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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 …
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 …