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Food and Drug Law Commons™

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University of Michigan Law School

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Articles 91 - 120 of 191

Full-Text Articles in Food and Drug Law

The Environmental Effects Of Cruelty To Agricultural Animals, Kyle H. Landis-Marinello Jan 2008

The Environmental Effects Of Cruelty To Agricultural Animals, Kyle H. Landis-Marinello

Michigan Law Review First Impressions

Laws criminalizing animal abuse should apply to the agricultural industry. When we exempt the agricultural industry from these laws, factory farms increase production to unnaturally high levels. This increased production causes devastating environmental effects, such as climate change, water shortages, and the loss of topsoil. In light of these effects, the law needs to do much more to regulate the agricultural industry, and the first step should be to criminalize cruelty to agricultural animals. This would force the industry to slow down production to more natural levels that are much less harmful to the environment.

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"It's The Right Thing To Do": Why The Animal Agriculture Industry Should Not Oppose Science-Based Regulations Protecting The Welfare Of Animals Raised For Food, Angela J. Geiman Jan 2008

"It's The Right Thing To Do": Why The Animal Agriculture Industry Should Not Oppose Science-Based Regulations Protecting The Welfare Of Animals Raised For Food, Angela J. Geiman

Michigan Law Review First Impressions

Since the beginning of history, people have used farm animals to assist with their work and to provide a source of food. These agricultural pursuits were not questioned; rather, they were a widely-accepted way of life. In fact, many people still say that the very purpose of livestock on this Earth is to provide these resources for mankind. As for the proper way to treat our livestock, we commonly hear farmers and livestock producers make comments like, “If we take care of the animals, they will take care of us,” and, “We treat our animals well because that’s just good …

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One Bad Day: Thoughts On The Difference Between Animal Rights And Animal Welfare, Neil D. Hamilton Jan 2008

One Bad Day: Thoughts On The Difference Between Animal Rights And Animal Welfare, Neil D. Hamilton

Michigan Law Review First Impressions

The lawsuit pitting the New Jersey Society for the Prevention of Cruelty to Animals against the New Jersey Department of Agriculture brings into sharp focus the issue of animal rights versus animal welfare that has been dividing animal activists, farmers, and society for decades. On one side are proponents of animal rights—a set of rights articulated by humans but granted to animals to govern how we treat them. For many believers this includes the right not to be owned and certainly not to be eaten. On the other side are proponents of animal welfare—also a set of human derived standards …

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A Case Study On Cruelty To Farm Animals: Lessons Learned From The Hallmark Meat Packing Case, Nancy Perry, Peter Brandt Jan 2008

A Case Study On Cruelty To Farm Animals: Lessons Learned From The Hallmark Meat Packing Case, Nancy Perry, Peter Brandt

Michigan Law Review First Impressions

“I need the public to understand that my office takes all cases involving animal cruelty very seriously . . . [and i]t doesn’t matter whether the mistreated animal is a beloved family pet or a cow at a slaughterhouse. Unnecessary cruelty will not be tolerated and will be prosecuted to the fullest extent allowed by law.” San Bernardino County District Attorney Michael A. Ramos (February 15, 2008) One morning in January 2008, images of horrific animal cruelty were blasted by Internet, television, and print media throughout the country. The story was all the more shocking in that the animals at …

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Pharma's Nonobvious Problem, Rebecca S. Eisenberg Jan 2008

Pharma's Nonobvious Problem, Rebecca S. Eisenberg

Articles

This Article considers the effect of the recent decision of the U.S. Supreme Court in KSR International Co. v. Teleflex, Inc. on the nonobviousness standard for patentability as applied to pharmaceutical patents. By calling for an expansive and flexible analysis and disapproving of the use of rigid formulas in evaluating an invention for obviousness, KSR may appear to make it easier for generic competitors to challenge the validity of drug patents. But an examination of the Federal Circuit's nonobviousness jurisprudence in the context of such challenges reveals that the Federal Circuit has been employing all along the sort of flexible …

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The Moral Hazard Problem With Privatization Of Public Enforcement: The Case Of Pharmaceutical Fraud, Dayna Bowen Matthew Dec 2007

The Moral Hazard Problem With Privatization Of Public Enforcement: The Case Of Pharmaceutical Fraud, Dayna Bowen Matthew

