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Malpractice Issues in Radiology |
1 Department of Radiology, Massachusetts General Hospital, 55 Fruit St., Boston,
MA 02114.
2 Department of Radiology, Rush Medical College, Chicago, IL, 60612, and Rush
North Shore Medical Center, 9600 Gross Point Rd., Skokie, IL 60076.
Received August 14, 2001;
accepted after revision August 30, 2001.
Case summaries are based on actual events and lawsuits, although certain
facts have been omitted or modified by the authors. All opinions expressed
herein are those of the authors and do not necessarily reflect those of the
American Journal of Roentgenology or the American Roentgen Ray
Society.
The Case
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When the radiologist spoke with the patient's legal guardian to discuss the procedure, the radiologist said that he would obtain a sample of one of the fluid collections by aspiration and also attempt to drain it if possible. The radiologist explained that he would perform the aspiration under CT guidance using an anterior approach with the patient lying supine because of concerns that a chest tube placed posteriorly might be accidentally dislodged by the patient. The patient's guardian gave written consent for the procedure.
Because a nurse was not available to place the patient under conscious sedation, the radiologist carried out the procedure with local anesthesia. After injection of the local anesthetic, the radiologist placed a needle in the anterior soft tissues, the position and angle of which were checked with reference to the lung abscess by repeating the CT scanning.
After reviewing the scan, the radiologist measured the distance from the tip of the needle to the abscess, calculating it to be 5 cm. A catheter was then inserted using the trocar method. The stylet was then removed, and the catheter was connected to a syringe. The radiologist attempted to aspirate the abscess, but when he was unable to obtain a return, he elected to place the stylet back into the catheter and advance it approximately 1 cm. He again attached a syringe and attempted aspiration.
Approximately 10 mL of dark blood was drawn into the syringe, but at this point, the patient began to gag and spit up blood. The radiologist attempted to suction blood from the patient's mouth, but she continued to bleed heavily. Now suspecting that he may have inadvertently placed the catheter into the pulmonary artery, the radiologist pulled the catheter back, and a code blue was called. A code team headed by an anesthesiologist responded immediately, and cardiopulmonary resuscitation was begun. With the catheter still in place, a portable chest radiograph was obtained. On the basis of this image, the team could neither rule in nor rule out the possibility that the catheter tip had punctured the pulmonary artery. The patient was stabilized medically and transferred to the intensive care unit, where she received blood transfusions. Her clinical condition progressively deteriorated, and she died 4 days later.
Eight months after the incident, the family of the patient filed a malpractice lawsuit against the radiologist and the hospital, alleging that the patient's death was a direct result of the radiologist's negligence in the performance of the attempted aspiration and drainage of the lung abscess.
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The attorney representing the defendant radiologist also retained as an expert a well-credentialed interventional radiologist who disagreed in almost every respect with the plaintiff's expert. In his deposition, the defense's expert contended that either the trocar or Seldinger technique could be used for pulmonary abscess aspiration and drainage, explaining that the interventional radiology community had never reached a consensus as to which method was safer or preferable. The expert also testified that the standard of radiologic care did not require that the defendant radiologist repeat the CT scanning when he advanced the trocar after failing to obtain aspirate on the first attempt, adding that this maneuver remains a matter of choice of the individual interventional radiologist. The defense's expert claimed that it is not unusual to advance the catheter to determine if there is any return of purulent material so long as there is no evidence of pulmonary bleeding or injury.
On the issue of whether the trocar should have been left in place or pulled back after hemorrhage began, the defense's expert stated that he disagreed with the opinion of the plaintiff's expert that the catheter should not have been withdrawn because it eliminated the tamponade effect of the catheter. The defense's expert argued that "it is natural" to remove a catheter that is "slightly off target" to try to obtain a more appropriate position. "There is simply no standard as to what to do in this situation," explained the defense's expert, "and furthermore, we're not even sure that the catheter was in the pulmonary artery—it could actually have been in the lung parenchyma itself."
As to whether the patient should have been turned on her side after the bleeding had started, the defense's expert agreed that such a maneuver "would have been preferable," but he stated he could "understand why in the midst of all the hubbub related to the code blue, the defendant radiologist did not turn the patient."
After the discovery depositions of the two expert interventional radiologists, the defendant radiologist, and members of the patient's family were completed, the defense attorneys representing the radiologist and the hospital met with the claims manager of the radiologist's insurance company, the hospital's risk manager, and the defendant radiologist to discuss a course of action. The defense attorneys believed that although they had sound medical testimony to counter the allegations made by the plaintiff's expert witness, it was nonetheless their opinion that there was a "better than 50-50 chance" that the jury would believe the testimony of plaintiff's expert interventional radiologist rather than that of the defense's expert.
