Delayed thermal perforation or intraoperative mishap?

Facts   
The patient presented to the defendant hospital gyn clinic on May 6, 2015. She reported continuous bilateral pelvic pain in the right and left quadrants somewhat relieved by oral contraceptives, but said she was taking ibuprofen “around the clock.”  She was examined by Dr. A, counseled regarding treatment options, given a referral for magnetic resonance imaging (MRI) and told to follow up in 3 weeks to

discuss whether surgery was indicated. In a Progress Note, Dr. A indicated that she discussed the causes of pelvic pain with the patient, advising her she likely had endometriosis for which an MRI could determine the extent of the disease and surgical planning.  

An MRI done on May 21, 2015 revealed bilateral endometriomas. A left hematosalpinx/hemosalpinx or pelvic endometrial implant also was noted posterior to the uterus.

The patient was seen by Dr. A to discuss the results of her MRI. She reported she was still taking ibuprofen “around the clock,” and was requesting surgery as both she and her family felt the pain was directly affecting the quality of her life. Dr. A documented that she discussed the surgical approach, risks, benefits and alternatives with the patient and her family. 

The patient presented for surgery on June 16, 2015. Dr. A’s Preoperative Note listed the indications for surgery as a history of dysmenorrhea, pelvic pain, bilateral cysts, and suspected endometriosis. The patient and Dr. A executed a Surgical Consent authorizing the performance of a hysteroscopy, dilation and curettage, laparoscopic bilateral ovarian cystectomy, possible salpingectomy, treatment of endometriosis, and possible cystoscopy. Hysteroscopy revealed a normal uterine cavity with some discoloration in the endometrium and possibly adenomyosis. Both ovaries were adherent to pelvic sidewall and the posterior cul de sac, peritoneum, and on the uterus. A 3-cm uterine mass was noted on the posterior superficial myometrium of the uterus, and the rectum was pulled to the mass. Endometrial curettings were obtained from the posterior uterine wall and sent to pathology.

The laparoscopic portion of the procedure was performed via umbilical incision. Two right ovarian cysts were incised, enucleated, and removed. Hemostasis was secured. The left ovary was mobilized from the pelvic side wall with hydrodissection; a left ovarian chocolate cyst was incised, enucleated, and removed. Hemostasis was secure. Adhesions from the posterior uterus to the rectosigmoid colon were taken down with hydro dissection and blunt dissection. The posterior uterine mass, which was about 3 cm, was grasped using the laparoscopic shears; the serosa was electro-dissected and the mass removed using a specimen bag. Peritoneal lesions were excised from the right uterosacral ligaments and posterior cul-de-sac using traction and hydrodissection. Chromotubation with methylene blue was performed and spillage noted from the left fallopian tube. No spillage was noted on the right side.

At the conclusion of the procedure, Dr. A. noted: “...air was pushed into the rectum with a syringe. The pelvis was then filled with irrigation fluid and no air leak was identified upon filling the colon with air. Evicel was placed over the operative sites and peritoneal dissection sites with excellent hemostasis noted. Ancillary ports were removed with decreased pneumoperitoneum and there was no bleeding.” 

On admission to the Postoperative Acute Care Unit (PACU) at 4:20 PM the patient’s vital signs were stable. Surgical incision was well-approximated with scant serosanguinous drainage.

At 5:00 PM, an RN noted the patient’s complaints of abdominal pain/discomfort at 6/10 intensity. Fentanyl 25 mcg intravenous (IV) push was given. By 5:15 PM the patient reported only partial relief from fentanyl and complained of 6/10 abdominal pain. At 5:30 PM her vital signs were blood pressure (BP) 119/77, pulse 105, and an additional dose of fentanyl (25 mcg IV push) was given. By 5:45 PM relief was obtained, with the patient’s pain at 2/10.  At 6:00 PM the patient complained of continuous nausea. Palpation of her abdomen revealed all quadrants as soft and non-tender. No drainage from the incision was noted. Promethazine 6.25 mg IV was administered. By 6:30 PM the patient reported relief of symptoms. 

At 7:00 PM the patient denied any pain or discomfort; her abdomen was soft and non-tender and there was no drainage from the incision. At 7:30 PM she was out of bed to the bathroom. At 8:00 PM the patient again complained of abdominal pain at 6/10 intensity. Her vital signs were 121/62, pulse 74, temperature 97.7°F. She was medicated with fentanyl 25 mcg and oxycodone 5 mg orally. By 8:15 PM the patient reported partial relief, and by 8:45 PM, confirmed relief of pain (with a rating of 2/10 at rest and activity) at which time she voided 400 mL. At that time, her vital signs were 110/65, pulse 88. At discharge, she was instructed to notify her physician about persistent vaginal bleeding, nausea or vomiting; inability to urinate or a fever greater than 100.4°F; and to follow up in the clinic on July 8. The patient left the hospital at approximately 9:00 PM accompanied by family.

