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Articles 1 - 29 of 29
Full-Text Articles in Law
Border Patrol, Carl E. Schneider
Border Patrol, Carl E. Schneider
Articles
Recently, the Supreme Court has encountered cases that concern perhaps our weightiest bioethical issue-how medical care is to be rationed. But this does not mean that the Court must therefore assess the justice of rationing, as many people incited by many journalists now fondly and firmly believe. In explaining why, we begin with a story about how Learned Hand remembered saying one day to Justice Holmes, "Well, sir, goodbye. Do justice!" Holmes turned quite sharply and said: "That is not my job. My job is to play the game according to the rules." If the Court doesn't do justice, what …
Just What The Doctor Ordered: The Admissibility Of Differential Diagnosis In Pharmaceutical Product Litigation, Wendy Michelle Ertmer
Just What The Doctor Ordered: The Admissibility Of Differential Diagnosis In Pharmaceutical Product Litigation, Wendy Michelle Ertmer
Vanderbilt Law Review
In the decade since Daubert v. Merrell Dow Pharmaceuticals Inc., federal judges have exercised their role as gatekeepers of expert witness testimony to evaluate many different categories of scientific evidence. They have not done so without controversy, however. Because the element of causation in pharmaceutical product litigation is frequently dispositive, the application of Daubert to scientific evidence of causation has been particularly contentious. Plaintiffs in such cases must prove both general causation-that the product is capable of causing an injury of the type from which the plaintiff suffers-and specific causation-that the product was the actual cause of the plaintiffs injury. …
Toward A More Communitarian Future? Fukuyama As The Fundamentalist Secular Humanist, June Carbone
Toward A More Communitarian Future? Fukuyama As The Fundamentalist Secular Humanist, June Carbone
Michigan Law Review
With The End of History and the Last Man, Francis Fukuyama established himself as the prophet of liberal democracy and free markets, heralding their triumph as the only form of governance capable of commanding legitimacy. Asked to reflect on his predictions a decade later, Fukuyama concluded that the greatest threat to liberalism comes from biotechnology because it alone has the potential to remake the human nature that liberal democracy was designed to serve. Fukuyama makes a compelling case that biotechnology may produce developments that should concern us; he is ironically less persuasive in articulating a liberal-democratic framework for governing the …
Myths Of Voluntary Compliance: Lessons From The Starlink Corn Fiasco, Rebecca M. Bratspies
Myths Of Voluntary Compliance: Lessons From The Starlink Corn Fiasco, Rebecca M. Bratspies
William & Mary Environmental Law and Policy Review
No abstract provided.
Random Drug Testing For Extracurricular Activites: Has The Supreme Court Opened Pandora's Box For Public Schools?, Ralph D. Mawdsley
Random Drug Testing For Extracurricular Activites: Has The Supreme Court Opened Pandora's Box For Public Schools?, Ralph D. Mawdsley
Brigham Young University Education and Law Journal
No abstract provided.
Drug Regulations And The Constitution After Western States, Margaret Gilhooley
Drug Regulations And The Constitution After Western States, Margaret Gilhooley
University of Richmond Law Review
No abstract provided.
Manual De Derecho Procesal Civil, Edward Ivan Cueva
Manual De Derecho Procesal Civil, Edward Ivan Cueva
Edward Ivan Cueva
No abstract provided.
Congress, Illinois Think Canada Is Answer To Prescription Drug Woes, Katherine Licup
Congress, Illinois Think Canada Is Answer To Prescription Drug Woes, Katherine Licup
Public Interest Law Reporter
No abstract provided.
Striking The Balance: Pharmaceutical Patent Values And Consumer Availability, Valerie Sarigumba
Striking The Balance: Pharmaceutical Patent Values And Consumer Availability, Valerie Sarigumba
Public Interest Law Reporter
No abstract provided.
