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Articles 1 - 13 of 13
Full-Text Articles in Law
What Recourse?—Liability For Managed Care Decisions And The Employee Retirement Income Security Act, Wendy K. Mariner
What Recourse?—Liability For Managed Care Decisions And The Employee Retirement Income Security Act, Wendy K. Mariner
Faculty Scholarship
Should managed-care organizations be accountable to patients injured by the company's negligence or wrongdoing? The general rule is that all organizations, including managed-care organizations, are legally liable for causing personal injury as a result of their own negligence or the negligence of their employees or agents.1-4 However, as most observers of the U.S. health care system know by now, there is an exception to this basic legal rule of accountability. The Employee Retirement Income Security Act of 1974 (ERISA) has been interpreted to grant health benefit plans provided by employers or unions (and the managed-care organizations that sell or …
Regulating Research With Decisionally Impaired Individuals: Are We Making Progress?, Diane E. Hoffmann, Jack Schwartz, Evan G. Derenzo
Regulating Research With Decisionally Impaired Individuals: Are We Making Progress?, Diane E. Hoffmann, Jack Schwartz, Evan G. Derenzo
Faculty Scholarship
No abstract provided.
Social Risk And The Transformation Of Public Health Law: Lessons From The Plague Years, Elizabeth B. Cooper
Social Risk And The Transformation Of Public Health Law: Lessons From The Plague Years, Elizabeth B. Cooper
Faculty Scholarship
Acquired Immune Deficiency Syndrome (AIDS) was the wake-up call that disturbed America from its mid-twentieth century slumber concerning the dangers of communicable diseases. Until AIDS was identified in 1981, most Americans felt largely impervious to health threats posed by viruses or bacteria. Polio, smallpox, and tuberculosis had been brought under control by the "magic bullets" of antibiotics and vaccines." We felt more susceptible to the ravages of cancer or the debilitation of heart disease. But, over the last twenty years, the (re)emergence of serious or life-threatening microbial- based conditions such as Ebola, hantavirus, Lyme disease, West Nile virus, and even …
Hormone Replacement Therapy, Or Just Eat More Meat: The Technological Hare Vs. The Regulatory Tortoise, Leticia M. Diaz
Hormone Replacement Therapy, Or Just Eat More Meat: The Technological Hare Vs. The Regulatory Tortoise, Leticia M. Diaz
Faculty Scholarship
Is meat with its high fat content the real culprit, or is it the FDA-approved growth hormones, the same hormones that have been rejected in Europe, that should bear the blame? Why is eating less meat associated with a lower incidence of many types of cancer? Could it be chemical overload? American women are about five times more likely to develop breast cancer than are women in less developed countries.
Drug Treatment Courts And Emergent Experimentalist Government, Michael C. Dorf, Charles F. Sabel
Drug Treatment Courts And Emergent Experimentalist Government, Michael C. Dorf, Charles F. Sabel
Faculty Scholarship
Despite the continuing "war on drugs," the last decade has witnessed the creation and nationwide spread of a remarkable set of institutions, drug treatment courts. In drug treatment court, a criminal defendant pleads guilty or otherwise accepts responsibility for a charged offense and accepts placement in a court-mandated program of drug treatment. The judge and court personnel closely monitor the defendant's performance in the program and the program's capacity to serve the mandated client. The federal government and national associations in turn monitor the local drug treatment courts and disseminate successful practices. The ensemble of institutions, monitoring, and pooling exemplifies …
Introduction: Fifteenth Anniversary Of The Edward V. Sparer Public Interest Law Fellowship Program, Elizabeth M. Schneider
Introduction: Fifteenth Anniversary Of The Edward V. Sparer Public Interest Law Fellowship Program, Elizabeth M. Schneider
Faculty Scholarship
No abstract provided.
Are Ethics Committee Members Competent To Consult?, Diane E. Hoffmann, Anita J. Tarzian, J. Anne O'Neil
Are Ethics Committee Members Competent To Consult?, Diane E. Hoffmann, Anita J. Tarzian, J. Anne O'Neil
Faculty Scholarship
No abstract provided.
