Food and Drug Law Commons^™

Voluntary Intoxication: A Defense To Intentional Injury Exclusion Clauses In Homeowner's Policies?, Tracy E. Silverman

Michigan Law Review

This Note argues that the current voluntary intoxication defense to the intentional injury exclusion clause should be modified to allow insurers subrogation rights against insureds who commit intentional acts while voluntarily intoxicated, subject to an exception for alcoholic insureds who successfully complete alcohol treatment programs. Part I discusses the public policy concerns of victim compensation and deterrence and how they influence courts deciding between the three traditional approaches to "intent." Part II analyzes the impact of these intent standards on courts' decisions to allow a voluntary intoxication defense and concludes that the defense as currently formulated promotes victim compensation at …

Umbilical Cords: The New Drug Connection, Margaret Phillips

Buffalo Law Review

No abstract provided.

Random Drug-Testing Of Public School Student Athletes: A Permissible Search Under The Fourth Amendment, Paul K. Madsen

Brigham Young University Education and Law Journal

No abstract provided.

Exporting United States Drug Law: An Example Of The International Legal Ramifications Of The "War On Drugs", D. Brian Boggess

BYU Law Review

No abstract provided.

Department Of Food And Agriculture, P. Penn, B. Reznik

California Regulatory Law Reporter

No abstract provided.

The Patentability And Patent Term Extension Of Lifesaving Drugs: A Deadly Mistake, Jonathan L. Mezrich

Journal of Law and Health

The pharmaceutical business is dominated largely by two types of entities: large, research-intensive corporations, and the smaller "generic" drug "knock-off" artists. because the former organizations have to put so much of their budget into research and development (R&D), a form of investment which is often akin to pouring money into a hole, the 17-year exclusive monopoly of a patient is often the only way such a company can remain profitable. However, because of a concern for public safety, all substances prepared for human consumption must be put through extensive testing by the FDA. This testing could take a long period …

International Regulation And Control Of The Production And Use Of Chemicals And Pesticides: Perspectives For A Convention, Hans-Wolfgang Micklitz

Michigan Journal of International Law

A wide variety of instruments and mechanisms for the regulation and control of chemicals and pesticides is already available internationally. What is missing is an analysis that attempts to systematize the different approaches, to create transparency, to define where they overlap, and to discover prospective deficiencies and shortcomings. In order to accomplish this task, this article covers legally binding rules as well as recommendations and codes - the international soft law. The overall purpose is to outline a framework for future international regulation of chemicals and pesticides and to propose an international convention as a possible solution.

The Right To Refuse Antipsychotic Drug Treatment And The Supreme Court: Washington V. Harper, Jeannette Brian

Buffalo Law Review

No abstract provided.

Risk And Value Judgments: A Case Study Of The Poison Prevention Packaging Act, William E. Hilton

RISK: Health, Safety & Environment (1990-2002)

Mr. Hilton attempts to show why important choices presented in current proposals to amend child-resistant packaging regulations are fundamentally normative. He then argues that these choices should not be obscured by the technical issues.

The Changing Landscape Of Human Experimentation: Nuremberg, Helsinki, And Beyond, George J. Annas

Faculty Scholarship

Since World War II there have been persistent efforts at both the national and international level to develop rules to protect the rights and welfare of subjects of human experimentation.' These efforts have focused primarily on codifying the rights of subjects, and protecting their welfare by prior peer review of research protocols. In recent years research regulations have been under attack by politicians, drug companies, researchers, and advocacy groups. In less than half a century, human experimentation has been transformed from a suspect activity into a presumptively beneficial activity. With this transformation, traditional distinctions between experimentation and therapy, subject and …

Book Review: The Aspirin Wars: Money, Medicine, And 100 Years Of Rampant Competition, Joseph A. Page

Georgetown Law Faculty Publications and Other Works

The recent identification of a possible link between the long-term use of aspirin and a reduced incidence of colon and rectal cancer has directed renewed attention to a familiar household medication whose origins reach back to antiquity.

Competition from other painkillers had begun to cut deeply into the market once dominated by aspirin-based products when studies indicated the possibilities, first that the regular consumption of aspirin might prevent second heart attacks, and later that it might lower the risk of heart attacks in healthy individuals. If these two discoveries, as well as the new finding about colon and rectal cancers, …

Department Of Food And Agriculture, P. Penn, B. Reznik

California Regulatory Law Reporter

No abstract provided.

