Copyright 2000 Federal News Service, Inc.
Federal News Service
February 10, 2000, Thursday
SECTION: PREPARED TESTIMONY
LENGTH: 5772 words
HEADLINE:
PREPARED TESTIMONY OF THE HEALTH CARE LIABILITY ALLIANCE
BEFORE
THE HOUSE COMMITTEE ON WAYS AND MEAN SUBCOMMITTEE ON HEALTH
SUBJECT - "THE PREVALENCE AND NATURE OF MEDICAL ERRORS IN THE
HEALTH CARE SYSTEM AND STRATEGIES FOR REDUCTION OF ERRORS"
BODY:
Executive Summary
The Institute
of Medicine (IOM) Report makes a significant contribution to the efforts members
of the Health Care Liability Alliance (HCLA) and others in the health care field
are making to improve the quality of patient care because it recognizes that:
a. the focus should be on systems, not individuals, and that prevention
of future errors is more important than retrospective faultfinding;
b.
reporting of adverse events is necessary to prevent future errors; and c.
reporting systems currently are not working adequately because the tort
litigation system discourages reporting of errors.
Because of its
concern for the effect the tort system has on the quality of care, HCLA welcomes
the IOM Report. The IOM Report takes the nation a significant step forward by
recognizing that the tort system is a major barrier to improving the quality of
care. That underlying conclusion provides the basis for meaningful federal
tort reforms. The IOM Report recommends expansion of the
immunity and protection provided for peer review materials although it
inconsistently recommends that confidentiality not be provided for reports of
serious adverse events. The members of HCLA believe that efforts to improve
quality are not impeded by the absence of centralized reporting. Barriers to
reporting are raised by a lack of confidentiality and the waste, randomness, and
injustice of the tort litigation system. While the IOM Report recognizes these
barriers, it does not recommend cures for them. HCLA's recommendations address
the problems identified but not addressed by the IOM Report.HCLA, while not
agreeing with the conclusions of The Harvard Medical Practice Study, does
recognize the underlying premise of the study. Patient safety and quality of
care must be paramount in the health care system. We should, as a health care
system and as a society, endeavor to eliminate avoidable injures. We must focus
on what can be done to identify, reduce and eliminate injuries.
HCLA
recommends, therefore, that to promote reporting and analysis of adverse event
reports and to enable providers and others to better collaborate on quality
improvement efforts, Congress should:
a. Focus on doing only what is
necessary, at the federal level, to empower the health care providers to address
this problem by allowing appropriate information regarding adverse events to
quickly reach the people in the health care system who will use such information
to improve patient safety.
b. Recognize that creation of a national
center for collection of adverse event reports will not yield its intended
result -- a reduction in such events.
c. Enact legislation providing
confidentiality protection for safety and quality reports and efforts, such as
peer review.
d. Enact into law the tort reforms
embodied in HCLA's model bill already proven successful in the MICRA legislation
in California.
The IOM is to be congratulated on its endeavors to
improve the nation's health care system by bringing its focus on the incidence
of medical errors. The I0M Report clearly identifies the obstacles to improving
patient safety. HCLA supports the IOM Report's conclusion that the current
methods of dealing with medical errors are counterproductive. HCLA believes a
more direct approach is necessary.
Federal reform of the tort system is
the sine qua non of that approach.
For additional information, please
visit the HCLA website:
www.hcla.org
*************
Statement of the Health Care Liability Alliance
The Health Care
Liability Alliance (HCLA) is a coalition of more than 30 organizations committed
to reform of the health care litigation system to enhance its fairness,
timeliness, and cost-effectiveness. HCLA's members are organizations and
associations of physicians, hospitals, blood banks, health device manufacturers,
health care insurers, pharmaceutical manufacturers, and biotechnology companies.
HCLA applauds the Chairman's timely leadership in connection with the
issue of' patient safety. We appreciate the opportunity to submit our views
regarding the report of the Institute of Medicine (IOM) entitled "To Err is
Human: Building a Safer Health System." We look forward to working with the
Chairman, members of the Committee, and their staff as Congress debates this
important issue.
