Inadequate Informed Consent Process for Orthopaedic Surgery Complicates Malpractice Defense
Details
Residents performing surgeries and procedures under the supervision of experienced physicians is an integral component of the medical educational process. At the same time, disclosing to patients which providers will be involved in their care is an essential component of the informed consent process, which recognizes patients’ rights to make informed decisions about their care.
In this case, the patient was a 66-year-old male with a long history of arthritic and orthopaedic problems in his right knee. His medical history included one arthroscopy and one high tibial osteotomy. Continued evaluation of the knee resulted in the recommendation that he have a total knee replacement, to which he consented. The patient was aware that a resident would be assisting in his surgery. In actuality, though, an orthopaedic resident (Dr. A) performed the procedure with an attending surgeon (Dr. B) assisting.
After Dr. A inserted the prosthesis and cemented it into place, he checked the range of motion, which was acceptable. The surgical instruments were removed and the tourniquet was deflated. Significant bleeding was noted, and steps were taken to maintain hemostasis (requiring 2 units of red blood cells). When the bleeding continued, the tourniquet was reapplied, and a vascular surgeon was summoned. Upon examining the patient, the vascular surgeon was concerned about the popliteal artery. He chose to leave the tourniquet in place temporarily and allowed the knee to be closed.
The patient was then rotated to the prone position to allow a more complete exploration of the popliteal fossa. The vascular surgeon then determined that both the popliteal artery and vein had been completely transected, and the popliteal nerve had been lacerated. The vascular surgeon successfully reconnected both vessels, resulting in the return of adequate peripheral blood flow. Dr. B then successfully repaired the nerve injury without difficulty. During the extended surgical treatment, the patient received an additional 2 units of red blood cells. Total blood loss was estimated at 2,500 cc.
In the post-anesthesia care unit, the patient was noted to have normal sensation and motion in his foot, and a Doppler scan confirmed the presence of a posterior tibial pulse. By the time the patient was transferred to the orthopaedic unit, his foot was warm and pink and he had brisk capillary refill.
Later that evening, the patient reported having no sensation in his foot and capillary refill was sluggish. He also was unable to move his foot or wiggle his toes. On Postoperative Day 1, the patient had no movement below his ankle and had developed a foot drop. By Postoperative Day 2, he had been fitted with a boot device; however, he could tolerate it only for short periods due to discomfort. He also said his foot had significant numbness and tingling. By Postoperative Day 3, the patient reported pain in his foot. An ultrasound of the foot was performed, but the results were inconclusive.
On Postoperative Day 4, an ankle-brachial index (ABI) test was done, and no pulses could be detected in the foot. Later that day, the vascular surgeon returned the patient to the operating room for an arteriogram. During this procedure, thrombus material was removed from the popliteal and posterior tibial arteries, resulting in the return of normal pulses. On Postoperative Day 5, the patient had increased swelling in his right leg and elevated compartment pressures. A second vascular surgeon performed a four compartment fasciotomy, and a plastic surgeon was consulted to determine how to preserve the lower leg muscles.
Ultimately, the patient was transferred to another facility. At the time of his transfer, the patient’s foot and ankle function were grossly abnormal. Although he could flex his knee normally, he could move only short distances and required the aid of a walker and ankle-foot orthosis.
A lawsuit was filed against Dr. B (the supervising orthopaedic surgeon and only MedPro insured), Dr. A (the resident and a hospital employee), and the hospital. With Dr. B’s consent, the case was settled on her behalf in the midrange; defense costs were also in the midrange. The other defendants were not MedPro Group insureds; thus, the amounts paid on their behalf are not known.
Discussion
When reviewing this case, the defense counsel’s main areas of concern were whether the informed consent process was adequate and whether the standard of care was met.
In relation to informed consent, it was the surgeon, Dr. B, who obtained the patient’s consent for the procedure; therefore, the patient reasonably assumed that Dr. B would perform the surgery. Because Dr. B was only going to assist in the procedure, Dr. A should have been part of the informed consent process and the patient should have been told that Dr. A was doing the surgery. An informed consent process that misleads the patient — even inadvertently — may not hold up from a legal standpoint.
Additionally, healthcare providers should understand that informed consent for treatment does not excuse deviations from the standard of care. Informed consent is intended to provide patients with important and sufficient information so that they can make educated decisions about treatment recommendations. Even if a patient has given a valid consent for treatment, he/she may still have a cause of action if it can be proven that the care provided did not conform to the applicable standard.
Defense experts who reviewed this case concluded that the resident’s use of an osteotome to remove a piece of bone from the tibia was the cause of the patient’s poor outcome. Specifically, the resident went too deep into the popliteal fossa, injuring the vessels and nerve. The defense experts noted that this is a rare, but known complication of this procedure. They also said that this complication might have been more likely by virtue of the fact that the patient probably had some bone adhesions as a result of previous knee surgeries. Regardless, the defense experts did not feel the informed consent process included an adequate discussion of the risks and potential outcomes, which ultimately led to the decision to settle the case.
Risk Strategies
Informed consent is a staple of patient-centered care and a vital component of the care process for elective procedures. Surgeons should consider the following risk management strategies related to informed consent:
- As part of the informed consent process, carefully consider the patient’s current understanding of his/her condition and the proposed treatment, the patient’s overall capacity to understand, and any cultural considerations, personal values, language barriers, or disabilities that might affect patient comprehension or decision-making.
- Clearly communicate to the patient which providers will be participating in the procedure and the roles and responsibilities of each individual.
- Disclose to the patient all known material risks of the proposed procedure. Discuss risks that are significant, risks that the patient might consider important, and risks that might affect the patient’s decision to accept or reject the treatment/procedure.
- Document the informed consent process in detail in the patient’s health record, including all relevant discussions and the provision of patient education. Include any consent forms in the patient’s record.
- Understand that a valid informed consent for treatment does not absolve responsibility for practices that fall below the standard of care.
- Be aware of, and ensure compliance with, organizational policies and procedures that delineate responsibilities for resident and attending physicians.
Resources
For more guidance on the informed consent process, see MedPro’s guideline Risk Management Strategies for Informed Consent and Risk Resources: Informed Consent.
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