Law Commons^™

So Many Have Died: Covid-19 In America's Nursing Homes, David M. English

Faculty Publications

As of the date of this writing in late September 2020, over 77,000 residents and staff of long-term care facilities have died of COVID-19 with more to come. This article will describe the reasons for this mass wave of death and provide practical suggestions for attorneys who represent a resident or family members of residents.

Covid-19 And Its Impact On America's Retirement System, David M. English

Faculty Publications

There is a long-standing debate over whether America's retirement system is in crisis. The COVID-19 pandemic has resolved the debate. Perhaps the system was merely challenged prior to March 2020, but it is certainly in crisis now. The pandemic has negatively impacted all four of the principal pillars of retirement: Social Security, employer-sponsored retirement programs, earnings from part-time work, and the worker's own savings. This short article will discuss the impact of the pandemic on the retirement system and discuss possible ways to restore the system to health or at least ameliorate the damage.

The Origins And Future Of Global Health Law: Regulation, Security, And Pluralism, Sam F. Halabi

Faculty Publications

The COVID-19 pandemic has presented a global health crisis unlike any seen in the seventy-five years since the United Nations and the World Health Organization were formed - one that is killing people, spreading human suffering, and upending people's lives. But this is much more than a health crisis. It is a human crisis. The coronavirus disease (COVID-19) is attacking societies at their core. It is therefore a crucial point around which to focus the capability of national and global institutions to address this essential threat to human health and life.

The purposes of this Article are to revisit and …

Early Access To Unapproved Medicines In The United States And France, Erika Lietzan

Faculty Publications

In 2018, President Trump signed a federal "right to try" law, claiming that it would give desperately ill patients earlier access to unapproved medicines, by allowing the patient, doctor, and drug company to arrange for access without federal oversight. Critics of the law argued that it would not meaningfully increase access to experimental medicines, because federal oversight was not the obstacle in the first place. And they were correct. U.S. law already permitted companies to provide terminally ill patients with early access to unapproved medicines. The problem was instead that companies did not take advantage of this option. This Article …

Moving Beyond Medical Debt, Brook E. Gotberg, Michael D. Sousa

Faculty Publications

In recent years it has become clear that medical costs are imposing severe financial burdens on American families, sometimes to the point that bankruptcy becomes the only escape from crippling debt. When evaluating the well-established connection between outstanding medical debt and consumer bankruptcy, most existing empirical studies attempt to quantify the percentage of consumer bankruptcies that are "caused" by unmanageable medical indebtedness. This Article addresses what we believe to be a more significant line of empirical inquiry, namely, the connection between health insurance coverage and consumer bankruptcy as a more precise measurement of how national health insurance programs may or …

"Undue Hardship" And Uninsured Americans: How Access To Healthcare Should Impact Student-Loan Discharge In Bankruptcy, Alexander Gouzoules

Faculty Publications

Student-loan debt has grown to unprecedented heights. Contributing to the severe burden imposed by these debts is the Bankruptcy Code’s unique presumption that they are not dischargeable. To overcome that presumption, a debtor must establish that repayment of her loans would constitute an “undue hardship.” This essay examines the disagreement among bankruptcy courts that have interpreted the “undue hardship” standard in situations where a debtor is unable to afford health insurance—a common occurrence among the economically disadvantaged. After examining recent healthcare reforms, I argue that Congress has expressed a judgment that all Americans should obtain minimum essential healthcare. Though this …

Zika And The Regulatory Regime For Licensing Vaccines For Use During Pregnancy, Sam F. Halabi

Faculty Publications

Microcephaly and other severe fetal brain defects (congenital Zika syndrome) caused by the Zika virus have prompted an urgent effort to develop and license a safe and efficacious vaccine. Yet, that effort has run up against one of the most formidable barriers in vaccine research: pregnant women are almost always excluded from clinical trials for fear that the intervention may harm the fetus. This article analyzes the existing regulatory framework for vaccines intended for use during pregnancy in an effort to identify ways the process may be reconsidered in light of recent public health emergencies that had a disproportionate effect …

Assessing The Relative Influence And Efficacy Of Public And Private Food Safety Regulation Regimes: Comparing Codex And Global Gap Standards, Sam F. Halabi, Ching-Fu Lin

