Food and Drug Law Commons^™

Adequate Drug Warnings In The Face Of Uncertain Causality: The Learned Intermediary Doctrine And The Need For Clarity, Michael Imbroscio, Gabriel Bell

West Virginia Law Review

No abstract provided.

Protecting Protected Speech: First Amendment Taxonomy And The Food And Drug Administration's Regulation Of "Enduring Materials", Daniel J. Gilman

Faculty Scholarship

Numerous comments have called upon the Food and Drug Administration (FDA) to exercise restraint in its treatment of the dissemination of “enduring materials” (e.g., textbooks, journal articles, etc.) that address off-label uses of drug or biological products. This article considers the constitutional protections that apply to enduring materials as examples of commercial speech, and questions whether such materials—even though distributed by manufacturers—might be viewed more properly as scientific speech. Four conclusions will be set forth: 1) enduring materials regarding off-label uses deserve at least as much protection as the Constitution affords commercial speech; 2) there are good reasons to think …

Debacle In Dixie: A Story Of Six Rivers, Three States, Two Compacts And One Well-Paved Path, George William Sherk

Publications

No abstract provided.

Delawate River Basin Compact, Jeffrey Featherstone

Publications

No abstract provided.

The Impact And Limits Of The Constitutional Deregulation Of Health Claims On Foods And Supplements: From Dementia To Nuts To Chocolate To Saw Palmetto, Margaret Gilhooley

Mercer Law Review

The Food and Drug Administration ("FDA") recently issued an enforcement policy identifying the types of health claims in the disclaimers that are constitutionally permitted on foods and dietary supplements. In 1990 Congress required that before a company could make a health claim on a food product, the FDA must approve the claim as based on significant scientific agreement. While the 1990 law gave the FDA discretion to establish a lesser standard for nutritional supplements than for food products, the FDA chose to apply the same standard. Thus, claims on nutritional supplements had to be supported by significant scientific agreement. Supplement …

Note: A Painful Catch-22: Why Tort Liability For Inadequate Pain Management Will Make For Bad Medicine, James R. Blaufuss

William Mitchell Law Review

Part I of this note reviews current issues relating to pain treatment. Part II examines theoretical justifications of proposed tort liability for inadequate pain management. Part III examines how pain mismanagement does not fit within traditional notions of medical malpractice. Part IV studies the issues relating to a physician’s role as “gate-keeper” for opioids and suggests why tort liability could compromise this legislatively imposed role. Part V examines the issue of pain management in the context of end-of-life care. Part VI discusses current shifts in pain management philosophies and explains how these movements will effectuate the changes suggested by advocates …

Stemming The Tide Of Stem Cell Research: The Bush Compromise, 38 J. Marshall L. Rev. 1061 (2005), Patrick Walsh

UIC Law Review

No abstract provided.

Water Privatization And Obstacles To Achieving Millennium Development Goal Seven's Targets For Sustainable Drinking Water, Maria Vanko

Sustainable Development Law & Policy

No abstract provided.

"Racially-Tailored" Medicine Unraveled, Sharona Hoffman

American University Law Review

In June 2005, the FDA approved BiDil, a heart failure medication that is labeled for use only by African-Americans and thus is the first treatment of its kind. The drug likely portends a future of growing interest in "race-based" medicine. This phenomenon is emerging at the same time that scientists, in light of the Human Genome Project, are reaching an understanding that "race" has no biological meaning, and consequently, "racially-tailored" medicine is both puzzling and troubling. This Article explores the reasons for the new focus on "racial-profiling" in medicine. It analyzes the risks and dangers of this approach, including medical …

Battle Of The Beef, The Rematch: An Evaluation Of The Latest E.C. Directive Banning Beef Produced With Growth Hormones And The U.S. Refusal To Accept The Directive As Wto Compliant, Darrel Chichester

American University International Law Review

No abstract provided.

Stomaching The Burden Of Dietary Supplement Safety: The Need To Shift The Burden Of Proof Under The Dietary Supplement Health And Education Act Of 1994, Morgan J. Wais

Seattle University Law Review

This article gives a brief historical perspective on dietary supplement regulation and discusses the evolution of drug regulation by the FDA. Part II concludes with a discussion of the political environment in which these regulations occur. Part III gives examples and show how the current system has caused injury and harm to consumers of dietary supplements. Part IV discusses the current burden of proof and how it was applied in the case of ephedra. Part V discusses how, under the current regulatory structure, consumers cannot be adequately protected, either by the FDA or the tort system. Part VI discusses the …

Access To Justice And The Right To Adequate Food: Implementing Millennium Development Goal One, Marc J. Cohen, Mary Ashby Brown

Sustainable Development Law & Policy

No abstract provided.

