This Case of the Month involves a patient’s death following aortic surgery¹ and highlights the importance of informed consent and documentation before high-risk procedures.
If certain actions had been taken, the patient’s death and resulting medical malpractice lawsuit could have possibly been avoided.
A 73-year-old male patient was referred to a vascular surgeon by his primary care physician. The patient suffered from exertional leg pain that tended to subside with rest and reported that he experienced more pain in his right leg compared to the left leg. A review of the patient’s medical record revealed he had a history of smoking, hypertension, hyperlipidemia, and medically managed coronary artery disease. Despite this history, the patient did not report any chest pain.
The surgeon noted that the patient was “absent a right femoral pulse, a diminished left femoral pulse, and no palpable pulses in the feet. The skin was pink without evidence of tissue loss. Noninvasive studies confirmed arterial occlusive disease bilaterally, worse on the right. A diagnostic arteriogram showed severe aortoiliac occlusive disease, with ‘coral reef-like projections’ at the aortic bifurcation and occlusion of the right common iliac artery.”¹
At the conclusion of the patient examination, the surgeon recommended extra-anatomic bypass and aortobifemoral bypass as viable surgeries for the patient. Extra-anatomic bypass may involve bypassing arteries in different parts of the body, while aortobifemoral bypass specifically targets blockages in the aorta and femoral arteries in the legs. After reviewing these options, the patient agreed to undergo an aortobifemoral bypass.
Upon review of the informed consent discussion with the patient, there was minimal information presented about the risks of aortobifemoral bypass for a patient with a history of coronary artery disease. Additionally, there was no discussion of alternative treatment, i.e., less invasive endovascular procedures. The surgeon scheduled the patient for surgery without ordering any preoperative clearance.
On the morning of the surgery two weeks later, the surgeon encountered serious complications. The patient’s aorta was significantly calcified, which hindered the surgeon’s efforts to place a clamp on it. The surgeon attempted to rectify the situation with an intraluminal balloon catheter, but the balloon ruptured after it was inflated. As a result, the patient experienced a hemorrhage and went into cardiac arrest requiring resuscitation efforts. Although bleeding was briefly controlled, the surgeon’s attempt to place a prosthetic graft was unsuccessful given the patient’s tearing in the aorta adventitia. The patient arrested again, however, resuscitation attempts failed and the patient died. The official cause of death was acute abdominal hemorrhage. An autopsy of the patient also revealed significant stenosis of the coronary arteries.
The patient’s family sued the vascular surgeon. Several significant issues were identified by both plaintiff and defense experts, which made this case extremely difficult to defend. The experts’ reviews revealed a troubling pattern leading up to the surgery and the subsequent surgery itself:
- Informed consent discussion and processes indicated a lack of attention to alternative interventions, primarily consideration of endovascular procedures.
- There was no preoperative clearance obtained on the patient.
- The patient did not have limb-threatening ischemia, raising questions about the need for the procedure in the first place.
- When the surgeon encountered difficulty clamping the aorta, the surgery should have been halted.
- The presence of atheromatous plaque was contraindicated to the balloon placement which ultimately ruptured.
- In general, sharp criticisms were made regarding the surgeon’s decision-making and rationale preoperatively and during the surgery.
- Lastly, documentation became a significant distraction. A review of the medical record revealed the patient’s admission history and physical exam did not take place until two months after the patient’s death.
The claim was settled prior to trial.
There were several junctures, prior to, during, and after the surgery where certain steps could have been taken to avoid this tragic and indefensible outcome.
A glaring flaw from the start was the lack of a well-executed informed process. This is an ongoing issue with many medical malpractice cases today and continues to be an area of needed attention.
To avoid the allegations that are associated with improper or incomplete informed consent, the Cooperative of American Physicians (CAP) recommends the following based on historical case precedent and best practices:²
- Explanation of the nature and purpose of the proposed treatment, including:
- The risks, complications, and expected benefits of the recommended treatment, along with the likelihood of success or failure.
- Any alternatives to the recommended treatment and their risks and benefits.
- The risks and benefits of declining the proposed treatment.
- For planned procedures, do not wait to obtain consent on the day of the procedure. The informed consent process should begin as early as two weeks prior to the planned procedure, preferably in the provider’s office setting. This allows enough time for the patient and physician to have a detailed discussion and to answer all the patient’s questions in a stress-free setting as opposed to a preoperative holding area.
- Thoroughly document the informed consent discussion and be sure to include all the previously mentioned elements. Also be sure to include any pertinent questions that the patient had, and what answer was provided.
- Do not just rely on the language in a standardized or general consent form. Your documentation of the informed consent conversation and the potential risks should be specific to the procedure being performed.
- Ensure that the copy of the signed consent form is placed in the patient’s medical record, and a copy is added to the hospital record as well if the procedure takes place in a hospital setting.
- Stay within the scope of the procedure noted on the signed consent form. Outside of an emergent life-threatening occurrence that would require the physician to take immediate life-saving measures, do not be tempted to “fix other problems” you might encounter intraoperatively.²
Today, evidence of a thorough informed consent process and discussion is critical for defending a medical malpractice case. A comprehensive informed consent process should empower patients to make decisions about their healthcare, ensuring that they have a full understanding of the risks, benefits, and alternatives associated with a particular procedure or treatment. It is important for healthcare providers to take the time to fully explain all relevant information to patients and answer any questions they may have to facilitate a truly informed decision-making process.
Unfortunately, in this case, alternative less invasive or risky interventions were not presented by the surgeon or discussed with the patient as part of a well-executed informed consent process. Specifically, the surgeon failed the patient by not discussing and documenting alternatives to the aortobifemoral bypass, such as endovascular intervention or medical management.
Lack of documentation of the surgeon’s rationale for the procedure and the patient’s admission history led to complications and became a major issue after the patient’s death.
Defense attorneys rely on complete and timely documentation with respect to patient medical records. Deficiencies in documentation detract from the validity and integrity of the care rendered to the patient. A defense attorney mantra is “do not let documentation become a distraction” in a medical malpractice case.
This case highlighted many key issues that unfortunately resulted in the death of a patient, the ultimate adverse event. The takeaway is that diligent incorporation of risk management strategies, notably properly executed informed consent, are designed to improve patient outcomes, reduce malpractice claims, and navigate a medical malpractice claim more successfully.
Brad Dunkin, MHA, is Assistant Vice President, Risk Management and Patient Safety. Questions or comments related to this article should be directed to BDunkin@CAPphysicians.com.
¹David Han, MD, FACS, and Jacqueline Ross, RN, PhD. “Lessons Learned from a Medical Malpractice Lawsuit: Aortic Surgery in a Patient with Significant Underlying Coronary Disease." American College of Surgeons. January 2025.
²Dunkin, Bradford S., MHA. “The Critical Link Between Informed Consent, Thorough Documentation, and Effective Defense of Medical Care.” Cooperative of American Physicians. January 2025. https://www.capphysicians.com/articles/critical-link-between-informed-c…