Faculty Publications

An extensive global system of private food regulation is under construction, one that exceeds conventional regulation, thought of as being driven by public authorities like FDA and USDA in the U.S. or the Food Standards Agency in the UK. Agrifood and grocer organizations, in concert with some farming groups, have been the primary designers of this new food regulatory regime. These groups have established alliances that compete with national regulators in complex ways. This article analyzes the relationship between public and private sources of food safety regulation by examining standards adopted by the Codex Alimentarius Commission, a food safety organization …

Zika, Pregnancy, And The Law, Sam F. Halabi

Faculty Publications

This Essay situates a crucial component of the public health response to Zika - the effort to develop a safe and effective vaccine - within the broader literature. It does so in an effort to highlight the need to revisit the relationship between law and pregnancy - not only in the areas legal scholars have prioritized so far, but also in the context of routine and emergency maternal health, which has heretofore been largely assumed to be governed by straightforward norms and practices based on medical evidence and physician ethics. In fact, whereas the current literature tends to assume or …

A Global Vaccine Injury Compensation System, Sam F. Halabi, Saad B. Ommer

Faculty Publications

Vaccines are extremely safe and harm is rare. Worldwide, more than 30000 vaccine doses are delivered per second through routine immunization programs, which, in turn, prevent an estimated 2 million to 3 million deaths annually. Yet the specter of vaccine injury plays a central role in vaccine access and will continue to do so as vaccine technologies evolve.

Collective Corporate Knowledge, The Federal False Claims Act, And The Future Of Federal Health Programs, Sam F. Halabi

Faculty Publications

While recent U.S. Supreme Court decisions have drawn focus to whether what corporations “say” is protected by the First Amendment or what they “believe” is protected by the federal Religious Freedom Restoration Act, the more relevant inquiry for a wide range of statutory and regulatory regimes is what corporations “know.” At the core of that question is what guides information relevant for legal compliance (including product safety, employee welfare, and material risks considered by investors) from its source to any given point in the firm, including decision-makers. This Article analyzes the federal False Claims Act as an underexploited resource in …

The Scope Of Preemption Under The 2009 Family Smoking Prevention And Tobacco Control Act, Sam F. Halabi

Faculty Publications

The 2009 Family Smoking Prevention and Tobacco Control Act endeavored to alter the regulatory regime for tobacco products in the United States by allocating authority to regulate tobacco products to the U.S. Food and Drug Administration (FDA). While the law aims at greater transparency in the constituent components of cigarettes and non-combustible tobacco products, it also includes a provision which will bring FDA’s consumer protection and tobacco control mandates into tension: Section 911’s process for the approval of modified risk tobacco products. That provision allows tobacco manufacturers to submit applications to label products as “reduc[ing] the harm or the risk …

Legal Preparedness And Ebola Vaccines, Sam F. Halabi, John T. Monahan

Faculty Publications

On Dec 9, 2014, US Secretary of Health and Human Services Sylvia Burwell issued a declaration under the US Public Readiness and Emergency Preparedness Act to provide immunity from legal claims in the USA related to manufacturing, testing, development, distribution, and administration of three candidate Ebola vaccines except in instances of willful misconduct. Although progress in combating Ebola in west Africa has shifted public attention away from vaccine development and deployment, we should not forget that the management of legal liabilities related to vaccines has been an important subject of discussion between national governments, international organizations, vaccine manufacturers, and other …

Sharing The Burden Of Ebola Vaccine Related Adverse Events, Sam F. Halabi, John Monahan

Faculty Publications

Based upon past experience with other vaccines, the proposed administration of Ebola vaccines (once testing has been completed) will inevitably result in at least some adverse events that will give rise to legal liabilities of only crudely estimable magnitude at this time. Manufacturers, beneficiary governments (e.g., Guinea, Liberia, Sierra Leone), supporting governments (e.g. U.S., U.K.), individuals suffering adverse events, and populations benefiting from widespread vaccination against the Ebola virus all have a shared interest in recognizing, understanding, and managing potential liability as effectively as possible within the framework of a global public health response. There are multiple options available to …

Multipolarity, Intellectual Property And The Internationalization Of Public Health Law, Sam F. Halabi

Faculty Publications

This Article critically examines the proliferation of international legal agreements addressing global health threats like the outbreak of infectious diseases, tobacco use and lack of access to affordable medicines. The conventional wisdom behind this trend is that a global normative shift has occurred which has caused states to regard health as “special” and less subject to the normal rules of international law making because health threats endanger all of humanity. This Article challenges that thesis, arguing that at the same time the number and scope of international health law treaties has grown, developed states have subordinated health law to intellectual …

