Law Commons^™

Meet Our New Faculty: Jenn Oliva, James Owsley Boyd

Keep Up With the Latest News from the Law School (blog)

Professor Jenn Oliva joined Indiana Law earlier this summer as a professor of law and as Val Nolan Faculty Fellow. Prior to joining the IU Maurer Law faculty, Professor Oliva served as Professor of Law and Co-Director of the UCSF/UC Law Consortium on Law, Science & Health Policy at the University of California College of Law, San Francisco. She has also served as Associate Dean for Faculty Research & Development and Director of the Center for Health & Pharmaceutical Law at Seton Hall University School of Law where she was selected as the law school’s 2021 Professor of the Year …

The Apex Bone Wearing Out In The Light Of Sharia And Science, Omar Gabis

An-Najah University Journal for Research - B (Humanities)

This research studies an issue in which Sharia scholars differed in the past, while was not of interest to scholars recently, namely: Does the last part of the human coccyx bone (apex) dissolve? Some hadith mentioned that the apex wears out, which was the reason for the divergence of the opinions of scholars in answer to this question over time. As far as informed, the researcher did not find a schooler who singled out this issue in any scientific research. The difficulty of answering this question may lie in the inability to conduct empirical research on this part, in addition …

State Flexibility In Emergency Medicaid To Care For Uninsured Noncitizens, Jin K. Park, Clarisa Reyes-Becerra, Medha D. Makhlouf

Faculty Scholarly Works

No abstract provided.

Dying In Isolation: Public Health Implications Of Transportation And Burial Of Human Remains During A Pandemic A Fifty State Survey, Christopher Ogolla

Faculty Scholarship

No abstract provided.

The Ruling Of Cosmetic Injections: A Jurisprudential Study, Ali Suleiman Al Saleh Dr.

مجلة جامعة الإمارات للبحوث القانونية UAEU LAW JOURNAL

Cosmetic injections are a medical procedure, completely different from surgery, where a long-term change occurs in the body. The materials used in this procedure varies by source, whether a human, animal or mineral, which would require to study the ruling of utilizing them in cosmetic or medication.

The research concluded that the ruling of using cosmetic injections varies by functions in terms of filling in facial wrinkles and organs, causing paralysis in muscles, or feeding and motivating the skin. It also varies according to the materials injected into the body in terms of generating them from human, animal or otherwise. …

The Ruling Of Cosmetic Injections: A Jurisprudential Study, Ali Suleiman Al Saleh Dr.

UAEU Law Journal

Cosmetic injections are a medical procedure, completely different from surgery, where a long-term change occurs in the body. The materials used in this procedure varies by source, whether a human, animal or mineral, which would require to study the ruling of utilizing them in cosmetic or medication.

The research concluded that the ruling of using cosmetic injections varies by functions in terms of filling in facial wrinkles and organs, causing paralysis in muscles, or feeding and motivating the skin. It also varies according to the materials injected into the body in terms of generating them from human, animal or otherwise. …

The Future Of Healthcare Is Generic: Expanding Hatch-Waxman To Equitably Regulate The Healthcare Products Industry, George Encarnacion Jr.

DePaul Journal of Health Care Law

This article serves to address the statutory disconnect in the healthcare industry regarding generic products. There has been marked success in the generics market pertaining to pharmaceutical drugs, but the same cannot be said for medical devices and, in more recent times, biosimilars. The end result for consumers is higher product prices, limited access of care, and a more burdensome healthcare system. This article explores the statutory history of drug and medical device approval and production. It also explores differences between modern regulation of generic drugs and generic medical devices, focusing on key issues of FDA approval, consumer safety and …

Blue Water Navy Veterans And The Agent Orange Rulings: A Lifeboat For The Veterans; A Storm Warning For The Vba, Jennifer Howley

Catholic University Law Review

Agent Orange was a herbicidal chemical used by the U.S. military for tactical use during the Vietnam War. Although initially told by the government not to worry about exposure to the chemical, veterans, their wives, and their offspring began having severe health and reproductive issues. In the early 1990’s, Congress passed the Agent Orange Act and the government directed the Institute of Medicine to report on the health effects of Agent Orange. Through this approach, Vietnam Veterans could claim benefits for illnesses listed in connection with Agent Orange. But only some Vietnam Veterans.

