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2395
COPYRIGHT © 2005
BY
THE JOURNAL
OF
BONE
AND JOINT
SURGERY, INCORPORATED
The Medical-Legal Aspects
of Informed Consent
in Orthopaedic Surgery
BY TIMOTHY BHATTACHARYYA, MD, HOWARD YEON, MD, JD, AND MITCHEL B. HARRIS, MD
Investigation performed at Medical Professional Mutual Insurance Company (ProMutual),
and Risk Management Foundation, Boston, Massachusetts
Background: Orthopaedic surgeons routinely obtain informed consent prior to surgery. Legally adequate informed
consent requires a thorough discussion of treatment options and risks and proper documentation; however, there is
little data to guide orthopaedic surgeons regarding effective methods of obtaining informed consent.
Methods: We performed a closed claims analysis on malpractice claims involving an allegation of inadequate informed consent brought during a twenty-four-year period with two malpractice insurers. Relevant malpractice claims
were reviewed, and data were abstracted. We then performed statistical analyses to identify factors that positively
correlated with a successful defense.
Results: We identified twenty-eight lawsuits that included a claim of inadequate informed consent. All of the cases
involved elective orthopaedic surgical procedures; there were no emergent cases. Three cases involved a disputed
surgical site; all three cases involved foot and ankle surgery and resulted in an indemnity payment.
Documentation of appropriate informed consent in the office notes of the surgeon was associated with a decreased
indemnity risk (p < 0.005). Obtaining the informed consent on the hospital ward or in the preoperative holding area
was associated with an increased indemnity risk (p < 0.004). When informed consent was obtained in the office by
the operating surgeon, the risk of malpractice payment was significantly decreased (p < 0.004).
Conclusions: Surgeons may be able to decrease the risk of a malpractice claim by obtaining informed consent in
their offices, rather than in the preoperative holding area, and by documenting the informed consent discussion
within their dictated office or operative notes.
T
he ongoing malpractice crisis continues to endanger
physicians’ ability to practice medicine1. In order to
practice medicine in an increasingly litigious environment, orthopaedic surgeons must gain expertise in the relevant legal aspects of their profession. Prior to every surgical
procedure, surgeons are required to obtain informed consent.
Informed consent embodies the communication between surgeon and patient in which the patient learns of the risks and
benefits of a proposed procedure and decides whether to proceed. While orthopaedic surgeons obtain informed consent on
a regular basis, there is very little data to guide them regarding
effective methods of obtaining and documenting this essential communication2.
Closed claims analysis is one analytical method that can
be applied to complex legal issues3,4. In closed claims analysis,
clinicians review the malpractice claims of an insurance company to identify factors that are associated with higher indemnity payments or with a successful defense. We conducted a
closed claims analysis of malpractice claims involving in-
formed consent with the hypothesis that written documentation of informed consent would be associated with decreased
indemnity risk.
Methods
ata on closed claims involving orthopaedic surgeons from
two large malpractice insurers from a single state over a
twenty-four-year period (January 1, 1980, to May 31, 2004)
were reviewed electronically for cases containing allegations involving informed consent. The database encompasses all of the
malpractice claims filed with the insurers that reach either a settlement or a verdict; pending cases were not included. The cases
are prospectively coded into the database, and there is a distinct
code for “inadequate informed consent.”
Twenty-eight claims involving twenty-eight surgeons
and twenty-eight patients were found. The insurance company files containing medical records, depositions, and other
work product were reviewed.