The defense attorneys also suggested that the "sympathy factor" would lie with the family, in that a 25-year old woman died during a drainage procedure that ordinarily would not cause death. Therefore, they feared that the jury might award extremely high indemnification to the family. The attorneys recommended that the case be settled, and the other members of the defense team agreed.
After extended negotiations, the case was settled for a total payment of $2 million, of which $1,625,000 was borne by the insurance company for the defendant radiologist. The remainder was paid by the hospital.
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Four major allegations of malpractice were levied against the defendant radiologist in this case: the trocar rather than the Seldinger technique of aspiration and drainage was used; the trocar needle was advanced during the procedure without CT monitoring; the trocar needle was pulled back when the hemorrhage occurred; and the patient was not turned onto her side after the hemorrhage began. Let us examine these allegations in detail.
Trocar Technique Versus Seldinger Technique
A major focus of disagreement among the interventional radiologists who
testified in this case centered on the issue of the relative safety of the
trocar and Seldinger techniques. The conflicting opinions that were rendered
cannot be totally resolved, for no published study has analyzed which of the
two techniques is the safer for use in draining an abscess. Nevertheless, the
subject has been freely discussed by various researchers. Kerlan
[1] has stated that there is no
specific catheter design or size that is superior for the evacuation of
abscesses, but others have spoken out in disagreement.
In discussing the difference between the trocar and Seldinger techniques, Erasmus et al. [2] seem to favor the Seldinger technique, stating that although direct puncture of the abscess cavity with a trocar drainage system often saves time, the Seldinger technique, with placement of the drainage catheter over a guidewire, allows more control and decreases the likelihood of complication. However, these researchers hasten to emphasize that drainage can be performed using either the trocar or Seldinger technique. VanSonnenberg et al. [3] have also cautioned that although the trocar technique may be quite safe, using it, nevertheless, may cause a higher incidence of undesirable trauma to the lung. These interventional radiology experts emphasize that the advantage of the Seldinger approach is that it is safer because all dilatation is performed through the original needle path, thus making bleeding or damage to adjacent organs less likely.
On the other hand, proponents of the trocar method, such as Silverman et al. [4], believe that the trocar method is superior to the Seldinger technique. According to these researchers, the use of exchange guidewires and dilators in conjunction with the Seldinger technique may allow introduction of air, increasing the likelihood of pneumothorax. Furthermore, these researchers contend that it is more difficult to advance a catheter intercostally through a thickened pleura without buckling the guidewire or catheter and that such kinking can result in loss of access or leakage of abscess contents along the dilatation path. In short, advocates of the trocar method believe that it is not associated with an increased incidence of complications and, in fact, is less likely to be associated with abscess contamination [5].
Clearly, the choice of whether to use the trocar or the Seldinger technique is made by the specific radiologist performing the procedure. Whether to use guidance by CT or sonography is also a matter of individual choice. From a historical perspective, the first reported percutaneous drainages of abscesses were undertaken with sonographic monitoring [6]. In the past two decades, however, monitoring by CT has been the common practice. Although most abscess drainage procedures today are still being performed with CT monitoring, a recent study suggests that sonographic guidance may be more advantageous than CT monitoring because recent advances in transducer design, signal processing, and Doppler technology have greatly improved sonographic imaging and guidance capabilities [7].
Advancing the Trocar Without CT Monitoring
A critical point of contention between the two expert interventional
radiology witnesses was whether the defendant radiologist, after discovering
that the initial aspiration yielded no return, should have advanced the
catheter without first obtaining another CT scan. The defendant radiologist
had testified that he placed the initial needle used for injecting local
anesthetic into the chest wall as a marker. In other words, after measuring
the needle depth required to enter the abscess, he then advanced the trocar
catheter to what he thought was the appropriately measured distance, a
maneuver known as the tandem technique. The tandem technique, originally
described by Ferrucci and Wittenberg
[8] in 1978 as a method to
assist in localizing tumors for CT-guided biopsy, involves placing a second
needle or trocar in tandem fashion adjacent to an initial marker needle. When
modified for abscess drainage, the technique assures reproduction of the
correct trocar path, angle, and depth. After the initial aspiration yielded no
fluid, the defendant radiologist admitted that he had advanced the catheter
"another centimeter or so." It was at this time that the
hemorrhage began.
