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Correspondence to: Kevin McIntyre, MD, JD, 160 Commonwealth Ave, Suite 801, Boston, MA 02116; e-mail: vericor{at}aol.com
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Introduction |
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 TOP Introduction The Problem of Liability...The Consensus ConferenceGovernment and Professional...Special Medicolegal Problems in...References |
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The Problem of Liability in Antithrombotic Therapy |
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TOPIntroductionThe Problem of Liability...The Consensus ConferenceGovernment and Professional...Special Medicolegal Problems in...References |
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As we have indicated before and do again in this section, very special and difficult liability problems exist in the ATT area. For example, the treatment of atrial fibrillation with anticoagulation to reduce the risk of devastating stroke as a result of cerebral embolization, a problem that represents for many physicians the most feared of bad outcomes, introduces the risk of potentially more devastating stroke due to intracerebral hemorrhage. While overwhelming scientific evidence may support such a therapeutic decision, a clever plaintiff’s attorney will transfer the responsibility from an intrinsically and unavoidably dangerous medicine to the physician, aided greatly by the presence of the patient in a wheelchair with a massive stroke. Clearly, we need better medicines with fewer side effects and dangers, and medicines that will not require continuous monitoring and regulation. Fortunately, some agents such as oral low-molecular-weight heparin may become available in the not-too-distant future. Until then, measures that enhance the physician-patient relationship and work toward the development of a kind of "co-management" agreement between physician and patient could contribute significantly to the quality of care for the individual patient. As in other areas of medical care, these efforts along with careful documentation of all relevant interactions related to patient care could go a long way toward reducing the risk of legal liability.
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The Consensus Conference |
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TOPIntroductionThe Problem of Liability...The Consensus ConferenceGovernment and Professional...Special Medicolegal Problems in...References |
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The Consensus Conference and the Standard of Care
The principal function of a consensus conference is to reflect a
standard of practice in the area of interest. This in turn will be seen
as representing an expression of what the legal profession calls the
standard of care. Strictly speaking, it is not the standard of care as
that designation applies in a malpractice trial, for example, because
that designation refers specifically to the performance of a particular
physician in a specific set of circumstances, and is developed for the
jury through the interaction of expert witnesses and the lawyers for
parties involved. Thus, a number of factors enter into the
development of the standard of care in the manner in which that
"standard" may most powerfully impact the practicing physician,
ie, the extent to which such a standard helps or harms that
physician’s case. These include the scientific, medical, and other
capabilities and personal qualities of the expert witnesses, including
reputation. Very important as well is the makeup of the jury, the final
arbiter in many cases of whether or not the physician charged with
malpractice met or failed to meet the perceived standard of care in the
context of the facts of the case presented. No doubt, the attitudes of
the jury toward physicians and the medical-care system may bear
importantly in their deliberations and decision. The appropriateness of
this system as medical science becomes increasingly complex, of course,
remains a subject of active debate.
Clinical Judgment and the Standard of Care
Another important factor to be considered with regard to the
standard of care in a malpractice trial must be the role of the
physician’s judgment in the context of the facts of the case. The
importance of physician judgment should be emphasized in any statement
that purports to contribute to the standard of care in a particular
area. It is not possible for any consensus statement or clinical
practice guideline (CPG) to anticipate all practice settings any more
than it is possible for either consensus statements or CPGs to impart
good judgment.
The Need To Demonstrate Enhancement of Quality of Care
The most important function of the consensus conference and any
CPGs that may issue from it is not their use in litigation but in the
improvement in the quality of care; the only real measure of success is
the extent to which the quality of care is elevated. Thus, the
organization, the scientific excellence of the participants and the
discussions, the brilliance of the writing, etc, all these
accomplishments fall short absent a positive impact on the quality of
care. Thus, a brilliant statement from the consensus conference can
hardly be considered a success in the absence of effective
implementation. And even if implementation is effective, how do we know
that the quality of care has indeed been elevated unless a credible
evaluation has been carried out? Olson3
wrote in an
editorial in JAMA that "Readers themselves must assess the
quality and validity of consensus statements as they do all
literature." While this is undoubtedly true, such an evaluation of
the quality of the written product cannot be the final measure of
whether or not a consensus statement has achieved what must be
perceived as its most important objective, ie, the elevation
of the quality of care.