Because of its concern for the effect the tort system
has on the quality of care, HCLA welcomes the IOM Report. The Report makes a
significant contribution by recognizing that the tort system is a major barrier
to improving the quality of care. That underlying conclusion provides the basis
for meaningful tort reforms.
INTRODUCTION
The
tort system as it now operates in this country increases health care costs by
forcing providers to practice defensive medicine and by imposing inordinate
litigation costs on the health care system. These costs are borne by patients,
people with insurance, people who are trying to buy insurance, people who need
care, and taxpayers--through higher health care costs, higher insurance
premiums, higher taxes, and reduced access to care.
The tort system does
not provide benefits that justify these costs. It does not carry. out its
intended functions. It does not establish a rational standard of care. Findings
of liability, made in court with hindsight and with the benefit of leisurely
contemplation that rarely are possible in the actual delivery of care, often do
not provide an accurate standard of medical conduct. As one expert on the tort
system has summarized this situation, "The fundamental problem of tort
liability, especially in the areas of products liability and medical
malpractice, stems from the unpredictability of its imposition."1
This
retroactive, case-by-case, and arbitrary standard making has caused doctors to
practice defensive medicine-- to order medical procedures out of a perceived
need to have a defense available if there should be an adverse event. Cesarean
delivery rates provide one example.
Because juries awarded large
recoveries for birth injuries where obstetricians did not perform a Cesarean
section, doctors have performed them more often than they otherwise would have.
Cesarean rates rose from 4.5 per 100 births in 1965 to 24.1 in 1986.2
The essentially unlimited power of juries to award non-economic damages
results in verdicts that are not just and that when publicized whet the appetite
of trial lawyers and traumatize providers. In many cases, (enough to engender
disdain for the litigation system and fear on the part of the provider), there
is no logical or medical connection between the provider's action and liability
or between the injury and the amount of damages awarded.
The Harvard
Study of hospital care in New York itself demonstrated that the filing of claims
was not correlated to negligence.3 In a follow-on study of claims of malpractice
filed by patients in the Study, several of the authors concluded that "the
severity of the patient's disability, not the occurrence of an adverse event or
an adverse event due to negligence, was predictive of payment to the
plaintiff."4 In other words, the amount patients recovered through the tort
system was a function of their health condition, not any negligence by the
health care system. The authors concluded more generally, therefore, that "the
standard of medical negligence performs poorly in malpractice litigation."5
The tort system thus presents a provider with the random risk of
catastrophic financial injury. This causes some providers to quit practice and
others to limit their practice, reducing patients' access to care, particularly
in inner-city and rural areas. Most of those who continue to practice are forced
to engage in defensive medicine. This results in more medical interventions for
patients, as the increased rate of Cesarean deliveries demonstrates, thereby
adding costs and putting patients at greater risk. It is estimated that
defensive medicine costs at least $50 billion per year.
At the same time, the litigation system does not provide fair and timely
compensation for injured patients. They must wait on average 3 1/2 years for
resolution of their claims by the litigation system. If they prevail, they
typically must give 33-60% of any recovery to their lawyers in contingency fees.
Only 28 percent of the amount spent to provide insurance coverage actually goes
to victims; the rest is spent in transaction costs and in operating the tort
litigation system.7 The tort system imposes a 72% tax on patients and providers.
Because of the threatening and contentious climate it creates, the
litigation system, rather than protecting patients, is actually impeding efforts
to improve the quality of care. It makes it difficult for providers to
acknowledge mistakes. It deters open discussion of possible errors. And it
discourages providers from filing reports, seeking assistance, and collaborating
with other providers and experts to improve quality.
The money spent on
defensive medicine and litigation expenses could be better used to improve the
quality of care and access to it. The energy and focus that the present system
channels into litigation- related and litigation-induced actions should be
redirected into developing better quality control systems and innovative ways of
delivering care.
