| Mark S. Sidoti is a partner with the law firm of
Gibbons, Del Deo Dolan, Griffinger & Vecchione, based in Newark, NJ,
and New York City. His legal practice predominantly focuses on the defense
of clinical laboratories in cytopathology and other laboratory litigation,
as well as risk management consulting with clinical laboratories, and
laboratory services technology and testing companies. He has lectured
on these issues to numerous organizations, including the Harvard Medical
School Department of Continuing Education, Armed Forces Institute of Pathology,
the American Society for Cytotechnology, and the International Academy
of Cytology. He was a member of the multidisciplinary National Cancer
Institute Bethesda 2001 Workshop Task Force, which reviewed issues regarding
terminology and reporting of cervical cytology. And he is on the editorial
board of CytoJournal, an open-access, peerreviewed cytopathology journal.
In the interest of full disclosure, Mr. Sidoti serves as a consultant
to Digene Corporation on risk management issues. Digene manufactures the
HPV DNA test.
What are the legal issues related to HPV DNA and cervical cancer
screening?
For years, the limitations of the conventional Pap test have been the
subject of vast media attention and sharp legal focus. Against that background,
the development and marked success of liquid-based cytology, credited
with dramatically improving sensitivity and reducing the limitations associated
with conventional preparations, have reached the point where many would
argue that this testing (or at least education of the patient about the
availability of this test) is, in fact, the standard of care in cervical
cancer screening.
Advances in HPV DNA detection and the implications of these results
for assessing the cervical cancer risk status of women are following a
similar path. In fact, a number of managed care and provider groups have
determined that current FDA approval and proven efficacy of certain HPV
tests justify endorsement of this technology and recommendation that it
become part of the diagnostic routine. It does seem that adoption of this
technology would provide clinicians with an effective approach to medical
and legal risk control, for their patients and themselves, respectively.
Those who feel that “standard of care” status for this technology
has not yet been formally attained may argue that they went “above
and beyond” the formally recognized standards in offering or providing
such testing to their patients, but—critically—did so in a
prudent manner given the proven test efficacy and the FDA’s formal
approval.
What are the benefits to clinicians and their patients to offering
HPV DNA testing?
While the health of their patient population is always paramount in
this analysis, the relationship of addressing this concern to the reduction
of liability risk for the practitioner should be apparent. Offering patients
HPV DNA testing within the FDA-approved parameters provides the following
benefits:
- Allows the clinician to reduce the overall number of cervical cancer
incidents which, in addition to clearly benefiting the patient population,
significantly reduces the risk of being involved in legal action arising
out of a “missed” cervical cancer diagnosis.
- Reduces reliance on the imperfect Pap test alone to determine the
risk status of the patient.
- Minimizes the effect of imperfect, patientprovided cytology and gynecological
symptomatology history in the risk assessment process.
- May minimize the effect of imperfect annual follow-up by patients
(although this is somewhat offset by the increased possibility of patients
being lost to follow-up as a result of the extended interval).
- Provides the clinician with the ability to claim that the newest
approved and proven effective technology was used (or offered) and supports
the clinician’s position that he or she has practiced consistent
with the highest standard of practice.
How does the legal issue of informed consent relate to HPV and
cervical cancer screening?
As mentioned briefly above, informed consent is an important legal issue
that relates to the adoption of new, proven technology in medical practice.
Today, in many jurisdictions, the informed consent standard is viewed
from the perspective of the “reasonable patient,” i.e., what
risks, complications, and alternatives would the reasonably prudent patient
wish to be advised of prior to the procedure. This patient-centric approach
to informed consent, many believe, places the emphasis where it should
be—on the health care consumer’s legitimate expectations in
receiving medical care or testing.
Advances in cervical cancer screening and detection are particularly
amenable to application of the “reasonably prudent patient”
informed consent standard. With HPV DNA testing, there is now available
an FDA-approved technology that has an established, proven efficacy, which
will provide women with greater assurances that they are cancer free,
or, conversely, allow them to be aware of a higher risk status and consequently,
be more vigilant and in control over a follow-up care designed to monitor
this status. Health care consumers are entitled to expect, therefore,
that clinicians make their patients aware of this technology and at least
offer them the option to accept or decline it, i.e., that they be given
the opportunity to provide fully informed consent to their doctor’s
ultimate approach to evaluating their cervical health. As in any risk
assessment analysis, failure to obtain such consent may often have no
adverse consequences for either the patient or the clinician. The risk
to be controlled by this practice, of course, is the potentially devastating
effect on the few affected patients, and, correspondingly, their doctors,
in situations where undetected cervical cancer could have been diagnosed
earlier by use of new technologies. |