Selling Hospice, Sam F. Halabi

Faculty Publications

Americans are increasingly turning to hospice services to provide them with medical care, pain management, and emotional support at the end of life. The increase in the rates of hospice utilization is explained by a number of factors including a “hospice movement” dating to the 1970s which emphasized hospice as a tool to promote dignity for the terminally ill; coverage of hospice services by Medicare beginning in 1983; and, the market for hospice services provision, sustained almost entirely by governmental reimbursement. On the one hand, the growing acceptance of hospice may be seen as a sign of trends giving substance …

Reducing The Discount Rate, Ben L. Trachtenberg

Faculty Publications

This article presents two arguments against the “discounting” of future human lives as part of cost benefit analysis, or CBA. Our first argument is that because CBA has thus far ignored evidence of rising health care expenditures, it underestimates the “willingness to pay” for health and safety that future citizens will likely exhibit, thereby undervaluing their lives. Our second argument is that until recently CBA has ignored the trend of improved material conditions in developed countries, and most agencies continue to ignore it entirely. As time advances, residents of rich countries tend to live better and spend more, meaning that …

How The Supreme Court Doomed The Aca To Failure, Thom Lambert

Faculty Publications

Now that the dust has settled somewhat, we may assess the likely consequences of the decision in National Federation of Independent Business v. Sebelius. This article briefly summarizes the reasoning underlying the decision's individual mandate ruling. It then considers what lies ahead for health insurance and medical care in the United States if the ACA, as modified by NFIB, is not repealed. Be warned: the picture isn't pretty.

The Patient Protection And Affordable Care Act Of 2010: Rulemaking The Shadow Of Incentive-Based Regulation, Sam F. Halabi

Faculty Publications

While legislators, scholars and mainstream observers are focused on the intense debates surrounding the constitutionality of the Patient Protection and Affordable Care Act’s individual mandate, the Department of Health and Human Services and other agencies are proceeding apace in promulgating rules to implement the law’s other requirements. Congress’s substantial delegation of administrative authority to HHS and other agencies will provide a second key area for constitutional challenges after the U.S. Supreme Court resolves the initial lawsuits based on the individual mandate. Between facial constitutional challenges to the Affordable Care Act and lawsuits based on defects in agency rules or the …

Nil: The Value Of Patents In A Major Crisis Such As An Influenza Pandemic, Dennis D. Crouch

Faculty Publications

This essay focuses on the role of patents in relation to a potential global crisis such as an influenza pandemic or other public health crisis. I argue that patent rights will be largely ignored during an epidemic and that any post-crisis compensation would likely be low when compared to traditional patent rewards or settlements entered under threat of injunctive relief. In some situations, such as use of a patented invention by a state or local government, a patentee may have no recourse. Part III of the essay raises a separate issue that stems from the relatively long time frame for …

Participation And The Right To Health: Lessons From Indonesia, Sam F. Halabi

Faculty Publications

The right to participation is the “the right of rights” — the basic right of people to have a say in how decisions that affect their lives are made. All legally binding international human rights treaties explicitly recognize the essential role of participation in realizing fundamental human rights. While the substance of the human right to health has been extensively developed, the right to participation as one of its components has remained largely unexplored. Should rights-based health advocacy focus on participation because there is a relationship between an individual’s or a community’s active involvement in health care decision-making and the …

The Patent Lottery: Exploiting Behavioral Economics For The Common Good, Dennis D. Crouch

Faculty Publications

Lotteries are immensely popular. Players are willing to give the organizer a large monetary cut of every ticket purchase in return for a chance at a jackpot. In some ways, our current patent system operates as a lottery as well. Most patents are relatively worthless, while a few are highly valuable. Reaching the major payout of a highly valuable patent takes perseverance in the face of tremendous uncertainty. Like lottery players, small entrepreneurial companies and individuals have shows signs of bounded rationality. In particular, what I call the patent lottery effect is associated with the phenomena of potential innovators overweighting …

Non-Beneficial Pediatric Research And The Best Interest Standard: A Reconciliation, Paul J. Litton

Faculty Publications

Federal efforts beginning in the 1990's have successfully increased pediatric research to improve medical care for all children. Since 1997, the FDA has requested 800 pediatric studies involving 45,000 children. Much of this research is "non-beneficial"; that is, it exposes pediatric subjects to risk even though these children will not benefit from participating in the research. Non-beneficial pediatric research (NBPR) seems, by definition, contrary to the best interests of pediatric subjects, which is why one state supreme court has essentially prohibited it. It also appears that the only plausible rationale for this research is utilitarian, as it risks some children …

Health Courts?, Philip G. Peters Jr.