INSTITUTE OF MEDICINE REPORT
With one
exception, the IOM Report avoids inflated rhetoric. The exception is its
statement that as many as 98,000 people may die annually because of medical
error. This figure is extrapolated in ways that are not explained from 71 deaths
that the Harvard Study of the medical records of 31,429 patients discharged from
51 New York hospitals in 1984 said were attributable to negligence.8 This
extrapolation has no scientific basis, as the authors of the Study themselves
have recognized.9
The Harvard Study, moreover, suffered from
methodological flaws, and its results have not been duplicated. The reviewers
who determined which records reflected negligence agreed in only 10% of the
cases. In an effort to confirm findings that rest on this shaky foundation, a
second set of reviewers examined a subset of 318 of the records. Apparently they
did not reach the same conclusions on individual records that were attributed to
the primary set of reviewers.10
The authors of the Harvard Study also
applied their methodology to patients in Colorado and Utah hospitals in 1992.
Extrapolating the results of this study, the authors concluded that 44,000
deaths were caused nationwide by medical error. The IOM Report finds this, and
the unexplained figure of 98,000 deaths, to represent a range.11 The more recent
study, however, could equally be seen as an indication that health care improved
in the 8 years after the New York study, that better care is provided in
Colorado and Utah, or, since the results of the Harvard Study could not be
duplicated, that the parameters of the Study are vague and the methodology is
flawed.
It is not our purpose here to discuss the weaknesses of the
Harvard Study or the exaggerated extrapolations that have been made from it.
Patient safety and quality care should not be a numbers game. We should, as a
health care system and as a society, endeavor to eliminate avoidable injuries.
In doing so we must remember, as the Harvard Study reminds us, medical
intervention is inherently risky and is provided by people.
People are
only human, and the title chosen for the IOM report reflects the reality this
presents; "To Err is Human." Because we are dealing with medical intervention by
human beings, we must focus on what we can do together to reduce the number of
unnecessary injuries suffered during the delivery of health care services.
The IOM Report makes a vital contribution to this effort by its
recognition and discussion of the three interrelated factors that now impede
efforts to improve patient safety.
First, it emphasizes that the problem
is not "bad apples,"13 although there are some "bad people" and they must be
weeded out. Mistakes are often caused, or are not prevented, by system (both
technical and organizational) failures. As the Report suggests, because
providers are only human, they need systems to help them avoid mistakes; but we
cannot let reliance on systems dull the special intelligence that humans posses
or lull them into lethargic complacency.
The focus must be on developing
systems that avoid future mistakes and not on attempting to pin blame for past
conduct on an individual. This important observation leads the Report to balance
public policy in favor of error prevention and away from faultfinding: "When an
error occurs, blaming an individual does little to make the system safer and
prevent someone else from committing the same error."14 "Although a punitive
response may be appropriate in some cases (e.g., deliberate malfeasance), it is
not an effective way to prevent recurrence."15
Secondly, the Report
emphasizes the need to report information about adverse events or potential
adverse events in order to identify patterns of conduct that threaten safety and
to assess the success of corrective actions. It correctly recognizes that
reporting is essential to the primary goal of prevention. The Report provides a
comprehensive summary of the numerous and varied reporting systems that are
currently in effect.
Thirdly, and most importantly, the Report
recognizes that there is a critical and common element or impediment that
prevents all the reporting systems, regardless of how they are structured, from
collecting the information they need. That impediment is the tort system.
Participants and witnesses to an adverse event are reluctant to report
it (even if required by law to do so) out of fear that doing so will trigger or
support a tort claim. The irrationality of the litigation system and the
randomness of its results trigger a defensive reaction. Fear of being enmeshed
in that system, even if one is ultimately found not to be liable, deters
reporting.
As the Report concludes, "Patient safety is also hindered
through the liability system and the threat of malpractice, which discourages
the disclosure of errors. The discoverability of data under legal proceedings
encourages silence about errors committed or observed."16 As a result, it finds
"All reporting systems, whether mandatory or voluntary, are perceived to suffer
from underreporting. Indeed, some experts assert that all reporting is
fundamentally voluntary since even mandated reporting can be avoided .... The
volume of reporting is influenced by more factors than simply whether reporting
is mandatory or voluntary .... One factor is related to confidentiality."17
"Thus," the Report concludes, "the prominence of litigation can be a substantial
deterrent to the development and maintenance of the reporting systems discussed
in this report.
