1. Informed consent process
2. Appropriate indications
3. Preoperative measures taken
4. Technical performance
5. Timely recognition and rescue
Case Scenario #1
John Doe is a 58 year old who presented to his internist with a recent history of swelling in the left leg. Concerned about a possible DVT, Dr. Smith ordered an ultrasound that revealed no evidence of thrombosis. When the swelling persisted, a CT of the abdomen was performed, again showing no evidence of a thrombosis but incidentally demonstrating a 6 cm solid lesion in the lower pole of the left kidney. The patient was referred to a urologist who recommended nephrectomy due to the high likelihood of malignancy. It was noted that the patient had multiple co-morbidities including morbid obesity (BMI 32), bipolar disorder, and hypertension. After appropriate informed consent was obtained, which included the risks of infection, bleeding, blood clots, injury to surrounding organs and death; the patient was scheduled for left radical nephrectomy. Surgery was performed the following week and was largely uneventful; final pathology confirmed the presence of a confined renal cell carcinoma. Postoperative pain was managed with a combination of epidural catheter using bupivicaine and short acting opioids and intravenous demand opioids. On the first postoperative night the patient was found by the nurse to be short of breath when his oxygen cannula came out; oxygen saturation at that time was 47 % but returned to 91 % when the cannula was replaced at 2 l per minute. The following day a consultation was obtained with the internist for management of his medications; the episode during the night was noted, and preoperative medications were continued, including a sleep medicine. That night, when the nurse visited the patient’s roommate, the patient was noted to be “snoring loudly”; she did not awaken him. One hour later the patient was found with his oxygen cannula on the floor, and he was unresponsive with pupils fixed and dilated. Resuscitative efforts were unsuccessful, and he was pronounced dead. Subsequent autopsy revealed cause of death to be acute right heart failure due to hypoventilation syndrome. Mrs. Smith subsequently brought a lawsuit against the surgeon, the internist, and the hospital.
What Went Wrong?
Let us apply the above-noted paradigm to determine if this unfortunate outcome could have been avoided and if the lawsuit should be defended.
1.
Upon review there was good evidence that the surgeon had spent considerable time with the patient going over the indication for the procedure, the risks inherent to it, the risks of not proceeding, the nature of the procedure itself, and the expected outcome. It was clear that the patient was adequately informed and no allegation was made about lack of consent. Of course informing a patient about the risk of a procedure does not protect from liability if it occurs, but it removes the separate allegation regarding lack of informed consent. In addition, it has been shown that patients who are adequately informed about the nature of their procedures have improved outcomes from the perspectives of shorter hospital stays, decreased pain medicine usage, and overall satisfaction.
2.
Certainly there was no concern about the indication for this surgery, as confirmed by the final pathology. In cases where the indications are marginal, or non-existent, however, patients are not well-served, particularly when they do suffer complications. The unique circumstances of each individual patient must be taken into consideration, and a recommendation for intervention must be tailored to the individual, especially when the circumstances are elective. Allegations of unnecessary surgery are unfortunately not infrequent, but can be defended when there is good documentation that the patient’s unique situation and needs were given full consideration and the diagnosis of their condition was accurate.
3.
As advances in patient safety have proceeded, we have become increasingly aware that much can be done preoperatively to reduce the risk of postoperative complications. Whether it may be appropriate administration of preoperative antibiotics to screening for underlying conditions such as hypercoagulability and obstructive sleep apnea, it is incumbent upon all providers caring for surgical patients to take all measures necessary to reduce their risk of complications prior to taking them to the operating room. Numerous resources are available to ensure adequate preoperative assessment is performed, including a guideline from NSQIP [1]. In this case, the allegation in the lawsuit was that the patient was not monitored carefully enough. While this was certainly accurate, in truth the failure was in not recognizing that the patient had obstructive sleep apnea, so that appropriate preoperative interventions were not taken. In addition to more careful monitoring (such as continuous pulse oximetry and/or telemetry or recovery in the ICU), adjustments in pain medicine administration and use of CPAP would likely have reduced the likelihood of this event. Each patient must be evaluated for risky conditions or pre-conditions that might increase their risk of a complication; in many cases this can be accomplished by the operating surgeon, however sometimes the judicious approach might include referral to a specialist or to a preoperative clinic. As always documentation in the medical record of the thought process that led to actions taken (or those not felt necessary) helps in the defense of a lawsuit should it result from that complication occurring.
4.
