Did surgeon inexperience result in iatrogenic injury?

Andrew I. Kaplan, Esq, is a partner at Aaronson, Rappaport, Feinstein & Deutsch, LLP in New York City, specializing in medical malpractice defense and healthcare litigation. He welcomes feedback on this column via email to aikaplan@arfdlaw.com.

 

Facts

On July 29, 2010, a 46-year-old obese primarily Spanish-speaking patient was admitted to a hospital by her private ob/gyn Dr. A for a total laparoscopic hysterectomy (TLH) and/or laparoscopically assisted vaginal hysterectomy (LAVH) that day. Dr. A was new to the facility, not yet board-eligible, and had never performed the procedure as primary surgeon.

The patient and Dr. A. signed a consent (in English) for the TLH and/or LAVH with removal of tubes and ovaries bilaterally, possible vaginal assistance, possible laparotomy and all related procedures. According to the pre-procedure history and physical examination authored by Dr. A, the patient was seeking surgical management of her fibroid uterus and menometrorrhagia after failed medical treatment with birth control pills. The risks, benefits, and alternatives of LAVH, TAH, and total vaginal hysterectomy (TVH) were discussed with the patient.

Dr. A believed that a laparoscopic approach was the best option because of the patient’s obesity, but she documented the possibility that the procedure might not be totally accomplished laparoscopically, and a vaginal approach or conversion to an open abdominal procedure was also possible.

The patient’s surgery was originally scheduled for 1:45 pm but did not start until 6:42 pm because of operating room (OR) back-ups; it ended at 3 am.

Dr. B, a fellow attending, observed the procedure at Dr. A’s request but did not scrub in. Dr. A and the chief resident were operating the equipment and Dr. B was watching on the screen. Dr. A had difficulty visualizing the right uterine artery because of the patient’s body habitus, which required them to tilt the patient back further in Trendelenburg to lift her bowels and omentum out of the area. When they did so, however, the anesthesiologist had difficulty adequately ventilating her in that position; therefore, the decision was made to attempt a vaginal approach.

Because multiple hands would be needed, Dr. B scrubbed in and held the retractor to improve visualization of the anatomy. While Dr. B was doing so, Dr. A clamped one pedicle of the uterus and “with the first bite” of her Mayo scissors inadvertently entered the bladder. The injury was immediately apparent (there was a burst of urine and Dr. A said she could feel the tubing of the Foley catheter within the bladder). Urology was called for a consult; the chief resident responded and, after consulting with his attending, decided that an abdominal incision was needed to fully evaluate the injury. Accordingly, the hysterectomy and BSO were completed by Dr. A via the abdomen, which she accomplished with the ob/gyn residents without further incident.

Dr. B did not participate in the open procedure; she later stated she believed she left the OR when the urology team arrived for their portion of the surgery.

According to the anesthesia record, the bladder injury occurred at 8:26 and the conversion to an exploratory laparotomy/abdominal hysterectomy commenced at 8:51. The anesthesia record indicates that the urology team began repairing the bladder at 9:32.

There is a brief, incomplete but electronically signed ob/gyn operative report that indicates that the LAVH was converted to an exploratory laparotomy, abdominal hysterectomy, bilateral salpingo-oophorectomy (BSO) with left ureteral reimplantation, and cystotomy repair. According to this incomplete operative report, the attending surgeons were Drs. A and B, assisted by ob/gyn residents Drs. C and D.

According to the urology operative report, the primary gyn surgical team noted that a cystotomy occurred during the anterior vaginal wall dissection. The gyn doctors immediately contacted the urologist on call and asked for an “intraoperative consultation.” By the time they scrubbed in, conversion to an exploratory laparotomy and dissection to the level of the uterus and posterior bladder had already been accomplished. After the gyn team completed the BSO and hysterectomy, the vaginal cuff was closed. At that point, the urology team took over and evaluation revealed a defect in the posterior wall of the bladder. The ureters were dissected and identified. The dome of the bladder was tented and opened.

The injury to the trigone of the bladder was apparent and an additional vaginal defect-described as very large with some ragged edges-could be palpated through the opening. The urology report noted that the gyn service used both electrocautery (endoshears) and sharp dissection in the area and that the defect was “quite substantial.”

The urology operative report goes on to state that the gyn surgeons repaired the anterior vaginal defect and completed the closure of the vaginal cuff. The urology team then began repair of the left ureter “as it was never identified originally.” The left ureteral orifice was likely involved in the defect, and it was never identified in the surgery. Therefore, a ureteral reimplant was necessary and accomplished.”

