Law Commons^™

“There's Danger Here, Cherie!”: Liability For The Promotion And Marketing Of Drugs And Medical Devices For Off-Label Uses, Richard C. Ausness

Law Faculty Scholarly Articles

Physicians often prescribe prescription drugs and other medications for uses that are not approved by the Food and Drug Administration ("FDA"), and such "off label" prescription is widely accepted within the medical community as a legitimate form of treatment. However, the federal government discourages off-label prescription and use in various ways. For example, the FDA restricts the dissemination of information by drug companies about potential off-label therapies. In addition, federally funded health insurance programs such as Medicaid do not reimburse health care providers for off-label uses. Because drug companies make large profits from off-label prescriptions, they are often tempted to …

Re Canada Post Corp And Cupw (Paris), Innis Christie

Innis Christie Collection

The Grievor had previously been reinstated to her position, with certain conditions. This grievance was submitted by the Union after the Grievor was again discharged for a positive drug test. The parties agreed to a consent award.

This is a consent award. A "last chance" reinstatement is ordered for the Grievor with numerous conditions, which include a treatment program. Jurisdiction is retained regarding any further alleged breach, but not to modify penalty.

The Road To The Antiquities Act And Basic Preservation Policies It Established, Francis P. Mcmanamon

Celebrating the Centennial of the Antiquities Act (October 9)

3 pages.

Soboba Band Of Luiseño Indians Settlement Agreement, Soboba Band Of Luiseño Indians Et Al

Native American Water Rights Settlement Project

Settlement Agreement: Soboba Band of Luiseño Indians Settlement Agreement of June 7, 2006, (final signatures Oct. 18, 2008) Parties: Soboba Band of Luiseño Indians, US, Eastern Municipal Water District, Lake Hemet Municipal Water District and Metropolitan Water District of Southern California. The Tribe is entitled to 9K acre-feet annually (afy) as a prior and paramount right. The districts agree to supply the Tribe water to the extent that it is not able to produce that amount. However, the Tribe agrees to limit its exercise of the right to 4,100 afy for 50 years. The Tribe may use water made available …

After Autonomy, Carl E. Schneider

Articles

Bioethicists today are like Bolsheviks on the death of Lenin. They have, rather to their surprise, won the day. Their principle of autonomy is dogma. Their era of charismatic leadership is over. Their work of Weberian rationalization, of institutionalizing principle and party, has begun. The liturgy is reverently recited, but the vitality of Lenin's "What Is To Be Done?" has yielded to the vacuity of Stalin's "The Foundations of Leninism." Effort once lavished on expounding ideology is now devoted to establishing associations, organizing degree programs, installing bioethicist commissars in every hospital, and staffing IRB soviets. Not-so-secret police prowl the libraries …

Hearing On Merger Enforcement, Panel On Treatment Of Efficiencies Antitrust Modernization Commission, Jonathan Baker

Congressional and Other Testimony

No abstract provided.

Is Prosecution "Medically Appropriate"?, Douglas Mossman Md

Faculty Articles and Other Publications

Each year, U.S. courts send thousands of incompetent defendants to hospitals for treatment, where psychiatrists frequently administer psychotropic medication that can alleviate symptoms and allow the defendants to proceed with criminal adjudication. Although defendants and their attorneys usually do not object to such treatment, treatment refusals in two recent, nationally prominent cases-those of Russell Eugene Weston, Jr., the accused Capitol shooter, and Charles T. Sell, a dentist charged with filing false insurance claims-have focused legal and media attention on whether and under what conditions competence restoration can be forced on an unwilling defendant.

