Clinical OMICs - Issue 7 - (Page 16)
Will Liability Drive
Personalized Medicine?
Gary E. Marchant, J.D., Ph.D., and Rachel A. Lindor, M.D., J.D.
M
edical malpractice lawsuits are a double-edged sword. On the one
hand, liability can compensate injured patients and push providers
to implement the most up-to-date technologies and practices. On
the other, the threat of liability can result in wasteful defensive medicine
and drive up insurance premiums.
New medical technologies such as personalized medicine trigger both edges of the
liability sword. On the positive side, the threat of liability may compel providers to
more quickly uptake useful genetic tests and data, but on the negative new liability
risks and uncertainties created by personalized medicine may incentivize premature
or inappropriate utilization of genetic tests and drive up insurance premiums.
After a somewhat slow start, there is now a rapid, albeit somewhat bumpy, acceleration in the clinical use of genetic and other molecular tests to customize healthcare
diagnosis and treatment based on an individual patient's profile. The emergence of
whole-genome sequencing and noninvasive prenatal testing will further
expand the clinical availability and use of genetic information.
GARY MARCHANT,
This new era of clinical genetics can pose new liability risks to all parJ.D., Ph.D.,
ties in the personalized medicine life cycle, including researchers, drug
is Regents' Professor and
Lincoln Professor of Law,
manufacturers, test developers, testing laboratories, physicians, genetic
Science & Innovation at
counselors, and even pharmacists. There are several warning signs, howthe Sandra Day O'Connor
ever, that this rapid growth in genetic data and technologies will present
College of Law at Arizona
a particularly significant and growing liability risk to health care providers,
State University.
in particular physicians.
(gary.marchant@asu.edu)
RACHEL LINDOR,
M.D., J.D.
is a resident at the Mayo
Clinic in Rochester, MN.
16
Clinical OMICs July 16, 2014
Lack of Training and Knowledge
First, most physicians lack significant training and knowledge in clinical
genetics, and specialists in genetic medicine or genetic counseling are in
extremely short supply. Important opportunities in which genetic testing could be useful in diagnosis or treatment are overlooked, and when
genetic tests are conducted, the significance and implications of the
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Contents
Clinical OMICs - Issue 7
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