Lack of Evidence of Quality of Care Enhancement by
Consensus Conferences and CPGs
In the 1980s, CPGs were few and far between. Perhaps the most
notable example of widely accepted and used CPGs were those that
formulated relatively uniform approaches to cardiopulmonary
resuscitation and emergency cardiac care.4
From the late
1980s to the present, there has been an explosion of CPGs as everyone,
from organized medicine, peer review organizations, insurers, and
state legislatures, to the US Congress, has become interested. By 1997,
> 2,500 CPGs had become available. Earlier CPGs were developed
primarily through the use of peer review and consensus conferences.
More recently, the trend has been to base the CPGs on a comprehensive
evaluation and weighing of scientific evidence by panels of experts.
And the enthusiasm for CPGs has not been limited to the United States.
Evaluations of the impact of CPGs on the quality of care and outcomes
have been distinctly less frequent than the emergence of new CPGs
themselves. Of 59 evaluations of CPGs in Britain, most found some
effect on the process of care delivery but only 11 of 59 looked at the
impact of CPGs on the outcomes of clinical care. A Canadian review of
the impact of CPGs on patient outcomes provided little support that
CPGs improved patient outcomes at the primary care level, but most
studies looked at process rather than outcomes.4
It has
been suggested that the failure to demonstrate positive outcome impact
may relate to the lack of methodologically sound studies. The lack of
evidence for the efficacy of consensus conferences and CPGs, despite
what appears to be unbridled enthusiasm, may be due to the fact that
they indeed may not positively affect clinical practice and outcomes.
Alternatively, acceptance may be low, implementation inadequate or the
evaluation process may so far be ineffective. However, the sheer weight
of enthusiastic support is insufficient reason to disregard the fact
that an innovation of such magnitude should not be permitted to go on
unevaluated. For all the enthusiasm, there remains the possibility that
CPGs could be having a negative impact on care, at some level, in some
sector, on physician performance or on the physician-patient
relationship that appears to be under continuing attack by the forces
of market-driven medical practice.
Market-Driven Medicine: Impact on Quality of Care
The growth of CPGs has taken place during a period of vastly
increased market-driven changes in medical-care delivery that have
transformed the medical-care delivery system and continue to do so. One
of the many consequences of the intensive market competition that has
resulted is an instability in the managed-care system that tends to
impact negatively on continuity of care. Some employees may offer a
single health plan that may or may not be able to provide care up to
the expectations implied by CPGs.
Thus, for whatever reasons, it is not yet clear whether CPGs have a positive impact on patient outcomes. However, it is quite clear that the number of CPGs that have been developed is greatly disproportionate to the paucity of evidence supporting their efficacy. And it may well be that a critical evaluation of the impact of CPGs, from the uniformity of implementation to the consistency and the quality of care delivery itself, may in the long run contribute more positively to health-care outcomes than the publication of more CPGs.
Objective of the Consensus Statement: Immediate and Longer
Term
The objective of the consensus statement must be defined clearly.
An example of a clear definition of objective was provided by Drs.
Dalen and Hirsh in the introduction to an earlier version of the ACCP
Consensus Conference on Antithrombotic Therapy: "We hope that these
recommendations will assist clinicians in providing safe and effective
antithrombotic therapy to their patients."5
While
clearly expressing the immediate objective, ie, to enhance
the quality of care delivery in the area of ATT, Dalen and
Hirsh5
went on to underscore the important catalytic role
of such a conference for the achievement of longer-term objectives:
"We are certain that these recommendations will lead to further
dialogue and stimulate further studies in this important area of
therapeutics." While this function has important implications for the
development of perfections in the scientific data over time that may be
expected to improve ATT in the future, the legal implication is also
clear: all the answers are not in. Thus, there is clearly room for the
clinician to exercise his or her judgment, as alluded to above, with
regard to a specific patient with a specific set of clinical
characteristics. The guidelines, then, are intended to be just that:
guidelines. If ideally developed and ideally packaged, these guidelines
will be of the greatest use to the greatest number of practitioners in
providing safe and effective ATT. As such, they will be helpful guides
to the standard of care for the protection of the practitioner from
charges of substandard performance, thus performing a legally
beneficial role for the benefit of the practitioner while hopefully
improving the quality of patient care. The better the guidelines are,
the easier it should be for the physician to act properly in the best
interests of his or her patient, although, to date, clear evidence to
support that highly desirable outcome has not been forthcoming.
