Health Law and Policy Commons^™

Vaccines And The Law, Michael Sanzo Ph.D.

Pepperdine Law Review

The last twenty years have seen a sea-change in the area of proving causation in the toxic tort setting, with courts demanding stronger, scientifically tested evidence. At the same time, a closely related debate has been raging about separating cause from coincidence under the National Childhood Vaccine Injury Act compensation program for injuries that might have been the result of vaccinations. The Vaccine Act created a no-fault compensation fund financed by a tax on childhood vaccines to address harms resulting from those vaccines. Unfortunately, Congress gave little direction with regard to the level of causal certainty that would be required …

Family Law—Egg Donation And Stem Cell Research—Eggs For Sale: The Scrambled State Of Legislation In The Human Egg Market, Kitty L. Cone

University of Arkansas at Little Rock Law Review

Rapid expansion of technology in medicine over the last few decades has both enhanced our lives and complicated our laws. For example, thanks to advances in science and medicine, couples who were previously unable to reproduce are now able to do so with the help of donors, medical personnel, and a host of other middlemen facilitating the process. The growth of medical technology has also lead to the advent of using human eggs for medical research. However, despite competing for eggs from a small pool of willing donors, there is a disparity in the law between the treatment of human …

Science On Law's Terms: Implications Of Procedural Legitimacy On Scientific Evidence, Nayha Acharya

LLM Theses

Scientific evidence is relied on more and more in litigation. Discussions and debates aimed at enabling courts to make the best use scientific evidence are increasingly critical. This thesis adds the perspective of procedural legitimacy to the science and law discussion. Procedural Legitimacy is the concept that consistent adherence to legal procedure maintains the overall legitimacy of the legal system, and the validity of its outcomes. I argue that the integrity of legal procedures must be maintained where scientific evidence is presented, so that judicial decisions that rely on scientific evidence are legitimate.

Adultery By Doctor: Artificial Insemination, 1890–1945, Kara W. Swanson

Chicago-Kent Law Review

In 1945, American judges decided the first court cases involving assisted conception. The challenges posed by assisted reproductive technologies to law and society made national news then, and have continued to do so into the twenty-first century. This article considers the first technique of assisted conception, artificial insemination, from the late nineteenth century to 1945, the period in which doctors and their patients worked to transform it from a curiosity into an accepted medical technique, a transformation that also changed a largely clandestine medical practice into one of the most pressing medicolegal problems of the mid-twentieth century. Doctors and lawyers …

It’S My Body: The Biomedical Ethics Of Cell And Organ Harvest, Christina Perri

Common Reading Essay Contest Winners

First Place

Incentivizing The Utilization Of Pharmacogenomics In Drug Development, Valerie Gutmann Koch

All Faculty Scholarship

Pharmacogenomics, the study and development of compounds according to how an individual’s genes affects the body’s response to drugs, holds enormous promise for increasing the safety and efficiency of drug development while decreasing adverse reactions and the trial-and-error nature of drug prescription. However, pharmacogenomics may not be the panacea for all development and prescription problems. This article explores some of the obstacles to pharmacogenomic advancement including industry reluctance to pursue research because of potentially prohibitive costs associated with developing products and legal liability concerns. The implications pharmacogenomics has for drug research and development as well as various areas of law …

Pgtandme: Social Networking-Based Genetic Testing And The Evolving Research Model, Valerie Gutmann Koch

All Faculty Scholarship

The opportunity to use extensive genetic data, personal information, and family medical history for research purposes may be naturally appealing to the personal genetic testing (PGT) industry, which is already coupling its direct-to-consumer (DTC) products with social networking technologies, as well as to potential industry or institutional partners. This article evaluates the transformation in research that the hybrid of PGT and social networking will bring about, and – highlighting the challenges associated with a new paradigm of “patient-driven” genomic research – focuses on the consequences of shifting the structure, locus, timing, and scope of research through genetic crowd-sourcing. This article …

Indefinite Freeze?: The Obligations A Cryopreservation Bank Has To Abandoned Frozen Embryos In The Wake Of The Maryland Stem Cell Research Act Of 2006, Maggie Davis

Journal of Health Care Law and Policy

No abstract provided.