University of Michigan Journal of Law Reform

This Article takes a law and economics approach to exploring some of the costs that arise when governments rely on private enforcement to accomplish the goals of public law. The analysis focuses on qui tam enforcement under the Civil False Claims Act, because a remarkable body of empirical data demonstrates the expansive role private qui tam relators are playing in enforcing Medicare and Medicaid fraud and abuse laws. The Article further focuses on the application of these laws to the pharmaceutical industry. This focus is enlightening because the Government, as well as private enforcers, have recently targeted this industry so …

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One Stop, No Stop, Two Stop, Terry Stop: Reasonable Suspicion And Pseudoephedrine Purchases By Suspected Methamphetamine Manufacturers, Andrew C. Goetz May 2007

One Stop, No Stop, Two Stop, Terry Stop: Reasonable Suspicion And Pseudoephedrine Purchases By Suspected Methamphetamine Manufacturers, Andrew C. Goetz

Michigan Law Review

This Note attempts to inject some clarity into courts' reasonable suspicion calculus for cold medicine purchases. It argues that the key factor in analyzing such purchases is whether the purchaser or purchasers appear to be circumventing pseudoephedrine purchasing restrictions in order to obtain inordinately large quantities of pseudoephedrine. Part I provides a general background on the domestic manufacture of methamphetamine in small, clandestine laboratories. Part II then examines the interplay between outward innocence and reasonable suspicion under the Supreme Court's Fourth Amendment jurisprudence. Finally, Part III establishes a framework for identifying purchasing strategies that methamphetamine manufacturers commonly use to circumvent …

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The R.F.I.D. Act Of 2006 And E-Pedigrees: Tackling The Problem Of Counterfeit Drugs In The United States Wholesale Industry, Suchira Ghosh Jan 2007

The R.F.I.D. Act Of 2006 And E-Pedigrees: Tackling The Problem Of Counterfeit Drugs In The United States Wholesale Industry, Suchira Ghosh

Michigan Telecommunications & Technology Law Review

Gaps within the drug distribution system make it increasingly vulnerable to bad actors, such as counterfeiters and terrorists. Congress intended the Prescription Drug Marketing Act (PDMA) of 1987 to close these gaps, but the PDMA has not fully succeeded. Important PDMA provisions that require tracking of drugs throughout the distribution chain in the form of "pedigrees" were set to be implemented as of Dec. 1, 2006, although a recent court order has stayed complete implementation. However, these PDMA requirements do not apply uniformly to all drug distributors in the United States. Moreover, since paper pedigrees can be forged, the pedigree …

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Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz Jan 2007

Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz

Michigan Telecommunications & Technology Law Review

Before a new drug can be marketed, the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented or advocated. This Article challenges the central argument that drug regulation and drug innovation are necessarily at odds with one another. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate does not fully capture the role that regulation plays in …

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Refusal To Dispense Emergency Contraception In Washington State: An Act Of Conscience Or Unlawful Sex Discrimination?, Dana E. Blackman Jan 2007

Refusal To Dispense Emergency Contraception In Washington State: An Act Of Conscience Or Unlawful Sex Discrimination?, Dana E. Blackman

Michigan Journal of Gender & Law

This Article will demonstrate that a pharmacist's refusal to fill a valid prescription for emergency contraception constitutes sex discrimination and violates the WLAD. Part I explains the nature and function of emergency contraceptive pills (ECPs) as well as their role in basic health care for women and the importance of their accessibility. Part II addresses federal civil rights protections and the failure of these protections to provide relief for women facing refusals. Focusing on the WLAD, Part II also explains how state public accommodation statutes protect women from discrimination in places of public accommodation. It further sets forth the prima …

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The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg Jan 2007

The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg

Michigan Telecommunications & Technology Law Review

This Article reexamines the role of FDA regulation in motivating investment in biopharmaceutical innovation. I begin by challenging the standard story that it is the patent system that makes drug development profitable, and drug regulation that makes it costly, by showing how patents add to costs and how drug regulation works in tandem with patents to protect profits. I then compare FDA-administered exclusive rights to patents as a means of fortifying drug development incentives, suggesting ways that FDA-administered rights might be preferable both from the perspective of policy makers and from the perspective of firms. In the remainder of the …

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Diversifying Without Discriminating: Complying With The Mandates Of The Trips Agreement, Graeme B. Dinwoodie, Rochelle C. Dreyfuss Jan 2007

Diversifying Without Discriminating: Complying With The Mandates Of The Trips Agreement, Graeme B. Dinwoodie, Rochelle C. Dreyfuss

