Science and Technology Law Commons^™

On Patenting Human Organisms Or How The Abortion Wars Feed Into The Ownership Fallacy, Yaniv Heled

Yaniv Heled

The idea of ominous technologies that put human individuals or parts of their bodies under someone else's control has been stirring emotions and terrifying people for centuries. It was a recent offshoot of this idea--the notion of “patenting humans”--that mobilized certain members of Congress to pass legislation prohibiting the issuance of patent claims “directed to or encompassing a human organism.” The values underlying this legislation may well have been agreeable, even admirable. Yet, the actual motivation for it was misguided; its execution, deeply flawed; its potential outcomes, hazardous

This Article reviews the history and background of this prohibition. It fleshes …

The Disabling Impact Of Wrongful Birth And Wrongful Life Actions, Wendy Hensel

Wendy F. Hensel

This article explores the torts of wrongful birth and wrongful life, which primarily arise when a physician or laboratory is negligent in the context of pre-natal genetic testing. In wrongful birth actions, the parents claim that if they had been properly informed of the genetic defect, they would have aborted their now-existing child or prevented his conception. In wrongful life actions, the disabled child brings suit in his own name claiming that it would have been better if he had never existed in the first place. Central to such actions is the child's assertion that his parents rightfully should have …

On Presidents, Agencies, And The Stem Cells Between Them: A Legal Analysis Of President Bush's And The Federal Governments Policy On The Funding Of Research Involving Human Embryonic Stem Cells, Yaniv Heled

Yaniv Heled

On August 9, 2001, President George W. Bush announced his policy on research involving human embryonic stem cells and proclaimed that federal funding would be allocated only to research involving human embryonic stem cell lines produced prior to his announcement (the Directive). Immediately thereafter, the National Institutes of Health (NIH) announced that it would act in accordance and full compliance with the Directive and took action to implement it. Since then, the Directive has dictated the nature and extent of scientific research involving human embryonic stem cells. Yet, astonishingly, despite being the subject of a boisterous debate, the Directive’s legality …

The Regulation Of Genetic Aspects Of Donated Reproductive Tissue - The Need For Federal Regulation, Yaniv Heled

Yaniv Heled

It is estimated that egg and sperm donations account for more than 60,000 births every year in the United States. However, surprisingly, and despite common misconceptions, there are no federal requirements and barely any state requirements to screen and test sperm and egg donors for genetic diseases. The only nationwide standards for genetic screening and testing of donated reproductive tissue are guidelines created by professional organizations, but compliance with those guidelines is voluntary so they cannot be enforced effectively. Furthermore, the few reported cases involving children born from genetically-compromised reproductive tissue illustrate the court system’s failure to afford such children …

Healthcare Reform Creates Pathway For Biosimilar Biologics, Frederick Rein, Scott Warren, Yaniv Heled

Yaniv Heled

No abstract provided.

Response To 'Pervasive Sequence Patents Cover The Entire Human Genome', Shine Tu, Yaniv Heled

Yaniv Heled

In a widely reported article by Jeffrey Rosenfeld and Christopher Mason published in Genome Medicine, significant misstatements were made, because the authors did not sufficiently review the claims – which define the legal scope of a patent – in the patents they analyzed. Specifically, the authors do not provide an adequate basis for their assertion that 41% of the genes in the human genome have been claimed.

"Do No Harm": A Comparative Analysis Of Legal Barriers To Corporate Clinical Telemedicine Providers In The United States, Australia, And Canada, Ian R. Landgreen

Georgia Journal of International & Comparative Law

No abstract provided.

Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget

Seattle University Law Review

Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the …

Ironic Simplicity: Why Shaken Baby Syndrome Misdiagnoses Should Result In Automatic Reimbursement For The Wrongly Accused, Jay Simmons

Seattle University Law Review

Shaken baby syndrome (SBS)’s shortcomings include the debatable science behind SBS theory and diagnosis—the questioning of which has grown more vociferous—and the arguably biased, discriminatory treatment of the accused. Professor Deborah Tuerkheimer notes that the evolving SBS skepticism and contentious debate has resulted in "chaos" in many SBS adjudications and within the medical and biomechanical fields, with the same SBS proponents and opponents continually crusading for and clashing over their beliefs. The issues surrounding the medical and biomechanical components of SBS diagnoses have been repeatedly examined and discussed, and are not the focus of this Note. This Note recounts those …

Who's Virus Is It Anyway? How The World Health Organization Can Protect Against Claims Of "Viral Sovereignty", Jason Carter

Georgia Journal of International & Comparative Law

No abstract provided.

Teaching The Biological Clock: Age-Related Fertility Decline And Sex Education, Kerry Macintosh

Kerry L Macintosh

Fertility in women declines significantly at age thirty-two and takes a sharp downward turn at age thirty-seven. Miscarriages also increase with age. In vitro fertilization cannot reverse the effects of aging, and embryo screening, egg freezing, and egg donation are imperfect solutions.