In order to protect confidentiality, a prospective data
D
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T H E M E D I C A L -L E G A L A S P E C T S
IN OR THOPAEDIC SURGER Y
OF
INFORMED CONSENT
➤
TABLE I Data on the Cases
Case
Sex, Age
Diagnosis
Procedure
Subspecialty
1
M, 22
Lumbar burst fracture
L4 corpectomy and arthrodesis
Spine
2
M, 21
Knee instability
Anterior cruciate ligament reconstruction
Sports
3
F, 57
Carpal tunnel syndrome;
ulnar sided wrist pain
Carpal tunnel release and ulna resection
Hand
4
F, 53
Neuromuscular foot; hammertoes
Distal interphalangeal resection arthroplasty of
second toe
Foot and ankle
5
F, 42
Posterior cruciate ligament tear
Posterior cruciate ligament reconstruction
Sports
6
F, 76
Bilateral bunion deformity
Exostectomy of bilateral bunions
Foot and ankle
7
M, 26
Medial meniscal tear
Arthroscopy with anterior cruciate ligament repair
Sports
8
F, 26
DeQuervain tenosynovitis
Tendon release
Hand
9
F, 27
Hammertoe deformities
Resectional arthroplasty of the proximal interphalangeal joint in toes 2-5
Foot and ankle
10
M, 40
C5-C6 myelopathy
Cervical corpectomy and fusion
Spine
11
M, 33
Tibial plateau fracture
Open reduction and internal fixation of tibial
plateau
Trauma
12
F, 60
Kienbock disease
Lunate excision and space placement
Hand
13
F, 46
Congenital kyphoscoliosis
Anterior thoracic release followed by posterior
arthrodesis
Spine
14
M, 44
L5 spondylolisthesis
L4-S1 spinal arthrodesis with pedicle screws
Spine
15
F, 56
Hand cyst
Cyst removal
Hand
16
M, 39
Locked knee
Arthroscopy with arthrotomy
medial meniscectomy
Sports
17
F, 39
Radiculopathy
Anterior cervical discectomy
and fusion
Spine
18
F, 52
Rotator cuff syndrome
Open acromioplasty
Sports
19
M, 69
Acetabular fracture
Total hip arthroplasty
Arthroplasty
20
F, 63
Osteonecrosis of the hip
Total hip arthroplasty
Arthroplasty
21
F, 60
22
M, 31
Failed total knee arthroplasty
Revision total knee arthroplasty
Arthroplasty
Back pain
Lumbar arthrodesis
Spine
23
24
F, 28
Anterior knee pain
Fulkerson osteotomy
Sports
F, 30
Pelvic instability
Symphysis arthrodesis
Trauma
25
F, 71
Back pain
Lumbar arthrodesis
Spine
26
M, 70
Back pain
Laminectomy
Spine
27
M, 76
Low back pain
Epidural steroid injection
Spine
28
F, 49
Hallux rigidus
Arthrodesis of first metatarsophalangeal joint
Foot and ankle
*NA = not available.
sheet was constructed. Information collected included demographic data on the patients and surgeons, clinical details
regarding the patients’ diagnosis and procedure, clinical outcome information, data on the legal strategy of the plaintiffs
and defendants, and data on the legal outcome. Data were also
collected on where and when the informed consent was obtained, how it was documented, and who obtained the con-
sent. Experienced legal analysts extracted the data from the
files. A synopsis of the testimony of each expert witness was
also produced. When available, the actual written consents
were stripped of identifying information and reviewed.
The datasheets were reviewed by one orthopaedic surgeon (T.B.), and the data were entered into an SPSS database
(version 10.0; SPSS, Chicago, Illinois) for statistical analysis.
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T H E M E D I C A L -L E G A L A S P E C T S
IN OR THOPAEDIC SURGER Y
OF
INFORMED CONSENT
TABLE I (continued)
Written
Consent
Who Obtained
Consent?
Consent
by Surgeon
in Office*
Documentation
of Consent
in Notes
Outcome
Total
Expense
Total Case
Indemnity
Yes
Resident
No
No
Settlement with payment
$157,638.00
$3,100,000.00
Yes
Operating surgeon
Yes
Yes
Settlement with payment
$107,503.00
$406,000.00
Yes
Operating surgeon
No
No
Settlement with payment
$8,646.00
$200,000.00
Yes
Operating surgeon
No
No
Settlement with payment
$15,822.00
$165,000.00
Yes
Resident
No
Yes
Settlement with payment
$12,900.00
$1,220.00
Yes
Resident
No
No
Verdict for plaintiff
$26,891.29
$94,527.00
Yes
Operating surgeon
No
No
Settlement with payment
$8,524.00
$60,000.00
Yes
Operating surgeon
No
No
Settlement with payment
$15,330.00
$54,000.00
Yes
Another surgeon
No
No
Settlement with payment
$24,909.00
$45,000.00
Yes
Nurse practitioner
No
No
Settlement with payment
$875,000.00
$26,068.00
Yes
Operating surgeon
No
Yes
Verdict for defendant
$59,881.00
$0.00
Yes
Operating surgeon
Yes
No
Verdict for defendant
$109,175.00
$0.00
Yes
Operating surgeon,
resident
No
Yes
Verdict for defendant
$28,877.00
$0.00
No
No written consent
NA
Yes
Dismissed
$14,337.00
$0.00
No
No written consent
NA
Yes
Dismissed
$4,829.00
$0.00
Yes
Operating surgeon
Yes
Yes
Dismissed
$6,846.00
$0.00
Yes
Operating surgeon
Yes
Yes
Dismissed
$18,451.00
$0.00
Yes
Operating surgeon
Yes
Yes
Dismissed
$3,651.00
$0.00
Yes
Operating surgeon
Yes
Yes
Dismissed
$116.00
$0.00
Yes
Operating surgeon
Yes
Yes
Dismissed
$2,775.92
$0.00
Yes
Operating surgeon
Yes
Yes
Dismissed
$11,960.00
$0.00
Yes
Operating surgeon
Yes
Yes
Dismissed
$75,000.00
$0.00
Yes
Operating surgeon
Yes
Yes
Dismissed
$50,000.00
$0.00
Yes
Operating surgeon
Yes
Yes
Dismissed
$3,003.00
$0.00
Yes
Operating surgeon
Yes
Yes
Dismissed
$3,927.00
$0.00
Yes
Operating surgeon
Yes
Yes
Dismissed
$4,762.00
$0.00
Yes
Operating surgeon
No
No
Dismissed
$10,464.00
$0.00
Yes
Resident
No
Yes
Dismissed
$4,740.00
$0.00
Categorical variables were analyzed with the Pearson chisquare test or the Fisher exact test.
