Legal Review and Commentary
Hospital settles and physician found liable for failure to obtain informed consent
By Blake J. Delaney, Esq., Buchanan, Ingersoll, & Rooney, Tampa, FL
News: A 70-year-old patient sought relief for respiratory problems. The woman consulted with various physicians, and she decided to undergo angioplasty and coronary stenting. After experiencing complications, the woman died that afternoon. The patient's estate alleged that there was a lack of informed consent from the patient. After the hospital settled for $25,000, a verdict of $156,000 was awarded against the operating physician.
Background: A woman, age 70, had a history of renal artery stenosis, coronary artery stenosis, high blood pressure, angina, emphysema, and chronic pulmonary disease. After experiencing severe respiratory problems, her primary care physician referred her to an interventional cardiologist, a doctor specializing in surgical procedures such as cardiac catheterization or angioplasty to diagnose and treat heart disease. The cardiologist discussed various possible interventional procedures, including coronary artery angiography, which would enable the doctor to see in detail the woman's coronary arteries as they supplied blood to her heart muscle. The procedure involved putting a tube into the woman's heart via an artery in her extremities and injecting a liquid into the coronary arteries so that they could be seen when viewed with X-rays. If the woman's blood flow was being blocked by the buildup of plaque in the artery wall, the injected contrast dye would show the cardiologist the precise location of the blockage.
After meeting with the patient, the cardiologist sent the woman's medical chart to another interventional cardiologist for a second opinion. The second cardiologist also recommended that a coronary artery angiography be performed. Although he never personally met with the patient, the second cardiologist performed the procedure a few days later. After the angiography, the cardiologist used coronary stenting to artificially keep the woman's arteries open and expanded. Coronary stenting consists of a stainless steel mesh tube with slots that is placed inside an artery to prevent the artery from closing after a procedure such as an angiography. The device comes in various sizes to match the size of the artery. Generally, the stenting is mounted on a balloon catheter in a collapsed state. The balloon is then inflated, which causes the stent to expand and push itself against the inner wall of the coronary artery. The balloon is then removed, which leaves the expanded stent in place. By forming a rigid support and helping to prevent closure of the artery, the stent can reduce the need for coronary bypass surgery.
Unfortunately, the woman died after surgery from complications of the procedure. The primary cause of death was listed as perforation of her circumflex artery.
The family brought suit against the two cardiologists and the hospital. The plaintiffs claimed that because the second cardiologist never saw the patient prior to operating on her and that the only procedure discussed was angiography, the doctor operated without the patient's informed consent. Both cardiologists claimed that the decedent was fully informed and that these procedures were the only options available to the patient.
Prior to trial, the hospital settled for $25,000. A motion for nonsuit was granted to the first cardiologist, and the issue went to the jury solely on issue of medical battery against the operating cardiologist. A verdict of $156,000 was returned, including economic damages for the hospitalization of $6,000 and noneconomic damages of $150,000.
What this means to you: This scenario raises interesting issues of informed consent when a patient is referred by one physician to another. In this case, it appears that the referring cardiologist, by virtue of the referral, essentially picked the interventional cardiologist for the patient. "Prudence suggests that referring physicians should have some information regarding the credentials, expertise, procedure volume, and patient outcomes of the physicians to whom they refer their patients, particularly in those situations where the patient has little choice or input into the referral selection," notes Marva West Tan, RN, ARM, FASHRM, associate director of quality initiative, Health Services Cost Review Commission in Baltimore.
Once the referral is made, Tan notes that some consultant physicians may tend to view the referring physician as their client and may rely on the referring physician to provide to the patient the critical discussion portion of the informed consent process, including information on risks, benefits, and alternatives of treatment associated with the proposed procedure and responses to any of the patient's concerns. In this case, for example, the interventional cardiologist may have reduced the informed consent process to having one of his nonphysician staff obtain the patient's signature on a form prior to under-going the procedure, with no further discussion between the interventional cardiologist and the patient. Tan recognizes that such practice is problematic: "The referring physician may not have the detailed information or expertise necessary to complete the informed consent or may provide some information to the patient assuming that the interventional cardiologist will perform the detailed informed consent process. Hence, each physician is assuming the other completed the informed consent, but neither actually did."