Updating The Patent System's Novelty Requirement To Promote Small-Molecule Medicinal Progress, 45 J. Marshall L. Rev. 1151 (2012), Jason Brewer

UIC Law Review

No abstract provided.

Biobanks As A Tissue And Information Semicommons: Balancing Interests For Personalized Medicine, Tissue Donors And The Public Health, Ken Gatter

Journal of Health Care Law and Policy

No abstract provided.

The Limits Of Government Regulation Of Science, John D. Kraemer, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The recent controversy over the National Science Advisory Board for Biosecurity’s (NSABB) request that Science and Nature redact key parts of two papers on transmissible avian (H5N1) influenza reveal a troubled relationship between science and security. While NSABB’s request does not violate the First Amendment, efforts to censor the scientific press by force of law would usually be an unconstitutional prior restraint of the press absent a compelling state interest. The constitutional validity of conditions on grant funding to require pre-publication review of unclassified research is unclear but also arguably unconstitutional.

The clearest case where government may restrict publication is …

"Introduction" (Chapter 1) Of Stories About Science In Law: Literary And Historical Images Of Acquired Expertise (Ashgate 2011), David S. Caudill

Working Paper Series

This is the introductory chapter of Stories About Science in Law: Literary and Historical Images of Acquired Expertise (Ashgate, 2011), explaining that the book presents examples of how literary accounts can provide a supplement to our understanding of science in law. Challenging the view that law and science are completely different, I focus on stories that explore the relationship between law and science, and identify cultural images of science that prevail in legal contexts. In contrast to other studies on the transfer and construction of expertise in legal settings, the book considers the intersection of three interdisciplinary projects-- law and …

The Impact Of The Biosimilars Provision Of The Health Care Reform Bill On Innovation Investments, 10 J. Marshall Rev. Intell. Prop. L. 553 (2011), Katherine N. Addison

UIC Review of Intellectual Property Law

The Biologics Price Competition and Innovation Act of 2009 provides an abbreviated FDA approval pathway for biosimilars. The passage of this biosimilar legislation is a positive step toward retaining a robust biotechnology industry in the United States while also protecting innovators. The Act’s increased FDA exclusivity is welcome, but FDA exclusivity alone is insufficient to encourage and protect innovation and investment in biosimilars. Instead, the exclusivity provided by a patent term, together with the ability to adjust this term to compensate an applicant for U.S. Patent and Trademark Office and FDA delays, is necessary to ensure development of highly specialized …

Patent Office As Biosecurity Gatekeeper: Fostering Responsible Science And Building Public Trust In Diy Science, 10 J. Marshall Rev. Intell. Prop. L. 423 (2011), Brian J. Gorman

UIC Review of Intellectual Property Law

When the fields of intellectual property law and biotechnology intersect, most analysis is driven byeconomic and ethical issues. This article examines these factors, but in relation to the emerging security threat posed by biohackers, or do-it-yourself (“DIY”) scientists, who operate free from oversight and industry norms at the fringes of the biotechnology community. Public health risks are poised to grow as these citizen-scientists race for lucrative discoveries in the new frontier of syntheticbiology. This article proposes that the existing paradigm adjust accordingly to leverage regulatory compliance from the most ambitious biohackers looking to benefit from patent protection. The U.S. government …

There Will Be Blood ... Testing: The Intersection Of Professional Sports And The Genetic Information Nondiscrimination Act Of 2008, Jesse A. Bland

Vanderbilt Journal of Entertainment & Technology Law

Genetic testing, professional baseball, and employment discrimination seldom intersect. This Note changes that. Thanks to scientific breakthroughs in genetic research over the past half-century, genetic testing is a powerful tool for producing rich, individualized information. Progress comes at a price, however. As genetic testing has advanced and become more prevalent, so too has the potential misuse of genetic information. A recently enacted federal law--the Genetic Information Nondiscrimination Act of 2008 (GINA)--seeks to eliminate one such threat by prohibiting the improper use of genetic information in employment decisions. While the law gained congressional momentum after tales of abuse in blue-collar industries, …

Approval Of New Pharmacogenomic Tests: Is The Canadian Regulatory Process Adequate?, Yann Joly, Emma Ramos-Paque

