Health Law and Policy Commons^™

Solving The Opioid Epidemic In Ohio, Lacy Leduc

Journal of Law and Health

On May 31, 2017, Ohio Attorney General Mike DeWine took a step in fighting Ohio's opioid epidemic, bringing the first of many lawsuits against five top pharmaceutical companies. However, under Federal and State law, there is an exception called the Learned Intermediary Doctrine, which can absolve drug manufacturers of liability from any misconduct that might be found and transfer that liability to a treating physician. This exception is the way many drug manufacturers were able to avoid being held responsible in the past. This Note proposes that with the current pending lawsuit in the State of Ohio, an exception to …

Dental Board Of California, Helene E. Mayer, Debra Jorgensen

California Regulatory Law Reporter

No abstract provided.

Department Of Managed Health Care, Kaitlyn Enticknap, Monet Mccord, Debra Jorgensen

California Regulatory Law Reporter

No abstract provided.

Sweeping Exposures: Lead Poisonings And Black Working Poor Populations In The United States, Shirley Reid

Dissertations, Theses, and Capstone Projects

The focus of my thesis is to explore some of the realities that the impoverished urban black poor populations face in America today. The goal of my thesis is to illustrate how poverty is reproduced within impoverished neighborhoods through the idea and mechanism of lead exposure, by recognizing how specific exposure to the element lead and its by-products is both a symbol and a material cause of black urban poor illness and disability. There is no mistake that people living in the U.S. are aware of the social injustices against black populations in the form of racial injustice. However, …

Medical Board Of California, Mason Bettencourt, Debra Jorgensen

California Regulatory Law Reporter

No abstract provided.

Board Of Registered Nursing, Heather Morse, Debra Jorgensen

California Regulatory Law Reporter

No abstract provided.

Board Of Pharmacy, John Lacrosse, John Mysliwiec, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.

Columbia Law Scholars Respond To New Hhs Rule, "Protecting Statutory Conscience Rights In Health Care", Law, Rights, And Religion Project

Center for Gender & Sexuality Law

During his National Day of Prayer remarks, President Trump announced a finalized rule that creates expansive legal protections for healthcare providers with specific religious beliefs, including opposition to abortion, sterilization, end-of-life care, and healthcare for LGBTQ persons. The final rule does not offer similarly broad protections to healthcare providers who feel religiously obligated to provide comprehensive sexual and reproductive healthcare to their patients.

Flushed And Forgotten: Sanitation And Wastewater In Rural Communities In The United States, Alabama Center For Rural Enterprise (Acre), Human Rights Institute, Institute For The Study Of Human Rights

Human Rights Institute

This report seeks to bring attention to the unique plight of rural U.S. communities struggling to secure basic sanitation and wastewater. The problem of inadequate and unaffordable water services has received increasing coverage in recent years, and the focus here is on bringing attention to less well-known structural challenges that impede access to sanitation, and the unique ways they impact rural residents.

Law And Power In Health Care: Challenges To Physician Control, Mary Anne Bobinski

Buffalo Law Review

No abstract provided.

Clinical Decision Making: A Case Study Of The Effects Of Evidence Based Medicine And Past Empirical Experience In The Emergency Department, Olivia Zeman-Renner

Theses/Capstones/Creative Projects

With a growing number of medical malpractice suits and the passage of policy that focuses on patient advocacy, an emphasis has been placed on research regarding the decision-making processes of physicians in everyday practices. Over the past decades, scholars have looked to specific clinical decision-making philosophies, how they can be implemented into practice, and the effects of such implementation, but little research has been done into the culmination of decision-making philosophies on a day-to-day basis. By focusing on single-case study of a Midwestern Emergency Department and asking Attending physicians to self-report their decision-making philosophies, this study serves as a transition …

Just Care: A Relational Approach To Autonomy And Decision Making Of Parents Committed To Religious Or Indigenous Traditional Practices, Tu-Quynh Trinh

