Assessing Legal Liability in Parmacogenetic Cases
![handle is hein.journals/wasbur42 and id is 637 raw text is: Assessing Legal Liability in Pharmacogenetic Cases
Victoria M. Kumorowski*
I. INTRODUCTION
A 1994 study disclosed that [a]dverse drug reactions are a major
cause of death in the United States.' The study also disclosed that
an estimated 2 million hospitalized patients suffer from severe [ad-
verse drug reactions] annually, even when the drugs are prescribed
and administered appropriately.'2 Fortunately, recent advances in ge-
netic research are revealing why individuals vary so much in their re-
sponses to prescription drugs, and these advances are promoting the
development of safer and more effective prescription drugs.3
Studies of the human genome continue to illuminate the critical
roles that genes play in predisposing individuals to diseases and in
producing beneficial or adverse drug reactions.4 Those studies show
that the genetic codes of all human beings are 99.9 percent identical
and that only 0.1 percent of human DNA is responsible for the indi-
vidual differences in response to different prescription drugs.5 They
reveal that individual variations in drug response are primarily caused
by alternative forms of genes, called polymorphisms, which can now
be detected on genetic scanners.6
This new genetic knowledge is rapidly transforming our under-
standing of health and disease.7 It is revolutionizing both the practice
of medicine and the pharmaceutical industry.8 A new field of science,
called pharmacogenetics, is developing which aims to produce and
market prescription drugs that will be suitable for individuals with cer-
tain genotypes. Genetic tests, designed to weed out individuals who
* J.D., Washburn University School of Law; Masters of Law in Tax, University of Mis-
souri School of Law at Kansas City; Masters of Judicial Studies, University of Nevada at Reno;
Masters of Divinity, Phillips Theological Seminary. This response was influenced in part by LE-
GAL RIGHTS AND HUMAN GENETIC MATERIAL (Bartha Maria Knoppers et al. eds., 1996). Many
thanks to the participants and organizers of the Ahrens Tort Symposium on Genomic Torts, to
Dean Dennis Honabach, to Professor Charlene Smith, and to Edward M. Kumorowski, for all of
his assistance.
1. Catherine Yetter Read, Pharmacogenomics: An Evolving Paradigm for Drug Therapy.
11 MEDSURG NURSING 122, 123 (June 2002); see also NAT'L CTR. FOR BIOTECHNOLOGY INFO.,
JUST THE FACTS: A BASIC INTRODUCTION TO THE SCIENCE UNDERLYING NCBI RESOURCES,
ONE SIZE DOES NOT FIT ALL: THE PROMISE OF PHARMACOGENOMICS, at http://www.ncbi.nlm.
nih.gov/About/primer/pharm.html (last revised Feb. 13, 2003).
2. Read, supra note 1, at 123 (citing Jason Lazarou et al., Incidence of Adverse Drug Reac-
tions in Hospitalized Patients: A Meta-analysis of Prospective Studies, 279 JAMA 1200-05
(1998)).
3. Id. at 122.
4. Chris Myers et al., Genomics: Implications for Health Systems, 17 FRONTIERS HEALTH
SERVICES MGMT. 316 (2001).
5. Read, supra note 1, at 122.
6. Id.
7. NICHOLAS WADE, LIFE SCRIPT: HOW THE HUMAN GENOME DISCOVERIES WIIL
TRANSFORM MEDICINE AND ENHANCE YOUR HEALTH 7 (2001).
8. See id. at 8-9.](ViewImageLocal?handle=hein.journals/wasbur42&div=35&collection=&method=preview&ext=.png&size=3)
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Assessing Legal Liability in Parmacogenetic Cases
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