In its June 2003 decision in Sell …

Water Conservation Plan, Rocky Boy / North Central Montana Regional Water System (2004), Hkm Engineering

Native American Water Rights Settlement Project

Tribal Water Code: Water Conservation Plan, Rocky Boy / North Central Montana Regional Water System (Sep. 2004). Parties: Chippewa-Cree Tribe and NCM-RWS. The Rocky Boy/North Central Montana Regional Water System Act of 2002 (Pub. L. 107-331) authorized construction of the Rocky Boy/North Central Montana Regional Water System in north-central Montana. To meet the requirements of the Act, the Chippewa Cree Tribe and the North Central Montana Regional Water Authority developed and submitted a water conservation plan to Reclamation. The purpose of this water conservation plan is to ensure that users of water from the core system, non-core system and the …

Extremely Preterm Birth And Parental Authority To Refuse Treatment: The Case Of Sidney Miller, George J. Annas

Faculty Scholarship

Disputes between physicians and patients over medical care have tended toward resolution in both the courts and ethics committees, with each of these bodies ultimately deciding that the informed, competent patient must be the final decision maker. Parents, too, have the authority to make medical decisions for their children, but these decisions can be challenged if physicians do not believe they are medically reasonable. One bioethical issue, however, is as intractable today as it was 30 years ago, when it began to be publicly discussed: the extent of parental authority to refuse life-sustaining medical treatment for an extremely premature infant. …

The Right To Health And The Nevirapine Case In South Africa, George J. Annas

Faculty Scholarship

Thanks to activists in South Africa, the right to health as a human right has returned to the international stage, just as it was being displaced by economists who see health through the prism of a globalized economy and by politicians who see it as an issue of national security or charity. The current post-apartheid debate in South Africa is not about race but about health, and in this context, the court victory by AIDS activists in the nevirapine case has been termed not only, as stated in one British newspaper, “the greatest defeat for [President Thabo] Mbeki's government” but …

Managing At-Risk Juvenile Offenders In The Community: Putting Evidence Based Principles Into Practice, Randy Borum

Mental Health Law & Policy Faculty Publications

More than a half-million juveniles are under community supervision as a result of violent or delinquent behavior. Research has shown that treatment can reduce their risk of reoffending. This article reviews and distills the key lessons from hundreds of empirical studies and metaanalyses and applies them to practice. The author argues for conducting systematic and developmentally informed risk assessments, selectively assigning intensive intervention to the highest risk offenders, focusing on criminogenic treatment targets, using proven interventions and treatment strategies, and applying rigor in implementation and follow-up.

The Girl Who Cried Pain: A Bias Against Women In The Treatment Of Pain, Diane E. Hoffmann, Anita J. Tarzian

Faculty Scholarship

In general, women report more severe levels of pain, more frequent incidences of pain, and pain of longer duration than men, but are nonetheless treated for pain less aggressively. The authors investigate this paradox from two perspectives: Do men and women in fact experience pain differently - whether biologically, cognitively, and/or emotionally? And regardless of the answer, what accounts for the differences in the pain treatment they receive, and what can we do to correct this situation?

A Plea For Rationality And Decency: The Disparate Treatment Of Legal Writing Faculties As A Violation Of Both Equal Protection And Professional Ethics, Peter Brandon Bayer

Scholarly Works

This article builds on the work of others by demonstrating that as a matter of academic ethics, informed by cardinal legal standards of decency, the disparate treatment and adverse terms and conditions imposed on writing professors are not simply unfair but defy the ethical aspirations of American law schools. Specifically, as the construct for analysis, this article establishes and utilizes the proposition that the discordant status of legal writing professors fails to satisfy minimal professional ethics. As a model, this article shows that it is not even minimally rational under the Equal Protection Clause of the United States Constitution, our …

Shivwits Band Of The Paiute Indian Tribe Of Utah Water Rights Settlement Act Of 2000, United States 106th Congress

Native American Water Rights Settlement Project

Federal Legislation: Shivwits Band of the Paiute Indian Tribe of Utah Water Rights Settlement, PL 106-263, 114 Stat. 737 ( Aug. 18, 2000) Parties: US, City of St. George, & Shivwits Band of the Paiute Indian Tribe of Utah. (Not other Bands of Ut Paiute Tribe) The Act provides for St. George (Utah) Water Reuse to divert and transport water for use by City of St. George and the Shivwits Band (2K acre-feet annually). St. George and the Band ($15M) will pay for the project. The Santa Clara Project will deliver 1,900 acre-feet annually to the Band. This project will …