Canadian Journal of Law and Technology

In the first part of our analysis, we will examine the impact which pharmacogenomics is expected to have on drug research and development, on the drug approval process and on post-marketing surveillance and clinical practice. This will allow us to show how pharmacogenomic testing could be beneficial to drug companies, regulatory bodies, and patients. The second part of our analysis will focus on the regulatory framework applicable to the approval of pharmacoge- nomic tests in Canada, although we are aware of the fact that most manufacturers decide to approve their tests outside of Canada. As mentioned, the applicable regu- lations …

Canadian Personal Data Protection Legislation And Electronic Health Records: Transfers Of Personal Health Information In It Outsourcing Agreements, Dara Lambie

Canadian Journal of Law and Technology

Personal data protection and privacy of personal health information in the electronic era is a broad topic that includes consent, security measures and access considerations. The focus of this article is on one component of the larger picture: data transfers of personal health information that occur in the context of informa- tion technology (“IT”) outsourcing. If the societal good envisioned by an inter-jurisdictional EHR is to be fully realized, then the necessity of outsourcing is a reality that must be addressed.

There Is A Time To Keep Silent And A Time To Speak, The Hard Part Is Knowing Which Is Which: Striking The Balance Between Privacy Protection And The Flow Of Health Care Information, Daniel J. Gilman, James C. Cooper

Michigan Telecommunications & Technology Law Review

Health information technology (HIT) has become a signal element of federal health policy, especially as the recently enacted American Recovery and Reinvestment Act of 2009 (Recovery Act or ARRA) comprises numerous provisions related to HIT and commits tens of billions of dollars to its development and adoption. These provisions charge various agencies of the federal government with both general and specific HIT-related implementation tasks including, inter alia, providing funding for HIT in various contexts: the implementation of interoperable HIT, HIT-related infrastructure, and HIT-related training and research. The Recovery Act also contains various regulatory provisions pertaining to HIT. Provisions of the …

From A Constitutional Right To A Policy Of Exceptions: Abigail Alliance And The Future Of Access To Experimental Therapy, Patricia J. Zettler, Seema K. Shah

Faculty Publications By Year

Although there has been considerable attention to the plight of terminally ill patients with highly sympathetic constitutional and contractual claims that they should be permitted access to unapproved drugs, courts have been appropriately reluctant to grant such claims. Congress and administrative agencies have the requisite institutional competence to decide complex policy issues related to science and health care such as those involved in establishing an expanded access program. Congress and FDA should allow only limited access to unapproved therapies because there are significant concerns about the safety and efficacy of unapproved drugs. Moreover, many of the proposals to widen access …

Scientific Understandings Of Postpartum Illness: Improving Health Law And Policy?, Stacey A. Tovino

Scholarly Works

In its broadest sense, the Article examines the relationship between science and the law in the context of postpartum illness. From classical antiquity to the present day, physicians and scientists have investigated the causes, correlates, and consequences of the depressions and psychoses that develop in some women following their transition to motherhood. The scientific investigation of postpartum illness has been characterized by an open-ended search for knowledge with the recgonition that scientific findings published one day are subject to revision the next. Legislators and judges also have sought to understand postpartum illness as necessary to make laws that affect and …

Dr. Cézanne And The Art Of Re(Peat)Search: Competing Interests And Obligations In Clinical Research, Robyn Bluhm, Jocelyn Downie, Jeff Nisker

Articles, Book Chapters, & Popular Press

Clinician researchers have a number of roles, each of which carries specific obligations. There are times when these obligations may be in competition (up to and including conflict) with each other. Using a narrative case study that describes a group of colleagues discussing their clinical department's participation in an industry-sponsored research protocol, we illustrate a number of the obligations faced by clinician researchers, and discuss how competing interests and obligations can lead to ethical problems. The case study is followed by a discussion of the effect of university–industry relations on competing interests and obligations in both clinical research and the …

Agenda: World Energy Justice Conference And Appropriate Technology Arcade, University Of Colorado Boulder. Center For Energy & Environmental Security, University Of Colorado Boulder. School Of Law

World Energy Justice Conference (October 23-24)

The 2009 CEES Energy Justice Conference took place at the University of Colorado Law School on October 23rd and 24th, 2009. It featured 11 sessions, more than 40 speakers, and attracted over 200 attendees. The Conference brought together leading international and U.S. decision-makers in politics, engineering, public health, law, business, economics, and innovators in the sciences to explore how best to address the critical needs of the energy-oppressed poor (EOP) through long-term interdisciplinary action, information sharing, and deployment of appropriate sustainable energy technologies (ASETs).

