Food and Drug Law Commons^™

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.

"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 …

The Problem Of New Uses, Rebecca S. Eisenberg

Articles

Discovering new uses for drugs that are already on the market seems like it ought to be the low-lying fruit of biopharmaceutical research and development (R&D). Firms have already made significant investments in developing these drugs and bringing them to market, including testing them in clinical trials, shepherding them through the FDA regulatory approval process, building production facilities, and training sales staff to market them to physicians. By this point, the drugs have begun to enjoy goodwill among patients and physicians and casual observations in the course of clinical experience may point to potential new uses. One might expect that …

Strictly Speaking About Ephedra: A Baseball Tragedy Helping To Define The Dynamic Between Warning Defect And Design Defect, Michael Kane

Jeffrey S. Moorad Sports Law Journal (1994 - )

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 …

Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg

Articles

Controversy over recent revelations concerning the adverse cardiovascular effects of selective cyclooxygenase- 2 (COX-2) inhibitors has generally been framed as a story of regulatory failure, in which the Food and Drug Administration (FDA) has failed in its mission to protect the public from unsafe products. But this simplistic understanding of the mission of the FDA seems to make failure all but inevitable, if the reliable observation of the risks and benefits of a drug requires rigorous long-term studies. Perhaps in an earlier era the goal of drug regulation was simply to protect the public from poisons. Today, drug regulation guides …

The End Of Azt Patent: A New Beginning Or Too Little Too Late?, Lindsay Frank

Public Interest Law Reporter

No abstract provided.

Do Recent Studies Prove That Farmed Salmon Are Toxic - A Commentary On Whether The Current Fda Guidelines Adequately Protect Consumers From Potential Toxins In Farmed Salmon, Arthur Cutillo

Villanova Environmental Law Journal (1991 - )

No abstract provided.

Weight-Loss Advertising Too Good To Be True: Are Manufacturers Or The Media To Blame?, Jodie Sopher

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Free Trade And Illegal Drugs: Will Nafta Transform The United States Into The Netherlands?, Taylor W. French

Vanderbilt Journal of Transnational Law

In the postwar era, the United States typically has taken an approach to dealing with illegal drugs different from Europe. Americans have favored prohibitionist measures to combat drug use, while Europeans have gradually relaxed many of their illicit substance laws. Recently, however, there has been a growing movement within the United States to decriminalize and legalize marijuana. Numerous states have already reformed their laws to allow doctors to prescribe marijuana to patients. Moreover, many states are dramatically decriminalizing personal use of cannabis.

A review of postwar Europe's experience with drugs provides a useful paradigm to explain the U.S.'s shifting attitude. …

The Roles Of Precaution And Political Accountability In The Regulation Of Polybrominated Diphenyl Ethers, Danielle Brim

Vanderbilt Journal of Transnational Law

The differing approaches used in the United States and the European Union to regulate toxic chemicals have been highlighted by debates about a group of chemicals called polybrominated diphenyl ethers, or PBDEs. PBDEs act as flame-retardants and are added to consumer products to increase their safety. Questions about the continued use of PBDEs have been raised, however, because of concerns that PBDEs may be dangerous to human health and the environment. The European Union has decided to ban two types of PBDEs, while the United States has not issued similar restrictions. In this Note, the Author argues that neither decision …

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 …

A Prescription For Drug Liability And Regulation, Victor E. Schwartz, Phil Goldberg

Oklahoma Law Review

No abstract provided.

The Experimental Purpose Doctrine And Biomedical Research, Tao Huang

Michigan Telecommunications & Technology Law Review

The experimental use doctrine is a common law rule in patent law that until a few years ago excused accused infringers who made and used patented products or processes on the basis of an experimental, educational, or nonprofit purpose when there was de minimis economic injury to the patent owner and de minimis economic gain to the infringer. While the application of the experimental purpose doctrine was always narrow, two recent Federal Circuit decisions indicate that there is not much left under its aegis. In Madey v. Duke University, the Federal Circuit strictly limited the application of the experimental purpose …

Breaking The Shield Of The Learned Intermediary Doctrine: Placing The Blame Where It Belongs, Sheryl Calabro

Cardozo Law Review

No abstract provided.

Modern Bootlegging And The Prohibition On Fair Prices: Last Call For The Repeal Of Pharmaceutical Price Gouging, Luke W. Cleland

ExpressO

This article discusses the recent passage of the Medicare Prescription Drug, Modernization and Improvement Act of 2003, and the executive and judicial decisions affecting the ability of the general public to access foreign pharmaceutical markets. The article examines the recent actions taken by the U.S. government, explore various state movements within the United States aimed at reducing pharmaceutical drug prices, outline the process of pharmaceutical drug prices in foreign countries, and advocate for a workable integration of all available mechanisms to feasibly reduce prescription drug prices for the benefit of both U.S. consumers and U.S. drug companies. As avenues to …