Michigan Telecommunications & Technology Law Review

Since the Patent Act was revised in 1952, patent law has expanded to cover an array of novel endeavors--new fields of technology (notably computer science and business methods) as well as the activities of researchers engaged in fundamental scientific discovery. These changes have been accompanied by shifts in the organizational structure of the technological community, with smaller firms and universities emerging as important players in the patent system, and by new marketplace expectations arising from consumer demand for interoperable technology and converging functionality. As a result of these developments, structural flaws in the legal order have become evident. Although the …

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Restoring The Genetic Commons: A Common Sense Approach To Biotechnology Patents In The Wake Of Ksr V. Teleflex , Anna Bartow Laakmann Jan 2007

Restoring The Genetic Commons: A Common Sense Approach To Biotechnology Patents In The Wake Of Ksr V. Teleflex , Anna Bartow Laakmann

Michigan Telecommunications & Technology Law Review

In this Article, I argue that a new approach to biotechnology patenting is necessary to fully realize the tremendous potential of recent advances in our understanding of the human genome. Part I places the gene patenting debate in context by highlighting the key landmarks that have shaped the biotechnology industry and outlining the products and stakeholders that comprise the industry. Part II describes the current state of the law on biotechnology patents, summarizing the Federal Circuit's application of the various doctrines that collectively define the patent landscape's parameters. In this Part, I explain how the Federal Circuit's jurisprudence is tied …

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The Patent End Game: Evaluating Generic Entry Into A Blockbuster Pharmaceutical Market In The Absence Of Fda Incentives, Jeremiah Helm Jan 2007

The Patent End Game: Evaluating Generic Entry Into A Blockbuster Pharmaceutical Market In The Absence Of Fda Incentives, Jeremiah Helm

Michigan Telecommunications & Technology Law Review

Generic drugs play an important role in the American system of health care. Most anticipate that the entry of these drugs into the market will lower prices and thereby increase treatment options for consumers. To stimulate generic entry, the Food and Drug Administration currently offers a period of marketing exclusivity to the first firm that gains approval for a generic version of a branded drug. During this 180-day period, only two firms can sell versions of the drug: the original, branded drug maker and the first approved generic firm. After the period of exclusivity expires, other generic firms are free …

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Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher Jan 2007

Fda Approval Of Generic Biologics: Finding A Regulatory Pathway, Kathleen R. Kelleher

Michigan Telecommunications & Technology Law Review

Biologics are becoming increasingly important for the potential treatment of widespread diseases such as cancer, anemia, and diabetes. As hundreds of biologics are going off-patent, the market has become ripe for the introduction of generic biologics. A regulatory pathway for biogenerics, however, is virtually nonexistent. The purpose of this paper is thus to analyze how a successful legislative pathway for generic biologics might be designed. The current regulatory scheme, economic concerns, health and safety concerns, and the need to provide proper incentives for innovation are analyzed. Finally, recent Congressional bills are outlined and critiqued, through which the structure of a …

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The Use Of Drug Testing To Police Sex And Gender In The Olympic Games, Haley K. Olsen-Acre Jan 2007

The Use Of Drug Testing To Police Sex And Gender In The Olympic Games, Haley K. Olsen-Acre

Michigan Journal of Gender & Law

Part I of this Article discusses the history and development of sex testing and drug testing and argues that the two are both historically and ideologically linked. Part II examines the current Code in detail and argues that the Code's focus on hormone-based controls acts to police sex and gender in Olympic athletes, thereby extending historical sex testing practices to a new era. This Article ultimately concludes that without recognizing and addressing the need for further research into the role of "sex" hormones in the body and the interplay of social context and biological circumstances, the IOC cannot maintain an …

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Secondhand Smoke Signals From Prison, Scott C. Wilcox Jan 2007

Secondhand Smoke Signals From Prison, Scott C. Wilcox

Michigan Law Review

This Note argues that courts should acknowledge current societal and medical perspectives on second hand smoke (SHS) and afford real protection to prisoners against SHS through injunctive relief. Part I examines evidence that conclusively demonstrates the serious risk of harm posed by SHS to the health of inmates. It reports that inmates' long-term exposure to SHS increases their risk of contracting lung cancer, heart disease, and other potentially life threatening conditions. Part II argues that, as required by the Helling standard, contemporary society does not tolerate involuntary, long-term exposure to SHS and that prison officials exhibit deliberate indifference by allowing …

