by Fernando A. Guerra, MD, MPH, FAAP
The following closed claim study is based on an actual malpractice
claim from Texas Medical Liability Trust (TMLT).
This case illustrates how action or inaction on the part of
physicians led to allegations of professional liability, and
how risk management techniques may have either prevented
the outcome or increased the physician’s defensibility. The
ultimate goal in presenting this case is to help physicians
practice safe medicine. An attempt has been made to make
the material less easy to identify. If you recognize your own
claim, please be assured it is presented solely to emphasize
the issues of the case.
Presentation
On 13 May, a 69-year-old woman was referred to a
gastroenterologist for abdominal pain in her right
lower quadrant. A previous abdominal ultrasound
was abnormal, indicating a dilated common bile duct.
Physician Action
The gastroenterologist examined the patient and
noted tenderness in her lower abdomen and right
upper quadrant area. There was no rebound or
guarding. The physician also noted that he could
feel the caudate lobe of the liver. The physician recommended
an endoscopic retrograde cholangiopancreatography
(ERCP) and explained the risks,
including perforation and pancreatitis. He obtained
informed consent for the procedure.
On 16 May, the gastroenterologist performed the
ERCP with sphincterotomy at a local hospital. At the
conclusion of the procedure note, he stated: “The procedure
was very prolonged due to constant inability to
stop motility, and this was complicated by the fact that
the air/water valve continuously stuck on the scope,
and no matter how we tried to change them out, all of
them seemed defective, a problem that we had in the
past. Nevertheless, the procedure was successful.”
After the operation, the patient complained of
severe bloating and nausea. She was ultimately discharged
from the hospital late on 17 May. Later that
day, the patient called the gastroenterologist and complained
of nausea and vomiting. The gastroenterologist
prescribed Phenergan suppositories and instructed
her to call if the pain became worse.
The next morning, 18 May, the patient called the
gastroenterologist and reported that her symptoms
persisted. The gastroenterologist told the patient to
go to the emergency department (ED) of the same
hospital where the procedure was performed.
Once at the ED, the patient complained of abdominal
pain and nausea. She was admitted to the hospital
with possible post-ERCP pancreatitis. The results
from a CT scan were normal with no evidence of a
hepatic abscess. A follow-up CT scan taken on 20 May
showed multiple low-density lesions in the lower left
lobe of the liver, most likely representing liver
abscesses. Blood culture revealed the patient had
developed Pseudomonas sepsis.
The gastroenterologist felt the patient needed
more specialized care. On 21 May, she was transferred
to another hospital under the care of a liver
specialist. The liver specialist placed the patient on
aggressive IV antibiotic therapy. Eventually her
abdominal tenderness decreased, and she was discharged
on 9 June. Her discharge diagnosis included
hepatic abscess, transient bilary obstruction, and
Pseudomonas sepsis.
The liver specialist saw the patient on a follow-up
visit on 13 August. He noted that the patient was
recovering remarkably well and was back to normal baseline function. A CT scan revealed significant
improvement with only two residual areas of question
in the liver. The specialist noted that she had
some focal tenderness over the left lower lobe of the
liver where the abscess was present.
The liver specialist saw the patient again on 10
September. He was concerned that her white blood
count was slowly going up with a differential shift
to the right. She was afebrile and no longer had a
palpable, tender liver. He indicated that she might
need a follow-up CT to reassess the size and location
of the abscess.
The liver specialist again saw the patient on 30
September as part of an independent medical exam.
He noted the patient was doing well but complained
of mild upper quadrant pain and pain radiating into
the inguinal area. He recommended the following:• follow-up chemistries, including a liver profile;
• helical CT scan of the liver with IV and oral
contrast; and
• a colonoscopy to screen for colorectal cancer and
investigate vague abdominal discomfort.
The CT scan of the liver revealed uniform attenuation
of the liver without abscess seen. The results
from the ultrasound were interpreted as normal.
Allegations
A lawsuit was filed against the gastroenterologist.
The plaintiffs alleged that while the ERCP was
appropriate, there was no indication for a sphincterotomy.
The plaintiff’s main criticism surrounded
the gastroenterologist’s decision to continue the
surgery after the scope’s air water valve malfunctioned.
A lawsuit was also filed against the hospital
where the ERCP took place.
Legal Implications
The plaintiff’s expert, a gastroenterologist, argued
that the sphincterotomy was unnecessary because he
did not believe the common bile duct had a stricture
narrow enough to warrant the sphincterotomy. He
further criticized the defendant for not stopping the
procedure once the air water valves began sticking. He
stated if the procedure had been stopped, significant
pancreatitis would not have occurred. Though he had
never seen it happen, this expert believed the liver
abscess was related to the ERCP complications.
The gastroenterologist reviewing this case for the
defense argued that the ERCP and sphincterotomy
were both indicated. Regarding the equipment malfunction,
this expert believed the defendant was obligated
to continue the procedure and identify the
problem. When the patient returned to the hospital
on 18 May, he believed she had pancreatitis caused by
a “relative” obstruction of the bile duct. The combination
of the pancreatitis and obstructed bile duct
caused her liver infection and sepsis.
The liver specialist who treated the patient was
supportive of the defendant. He testified that he
had encountered similar scope-related problems
during an ERCP and that standard procedure
requires attempting to fix the problem so the procedure
can be completed.
He would only terminate a procedure if he could
not fix the equipment. The liver specialist also stated
the defendant would have been in the best position
to determine if the sphincterotomy was needed.
Regarding the pancreatitis, he believed the patient
may have had some infectious process prior to the
ERCP that was somewhat exacerbated by the ERCP.
The liver specialist has not seen this type of liver
abscess occur following an ERCP.
Disposition
This case was taken to trial and the jury reached a
verdict in favor of the plaintiffs.
After the verdict, this case was mediated and settled
on behalf of the gastroentrologist.
The hospital settled the case before trial.
Risk management considerations
Thorough, accurate documentation benefits the physician in
the event of litigation. Describing the stricture and the rationale
for subsequently performing the sphincterotomy may have assisted
in the defense of this physician. Comprehensive documentation
may provide an opportunity to close a claim without an
indemnity payment and may avoid a trial such as this, where the
jury ruled in favor of the plaintiffs.
Obtaining informed consent is a non-delegable duty of the
physician. This is the process whereby the physician educates
the patient regarding the risks, benefits, and any alternative
forms of treatment. This discussion should be documented in
the medical record.
The following is a sample of such documentation:“Advised patient of the need for _____________
related to ____________. Risks, benefits, and alternatives
were discussed. Patient reviewed educational
materials/instructions and states that he/she understands
and agrees to proceed. In my judgment, the
patient does understand the treatment plan.”
The information and opinions in this article should not
be used or referred to as primary legal sources nor construed
as establishing medical standards of care for the
purposes of litigation, including expert testimony. The
standard of care is dependent upon the particular facts
and circumstances of each individual case and no generalization
can be made that would apply to all cases.
The information presented should be used as a resource,
selected and adapted with the advice of your attorney. It
is distributed with the understanding that neither Texas
Medical Liability Trust nor Texas Medical Insurance
Company is engaged in rendering legal services.
