Legal Review & Commentary
Wrong-site surgery results in $455,000 verdict in New York
By Jan J. Gorrie, Esq. and Blake J. Delaney, Esq., Buchanan Ingersoll PC, Tampa, FL
News: A man was diagnosed with a cancerous tumor in his left kidney. After determining that the diseased kidney needed to be removed, an embolization procedure was scheduled to minimize bleeding during the surgery. A radiologist used a fluoroscope, which created a referential image of the patient's kidneys on the screen. As a result of the reversed image, the doctor embolized the wrong kidney. Although the doctor ultimately performed surgery on the correct, left kidney, the interventional procedure performed on the wrong kidney resulted in reduced function. The patient brought suit against the physician who preformed the procedure, the hospital, and the manufacturer of the fluoroscope. The jury found each approximately one-third at fault for the $455,000 verdict.
Background: A 57-year-old man was diagnosed with a cancerous tumor in his left kidney. Before undergoing surgery to have the diseased left kidney removed, doctors scheduled an embolization procedure to control bleeding during the procedure by occluding a problematic blood vessel. The procedure consisted of injecting foam into the relevant artery to halt blood flow to the kidney, thus minimizing blood loss during the kidney's removal.
An interventional radiologist performed the embolization with a fluoroscope, an instrument consisting of an X-ray machine and a fluorescent screen to observe the size, shape, and movement of the patient's blood vessels during the procedure. Using the fluoroscope to locate what the doctor thought to be the left kidney and relevant artery, the radiologist commenced the embolization. Unfortunately, however, the fluoroscope had erroneously created a reverse image of the patient's kidneys on its screen, leading the radiologist to begin the procedure on the patient's right side. The procedure was halted when the patient complained of pain on his right side. The physician immediately realized that he had begun to embolize the wrong kidney.
It took four days of hospitalization for the patient's right kidney to stabilize. His tumorous left kidney was subsequently embolized and removed. The patient claimed that his remaining right kidney had been permanently damaged and its function was decreased significantly. He also contended that he has experienced significant distress stemming from his concern regarding his remaining kidney's health. His expert urologist added that as a result of the compromised kidney, he might require dialysis in the future.
The patient brought suit against the radiologist, the hospital, and the manufacturer of the fluoroscope. His wife also joined the suit and claimed loss of services. Testimony indicated that the fluoroscope had a history of image-reversal malfunctions and that the physician performing the wrong site procedure already had experienced at least one prior instance of this particular imaging device malfunctioning in this manner. As it turns out, the hospital staff also were aware of the malfunction and had made several service calls to the manufacturer, but the staff failed to provide evidence that they had warned the radiologist of the situation. The plaintiff produced hospital maintenance records, which showed that the machine had malfunctioned on numerous occasions and that the manufacturer had failed to fully repair the device. The plaintiff maintained that even in the absence of the warning by staff, the treating physician should have taken extra precaution to ensure that the embolization was performed on the correct kidney. The patient argued that such precautions could have been affected through the use of markers or other visual aids.
As for the manufacturer of the fluoroscope, the plaintiff claimed that the company had knowingly produced and marketed a defective fluoroscope and that the company's service crew was negligent for failing to have properly diagnosed and repaired the fluoroscope's repeated malfunction.
The physician contended that the standard of care did not require that he use markers prior to an embolization because the orientation of the patient was checked at the beginning of the procedure. He also added that he did not "expect" the fluoroscope to malfunction. The hospital tried to affix blame on the manufacturer for failing to fix the device when they had repeatedly requested them to do so. The manufacturer countered with the notion that the image reversal was not an inherent problem with the device, but rather it was an operator error.
The jury found the radiologist liable for 30% of the damages and the hospital and manufacturer each 35% liable. The jury awarded the patient and his wife a total of $455,000. The patient received $150,000 for past pain and suffering and $250,000 for future pain and suffering; his wife received $55,000 for past and future pain, suffering, and loss of services.
