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Citation
Caplan RA, Posner KL: Informed consent in anesthesia liability: Evidence from the Closed Claims Project. ASA Newsletter 59(6):9-12, 1995.
Full Text
Informed consent is considered a basic aspect of the prenaesthesia evaluation. Little is known, however, about the impact of informed consent on professional liability. The database of the ASA Closed Claims Project offers an opportunity to explore this question
The Closed Claims Project is a study of claims against anesthesiologists, with data collected on an ongoing basis from professional liability insurance claim files by anesthesiologist-reviewers.1 This project has been conducted under the auspices of the Committee on Professional Liability since 1985. To date, detailed summaries of more than 3,000 claims have been accumulated in the project database.
Information about informed consent was available in 1,984 (61 percent) of the 3,269 claims in the current database [Figure 1]. Appropriateness of informed consent was an implicit judgment, based upon the reviewer’s determination of reasonable and prudent practice at the time of the event.
Figure 1
Adequacy of Informed Consent in Closed Anesthesia Claim Files
Adequate Informed Consent
Reviewers judged that adequate informed consent was documented in 1,277 claims (39 percent of database). Within this group of claims, informed consent was cited as a factor in litigation in 15 cases (1 percent). Three specific patterns were identifiable.
The first group of claims involving four cases was characterized by specific patient requests that were ignored by the anesthesiologist. As an example, two patients specified that no residents be involved in the anesthetic care, a restriction that was ignored. Postoperative complications ensued in both cases. Despite the fact that the complications were not clearly linked to anesthetic care, both patients received sizable payments ($300,000 and $400,000). Such claims serve as a reminder that the failure to honor specific requests can provide a powerful stimulus for litigation.
The second group of claims involved patients in three cases who received appropriate informed consent for the anticipated procedure, but the circumstances surrounding the anesthesia and surgery underwent an unexpected change. In one illustrative case, a general anesthetic was abandoned when intubation proved difficult. The surgery then proceeded uneventfully using local anesthesia and sedation. In the postoperative period, the patient experienced emotional problems that were attributed to the unexpected approach to anesthesia. Settlement of the claim resulted in a payment of $7,500. This type of claim underscores the importance of discussions that emphasize the unpredictable course of perioperative events and the associated need for alternative approaches.
The third group, also involving three cases, was characterized by claims in which the patient alleged that he or she had not been informed of the possibility of the specific complication that occurred. One case involved infection after an epidural steroid block, another involved headache after spinal anesthesia, and a third involved pneumothorax after stellate ganglion block.
The first case mentioned (infection following epidural) was dismissed, and the patient had no residual symptoms. In the case of the post-spinal headache, the suit was eventually dropped. The case of the pneumothorax resulted in a payment of $12,500. Although only this third case of the three resulted in any payment to the plaintiff, these cases serve as a reminder that general descriptions of risk should be supplemented, when feasible and appropriate, with a specific discussion of complications that are especially serious or more likely to arise with the chosen anesthetic technique.
Inadequate Informed Consent
Closed claims reviewers found evidence of inadequate informed consent in 707 (22 percent) of the 3,269 claims in the database. However, the inadequacy of informed consent was a factor in litigation in only 22 (3 percent) of these cases. These 22 cases were characterized by basic deficits in the conduct of informed consent. The most common recurrent factor among the group of cases characterized by inadequate informed consent was failure to obtain any type of consent (n=5). While one of these five cases was dismissed, payment in the other four ranged from $12,500 (for temporary diplopia, back and neck pain following epidural analgesia for labor) to $1 million (for brain damage following a lumbar epidural block and cardiac arrest in a young, healthy patient for arthroscopy).
Other recurrent examples of basic deficits in consent included failure to document consent in the medical record (n=3), failure to advise the patient of possibility of any risks or complications (n=2), failure to use an interpreter for patients unable to understand English (n=2) and performing anesthetic and surgical procedures against the expressed wishes of the patient (n=2). All but one of these recurrent examples resulted in payment to the plaintiff, with payments ranging from $6,500 to $1.5 million.
Liability Profile of Cases With Informed Consent as a Litigation Issue
An analysis of the small number of claims in which informed consent was an issue in litigation reveals that the liability profile of claims involving inadequate informed consent (n=22) was less favorable overall than the profile of claims in which informed consent was considered adequate (n=5). Major adverse outcomes (e.g., death, brain damage, permanent injury) were found in 73 percent of claims in which inadequate informed consent was a liability issue (16 or 22) compared to 20 percent of claims associated with adequate informed consent (3 or 15) [Table 1]. Payment to the plaintiff was made in 73 percent of the 22 claims associated with inadequate informed consent as opposed to 40 percent of those 15 with adequate consent [Table 1].
Table 1
Liability Profile
of Cases
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|
Informed Consent |
|
|
Adequate |
Inadequate |
|
|
Death, brain damage or permanent injury |
3 (20%) |
16 (73%) |
|
Payment to plaintiff |
6 (40%) |
16 (73%) |
|
Range of payments* |
$13,000-$400,000 |
$2,000-$1,500,000 |
|
* Note: Claims with no payment or missing payment data were excluded. |
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Not only were more claims paid, but the upper end of the payment range was considerably higher in the claims with inadequate informed consent. A closer look at the payments reveals no claims with payments of more than $500,000 among the claims with adequate informed consent compared to four claims with payments of $1 million or more in the claims with inadequate informed consent [Table 2]. While informed consent was not the only issue in these claims, it did play a role in the litigation process.
Table 2
Distribution of Payments in Claims With Consent as a Litigation Issue |
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|---|---|---|
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Informed Consent - Claims with Payment |
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|
Payments |
Adequate |
Inadequate |
|
<$50,000 |
2 (33%) |
9 (56%) |
|
$51,000 - $100,000 |
2 (33%) |
0 (0%) |
|
$101,000 - $500,000 |
2 (33%) |
3 (19%) |
|
$501,000 - $999,000 |
0 (0%) |
0 (0%) |
|
$1,000,000 |
0 (0%) |
1 (6%) |
|
>$1,000,000 |
0 (0%) |
3 (19%) |
|
* Note: Claims with no payment or missing
payment were excluded. |
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Although it appears that informed consent may often play a contributory rather than a focal role in the claims process, the apparent relationship between informed consent and liability may also be confounded by missing information in the claim files and the subjective nature of informed consent practices and reviewer assessments.
Summary
Informed consent plays a relatively minor role in anesthesia liability as profiled by the current database of the ASA Closed Claims Project. Overall, informed consent was an issue in 37 of 3,269 claims, just 1 percent of the overall database. From the perspective of risk management, these cases suggest that failure to perform or document informed consent is less of a problem than related but secondary issues. These secondary issues include honoring specific requests, emphasizing the possibility of alternatives and explicitly delineating risks that are relatively common or especially serious.
Reference
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Cheney FW, Posner K, Caplan RA, Ward RJ. Standard of care and anesthesia liability. JAMA. 1989; 261(11):1599-1603. [Abstract]
Caplan RA, Posner KL: Informed consent in anesthesia liability: Evidence from the Closed Claims Project. ASA Newsletter 59(6):9-12, 1995 was reprinted with permission of the American Society of Anesthesiologists, 520 N. Northwest Highway, Park Ridge, Illinois 60068-2573.