LLM Theses

Hamilton Health Sciences Corp. v. D.H. and B. (R.) v. Children’s Aid Society of Metropolitan Toronto tell important stories about people and relationships—and about parenthood; autonomy; religious believers and cultural communities; and the role of the state in family, culture, and religion. Their narratives were influenced by liberalism and emphasize a degree of individualism that is incongruous given the subject matter of parent child relationships and their place within communities and the law. This thesis explores the application of relational theory and the integrated principles of justice and care to these issues. Ultimately, the stories these judicial opinions tell help …

J Mich Dent Assoc May 2019

The Journal of the Michigan Dental Association

Every month, The Journal of the Michigan Dental Association brings news, information, and features about Michigan dentistry to our state's oral health community and the MDA’s 6,200+ members across the state. No publication reaches more Michigan dentists!. This month's issue features an interview with Dr. Margaret Gingrich, MDA president, the MDA's partnership with TDSC, The Dentists Supply Company, and more on our 100th anniversary celebration.

Consumer Power To Change The Food System? A Critical Reading Of Food Labels As Governance Spaces: The Case Of Acai Berry Superfoods, Christine Parker, Hope Johnson, Janine Curll

Journal of Food Law & Policy

This article argues that the marketing claims on food labels are a governance space worthy of critical examination. We use a case study of superfood açaí berry products to illustrate how marketing claims on food labels encapsulate dominant neoliberal constructions of global food systems. These marketing claims implicitly promise that by making careful choices consumers can resist and redress the ravages of unbridled global capitalism. Food labels suggest that consumers can use market signals to simultaneously govern our own selves and the market to ensure sustainable, fair, and healthy consumption. In response, this article develops, justifies and applies a socio-legal …

The Clash Of Agricultural Exceptionalism And The First Amendment: A Discussion Of Kansas' Ag-Gag Law, Meredith Kaufman

Journal of Food Law & Policy

Since the Nation’s founding, agricultural production has been treated differently than other industries. This concept, known as “agricultural exceptionalism,” has manifested in many different ways throughout U.S. history. Since the 1990s, one manifestation of agricultural exceptionalism has been the enactment of “Ag-gag laws,” state laws that limit information gathering activities at animal production facilities. Ag-gag laws are frequently criticized by animal welfare advocates and legal scholars for seeking to shield animal production facilities from public scrutiny, a state-sanctioned protection not afforded to other industries.

Blockchain Meets Genomics: Governance Considerations For Promoting Food Safety And Public Health, Walter G. Johnson

Journal of Food Law & Policy

Foodborne illness remains an ongoing public health challenge in both the developing and industrialized worlds. In the United States, almost 50 million reported cases of infectious disease occur every year from a food product, resulting in substantial morbidity and mortality with economic burdens to health care and productivity. Despite recognition as a leader in food safety, the U.S. experiences longstanding and novel issues in food safety. Advances in whole genome sequencing (WGS) promise to bolster food safety regulators’ capabilities to identify pathogens and determine their source. However, inefficiencies in tracing food products through the supply chain remain.

Federal Regulation Of Pesticide Residues: A Brief History And Analysis, Kate Z. Graham

Journal of Food Law & Policy

In the United States today, there are over 900 pesticides in use1 and over 400 are approved for use in food production, whether used as part of the growing process or in post-harvest handling. Although the history of pesticide use in food crops goes back centuries, the post-war period has seen an enormous growth in the varieties and amounts of pesticides used in our food system. As our reliance on pesticides has grown, pesticides have become a divisive issue. Pesticide advocates view them as essential to a secure and reliable food supply needed to feed a growing world population. Detractors, …

Legislative And Executive Branch Developments Affecting The United States Department Of Agriculture Supplemental Nutrition Assistance Program, Sheila Fleischhacker, Alyssa Moran, Sara N. Bleich