Credibility of the Consensus Conference
The credibility of the consensus conference recommendations
clearly will depend on the degree to which legitimate differing views
are presented and discussed openly. Not only is this important from the
view of comprehensive discussion, it is important from a legal
viewpoint, in that the law has recognized the opinions of
"respected" minorities, which may differ from the majority opinion.
Thus, "consensus" must not be forced: it is an anticipated and
desirable outcome if it can be achieved. If legitimate respected
minority opinions exist, these also should be disclosed as such.
Selection of Participants
Thus, selection of the participants so that a comprehensive range
of scientific and medical opinions will be represented, presented, and
discussed is of paramount importance to ensure a credible and
comprehensive set of recommendations. Not only need there be balance on
the issue of content, there must also be balance on the issue of
personality. A daunting figure on one pole of an argument should not be
permitted the opportunity to intimidate a less confident presenter at
the other pole.
Selection, Evaluation, and Presentation of Evidence
An excellent section on this subject is included in this volume,
and only a few brief comments will be made here. When prior consensus
conferences have been held and published recommendations issued, each
of the prior recommendations must be reviewed and critiqued carefully
and comprehensively by experts who represent the extent and range of
opinions on the subject. Criteria for evaluating new scientific and
medical data have now been developed as the earlier chapter on this
subject in this publication indicates. The new JAMA format,
referred to above, along with the rationale for it provided by Olson,
are particularly helpful guides in the development and
implementation of the consensus process.2
3
Opinion,
however expert, should clearly be subservient to credible data
published in respected peer-reviewed journals and preferably validated
by independent investigators. Absent of a credible scientific database,
expert opinion honed by the process of informed discussion remains the
only alternative approach to developing state-of-the-art guidelines.
Legal Implications of the Scientific Database
The importance of the scientific database to the consensus
statement and any CPGs that may emerge from it springs from the
connection of any guideline to its scientific basis: if the scientific
basis is unequivocal, the guideline based on it is likely to be strong
as well. It is now common practice to characterize the strength of the
science, and such a grading was carried out at the Sixth ACCP Consensus
Conference on Antithrombotic Therapy, as per the chapter on the
selection and evaluation of the science, vide supra.
Theoretically, then, the stronger the scientific basis the more
difficult it would be to defend deviation from a guideline based on it.
The grading of the science should reveal the limitations of the science
base and, in so doing, provide justification for deviation from a
recommended guideline in certain circumstances, and support such
deviations as were made on the basis of physician judgment.
When contradictory opinions are present in respected medical journals, the work of the consensus conference may become more important and more difficult. A careful discussion of all credible information may lead to an impasse. If so, this must be confronted and reported, and the best recommendations based on expert opinion may be the only available alternatives. The level of urgency of any call to expedient development of needed research data should depend on the gravity of the unanswerable therapeutic question.
The Consensus Process
It is well recognized that the process by which the consensus
statement and any other product that may issue from it will rely
heavily on the manner and quality of the process by which consensus
itself is developed.6
An array of approaches to the
development of consensus has been identified. These range, for example,
from the National Institutes of Health process that "combines aspects
of the judicial system [in which an impartial jury makes a decision
based on the evidence presented], a scientific meeting [in which
professional colleagues share their findings], and a town meeting
[where any interested person can express an
opinion]".3
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The central purpose in the consensus process, whatever format is chosen, is the following: (1) to ensure a comprehensive presentation of all relevant scientific information, including minority opinions by respected experts who are dedicated to the objectives of the conference; (2) to ensure a full and balanced discussion of this information among these experts, usually in small groups and in a manner in which the facts are emphasized and personal qualities of persuasion are minimized; (3) presentation of what has been agreed on and what has not been agreed on to the general session; and (4) faithful incorporation of the developed consensus and exceptions to consensus in the article for publication.
Finally, the practice of bringing manuscripts to the conference so that publication deadlines can be met should be examined carefully, and clearly all such manuscripts should be subject to prior review and open discussion and debate at the time of the conference.