Facts (continued)
A few hours after being discharged from the PACU, the patient presented to the ED complaining of severe lower abdominal pain with radiation to her shoulder, unrelieved by pain medications, as well as a fever of 101˚F recorded at home. Her admitting lab work was notable for an elevated white blood count (WBC) of 11.0 which later rose to 15.2. At 10:00 PM a computed tomography (CT) scan of the abdomen/pelvis with contrast was performed and revealed, “post-surgical changes in the abdomen including free intraperitoneal air; a moderate amount of complex free pelvic fluid; and no abscess.” The report noted subcutaneous gas in the right abdominal wall extending towards the pelvis and around the umbilicus which was felt to be consistent with laparoscopy port sites. These findings were not deemed suspicious by the radiologist and no further imaging or workup was suggested.  

The patient was ultimately admitted to the gynecology service and seen by residents during the night who were in contact with Dr. A.  She was medicated for pain but continued to complain of throbbing, constant abdominal pain. At 4:28 AM her vital signs were 120/40, pulse 116; temperature 97.9°F. At 4:45 AM the patient reported no improvement from the last dose of ketorolac  although she acknowledged that her pain was currently less intense in her shoulder. On exam the patient appeared uncomfortable although she was sitting up and  walking around. The resident noted that an abdominal ultrasound revealed a small amount of fluid around Monson’s pouch, though she was “unable to determine if it was new or post-operative as seen on CT.”  On exam, the woman’s abdomen was described as “soft” and appropriately tender; her incisions were clean dry and intact. The resident ordered additional lab work and indicated that she discussed her plan of continued analgesia and monitoring of vital signs with Dr. A.

A 7:00 AM the RN noted the patient “reported high level of pain partially relieved by morphine. Guarding, grimacing and moaning.” At 8:21 AM the patient was examined by a PGY-4, who noted that the patient was still complaining of abdominal pain at 5/10.
Her physical exam was notable for “voluntary guarding,” no rebound, and mid-abdominal bruising at the site of greatest pain. The resident felt the pain was likely secondary to “insufflated air and small hematoma at port site.” She ordered acetaminophen plus oxycodone and ketorolac on a prn basis and encouraged ambulation with possible discharge if the woman’s pain improved.

At 10:15 AM the patient was evaluated by Dr. A who agreed with the resident’s assessment and treatment plan. Dr. A described the woman’s pain as improved; she had passed flatus. On exam the woman’s abdomen was soft, appropriately tender, non-distended with no rebound or guarding; an area of ecchymosis was noted.  Dr. A advised initiation of oral pain medications, ambulation, and discharge planning. There were no further Progress Notes by a physician in the record.  

At 10:19 AM the patient was medicated with ibuprofen 600 mg.  At 12:20 PM she received ibuprofen 2 tabs. At 4:30 PM she received ibuprofen 2 tabs and ondansetron 4 mg po. In her final entry at 4:37 PM the RN documented, “Explained to patient that pain is normal post-op, encouraged to take pain meds OTC, eat small frequent meals with pain meds, drink plenty of water and increase ambulation when at home.” At 5:22 PM the patient was discharged.

Facts (continued)
On June 25, 2015 at 11:16 AM the patient presented to the ED complaining that since her surgery, she had been experiencing radiating abdominal pain, primarily lower; back pain; nausea and vomiting; and shortness of breath when the pain became severe. Two days prior to admission, she started to notice bright red blood with each bowel movement, but denied black tarry stools. She also had fever and chills with a highest temperature of 101.9°F, but denied chest pain, dizziness or urinary symptoms. 

On exam, she was alert and oriented and noted to be in “severe” distress. Her abdomen was soft, with minimal diffuse tenderness to palpation, but no rebound or guarding. A pelvic exam revealed a non-tender bladder; no adnexal tenderness bilaterally; a normal uterus; no rectal tenderness or hemorrhoids but blood in the vault; and abdominal scars from the laparoscopy which were clean, dry, and intact. 