The expert interventional radiology witness for the plaintiff asserted that the standard of care required the defendant radiologist to repeat the CT scanning before advancing the trocar catheter. The expert witness for the defense, on the other hand, stated that the decisions to advance the trocar and obtain another CT scan were a matter of choice for the radiologist and that it would not have been out of the ordinary to advance the catheter slightly in an attempt to obtain a return of purulent material. Certainly, pointed out the defense's expert, there was no evidence of pulmonary bleeding or patient complaint while the radiologist was advancing the catheter. This difference in opinion highlights one of the many judgment issues that is often raised in interventional radiology. Many interventional radiologists who use the trocar technique state that they do not hesitate to advance the catheter system a short distance if an aspirate is not obtained after initial placement, but others insist that the catheter should be advanced only if, and only after, fluid or pus is aspirated [5].
No consensus has ever been achieved within the interventional radiology community on the question of whether a second CT scan should be obtained before advancing the catheter after an unsuccessful aspiration attempt. Furthermore, the issue has not been addressed in the scientific literature or in any standard published by the American College of Radiology.
Withdrawal of the Catheter After Onset of Hemorrhage and the
Tamponade Effect
The expert witness for the plaintiff in this case argued that removal of
the catheter after the hemorrhage began eliminated the tamponade effect, thus
promoting rather than abating bleeding from a damaged pulmonary artery. The
defense expert witness, on the other hand, contended that it was a natural
response to remove the catheter and, furthermore, that once the code blue was
called and a resuscitation team appeared, it was common practice for the
defendant radiologist to stand back and let resuscitative efforts begin.
Again, nothing in the scientific literature or in standards published by the
American College of Radiology addresses this point.
Turning the Patient After the Hemorrhage Begins
The final criticism lodged against the defendant radiologist by the expert
witness for the plaintiff was that as soon as the hemorrhage began, the
patient should have been turned to the decubitus position, with the injured
lung dependent. This criticism could not be refuted. Some degree of hemoptysis
occurs in as many as 20% of patients in whom percutaneous lung biopsy or
aspiration and drainage procedures are performed, but most of these
occurrences are benign and self-limited
[9]. Blood transfusions are
required in only 1% of such cases
[10]. If marked hemoptysis is
encountered, the patient should be placed in the decubitus position with the
biopsied side down, for this position minimizes aspiration of blood into the
normal lung [11,
12].
To Settle or Not to Settle
Even though the defense attorneys acknowledged that they would have some
difficulty explaining the defendant radiologist's failure to turn the patient
to the decubitus position, they nonetheless felt confident that the defendants
would prevail in a jury trial if the case were judged strictly on its medical
merits. Nevertheless, the attorneys and defendants recognized that there was a
strong likelihood that the jury would find in favor of the plaintiff because
of the horrendous nature of the injury, given that the patient had been a
25-year-old woman undergoing what should have been an uneventful
interventional radiologic procedure. The defense team's assessment was
undoubtedly realistic. In 1996, Brennan et al.
[13] published the results of
a study of 51 malpractice lawsuits that were evaluated to identify factors
predictive of payment to the plaintiffs. These researchers reviewed each
claim, made an independent evaluation of whether physician negligence had
occurred, and then correlated their assessments with eventual outcome of the
litigation. The researchers discovered that serious injuries led to
settlements even in cases in which no negligence was evident. In fact, they
found that whether negligence had occurred or not bore little relation to the
outcome of any of the claims. Brennan et al. concluded that it was the
severity of the patient's disability, not whether medical negligence had
occurred, that was predictive of payment to the patient.
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A physician may rightfully choose to practice his profession in accordance with a school of thought which differs in its concept and procedures from another school of thought. Even though the school that he follows is a minority one, he will not be deemed to be negligent of practicing properly, so long as it is reputable and respected by reasonable medical experts.
Notwithstanding whether a defendant radiologist has or has not conformed to the standard of care, the occurrence of serious hemorrhage leading to death will almost always generate suspicion of negligence and frequently precipitate malpractice litigation, especially in procedures, such as percutaneous aspiration and drainage of abscesses, in which complications are rare.
Risk management in radiology can lessen the likelihood of incurring a medical malpractice lawsuit stemming from abscess aspiration and drainage procedures and can maximize chances for a successful defense if a suit is filed, in addition to enhancing patient care. The following risk management pointers will help radiologists meet all three of these objectives:
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  F. Herth, A. Ernst, and H. D. Becker Endoscopic Drainage of Lung Abscesses: Technique and Outcome Chest, April 1, 2005; 127(4): 1378 - 1381. [Abstract] [Full Text] [PDF]
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