Pharmaceutical Tort Liability: A Justifiable Nemesis To Drug Innovation And Access?, 38 J. Marshall L. Rev. 987 (2005), Paula Jacobi

UIC Law Review

No abstract provided.

Patients Beware: Preemption Of Common Law Claims Under The Medical Device Amendments, 39 J. Marshall L. Rev. 75 (2005), Michael P. Dinatale

UIC Law Review

No abstract provided.

Regulating The Regulators: The Impact Of Fda Regulation On Corporations' First Amendment Rights, 39 J. Marshall L. Rev. 95 (2005), Lisa M. Fealk-Stickler

UIC Law Review

No abstract provided.

Public Use Or Experimental Use: Are Clinical Trials Susceptible To Another Attack Similar To That In Smithkline Beecham Corp. V. Apotex Corp., 39 J. Marshall L. Rev. 149 (2005), Nimalka Wickramasekera

UIC Law Review

No abstract provided.

Staying Within The Negotiated Framework: Abiding By The Non-Discrimination Clause In Trips Article 27, Kevin J. Nowak

Michigan Journal of International Law

This Note argues that the Panel in Canada-Generic Medicines correctly decided that the non-discrimination clause in Article 27 applies to the exceptions of Articles 30 and 31. Because Article 27 is the guiding force of Section 5, any exceptions to the rights granted under Section 5 must comply with the requirements set forth in Article 27. Although extreme applications of the non-discrimination clause could be limiting upon some exceptions, Articles 30 and 31 were not placed into TRIPs as complete escape clauses from the framework of Section 5. Additionally, the application of the non-discrimination clause to Articles 30 and 31 …

Want Fries With That - A Critical Analysis Of Fast Food Litigation, Donald R. Richardson

West Virginia Law Review

No abstract provided.

Cured Meat And Idaho Potatoes: A Comparative Analysis Of European And American Protection And Enforcement Of Geographic Indications Of Foodstuffs, Lilian V. Faulhaber

Georgetown Law Faculty Publications and Other Works

Geographic indications, as defined by the Agreement on Trade-Related Aspects of Intellectual Property Rights ("TRIPS Agreement"), are "indications which identify a good as originating in the territory of a member or region or locality in that territory where a given quality, reputation or other characteristic of the good is essentially attributable to its geographical origin."

While the general concept of protecting geographically-significant products from competition has existed for centuries, the protection provided to geographic indications varies significantly, both between countries and according to the product being protected.

Since the protection of foodstuffs in both Europe and America is a less …

"As The Federal Circuit Turns": The Supreme Court's Consideration Of Merck V. Integra And The Safe Harbor Provision, 4 J. Marshall Rev. Intell. Prop. L. 368 (2005), Blair M. Jacobs, Christina A. Ondrick

UIC Review of Intellectual Property Law

The Hatch-Waxman Act was enacted to balance the competing interests in the pharmaceutical marketplace between brand name and generic drug manufacturers. In the twenty years since its inception, the safe harbor provision contained in § 271(e)(1), has been interpreted to provide broad protection to those involved in research activities. However, in 2003, the Federal Circuit narrowly interpreted the safe harbor provision in a move that could potentially frustrate future research and improvements on patented technologies. Merck v. Integra is currently before the United States Supreme Court, who has the challenge of unraveling the competing interests involved. In order to encourage …

Minnesota: Leading The Way On Canadian Prescription Medicine Importation, Kevin Goodno, Karen Janisch

William Mitchell Law Review

In the United States, about $160 billion is spent on prescription medicines each year, with Minnesotans spending about $3 billion. The costs of prescription medicines receive so much attention in large part because, although prescription medicine costs constitute only 10.5% of total health care spending, they account for 23% of the total out-of-pocket costs that people incur when purchasing health care. Minnesota has been a leader in controlling prescription medicine costs. It has aggressively used purchasing pools when possible, and encouraged the use of lower cost, generic prescription medicines when appropriate. Even with these efforts to control costs, prescription medicines …

Aetna V. Davila/Cigna V. Calad: A Missed Opportunity, Leonard A. Nelson

William Mitchell Law Review

On June 21, 2004, the United States Supreme Court decided the health law “case of the year” in the two consolidated cases of Aetna Health, Inc. v. Davila and CIGNA HealthCare of Texas, Inc. v. Calad. The Court held that section 502(a) of the Employee Retirement Income Security Act of 1974 (ERISA) “completely preempt[s]” and thus invalidates the tort liability provisions of the Texas Health Care Liability Act (THCLA). The case could potentially affect the rights of millions of Americans in a matter of vital concern—whether they will receive the health insurance coverage promised them if they become unable to …

Off-Label Use And The Medical Negligence Standard Under Minnesota Law, Cynthia A. Moyer