Initially, only veterans who served on-shore or …

Fixed Payment Schedules Do Not Foreclose Liability Under The False Claims Act, Glen Mcclain

University of Cincinnati Law Review

No abstract provided.

Artificial Intelligence Tools In Clinical Neuroradiology: Essential Medico-Legal Aspects, Dennis M. Hedderich, Christian Weisstanner, Sofie Van Cauter, Christian Federau, Myriam Edjlali, Alexander Radbruch, Sara Gerke, Sven Haller

Faculty Scholarly Works

Commercial software based on artificial intelligence (AI) is entering clinical practice in neuroradiology. Consequently, medico-legal aspects of using Software as a Medical Device (SaMD) become increasingly important. These medico-legal issues warrant an interdisciplinary approach and may affect the way we work in daily practice. In this article, we seek to address three major topics: medical malpractice liability, regulation of AI-based medical devices, and privacy protection in shared medical imaging data, thereby focusing on the legal frameworks of the European Union and the USA. As many of the presented concepts are very complex and, in part, remain yet unsolved, this article …

Medical Falsity: The False Claims Act’S Quagmire For Medicare And Medicaid Claims, Jordan R. Einhorn

Buffalo Law Review

No abstract provided.

Death By Detox: Substance Withdrawal, A Possible Death Row For Individuals In Custody, Dorothea R. Carleton

Journal of Law and Health

Suffering through substance withdrawal is a major problem for the majority of individuals in custody, yet there are no guidelines or standards to ensure their safety. Instead, individuals in custody are having their Constitutional rights violated and many die at the hands of the justice system. When their families seek accountability for the lack of adequate care provided by correctional facilities and employees, families are faced with a lack of consistency from one circuit to the next for knowing as to the correct standard to have a successful claim. Strain v. Regalado was a chance for the Supreme Court to …

Hacking Or Hatching The Skinny Label: How The Federal Circuit’S Decision In Gsk V. Teva Threatens Generics And Induced Infringement, Kayla Mccallum

Texas A&M Journal of Property Law

This Note focuses on the recent precedential decision handed down by the Federal Circuit in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., which impacts “one of the greatest public health inventions of the 21st century”: generic drugs. An invention that rose to prominence when former President Ronald Reagan signed into law the Hatch-Waxman Act (“the Act”), formally known as the Drug Price Competition and Patent Term Restoration Act of 1984. The Act aimed to increase competition between brand-name and generic manufacturers while balancing two seemingly opposing interests: (1) encourage and reward innovation by pioneer drug companies and (2) increase access …

Optimizing Cybersecurity Risk In Medical Cyber-Physical Devices, Christopher S. Yoo, Bethany C. Lee

William & Mary Law Review

Medical devices are increasingly connected, both to cyber networks and to sensors collecting data from physical stimuli. These cyber-physical systems pose a new host of deadly security risks that traditional notions of cybersecurity struggle to take into account. Previously, we could predict how algorithms would function as they drew on defined inputs. But cyber-physical systems draw on unbounded inputs from the real world. Moreover, with wide networks of cyber-physical medical devices, a single cybersecurity breach could pose lethal dangers to masses of patients.

The U.S. Food and Drug Administration (FDA) is tasked with regulating medical devices to ensure safety and …

Smart Wearables: The Overlooked And Underrated Essential Worker, Rebekah Hill

William & Mary Law Review

This Note argues that the FDA should revamp its criteria for regulating medical devices to unambiguously include smart wearables. Specifically, this Note calls for the FDA to amend its definition of “medical device” to focus on what a device is technologically capable of rather than its intended use.

