Law Commons^™

Verify, Then Trust: How To Legalize Off-Label Drug Marketing, Fazal Khan, Justin Holloway

Scholarly Works

This article will discuss the current state of off-label medicine, relevant legislation in the area, and a proposal designed to capture the benefits of off-label medicine while limiting its dangers when practiced perniciously. Part II will discuss the regulations in place governing off-label promotion and will detail the practice of ghostwriting and its associated concerns. Part III will analyze the costs and benefits of off-label marketing and practice of medicine, and will utilize a case study to demonstrate the predicament of drug manufacturers. Part IV will set forth a proposal to use the newly created Patient-Centered Outcomes Research Institute to …

Amici Curiae Brief In Support Of Petitioners Urging Reversal On The Minimum Coverage Provision Issue, Department Of Health And Human Services V. State Of Florida, Wendy Parmet, Lorianne Sainsbury-Wong

Faculty Scholarship

This amicus brief was filed before the Supreme Court in the Affordable Care Act (ACA) litigation on behalf of Health Care for All and other Massachusetts organizations that have been involved in the implementation of Massachusetts’ health 2006 health reform legislation. The brief argues that Massachusetts’ health reform law, upon which the ACA is modeled, has been very effective in expanding insurance coverage within the State, but it required substantial federal support, through a Medicaid waiver, to achieve its success. In addition the Commonwealth’s experience illustrates that the health insurance and health care markets are inherently interstate commerce and that …

Introduction - Symposium Issue On Health Data Security Systems, Sharona Hoffman

Faculty Publications

Introduction to the Health Data Security System symposium 2012 Huston, TX.

Professional Power And The Standard Of Care In Medicine, Maxwell J. Mehlman

Faculty Publications

Since before the founding of the Republic, American medicine has been fighting a war to control the standard of care that physicians are expected to provide to their patients. It has waged battles on two fronts: against internal disagreements within the profession over what constitutes proper care, and against attempts to delineate the standard of care by forces outside the profession, such as private health insurers, the government, and the judicial system.

Substitute Decision Making About Research: Identifying The Legally Authorized Representative In Four Canadian Provinces, Sheila Wildeman, Gina Bravo, Marie-France Dubois, Carole Cohen, Janice Graham, Karen Painter, Suzanne Bellemare

Articles, Book Chapters, & Popular Press

When an adult is legally incapable of deciding whether to participate in health research, who (if anyone) has the legal authority to make that decision? Furthermore, how well do Canadians with a stake in health research, such as older adults, informal caregivers of older persons with cognitive impairments, researchers in aging, and members of research ethics boards (“REBs”), understand the state of the law on this question? These two interrelated matters are addressed by our study.

We find that the laws of the four provinces we target are frequently unclear as to whether, or in what circumstances, a guardian, proxy …

Rethinking The New Public Health, Lindsay Wiley

Articles in Law Reviews & Other Academic Journals

This Article contributes to an emerging theoretical debate over the legitimate scope of public health law by linking it to a particular doctrinal debate in public nuisance law. State and local governments have been largely stymied in their efforts to use public nuisance litigation against harmful industries to vindicate collectively-held, common law rights to non-interference with public health and safety. The ways in which this litigation has failed are instructive for a broader movement in public health that is only just beginning to take shape. In response to evolving scientific understanding about the determinants of health, public health advocates are …

All For One And One For All: Informed Consent And Public Health, Jessica Wilen Berg

Faculty Publications

The concept of informed consent is well established in the field of bioethics, but its application is unclear in the area of public health. The increasing prevalence of public health interventions creates a need to analyze the scope of government power as it relates to individual choice. This Article explores three different types of public health measures in which individual choice has been limited: (1) environmental interventions; (2) classic public health interventions to prevent contagious disease; and (3) public health information reporting or use. The reasons for limiting informed consent vary depending on the context, and the implications for the …

The Individual Mandate And The Taxing Power, Erik M. Jensen

Faculty Publications

This article, prepared for a symposium at the Salmon P. Chase College of Law, Northern Kentucky University, considers whether the Taxing Clause provides an alternative constitutional basis, as some have recently argued, for the individual mandate in the Patient Protection and Affordable Care Act of 21 - the requirement, going into effect in 214, that most individuals acquire satisfactory health insurance or pay a penalty. The article concludes that the Taxing Clause arguments are misguided. At best, the Clause can provide authority for the penalty, not for the mandate as a whole. Furthermore, the article questions whether the penalty will …