Legal Review & Commentary: Unresolved gallstones cause bile leakage, death
Legal Review & Commentary
Unresolved gallstones cause bile leakage, death
News: An obese, middle-aged woman suffering from pancreatitis and gallstones underwent gallbladder removal surgery at a hospital. Over the next two weeks, she continued to experience abdominal pain, nausea, and vomiting. Although doctors suspected that the woman might have gallstones floating freely in her bile duct, they were unable to perform the necessary procedures to confirm that suspicion due to the patient's size. The woman subsequently died. An autopsy discovered numerous gallstones throughout the woman's bile ducts caused bile to leak into the patient's abdomen and ultimately kill her. After the woman's estate sued the doctors and the hospital, the parties settled for $545,000.
Background: A 56-year-old woman weighing 425 pounds and suffering from chronic hypertension and renal insufficiency went to the hospital complaining of persistent nausea and abdominal pain. An internist at the hospital diagnosed pancreatitis and gallstones and referred her to a general surgeon, who recommended gallbladder removal to be performed five days later.
On the day of the surgery, the woman was feeling better, and her doctors thought she might have passed the gallstone or that it was floating freely in her bile duct. The general surgeon was unable, however, to perform a preoperative endoscopic retrograde cholangiopancreatography (ERCP) because of the patient's weight and the weight limits of the hospital equipment. The surgeon subsequently operated on the patient to remove her gallbladder, but he again was unable to perform an intraoperative cholangiogram to determine if any stone remained in the bile ducts due to the patient's size. The gallbladder removal was uneventful, and the woman's renal insufficiency immediately improved. The patient was discharged two days later.
Four days after discharge, the woman followed up with the internist, who noted that she was doing well. But two days later, the woman was experiencing abdominal pain, and fluid was draining from one of her abdominal incisions. The internist instructed the woman to collect the fluid in an ostomy bag and return in one month.
Two days later, however, the woman went back to the hospital complaining of abdominal pain and tenderness, nausea, and vomiting. The triage nurse and an emergency department physician noted that bile was leaking from the patient's abdominal incision site. A general surgeon who was covering for the first general surgeon diagnosed a biliary cutaneous fistula and admitted the woman to the hospital. Blood tests showed the bilirubin to be within normal limits, but the alkaline phosphatase was twice normal.
The covering surgeon contacted the first surgeon the next morning and told him that the patient had a suspected bile leak. The first surgeon came to the hospital that day, and when he examined the woman, she told him that she was feeling better and was no longer leaking fluid from the incision site. The doctor accordingly declined to perform a work-up, and he instead discharged her with instructions to return to his office in two weeks.
Three days later, however, the woman returned to the emergency department complaining of abdominal pain, nausea, and vomiting. Noting that her abdomen was firm and tender, the same emergency department physician admitted her for a work-up. Within several hours of admission, the woman developed shortness of breath, causing the physician to suspect a pulmonary embolus. The physician called the first general surgeon in the middle of the night to discuss the diagnosis, and the surgeon agreed. The surgeon informed the physician that he would arrive at the hospital in a few hours, at which point he would check on the patient. But the patient unfortunately died before the surgeon arrived.
During the subsequent autopsy, several liters of bile-stained fluid spilled out onto the floor when the pathologist opened the decedent's abdomen. The autopsy was immediately terminated because the floor became so slippery, and no cause of death was determined until four years later when the body was exhumed for a second autopsy. At that time, 31 gallstones were found throughout the decedent's bile ducts. Although no perforation of a bile duct was found, the pathologist did find evidence of peritonitis and marked ascites, which is excess fluid in the space between the tissues lining the abdomen and abdominal organs. The pathologist determined that the stones left in the bile ducts at the time of surgery caused bile to leak into the patient's abdomen by the process of pressure diffusion through the membranous wall of the duct. The pathologist determined that the patient's death was caused directly by the leaking bile, as it produced an inflammatory response causing the body to produce huge amounts of ascitic fluid. When the fluid could not leak out after the incision healed, the woman suffered respiratory arrest.
The woman's husband and two children sued the general surgeon, the emergency physician, the covering surgeon, and the hospital. The plaintiffs claimed that the defendants failed to meet the applicable standard of care in treating their decedent when they failed to properly diagnose her condition, perform appropriate diagnostic testing, or provide appropriate treatment.
The defendants denied liability, principally claiming that the decedent's weight prevented the performance of certain standard tests to find remaining stones in the bile ducts prior to surgery. The defense also claimed that the clinical presentation was not typical of bile leak because the patient's temperature had not been elevated and because her bilirubin and white blood cell counts were normal. The general surgeon claimed that exploratory surgery was not warranted because the patient was feeling fine when he came to visit her and because there was no further evidence of drainage when she left the hospital after the first emergency department visit. The defense also claimed that the patient died of heart failure as a result of chronic hypertension.
The parties settled prior to trial for $545,000, including $430,000 from the first surgeon, $50,000 from the emergency physician, $25,000 from the covering surgeon, and $40,000 from the hospital.
What this means to you: The patient was extremely obese, says Ellen L. Barton, JD, CPCU, a risk management consultant in Phoenix, MD. "Thus, regardless of what else was happening, this was an overriding factor and should have led to some better decision making," she says.
The fact that on the day of surgery the appropriate tests could not be performed before or during surgery because of her weight should have been a red flag to the surgeon. It already was suspected that gallstones might be floating freely in the patient's bile duct. Unfortunately, this proved to be the case.
The patient returned to the internist and complained of fluid draining from the incision; however, instead of referring her to the surgeon immediately, the internist told the patient to collect the fluid and return in a month. "The appropriateness of this action was highly questionable given the suspicion that gallstones might be floating in the bile duct," says Barton.
The first visit to the emergency department resulting in the admission appeared to be appropriate. However, when the first surgeon visited the patient and she "appeared" to be doing better and had no leaking from the incision site, the surgeon declined to perform a work-up. Instead, he discharged the patient with instructions to follow up in his office in two weeks.
The second visit to the emergency department occurred just three days after the patient's discharge from the hospital and, again, the same emergency department physician admitted the patient for a work-up. The covering surgeon contacted the first surgeon, who agreed to come to the hospital in a few hours to perform the "work-up." "Unfortunately for the patient, it was not only several hours but probably several days too late," says Barton.
Although delayed for four years, the autopsy revealed that the cause of death was related to gallstones in the bile duct that had been suspected on the patient's initial hospitalization but not acted on. The failure to refer the patient to a facility that could do the appropriate testing was clearly a breach of the standard of care. "It was this failure to refer for appropriate diagnostic testing that undid the defense's arguments, and not the patient's weight," says Barton.
Finally, according to Barton, the issue of the patient's weight should have been openly discussed as part of the informed consent process. However, this would not have discharged or overridden the duty to refer the patient to an appropriate facility.
Reference
Jasper County (MO) Circuit Court, Case No. 02CV679159.
News: An obese, middle-aged woman suffering from pancreatitis and gallstones underwent gallbladder removal surgery at a hospital. Over the next two weeks, she continued to experience abdominal pain, nausea, and vomiting. Although doctors suspected that the woman might have gallstones floating freely in her bile duct, they were unable to perform the necessary procedures to confirm that suspicion due to the patient's size. The woman subsequently died.Subscribe Now for Access
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