The Last Resort: The Use Of Physical Restraints In Medical Emergencies, George J. Annas

Faculty Scholarship

Public awareness of the use of restraints in medicine has been greatly heightened by a five-part investigative series on physical restraints in psychiatric hospitals by the Hartford Courant and reaction to it by Connecticut's U.S. senators, Joseph Lieberman and Christopher Dodd. In October 1998 the Courant 's 50-state survey identified 142 patients who had died while in restraints or seclusion in the past decade, and the total number is probably much higher. The newspaper advocated the need for national standards for the use of restraints, impartial oversight, and accountability “for behavior that is cruel and even criminal.” The use of …

A National Bill Of Patients' Rights, George J. Annas

Faculty Scholarship

In one of the most enthusiastically received proposals in his January State of the Union address, President Bill Clinton called on Congress to enact a national bill of rights in health care. The President said, “You have the right to know all your medical options, not just the cheapest. You have the right to choose the doctor you want for the care you need. You have the right to emergency room care, wherever and whenever you need it. You have the right to keep your medical records confidential.”

Informed Consent, Cancer, And Truth In Prognosis, George J. Annas

Faculty Scholarship

Barbara Tuchman records that during the Black Death epidemic in the early 14th century, “doctors were admired, lawyers universally hated and mistrusted”. The great plagues and wars of the Middle Ages produced a “cult of death,” including a vast popular literature that had death as its theme. As the 20th century closes, our emphasis is on the denial of death, and the honest discussion of death remains rare both in popular literature and in conversations between physicians and patients. This is one reason why Shana Alexander shocked a national conference of bioethicists last year by saying, “I trust my lawyer …

Fort Mcdowell Indian Community Water Settlement (Yavapai Nation), Fort Mcdowell Indian Community, United States, State Of Arizona, Salt River Valley Water User's Association, Salt River Project Agricultural Improvement And Power District, Roosevelt Water Conservation District, Central Arizona Water Conservation District, Phoenix, Az, Scottsdale, Az, Glendale, Az, Mesa, Az, Tempe, Az, Chandler, Az, Town Of Gilbert

Native American Water Rights Settlement Project

Settlement: Fort McDowell Indian Community Water Settlement (Jan. 15, 1993) Parties: Fort McDowell Indian Community, Yavapai Nation, Arizona, US, Salt River Valley Water Users Association, Salt River Project Agricultural Improvement and Power District, Roosevelt Water Conservation District, Chandler, Glendale, Mesa, Phoenix, Scottsdale, Tempe, Gilbert, and Central AZ Water Conservation District. Overall plan is to find enough water to irrigate 4,000 acres with a duty of 4.5 a/f/y and support 18,350 acres with a duty of 1 a/f/y. of urban development. With an exception for the Verde River Spill Water, total diversion (all from above Granite Reef Dam) is limited to …

Defining The Right To Die, David M. English

Faculty Publications

Although Friedrich Nietzsche was not noted for his views on medical ethics, the above quotation captures the essence of James Lindgren's article. Lindgren posits that the recent O'Connor' and Cruzan decisions signal a shift in the law on the withdrawal or withholding of treatment. He concludes that the requirement set forth in those cases-that an individual must have clearly and convincingly expressed his or her wishes before treatment can be terminated--errs unduly on the side of life. Basing his conclusion primarily on preferences revealed by public opinion polls, he contends that a better rule would be to presume, subject to …

Control Of Tuberculosis -- The Law And The Public's Health, George J. Annas

Faculty Scholarship

In their history of tuberculosis, The White Plague, Rene and Jean Dubos note that the first national movement to control tuberculosis in the United States came from the Medico-Legal Society of the City of New York, a group of lawyers, scientists, and physicians devoted to solving social problems. At a meeting in 1900 to organize an American Congress on Tuberculosis, the group drafted legislation designed to prevent the spread of the disease. Even though almost every state eventually passed tuberculosis-control laws, it was not the passage of legislation, or even the development of effective treatment, that led to the decline …