The Colorado Journal of International Environmental Law & Policy (CJIELP) at the University of Colorado Law …

A Defense Of Embryonic Stem Cell Research, Gregory Dolin

All Faculty Scholarship

On November 21, 2007, sensational scientific developments were reported by major newspapers, both in the United States and abroad. The media reported a new breakthrough in the area of stem cell research. According to two articles published in Science and Cell (both highly respected scientific journals), two teams of scientists were able to “reprogram” adult stem cells into embryonic stem cells, without actually having to experiment on embryos. The discovery was immediately hailed by the White House and other opponents of embryonic stem cell research. The New York Times gushed that the “stem cell wars” may be at an end. …

The Life Science Lawyer, Erin Albert

Butler University Books

Health care and life sciences are increasingly complex. There are many global players in life sciences and healthcare-patients, governments, hospitals, managed care companies, pharmaceutical, biotechnology, and medical device companies and pharmacies are only a few. With this increasing complexity comes a higher demand for hybrid professionals who can translate both the science as well as the legal issues surrounding this complicated environment. In the US, there are thousands of life science lawyers--people who have both a scientific/healthcare background and also who have gone on to law school (or in one case, vice versa). This book explores the following through interviews: …

Conflicts Of Interest In Clinical Trial Recruitment & Enrollment: A Call For Increased Oversight, Valerie Gutmann Koch

All Faculty Scholarship

This White Paper makes several policy recommendations to eliminate or manage the conflicts of interest that arise pursuant to the compensation arrangements between investigators and their institutions with drug and medical device manufacturers as they affect the recruitment and enrollment of human research subjects in clinical trials. The paper seeks to accomplish overall financial neutrality as between treatment and research, so that physicians' decisions regarding inclusion of patients in clinical trials is unaffected by their own financial interests.

Giving In To Baby Markets: Regulation Without Prohibition, Sonia M. Suter

Michigan Journal of Gender & Law

The commodification of reproductive material evokes different responses. Some argue that the sale of reproductive material should be prohibited. Others argue in favor of unfettered baby markets on principle or to achieve broad-scale access to reproductive technologies. In this Article, the author responds to the emergence of baby markets with great skepticism, but reluctant acceptance. Drawing on a relational conception of autonomy and self-definition, she argues that commodification of reproductive material is intrinsically harmful. Moreover, such commodification poses a number of consequential harms. Nevertheless, in spite of these concerns, the author "gives in" to baby markets, which is to say …

Marketing Mothers' Milk: The Commodification Of Breastfeeding And The New Markets For Breast Milk And Infant Formula, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

This paper explores the commodification of women and biological processes, the confusion of scientific evidence with social agendas, and the conflict between marketing and public health. I assert that key actors in the healthcare marketplace - government, businesses, and doctors – have acted to enable weak medical and scientific evidence to be manipulated by ideological and profit-making partisans in a poorly regulated market. I focus on the unique role of the medical profession, which has acted with government and the private sector to shape the markets in human milk and infant formula. In a striking parallel to the pharmaceutical industry, …

The Implications Of Post-Phase 1 And "Off-Label" Treatment Use Of Experimental Drugs: How Expansive Should Expanded Access Be?, Patricia J. Zettler

Faculty Publications By Year

No abstract provided.

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Journal Articles

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

Demythologizing Phosita: Applying The Non-Obviousness Requirement Under Canadian Patent Law To Keep Knowledge In The Public Domain & Foster Innovation, Matthew Herder

Articles, Book Chapters, & Popular Press

The Supreme Court of Canada recently revised the doctrine of non-obviousness in a pharmaceutical “selection patent” case, Apotex Inc. v. Sanofi-Synthelabo Canada Inc. Although cognizant of changes to the same doctrine in the United States and the United Kingdom, a critical flaw in how the doctrine is being applied in Canada escaped the Court’s attention. Using content analysis methodology, this article shows that Canadian courts frequently fail to characterize the “person having ordinary skill in the art” (PHOSITA) for the purpose of the obviousness inquiry. The article argues that this surprisingly common analytical mistake betrays a deep misunderstanding of innovation, …