Tan warns that such an approach to the informed consent process is a setup for patient dissatisfaction and potential claims when complications to the interventional cardiology procedure arise. Because there is typically no prior personal relationship with the consultant physician that might mitigate the patient's or family's dissatisfaction, the formal documented consent process takes front and center stage. "Interventional cardiologists and other physicians who perform interventional procedures based on referrals should not assume that the referring physician has performed the informed consent. They should complete informed consent for their own procedures prior to any patient sedation and should attempt, in the brief pre-procedure time available, to establish personal contact and develop a rapport with the patient," says Tan.
Having determined that the interventional cardiologist should have engaged the informed consent process with the patient in this case, Tan recommends a thorough, well-documented process governed by a written informed consent protocol. It is not clear in this case if a completed informed consent form or a progress note addressing consent was present in the medical record. Generally, such documentation, however brief, does form a basis for a defense to a claim of no consent.
If there was no documented informed consent in the medical record, a preoperative check should have identified that this critical information was missing. The Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery developed by the Joint Commission on Accreditation of Healthcare Organizations is a good starting point for such a process. The protocol calls for a preoperative verification process to ensure that all relevant documents and studies are available prior to the start of the procedure. A signed informed consent form is one of the relevant documents that should be available. Tan notes that before the development of the Universal Protocol, a Joint Commission standard recommended that prior to any procedure the patient have a current documented history and physical examination and a pre-anesthesia evaluation, if relevant. Preoperatively, the doctor also would review any required preoperative test results, and the patient would sign an informed consent form. "Typically, it was the responsibility of the nursing or technical staff to check that all required documents were in the record before the start of the procedure," Tan says.
Once a problem developed in this case as a result of the surgery, it is unclear how information about the untoward outcome and patient death was conveyed to the patient's family. Tan recognizes that each facility is now required by the Joint Commission to have a process to discuss unexpected outcomes with the patient and/or family, and most institutions have been working to develop a transparent process over the past several years. Even prior to this requirement, there were ethical guidelines regarding informing patients and their families of untoward events. "In this case, it may have been helpful for the referring cardiologist and the interventional cardiologist to meet with the family to offer a brief factual description of the event and offer their support without pointing fingers or assigning blame," suggests Tan. The physicians also could have explained their plan to investigate the case more fully and share any additional information with the family.
Finally, Tan emphasizes the emergence of shared decision making in recent years in providing quality health care. Shared decision making overlaps in certain aspects with informed consent in that it concerns the discussion of risks, benefits, and alternatives of specific treatments. However, it generally has a much broader scope, involving such things as discussions between physicians and patients about medications and noninvasive treatments, self-management of chronic illness, end-of-life decisions, and other personal health care preferences. Tan points out that national studies have shown a lack of correlation between cost and quality of care, which elevates the importance of personal preferences where there are alternatives. She also notes that various providers, insurers, and consumer groups are developing tools and videos to educate consumers about treatment options, particularly when there are alternatives available, such as in breast cancer treatment. "Physicians seem more comfortable with the practice of shared decision making, while recognizing that some patients want their physicians to take a leading role in medical decisions," Tan says.
Despite the fact that the field of shared decision making seems to be expanding in research and practical applications and despite the best educational efforts of risk managers to emphasize the importance of the discussion portion of the informed consent process, the old problem of physicians tending to think that "informed consent" means "signing a form" persists. Tan suggests that perhaps what is needed is a new term for informed consent, involving the discussion and the documentation, to gain traction with busy physicians in their everyday practices.
- San Diego County (CA) Superior Court, Case No. GIC780566.