Unfortunately, many women fail to grasp these facts until it is too late. Various factors are to blame, including physicians who shy away from the topic of age-related fertility decline, persistent messaging about the need for pregnancy prevention (implying that conception is easy), and media accounts of celebrities who are pregnant in their forties.

This Article argues that …

Generic Entry Jujitsu: Innovation And Quality In Drug Manufacturing, W. Nicholson Price Ii

IP Theory

The manufacturing side of the pharmaceutical industry has been neglected in innovation theory and policy, with the unfortunate result of stagnant manufacturing techniques driving major problems for the healthcare system. This innovation failure has roots in ineffective intellectual property incentives and high regulatory hurdles to innovative change. Changes in pure regulation or intellectual property incentives have significant potential to help the innovation deficit, but are not the only possibility for change. A relatively minor regulatory change could harness the powerful dynamics of pioneer/generic competition surrounding generic drug market entry. If pioneer firms were permitted to make label claims committing to …

Defining Death: A Call For The Reformation Of The Standard For Declaration Of Death In The Modern Era, Jayme M. Reisler

Jayme M Reisler

Prior to the mid 20th century, a declaration of death was a relatively definite determination because the functioning of each vital organ was inextricably linked to the other. With the advent of the positive-pressure mechanical ventilator, however, came the loss of integration among these organ systems. The ability to maintain metabolic functioning of a patient as well as the ability to successfully transplant viable organs have given rise to a host of legal issues revolving around the determination of death. The main issue that arises is two fold. On one hand, such medical technology can prolong an individual’s life even …

The Limits Of Regulatory Science In Transnational Governance Of Transgenic Plant Agriculture And Food Systems, Taiwo Oriola

Taiwo Oriola

The current national and transnational regulatory and policy framework for transgenic plant agriculture and food is arguably largely defined by science. Notably, transgenic plant agriculture policy deference to science is ostensibly premised on the general perception that science is neutral, objective, reliable, and agnostic. This is exemplified by cases ranging from Alliance for Bio-integrity v Donna Shalala, European Communities: Measures Affecting the Approval and Marketing of Biotech Products, to European Commission v Republic of Poland, in which conscientious, ethical, religious, and cultural oppositional grounds to transgenic plant agriculture and food were trumped by scientific imperatives. However, the lack of unanimity …

California Egg Toss - The High Costs Of Avoiding Unenforceable Surrogacy Contracts, Jennifer Jackson

Jennifer Jackson

In an emotionally charged decision regarding surrogacy contracts, it is important to recognize the ramifications, costs, and policy. There are advantages to both “gestational carrier surrogacy” contracts and “traditional surrogacy” contracts. However, this paper focuses on the differences between these contracts using case law. Specifically, this paper will focus on the implications of California case law regarding surrogacy contracts. Cases such as Johnson v. Calvert and In Re Marriage of Moschetta provide a clear distinction between these contracts. This distinction will show that while gestational carrier surrogacy contracts are more expensive, public policy and court opinions will provide certainty and …

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Journal Articles

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

Consciousness And Futility: A Proposal For A Legal Redefinition Of Death, Christopher Smith

Christopher R Smith

Recent controversies in Texas (with the Marlise Muñoz case) and in California (with the Jahi McMath case) have highlighted a lamentable flaw in the current legal conception of human death, and the difficulty of defining when death finally occurs. The unworkable notion of “brain-death” remains the law in every state in the union, yet the philosophical and scientific foundations of this notion remain open to attack. This article posits that death is a fundamentally social construct, and that it is society at large (through its laws, public opinions, religious attitudes, etc.) that actually defines death. This essay then argues that …

Foreseeability Decoded, Meiring De Villiers

Meiring de Villiers

The Article reviews the conceptual and doctrinal roles of the foreseeability doctrine in negligence law, and analyzes its application in cases where a new technology or unexplored scientific principle contributed to a plaintiff’s harm. It adopts the common law definition of foreseeability as a systematic relationship between a defendant’s wrongdoing and the plaintiff’s harm, and demonstrates translation of the concept into the language of science so that the common law meaning of the foreseeability doctrine is preserved. An analysis of the foreseeability of HIV/AIDS as a blood-borne risk illustrates application of the concept to contemporary issues in medical science.

Protecting Health Privacy In An Era Of Big Data Processing And Cloud Computing, Frank Pasquale, Tara Adams Ragone

Faculty Scholarship

No abstract provided.

Uncle Sam Knows What’S In Your Medicine Cabinet: The Security And Privacy Protection Of Health Records Under The Hitech Act, 30 J. Marshall J. Info. Tech. & Privacy L. 667 (2014), Ranjit Janardhanan

UIC John Marshall Journal of Information Technology & Privacy Law

No abstract provided.