According to the 3:10 am brief ob/gyn operative note written by ob/gyn resident Dr. C, Drs. A and B were assisted by Drs. D and C. The estimated blood loss was 800 cc and the patient received 4800 cc of Lactated Ringer’s solution. The findings included a 12-week size fibroid uterus, a right ovarian cyst, and a normal left ovary. The patient was sent to the recovery room in stable condition and the operative report was to be “dictated by Dr. A.”

The pathology report indicates the uterus was noted to be 10 x 8 x 7 cm (440 g) and was deformed by “multiple nodules measuring from 1 cm to 3 cm in diameter.” The cervix had mild parakeratosis; there was proliferated endometrium, leiomyomata, and cystic ovaries noted.

The discharge summary written by chief ob/gyn resident Dr. D describes a 19- to 20-week sized uterus. On August 3, the patient was discharged with a Foley catheter in place and instructions to follow up with urology and gynecology.

On August 18, the patient was admitted to the hospital for a cystogram. According to the operative/cystoscopy report, the patient was aware that because of the anatomic location of her injury, vascular blood supply to the area might be compromised and the risk of vesicovaginal fistula was significant. Examination revealed a significant defect consistent with a vesicovaginal fistula.

The urologist documented an extended conversation with the patient, her husband, and daughter over the etiology and prognosis that further operative repair would be required. In addition, the ureteral stent would need to be removed approximately 3 weeks later. The plan was for the patient to follow up in the urology clinic.

On September 14, the patient was again admitted to the hospital for removal of the ureteral stent. During the procedure, a left retrograde pyelogram revealed good drainage into the bladder. The vesicovaginal fistula was not visualized; however, repeat cystogram dye test demonstrated leakage into the vagina.

On October 18, the patient was admitted to the hospital for vaginal repair of the vesicovaginal fistula. According to the operative report, the patient was told she would need at least 3 weeks of postoperative suprapubic tube drainage as well as a Foley catheter.

The next day the patient was discharged with the suprapubic tube in place and instructions to follow up with urology. On November 3 the patient was seen by urology. She reported pain at the suprapubic tube site and mild leakage through the urethra was reported with bowel movements. On pelvic exam, the fistula site was visualized without evidence of leakage. The patient was instructed in how to clamp the suprapubic tube. If no leakage was apparent, the suprapubic tube would be removed the following week.

On November 10 the patient was seen in the urology clinic. She reported being unable to tolerate suprapubic tube clamping due to bladder spasms, so the tube was not removed as planned. The fistula site revealed no evidence of leakage. Medications were ordered for a superficial wound infection and the reported bladder spasms. The patient was told to try to clamp the tube 48 hours before the next urology visit.

On January 5, 2011, the patient underwent cystoscopy with video dynamics. She reported that following the fistula repair, she remained dry after the suprapubic tube was clamped, but that she later developed urinary incontinence/stress incontinence. She reported that she had to wear diapers, but her symptoms could not be reproduced on exam in the office. Cystoscopy was done and the vaginal fistula was noted through the old suture line. The plan was to attempt to manage the condition conservatively with diversion of urine via indwelling Foley for 2 more weeks.

On January 21 the patient returned to the hospital for another cystoscopy, examination under anesthesia, and possible fistulogram. Per the history, she had sustained a complicated bladder and ureteral injury during hysterectomy and underwent primary repair at time of injury, but then developed a urethrovaginal fistula. Urethrovaginal repair was initially successful, but she began leaking from her vagina. Pelvic exam suggested recurrence of fistula without leakage per urethral meatus. Surgery was suggested to repair it.

On February 11 the patient was admitted to the defendant hospital and underwent a repeat fistula repair. She was discharged on February 15 to follow up at an incontinence clinic. On April 22 another cystoscopy was performed and stress incontinence was confirmed.

On June 13 the patient was admitted to the hospital to undergo a mid-urethral sling procedure to treat her for incontinence. On July 11, she had a follow-up cystoscopy for complaints of incontinence and urinary frequency. On cystoscopy, however, there was no evidence of mesh erosion, leak, or fistula.

In 2011 the patient was diagnosed with post-traumatic stress disorder and adjustment disorder; she reported being nervous and anxious about her surgical course and incontinence.