"18
It is refreshing that the IOM Report
recognizes this problem. It is important to the debate that it does so. The tort
system impedes efforts to improve health care by deterring the reporting of data
needed to make improvements in the health care system.Recognition of this fact
by The IOM should provide the needed impetus for addressing this basic problem.
As the Report recognizes, the tort system deters reporting even where
confidentiality is promised. There is concern that confidential data will leak.
There is also fear that what is confidential today may not be protected
tomorrow. The Report cites the powerful example of the continuing political
pressure to "open up" the National Practitioner Data Bank. 19 Providers are
concerned that the constant political pressure eventually will be successful,
leading to a breach not only of a particular data source but also inserting the
opening wedge for a more general release.
Confidentiality of adverse
event reports, therefore, is necessary to develop an effective reporting system
that will permit identification of safety problems and permit assessment of
remedial actions. But there is on-going concern that even confidential reports
will be fed into the litigation system--by leaks or by surrender to political
pressure to remove the confidentiality protection. Confidentiality of reports is
necessary to improve reporting, but it is not sufficient. The tort system also
must be reformed.
TWO REFORMS THAT ARE NEEDED
The findings of
the IOM Report, therefore, confirm the need for a combination of two reforms:
confidential protection for adverse event reports and a reformed tort system.
Confidential reporting
It is important that Congress act on the
findings of the Report by protecting the confidentiality of reports made of
adverse events or of problems that could lead to adverse events.
The
Report in several places emphasizes the need for reporting to be confidential.
It appears, in fact, to call for Federal legislation to protect confidentiality
of all reports although it also makes an inconsistent recommendation that would
deny confidentiality to reports of adverse events leading to serious injury. The
Report recommends Federal legislation to "extend peer review protections to data
related to patient safety and quality improvement that are collected and
analyzed by health care organizations for internal use or shared with others
solely for purposes of improving safety and quality."20
As the Report's
discussion of peer review protection reflects, the nature and the scope of the
current protection varies widely from state to state.21 Not only does the scope
of the protection afforded by each state differ greatly, but in some instances
the sharing of peer review materials with third parties engaged in health care
quality efforts, such as The Joint Commission on Accreditation of Healthcare
Organizations (JCAHO), has been held to waive any confidentiality protection.22
Moreover, the efficacy of these state protections is further undermined by
uncertainty surrounding the application of the peer review privilege should the
parties be drawn into federal court. This occurs, for instance,in actions
brought under a Federal statute with related medical malpractice claims under
state law (i.e., pendent state claims).
As the Report recognizes, health
care providers must have confidence that the peer review privilege will be
applied with consistency and predictability if they are to come forward with
information regarding medical errors.23 The discussion in the Report focuses on
immunity and protection of peer review materials and deliberations from
discovery. In urging that the protection be expanded, the Report at a minimum
recommends that quality and safety information derived from reports or from
investigation (the main areas now protected in different ways by peer review
statutes) be protected from use in litigation and from public dissemination. The
information derived through the peer review process may involve the "most
serious adverse events"; thus this recommendation calls for the appropriate
confidential treatment of such information.
However, the Report also
says that such information should be available for public consumption and that
only reports of events other than the "most serious adverse events" should have
confidentiality protection.23 We discuss this misplaced, and internally
inconsistent, position below. The important fact is that the Report finds that
confidentiality is necessary for effective reporting and patient safety
improvements and recommends in, at least one place, across-the- board
confidentiality.
Tort reform
Even where
confidentiality would be provided, but particularly where it would not,
reporting and improvements in the health care system quality can best be
advanced by reforming the tort system to protect providers from random and
excessive judgments. HCLA urges Congress to enact the tort
reforms embodied in its proposed legislation which is modeled on the
MICRA reforms enacted in California in 1975.
