The Journal of Health and Life Sciences Law is published four times a year in coordination with LexisNexis, and will contain in-depth, professionally reviewed articles of interest to healthcare attorneys -- including those who represent researchers, board members, institutions, practitioners, employers, and multi-state entities. The Journal will also contain "Notes and Comments" focused on new ideas as well as current developments, as well as "Practice Resources" which will help the reader excel in their practice-checklists, glossaries, reference tools and other useful items.
Articles featured in Volume II, Issue #1 (October 2008):
Patient-Tailored Medicine, Part One: The Impact of Race and Genetics on Medicine -- American Health Lawyers Association's Advisory Council on Racial and Ethnic Diversity Limitations on the Use of the False Claims Act to Enforce Quality of Care Standards -- John T. Brennan, Jr. and Michael W. Paddock The Ins and Outs of Independent IRBs -- Janet M. Lis and Melinda G. Murray Implementing Donation After Cardiac Death Protocols -- Suzanne A. Fidler Physician-Vendor Marketing and Financial Relationships Under Attack -- John R. Washlick and Sidney Summers Welch Practice Resource: Disparate Treatment of Employees with Caregiving Responsibilities: Examples of Unlawful Discrimination -- Elena D. Marcuss and Simona F. Cole
Patient-Tailored Medicine, Part One: The Impact of Race and Genetics on Medicine
American Health Lawyers Association's Advisory Council on Racial and Ethnic Diversity
ABSTRACT: One of the more controversial elements of advancing technology is the use of race and genetics to help create more specific types of medicines that will help combat diseases and conditions that appear to be more prevalent within certain races or ethnic groups than in others. Considering the history of discrimination and inadequate treatment of individuals on the bases of race and gender in the United States, there is justifiable concern that race or gender-based treatment could be used to legitimate discrimination. On the other hand, there is substantial proof that the current method of creating medicines for the general public is problematic and could prevent effective treatments from reaching the marketplace. Part One of this series addresses the relevance of genetic information, and how race and genetics have affected and may impact the development of medicines, pharmacogenomics, and personalized medicine in the United States. Part Two, which will appear in the next issue of the Journal of Health and Life Sciences Law, will focus on how personalized medicine may affect the American legal, regulatory, and legislative environment.
Limitations on the Use of the False Claims Act to Enforce Quality of Care Standards
John T. Brennan, Jr. and Michael W. Paddock
ABSTRACT: The False Claims Act (FCA) is established as the federal government?s prosecutorial weapon of choice in combating fraud and abuse in healthcare today. The FCA's substantial penalties present potential defendants with daunting risks should they elect to put the government?s case to the test at trial. The government and relators have sought to extend the contours of the FCA's coverage beyond actions involving "factually false" claims to pursue cases involving alleged violations of other laws that give rise to "legally false" claims. This article considers the viability of the legal bases upon which the FCA may be used in this regard, with specific attention to the appropriateness of implied and express false certification liability theories to punish violations of the Medicare Conditions of Participation. It is the thesis of this article that on both sound legal and policy grounds, the FCA is not an appropriate tool for punishing the failure to provide quality care, unless the quality of care provided is so substandard as to result in a factually false claim (e.g., the services billed were not actually rendered).
The Ins and Outs of Independent IRBs
Janet M. Lis and Melinda G. Murray
ABSTRACT: Independent institutional review boards (IRBs) are playing an increasingly important role in the review of human subjects research. Many research institutions have been hesitant to use independent IRBs because regulatory recognition of their use has been inconsistent and clear guidance has been lacking. The authors review the evolution of the independent IRB and address how acceptance has differed between the two primary regulatory agencies, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The article briefly describes the history of independent IRBs, how they currently fit into the regulatory schemes of HHS and FDA, factors relating to the decision to use an independent IRB (including advantages and disadvantages of their use), factors to consider when selecting an independent IRB, practical guidelines for use of an independent IRB by a research institution, and contractual issues involved in implementing a relationship with an independent IRB.
Implementing Donation After Cardiac Death Protocols
Suzanne A. Fidler ABSTRACT: As organ transplantation becomes increasingly successful and the demand for organs outnumbers available organs, the transplantation community has revived the transplantation process of donation after cardiac death (DCD). In DCD donation, organ procurement begins once the donor's cardiopulmonary function ceases. This is in contrast to the more common practice of donation after brain death (DBD), where organ procurement begins once the donor is declared brain dead -- even while the donor's cardiopulmonary function is artificially supported to perfuse and maintain the donor's organs. In January 2007, the Joint Commission required hospitals, in coordination with their Organ Procurement Organizations (OPO),* either to create donation after cardiac death policies or document efforts to formulate the policies and justifications for opting out. As DCD practice grows, legal and ethical issues surface. This article will discuss these legal and ethical issues, including determining a donor's death based on the irreversible cessation of cardiopulmonary function, procedures conducted on the donor for the benefit of the donee, informed consent and the surrogate decisionmaker, choosing appropriate DCD candidates, and conflicts of interest. This article will summarize general recommendations for donor candidate selection, consent and approval, withdrawal of life-sustaining measures, criteria for determining death, organ recovery, and financial considerations.
Physician-Vendor Marketing and Financial Relationships Under Attack
John R. Washlick and Sidney Summers Welch* ABSTRACT: The appropriateness of gifts, payments, and other remuneration paid to those in a position to influence the purchase or distribution of pharmaceuticals, medical devices, and other goods and services -- or those who sell and distribute those goods and services -- has come under increased government scrutiny. While providers and vendors scramble to respond to growing concern over potential conflicts of interest and undue influence, federal and state legislators have introduced legislation targeting provider/vendor relationships and regulators have launched significant enforcement actions. This article describes common industry practices, potential legal implications, physician and industry responses, federal and state legislative initiatives, and compliance planning.
PRACTICE RESOURCE
Disparate Treatment of Employees with Caregiving Responsibilities: Examples of Unlawful Discrimination
Elena D. Marcuss and Simona F. Cole
Worldwide
Leadership