What this means to you: Wrong-site surgery is one of the gravest issues facing risk managers, practitioners, and facilities. "Despite increased awareness, preventive recommendations, zero tolerance on behalf of health care facility and practitioner regulators, wrong-site, wrong-person, or wrong-procedure surgery remains the close second leading sentinel event reported to the Joint Commission on Accreditation of Healthcare Organizations [JCAHO] by general hospitals," states Leilani Kicklighter, RN, ARM, MBA, CPRHM, director of risk management services and patient safety officer at Miami Jewish Home & Hospital for the Aged in Miami and past president of the American Society for Healthcare Risk Management. "There is the pervasive belief that these occurrences simply should never happen, but in reality, we should never say 'never,' but we should endeavor to prevent such occurrences."
"A root-cause analysis, of course, must be done whenever such incidents occur, as these are JCAHO reportable sentinel events," notes Kicklighter.
"The JCAHO summary data from reported sentinel events reflects that communication is the leading contributory factor, and there was certainly a great lack of communication among the providers in this case," she adds.
The facts of this case generate an abundance of questions. "According to the facts of this case, there was a known history of the reversing images when using this particular fluoroscope. This raises several issues. First, to whom were these prior incidents reported? Second, what was done about these recurring errors? Finally, was this ever reported under the Safe Medical Device Act [SMDA] to the Food and Drug Administration [FDA] and the manufacturer? Since this was a known recurring error, why was the fluoroscope allowed to remain in service? Why weren't the interventional radiologists ever advised of this recurring error?" queries Kicklighter.
"What all this boils down to is a question of where risk management was in this situation before this final incident. Why was this piece of equipment allowed to remain in service?" asks Kicklighter. "Reporting under the SMDA is a collaborative effort between biomedical/materials management and risk management with the 'buck stopping' at risk management. Risk management should oversee the education of all employees and physicians regarding their role in the identification, tag out and lock out, and reporting of any piece of equipment that malfunctions, even if it is due to 'user error.' Incident reports of malfunctioning equipment should be reported to risk management just like any other unusual event."
Unfortunately, this piece of machinery remained in circulation, and processes were not in place to counter its use. "In view of the fact that this equipment had been sent to the manufacturer for repair but was not actually repaired, risk management should have been more involved with the FDA and the manufacturer to be sure the equipment was indeed repaired. If the manufacturer's feedback was that it was 'user error,' risk management and biomed should have initiated educational sessions with the manufacturer's representative and the users of the equipment to overcome that user defect. As it was, physicians and staff just kept using it," observes Kicklighter.
In 2004, the Joint Commission listed wrong-site surgery among its principal safety goals and suggested that facilities create and use a preoperative verification process, such as a checklist, to confirm that appropriate documents — including medical records and imaging studies — are available to the surgical team. In addition, the Joint Commission recommended that providers implement a process to mark the surgical site and, to the extent possible, involve the patient in the marking process.
The Joint Commission also has approved a universal protocol for preventing wrong-site, wrong-procedure, and wrong-person surgery. The principal components include the preoperative verification process, marking of the operative site, taking a "time out" immediately before starting the procedure, and adapting the requirements to nonoperating room settings, including bedside procedures.
"It would appear that this unfortunate outcome was not the usual wrong-side or wrong-site surgery scenario that would have been avoided by using the time out or marking of the proper site, since this was an error caused by a flipping of the fluoroscopy visualization. Although preoperative, or in this case pre-procedure, verification and perhaps even earlier patient involvement may have been beneficial, this makes it all the more critical that compliance with the SMDA process is revisited and implemented with frequent reinforcements. It would appear that the root cause of this untoward outcome was failure to communicate among all the parties who were in any way involved with this equipment on all levels, which as noted earlier is the most common element in wrong-site incidents," concludes Kicklighter.
Reference
• Queens (NY) Supreme Court, Index No. 22859/95.
A man was diagnosed with a cancerous tumor in his left kidney. After determining that the diseased kidney needed to be removed, an embolization procedure was scheduled to minimize bleeding during the surgery.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content