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Government and Professional Organization and Practice Guidelines |
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Special Medicolegal Problems in ATT |
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Informed Consent as a Basis for Shared Responsibility in
ATT
This is particularly likely to be true once both patient and
physician confront together the fact that bad outcomes occur when
dangerous medical problems exist, especially when such problems require
therapies that also are inherently dangerous. Unlike a number of other
medical conditions, once the patient becomes a candidate for ATT, that
patient is often at risk either with or without ATT for the rest of his
or her life. Furthermore, with regard to the most feared and most
devastating problems for which ATT is prescribed, ie,
crippling stroke and death, the therapy used to reduce the risk of the
underlying disease contributes another basis for crippling stroke and
death. This reality argues formidably for a unique kind of
interpersonal contract between physician and patient, a contract that
implies not only full discussion and disclosure of risks and benefits,
but a kind of "co-care" pact in which the patient accepts
co-management responsibility and commits to maintain that role over
time. This may be facilitated through the use of a kind of running
"report card" by which patient and physician can keep track of
patient-specific responsibilities in the co-care endeavor. Efforts to
develop such a model have begun and will be tested in the clinical
arena. The recording of events and behaviors that may negatively affect
either the underlying disease process and/or the therapy will serve as
a basis for grading the participation of both physician and patient
over time; will serve as a basis for in-course corrections on an
as-needed basis; should improve both the quality of care and the
physician-patient relationship, and, hopefully, by multiple mechanisms
reduce the propensity for litigation by improving the physician patient
relationship, and by providing a careful chronicle of the care provide
to the patient as well as the patient’s contribution to that care
program.
The Medicolegal Risk of ATT
The legal nightmares of ATT are, of course, a plaintiff
attorney’s dream. In few areas of medicine are the "complications"
of the decision to use or the decision to withhold therapy as
predictable and as devastating as a crippling stroke, the adverse
effect we will concentrate on not because of its frequency but because
of its potentially dramatic effects. It is perceived by many as being
worse than loss of life. From the viewpoint of legal liability,
the patient who has suffered a devastating stroke and has survived
brings a much more powerful weapon to the court in a malpractice
action, that weapon being the deformed partial person who was like any
juror prior to the stroke. Jurors, like most of us, are terrified by
the prospect of being the victim of a stroke. Empathy is immediate and
powerful. How could this happen? "If it happened to her, it could
happen to me." Sensibilities may be rubbed raw, especially with the
help of an experienced plaintiff’s attorney. It is the physician’s
job to prevent such a catastrophe in this day and age, is it not? There
is a spontaneous reflex toward compensation on the part of the jury
that must be overcome by the defense, and this may not be possible. The
orientation of the jury may be shaped more by emotion than by an
inclination to plumb the truth. There is a natural tendency to hold the
physician responsible even before the facts are heard. This is a
difficult climate, one in which even the blameless physician may be
unable to elude a sense of hostility.
Legal Liability Crisis Points
There are a number of medical crisis points in the decision-making
process in the antithrombotic area, and each of these may become a
legal crisis point. As with medical decisions in general, the potential
for legal liability in the area of ATT begins when the patient is first
considered to be a candidate for ATT or should have been considered a
candidate. However, this field is rather unique, in that many such
patients are from that moment on at risk for what may be the most
feared complication in medicine, ie, a devastating stroke
and, worse yet, that such a patient is at risk both with ATT and
without it.
As noted above, the physician may become liable either for the decision to use ATT, eg, should the patient suffer a hemorrhagic stroke, or for the decision to withhold or withdraw should the patient suffer an embolic stroke. Once therapy has been started, the physician may find himself or herself at risk for not reaching therapeutic range in time, for not maintaining the therapeutic range, for failing to detect bleeding at an earlier time. Since a disastrous outcome is to be expected in a predictable percentage of patients with or without treatment and with or without "ideal" treatment, it is clear that there is no "safe" area once the patient is in the "club" as a candidate for ATT. This reality brings with it important forebodings for the physician who is charged with malpractice. The fact that the physician made decisions that would have been viewed to be within the standard of practice does not necessarily mean he or she will be exonerated. While there may be many reasons for such an unreasonable result, one important one is that the jury may not be educated successfully to the fact that these patients are truly living at the edge of disaster, not because of their physician but because of the disease substrate, which poses a direct and serious threat, and by the treatment that also poses a direct and serious threat, not to mention the important additional factor which is time, since many patients will require ATT for the rest of their lives.
