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2006

Food and Drug Law

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Brief Of Amicus Curiae, The National Legislative Association On Prescription Drug Prices, The New Hampshire Medical Society, And Prescription Policy Choices In Support Of Defendant's Objection To Plaintiff's Motion For Preliminary Injunction, Sean Flynn Dec 2006

Brief Of Amicus Curiae, The National Legislative Association On Prescription Drug Prices, The New Hampshire Medical Society, And Prescription Policy Choices In Support Of Defendant's Objection To Plaintiff's Motion For Preliminary Injunction, Sean Flynn

Amicus Briefs

Plaintiffs in this case seek a preliminary injunction to prevent the enforcement of the New Hampshire Prescription Confidentiality Act, which protects consumers and the privacy interests of doctors in the state of New Hampshire from the increasingly common practice of using doctor-identifying information in prescription records to facilitate targeting of pharmaceutical marketing and gifts toward doctors who prescribe the most expensive drugs for their patients. This practice raises drug costs for all New Hampshire residents and compromises the professional autonomy of doctors. This brief addresses the failure of the plaintiffs to show that they are likely to succeed on the ...


An Information Prescription For Drug Regulation, Anita Bernstein, Joseph Bernstein Dec 2006

An Information Prescription For Drug Regulation, Anita Bernstein, Joseph Bernstein

Buffalo Law Review

No abstract provided.


A Complete Property Right Amendment, John H. Ryskamp Oct 2006

A Complete Property Right Amendment, John H. Ryskamp

ExpressO

The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.


Water Forum 2006, Susan Kelly Oct 2006

Water Forum 2006, Susan Kelly

Publications

No abstract provided.


Why Pharmaceutical Firms Support Patent Trolls: The Disparate Impact Of Ebay V. Mercexchange On Innovation, Jeremiah S. Helm Oct 2006

Why Pharmaceutical Firms Support Patent Trolls: The Disparate Impact Of Ebay V. Mercexchange On Innovation, Jeremiah S. Helm

Michigan Telecommunications & Technology Law Review

Before the unanimous decision in eBay v. MercExchange, patent holders were almost always granted an injunction against an infringer. In fact, the Federal Circuit, in deciding eBay, noted that, upon a finding of infringement, an injunction would issue unless there were extraordinary circumstances. The Court, in a brief opinion, disagreed with the Federal Circuit and explained that the injunction issue in a patent case must be analyzed under the traditional four-factor test.[...] Is the four-factor test fairer or better than the Federal Circuit's near-automatic injunction rule? It is certainly more difficult to administer a factor test as compared to ...


Un-Fair Trade As Friendly Fire: The Australia-Usa Free Trade Agreement, Benedict Sheehy Sep 2006

Un-Fair Trade As Friendly Fire: The Australia-Usa Free Trade Agreement, Benedict Sheehy

ExpressO

Trade, economists and trade theorists advise, is a mutually beneficial exercise. Among this group, a particular set of advocates, claim that “Free Trade” is in the interest of all parties. As will be demonstrated, Free Trade is not truly “free” but an exercise of foreign policy and the implementation of policies favouring wealthy corporate interest groups. Free Trade is controlled by wealthy nations who have stacked the rules in favour of themselves, and in particular their corporate interests, and against the poor producers in poor nations. This control is used contrary to fairness, economic and ecological logic. Fair trade, by ...


On The Legal Consequence Of Sauces: Should Thomas Keller's Recipes Be Per Se Copyrightable, Christopher J. Buccafusco Aug 2006

On The Legal Consequence Of Sauces: Should Thomas Keller's Recipes Be Per Se Copyrightable, Christopher J. Buccafusco

ExpressO

This article is devoted to copyright protection for one of the restaurant industry’s most valuable assets – original recipes. The two most recent appellate courts to consider the issue have been hostile to the notion that recipes are copyrightable, but given the enormous amount of money at stake, litigation in this area is likely about to expand. The article begins by critiquing the courts’ conclusions. Following an analogy to musical composition, I argue that recipes are simply the means of fixation for culinary works of authorship, i.e, dishes. Next, based on interviews with some of America’s leading chefs ...


The Final Battle For Preemption: The Fda And Prescription Drug Labeling Product Liability Actions, Mary J. Davis Aug 2006

The Final Battle For Preemption: The Fda And Prescription Drug Labeling Product Liability Actions, Mary J. Davis

ExpressO

The Food and Drug Administration (FDA) has promulgated a new regulation which revises the format for prescription drug labeling, and, in the process, has taken the position that the regulation displaces, or preempts, state products liability laws that seek to assess liability on the manufacturer for a label’s warning adequacy. In the FDA’s 100 year history, it has not taken the position that federal prescription drug labeling regulations preempt common law tort claims until the last few years, beginning with Motus v. Pfizer in 2002. This position, radical to many and rational to others, places federal preemption of ...