A CT scan with contrast (compared with a the post-op study of June 20) revealed: “a large volume pneumoperitoneum, out of proportion to expected post-surgical findings and consistent with perforated viscus; ascites, some complex, with peritoneal enhancement present consistent with peritonitis; a large multi-loculated collection of fluid and  gas (abscess) is noted in the cul-de-sac, with an adjacent small collection along the pelvic sidewall; gas containing debris within the first (collection), of uncertain etiology; infection or fistula is not excluded.”  The woman was admitted to the ob/gyn service to “rule out anemia and post-op complications.” 

In her 5:00 PM Progress Note, Dr. A noted she had examined the patient and discussed the CT scan finding of a  “large free air pelvic collection” with her and her family. Dr. A noted the patient’s complaints of increased pain and rectal bleeding since June 23, 2015, which she felt was “likely a delayed thermal injury to the descending colon and rectal area.” Dr. A noted that the colorectal surgeon would be evaluating the patient for surgery and she discussed with the patient and family the need for possible laparoscopy/laparotomy and repair of primary bowel/bowel resection or diverting colostomy, noting that all questions and concerns were addressed. Dr. A also indicated she would be present during surgery. 

On June 25 the colorectal surgeon performed an emergency exploratory laparotomy for ruptured viscus and a worsening clinical picture. According to the Operative Report, the findings included a 5-cm longitudinal tear in the anterior rectal wall with purulent material and a small amount of stool in the pelvis with a small abscess. An anterior bowel resection with end-to-end anastomosis and diverting ileostomy was performed. The patient was transferred to the PACU in critical but stable condition. Culture and gram stain of the pelvic fluid and wound revealed many (4+) Gram-positive rods and WBCs.  

Postoperatively the patient remained in the surgical intensive care unit, with a nasogastric tube (NGT) in place, a Foley catheter, IV fluids, IV patient-controlled analgesia (PCA), and antibiotics. On postoperative day #4, she was transferred to the floor and PCA was restarted for pain control. She was also started on leuprolide for endometriosis following a discussion with the patient and her family about the risks/benefits of same. On July 2, a CT scan with contrast (compared with study of June 25) revealed an irregular pelvic abscess. On July 5, the NG tube was removed and the patient was started on a clear diet. On July 8, a repeat CT scan with contrast ordered for persistent elevated WBC count and “known pelvic abscesses” (compared with the study of July 2) revealed a “partial proximal small bowel obstruction with transition in the left abdomen; significant interval decrease in fluid collection in the pelvis; a decrease in the tiny collection previously identified  in the right lower abdomen; a resolution of the small fluid collection in the left hemi-abdomen; interval removal of the left surgical drain; and slight increase in bilateral pleural effusions, right greater than left.” 

A later CT scan with contrast (compared with the study of July 8) demonstrated that the patient was “s/p low anterior resection with expected post-surgical findings; no intra-abdominal fluid collection or free intraperitoneal air; and a mildly increased right effusion.” Repeat blood and urine cultures from July 13 proved negative. On July 24, she underwent thoracentesis with chest tube placement under IV sedation. On July 26, the chest tube was removed. On July 28, the patient was discharged home to continue on a 2-week course of amoxicillin plus clavulanic acid. At discharge she was ambulating with assistance, tolerating a low-residue diet, voiding adequately, and her ileostomy was functioning well. 

The patient returned on September 8 for closure and reversal of her ileostomy and was discharged home on September 16, 2015.  

The patient  returned a day later complaining of abdominal pain, nausea and vomiting. Physical exam was notable for severe abdominal tenderness on palpation with rebound and guarding. Admitting lab work abnormalities included a WBC of 11.0. A CT scan of the abdomen suggested a small obstruction over the ileus. The colorectal surgeon performed an exploratory laparotomy with lysis of
adhesions and diverting loop ileostomy. Operative findings included a distal small bowel obstruction secondary to adhesions; a stool-filled colon without evidence of obstruction; and a patent colorectal anastomosis. The patient’s postoperative course was uneventful. On July 23, at the request of the patient and her family, she was transferred to another hospital. 

On December 3, 2015, the patient underwent an ileostomy takedown, appendectomy, resection of prior ileal anastomosis and creation of a new hand-sewn ileo-ileostomy. Her weight was 90 lb, 2.7 oz, and her appetite was “great.”  

ALLEGATIONS
The patient alleged that the defendants failed to protect her intraabdominal organs during the June 19 surgery, resulting in a 5-cm bowel/ rectal perforation, which was not detected intraoperatively because of a purported failure to properly inspect prior to closing. She also claimed a failure to timely diagnose and treat the perforation postoperatively resulting in prolonged exposure to fecal material in the pelvis, causing infection, abscesses and adhesions and requiring four surgeries to correct. A lack of informed consent was also alleged as was bilateral fallopian tube blockage and impaired ability to conceive; post-traumatic stress response; anxiety; depression; and loss of enjoyment of life. The patient claimed to be in constant pain for which she ingested medical marijuana twice a day, impacting her cognition and her ability to work. 

