Informed Consent

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Informed consent of patients contemplating neurosurgical procedures is an important process in preoperative care. While the majority of neurosurgical cases have expected or better than expected results there are times when outcomes are less than desired or different than expected. Even in these cases most patients and their families are appreciative of a situation that may be beyond the control of the patient or surgeon. Occasionally however, when expectations are not met, patients may reflect on what they understood or believed they understood when consent for the procedure was obtained. As they recount these memories and contemplate legal redress for their current state a neurosurgeon may come face to face with the inherent duties of informed consent. Knowledge of informed consent is one of the best ways to prevent these unpleasant situations from arising.

The law of informed consent is relatively new in the field of health law. The first mention in a court of law of a physician duty to disclose details and information regarding a contemplated procedure came in 1957. Over the ensuing years, courts and legislatures have continued to expand on this duty. In most cases these new decisions and laws have been in response to patients’ desire to be more informed about what they become involved in. Studies consistently show that more than 90% of patients want to be informed and participate in the decision-making of their health care. In addition, physicians routinely underestimate a patient’s desire for information and overestimate the amount of time spent giving consent. Ironically, it is a lack of information that often leads to increased patient anxiety, increased refusal of treatment, and decreased patient satisfaction.

Informed Consent in the Construct of the Law [1]

The law of informed consent is constructed from both civil law (a.k.a. tort law) and codified law (a.k.a. constitutional law). The body of decisions made by both state and federal courts comprises civil law. A legislature may take this civil law and codify it into laws (constitutional laws) if it perceives a public need for such action. The law of informed consent is based predominantly in civil law with occasional constitutional laws codifying some essential elements. In addition the federal government has added several administrative regulations contingent to participation in Medicare. [2]

Informed consent is not a document. It is not a waiver of rights by the patient nor does it shield the surgeon from potential litigation. Informed consent is a process – a dialog between surgeon and patient that establishes expectations for both the patient and surgeon with regard to a specific intervention. A document, no matter how detailed, is only a historical record of this process and cannot replace the exchange of information between a patient and health care provider. Although most hospitals and many insurers may require a written informed consent, such a form does not shield a physician from liability.

Legal Doctrine of Informed Consent

The first issue that must be addressed in a discussion of informed consent is which procedures require it. In a few states this has been codified after several court cases tried to resolve the issue. A good rule of thumb is that any surgical procedure performed under general anesthesia, spinal anesthesia or major regional anesthesia, or a diagnostic procedure with intravenous or intrathecal injection should have consent.

Elements of Informed Consent: As stated previously, the law of informed consent is largely governed by civil law as a form of tort. A tort is composed of four elements: duty, breach, causation, and damage. In addition to these four elements the circumstances leading to the damages and the damage itself must be ‘reasonably foreseeable’ and timely. This is often referred to as a requirement of proximate cause. It is the plaintiff’s (patient’s) burden to prove the elements of the tort have been met.

Duty: A physician’s duty regarding informed consent is two-fold. A physician has a duty to inform the patient and obtain the patient’s consent. The legal approach to establishing this duty is pragmatic. Although the patient has the right to refuse, it is the physician who possesses the greater information and power to control the circumstances under which the two parties meet. Additionally, the physician has a duty to respect and promote the patient’s best interest. As such, it is the physician who is held to a higher standard and thus a greater duty.

A discussion about the proposed procedure should proceed with language that the patient can understand and start with the results of pertinent diagnostic results leading to the decision to offer surgery. This would include things such as MRI and nerve conduction study results but not necessarily chest x-rays, blood counts or electrocardiogram results if those tests would not affect the decision for surgery or its probable outcome. The surgeon should make particular mention of the purpose, probable outcome and likely benefits of the surgery. This is important information that should only be given with great care and honesty as it is often recalled by patients in subsequent lawsuits. Thus express or implied “guarantees” of outcome are very unwise while reasonably broad statements that reflect either personal or published experience with a particular surgery are more appropriate. The patient should be reminded that the outcome even from more routine surgeries may have great variability depending on the patient’s age, history, co-morbidities, and imaging characteristics.