In Sickness, Health, And Cyberspace: Protecting The Security Of Electronic Private Health Information, Sharona Hoffman, Andy Podgurski Aug 2006

In Sickness, Health, And Cyberspace: Protecting The Security Of Electronic Private Health Information, Sharona Hoffman, Andy Podgurski

ExpressO

The electronic processing of health information provides considerable benefits to patients and health care providers at the same time that it creates serious risks to the confidentiality, integrity, and availability of the data. The Internet provides a conduit for rapid and uncontrolled dispersion and trafficking of illicitly-obtained private health information, with far-reaching consequences to the unsuspecting victims. In order to address such threats to electronic private health information, the U.S. Department of Health and Human Services enacted the HIPAA Security Rule, which thus far has received little attention in the legal literature. This article presents a critique of the ...


Learning The Wrong Lessons From "An American Tragedy": A Critique Of The Berger-Twerski Informed Choice Proposal, David E. Bernstein Aug 2006

Learning The Wrong Lessons From "An American Tragedy": A Critique Of The Berger-Twerski Informed Choice Proposal, David E. Bernstein

Michigan Law Review

Margaret Berger and Aaron Twerski are among the leading scholars in their respective fields of Evidence and Products Liability. I have benefited from their work on many occasions. Precisely because of the deserved respect and esteem in which Berger and Twerski are held-not to mention the prominence of their forum, the Michigan Law Review-their proposal to create a new "informed choice" cause of action in pharmaceutical litigation is likely to receive sympathetic attention. Because I believe that their proposal is ill-conceived and dangerous, I feel compelled (with some trepidation) to write this response. Berger and Twerski propose that courts recognize ...


From The Wrong End Of The Telescope: A Response To Professor David Bernstein, Margaret A. Berger, Aaron D. Twerski Aug 2006

From The Wrong End Of The Telescope: A Response To Professor David Bernstein, Margaret A. Berger, Aaron D. Twerski

Michigan Law Review

On the pages of this law review, in an article entitled Uncertainty and Informed Choice: Unmasking Daubert, the authors argued for the recognition of a new product liability cause of action when drug companies fail to warn about uncertain risks attendant to the use of non-therapeutic drugs whose purpose is to enhance lifestyle. We noted that in the post-Daubert era, plaintiffs have faced increasing difficulty in proving that a given toxic agent was causally responsible for the injuries suffered after ingesting a drug. That plaintiffs cannot overcome the barriers to proving injury causation does not mean that defendants have met ...


Why It Is Time To Eliminate Genomic Patents, Together With Natural Extracts Doctrine That Have Supported Such Patents, Allen K. Yu Jul 2006

Why It Is Time To Eliminate Genomic Patents, Together With Natural Extracts Doctrine That Have Supported Such Patents, Allen K. Yu

ExpressO

The constitutional purpose of intellectual property is to “promote the progress of science and useful arts.” Given the utilitarian basis of patents, it is critical that policies and laws must be continually adjusted to reflect the needs of new technologies. When the law tries to shield itself from rather than confront the realities of underlying technologies, patents end up actually subverting rather than promote technological progress. This paper explores why the natural extracts doctrine belongs to the class of doctrines that subvert progress. The doctrine, established over a century ago to enable the patenting of purified compounds for use as ...


The Transatlantic Gmo Dispute Against The European Communities: Some Preliminary Thoughts, David A. Wirth Jul 2006

The Transatlantic Gmo Dispute Against The European Communities: Some Preliminary Thoughts, David A. Wirth

Boston College Law School Faculty Papers

Any day now, a World Trade Organization panel is expected to rule in a dispute between the U.S. and the EU concerning market access for genetically-engineered foods and crops. This piece, written before the release of the WTO panel's report, analyzes novel systemic issues concerning the impact of WTO law on regulatory design, at both the national and international levels, that are raised by this dispute. These include (1) the application of WTO disciplines to regulatory schemes that require prior governmental approval to protect the environment and public health from newly-introduced products and substances; (2) the role of ...


Drugged, Carl E. Schneider Jul 2006

Drugged, Carl E. Schneider

Articles

The Supreme Court's recent decision in Gonzales v. Oregon, like its decision last year in Gonzales v. Raich (the "medical marijuana" case), again raises questions about the bioethical consequences of the Controlled Substances Act. When, in 1970, Congress passed that act, it placed problematic drugs in one of five "schedules," and it authorized the U.S. attorney general to add or subtract drugs from the schedules. Drugs in schedule II have both a medical use and a high potential for abuse. Doctors may prescribe such drugs if they "obtain from the Attorney General a registration issued in accordance with ...


Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp Jun 2006

Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp

ExpressO

This brief comment suggests where the anti-eminent domain movement might be heading next.