Allegations

The plaintiff alleged that through Dr. A’s inexperience and surgical negligence, she was caused to suffer bladder laceration; trigonal injury and left ureteral injury requiring emergent surgical repair and left ureteral reimplantation; ureteral stenting; vaginal wall tears; urethrovaginal and vesicovaginal fistula requiring repeated surgical repair; urinary incontinence; bladder overactivity; recurrent vesicovaginal/urethrovaginal fistula; pain and suffering; post-traumatic stress/adjustment disorder for which she takes antianxiety medications; prolonged disability; scarring hip to hip; and inability to engage in social, sexual, and work activities.

The plaintiff also alleged that Dr. A failed to write a complete operative report or brief op note and that the urologists involved botched the primary repair and the subsequent fistula repairs.

Discovery

The plaintiff testified that despite the fact that the conversations were all conducted in English, she understood what Dr. A was explaining to her, and had the opportunity to ask questions. In addition, she and Dr. A discussed the option of removing only her uterus and not her ovaries, but she was aware that the ovarian cysts could return and she opted to have both the ovaries and the uterus removed during the same procedure.

The plaintiff described her urinary complaints as causing lower abdominal pain, urinary urgency when sitting, poor bladder control when standing, and the need to use the bathroom 3 to 4 times per hour. She used incontinence pads and needed to change them frequently. She was unable to sleep, and needed to get up to urinate 6 or 7 times during the night. She conceded incontinence prior to her procedure but described it as urinary leakage while coughing, laughing, or sneezing, but not more than twice an hour.

Dr. A had testified she had included the risk of bladder injury in her discussion with the patient. She recommended a laparoscopic approach because of the patient’s obesity; there was a concern about wound separation. Additionally, time was a consideration and the patient wanted a shorter recovery period. She also wanted the surgery sooner rather than later, despite Dr. A’s advice that there was no urgency.

Going into the surgery, the intent was to use a laparoscopic approach, converting to a vaginal approach if necessary. Dr. A had difficulty visualizing the uterine artery and asked for the patient to be put in steeper Trendelenburg. However, Trendelenburg could not be maintained secondary to the patient’s respiratory status. The surgical team tried this a few times but each time the respiratory status deteriorated when the patient was placed in Trendelenburg and improved when she was brought down.

When the patient was lying flat, Dr. A could not visualize the uterine artery secondary to the bowel and omentum. The new plan was then to enter the peritoneal cavity through the vagina. Suddenly Dr. A felt the bulb in the bladder with her finger. There had been an inadvertent entry into the bladder with the Mayo scissors. Dr. A immediately removed the instrumentation and called urology.

Dr. A testified that she was a new attending and requested the assistance of Dr. B, who was a more senior surgeon, familiar with customary surgical practice at the hospital, and who had performed many laparoscopic and vaginal hysterectomies.

Our expert ob/gyn felt this surgery was too complicated for Dr. A’s level of expertise and she should have requested that a more seasoned senior attending surgeon review the case well in advance, evaluate the patient and the sonograms, and be present at the surgery for advice and assistance. He believed that a more experienced surgeon should have evaluated the patient’s ultrasounds and determined the actual size of the fibroid uterus before deciding if a LAVH was an option.

A 12-week fibroid uterus can be removed laparoscopically without problem but morcellating and removing a 19– to 20-week fibroid uterus laparoscopically is difficult, even in the most skilled hands. In addition, the expert ob/gyn witness believed that the patient’s complaints of stress incontinence needed to be worked up by a urologist before the hysterectomy, so that if warranted, a sling procedure could have been performed simultaneous with the hysterectomy.

In this case, he believed that the extent of this bladder, trigone, ureter, and vaginal wall injury spoke to Dr. A’s inexperience and that the extent and location of the injuries made blood supply and healing an issue, prolonged the time needed for Foley catheterization and ureteral stenting, and made fistula formation far more likely.

Verdict

The case settled on the eve of trial as to Dr. A.

Analysis

This was a case that ultimately had to settle not only because of the documented persistent injuries suffered by the patient, but also because of the many pitfalls of attempting trial by jury, including but not limited to the surgeon’s inexperience, the partially dictated operative report signed 2 months after the surgery, and the urologist’s hypercritical note regarding the defects initially encountered intraoperatively and the cause thereof.

Although the patient had recently undergone additional surgery to address her urinary incontinence and recurring vesicovaginal fistula, her problems continued, and according to her surgeon, further surgery will need to be considered.

At the time of the settlement, the patient still required a diaper when she went out and still had incontinence when she engaged in any physical activity. She and her husband had not had sexual intercourse since the hysterectomy.