Results
Epidemiology
f the 30,504 closed claims in the combined databases, 1810
(5.9%) involved orthopaedic surgeons. Twenty-eight claims
O
involving twenty-eight cases with an allegation of inadequate
informed consent were identified. The insurers provided coverage for an average of 494 orthopaedic surgeons per year. The
majority were community-based orthopaedic surgeons. Thus,
the rate of malpractice claims involving informed consent can
be estimated as 0.0024 claims per year of practice per surgeon.
On the basis of this rate, a group of twenty orthopaedic sur-
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geons practicing for thirty years each could anticipate approximately one malpractice claim involving informed consent for
the entire group.
Descriptive Data
Summary information on the twenty-eight cases is shown in
Table I. All of the cases involved elective orthopaedic surgery.
There were no emergent cases. The cases were from a variety
of orthopaedic subspecialties.
The average age of the patients was forty-six years.
Twenty-four of the twenty-eight patients were white with at
least a high-school education, which is consistent with previous studies noting that patients of higher socioeconomic status are more likely to file a malpractice claim5. The average
time from the surgical procedure to the filing of a malpractice
claim was 3.1 years. The average time from the filing of a claim
to the settlement or verdict was 3.1 years.
All of the orthopaedic surgeons had been in practice for
a minimum of three years. The average age of the surgeons
was forty years. The majority (64%) were board-certified in
orthopaedic surgery.
The legal outcome of the claims is summarized in Table
II. Fifteen claims were dismissed by the courts. Three claims
went to trial and had judgment in favor of the defense. One
claim resulted in a jury verdict for the plaintiff. The remaining
nine cases were settled with an indemnity payment. Thus,
eighteen of the twenty-eight claims were resolved in favor of
the defendant, and ten of the twenty-eight were resolved in favor of the plaintiff. The 36% rate of indemnity payment is
slightly higher than the 30% rate of indemnity payment seen
in all orthopaedic malpractice suits6.
Patient Allegations
In twenty-eight cases, the plaintiffs alleged a lack of informed consent. Fifteen plaintiffs alleged that the underlying
orthopaedic condition was not adequately described. Five
plaintiffs alleged that the natural history of the condition
without intervention was not discussed. Thirteen plaintiffs
alleged that they experienced a complication that had not
been described preoperatively, and twenty plaintiffs alleged
that all of the risks of the procedure had not been described.
Only one patient alleged that they were incapable of giving
informed consent (an alleged language barrier; the surgeon’s
TABLE II Summary of Legal Outcomes for the Twenty-eight
Cases
Legal Result
Dismissed
No. (%) of Cases
15 (54)
Settled without an indemnity payment
0
Settled with an indemnity payment
9 (32)
Verdict for plaintiff
1 (4)
Verdict for defense
3 (11)
T H E M E D I C A L -L E G A L A S P E C T S
IN OR THOPAEDIC SURGER Y
OF
INFORMED CONSENT
notes documented that an interpreter was present).
Twenty-six plaintiffs alleged negligence and a failure to
adhere to the standard of care. In general, the allegation of a
lack of informed consent was part of a number of allegations
constituting negligence. Only one patient alleged battery; the
case was dismissed very early on in the process. With the numbers available, no particular plaintiff strategy was associated
with an indemnity payment.