The Academy Chokes On Food Biotech, Public Policy Suffocates, Henry I. Miller
The Academy Chokes On Food Biotech, Public Policy Suffocates, Henry I. Miller
Richmond Journal of Law & Technology
The National Academy of Sciences, under its 1863 congressional charter, is supposed to be dedicated to “investigate, examine, experiment, and report upon any subject of science or art whenever called upon to do so by any department of the government.” At least insofar as judging the scienti c integrity of governmental regulation of biotechnology is concerned, however, two recent “expert” committees of the National Research Council (NRC), the research arm of the Academy, have been plagued by apparent bias, and their recommendations have been dubious.
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Articles
Allowing universities to patent the results of government-sponsored research sometimes works against the public interest.
New Drug Research, The Extraterritorial Application Of Fda Regulations, And The Need For International Cooperation, William Dubois
New Drug Research, The Extraterritorial Application Of Fda Regulations, And The Need For International Cooperation, William Dubois
Vanderbilt Journal of Transnational Law
In recent years, U.S. pharmaceutical companies have expanded their new drug trials beyond the borders of the United States. While the companies have a variety of reasons for making this move, among them may be a desire to avoid Food and Drug Administration (FDA) regulation and monitoring. Lack of adequate supervision of drug trials conducted in the developing world endangers both the subjects of the tests and the consumers in the United States. It is unclear whether the FDA can execute regulatory and supervisory authority abroad. The FDA statute does not clearly authorize the agency to regulate extraterritorially. Applying the …
Internet Pharmacies And The Need For A New Federalism: Protecting Consumers While Increasing Access To Prescription Drugs, Linda C. Fentiman
Internet Pharmacies And The Need For A New Federalism: Protecting Consumers While Increasing Access To Prescription Drugs, Linda C. Fentiman
Elisabeth Haub School of Law Faculty Publications
In this article I will argue that Internet pharmacies pose a significant public health problem, as they raise the classic eternal triangle of health care issues--access, quality, and financing--in a new technological context. Part II describes the phenomena of Internet pharmacies, and Part III reviews the present regulatory scheme. Part IV explains why the current legal framework is inadequate to address the public health and safety problems posed by Internet pharmacies, focusing particularly on the jurisdictional, constitutional, and practical obstacles to effective state oversight of Internet pharmacies. Part V argues that comprehensive federal oversight of Internet prescribing and dispensing is …
Disciplining Globalization: International Law, Illegal Trade, And The Case Of Narcotics, Chantal Thomas
Disciplining Globalization: International Law, Illegal Trade, And The Case Of Narcotics, Chantal Thomas
Michigan Journal of International Law
This Article is the first in a series of studies of the globalization of illicit markets. My theses are as follows: First, the increase in international trade in illicit products and services parallels the growth in international trade more generally that accompanies the phenomenon of globalization. Second, at the same time that most international trade law has moved toward a posture of liberalization, there has been a movement to strengthen the prohibition and punishment of trade in illicit transactions. Third, the mechanisms that have developed to regulate this prohibition constitute a significant development in the international legal order.
Pharmacogenomics, Genetic Tests, And Patent-Based Incentives, Michael J. Meurer
Pharmacogenomics, Genetic Tests, And Patent-Based Incentives, Michael J. Meurer
Faculty Scholarship
Pharmacogenomics promises to revolutionize medicine by using genetic information to guide drug therapy. Genetic tests will help doctors improve drug safety and efficacy by better matching patients and drugs. This Article evaluates the effectiveness of patent-based incentives to create genetic tests, and the optimal mix of public and private sector pharmacogenomic R&D. Drug patent owners have a strong incentive to develop genetic tests that predict adverse drug reactions and allow them to market drugs that otherwise would be shelved. Incentives are also strong for genetic tests that are created as part of the drug development process. Incentives tend to be …
Can We Talk? About Food And Drug Regulation And The First Amendment, Marsha N. Cohen
Can We Talk? About Food And Drug Regulation And The First Amendment, Marsha N. Cohen
Faculty Scholarship
No abstract provided.