Part I will examine the established legislation regarding medical devices; in particular, it will examine the relationship between FDA regulations and the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and argue that when taken together, HIPAA creates a strong presumption that smart wearables should be regulated by the FDA. This …

Pain Management, Disorders Of Consciousness, And Tort Law: An Emergency Tort To Fix A Longstanding Injustice, Joseph J. Fins, Zachary E. Shapiro

Indiana Law Journal

We address the systemic undertreatment of pain for individuals diagnosed with disorders of consciousness (DoC). Patients with DoC are often unable to communicate due to damage to their brains, and because DoC patients appear to be insensate, practitioners often believe that these patients are unable to feel pain and may not offer them analgesia, even before painful medical procedures. However, science shows that many DoC patients are able to feel pain, even if they are unable to communicate their distress. This Article moves from recognition of this problem to proposing solutions, in particular exploring what the legal system can do …

Forgotten Parties: Shifting The Focus Of Donor Conception To Donor-Conceived Persons Through Reasonable Regulation, Tiffany D. Gardner

Mercer Law Review

In an age in which information is at our fingertips with a few keystrokes, members of the fertility industry are increasingly confronting the reality that anonymous sperm and egg donation is no longer realistic—and has not been for some time. With the advent of at-home commercial DNA testing, multiple generations are not only learning they were conceived through the use of reproductive material provided by third parties (“donors”) but also identifying those formerly anonymous donors. These revelations, and increasing advocacy by the people born of such donations (i.e., donor-conceived people) are changing the landscape of third-party reproduction around the world. …

Law Library Blog (March 2023): Legal Beagle's Blog Archive, Roger Williams University School Of Law

Law Library Newsletters/Blog

No abstract provided.

What A Waste! An Evaluation Of Federal And State Medical And Biohazard Waste Regulations During The Covid-19 Pandemic And Their Impact On Environmental Justice, Samantha Newman

Villanova Environmental Law Journal

No abstract provided.

Liability For Deadly Failure: Rejecting The Push For Prep Act Preemption And Restraining Prep Act Immunity For Senior Living Facilities And Nursing Homes, Mai R. Contino

Pepperdine Law Review

In the wake of COVID-19, there has been a surge of wrongful death cases filed by plaintiff families in state courts. These families allege that their loved one contracted and died from COVID-19 because the nursing home or senior living facility at which their loved one resided failed to take proper COVID-19 prevention measures. In response, defendant facilities have removed these actions to federal court, arguing that the PREP Act preempts plaintiffs’ state law claims and grants facilities immunity from liability for loss related to qualified actions taken during a public health emergency. This Comment rejects facilities’ push for preemption …

Section 1115 Waivers: Innovation Through Experimentation, Or Stagnation Through Routine?, Nicole Johnson

Emory Law Journal

The Medicaid program operates as a federal-state partnership, in which the states agree to meet certain federally mandated requirements in exchange for federal matching funds for program expenditures. These federal matching funds can be anywhere from 50–90% of health care expenses incurred through state Medicaid programs. As such, states have a substantial interest in continuing this partnership and ensuring that their state plans comply with federal requirements. There is a way, though, in which states can gain more freedom in building their individual state plans. Through section 1115 waivers, states can ask the Centers for Medicare and Medicaid Services (“CMS”) …

Off-Label Speech, David A. Simon

Emory Law Journal

This Article argues that the Food and Drug Administration (“FDA”) should regulate drug manufacturer speech about off-label uses based on the evidentiary support for the relevant use. The more evidence that an off-label use is safe and effective, the less restrictive the regulation should be. The less evidence that an off-label use is safe and effective, the more restrictive the regulation should be. Although intuitive, this is not exactly how current regulation of off-label information works. If the FDA approves a drug, the manufacturer can advertise to doctors and patients for the approved indication. Drug manufacturers cannot, however, promote or …

Moving Away From Masking Pain: A Need For Modernization In Pain Management, Tori Collins

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.

The Right To Personality: Navigating The Brave New World Of Personality-Altering Interventions, Christopher S. Sundby

Connecticut Law Review

As neuroscience progresses, policy makers will have an increasing arsenal of behavior-modifying interventions at their disposal to deploy in the hopes of reducing recidivism and making the criminal justice system more rehabilitative. While these interventions are promising, they also can pose grave risks to individual liberty interests that are insufficiently acknowledged, much less protected, by current jurisprudence. Specifically, the current legal regimes and proposed alternatives either fail to identify the nature of the liberty at stake by overly focusing on physical side effects to the exclusion of thought- and personality-altering side effects, reject completely the potential for these interventions to …