Also included should be an explanation of what the procedure will entail including details regarding where and how large the incision will be, general anatomy of the area where the surgery will take place, hardware and instrumentation, number of levels involved, probable length of hospital stay, and mobility after the surgery. This should be followed by a frank discussion on complications, both temporary and permanent, that are reasonably foreseeable. This discussion should involve specifics about postoperative pain, infection, cerebrospinal fluid leaks, blood loss, scars, paralysis, plegia, incoordination, loss of vision, hearing or language, and personality changes. Note the emphasis on reasonably foreseeable. Remote risks are generally not necessary to disclose (e.g. brain stem hemorrhage after removal of a chronic subdural hematoma). The scope of disclosure may vary by patient however. For example, a diabetic patient should probably be told about delayed wound healing even though under most circumstances this would be a remote risk.

A patient should also be told about the availability of reasonable alternatives to the proposed procedure including the option of no surgical intervention. For example, a patient contemplating a procedure for trigeminal neuralgia should be advised of treatments alternatives that include microvascular decompression, glycerol rhizotomy, radiofrequency ablation, radiosurgery and medications. The discussion of these alternatives should outline the respective risks and benefits associated with each one. Failure of the surgeon to outline alternative care plans would invalidate the consent.

One final duty of the consenting physician is to inform the patient of who will be performing specific surgical tasks. These include opening and closing, harvesting grafts, dissecting tissue, removing tissue, implanting devices or altering tissue. When practitioners other than the primary surgeon will perform important parts of the surgical procedure, even when under the primary surgeon’s supervision, the patient must be informed of who these other practitioners are, as well as what tasks each will carry out. [2] Thus the use of residents, mid-level practitioners or nurses during a surgery where those individuals perform any of the tasks above would compel that disclosure as part of the informed consent.

Breach: Failure of the surgeon to fulfill the duty outlined above creates a risk of liability. Accordingly, a surgeon who delegates this responsibility to another health care provider risks the patient relying on information that may not have been what the surgeon intended. The law makes it clear that the duty to consent lies with the one doing the surgery. If that responsibility is delegated away it is important that the surgeon know exactly what their representative will communicate to the patient.

For neurosurgical residents this is an important point. If a resident is to perform a case alone then the resident carries the duty to obtain consent. If the procedure is to be done by both resident and attending surgeon, either may obtain consent. If however the case is to be done by the surgeon alone, the resident who obtains the consent acts as the agent of the surgeon and the duty to consent remains with the surgeon.

Causation: If a patient is injured as a result of a failure on the part of the physician to disclose information about a procedure, the patient may collect damages from the physician for causing the injury. Here the burden rests squarely on the shoulders of the plaintiff (patient). The patient must show that had he been informed of the outcome or risk, he would not have consented to the procedure. This is often a difficult set of facts for a judge or jury to sort out. They must decide how a “reasonable person” under similar circumstances would have responded with this new information – a largely subjective task.

Damages: With regard to the injury incurred as a result of the lack of information, the plaintiff must show that he is worse off in financially measurable terms than if the procedure had not been performed. Again the responsibility for determining this amount, aided by expert witness testimony from the plaintiff, lies with the judge or jury. For example, money may be awarded for pain and suffering, lost wages, and physical, emotional or psychological defects.

Statute of Limitations: Just as with medical malpractice claims, a statute of limitations applies to breaches of informed consent. The amount of time varies from state to state with the clock starting at different times depending on the individual state law. Typical state statute of limitations run from one to five years and may start when the consent was obtained, when treatment related to that consent ended, when an injury occurred, or when the patient became aware of the injury.

Even if a plaintiff has proven the four elements of the claim and proximate cause, a neurosurgeon may be exempt from liability in the event care was rendered during a medical emergency. The medical emergency exemption is based on the obvious tenant that delay of treatment would result in further harm or death to the patient. '

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In summary, the prudent neurosurgeon will remember that informed consent is not a document but rather a process. It is a dialog between physician and patient that establishes expectations for specific procedures. The judicial system holds physicians to a high standard and expects them to respect and promote patient’s interests. Failure to fulfill this duty may result in frustration and repeated litigation for the neurosurgeon.

References

  1. A.M. Scarrow, M.R. Scarrow: Informed consent for the neurosurgeon. Surg Neurol 57:63-68, 2002.
  2. 42 CFR §382.51(b)(2)
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