Surgical Site
Three cases could best be described as a dispute involving the
surgical site. All three involved foot and ankle surgery. In one
case, the hospital chart described a unilateral bunion procedure, the surgeon’s notes described a unilateral procedure, and
the written consent documented a bilateral procedure. A bilateral procedure was performed. The patient sustained a complication on the foot that had been operated on second, and
the case resulted in an indemnity payment of $94,527. In another case, there was a discrepancy between the notes and the
consent regarding which hammertoe (e.g., the third or the
fifth toe) was to have the operation; the case resulted in an indemnity payment. In the third case, the consent was for the
correction of two hammertoes. Intraoperatively, the surgeon
thought that two additional toes should be corrected as well,
for cosmetic reasons. The patient sustained a poor result with
chronic pain. The malpractice claim was settled with an indemnity payment. In total, all three cases involving a dispute
about the surgical site resulted in an indemnity payment to
the plaintiff that averaged $101,000.
Informed Consent Documentation
In twenty-six of the twenty-eight cases, a written consent for
the procedure, including the patient’s signature, was obtained.
In two cases in which no written consent for the procedure
was obtained, the surgeons’ notes documented that a discussion of the risks and benefits had taken place. It is of note that
neither case resulted in an indemnity payment.
Of the twenty-six cases with written consent, twenty had
documentation that the operating surgeon had obtained the
consent. In five cases, the informed consent was obtained by a
resident or nurse practitioner, and, in one case, the informed
consent was obtained by another surgeon.
In eighteen cases, the surgeon had documented some
form of a discussion of informed consent in his or her notes.
The documentation was generally in the office notes or at the
beginning of the operative notes. The most common method
of documentation was a dictated statement that the risks and
benefits had been discussed. Two cases included a more exhaustive list of possible risks and benefits. No case included a
progress note in the chart. Sixteen of the eighteen cases resulted in no indemnity payment. Documentation of the informed-consent process in the notes was associated with a
significantly decreased indemnity risk (p < 0.005).
Because the cases were elective, the consent could have
been obtained in the office, the preoperative holding area, or
on the hospital floor. Thirteen cases had documentation indi-
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cating that consent was not obtained in the surgeon’s office,
and nine of those cases resulted in an indemnity payment. In
thirteen other cases, consent was obtained in the surgeon’s office and only one case resulted in an indemnity payment. For
the remaining two cases, no written consent was available.
Thus, obtaining the informed consent on the hospital ward or
in the preoperative holding area was associated with an increased indemnity risk (p < 0.004). Interestingly, cases in
which the informed consent was obtained in the surgeon’s office by the operating surgeon were associated with a significantly reduced indemnity risk (p < 0.004).
Documentation of Risks
Most courts require surgeons to disclose the risks inherent to a
procedure that would be deemed material by a reasonable person. Although this so-called objective legal standard ostensibly
protects physicians against having to guess the subjective preferences of individual patients, in practice, orthopaedic surgeons
have little guidance regarding which risks must be disclosed. For
example, it is unclear whether a minimal risk of a catastrophic
complication such as amputation or death would be deemed a
material risk. Unfortunately, there were insufficient data in our
analysis to clarify this question. In seven of the twenty-eight patients, a complication developed that had been documented as a
risk in the consent; five of the seven cases resulted in no indemnity payment. Of the twenty-eight patients, thirteen had development of a complication that had not been documented in the
consent; seven of the thirteen cases resulted in no indemnity
payment. With the data available, the occurrence of a complication that had not been described in the informed consent was
not significantly associated with an indemnity payment.
Discussion
he doctrine of informed consent for surgery arose in the
early twentieth century as courts moved to protect patient
autonomy. A prominent jurist, Justice Cardozo, articulated the
principle in 1914, stating that “Every human being of adult
years and sound mind has a right to determine what shall be
done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault . . .”7
Subsequent case law has further defined informed consent in
various jurisdictions generally to require the disclosure of a
reasonable spectrum of risks that would be relevant to the decision of a reasonably prudent patient. After informed consent
is obtained, documentation including a signed surgical consent form is essential evidence of the communication. Currently, there is a wide variation among orthopaedic surgeons
regarding the procedures used to obtain and document informed consent. In the present study, using closed claims
analysis, we have elucidated some factors that strengthen an
orthopaedic surgeon’s claim that appropriate informed consent was, in fact, obtained.
Our main finding was that the location where the informed consent was obtained is important. When informed
consent was obtained by the operating surgeon in the office,
there was a decreased risk of indemnity payment (p < 0.004).