These reforms would
preserve the ability of injured patients to obtain compensation for their
economic injury and to recover reasonable non- economic damages. They would: 1)
encourage non-judicial resolution of claims and ensure that plantiffs' lawyers
did not capture an excessive contingency fee from their clients; 2) prevent
plaintiffs from obtaining double recovery (collateral source rule); 3) limit
noneconomic damages to a reasonable amount ($250,000); 4)
require plaintiffs to bring any action in a reasonable time after the injury
occurs or is recognized (statute of limitations and statute of repose); 5)
protect any particular defendant from paying a larger percentage of any recovery
than is warranted by his/her conduct (joint and several liability).
Passage of these measures will restore a measure of balance to the tort
system, give providers more faith in the system, and therefore facilitate
reporting--which ultimately will result in greater patient safety.
As
the IOM Report recognizes, patient safety is not adequately served by the
present system. If the tort system in its current state were adequately
protecting patient safety, the Report would not have been necessary. The tort
system is not only not the answer; it is the barrier to the enhanced quality
systems that the Report correctly finds are the best way to improve safety. The
underlying, if unarticulated, theme of the Report, therefore, is that
tort reform is necessary to improve the quality of health care
in this country.
ACTIONS THAT SHOULD NOT BE TAKEN
The Report
correctly concludes that the barrier to systems improvements in health care is
not the lack of reporting mechanisms but the tort-induced reluctance of
participants to provide data through the existing avenues. There is no
indication that there are not enough reporting requirements. The Report
describes them comprehensively. The need is to make the changes necessary to
encourage more reporting, and for the agencies and institutions to which reports
are made to analyze the information and act on them more vigorously.
HCLA questions, therefore, whether any purpose would be served by adding
new reporting requirements or creating new agencies to collect or coordinate
reports. In fact, adding new reporting requirements would only distract
attention from the need to make the essential tort changes to support the
existing reporting requirements.
No new reporting requirements without
confidentiality
While recognizing that the barrier to existing reporting
requirements is a lack of confidentiality and fear of the tort system, the
Report does not address this barrier, except in its recommendation that peer
review protections be expanded.
Instead it recommends that mandatory
reporting of serious adverse events be expanded by federal statute, without
corresponding confidentiality protection. Indeed. while it offers a gesture
toward the states' role, it would make mandatory reporting a federal requirement
in any state that did not on its own come to the conclusion that mandatory
reporting is needed.25 Although The Report recognizes that the absence of
confidentiality is impeding compliance with existing reporting requirements, it
would make mandatory reporting a national requirement while providing no
confidentiality protection.
The Report would permit confidentiality
protection only for voluntary reporting of events that are not serious--where it
is least useful.
If an event results in little or no harm, there
may be less concern about tort litigation. The Report offers confidentiality
protection here, where it is worth less, but would deny it in the serious cases,
where it is important to elicit reporting. Recommending confidentiality for
voluntary reports is not a sufficient response to the problem identified by the
Report itself--that lack of confidentiality deters reporting.
Drawing a
line, moreover, on when reporting is required and when it is confidential on the
basis of whether the action resulted in "serious" harm will bog down the health
care system in line-drawing and hair- splitting. What is serious harm? Who
defines it? Suppose the event could have had a serious harm if it had not been
caught? How long is serious? Is an extra day in a hospital serious? Is a false
positive that leads to patient concern serious? Suppose the patient was not able
to understand the test result; is a false positive serious in that case?26
Rather than trying to impose reporting by regulation and mandates, and
varying the protection for different types of reports, Congress should provide
protection for all safety and quality reports, and for consideration of them.
This is the best way to advance patient safety efforts.
No
centralization of safety efforts
It would be both unnecessary and
harmful to create the new Federal Center proposed in the IOM Report. The Report
envisages various roles for this new Center. HCLA believes these are unnecessary
and would actually detract from efforts to improve patient safety.
