Do You Know What You Need to Know About Informed Consent?
December 1, 2013
Do You Know What You Need to Know About Informed Consent?
A Quiz for Emergency Department Providers
By Joshua J. Moore, BA, Emergency Department, Madigan Army Medical Center; W. Allen Fink, DO, MHA, FACEP, Attending Emergency Medicine Residency, Madigan Army Medical Center, Department of Emergency Medicine, Tacoma, WA, Regional Dean — Puyallup/Adjunct Clinical Assistant Professor PNWU-COM; Malia J. Moore, MD, Emergency Medicine Residency, Darnall Army Medical Center, Killeen, TX
The issue of informed consent is becoming increasingly common in court cases involving medical malpractice. This may be due to a physician’s lack of awareness concerning the precautions that must be taken in select scenarios. There is substantial risk of legal penalties for the lack of informed consent when there are poor patient outcomes. It is important for physicians to understand the steps necessary to avoid these possible penalties. This article provides a brief quiz to test physicians’ knowledge of informed consent and discuss some caveats that every ED physician should be aware of.
Question 1: What are the components of informed consent and what constitutes informed consent malpractice?
The first notable case concerning failure to provide information about what the objective patient would find material was Canterbury v. Spence (1972).1 The patient presented to Dr. Spence with severe pain between his scapulae. Dr. Spence, a neurosurgeon, performed a myelogram to determine the location of the aberration. Once the location was determined, Dr. Spence decided to perform a laminectomy to repair a ruptured disc. He did not inform the patient of the risk of paralysis that could complicate the procedure. When the patient’s mother asked if the operation was serious, Dr. Spence replied, "Not any more than any other operation." He felt that it was poor practice to reveal the risks, as it could deter the patient from undergoing a necessary procedure. The day after the operation, the patient fell out of the bed while attempting to void. Hours later, he complained that he could not feel his legs. A second emergency operation was performed, but the patient was left with paralysis of the legs and incontinence. Four years after the laminectomy, the patient sued Dr. Spence for negligent care in the performance of the procedure and failure to inform him of the risks of the operation. The court ruled that there was no evidence suggesting that Dr. Spence’s treatment was responsible for the negative outcome. However, the court determined Dr. Spence was guilty of failure to reveal the risk of paralysis that the surgery presented to the patient.
In its discussion of Canterbury v. Spence, the court defined what constitutes informed consent. The physician is mandated not only to treat the patient skillfully, but also to "communicate specific information to the patient when the exigencies of reasonable care call for it."1 To summarize, the key components are that the physician discloses to the patient: 1) the risks and benefits of a procedure; 2) the alternatives to the proposed procedure; and 3) the consequences of not undertaking the procedure. The threshold for obtained consent involves exposing a risk when the patient would personally consider it significant to his or her decision.
The decision to inform, however, is made in foresight by the physician. The physician is only responsible to inform the patient based his or her personal knowledge and information base at the time of care. It is up to the provider to personally determine the necessity of information that should be relayed to the patient. Once again, this determination should be made in an effort to educate the patient on any possible elements involved in the care that they would personally like to know about before selecting a method of treatment.
Canterbury v. Spence also labeled lack of informed consent as true malpractice and defined the elements of negligence in this situation. The physician is negligent if: 1) an unrevealed risk should have been made known; 2) the risk does occur and causes harm to the patient; and 3) the patient would not have undergone the risk if he or she had been informed before the procedure.1
Question 2: Which of following scenarios is an exception to informed consent?
Scenario A: A 45-year-old female collapses at work. She arrives at the ED in shock. A central line is placed. The subclavian artery is punctured. The patient exsanguinates and dies. Will a lawsuit alleging lack of informed consent likely be successful?
Scenario B: A woman has idiopathic intracranial hypertension (pseudotumor cerebri). She undergoes a lumbar punctures on a regular basis. Does she require informed consent before each lumbar puncture?
| Elements of Informed Consent Negligence |
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The facts of Scenario A above are based on a recent actual case.2 The court issued a defense verdict for the physician. In Canterbury v. Spence, the court also discussed exceptions to a physician’s obligation to inform and obtain consent.1
The first exception to giving informed consent is an emergency situation: "When the patient is unconscious or otherwise incapable of consenting, and harm from a failure to treat is imminent and outweighs any harm threatened by the proposed treatment. When a genuine emergency of that sort arises, it is settled that the impracticality of conferring with the patient dispenses with need for it."1 "Even in situations of that character, the physician should, as current law requires, attempt to secure a relative’s consent if possible. But if time is too short to accommodate discussion, obviously the physician should proceed with the treatment."1
A second exception is when a patient would generally already understand the risk. For example, most any person would understand that a surgery has a risk of infection. A third exception arises when the patient is already familiar with the proposed procedure. Thus, in scenario B, the physician would not be expected to give informed consent for each lumbar puncture. Although not required, repeatedly giving informed consent would further decrease liability. A final exception is if delivering informed consent would make the patient "so ill or emotionally distraught on disclosure as to foreclose a rational decision, or complicate or hinder the treatment, or perhaps even pose psychological damage to the patient."1 This is called the "physician privilege exception."
| Exceptions to Informed Consent |
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Question 3: Is informed consent only required for procedures?
