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18 Health Law. 1 (2005-2006)

handle is hein.journals/healaw18 and id is 1 raw text is: THE ABA HEALTH LAW SECTION H EALTH LAWYER IN THIS ISSUE Product Liability Protection for Stem Cell Research and Therapies - A Proposal .......... 1 A Review of The Patient Safety and Quality Improvement Act of 2005 ....... 20 HHS Proposes New Safe Harbor for Federally Qualified Health Centers .................. 24 An Overview of FEHBA and the Power of its Preemption .... 27 Recent Developments with Respect to the Stark Law Specialty Hospital Moratorium ........................ 34 Volume 18, Number 1 October 2005 PRODUCT LIABILITY PROTECTION FOR STEM CELL RESEARCH AND THERAPIES - A PROPOSAL James M. Wood, Esq., II. Stem Cell Research - Reed Smith, Oakland, CA, A Primer Areta L. Kupchyk, Esq., Californians are known for their Reed Smith, Washington, DC, populist efforts to improve their quality of and Jessica M. Perry, life via the ballot initiative. In November University of Michigan, Ann Arbor, MI 2004, Californians passed an initiative to fund all forms of stem cell research with the appropriation of $295 million each I. Introduction year for the next decade.' Many of the advocates for the measure were families Stem cell research presents as many affected by the diseases that are likely to scientific, legal and, when involving fetal benefit from this research.' tissue, ethical issues as it does potential ther- apies. Once the increasingly volatile debate he nubers i e v are staggering: over these issues is resolved, the promises of * 58 million Americans have stem cell research can be brought to clinical card io c A ri as therapies.' However, they can be just as readily undone without a formal legislative * 30 million suffer from autoimmune scheme that provides compensation for the disease; patient harmed while simultaneously * 16 million are diabetics; protecting the industry from unbridled liti- * 10 million are afflicted with gation. This article proposes such a liability osteoporosis; model for both patients receiving care or e 8.2 million have some form of those participating in a clinical trial. To do malignancy; so, this article summarizes the history of the * 5.5 million are Alzheimer's undoing of the vaccine industry by product patients.4 liability cases, identifies past efforts to mini- the key for developing cures for these mize liability in related endeavors (with conditions, urged by the promoters of the mixed results), and summarizes the elements initiative as well as many independent of a national compensation program. researchers, is the stem cell. continued on page 3

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