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Other Publications
It's a great honor for me to be invited to deliver the Levine Distinguished Lecture at Fordham, and a great opportunity to try out some new ideas before this audience. As some of you know, I've been studying the role of patents in biomedical research and product development ("R&D") for close to twenty years now, with a particular focus on how patents work in "upstream" research in universities and biotechnology companies that are working on research problems that arise prior to "downstream" product development. But, of course, the patent strategies of these institutions are designed around the profits that everyone …
Cornering The Market In A Post-9/11 World: The Future Of Horizontal Restraints, 36 J. Marshall L. Rev. 557 (2003), Daniel Goldberg
Cornering The Market In A Post-9/11 World: The Future Of Horizontal Restraints, 36 J. Marshall L. Rev. 557 (2003), Daniel Goldberg
UIC Law Review
No abstract provided.
The Authority Of A Court To Order Disgorgement For Violations Of The Current Good Manufacturing Practices Requirement Of The Federal Food, Drug, And Cosmetic Act, Erika Lietzan, Elizabeth M. Walsh
The Authority Of A Court To Order Disgorgement For Violations Of The Current Good Manufacturing Practices Requirement Of The Federal Food, Drug, And Cosmetic Act, Erika Lietzan, Elizabeth M. Walsh
Faculty Publications
This article addresses the question as to whether a federal court has the authority to compel a pharmaceutical company to disgorge profits obtained from an alleged violation of the FDCA, specifically the failure of a pharmaceutical company to comply with current good manufacturing practices (GMPs). Section II of this article summarizes the article to which we are responding. In all fairness, it did not purport to be a full-blown defense, and we expect the agency's comprehensive defense of disgorgement would be considerably more detailed. Section III turns to the Sixth Circuit case on which FDA rests its argument for disgorgement, …
The Fordham Law Drug Policy Reform Project: America's Oldest War: The Efficacy Of United States Drug Policy, John Nicholas Iannuzzi, Graham Boyd, Asa Hutchinson
The Fordham Law Drug Policy Reform Project: America's Oldest War: The Efficacy Of United States Drug Policy, John Nicholas Iannuzzi, Graham Boyd, Asa Hutchinson
Fordham Urban Law Journal
The Fordham Law Drug Policy Reform Project planned and executed the debate, "America's Oldest War: The Efficacy of United States Drug Policy," on April 23, 2002 at the end of the organization's first year. The goal of the debate was to bring to one forum the leading voices at both ends of the drug policy spectrum. Professor John Nicholas Iannuzzi moderated, giving each speaker three minutes to answer each question from the floor. Over one hundred and twenty professionals, students, and community members attended the debate.
Engaging The Debate: Reform Vs. More Of The Same, Kevin B. Zeese
Engaging The Debate: Reform Vs. More Of The Same, Kevin B. Zeese
Fordham Urban Law Journal
This Essay dispels common myths put forward by drug war advocates and describes more effective alternatives available than present policy contemplates. We all want to prevent adolescent drug abuse, protect the health and safety of the community, deny drug profits to terrorists and other criminals, and develop a drug policy that works and is based on our common humanity, as well as on research and reality, rather than myth and rhetoric. The essential paradigm shift that needs to occur is to move away from a policy dominated by law enforcement . . . and toward a policy based on public …
Report Of The Task Force On The Use Of Criminal Sanctions To The King County Bar Association Board Of Trustees
Fordham Urban Law Journal
The King County formed the Task Force on the Use of Criminal Sanctions as part of the King County Bar Association's Drug Policy Project to examine current criminal sanctions related to the non-medical use of drugs both in Washington and on the federal level. The founders charged the Task Force with the goal of assessing the effectiveness of criminal sanctions in reducing both illegal drug use and drug-related crime, and assessing the public costs associated with the use of criminal sanctions. The Task Force drew specific conclusions regarding the state response to drug use and the provision of drug addiction …
Reaching Through The Genome, Rebecca S. Eisenberg
Reaching Through The Genome, Rebecca S. Eisenberg
Book Chapters
The past two decades have been a period of rapid evolution in the science of biotechnology and therefore in patent strategies, if not in patent law itself. Patent law takes a long time to catch up with science, and commentators take a long time to catch up with the law, but patent lawyers don’t have that luxury. They have to keep ahead of the game, figuring out claiming strategies that allow their clients to capture the value of future discoveries. I want to discuss some of these strategies today.
