Data 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 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 consent. 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. Categorical variables were analyzed with
the Pearson chi-square test or the Fisher exact test.
Epidemiology
Of the 30,504 closed claims in the combined databases, 1810 (5.9%)
involved orthopaedic surgeons. Twenty-eight claims 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 surgeons 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 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 indicating 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.
The 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). 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 twenty-eight 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 informed-consent 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 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.