The
Report sees a need for the Center to establish a "national focus to create
leadership, research, tools, and protocols to enhance the knowledge base about
safety."2? The premise that only the creation of a government Center can create
a national focus and provide leadership is disturbing.
As the Report
indicates, efforts to enhance patient safety are being undertaken in different
ways by a variety of individuals and institutions: insurers, manufacturers,
providers, academic institutions, trade associations, etc. It may look messy and
confused, but the pursuit of knowledge often is, particularly in an area as
complex and varied as the design and manufacture of health care products and the
delivery of health care.
Commissions, meetings, and public awareness can
all contribute to a national focus. So can efforts by political leaders, if
conducted without demagogy and finger pointing. A new Center is not necessary to
do this. This proposal is really symbolic; concern would be demonstrated by
creating a new Center and spending more money.
An approach based on
centrally developing and collecting safety- related data could in fact impair
safety research and promotion of safety activities. A centralized agency for
safety research could well become hitched to a particular view or approach,
subordinating all others. It is more effective for different people to try
different approaches.
Creating a "highly visible (governmental) center"
is likely not only to diminish the diversity of research and views but to
politicize patient safety. Once there is a "highly visible" government agency
tasked to provide leadership and develop research and recommendations, every
interest group will descend on it in an effort to gets its agenda adopted.
Congress will inevitably be drawn in. It would be far more effective, if more
research is needed, to provide funding to a variety of researchers on a
scientific, non-political basis.The Report also has another role in mind for the
new Federal safety Center. It would not be limited to research. It would receive
and analyze reports (from the states)-apparently the mandatory reports of
"serious adverse events" discussed above. The Center would become a national
data bank for at least some kinds of reports. But it is unclear how the
information would be used and who would have access to it. The Center apparently
would "identify persistent safety issues that require more intensive analysis
and/or a broader-based response."28 In other words, it would use the data to do
more studying. But would the agency act on the information? To whom would it
give its findings?
What is needed is not central collection of
information, nor more analysis and dissemination. Needed information should be
given to those in a position, and with the most powerful incentive, to use it to
improve patient safety. Instead of funneling data through a centralized, and
possibly politicized, government agency, the focus should be on doing what is
necessary to get the information to those who will actually use it to improve
patient safety.
Hospitals need more information about errors that are
made there. Licensing boards need more information about their licensees. It is
far simpler, and more effective. to inform a device manufacturer that the
labeling is confusing than to report this to Washington. With this information,
manufacturers, providers, and insurers would have the greatest incentive and the
best ability to use it to improve safety.
Instead of creating a
centralized, nation-wide, government-led reporting system. we should focus on
doing what is necessary to get more information to the people on the front lines
of health care quality.
Compliance will be enhanced if reporters know
they are reporting to an entity that will use the information effectively. A
nurse is far more likely to report an error to her nursing supervisor or to
report a problem with a device to its manufacturer than to file a form destined
for a distant Federal bureaucracy. Health care providers are the people who are
most concerned with quality of care and patient safety. They are more personally
and directly concerned than is a distant government bureau. They strongly want
to avoid adverse events. They want to provide good care.
There is
another practical factor that must be considered. Providers function under
conditions of considerable stress. They are quite astute in distinguishing
between what is real and what is more government make-work. They are more likely
to report when they believe it will do good (particularly if they have
protections of confidentiality) than where they are told to fill out another
government-imposed form that seems to bear little or no relation to their real
world--patient care.
Providers, manufactures, suppliers, employers who
sponsor health plans, and insurers, deal with each other and with various
licensing and quality institutions on an ongoing basis. They should be
encouraged to report potential or existing problems and discuss improvements
among themselves. This can best be achieved by protection of confidentiality for
reports and discussions, and by reform of the tort system. Requirements that
they file reports with a state agency for forwarding to Washington, D.C., will
not encourage reporting or enhance collaborative efforts to improve the quality
of care.
CONCLUSION
The IOM Report documents the obstacles to
greater patient safety efforts: the difficulties in securing more reporting that
result from the lack of confidentiality and the shadow cast by the litigation
system. But rather than addressing these problems, it recommends more reporting
(but without confidentiality) and centralizing the reporting system.