Journal of Food Law & Policy

For more than forty years, the United States Department of Agriculture Supplemental Nutrition Assistance Program (SNAP; formerly Food Stamps) has offered nutrition assistance to nearly forty million eligible individuals and families each month. This article first provides a brief overview of the evolution of the United States’ largest domestic food security and nutrition safety net program. Then, the article reviews Congressional actions taken regarding SNAP during the 2018 Farm Bill deliberations, appropriations for fiscal years 2017 through 2020, and oversight (in)activities. The article focuses on Congressional activities regarding block grants; participant eligibility; benefit adequacy, issuance, and redemption; and strengthening SNAP’s …

Keep Your Friends Close And Your Medical Records Closer: Defining The Extent To Which A Constitutional Right To Informational Privacy Protects Medical Records, Lauren Newman

Journal of Law and Health

The following Article discusses the extent to which the constitutional right to informational privacy protects medical data from improper acquisition or dissemination by state agents. Part I provides background on Whalen v. Roe, the Supreme Court case that has been understood to establish the right to informational privacy. Part I also discusses the variations across the circuit courts as to what medical information is afforded protection by the right. Part II analyzes the well-established approaches adopted by the Second and Third Circuits as they present opposing interpretations of Whalen, one wholly protecting medical information and the other protecting …

The Bell Has Rung: Answering The Door For Student-Athlete Concussion Issues In The National Collegiate Athletic Association, Aaron Caputo

Journal of Law and Health

This Note examines the NCAA's unwillingness to enforce the requirement that all NCAA institutions must implement a concussion management plan; the NCAA's refusal to apply its appropriate enforcement mechanism when member institutions violate their concussion management plans, which are instituted in order to protect student-athletes from concussions; how both of these failures result in more concussions and a higher probability of debilitating long-term effects; and solutions to remedy this grave injustice. Part II describes what a concussion is, the long-term effects of concussions, the NCAA's management of concussions, and lawsuits challenging the NCAA in relation to concussions. Part III analyzes …

Access Before Evidence And The Price Of The Fda’S New Drug Authorities, Erika Lietzan

University of Richmond Law Review

Sometimes drug innovation seems to happen in reverse. Patients enjoy a treatment for years even though the treatment has not been approved by the FDA or proven safe and effective to the FDA’s standards. (Sometimes this happens because the FDA has declined to take enforcement action.) The agency encourages companies to perform the work necessary to satisfy the United States “gold standard” for new drug approval, however, by promising exclusivity in the marketplace. When a company does this work, at considerable expense, the results are predictable. The new drug is expensive, and patients and payers (and sometimes policymakers) are outraged. …

“Big” Food, Tobacco, And Alcohol: Reducing Industry Influence On Noncommunicable Disease Prevention Laws And Policies, Belinda Reeve, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The food, tobacco and alcohol industries have penetrated markets in low- and middle-income countries (LMICs), with a significant impact on these countries’ burden of noncommunicable diseases (NCDs). Tangcharoensathien and colleagues describe the aggressive marketing of unhealthy food, alcohol and tobacco in LMICs, as well as key tactics used by these industries to resist laws and policies designed to reduce behavioural risk factors for NCDs. This commentary expands on the recommendations made by Tangcharoensathien and colleagues for preventing or managing conflicts of interest and reducing undue industry influence on NCD prevention policies and laws, focusing on the needs of LMICs. A …

Got Mylk?: The Disruptive Possibilities Of Plant Milk, Iselin Gambert

Brooklyn Law Review

Milk is one of the most ubiquitous and heavily regulated substances on the planet—and perhaps one of the most contested. It is tied closely to notions of purity, health, and femininity, and is seen as so central to human civilization that our own galaxy—the Milky Way—is named after it. But despite its wholesome reputation, milk has long had a sinister side, being bound up with the exploitation of the (human and nonhuman) bodies it comes from and being a symbol of and tool for white dominance and superiority. The word itself, in verb form, means “to exploit.” It is also …

A Brand-Name Drug Company May Violate Section Two Of The Sherman Act By Mislabeling A Submitted Patent In The Orange Book: An Implication From In Re Actos End-Payor Antitrust Litigation, 848 F.3d 89 (2d Cir. 2017), Ping-Hsun Chen