Genetically Modified Crops In The Philippines: Can Existing Biosafety Regulations Adequately Protect The Environment?, Christina L. Richmond Jun 2006

Genetically Modified Crops In The Philippines: Can Existing Biosafety Regulations Adequately Protect The Environment?, Christina L. Richmond

Washington International Law Journal

Global concern persists about the use of genetically modified crops (“GM crops”). This concern originates from the divergent perspectives of nations with a stake in either the production or consumption of GM crops. Proponents of GM crops in developing countries claim that the crops could increase food supply by improving plant resistance to pesticides, thereby alleviating the need for farmers to purchase chemicals that are frequently expensive or unavailable. However, many organizations and countries are hesitant or outright opposed to GM crops, particularly regarding their potentially undesirable ecological and agricultural consequences. As one of the first Asian nations to approve ...


Active Water Resource Management: Tools For Better Water Management, John D'Antonio, P.E. May 2006

Active Water Resource Management: Tools For Better Water Management, John D'Antonio, P.E.

Publications

No abstract provided.


Water For Energy In The Southwest: Finding Water For Mohave, Stanley M. Pollack May 2006

Water For Energy In The Southwest: Finding Water For Mohave, Stanley M. Pollack

Publications

No abstract provided.


Water For Energy In The Southwest: Where Will It Come From?, Marilyn C. O'Leary May 2006

Water For Energy In The Southwest: Where Will It Come From?, Marilyn C. O'Leary

Publications

No abstract provided.


Reprocessing Single-Use Medical Devices: The State Of The Debate, Brian E. Ray, Mark Hermann May 2006

Reprocessing Single-Use Medical Devices: The State Of The Debate, Brian E. Ray, Mark Hermann

Law Faculty Articles and Essays

Reprocessing single-use medical devices is a growing but controversial industry subject to an increasingly complex and fast-developing set of regulations and a wide range of unresolved legal issues.


Discovering The Boundaries: Federal Preemption Of Pharmaceutical Labeling Product Liability Actions, Mary J. Davis Apr 2006

Discovering The Boundaries: Federal Preemption Of Pharmaceutical Labeling Product Liability Actions, Mary J. Davis

ExpressO

Federally approved prescription drug labeling has not been considered conclusive on the reasonableness or adequacy of the label for assessing tort liability on the manufacturer because federal regulations in this field set a minimum standard rather than an optimal one. That fundamental statement of black-letter tort law is under attack. The Food and Drug Administration (FDA) has promulgated a regulation which revises the format for prescription drug labeling, and, in the process, has taken the position that the regulation displaces, or preempts, state products liability laws that seek to assess liability on the manufacturer for a label’s warning adequacy ...


A Taxonomy Of Obesity Litigation, Theodore H. Frank Apr 2006

A Taxonomy Of Obesity Litigation, Theodore H. Frank

University of Arkansas at Little Rock Law Review

No abstract provided.


Regulating Food Advertisements: Some First Amendment Issues, John M. A. Dipippa Apr 2006

Regulating Food Advertisements: Some First Amendment Issues, John M. A. Dipippa

University of Arkansas at Little Rock Law Review

No abstract provided.


Setting The Stage For Public Health: The Role Of Litigation In Controlling Obesity, Jason A. Smith Apr 2006

Setting The Stage For Public Health: The Role Of Litigation In Controlling Obesity, Jason A. Smith

University of Arkansas at Little Rock Law Review

No abstract provided.


The Use Of Hair Analysis To Test Children For Exposure To Methamphetamine, Michael T. Flannery, Jerry Jones, Karen Farst, Karen Bord Worley Apr 2006

The Use Of Hair Analysis To Test Children For Exposure To Methamphetamine, Michael T. Flannery, Jerry Jones, Karen Farst, Karen Bord Worley

Faculty Scholarship

No abstract provided.


Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson Mar 2006

Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson

ExpressO

This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of ...


Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson Mar 2006

Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson

ExpressO

This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of ...


Getting It Right By Getting It Wrong: How The Supreme Court Helped Healthcare Reform By Incorrectly Applying The Standard Of Review In Pharmaceutical Research And Manufacturers Of America V. Walsh, Brian Y. Furuya Mar 2006

Getting It Right By Getting It Wrong: How The Supreme Court Helped Healthcare Reform By Incorrectly Applying The Standard Of Review In Pharmaceutical Research And Manufacturers Of America V. Walsh, Brian Y. Furuya

Brigham Young University Journal of Public Law

No abstract provided.


Merck V. Integra: Bailing Water Without Plugging The Hole, Benjamin G. Jackson Mar 2006

Merck V. Integra: Bailing Water Without Plugging The Hole, Benjamin G. Jackson

Brigham Young University Journal of Public Law

No abstract provided.


House Passage Of Cheeseburger Bill Cheered On By Food Industry, Andrea Binion Jan 2006

House Passage Of Cheeseburger Bill Cheered On By Food Industry, Andrea Binion

Public Interest Law Reporter

No abstract provided.