A 67-year-old man was referred by his primary care physician to a gastroenterologist for a routine screening colonoscopy. The patient’s medical history included high cholesterol, hypertension, prostate cancer, hypothyroidism, coronary artery disease and myocardial infarction, anxiety, and depression. His surgical history included cervical spine fusion and lumbar spine fusion.
In addition, the patient underwent a coronary angiogram with percutaneous transluminal coronary angioplasty and placement of six coronary artery stents almost a year before seeing the gastroenterologist. The patient’s medications included one 81-mg chewable aspirin daily and clopidogrel bisulfate, 75-mg tablet one PO daily.
One day before the colonoscopy, the patient called the gastroenterologist's office to tell them he was scheduled to undergo a screening colonoscopy, but could not stop taking the clopidogrel. The nurse who returned the patient’s call documented that the patient had several cardiac stents and was afraid to stop his warfarin (an erroneous reference to the patient’s antiplatelet medication). The nurse documented that she “explained to pt danger of taking large polyps out” while taking warfarin sodium. She explained that “small ones would be OK” and documented that the patient understood. There was no documentation that the patient’s aspirin use was discussed.
The gastroenterologist performed the colonoscopy the next day without complications. He removed and biopsied seven polyps, five of which were small and two of which were 8 mm and 1.2 cm, respectively. The gastroenterologist removed the first three polyps with biopsy forceps, and performed “hot snare” polypectomy for the last four. Pathology showed the polyps to be adenomatous or pre-cancerous.
Signed consent forms for the procedure had been obtained, and the procedure report noted that the physician discussed the risk of post-polypectomy bleeding with the patient. The physician also noted that the patient was on clopidogrel until just 48 hours prior to the procedure, and that he asked the patient to hold off on taking it for an additional 72 hours post-procedure.
Three days after the colonoscopy, the patient experienced bloody bowel movements and was admitted to the hospital by another physician in the gastroenterology group. The patient’s vital signs, hemoglobin, and hematocrit values were normal. The history and physical dictated by the admitting physician stated that the patient had been taking clopidogrel until the day of the colonoscopy (not, as the procedure report stated, two days before).
The patient was admitted with orders for an EKG, IV fluids, and a colonoscopy the next day. While undergoing bowel prep, the patient was found on the bathroom floor in a puddle of blood. The patient was assisted to the toilet, where he suffered a cardiac arrest. He had no pulse or respirations, and a code was called.
The code team was able to resuscitate the patient within five minutes. An EKG showed a normal sinus rhythm with ischemic changes. He was transfused with four units of PRBCs. A colonoscopy to search for the source of the bleeding found no evidence of ongoing hemorrhage. The patient’s clopidogrel was withheld for the remainder of his hospital stay. The patient’s hematocrit and hemoglobin levels stabilized and the bleeding stopped. He was discharged three days after admission. The patient alleged that the anoxic event resulted in permanent cognitive deficits.
Lawsuits were filed against the gastroenterologist and his group. Allegations against the gastroenterologist included:
- failure to assess the patient before the colonoscopy;
- failure to obtain cardiac clearance before the colonoscopy;
- performing polypectomy which plaintiffs alleged was contraindicated since the patient had not discontinued clopidogrel for at least 5 days; and
- failure to disclose the risks of the procedure and obtain informed consent from the patient.
The patient also alleged that office staff never told him to discontinue aspirin before the procedure.
Consultants who reviewed this case felt that the gastroenterologist’s decision to perform the colonoscopy and polypectomy was reasonable. While the rate of bleeding after a polypectomy is significantly increased in patients taking clopidogrel and aspirin, medical literature supports the continuation of clopidogrel therapy during an elective colonoscopy and polypectomy of small polyps.
However, removal of polyps greater than 1 cm in size, and use of “hot snare” polypectomy are associated with a higher risk of bleeding. The patient’s pathology report revealed that the polyps were pre-cancerous, which offered some validation regarding the gastroenterologist’s decision to proceed with colonoscopy and polypectomy.
The gastroenterologist’s procedure note included documentation of a discussion with the patient about the risk of post-procedure bleeding, which was helpful. However, the patient and spouse claimed that the patient was already partially sedated when he signed the surgical consent form. If true, this could potentially invalidate the “informed consent” discussion.
The case was settled on behalf of the gastroenterology group. The gastroenterologist was dismissed from the suit.
Risk management considerations
Documentation of informed consent is essential in defense of a claim of malpractice stemming from a screening or surgical procedure. Whenever possible, discussion of the risks of a procedure and documentation of this discussion before the actual date of the procedure is recommended. If this isn’t possible, a thorough discussion of risks before sedation is critical.
In this case, the physician’s good documentation of the discussion of risks of post-procedure bleeding was helpful to the defense. The patient, however, claimed that sedatives had already been given at the time the consent form was signed. Physicians are encouraged to take precautions to ensure both thorough documentation of the informed consent discussion and appropriate timing of the patient’s signature on consent forms.
The documentation of the patient’s phone call to staff the day before the procedure was a complicating factor in the defense of the claim against the group. The notes written by the nurse and staff never mentioned anything about withholding aspirin before the procedure. This, combined with the fact that the nurse misnamed the patient’s medication in the phone call documentation, presented a challenge to the defense. Careful documentation of all details of a phone call and checking for accuracy when medications are discussed is good risk management.