Finessing The Siting Conundrum, Michael B. Gerrard

Faculty Scholarship

There is a place that today's industrial society desperately wishes to find. In prior eras, people sought Nirvana or the Fountain of Youth or Shangri-La – states of mind (or nothingness) as much as places, really. The object of today's quest has no neighbors, no endangered or threatened species, no hydraulic link to precious groundwater; ideally, it has no connection to the biosphere at all.

That place is called "away," as in, "Let's dig up this contamination and haul it away," or, "We need to take this waste away." The public and private sectors in the United States have spent …

Legislative Control Of Air Pollution & Water Pollution Of The P.R. China, Longan Xiao

New Challenges for Environmental Protection: Second Sino-American Conference on Environmental Law (October 12-13)

10 pages.

Equitable Access To Biomedical Advances: Getting Beyond The Rights Impasse, Wendy K. Mariner

Faculty Scholarship

In 1988, gay rights activists and supporters demonstrated outside a Food and Drug Administration building demanding unrestricted access to experimental drugs being tested for the treatment of human immunodeficiency virus ("HIV") infection and acquired immunodeficiency syndrome ("AIDS").² Across the ocean in France, in October of the same year, came an equally insistent demand from women's groups, scientists, and family planning agencies that the pharmaceutical company Groupe Roussel Uclaf put its abortifacient RU 486 back on the market.' Early in 1989, people were outraged when newspapers reported that New Hampshire's Medicaid program would not pay for a life-saving bone marrow …

Salt River Pima-Maricopa Indian Community Water Rights Settlement Agreement Of 1988, Salt River Pima-Maricopa Indian Community Et Al

Native American Water Rights Settlement Project

Settlement Agreement: Salt River Pima-Maricopa Indian Community Water Rights Settlement Agreement of 1988. Parties: US, AZ, Salt River Pima-Maricopa Indian Community, Salt River Project Agricultural Improvement and Power District, Salt River Water Users Association, Roosevelt Water Conservation District, Roosevelt Irrigation, Chandler, Glendale, Mesa, Phoenix, Scottsdale, Tempe, Gilbert,Central AZ Water Conservation District. Contains stipulations, sources of water, expected groundwater recharge, Kent water, Bartlett Dam water, spill water, contracts with cities such as Phoenix, limitations on use, CAP water leasing and multiple exhibits.Exhibits 2.17-3.d of SRPMIC Settlement includes a "Map of SRPMIC Reservation" and several cases: Salt River Pima-Maricopa Indian Community v. …

The Right Of Elderly Patients To Refuse Life-Sustaining Treatment, George J. Annas

Faculty Scholarship

Some legislation, such as law permitting living wills, has addressed the problem of decisions regarding life-sustaining treatment for the elderly. Most of the developing law on the subject is, however, being made by the courts, often in prospective decisions about treatment. These rulings have followed a variety of approaches to the ends of protecting incompetent patients and enforcing the right of the competent to make their own decisions.

The Right To Refuse Treatment: A Model Act, George J. Annas

Faculty Scholarship

Although the right to refuse medical treatment is universally recognized as a fundamental principle of liberty, this right is not always honored. A refusal can be thwarted either because a patient is unable to competently communicate or because providers insist on continuing treatment. To help enhance the patient's right to refuse treatment, many states have enacted so-called "living will" or "natural death" statutes. We believe the time has come to move beyond these current legislative models, and we therefore propose a Model Act that clearly enunciates an individual's right to refuse treatment, does not limit its exercise to the terminally …

The Resource Conservation And Recovery Act And Mineral Development, Robert E. Hamel

Federal Lands, Laws and Policies and the Development of Natural Resources: A Short Course (Summer Conference, July 28-August 1)

30 pages.