T
T H E M E D I C A L -L E G A L A S P E C T S
IN OR THOPAEDIC SURGER Y
OF
INFORMED CONSENT
This finding is likely due to the effect of communication on malpractice claims. Poor communication has been established as the
critical factor linked to malpractice claims8-10. It seems logical
that the physician-patient communication that occurs in the office is more interactive and substantive than discussions that occur on the hospital floor or in the preoperative holding area. A
closed claims analysis conducted in Florida, which included 127
mothers of infants who had experienced permanent perinatal
injuries and who subsequently sued their physicians, showed
that nearly all complained that their physicians would not talk,
answer questions, or listen11. Clearly, the office is the best setting
for quality discussions on informed consent to occur.
A second finding was that the method of documentation
of informed consent proved pertinent. Written informed consent was obtained from the patients in twenty-six of the twentyeight cases. However, a signed surgical consent form alone
proved to be of small value for a number of cases. Documentation in the surgeon’s notes that informed consent took place
was associated with a decreased risk of an indemnity payment
(p < 0.005). Dictating even a brief description of the informed
consent process—whether as part of the operative notes or the
office notes—provides strong evidence should a malpractice
claim arise. The transcribed dictation is accessible, legible, and
more legally substantive than the standard informed-consent
form. In fact, the two cases in which no written informedconsent form was available were successfully defended with use
of the surgeons’ dictated notes.
Three cases involved a disputed surgical site. All three
cases resulted in an indemnity payment, which averaged
$101,000. Recent data have shown that marking of the surgical
site can decrease the prevalence of wrong-site surgery12. We believe that marking the site complements the informed-consent
discussion, but it does not substitute for it.
The present data, unfortunately, do not clarify to what
extent an orthopaedic surgeon is obligated to disclose or document the risks of a procedure; the best guidance for physicians regarding this issue remains the statutory and common
law of each state. Also, our data do not elucidate whether it is
better from a liability-limiting standpoint to document a
comprehensive list of possible complications or simply to document that appropriate risks and benefits were discussed. The
American Academy of Orthopaedic Surgeons recommends
that physicians document at least one extreme complication,
such as death or amputation5.
This study has a number of limitations. First, the small
number of claims results in limited power to examine the risk
factors. Only strongly associated risk factors demonstrated a
significant difference. Second, no negative cases were reviewed. There may be many cases in which poor informed
consent is obtained but no malpractice claim is filed. Third,
these data represent the experience of malpractice insurers in
only one state and may not be applicable to the general population or other jurisdictions. Fourth, most of these cases included other allegations in addition to informed consent. Lack
of informed consent was usually only a part of the plaintiffs’
strategy. However, presenting multiple allegations is the most
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common strategy in pursuing legal claims. Considered together, this cohort provides insight into the role of informed
consent in orthopaedic malpractice. Fifth, our findings may
help surgeons to reduce the indemnity risk should a lawsuit be
filed, but they may not reduce the number of lawsuits filed. Finally, the study uses indemnity payment as a surrogate marker
of a poor informed-consent process. However, the fact that a
malpractice claim results in an indemnity payment does not
prove that any wrongdoing has occurred13.
In summary, an analysis of closed malpractice claims involving informed consent in orthopaedic surgery identified
significant potential liability. Surgeons may be able to reduce
the risk of a malpractice claim by obtaining informed consent
themselves in the office (rather than in the preoperative holding area) and by documenting the informed-consent process
in their dictated office notes or operative report. NOTE: The authors thank Maureen Mondor and Elizabeth Halloran of ProMutual Group and
Kathy Dwyer of the Risk Management Foundation for their generous assistance with this
project.
T H E M E D I C A L -L E G A L A S P E C T S
IN OR THOPAEDIC SURGER Y
OF
INFORMED CONSENT
Timothy Bhattacharyya, MD
Howard Yeon, MD, JD
Partners Orthopaedic Trauma Service, Massachusetts General Hospital,
35 Fruit Street, Yawkey 3600, Boston, MA 02114. E-mail address for T.
Bhattacharyya: tbhattacharyya@partners.org
Mitchel B. Harris, MD
Department of Orthopaedic Surgery, Brigham and Women’s Hospital,
75 Francis Street, Boston, MA 02115
The authors did not receive grants or outside funding in support of their
research or preparation of this manuscript. They did not receive payments or other benefits or a commitment or agreement to provide such
benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit
organization with which the authors are affiliated or associated.
doi:10.2106/JBJS.D.02877
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