amid horrifying media reports documenting life inside nursing homes, and in response to mounting public outrage, legislators sprang into action. The most aggressive policy proposed was a direct care ratio, which caps the profits that nursing home owners can extract from facilities by mandating a minimum …

Headquarters Report: Without Mda Advocacy, Michigan Dentistry Would Look Very Different, Karen Burgess Cae

The Journal of the Michigan Dental Association

This Headquarters Report reflects on the impactful advocacy efforts of the Michigan Dental Association (MDA) over the past three years. Highlighting various scenarios, the report envisions a different landscape for dentistry in Michigan without MDA advocacy. The article emphasizes the critical role played by MDA in addressing issues related to COVID-19, regulations, funding, public protection, and dental policies. The advocacy initiatives have not only protected dental professionals but have also ensured the best interests of the public, contributing to a resilient and thriving dental community in Michigan.

The Teacher, Yoga, And The Third Eye, Christopher J. Smiley Dds

The Journal of the Michigan Dental Association

This editorial discusses a dental assistant's concern about a teacher promoting unfounded claims about fluoride and the "third eye" concept, impacting students' choices. The author explores the dubious origins of the third eye idea, referencing a yoga article, and emphasizes the importance of evidence-based approaches in dental care. Drawing from historical examples and challenges in patient beliefs, the editorial stresses the need for clinicians to blend scientific evidence, expertise, and patient preferences in a patient-centered approach. The author advocates presenting valid, reliable information in plain language to empower patients in making informed decisions and highlights the obligation to provide care …

10-Minute Ebd: Are Neoplasms A Risk Factor For Peri-Implantitis?, Farah Safieddine Bs, Naama Sleiman Ms, Phd, Melanie E. Mayberry Dds, Ms-Hcm

The Journal of the Michigan Dental Association

This 10-Minute EBD column explores the potential association between neoplasms and the risk of peri-implantitis in patients with dental implants. A case study involving a patient with a history of an ossifying fibroma raises questions about the impact of neoplasms on implant success. The literature search, conducted on PubMed, reveals relevant insights. The evidence suggests that ossifying fibromas, particularly with augmentation, may pose a risk for peri-implantitis. However, the direct causative relationship between neoplasms and peri-implant pathology remains unclear. Other risk factors such as periodontitis, foreign bodies, and augmentation procedures are also discussed in the context of implant complications.

Making Your Robotic Surgery Systems General Purpose: A Possible Preventive Measure For Induced And Contributory Infringement Liability Arising In Medical Procedures, Mengmeng Du

Minnesota Journal of Law, Science & Technology

No abstract provided.

Inconsistency At The Pole: Exotic Dancer's Employment Status Should Be Uniform Throughout The U.S., T.J.D. Nadas

Journal of Law and Health

As states start to recognize exotic dancers as employees under Fair Labor Standards Act (FLSA), states that have not yet classified exotic dancers as employees have put club owners in danger of costly litigation for violating the FLSA. Thus, this Note is designed to act as a road map for club owners and state legislators to recognize exotic dancers as employees in compliance with the FLSA and provide insight into how to avoid litigation. This Note analyzes this issue in four parts; Part IV, the analysis, is split into four substantial sections. Part I gives a short summary of the …

Parens Patriae, Punishment, And Pandemics: The State’S Responsibility For Incarcerated Persons During A Public Health Emergency, Meredith Harrell

Journal of Law and Health

This article looks at the nation’s response to the COVID-19 pandemic since March 2020 and explores the commonalities and differences of states’ actions to protect their citizens, especially the most vulnerable populations. The article discusses the government’s obligations to jailees and prisoners during the COVID-19 pandemic and how incarcerated persons have been consistently failed by the institutions that are required to protect them. The article examines possible remedies for these governmental and institutional failings under the Eighth Amendment and § 1983 civil rights claims. Ultimately the article proposes that monetary damages would provide relief to incarcerated individuals and their families …

How The Conviction And Sentencing Of "Tiger Mandingo" Modernized Missouri's Hiv-Related Statutes In 2021, Ryan Jay Mcelhose

Journal of Law and Health

Michael Johnson or “Tiger Mandingo” as he referred to himself on social media, engaged in sexual acts with six different men, all of whom claimed that Michael lied about living with human immunodeficiency virus (HIV). As a result, the State of Missouri charged him with recklessly infecting a partner with HIV exposing or attempting to expose another with HIV. With contradictory trial testimony, no genetic fingerprint testing, and little to no questioning of his sexual partners’ credibility, the jury found Michael Johnson guilty of five felony counts which resulted in a 30-year prison sentence. Ultimately the Missouri Court of Appeals …

Systematic Racism, Abortion And Bias In Medicine: All Threads Woven In The Cloth Of Racial Disparity For Mothers And Infants, Gabrielle Ploplis

Journal of Law and Health

This note argues that decisions like that of NAACP v. Wilmington Medical Center, Inc. have been one of many contributing factors in the disparity in mortality rates of both black and American Indian/Alaska Native newborns in comparison to white newborns across the country. Part II examines the current state of the law regarding issues of discrimination, accessibility of health care, and relocation and closure of medical centers that has disproportionately affect minorities in the U.S. Part III discusses the statistics of white, black, and American Indian/Alaska Native newborn and maternal mortality rates in the United States. Part IV addresses the …

A Pandemic Of Separation Of Powers Violations In Texas: The Interrelationship Of The Texas Disaster Act And Texas Gov’T Code Section 22.0035, Ron Beal

St. Mary's Law Journal

This Article is on the interrelationship of the Texas Disaster Act and Texas Government Code Section 22.0035. The author demonstrates that the Governor of Texas and the Texas Supreme Court have grossly violated the separation of powers on a continuing basis since March 29, 2020 by Governor Abbott issuing Executive Order 13, which prohibits the granting of bail to anyone awaiting trial, and the Texas Supreme Court’s unwillingness to invalidate that order administratively or judicially. Finally, the Article addresses the nearly one thousand district and county court judges who are constantly violating the separations of powers by failing to invalidate …

Why Reproductive Health Rights Should No Longer Be A Partisan Issue: A Call To Invest In Family Planning, Sofia Waterhouse

University of Miami Inter-American Law Review

The concepts of family planning and reproductive health rights are often obscured by the controversy that surrounds the topic of abortion. This controversy has substantially impacted the U.S.’s outlook on reproductive health rights and its support toward family planning organizations, often limiting funding and aid depending on each administration’s political views. While international law has recognized the importance of reproductive health rights and the necessity of family planning programs, the U.S. continues to fall be-hind when it comes to promoting such rights. This article calls for a bipartisan effort to end these regressive and harmful anti–abortion policies so that the …