The
problem, however, is not a lack of centralized reporting; it is the barriers to
reporting and to safety-improvement measures posed by the tort system.
The problem is not a lack of reporting mechanisms, but a lack of assured
confidentiality and fear on the part of the people who would report that they
will be enmeshed in the litigation system.
The primary need is not more
data and more studies; it is for those in the field attempting to improve
patient safety to have confidence that cooperating in safety improvement
measures will not result in involvement in burdensome tort litigation.
The fears induced by the tort system cannot be resolved by expanding the
already unsuccessful requirements to report. The problems of the tort system
itself must be addressed.
The solution should not be centralized or
governmental; it should be private and dispersed. Medical errors, when they
occur, happen at the local level, and local solutions are best crafted to solve
local problems.
The quality of health care, consequently, can best be
improved by reforming the tort system to: 1) reduce the number of lawsuits, 2)
make the system more fair and efficient, and 3) reduce its costs.
Reforms in this direction would lessen the pressures to practice
defensive medicine, lower health care costs, and increase access to care. At the
same time, a fairer and less random tort system, and assurances of
confidentiality, would reduce the barriers to reporting and enhance the ability
of the field to identify problems and to make corrections.
FOOTNOTES:
l Jeffrey O'Connell, "Two-Tier Tort Law: Neo No-Fault &
Quasi-Criminal Liability," 27 Wake Forest Law Review 871 (1992).
2
Richard E. Anderson, "Billions for Defense," Archives of Internal Medicine.
1999; 159:2401
3 Paul Weiler et al., A Measure of Malpractice.
Cambridge: Harvard University Press; 1993.
4 Troyen A. Brennan et al,
"Relation Between Negligent Adverse Events and the Outcomes of
Medical-Malpractice Litigation," N Engl J Med 1996; 335:1963-7.
5 Ibid.
6 David Kessler and Mark McClellan, "Do Doctors Practice Defensive
Medicine," QJ Econ. 1996; 111: 353-390.
7 Jeffrey O'Connell and C. Brian
Kelly, The Blame Game. Lexington Books; 1987:127. Berkeley Rice, "Do doctors
kill 80,000 patients a year'?" Medical Economics. November 21, 1994;
8
(discussing extrapolation to 80,000 deaths).
9 Troyen Brennan et al.,
"Incidence of Adverse Events and Negligence in Hospitalized Patients: Results of
the Harvard Medical Practice Study," N Eng. J Med 1991; 324: 370-6.
10
"Billions for Defense" at 2400. The second set of reviewers found the same
incidence of adverse events and adverse events due to negligence, but not in the
same charts. Rather than confirming the reliability of the methodology used,
this provides further demonstration of the uncertainty of what is an adverse
event and what is negligence.
11 "To Err is Human" at 1, 22.
12
A Measure of Malpractice at 138.
13 "To Err is Human" at 42.
14
Id. at 4.
15 Id. at 47.
16 Id. at 37.
17 Id. at 85.
18 Id. at 94.
19 Id. at 105.
20 Id. at 9.
21 Id.
at 103-104.
22 As the Report recognizes, "One legal fear is that
disclosure of internal quality data to outside reviewers not under a peer review
statute will lead to discovery, from JCAHO in lawsuits; indeed, many fear that
disclosure to JCAHO would invalidate even the nondiscoverability protections
each hospital enjoys for its own data under its state peer review statute." Id.
at 108.
23 Id. at 96.
24 Id. at 9.
25 Id. at 8.
26 Unintentionally demonstrating the problem, the Report also refers to
the kinds of acts that would fall under the voluntary (and confidential)
reporting scheme as ones that resulted in "no harm...(near misses) or very
minimal patient harm." (p. 74) What is supposed to be done with respect to
injuries that fall between serious and minimal.
27 "To Err is Human" at
5.
28 Id. at 76.
END
LOAD-DATE:
February 15, 2000 