Using Egg Freezing To Extend The Biological Clock: Fertility Insurance Or False Hope?, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Toward A Jurisprudence Of Drug Regulation, Matthew Herder

Articles, Book Chapters, & Popular Press

Efforts to foster transparency in biopharmaceutical regulation are well underway: drug manufacturers are, for example, legally required to register clinical trials and share research results in the United States and Europe. Recently, the policy conversation has shifted toward the disclosure of clinical trial data, not just trial designs and basic results. Here, I argue that clinical trial registration and disclosure of clinical trial data are necessary but insufficient. There is also a need to ensure that regulatory decisions that flow from clinical trials — whether positive (i.e. product approvals) or negative (i.e. abandoned products, product refusals, and withdrawals) — are …

Response To "Pervasive Sequence Patents Cover The Entire Human Genome", Shine Tu, Christopher M. Holman, Adam Mossoff, Ted M. Sichelman, Michael Risch, Jorge L. Contreras, Yaniv Heled, Gregory Dolin, Lee Petherbridge

All Faculty Scholarship

In a widely reported article by Jeffrey Rosenfeld and Christopher Mason published in Genome Medicine, significant misstatements were made, because the authors did not sufficiently review the claims – which define the legal scope of a patent – in the patents they analyzed. Specifically, the authors do not provide an adequate basis for their assertion that 41% of the genes in the human genome have been claimed.

Pinwheel Of Fortune, 13 J. Marshall Rev. Intell. Prop. L. 761 (2014), James Ming Chen

UIC Review of Intellectual Property Law

This paper examines public health law in the context of prospect theory, the leading behavioral account of risk aversion and risk-seeking. The paper first demonstrates how international environmental law can be mapped along prospect theory’s risk-seeking axis. It then completes this picture of prospect theory by examining National Federation of Independent Business v. Sebelius, which upheld the constitutionality of the Patient Protection and Affordable Care Act (“PPACA”). Although Sebelius upheld the PPACA as an exercise of the federal government’s taxing authority, it reasoned that a directive aimed at uninsured individuals to buy health insurance lay beyond the power of Congress …

A Scientific Approach To Intellectual Property And Health: Innovation, Access, And A Forgotten Corner Of The Universal Declaration Of Human Rights, 13 J. Marshall Rev. Intell. Prop. L. 794 (2014), Adam Houston

UIC Review of Intellectual Property Law

For years, there has been vigorous debate over the relationship between intellectual property and health, especially in the context of pharmaceutical patents. Despite numerous attempts to strike a balance between innovation and access, however, few have looked to Article 27 of the Universal Declaration of Human Rights for guidance. Article 27, and its further elaboration and codification under Article 15 of the International Covenant on Economic, Social, and Cultural Rights, explicitly address this balance by pairing the right of everyone “to share in scientific advancement and its benefits” with a similarly universal right of authors to “material interests resulting” from …

Layers Of Law: The Case Of E-Cigarettes, Eric A. Feldman

All Faculty Scholarship

This paper, written for a symposium on "Layers of Law and Social Order," connects the current debate over the regulation of electronic cigarettes with socio-legal scholarship on law, norms, and social control. Although almost every aspect of modern life that is subject to regulation can be seen through the framework ‘layers of law,’ e-cigarettes are distinguished by the rapid emergence of an unusually dense legal and regulatory web. In part, the dense fabric of e-cigarette law and regulation, both within and beyond the US, results from the lack of robust scientific and epidemiological data on the behavioral and health consequences …

A System Of Men And Not Of Laws: What Due Process Tells Us About The Deficiencies In Institutional Review Boards, Greer Donley

Articles

Governmental regulation of human subjects research involves unique agency action. It delegates power to non-expert committees, Institutional Review Boards, to decide whether research protocols are "ethical" according to vague federal regulations. Without IRB approval, the protocol cannot be investigated. The empirical evidence regarding this system demonstrates that IRBs render deeply inconsistent and inaccurate outcomes. This Article argues that the lack of due process in the IRB system is to blame for such arbitrary agency action. By juxtaposing the levels of process required for IRB approval or research with FDA new drug approval--agency action involving similar interests--this Article highlights that IRBs …

Enlightened Regulatory Capture, David Thaw

Articles

Regulatory capture generally evokes negative images of private interests exerting excessive influence on government action to advance their own agendas at the expense of the public interest. There are some cases, however, where this conventional wisdom is exactly backwards. This Article explores the first verifiable case, taken from healthcare cybersecurity, where regulatory capture enabled regulators to harness private expertise to advance exclusively public goals. Comparing this example to other attempts at harnessing industry expertise reveals a set of characteristics under which regulatory capture can be used in the public interest. These include: 1) legislatively-mandated adoption of recommendations by an advisory …