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Child Dies when Trial Model Ventilator Fails
ISSUE: What is the duty of a healthcare provider to inform a patient of the use of untested or experimental equipment?
A one-year-old boy was admitted into the pediatric intensive care unit (PICU) at a children's hospital as a result of severe injuries he sustained in a car accident. During his treatment, his physician concluded that a CT-scan was necessary to determine if bleeding or a blood clot in his brain was causing his deteriorating condition. The CT-scanner was located on a different floor of the hospital, so a transport ventilator was used to facilitate the child's transfer. The ventilator was a sales model of the unit that the hospital was considering purchasing. The child was placed on the ventilator for approximately an hour before the transport and was transported only after it was determined that the ventilator would provide the support needed. While returning to the PICU after the CT-scan, the ventilator lost power. Resuscitation attempts failed, and the child died.
The hospital had developed a procedure to test and evaluate equipment it was considering for purchase, such as the ventilator. The process included identifying the type of appropriate test-patient and then obtaining consent from the patient's parent before the equipment was used. This ventilator was only supposed to be used on "moderately ill" patients for air transport. The child's father was told that there was "some risk involved" in transporting the child, but he was not told that the ventilator was a test model being used for the first time. Several people accompanied the patient as he was moved to observe the ventilator in action, including a representative from the ventilator manufacturer.
The father sued, alleging negligence and failure to obtain informed consent. The hospital argued that expert testimony was needed to explain what information should have been given. The father contended that the matter was so straightforward that he did not need to provide expert testimony to establish the hospital's failure to obtain informed consent to use the ventilator.
A one-year-old boy was admitted into the pediatric intensive care unit (PICU) at a children's hospital as a result of severe injuries he sustained in a car accident. During his treatment, his physician concluded that a CT-scan was necessary to determine if bleeding or a blood clot in his brain was causing his deteriorating condition. The CT-scanner was located on a different floor of the hospital, so a transport ventilator was used to facilitate the child's transfer. The ventilator was a sales model of the unit that the hospital was considering purchasing. The child was placed on the ventilator for approximately an hour before the transport and was transported only after it was determined that the ventilator would provide the support needed. While returning to the PICU after the CT-scan, the ventilator lost power. Resuscitation attempts failed, and the child died.
The hospital had developed a procedure to test and evaluate equipment it was considering for purchase, such as the ventilator. The process included identifying the type of appropriate test-patient and then obtaining consent from the patient's parent before the equipment was used. This ventilator was only supposed to be used on "moderately ill" patients for air transport. The child's father was told that there was "some risk involved" in transporting the child, but he was not told that the ventilator was a test model being used for the first time. Several people accompanied the patient as he was moved to observe the ventilator in action, including a representative from the ventilator manufacturer.
The father sued, alleging negligence and failure to obtain informed consent. The hospital argued that expert testimony was needed to explain what information should have been given. The father contended that the matter was so straightforward that he did not need to provide expert testimony to establish the hospital's failure to obtain informed consent to use the ventilator.
From your analysis of the case, assess whether the following statesments are true or false:
| * | A hospital or healthcare provider using a test model of new equipment does not need to reveal that fact to the patient, as long as the equipment still belongs to the salesperson. | True or False |
| * | Informed consent involving the use of test or experimental equipment requires more extensive informed consent than procedures or treatment using standard equipment. | True or False |
| * | A jury may be able to understand the need for providing more information regarding use of a test model or experimental procedure without an expert witness to explain the need. | True or False |
Expand to check answers
GENERAL PRINCIPLE: When a healthcare provider is using untested equipment and is therefore unaware of all the risks it may pose, specific informed consent is necessary.
APPLIED PRINCIPLE: Often, an expert is needed to determine if the information provided in the course of securing informed consent was adequate. At a minimum, in some states, expert testimony may be required in cases alleging a lack of informed consent to prove the materiality of the risk involved. However, in this case, the father based his claim not on perceived deficiencies in the disclosures made, but on the complete absence of any disclosure about the untested nature of the ventilator and the risks of its use. If the father’s theory had been that disclosures were made to him but the disclosures were misstated or did not include material information, then it may well have been that he would need an expert to establish exactly what information he was entitled to have disclosed to him. Instead, the father claimed that he was entitled to know one basic fact that was so obvious that an expert was not needed to illustrate: this ventilator was unproven and was being tested by the hospital to determine if it should be purchased.
Where the physician fails to disclose to his patient any information concerning a material fact, there is no question of skill and judgment, no question of practice beyond the knowledge of laymen that must be established through expert testimony. An expert is not needed to establish that the father should have been informed that the ventilator was in the hospital on a trial basis for experimental purposes; that it was still under evaluation; that it was actually intended for "life flight" transport; and, most importantly, that the ventilator had never been used before on a patient. Expert testimony was unnecessary to establish the standard of care owed the father where the propriety of the treatment received was within the common knowledge and experience of a layman.
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APPLIED PRINCIPLE: Often, an expert is needed to determine if the information provided in the course of securing informed consent was adequate. At a minimum, in some states, expert testimony may be required in cases alleging a lack of informed consent to prove the materiality of the risk involved. However, in this case, the father based his claim not on perceived deficiencies in the disclosures made, but on the complete absence of any disclosure about the untested nature of the ventilator and the risks of its use. If the father’s theory had been that disclosures were made to him but the disclosures were misstated or did not include material information, then it may well have been that he would need an expert to establish exactly what information he was entitled to have disclosed to him. Instead, the father claimed that he was entitled to know one basic fact that was so obvious that an expert was not needed to illustrate: this ventilator was unproven and was being tested by the hospital to determine if it should be purchased.
Where the physician fails to disclose to his patient any information concerning a material fact, there is no question of skill and judgment, no question of practice beyond the knowledge of laymen that must be established through expert testimony. An expert is not needed to establish that the father should have been informed that the ventilator was in the hospital on a trial basis for experimental purposes; that it was still under evaluation; that it was actually intended for "life flight" transport; and, most importantly, that the ventilator had never been used before on a patient. Expert testimony was unnecessary to establish the standard of care owed the father where the propriety of the treatment received was within the common knowledge and experience of a layman.
| * | A hospital or healthcare provider using a test model of new equipment does not need to reveal that fact to the patient, as long as the equipment still belongs to the salesperson. | False |
| * | Informed consent involving the use of test or experimental equipment requires more extensive informed consent than procedures or treatment using standard equipment. | True |
| * | A jury may be able to understand the need for providing more information regarding use of a test model or experimental procedure without an expert witness to explain the need. | True |