The statistical presentations by expert witnesses are often doomed to failure because they require a sophisticated understanding of the unique nature of ATT, an area in which dangerous measures must be mobilized because the patient’s predisposition to form blood clots within his or her circulatory system is a very dangerous condition. A second reason why the physician may fail to prevail despite having provided an acceptable level of care is that even an excellent defense may be insufficient to overcome the emotional impact of the once-healthy plaintiff now before the jury in a wheelchair, drooling, with a flaccid arm on his or her lap. The physician may be painted as a monster by the dramatic power of the outcome even in the absence of clear evidence of deviation from the standard of practice in this area. The wily plaintiff’s attorney may be successful in pointing out that the physician’s first obligation is to do no harm, and that when there is a risk of great harm, the diligence that the physician must exercise must be proportionate to the severity of that risk. The inference is that the outcome was preventable and the physician failed to prevent that outcome.
We are aware, of course, that some such outcomes, ie, stroke, are not preventable since stroke will occur in a small but predictable percentage of patients in whom ATT is indicated even when the therapeutic decisions are flawless. We are also aware that the frequency of stroke will increase as the therapy falls farther and farther below the ideal, whether or not such less-than-ideal therapeutic control is the fault of the physician or due to a number of other uncontrollable factors that are known to influence ATT.
Can Consensus Statements Help Reduce Legal Liability?
Perhaps. If we could live in an ideal world, we would do well from
a medicolegal viewpoint to minimize or better yet eliminate variations
in the indications for and methods of initiating, maintaining,
monitoring, and suspending ATT. This, of course, is one of the main
objectives of a consensus conference. It is also an objective that is
virtually never achieved, primarily because there is insufficient
scientific evidence to force complete unanimity on all important
questions. Compromise alone may not be sufficient, however reasonable
and well intended. It is often more desirable in the face of differing
views to have each view analyzed as to justification. In the absence of
credible justification, a view should be rejected. If credible
justification exists for differing views, consideration must be given
to setting forth these alternative approaches as acceptable options
until persuasive data emerge to justify a reappraisal. Practice
patterns that have been proved to be effective in a given set of
circumstances should not be rejected without solid justification.
Alternatively, practice patterns that have been proved to be less
effective and that subject the patient to avoidable excess risk must be
rejected if the improvements are feasible. The primary purpose of a
consensus conference, of course, is to provide optimal guidance to the
practitioner in the setting of his or her practice. If the practice
guidelines generated by the consensus conference are successful in this
regard, they will provide protection to the practitioner against
unjustified malpractice actions.
Informed Consent: a Potential Mitigator of Liability Risk?
The purpose of informed consent is to preserve the autonomy of the
patient. This is accomplished by educating the patient to the risks and
benefits of the range of procedures and therapies that could be
appropriate in view of the patient’s problems. The process by which
informed consent is achieved should be based on an interaction between
patient and physician in the course of which the patient is given
sufficient information to make a choice. The physician is obliged to
become persuaded that the patient has sufficient information and
understanding to make an "informed" choice. In the course of
this process, the patient forms certain opinions about the physician;
among the more important of these opinions are those that go to the
issue of trust and the presence or absence of a sincere interest in the
patient. Many a malpractice case has its seeds in the impression made
by the physician on the patient during this encounter, an encounter
that is more than likely fairly routine for the physician but is far
from routine for the patient. Should the physician fail this test, and
an adverse outcome follows, most experts would agree that the
likelihood of litigation is much higher for any given set of facts.
"Emotional malpractice" is real, is common, and is a powerful
stimulus to litigation.
Informed Consent and the Physician-Patient Relationship:
Alternatively, the process of achieving informed consent (or
informed refusal that may be equally important) can be an important
opportunity to enhance the physician-patient relationship, which seems
to have taken a bad beating over the last decade. An attitude of
interest and caring on the part of the physician can make a giant
contribution to patient understanding, should an outcome be less than
expected. Further, a meaningful discussion will permit the physician to
understand and deal with specific apprehensions, and a brief notation
of the patient’s concerns and the doctor’s responses to them can be
important evidence in any subsequent malpractice action should the
adequacy of informed consent come into question. This is particularly
true in the face of the "antithrombotic dilemma,"
ie, the fact that the patient requiring ATT is in a
unique situation, in that he or she is at significant risk both from
the therapy itself and from the disease.