Rules For Research On Human Genetic Variation: Lessons From Iceland, George J. Annas
Rules For Research On Human Genetic Variation: Lessons From Iceland, George J. Annas
Faculty Scholarship
Research on genetic variation aims to understand how genes function and requires the comparison of DNA samples from groups of individuals to identify variations that might have importance for health or disease. This work is easier if the samples are linked to accurate medical records and genealogic information. Iceland has medical records for all its citizens going back to World War I and detailed genealogic information going back even further. Because Iceland's small population (270,000) has long been isolated and homogeneous, it is thought by many to be an ideal place to search for disease-related genes. Journalists have cavalierly labeled …
Symposium: Advances In Biomaterials And Devices, And Their Financing, Michael S. Baram, Ronald A. Cass, Steven Bauer, Joyce Wong, Martin Yarmush, Joshua Tolkoff, Rufus King
Symposium: Advances In Biomaterials And Devices, And Their Financing, Michael S. Baram, Ronald A. Cass, Steven Bauer, Joyce Wong, Martin Yarmush, Joshua Tolkoff, Rufus King
Faculty Scholarship
My name is Professor Michael Baram and I direct the Center for Law and Technology here at the law school. Today's meeting is the third annual Technology Law Symposium to be held here, sponsored by the high technology law firm of Testa, Hurwitz & Thibeault, LLP and the Center for Law and Technology.
Our meeting today is focused on an exciting area of research and product development. This area involves the use of conventional as well as new genetically engineered biomaterials in new medical device configurations for implantation and with the purpose of restoring bodily functions, regenerating tissue, bone, cartilage, …
Adverse Drug Reactions: Harnessing Experiential Data To Promote Patient Welfare, Barbara A. Noah
Adverse Drug Reactions: Harnessing Experiential Data To Promote Patient Welfare, Barbara A. Noah
Faculty Scholarship
Part I of this Article evaluates the pre-approval and post-approval regulatory framework governing prescription drugs, and the FDA's spontaneous reporting system for adverse events, as it contrasts that system with the regulatory mechanisms used to monitor risks associated with other products. Part II summarizes the recent series of prescription drug marketing withdrawals prompted by reports of unexpected adverse reactions. Finally, Part III offers some possible solutions designed to improve the efficiency of postapproval surveillance so that fewer patients will suffer the consequences of unexpected adverse drug reactions and interactions. This Article concludes that the existing regulatory system requires fundamental reprioritization …
Ulysses And The Fate Of Frozen Embryos - Reproduction, Research, Or Destruction?, George J. Annas
Ulysses And The Fate Of Frozen Embryos - Reproduction, Research, Or Destruction?, George J. Annas
Faculty Scholarship
On his 10-year voyage back to Ithaca from the Trojan War, Ulysses was warned by Circe to take precautions if he wanted to hear the Sirens' transfixing song, or there would be “no sailing home for him, no wife rising to meet him, /no happy children beaming up at their father's face.” Ulysses accordingly ordered his men to stop their ears with beeswax and bind him firmly to the mast and instructed them that if he gestured to be set free, they should stick to the original agreement and bind him tighter still. Making an agreement that has as a …
Tobacco, The Food And Drug Administration, And Congress, George J. Annas
Tobacco, The Food And Drug Administration, And Congress, George J. Annas
Faculty Scholarship
Smoking has been the number-one target of public health professionals in the United States for more than a decade because it is the leading cause of premature death. Nonetheless, no unified public health strategy has been developed. In 1995, with the strong endorsement of President Bill Clinton and Vice President Al Gore, the commissioner of the Food and Drug Administration (FDA), Dr. David Kessler, announced that the agency had jurisdiction over tobacco and would regulate cigarettes as “drug-delivery devices.”1 The tobacco companies objected and sued the FDA, arguing that Congress had not given the FDA jurisdiction over their product. …
Symposium: Regulatory And Liability Considerations, Michael S. Baram, Ellen Flannery, Patricia Davis, Gary Marchant
Symposium: Regulatory And Liability Considerations, Michael S. Baram, Ellen Flannery, Patricia Davis, Gary Marchant
Faculty Scholarship
You can tell from remarks by prior speakers that regulatory approvals and liability prevention are of critical importance to progress in biomaterials. Gene therapy trials and the tragic outcomes of some of those trials have raised the specter of government suspension of clinical studies, termination of funding, and potential liability for personal injury under malpractice or products liability doctrines. Regulatory requirements and the terms of research grants and contracts have to be very carefully addressed by organizations testing, developing, making, selling and using biomaterials, biotechnology, and medical devices. However, many regulatory requirements are incomplete, ambiguous and confusing because the agencies …