William Mitchell Law Review

Who decides whether a drug can be used off-label and under what circumstances? If a physician decides to prescribe a drug off-label, what legal issues, if any, should the physician be aware of? With the increased practice of prescribing drugs for off-label use, coupled with a somewhat dated and incomplete medical negligence standard in Minnesota, the intersection of the off-label use doctrine with Minnesota’s medical negligence standard is ripe for review. This article examines the off-label use doctrine and the medical negligence standard under Minnesota law. First, the article examines what the phrase “off-label use” means. Next, the article explores …

Molloy V. Meier Extends Genetic Counseling Duty Of Care To Biological Mcclain Parents And Establishes That Legal Damages Must Occur Before A Wrongful Conception Action Accrues For Statute Of Limitations Purposes, Mark Hallberg, Teresa Fariss

William Mitchell Law Review

Inherited genetic disorders are a well-known cause of developmental delays in children. It is, therefore, “foreseeable” to physicians treating developmentally delayed children that parents of these children will rely on the physicians’ opinions of whether a genetic cause exists. Accordingly in 1992, when Dr. Diane Meier, a pediatrician, discovered developmental delays in S.F., the three-year-old daughter of Kimberly Flomer (now Molloy) and Robert Flomer, “accepted standards of pediatric practice” required Dr. Meier to order genetic testing, including testing for Fragile X Syndrome, one of the most common causes of inherited mental retardation. The foreseeable consequences of Dr. Meier’s alleged failure …

Raich, Health Care, And The Commerce Clause, Alex Kreit, Aaron Marcus

William Mitchell Law Review

This article considers to what extent health care may be viewed as a traditional area of state concern in the context of the Supreme Court’s revival of federalism principles, in particular limits on Congress’ Commerce Clause power, and what effect Raich v. Ashcroft, heard by the Court in the fall 2004 term, might have on these issues. Addressing these questions will necessarily involve exploration of medical marijuana policy as well as the role of the “traditional state interest” principle within the Commerce Clause. However, the central focus of this article is not what impact Raich may have on the Commerce …

World News, Blase Kornacki, Abby Okrent, Jennifer Rohleder, Mauro Zinner

Sustainable Development Law & Policy

No abstract provided.

Note: Capping Noneconomic Damages In Medical Malpractice Suits Is Not The Panacea Of The “Medical Liability Crisis”, Melissa C. Gregory

William Mitchell Law Review

This note explores the history behind the rising costs of medical malpractice insurance rates and the responsive state legislative proposals to limit noneconomic damages. The current state of health care liability and the recent federal proposals that include caps on noneconomic damages are then discussed. This note analyzes the reasons why the federal government should not cap noneconomic damages, primarily because: (1) states are better able to regulate health care, (2) noneconomic damages are not the determinate cause of rising medical malpractice insurance rates, and (3) caps infringe on equal protection guarantees by limiting compensation of medical malpractice victims. This …

Note: Exclusive Licensing Of Dna Diagnostics: Is There A Negative Effect On Quantity And Quality Of Healthcare Delivery That Compels Nih Rulemaking?, Edward Weck

William Mitchell Law Review

This comment surveys the costs of deoxyribonucleic acid (DNA) diagnostic tests and argues in favor of non-exclusive licensing as a means to provide broad access to affordable DNA diagnostic testing. Part II provides background information on genetic testing, patenting genes as applied to genetic testing, the Bayh-Dole Act, and technology transfer. In addition, Part II summarizes academic commentary regarding the implications of exclusive licensing for biotechnology. Scholars propose a number of solutions, including expanding the experimental use exception. Part III details proposed rulemaking for DNA diagnostics. Part IV reviews anecdotal examples of genetic testing for breast cancer, hereditary hemochromatosis, and …

Note: Poison In Our Own Backyards: What Minnesota Legislators Are Doing To Warn Property Purchasers Of The Dangers Of Former Clandestine Methamphetamine Labs, Signe Land Levine

William Mitchell Law Review

The article begins with an overview of the problems of meth abuse and manufacture in Minnesota, as well as the toxins that are left behind after physical evidence of meth labs has been removed. A discussion of current statutory seller disclosure provisions in Minnesota and in other states then follows. The article next analyzes proposed Minnesota legislation that has attempted to address the problem. A survey follows of six statutory models that provide guidance for drafting legislation to encompass disclosure, buyers’ remedies, filing forms in county land records, and requiring state-wide standards for proper cleanup. Finally, a comprehensive workable solution …

Obesity And The Struggle Within Ourselves, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

The author argues that we ought to treat our eating, exercise habits, and girth as personal matters, for the most part, but that law can and should make a contribution, as an ally of our longer-term will against our immediate cravings. Law can be our ally in this fashion without command-and-control intrusion into our private lives. Such intrusion is at odds with our core beliefs and unlikely to produce public health success. It is more likely to provoke popular backlash--one reason why some who stand to gain from our unhealthy dining choices try to cast government efforts to inform these …