Faculty Publications

This article undertakes the first detailed critique of the proposal from Common Good and the Harvard School of Public Health to replace medical malpractice jury trials with adjudication before specialized health courts. Professor Peters concludes that the modest benefits likely to be produced by the current health court proposal are matched by the risks of bias and overreaching that these courts would also present. Missing from the plan is the doctrinal change mostly likely to improve patient safety - hospital enterprise liability. Without enterprise liability, the health court proposal is unlikely to achieve its patient safety goals and, as a …

The Case Against Smoking Bans, Thom Lambert

Faculty Publications

In recent months, numerous localities and states have banned smoking in public places (i.e., privately owned places to which members of the public are invited). Such sweeping bans are typically justified on grounds that they alleviate externalities, shape individuals' preferences in a desirable manner, and reduce risks. This essay rebuts the externality, preference-shaping, and risk-reduction arguments for smoking bans and contends that such bans are unnecessary and, on the whole, utility-reducing.

The Ambiguous Meaning Of Human Conception, Philip G. Peters Jr.

Faculty Publications

Nearly all of the state and federal laws that treat embryos as persons contain a fundamental ambiguity. Contrary to common belief, there is no "moment" of conception. Instead, conception is a forty-eight hour process, during which the haploid genomes of the sperm and egg are gradually and precisely transformed into the functioning diploid genome of a new human embryo. During that two-day period, many common clinical and laboratories activities take place, including the culling of unsuitable embryos, the freezing of others, and the testing of embryos for genetic abnormalities. The legal status of these activities will turn on the point …

Unwarranted Variations In The Quality Of Health Care: Can The Law Help Medicine Provide A Remedy/Remedies?, Philip G. Peters Jr., John E. Wennberg M.D.

Faculty Publications

This article reviews the essential findings of studies of variations in quality of care according to three categories of care: effective care, preference-sensitive care, and supply-sensitive care. It argues that malpractice liability and informed consent laws should be based on standards of practice that are appropriate to each category of care. In the case of effective care, the legal standard should be that virtually all of those in need should receive the treatment, whether or not it is currently customary to provide it. In the case of preference-sensitive care, the law should recognize the failure of the doctrine of informed …

Income Tax Planning For Long-Term Care, David M. English

Faculty Publications

Planning for long-term involves more than the preparation of powers of attorney and counseling on possible asset transfers to qualify for Medicaid reimbursement. Steps should also be taken to make certain that the person receiving care continues to file an income tax return and does so at a minimum possible income tax cost. Practitioners should be familiar with the procedure for filing a return on behalf of an incapacitated individual. The medical expense deduction, while of little importance for most taxpayers, is critical for many elderly, particularly for those receiving long-term care. Long-term care insurance and life insurance may be …

The Role Of Jury In Modern Malpractice Law, Philip G. Peters Jr.

Faculty Publications

This article explores the policy issues raised by the choice between a custom-based standard of care and a jury-determined reasonability standard. The author examines not only traditional legal arguments but also the recent findings of cognitive psychology, jury performance studies, and health industry research. Not surprisingly, this analysis reveals that both options are imperfect. However, the author cautiously recommends the reasonable physician standard. The revolutionary transformation of the health care industry in last quarter of a century has transferred considerable power from physicians to the health insurance industry, an industry that has not yet earned the privilege of self-regulation. Unlike …

The Uniform Health-Care Decisions Act And Its Progress In The States, David M. English

Faculty Publications

Over the past decade, planning for health care decision making through the making of an advance directive has become a routine part of personal counseling. Public interest in the subject has been fueled by well-publicized cases such as Cruzan v. Director, Missouri Department of Health, 497 U.S. 261 (1990). In response to this interest, most states authorize their citizens to make at least one form of advance directive: all states statutorily authorize powers of attorney for health care, and all but Massachusetts, Michigan and New York authorize living wills. State legislation has been a mixed blessing. Although intended to facilitate …