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Improper Informed Consent Leads to Allegation of Negligent Supervision

July 5, 2017

In this interaction, the involved physicians avoided disclosing important information to the patient during the informed consent process. An informed consent exchange that is not truthful and complete violates standards of medical ethics.

Allegation

Improper performance of a procedure; negligent supervision; improper informed consent

Case File

Four Basic Principles of Medical Ethics2

  1. Beneficence — acting for the patient’s good
  2. Nonmaleficence — doing no harm
  3. Autonomy — recognizing the patient’s values and choices
  4. Justice — treating patients fairly

A 59-year-old female patient was scheduled for burr-hole drainage of a subdural hematoma she had sustained in a fall. The night before the surgery, the patient was evaluated by a neurosurgeon and a third-year neurosurgery resident. The burr-hole procedure was agreed upon, the risks and benefits were discussed with the patient and her husband, and the patient signed an informed consent form.

The next morning the resident brought the patient to the operating room and performed burr-hole drainage of a right subdural hematoma with placement of two subdural drainage catheters. The resident’s supervising neurosurgeon was not in the operating room during the surgery, although he had reviewed the procedure with the resident before the surgery. Postoperatively, the patient had left hemiparesis. A CT scan revealed that the right frontal catheter had entered the right frontal cortex. The attending physician met with the patient and her husband and explained the nature of the complication. The catheters were subsequently removed, and the patient was discharged to a rehabilitation center. She continued to have left-sided weakness, paralysis and pain.

The patient and her husband sued the attending neurosurgeon and the resident, alleging improper performance of the procedure, negligent supervision of a physician in training and improper informed consent. They testified that their understanding was that the attending physician — not the resident — would perform the surgery. Complicating this situation were the facts that the attending physician was listed as the primary surgeon on the operative report, and the resident had never before performed the procedure independently.

Expert reviewers thought that while the decision to perform the burr-hole drainage of the hematoma was proper, the attending physician should have been present during surgery to supervise and assist. They believed the resident’s placement of the drainage catheter into brain tissue caused significant, permanent paralysis. In addition, experts asserted that if the resident had been directly observed and supervised during the procedure, the complication would likely have been prevented. Further, experts believed the informed consent process was flawed because the attending physician’s name, not the resident’s, appeared on the consent form and the patient and her husband testified in depositions that they had expected the attending neurosurgeon to perform the surgery. Because expert reviewers thought the care and informed consent process did not meet the standard and more likely than not caused harm to the patient, the case was settled.

Discussion

Nonmaleficence is the key ethical principle in this case. The involved physicians failed to observe this principle; their actions caused harm. They were not straightforward during the informed consent process. Also, the attending physician’s neglect of supervision and training obligations coupled with the resident’s reluctance to truthfully admit his inexperience with the specific procedure to be performed resulted in the patient’s being injured.

Informed consent is the “willing acceptance of a medical intervention by a patient after adequate disclosure by the physician of the nature of the intervention, its risks and benefits and also its alternatives with their risks and benefits,”1 and it has both ethical and legal aspects. Ethically, physicians have a responsibility to conduct the consent process not as a “bureaucratically necessary ritual” but as an opportunity for a dialogue in which physicians’ comprehensible and thorough explanations (beneficence) and patients’ opinions and viewpoints (autonomy) meld into shared decision-making conversations that give rise to reasonable treatment strategies.1 To be ethical, the informed consent exchange must be truthful. “Deception, by stating what is untrue or by omitting what is true, should be avoided,” Jonsen and colleagues insist, adding that if some facts are uncertain, “that uncertainty should be acknowledged.”1 State and federal laws back up these ethical obligations by setting standards associated with gaining a patient’s unambiguous permission to undertake surgical or invasive procedures.

Attending physicians’ tasks often include taking on the role of supervisor and teacher to guide resident physicians as they learn by doing. Attending physicians who accept supervisory responsibility also assume an increased burden of liability should subsequent litigation arise out of negligent care rendered by a resident; therefore, a supervising physician must demonstrate good medical judgment when allowing a resident to take care of a patient or perform a surgical procedure. Good medical judgment and attention to appropriate supervision on the part of the attending physician are essential to preventing patient harm and complications that may develop in the less experienced hands of the resident.

Medical Liability Risk Management Recommendations

Interactions that Require Shared Decision-Making

  • Remember that obtaining informed consent is a communication, education and decision-making process rather than just a tedious and routine chore of obtaining a signature on a form.
  • Use lay language to educate the patient about his or her medical situation and possible helpful therapies or procedures. Proceed with respect for the patient and in a way designed to foster a therapeutic alliance in which the patient has realistic expectations.1
  • Documentation of the informed consent discussion with and education of the patient is part of the consent process. Document notes in the patient’s medical record that reflect the main points of the informed consent discussion. List educational information, literature or other learning tools provided to the patient. List the individuals who were present for the informed consent discussion.
  • During the informed consent process, a patient should be made aware when a resident will be performing the procedure.
  • Supervising physicians should be attentive to their teaching obligations by being available and accessible and by creating an atmosphere in which residents can ask questions and receive instruction and advice.
  • If a patient is identified as high risk, the supervisor and resident should remain in close communication about all aspects of that patient’s management.
  • The supervising physician should carefully review a case before allowing a resident to perform a procedure for the first time. A patient’s history or complicated medical problems may make the patient a poor candidate for surgery even under optimal conditions with the most experienced surgeon. Such a patient may not be an appropriate choice for a teaching case unless there is close direction and guidance from the supervising physician.

This content from Claims Rx

References

1. Jonsen AR, Siegler M, Winslade WJ. Clinical Ethics: A Practical Approach to Ethical Decisions in Clinical Medicine. 7th ed. New York, NY: McGraw Hill; 2010:52-57.

2. Beauchamp TL, Childress JF. Part II: moral principles. Principles of Biomedical Ethics. 7th ed. New York, NY: Oxford University Press;2012:99-288.

Filed under: Patient Relationship, Medical Ethics, Informed Consent, Case Study, Physician

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