A patient, Thomas Jandre, came to the ED after experiencing drooling, slurred speech, and a facial droop on the left side. He also presented with dizziness and weakness. Dr. Bullis, the ED physician, took a medical, social, and family history. She then performed a physical exam and ordered a head CT scan. Dr. Bullis diagnosed the patient with Bell’s palsy and ruled out a hemorrhagic stroke using the CT scan. Rather than order a carotid ultrasound, she listened to Jandre’s carotid arteries to determine if she heard a bruit that would indicate an increased risk for thromboembolic ischemic stroke. Eleven days later, Jandre suffered a significant stroke. The carotid ultrasound performed following the stroke indicated that his right internal carotid artery was 95% blocked.3
Thomas Jandre and his wife brought suit, alleging that Dr. Bullis negligently diagnosed his condition and failed to provide the information necessary for him to make an informed decision regarding his treatment. They argued that the physician should have informed them of other tests that were available to assist in correct diagnosis (carotid ultrasound). The jury determined that the mistaken diagnosis of Bell’s palsy was not negligent and, thus, not medical malpractice. However, Dr. Bullis was found negligent of a failure to achieve an informed consent from the patient. The jury awarded the Jandres approximately $2 million.
It is important for ED providers to be aware of this case. There are multiple other similar court cases stating that the principles of informed consent apply not only to procedures but also to medical decisions.
| Correct Answers to Quiz | ||
|---|---|---|
| Question | Court Ruling | Summary |
| Question 1 | For plaintiff | A physician must inform the patient of risks associated with a surgical procedure before performing the procedure. |
| Question 2 scenario a | For physician | Informed consent is not mandated in emergency situations when a patient is incapable of consenting. |
| Question 2 scenario b | For physician | Informed consent is not mandated when performing a procedure with which the patient is familiar. |
| Question 3 | For plaintiff | A physician must make the patient aware of all possible routes of care that the patient may seemingly wish to take. |
| Question 4 | For plaintiff | A physician must inform patients of more qualified physicians and give accurate statistics concerning a procedure. |
| Question 5 | For plaintiff | Signed procedural forms are not independently sufficient to obtain consent. |
Question 4: Should a physician disclose his or her level of expertise when getting informed consent for a procedure?
Donna Johnson presented to her family physician with persistent headaches and had a CT scan performed. Her family physician referred her to Dr. Kokemoor, a neurosurgeon. He diagnosed Johnson with an enlarging aneurysm in her brain and recommended a surgery to remove it. Dr. Kokemoor spoke to Johnson and ensured her that he had performed the surgery "dozens of times," relating its seriousness to a tonsillectomy or gall bladder surgery. He revealed that the surgery had a 2% mortality rate, when, in truth, the rate was closer to 30% when performed by inexperienced physicians. He also failed to inform Johnson that she had an option to seek care from more experienced surgeons. There were complications from the operation that caused Johnson to become a wheelchair-dependent quadriplegic with impaired vision and speech.
Johnson brought suit against Dr. Kokemoor, claiming that he obtained inadequate consent for the procedure. The courts ruled in favor of Johnson, citing that Dr. Kokemoor failed to adequately inform the patient of the morbidity and mortality rates and refer her to a more experienced surgeon. A physician is required to give any information concerning what a patient would like to know to make an informed decision. The courts have decided that revealing more qualified physicians as an option is part of obtaining informed consent.4
By the very nature of the environment, ED providers likely will not have time in emergent situations to seek out and offer more experienced providers to ED patients. This case should not cause great alarm to ED physicians, but is informative and one to be aware of. What about training facilities? Are providers obligated to let only the most experienced clinician perform a procedure? In reality, when patients come to a teaching hospital, there is obvious acknowledgement that training is occurring and likely implied consent (i.e., assumption of risk). Thus, it is unlikely in a teaching environment that a court would enforce the same obligation as in the case above. If, however, a patient states that he or she does not want a training student/resident to perform a procedure, it would be optimal to honor the patient’s desire.
Question 5: Does a signed consent form relieve a physician from liability if a complication mentioned on the form occurs?
Betty Havens was referred to Dr. Hoffman for an evaluation of a painful epigastric mass. A ventral hernia had developed due to a prior abdominal surgery. Dr. Hoffman and Betty Havens agreed that he would repair the ventral hernia and perform the procedure under anesthesia. As a result of the thoracotomy, one of Havens’ ribs was broken and the costal cartilage was torn away at the costochondral junction. This injury resulted in permanent and chronic pain. This injury commonly occurs during this particular surgery in more than half of the cases. Havens brought suit against Dr. Hoffman, claiming that he failed to inform Havens that rib fracture and cartilage tearing are frequent complications of the procedure. She claimed that she was not informed that the procedure could specifically result in torn cartilage, chronic pain, or debilitating pain. Furthermore, she alleged that Dr. Hoffman did not inform her of alternative procedures that are less hazardous. Dr. Hoffman argued that Havens had signed a fully executed consent form for the procedure and offered this as evidence of informed consent. The court ruled that while an executed consent form is evidence that a discussion took place, it does not prove what the content of the discussion was. The content of the discussion must be determined from further testimony.5 In other words, a signed form does not independently prove there was informed consent.
It is important for ED providers to be aware of this case and document components of an informed consent on the chart and not exclusively rely on signed forms.
Conclusion
We have provided a provocative quiz with legal case discussions to illustrate basic concepts and interesting caveats with regard to informed consent. (See Table 3.) The issue and utilization of informed consent are pervasive throughout the practice of emergency medicine. To avoid increased liability, it is imperative for ED providers to comprehend and utilize the legal requirements with regard to informed consent.
References
- Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972)
- Smith v. Franks, Boyd County, Kentucky, circuit court case no. 09-670
- Jandre vs. Physicians Ins. Co. of Wisconsin, 792 N.W.2d 558, (2010) 2010 WI App 136
- Johnson v. Kokemoor, 545 N.W.2d 495, 199 Wis.2d 615 (Wi 1996)
- Havens v. Hoffman, 902 P.2d 219 (Wyo. 1995)
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