Hatch-Waxman’S Renegades, John R. Thomas

Georgetown Law Faculty Publications and Other Works

No intellectual property rights impact society more forcefully than patents on pharmaceuticals. But as a practical matter, only a handful of jurists resolve disputes involving them. Two neighboring federal districts, Delaware and New Jersey, adjudicate the vast majority of patent contests between brand-name drug companies and generic manufacturers. And in contrast to Eastern Texas, which has been persistently derided as a renegade jurisdiction, the authority of the mid-Atlantic courts has seldom been questioned. The complex workings of the Hatch-Waxman Act, the compromise legislation that governs pharmaceutical patent litigation, go a long way to explaining such distinct shareholder reactions to highly …

Legislated Ableism: Bill C-7 And The Rapid Expansion Of Maid In Canada, Isabel Grant

All Faculty Publications

This paper explores the recent expansion of medical assistance in dying to disabled people who are suffering intolerably but are not at the end of their lives. The paper argues that it is impossible to separate suffering caused by an irremediable disability and suffering caused by the impacts of systemic ableism, which include high rates of poverty, social isolation and exclusion for people with disabilities. The paper suggests that this expansion raises constitutional issues under s. 15 and s. 7 of the Charter because it is premised on a view that portrays disability as potentially worse than death and thus …

Don't Tread On My Ip Rights: A Law And Economics Analysis Of "March-In Rights" Under The Bayh-Dole Act, Caitlin Grow

Cleveland State Law Review

The Bayh-Dole Act has been imperative to the development of the United States’ dynamic pharma-biotech sector. However, the use of march-in rights under the Bayh- Dole Act has remained controversial. On the one hand, there is the idea of market equilibrium with a need to secure health care for the public. Many believe march-in rights should be used to create this balance by regulating the pricing of drugs that were developed using federally funded research. On the other hand, some advocates recognize that the current relationship between public-sector institutions and business as the developers of basic research, and private-sector biotechnology …

Embracing The End: A Comparative Analysis Of Medical Aid In Dying In Canada And The United States, Joel Krinsky

Brooklyn Journal of International Law

Since the late nineteenth century, debate has unfolded over the use of euthanasia and physician-assisted death to alleviate the suffering of individuals with medical illnesses. The controversy surrounding the issue persists and its implications are significant. While most countries prohibit Aid in Dying (AID), legalization of the practice has expanded globally in recent years. Canada and the United States (US) are two such jurisdictions that have expanded access to AID. Canada has federally legalized the practice, which the country refers to as Medical Aid in Dying (MAID), and in 2021, the country expanded the eligibility criteria for individuals seeking access …

Determinism V. Free Will & Genetic Evidence Of Addiction In Plea Bargaining And Sentence Mitigation: Conversion Of Incarceration To Probation And Rehabilitation Based On Genetic Addiction Risk Severity (Gars) Test, Kenneth Blum, Paul Mullen, Richard Green

St. Mary's Law Journal

In this Article, Dr. Kenneth Blum and his team present the case of a presently abstinent, thirty-five year old alcoholic (“AG”) who has several convictions for DWI. AG has undergone and continues to be engaged in out-patient substance abuse treatment. He entered treatment before adjudication and was mandated by the court to continue treatment to assist in maintaining sobriety. Treatment included the administration of the Genetic Addiction Risk Severity (“GARS”) Test.

AG was facing a probable five-year sentence for his fifth DWI conviction in Bexar County, Texas. However, because AG’s genetic risk results indicated a genetically induced dopamine dysfunction, hypodopaminergia, …

Navigating A Multi-Billion Dollar Industry: Protecting Drug-Related Inventions To Further Research And Development, Minal Patel

Brooklyn Journal of Corporate, Financial & Commercial Law

Even with advancements in science and technology, pharmaceuticals continue to find themselves tethered to patent protection guidelines that once ensured revenue would continue to flow and provide funding for the next blockbuster drug or antibodies. However, as the Federal Circuit appears to inch towards unpredictability in the realm of patent validity, challenges involving patenting are imminent. In fact, gaps are forming in the ability of pharmaceuticals to further research and develop drugs. This Note proposes a solution that encapsulates a more precise standard supported by economic and policy rationales to determine patent validity. It begins with the general requirements of …