Department Of Food And Agriculture, S. Gerry, L. Rainey, D. Rupard

California Regulatory Law Reporter

No abstract provided.

Pretrial Drug Testing: Is It Vulnerable To Due Process Challenges?, Peter H. Meyers

Brigham Young University Journal of Public Law

No abstract provided.

Pretrial Drug Testing?An Essential Component Of The National Drug Control Strategy, Reggie B. Walton, Gary J. Peters, J. Anthony Towns

Brigham Young University Journal of Public Law

No abstract provided.

Pretrial Drug Testing: An Essential Step In Bail Reform, John A. Carver

Brigham Young University Journal of Public Law

No abstract provided.

A Special Needs Exception To The Warrant And Probable Cause Requirements For Mandatory And Uniform Pre-Arraignment Drug Testing In The Wake Of Skinner V. Railway Labor Executives' Association And National Treasury Employees' Union V. Von Raab, Russell C. Skousen

Brigham Young University Journal of Public Law

No abstract provided.

Consenting To Searches After Being Arrested: Pretrial Drug Testing , David R. Nielson

Brigham Young University Journal of Public Law

No abstract provided.

Survey Of Current And Prior Pretrial Drug Testing Sites, Cynthia Durrant Jensen

Brigham Young University Journal of Public Law

No abstract provided.

Department Of Food And Agriculture, S. Gerry, L. Rainey, D. Rupard

California Regulatory Law Reporter

No abstract provided.

Beyond The War On Drugs: Overcoming A Failed Public Policy, Kenneth R. Hillier

Michigan Law Review

A Review of Beyond the War on Drugs: Overcoming a Failed Public Policy by Steven Wisotsky

Strict Liability In The Manufacture Of Pharmeceuticals: The Halcion Homicide, Martin J. Macneill

Brigham Young University Journal of Public Law

No abstract provided.

Department Of Food And Agriculture, S. Gerry, L. Rainey, D. Rupard

California Regulatory Law Reporter

No abstract provided.

Neonatal Hiv Testing: Governmental Inspection Of The Baby Factory, 24 J. Marshall L. Rev. 571 (1991), Scott H. Isaacman

UIC Law Review

No abstract provided.

Presumed Innocent: Illinois' Rejection Of Market Share Liability In Smith V. Eli Lilly & (And) Company Is Cause In Fact To Celebrate, 24 J. Marshall L. Rev. 869 (1991), Steven Bonanno

UIC Law Review

No abstract provided.

Judicially Imposed Liquor Liability And Developments In West Virginia Negligence Actions, R. Scott Summers

West Virginia Law Review

No abstract provided.

Prescription Drugs And The Duty To Warn: An Argument For Patient Package Inserts, Alan R. Styles

Cleveland State Law Review

It has been more than ten years since the Food and Drug Administration proposed regulations which would have required detailed patient information for all prescription drugs. The proposed regulations, intended to promote the safe and effective use of prescription drugs, would have required a manufacturer to supply non-technical, non-promotional information, referred to as patient package inserts, directly to the patient. This note will analyze the need for patient information in satisfying the tort objectives of informed consent and public safety. The note will then analyze the practical effect of the learned intermediary and informed consent doctrines upon the manufacturer's and …

Accutane: Has Drug Regulation In The United States Reached Its Limits, Joan H. Krause

Journal of Law and Health

By a careful examination of the Accutane experience, both here and abroad, I will illustrate some of the shortcomings of the current American system of drug regulation. There are a number of ways in which this system fails to live up to the strict regulatory philosophy that it purports to follow; in particular, there are systematic inadequacies in the design of clinical trials, the official labeling received by drugs, and the manner in which adverse reaction reports are collected and assessed. Additionally, although the system often works well, there are natural limitations to a system of pre-approval testing; for some …

Getting New Drugs To People With Aids: A Public Policy Response To Lansdale, Marsha N. Cohen

Faculty Scholarship

No abstract provided.

The Regulation Of Medical Devices: A Comparative Study Of American And Eec Law, Martine Carliese Pijnappels

LLM Theses and Essays

Part I of this thesis will describe the regulation of medical devices in the EEC. Before coming to the actual medical device legislation, a description of the legislative system in Europe will be given, to the extent that it is relevant for the Directives on medical devices. After dealing with the history of Directives and their current contents, the status of the Directives and their future prospects will be discussed. Part II will deal with the regulation of medical devices in the United States under the Food Drug & Cosmetic Act as amended by Medical Device Amendments of 1976. First, …