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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 a …

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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 …

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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 …

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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 the …

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Uncertainty And Informed Choice: Unmasking Daubert, Margaret A. Berger, Aaron D. Twerski Nov 2005

Uncertainty And Informed Choice: Unmasking Daubert, Margaret A. Berger, Aaron D. Twerski

Michigan Law Review

This Article will first examine why it is that plaintiffs have been unable to prove causation under the Daubert guidelines in toxic tort litigation. Second, it will look at the two existing models for informed choice litigation medical malpractice and products liability-and demonstrate why neither of these models gives toxic tort plaintiffs a fair opportunity to recover for the deprivation of patient autonomy against drug manufacturers who have breached their duty to warn of known or knowable risks. Finally, this Article will explore the elements of a causation-free informed choice cause of action. It will suggest the appropriate standard for …

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A Government Of Limited Powers, Carl E. Schneider Jul 2005

A Government Of Limited Powers, Carl E. Schneider

Articles

Roscoe C. Filburn owned a small farm in Ohio where he raised poultry, dairy cows, and a modest acreage of winter wheat. Some wheat he fed his animals, some he sold, and some he kept for his family's daily bread. The Agricultural Adjustment Act of 1938 limited the wheat Mr. Filburn could grow without incurring penalties, but his 1941 crop exceeded those limits. Mr. Filburn sued. He said Claude Wickard, the Secretary of Agriculture, could not enforce the AAI's limits because Congress lacked authority to regulate wheat grown for one's own use. He reasoned: In our federal system, the states …

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Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde Apr 2005

Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde

Michigan Telecommunications & Technology Law Review

Support for new drug development has taken some interesting turns in current patent law jurisprudence. Beginning with the severe curtailment of scope of the common law experimental use doctrine in Madey v. Duke University, and culminating with the recent Supreme Court decision in Merck KGaA v. Integra Lifesciences I, Ltd., broadening the scope of the statutory research exemption, the freedom to conduct experimental research using another's patented inventions becomes dependent in part on the purpose of the research. That the patent at issue in Merck was characterized by the Federal Circuit as being directed to a research tool raised the …

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Staying Within The Negotiated Framework: Abiding By The Non-Discrimination Clause In Trips Article 27, Kevin J. Nowak Jan 2005

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 …

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The Problem Of New Uses, Rebecca S. Eisenberg Jan 2005

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 …

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Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg Jan 2005

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 …

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The Experimental Purpose Doctrine And Biomedical Research, Tao Huang Oct 2004

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 …

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Wto And Gmos: Analyzing The European Community's Recent Regulations Covering The Labeling Of Genetically Modified Organisms, Brian Schwartz Jan 2004

Wto And Gmos: Analyzing The European Community's Recent Regulations Covering The Labeling Of Genetically Modified Organisms, Brian Schwartz

Michigan Journal of International Law

This Note explores the compatibility of the EC's GMO regulations within the framework of the Agreement on the Application of Sanitary and Phytosanitary Measures ("SPS Agreement"), the Agreement on Technical Barriers to Trade ("TBT Agreement"), and the General Agreement on Tariffs and Trade 1994 ("GATT 1994" or "GAT"), all integral parts of the WTO Agreement. Part II presents arguments for or against the use of GM-products. Part III explores the concept of ecolabeling by analyzing the general goals of such programs, including the economic theory behind green consumerism and the characteristics necessary for effective schemes. Part IV describes the core …

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The New Codex Alimentarius Commission Standards For Food Created With Modern Biotechnology: Implications For The Ec Gmo Framework's Compliance With The Sps Agreement, Aaron A. Ostrovsky Jan 2004

The New Codex Alimentarius Commission Standards For Food Created With Modern Biotechnology: Implications For The Ec Gmo Framework's Compliance With The Sps Agreement, Aaron A. Ostrovsky

Michigan Journal of International Law

This Note makes two assertions. First, despite the fact that the Codex guidelines do not specifically invoke the Precautionary Principle in name, it can indeed be read into the guidelines in the amount of deference given to states in how they assess risk. This in turn means that the E.C.'s Deliberate Release Directive should be enjoy a presumption of compliance with both the SPS Agreement and the GATT. The second assertion is that even if the adjudicating body of the WTO finds that the Deliberate Release Directive, in relying on the Precautionary Principle, prescribes a higher level of protection than …

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