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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