The Medicolegal Dilemma of ATT:
If we address the ways
in which the product of a consensus conference may best produce the
desired enhancement of the quality of medical practice and reduce the
threat of legal liability, each alternative approach at every step in
the continuum of ATT needs to be considered in these terms. It may be
possible to utilize informed consent as both an educational tool with
the patient and a defensive measure with regard to legal liability
risk. The process of informed consent can be, and perhaps should be,
used to convey the fact that the patient being considered for ATT will
from that moment never be in an entirely safe condition with regard to
such serious complications as stroke. While this is conveyed to some
extent by the listing of the potential complications of receiving and
not receiving ATT on the informed consent form, the manner in which
this information is imparted often fails to characterize the fact that
the patient will be, often for the remainder of his or her life, at
risk for serious complications, with or without ATT. The purpose of
this emphasis is not to protect the physician at the expense of badly
frightening the patient, but to provide to the patient what is in fact
required by the legal requirements of informed consent, that is, an
understanding of all material information about the therapy that the
individual may choose to accept and the alternatives to that therapy.
Such a process should permit the patient to appreciate that he or she
from that moment on is at risk, however small, of a potentially
disastrous occurrence as a result of either his or her disease or of
the therapy used to protect the patient from that disease.
Informed Consent in the "Treatment" of the ATT Dilemma:
One approach to the dilemma of ATT might be to attack the dilemma head
on, and elicit the patient’s full commitment of cooperation to deal
with the potential problems, thus making patient and physician a team
working to reduce patient risk. This may be possible by confronting the
patient with the dilemma at the outset, making certain that the patient
understands the problem, and immediately thereafter addressing the
strategy that the physician has developed for them to best reduce risk
by working together. The discussion thereafter may then focus on the
importance of adherence, the critical importance of maintaining ranges
of therapeutic effects when necessary, dietary advice, and early
response by the patient to particular new symptoms and/or signs, etc.
And perhaps as importantly, the elements of this discussion
should be documented carefully in the patient’s medical record and
should clearly document those patient responses that indicate
understanding of both the risks, the fact that those risks exist both
with and without the therapy and thus create the dilemma, and the fact
that the patient understands the importance and relevance of those
factors that may impact negatively on the patient.
Such an approach to informed consent is appropriate because anything short of it fails to adequately set forth the patient’s reality, with and without therapy. Furthermore, it forms a solid basis for the patient’s cooperative participation in his or her care. And finally, it may be the single most important aspect of the physician-patient relationship to be introduced to the jury should a malpractice action be brought.
Strength in Unanimity:
When justified by scientific
fact, however, unanimity is most desirable both from a medical practice
basis and as a means of minimizing the risk of legal liability. There
are a number of areas in ATT that may be amenable to the potential
benefits of unanimity, but one should suffice as an example.
Anticoagulant clinics are not employed universally for the follow-up of
patients receiving ATT, and there are good reasons put forward by both
those who use and favor the use of such clinics and by those who use
and favor the use of alternative approaches. If there are credible data
to support one approach over the other in terms of better control and
fewer side effects,there is little doubt that practitioners who use the
"less effective" system are at higher risk of legal liability. In
the absence of credible evidence to support equivalency of a method in
question, a defendant may be seen by a jury as not having exercised a
level of diligence demanded by the risk (especially of stroke) to the
patient, and should stroke supervene, it will be very difficult to
mount a defense sufficient to overcome this charge. While there may be
good, important, and practical reasons for the less desirable approach,
including the fact that it may not be less desirable but simply has not
been adequately evaluated, in the face of the stroke victim staring
into the jury, these practical reasons are likely to fall on deaf ears.
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Footnotes |
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References |
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This article has been cited by other articles:
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  M. I. Weintraub Thrombolysis (Tissue Plasminogen Activator) in Stroke: A Medicolegal Quagmire Stroke, July 1, 2006; 37(7): 1917 - 1922. [Abstract] [Full Text] [PDF]
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