Brooklyn Journal of Corporate, Financial & Commercial Law

The Hatch-Waxman Act encourages generic drug companies to submit an abbreviated new drug application (“ANDA”) for a generic version of a drug approved by the U.S. Food and Drug Administration (“FDA”). Nevertheless, a mechanism exists for a brand-name drug company to adjudicate a patent infringement dispute before the FDA approves an ANDA. The mechanism includes the regulatory scheme of patent information submission implemented by the FDA. 21 U.S.C. § 355(b)(1) requires that patent information be correct. False patent information destroys the objectives of the Hatch-Waxman Act. In re Actos End-Payor Antitrust Litigation, 848 F.3d 89 (2d Cir. 2017), may demonstrate …

Utility Functions For Mild And Severe Health Risks, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

This article reviews economic evidence on health-dependent utility functions and presents new estimates of utility functions for cancer. Estimates of health-dependent utility functions have found that mild adverse health impacts can be treated as monetary equivalents. Severe health consequences also reduce utility levels but have an additional effect of altering the structure of utility functions by reducing the marginal utility of income. The implications of past studies are often misleading when they fail to account for income losses and medical expenses associated with serious ailments. This article’s estimates of the structure of utility functions for cancer indicate a substantially lower …

American Democratic Deficit In Assisted Reproductive Technology Innovation, Myrisha S. Lewis

Faculty Publications

In many areas of innovation, the United States is a leader, but this characterization does not apply to the United States' position in assisted reproductive technology innovation and clinical use. This article uses a political science concept, the idea of the "democratic deficit" to examine the lack of American public discourse on innovations in ART. In doing so, the article focuses on America's missing public consultation in health care innovation. This missing discourse is significant, as political and ethical considerations may impact regulatory decisions. Thus, to the extent that these considerations are influencing the decisions of federal agency employees, namely …

Epilogue: Health Care, Federalism, And Democratic Values, Nicole Huberfeld

Faculty Scholarship

Is the United States experiencing a “crisis of democracy in health care”? This symposium's central question can only begin to be addressed here. The answer depends, in part, on where we look and how we measure democracy.

Democracy is a complex ideal often said to be promoted by federalism. In health care, each level of government exercises power because federalism is a default choice in health reform efforts. This default enables state governments and the federal government to create, enforce, and adjudicate health law and policy - democratic operations at the national and the subnational levels. But on each democratic …

Biobanks As Innovation Infrastructure For Translational Medicine, W. Nicholson Price Ii

Book Chapters

Biobanks represent an opportunity for the use of big data to drive translational medicine. Precision medicine demands data to shape treatments to individual patient characteristics; large datasets can also suggest new uses for old drugs or relationships between previously unlinked conditions. But these tasks can be stymied when data are siloed in different datasets, smaller biobanks, or completely proprietary private resources. This hampers not only analysis of the data themselves, but also efforts to translate data-based insights into actionable recommendations and to transfer the discovered technology into a commercialization pipeline. Cross-project technological innovation, development, and validation are all more difficult …

Section 1332 State Innovation Waivers: Waiving Goodbye To Cooperative Federalism And Hello To Collaborative Federalism, Brittany Hynes

University of Miami Business Law Review

No abstract provided.

Regulating Sugar-Sweetened Beverages, Tyler Rauh

University of Miami Business Law Review

American waistlines are an international punchline, and United States taxpayers spend hundreds of billions of dollars each year to combat medical complications resulting from obesity. The personal costs are financial, emotional, and mortal. Projections insist that it will become worse. Section I details the obesity epidemic and ponders why the United States is uniquely unhealthy.

The reason could be that America consumes more sugar than any other country. In recent years, some municipal policymakers have attempted to restrain America’s sweet tooth by taxing sugar-sweetened beverages. Initial responses are polarizing. Chicago’s tax did not last three months before its abolishment. Philadelphia’s …