An Effective Drug Policy To Protect America's Youth And Communities, Asa Hutchinson
An Effective Drug Policy To Protect America's Youth And Communities, Asa Hutchinson
Fordham Urban Law Journal
Drug abuse and addiction, and the government's response to these problems, are frequently and appropriately a topic for public debate. Law enforcement has made significant advances in both reducing the number of people using illegal drugs and in the fight against traffickers. Legalization of illegal drugs would not elinate the black market or eliminate drug-related violence. The facts on the issue make a strong case for a national policy geared toward effective drug abuse education and prevention, and treatment for people dependent on illegal drugs. Our nation should also continue to conduct research to determine the most effective means of …
Going To Pot, Carl E. Schneider
Going To Pot, Carl E. Schneider
Articles
In several earlier columns, I suggested that judges are usually poorly placed to make good biomedical policy, not least because the law so rarely offers them direct and cogent guidance. Recently, the U.S. Court of Appeals for the Ninth Circuit proffered a new example of this old problem. In 1996, California's voters approved Proposition 215. Its "Compassionate Use Act of 1996" provided -that a patient "who possesses or cultivates marijuana for the personal medical purposes of the patient upon the written or oral recommendation or approval of a physician" committed no crime.
Disciplining Globalization: International Law, Illegal Trade, And The Case Of Narcotics, Chantal Thomas
Disciplining Globalization: International Law, Illegal Trade, And The Case Of Narcotics, Chantal Thomas
Cornell Law Faculty Publications
This Article is the first in a series of studies of the globalization of illicit markets. My theses are as follows: First, the increase in international trade in illicit products and services parallels the growth in international trade more generally that accompanies the phenomenon of globalization. Second, at the same time that most international trade law has moved toward a posture of liberalization, there has been a movement to strengthen the prohibition and punishment of trade in illicit transactions. Third, the mechanisms that have developed to regulate this prohibition constitute a significant development in the international legal order.
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Articles
Advances in fundamental biomedical research play an important and growing role in the development of new therapeutic and diagnostic products. Although the development of pharmaceutical end products has long been a proprietary enterprise, biomedical research comes from a very different tradition of open science. Within this tradition, long-standing norms call for relatively unfettered access to fundamental knowledge developed by prior researchers. The tradition of open science has eroded considerably over the past quarter century as proprietary claims have reached farther upstream from end products to cover fundamental discoveries that provide the knowledge base for future product development.
Problem-Solving Courts: From Innovation To Institutionalization, Michael C. Dorf, Jeffrey A. Fagan
Problem-Solving Courts: From Innovation To Institutionalization, Michael C. Dorf, Jeffrey A. Fagan
Faculty Scholarship
The phenomenal growth of drug courts and other forms of "problem-solving" courts has followed a pattern that is characteristic of many successful innovations: An individual or small group has or stumbles upon a new idea; the idea is put into practice and appears to work; a small number of other actors adopt the innovation and have similar experiences; if there is great demand for the innovation – for example, because it responds to a widely-perceived crisis or satisfies an institutional need and resolves tensions within organizations that adopt it – the innovation rapidly diffuses through the networks in which the …
State Laws And The Independent Judiciary: An Analysis Of The Effects Of The Seventeenth Amendment On The Number Of Supreme Court Cases Holding State Laws Unconstitutional, Donald J. Kochan
Donald J. Kochan
In recent years, the Seventeenth Amendment has been the subject of legal scholarship, congressional hearings and debate, Supreme Court opinions, popular press articles and commentary, state legislative efforts aimed at repeal, and activist repeal movements. To date, the literature on the effects of the Seventeenth Amendment has focused almost exclusively on the effects on the political production of legislation and competition between legislative bodies. Very little attention has been given to the potential adverse effects of the Seventeenth Amendment on the relationship between state legislatures and the federal courts. This Article seeks to fill part of that literature gap, applying …