DISCOVERY
The plaintiff’s ob/gyn expert reported that the patient described being in constant pain for which she used medical marijuana daily. She reported not getting her period at this time. She had experienced significant weight loss, weighing 84 lbs at the time of the exam, which she attributed to chronic difficulty with bowel movements that made it uncomfortable and difficult for her to eat. Her normal weight before her surgery was 120 lbs. Recent studies indicated that both fallopian tubes were now blocked. The expert believed that the main contributing factor to the woman’s fallopian tube disease/bilateral blockage was the rectal perforation and subsequent fecal peritonitis, and although the endometriosis was felt to be a contributing factor, he believed that complications of the June 19, 2015 surgery caused the worsening. He also believed that the tubal disease was a permanent condition which could not be fixed and that surgical removal of the dilated tube would be necessary to increase the likelihood of success with in vitro fertilization. In addition, he believed that the small bowel obstruction requiring emergency surgery with diversion ileostomy was secondary to abdominal adhesions caused by the undiagnosed and untreated fecal peritonitis. He also believed that the woman remained at risk for recurrent small bowel obstructions. 

The defendant ob/gyn expert  believed that this case involved a “classic” delayed thermal injury which occurred during the June 19 surgery, during removal of the endometrial masses. He described it as a rare, yet known risk which happens in the best of hands and is not an indication of medical malpractice. He noted that the patient was a candidate for the surgery because she had chronic symptomatic painful endometriosis that had not responded to conservative management. 

The ob/gyn expert also believed the patient was appropriately discharged the evening of June 19, 2015. She reported pain relief, she had voided and her vital signs were stable. When she returned to the ED the next day, a CT scan was performed which revealed normal non-concerning postsurgical changes in the abdomen. The expert reported that if Dr. A had created a longitudinal tear in the anterior rectal wall during the June 19 surgery it would have been apparent on the CT scan on June 20 and there would have been “tons of air” and purulent material in the pelvis. Moreover, if a frank perforation had occurred during the surgery, stool would have been seen immediately, the air/leak test performed prior to closure would have shown it, and the patient would have developed peritonitis within a few hours of closure.  

The defendant colorectal surgery expert doubted that the patient had an immediate perforation because she passed the “leak test” that Dr. A performed prior to closure. The woman’s admitting lab work was notable for an elevated WBC of 11.0 but at discharge it was 9.6. He opined that the WBCs did not support a finding of a perforation, especially since the woman was not on antibiotics. He also believed that if she had been taken to the OR on June 21, she would have had the same surgery that was performed on June 25. 

The defendant radiology expert conducted a blind review of the pertinent films. Overall, she did not see a bowel perforation on the June 20 CT scan but she felt that the one performed on June 25 strongly suggested one. 

The patient had some potential culpable conduct in delaying surgery (she was first advised to undergo surgery in October 2014). This allowed her ovarian cysts to enlarge thus complicating the surgery. The woman testified that she may have been taking excessive quantities of ibuprofen, which may have contributed to the surgical complications and alleged injuries. With respect to informed consent, the patient provided helpful testimony in that, due to endometriosis, her periods were so painful that it caused her to get fired from her job and it adversely impacted her activity level, making it unreasonable to presume she would have refused surgery irrespective of the potential risks. With respect to damages, the patient provided helpful testimony in that she got married in July 2016; traveled to Atlantic City for her bachelorette party and, thereafter, travelled on a cruise and to Miami in 2017.  The patient admitted that her wedding videos and photos showed her dancing. Thus, her claims that she had restricted motion due to the alleged malpractice were undermined. The woman’s claims of diminished fertility were mitigated by her long history of endometriosis, which is known to adversely impact fertility. 

TRIAL
Prior to the start of the trial, the  patient’s attorney initially demanded $12 million to settle and then came down to a “firm” $1.5 million demand. The trial commenced with testimony of Dr. A who performed as well as could be expected under aggressive examination. The patient’s radiology expert then testified and was subjected to blistering cross-examination during which he became extremely combative and made references to multiple theories under duress in order to support his opinions, which were not supported by the record. Thereafter, opposing counsel voiced a desire to attempt to settle within reason and the case eventually settled for $885,000.