The proper technical performance of a procedure is a source of great pride to all surgeons; it requires judgment, learned dexterity, experienced decision making, and extensive knowledge of anatomy, physiology, and pathology. We join with our patients in desiring perfect outcomes, and suffer with them when that ideal is not reached despite our best efforts. Whether those “best efforts” were sufficient from a legal perspective is determined by a jury after evidence is presented by experts in a court of law; in most cases those experts were not present at the time of surgery, and they need to rely on the medical record to determine what happened. Thus the documentation of the operative report is key to making such a determination, and should reflect not only the actions of the surgeon but also something of the thought processes that led to those actions. In addition, many of the actions that can affect the success of the procedure are not commonly reflected in the record, such as participation in preoperative briefings and time-out processes, which have also been shown to correlate with outcomes and risks of complications. In these areas it is important that surgeons show leadership in promoting patient safety by adhering to and encouraging in others behaviors that are known to reduce complication rates.
5.
No surgeon wishes to believe that a complication has occurred to his patient. Nonetheless the likelihood that a patient can recover from a complication depends directly on the speed of recognition of that complication and subsequent rescue. In addition the most frequent cause for indefensibility of a known complication in legal actions is delay in recognition and rescue. The reasons for these failures are manifold, and include denial by the surgeon, failure to communicate with partners and other providers such as specialists and nurses, and system failures which can lead to lack of critical information [2, 3]. Surgeons must be cognizant of the complications which can occur, willing to investigate at the first sign of trouble, and able to act quickly to mitigate the effects when they occur. This includes keeping an open approach to communication with other providers, so that nurses and others feel comfortable in contacting them when they have concerns, even if they are ultimately not confirmed. We will discuss in another chapter how a surgeon can be proactive in helping their patient through these events from emotional and financial perspectives as well as the physical recovery, once the complication has been addressed. Certainly in this case an opportunity was lost in at least two instances when the patient became hypoxic and no further measures were taken to prevent recurrence; part of that would be education of providers that snoring does not necessarily mean that the patient is safely resting, and that physicians were not notified on the occasions when the hypoxia off oxygen was dangerously low.
Case Scenario #2
John Doe is an established patient of Dr. Smith, having previously undergone ACDF for disc problems in the cervical spine. He presented with a recent history of thoracic back pain without focal neurological deficit. An MRI was obtained which revealed an epidural mass at the T8–9 level; the radiologist could not definitively determine the nature of the lesion but could not rule out neoplasm. The patient met with Dr. Smith who recommended thoracic exploration and possible excision. The clinic notes reflect that the meeting occurred and informed consent was obtained. Surgery was scheduled for the next week. Open thoracotomy was performed and exploration with mass excision performed. Initially the patient did well, however, on the second postoperative day he developed weakness and paresthesias in both lower extremities. Despite prompt workup and re-exploration he went on to complete paralysis below the waist. Final pathology report on the surgical specimen revealed an inflammatory lesion with no evidence of malignancy. The patient and his spouse subsequently filed a lawsuit against Dr. Smith for failure to obtain informed consent and unnecessary surgery. During the discovery process pre-trial, the written permit was found in the hospital records. The pre-printed portion noted the risks of infection, bleeding, nerve injury, and death; the specific risks portion, however, showed that the physician had written “there are no guarantees, anything can happen”. During the subsequent jury trial this was shown in court; after both sides had presented their cases the jury deliberated before returning a verdict in favor of the plaintiff for in excess of $5 M. Following the case, interviews of the jurors revealed that in their opinion, the patient had not been adequately consented as to the risks of the surgery and that surgery may have been unnecessary.
What Went Wrong?
1.
This case highlights a rather flagrant example of disregard by the physician towards the informed consent process,and as a consequence poor care that is challenging to defend. Paralysis is a recognized risk of spinal surgery, and patients have the right to understand that risk and the others specific to their operations so they can make an informed decision. Patients who have undergone a thorough informed consent process have been shown to have improved clinical outcomes, in the form of reduced requirement for pain medicine, reduced hospital stays, and reduced recovery times. Note that we have used the term “process” in this discussion, for it is not a single event but rather ongoing education throughout the care of the patient [4]. The documentation should include the conversations that are held with the patient, any drawings or pictures that are shared, and any other materials including videos that are used during the process. Performance of this process protects to some degree the physician from litigation being filed should a complication occur. Documentation of the process, including the written permit, is most effective in defending the physician against allegations of negligent informed consent once a lawsuit is filed. We should also keep in mind that many patients may not understand some of the aspects of their care due to literacy challenges, and can be afraid to speak up when meeting with their physician. It is appropriate to ask directed questions during the discussion to assess their understanding, further explain as needed, and to document that effort. The discussion should be tailored to the patient’s particular concerns and interests, for example how a complication might affect their specific livelihood. A paternalistic approach should be avoided, and efforts should be made to achieve shared decision-making.
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